Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions

Resource Profile: DrugSubstanceNomenclatureStructure - Detailed Descriptions

Active as of 2024-04-08

Definitions for the pqcmc-drug-substance-nomenclature-structure resource profile.

Guidance on how to interpret the contents of this table can be found here

0. SubstanceDefinition
Invariantscmc-when-unii-required: A UNII is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer','Protein'. (classification.coding.where(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code in ('C48807' | 'C45305' | 'C706' | 'C48803' |'C17021') ).exists() implies code.code.text.exists())
cmc-name-isbt: Name.type ISBT 128 required for blood products. (classification.where(coding.where(code = '8' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy').exists()).exists() implies name.type.coding.exists(code = '226' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy'))
cmc-structure-required: A structure is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer','Protein'. (classification.coding.where(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code in ('C48807' | 'C45305' | 'C706' | 'C48803' |'C17021') ).exists() implies structure.exists())
cmc-substance-structure-graphic-required: A Substance Structure Graphic is required Required for Small Molecules. Equivalent to classification code equals 'Chemical'. ((classification.where(coding.where(code = '1' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy').exists()).exists()) implies structure.representation.exists())
2. SubstanceDefinition.meta
4. SubstanceDefinition.meta.profile
Control1..1
Must Supporttrue
6. SubstanceDefinition.identifier
Shortoptional user designated identifier
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1
Must Supporttrue
8. SubstanceDefinition.classification
Definition

A controlled vocabulary as provided by the prEN ISO 11238 - Health informatics identification of medicinal products - Structures and controlled vocabularies for drug substances to group drug substances at a relatively high level acording to the Substance and the Substance Preparation Model. [Source: Adapted from 'Logical model of the classification and identification of pharmaceutical and medicinal Products', HL7]

ShortSubstance Type
Control1..?
BindingThe codes SHALL be taken from Substance Classification
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/substance-classification)
Must Supporttrue
10. SubstanceDefinition.manufacturer
Control1..1
TypeReference(Manufacturing and/or Test Site Organization)
Must Supporttrue
12. SubstanceDefinition.supplier
Control0..1
TypeReference(Supplier Organization)
Must Supporttrue
14. SubstanceDefinition.molecularWeight
Definition

The average mass of a molecule of a compound compared to ¹/₁₂ the mass of carbon 12 and calculated as the sum of the atomic weights of the constituent atoms. [Source: Merriam Webster]

ShortMolecular Weight
Control0..1
Must Supporttrue
16. SubstanceDefinition.molecularWeight.amount
Must Supporttrue
18. SubstanceDefinition.molecularWeight.amount.unit
Definition

The labeled unit of measure for the molecular weight. [Source: Adapted for NCI EVS C117055]

ShortMolecular Weight UOM
20. SubstanceDefinition.molecularWeight.amount.code
Control1..?
BindingThe codes SHALL be taken from Units Of Measure Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology)
Must Supporttrue
22. SubstanceDefinition.structure
Control1..?
Must Supporttrue
24. SubstanceDefinition.structure.molecularFormula
Definition

Molecular Formula: An expression which states the number and type of atoms present in a molecule of a substance or sequence for biotechnology products. [Source: SME Defined] Biopolymer Sequence: TBD

ShortMolecular Formula | Biopolymer Sequence
Must Supporttrue
26. SubstanceDefinition.structure.technique
Definition

The technique used to elucidate the structure or characterization of the drug substance. [Source: SME Defined] Examples: x-ray, HPLC, NMR, peptide mapping, ligand binding assay.

ShortSubstance Characterization Technique
Control1..1
Must Supporttrue
28. SubstanceDefinition.structure.technique.text
Control1..?
Must Supporttrue
30. SubstanceDefinition.structure.representation
Control1..?
Must Supporttrue
32. SubstanceDefinition.structure.representation.representation
Definition

A machine-readable representation of the structure of the chemical. [Source: SME Defined] Examples: SDF, MOLFILE, InChI file (small molecule), PDB, mmCIF (large molecules), HELM.

ShortDrug Substance Structural Representation
Must Supporttrue
34. SubstanceDefinition.structure.representation.format
Definition

A format name or abbreviation that identifies a file structure. [Source: SME Defined] Examples: SMILES, MOLFILE, HELM, etc.

ShortStructural Representation Type
Must Supporttrue
36. SubstanceDefinition.structure.representation.format.coding
BindingThe codes SHALL be taken from Chemical Structure Data File Type Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-chemical-structure-datafile-type-terminology)
38. SubstanceDefinition.structure.representation.document
Definition

A pictorial representation of the structure of the drug substance. [Source: SME Defined] Note: Refer to the 'Acceptable File Formats for use in eCTD' Example: This is the representation of the molecule CH3OH, or the sequence SHLVEALALVAGERG.

ShortSubstance Structure Graphic
TypeReference(Document Reference Attachment)
Must Supporttrue
40. SubstanceDefinition.code
Definition

Implementation Note: the cardinality represents the business rule for unii, uniprot, or some other code being required

Control1..?
Must Supporttrue
42. SubstanceDefinition.code.code
Control1..?
Must Supporttrue
44. SubstanceDefinition.code.code.coding
SlicingThis element introduces a set of slices on SubstanceDefinition.code.code.coding. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ system
  • 46. SubstanceDefinition.code.code.coding:unii
    Slice Nameunii
    Definition

    The UNII is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. [Source: http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem-UniqueIngredientIdentifierUNII/] Example: 362O9ITL9D Note: If a UNII does not exist, please go to http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem-UniqueIngredientIdentifierUNII/

    ShortUNII
    Control0..1
    48. SubstanceDefinition.code.code.coding:unii.system
    Control1..?
    Pattern Valuehttp://fdasis.nlm.nih.gov
    50. SubstanceDefinition.code.code.coding:uniProt
    Slice NameuniProt
    Definition

    The UniProt ID is an index to the UniProt knowledgebase, a large resource of protein sequences and associated detailed annotation. It is accessible at https://www.uniprot.org/

    ShortUniProt ID
    Control0..1
    52. SubstanceDefinition.code.code.coding:uniProt.system
    Control1..?
    Pattern Valuehttps://www.uniprot.org
    54. SubstanceDefinition.name
    Definition

    Substance Name is identified by its Substance Type. Substance Type: Identifies the source that assigned the product ingredient name. [Source: SME Defined] Examples: GSRS Preferred Term, Systematic Name, INN, USP/NF

    ShortSubtance Name
    Control1..?
    Must Supporttrue
    Invariantscmc-name-preferred: Name.preferred: at most one = true (select(preferred = true).count() < 2)
    SlicingThis element introduces a set of slices on SubstanceDefinition.name. The slices are unordered and Closed, and can be differentiated using the following discriminators:
    • value @ type.coding
    • 56. SubstanceDefinition.name.preferred
      ShortTrue when the name type is Substance Name
      Must Supporttrue
      58. SubstanceDefinition.name:sys
      Slice Namesys
      Control0..1
      Must Supporttrue
      60. SubstanceDefinition.name:sys.name
      Definition

      A name derived directly from the chemical structure. [Source: SME Defined]

      ShortSystematic
      Must Supporttrue
      62. SubstanceDefinition.name:sys.type
      Control1..?
      Must Supporttrue
      64. SubstanceDefinition.name:sys.type.coding
      Control1..1
      Must Supporttrue
      Pattern Value{
        "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "code" : "C203357",
        "display" : "Systematic Name"
      }
      66. SubstanceDefinition.name:sys.preferred
      Must Supporttrue
      68. SubstanceDefinition.name:sub
      Slice Namesub
      Control0..1
      Must Supporttrue
      70. SubstanceDefinition.name:sub.name
      Definition

      A non-branded nor registered name that meant for common use.

      ShortGeneric
      Must Supporttrue
      72. SubstanceDefinition.name:sub.type
      Control1..?
      Must Supporttrue
      74. SubstanceDefinition.name:sub.type.coding
      Control1..1
      Must Supporttrue
      Pattern Value{
        "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "code" : "C97054",
        "display" : "Generic Name"
      }
      76. SubstanceDefinition.name:sub.preferred
      Must Supporttrue
      78. SubstanceDefinition.name:brand
      Slice Namebrand
      Control0..1
      Must Supporttrue
      80. SubstanceDefinition.name:brand.name
      Definition

      The part of the name or logo associated with a specific product or service identifying and distinguishing it from varieties of the same product or service marketed by competing companies.

      ShortBrand
      Must Supporttrue
      82. SubstanceDefinition.name:brand.type
      Control1..?
      Must Supporttrue
      84. SubstanceDefinition.name:brand.type.coding
      Control1..1
      Must Supporttrue
      Pattern Value{
        "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "code" : "C71898",
        "display" : "Brand"
      }
      86. SubstanceDefinition.name:brand.preferred
      Must Supporttrue
      88. SubstanceDefinition.name:gsrs
      Slice Namegsrs
      Control0..1
      Must Supporttrue
      90. SubstanceDefinition.name:gsrs.name
      Definition

      Default display name identified within FDA Global Substance Registration System (GSRS).

      ShortGSRS Preferred Term
      Must Supporttrue
      92. SubstanceDefinition.name:gsrs.type
      Control1..?
      Must Supporttrue
      94. SubstanceDefinition.name:gsrs.type.coding
      Control1..1
      Must Supporttrue
      Pattern Value{
        "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "code" : "C203355",
        "display" : "GSRS Preferred Term"
      }
      96. SubstanceDefinition.name:gsrs.preferred
      Must Supporttrue
      98. SubstanceDefinition.name:usp
      Slice Nameusp
      Control0..1
      Must Supporttrue
      100. SubstanceDefinition.name:usp.name
      Definition

      A unique nonproprietary name assigned to drugs and biologics and assigned by the United States Pharmacopeia (USP) and excipients by the National Formulary (NF). [Source: SME Defined]

      ShortUSP-NF Established Name
      Must Supporttrue
      102. SubstanceDefinition.name:usp.type
      Control1..?
      Must Supporttrue
      104. SubstanceDefinition.name:usp.type.coding
      Control1..1
      Must Supporttrue
      Pattern Value{
        "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "code" : "C203358",
        "display" : "USP-NF Established Name"
      }
      106. SubstanceDefinition.name:usp.preferred
      Must Supporttrue
      108. SubstanceDefinition.name:comp
      Slice Namecomp
      Control0..1
      Must Supporttrue
      110. SubstanceDefinition.name:comp.name
      Definition

      An internal identifier assigned by the sponsor to this drug substance. [Source: SME Defined]

      ShortCompany ID/Code
      Must Supporttrue
      112. SubstanceDefinition.name:comp.type
      Control1..?
      Must Supporttrue
      114. SubstanceDefinition.name:comp.type.coding
      Control1..1
      Pattern Value{
        "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "code" : "C203354",
        "display" : "Company ID/Code"
      }
      116. SubstanceDefinition.name:comp.preferred
      Must Supporttrue
      118. SubstanceDefinition.name:cas
      Slice Namecas
      Control0..1
      Must Supporttrue
      120. SubstanceDefinition.name:cas.name
      Definition

      Chemical Abstract Service (CAS) Registry Numbers (often referred to as CAS RNs or CAS Numbers) are used to provide identifiers for chemical substances. A CAS Registry Number itself has no inherent chemical significance but provides a way to identify a chemical substance or molecular structure when there are many possible systematic, generic, proprietary or trivial names. [Source: Adapted from CAS.org] Example: CAS [103-90-2]

      ShortCAS Number
      Must Supporttrue
      122. SubstanceDefinition.name:cas.type
      Control1..?
      Must Supporttrue
      124. SubstanceDefinition.name:cas.type.coding
      Control1..1
      Must Supporttrue
      Pattern Value{
        "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "code" : "C54682",
        "display" : "CAS Number"
      }
      126. SubstanceDefinition.name:cas.preferred
      Must Supporttrue
      128. SubstanceDefinition.name:inn
      Slice Nameinn
      Control0..1
      Must Supporttrue
      130. SubstanceDefinition.name:inn.name
      Definition

      International Nonproprietary Names (INN) is a unique name that is globally recognized and is public property. A nonproprietary name is also known as a generic name. Note: International Nonproprietary Names (INN) facilitate the identification of pharmaceutical substances or active pharmaceutical ingredients [Source: http://www.who.int/medicines/services/inn/en/] Example: Paracetamol

      ShortINN
      Must Supporttrue
      132. SubstanceDefinition.name:inn.type
      Control1..?
      Must Supporttrue
      134. SubstanceDefinition.name:inn.type.coding
      Control1..1
      Must Supporttrue
      Pattern Value{
        "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "code" : "C142585",
        "display" : "INN"
      }
      136. SubstanceDefinition.name:inn.preferred
      Must Supporttrue
      138. SubstanceDefinition.name:usan
      Slice Nameusan
      Control0..1
      Must Supporttrue
      140. SubstanceDefinition.name:usan.name
      Definition

      A unique nonproprietary name assigned to drugs and biologics and assigned by the United States Adopted Names Council [Source: SME Defined] Example: acetaminophen

      ShortUSAN
      Must Supporttrue
      142. SubstanceDefinition.name:usan.type
      Control1..?
      Must Supporttrue
      144. SubstanceDefinition.name:usan.type.coding
      Control1..1
      Must Supporttrue
      Pattern Value{
        "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "code" : "C96973",
        "display" : "USAN"
      }
      146. SubstanceDefinition.name:usan.preferred
      Must Supporttrue
      148. SubstanceDefinition.name:iupac
      Slice Nameiupac
      Control0..1
      Must Supporttrue
      150. SubstanceDefinition.name:iupac.name
      Definition

      A name assigned to a chemical substance according to the systematic nomenclature rules defined by the International Union of Pure and Applied Chemistry (IUPAC) [Source: SME Defined] Example: N- (4-hydroxyphenyl)acetamide

      ShortIUPAC Name
      Must Supporttrue
      152. SubstanceDefinition.name:iupac.type
      Control1..?
      Must Supporttrue
      154. SubstanceDefinition.name:iupac.type.coding
      Control1..1
      Must Supporttrue
      Pattern Value{
        "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "code" : "C203356",
        "display" : "IUPAC Name"
      }
      156. SubstanceDefinition.name:iupac.preferred
      Must Supporttrue
      158. SubstanceDefinition.name:isbt
      Slice Nameisbt
      Control0..1
      Must Supporttrue
      160. SubstanceDefinition.name:isbt.name
      Definition

      It is the global standard for the terminology, identification, coding and labeling of medical products of human origin (including blood, cell, tissue, milk, and organ products). [Source: https://www.iccbba.org/]

      ShortISBT-128 DIN
      Must Supporttrue
      162. SubstanceDefinition.name:isbt.type
      Control1..?
      Must Supporttrue
      164. SubstanceDefinition.name:isbt.type.coding
      Control1..1
      Must Supporttrue
      Pattern Value{
        "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "code" : "C95517",
        "display" : "ISBT-128 DIN"
      }
      166. SubstanceDefinition.name:isbt.preferred
      Must Supporttrue
      168. SubstanceDefinition.relationship
      Must Supporttrue
      170. SubstanceDefinition.relationship.substanceDefinition[x]
      [x] NoteSee Choice of Data Types for further information about how to use [x]
      SlicingThis element introduces a set of slices on SubstanceDefinition.relationship.substanceDefinition[x]. The slices are unordered and Open, and can be differentiated using the following discriminators:
      • type @ $this
      • 172. SubstanceDefinition.relationship.substanceDefinition[x]:substanceDefinitionReference
        Slice NamesubstanceDefinitionReference
        ShortThe substance definition of a polyphorm of the Drug Substance
        Control0..1
        TypeReference(Polymorphic Form)
        [x] NoteSee Choice of Data Types for further information about how to use [x]
        174. SubstanceDefinition.relationship.type
        176. SubstanceDefinition.relationship.type.text
        ShortPolymorph
        Pattern ValuePolymorph

        Guidance on how to interpret the contents of this table can be found here

        0. SubstanceDefinition
        Definition

        The detailed description of a substance, typically at a level beyond what is used for prescribing.

        ShortThe detailed description of a substance, typically at a level beyond what is used for prescribing
        Control0..*
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
        dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
        dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
        dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
        dom-6: A resource should have narrative for robust management (text.`div`.exists())
        cmc-when-unii-required: A UNII is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer','Protein'. (classification.coding.where(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code in ('C48807' | 'C45305' | 'C706' | 'C48803' |'C17021') ).exists() implies code.code.text.exists())
        cmc-name-isbt: Name.type ISBT 128 required for blood products. (classification.where(coding.where(code = '8' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy').exists()).exists() implies name.type.coding.exists(code = '226' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy'))
        cmc-structure-required: A structure is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer','Protein'. (classification.coding.where(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code in ('C48807' | 'C45305' | 'C706' | 'C48803' |'C17021') ).exists() implies structure.exists())
        cmc-substance-structure-graphic-required: A Substance Structure Graphic is required Required for Small Molecules. Equivalent to classification code equals 'Chemical'. ((classification.where(coding.where(code = '1' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy').exists()).exists()) implies structure.representation.exists())
        2. SubstanceDefinition.meta
        Definition

        The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

        ShortMetadata about the resource
        Control0..1
        TypeMeta
        Is Modifierfalse
        Must Supportfalse
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        4. SubstanceDefinition.meta.profile
        Definition

        A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url.

        ShortProfiles this resource claims to conform to
        Comments

        It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.

        Control10..1*
        Typecanonical(StructureDefinition)
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        6. SubstanceDefinition.implicitRules
        Definition

        A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

        ShortA set of rules under which this content was created
        Comments

        Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.

        Control0..1
        Typeuri
        Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supportfalse
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        8. SubstanceDefinition.contained
        Definition

        These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

        ShortContained, inline Resources
        Comments

        This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.

        Control0..*
        This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
        TypeResource
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Alternate Namesinline resources, anonymous resources, contained resources
        10. SubstanceDefinition.modifierExtension
        Definition

        May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

        Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

        ShortExtensions that cannot be ignored
        Comments

        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

        Control0..*
        TypeExtension
        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
        Must Supportfalse
        Summarytrue
        Requirements

        Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

        Alternate Namesextensions, user content
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        12. SubstanceDefinition.identifier
        Definition

        Identifier by which this substance is known.

        Shortoptional user designated identifierIdentifier by which this substance is known
        NoteThis is a business identifier, not a resource identifier (see discussion)
        Control0..1*
        TypeIdentifier
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        14. SubstanceDefinition.classification
        Definition

        A controlled vocabulary as provided by the prEN ISO 11238 - Health informatics identification of medicinal products - Structures and controlled vocabularies for drug substances to group drug substances at a relatively high level acording to the Substance and the Substance Preparation Model. [Source: Adapted from 'Logical model of the classification and identification of pharmaceutical and medicinal Products', HL7]


        A high level categorization, e.g. polymer or nucleic acid, or food, chemical, biological, or a lower level such as the general types of polymer (linear or branch chain) or type of impurity (process related or contaminant).

        ShortSubstance TypeA categorization, high level e.g. polymer or nucleic acid, or food, chemical, biological, or lower e.g. polymer linear or branch chain, or type of impurity
        Control10..*
        BindingThe codes SHALL be taken from For codes, see Substance Classification
        (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/substance-classification)
        TypeCodeableConcept
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        16. SubstanceDefinition.manufacturer
        Definition

        The entity that creates, makes, produces or fabricates the substance. This is a set of potential manufacturers but is not necessarily comprehensive.

        ShortThe entity that creates, makes, produces or fabricates the substance
        Control10..1*
        TypeReference(Manufacturing and/or Test Site Organization, Organization)
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        18. SubstanceDefinition.supplier
        Definition

        An entity that is the source for the substance. It may be different from the manufacturer. Supplier is synonymous to a distributor.

        ShortAn entity that is the source for the substance. It may be different from the manufacturer
        Control0..1*
        TypeReference(Supplier Organization, Organization)
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        20. SubstanceDefinition.molecularWeight
        Definition

        The average mass of a molecule of a compound compared to ¹/₁₂ the mass of carbon 12 and calculated as the sum of the atomic weights of the constituent atoms. [Source: Merriam Webster]


        The average mass of a molecule of a compound compared to 1/12 the mass of carbon 12 and calculated as the sum of the atomic weights of the constituent atoms.

        ShortMolecular WeightThe average mass of a molecule of a compound
        Control0..1*
        TypeBackboneElement
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        22. SubstanceDefinition.molecularWeight.modifierExtension
        Definition

        May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

        Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

        ShortExtensions that cannot be ignored even if unrecognized
        Comments

        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

        Control0..*
        TypeExtension
        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
        Summarytrue
        Requirements

        Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

        Alternate Namesextensions, user content, modifiers
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        24. SubstanceDefinition.molecularWeight.amount
        Definition

        Used to capture quantitative values for a variety of elements. If only limits are given, the arithmetic mean would be the average. If only a single definite value for a given element is given, it would be captured in this field.

        ShortUsed to capture quantitative values for a variety of elements
        Control1..1
        TypeQuantity
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        26. SubstanceDefinition.molecularWeight.amount.comparator
        Definition

        How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.

        Short< | <= | >= | > | ad - how to understand the value
        Control0..1
        BindingThe codes SHALL be taken from QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
        (required to http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0)

        How the Quantity should be understood and represented.

        Typecode
        Is Modifiertrue because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Summarytrue
        Requirements

        Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.

        Meaning if MissingIf there is no comparator, then there is no modification of the value
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        28. SubstanceDefinition.molecularWeight.amount.unit
        Definition

        The labeled unit of measure for the molecular weight. [Source: Adapted for NCI EVS C117055]


        A human-readable form of the unit.

        ShortMolecular Weight UOMUnit representation
        Control0..1
        Typestring
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Summarytrue
        Requirements

        There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        30. SubstanceDefinition.molecularWeight.amount.code
        Definition

        A computer processable form of the unit in some unit representation system.

        ShortCoded form of the unit
        Comments

        The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.

        Control10..1
        This element is affected by the following invariants: qty-3
        BindingThe codes SHALL be taken from For codes, see Units Of Measure Terminology
        (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology)
        Typecode
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Summarytrue
        Requirements

        Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        32. SubstanceDefinition.structure
        Definition

        Structural information.

        ShortStructural information
        Control10..1
        TypeBackboneElement
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        34. SubstanceDefinition.structure.modifierExtension
        Definition

        May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

        Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

        ShortExtensions that cannot be ignored even if unrecognized
        Comments

        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

        Control0..*
        TypeExtension
        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
        Summarytrue
        Requirements

        Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

        Alternate Namesextensions, user content, modifiers
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        36. SubstanceDefinition.structure.molecularFormula
        Definition

        Molecular Formula: An expression which states the number and type of atoms present in a molecule of a substance or sequence for biotechnology products. [Source: SME Defined] Biopolymer Sequence: TBD


        An expression which states the number and type of atoms present in a molecule of a substance.

        ShortMolecular Formula | Biopolymer SequenceAn expression which states the number and type of atoms present in a molecule of a substance
        Control0..1
        Typestring
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        38. SubstanceDefinition.structure.technique
        Definition

        The technique used to elucidate the structure or characterization of the drug substance. [Source: SME Defined] Examples: x-ray, HPLC, NMR, peptide mapping, ligand binding assay.


        The method used to elucidate the structure of the drug substance. Examples: X-ray, NMR, Peptide mapping, Ligand binding assay.

        ShortSubstance Characterization TechniqueThe method used to find the structure e.g. X-ray, NMR
        Control10..1*
        BindingFor example codes, see StructureTechniquehttp://hl7.org/fhir/ValueSet/substance-structure-technique
        (example to http://hl7.org/fhir/ValueSet/substance-structure-technique)

        The method used to elucidate the structure of the drug substance.

        TypeCodeableConcept
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        40. SubstanceDefinition.structure.technique.text
        Definition

        A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

        ShortPlain text representation of the concept
        Comments

        Very often the text is the same as a displayName of one of the codings.

        Control10..1
        Typestring
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Summarytrue
        Requirements

        The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        42. SubstanceDefinition.structure.representation
        Definition

        A depiction of the structure of the substance.

        ShortA depiction of the structure of the substance
        Control10..*
        TypeBackboneElement
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        44. SubstanceDefinition.structure.representation.modifierExtension
        Definition

        May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

        Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

        ShortExtensions that cannot be ignored even if unrecognized
        Comments

        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

        Control0..*
        TypeExtension
        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
        Summarytrue
        Requirements

        Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

        Alternate Namesextensions, user content, modifiers
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        46. SubstanceDefinition.structure.representation.representation
        Definition

        A machine-readable representation of the structure of the chemical. [Source: SME Defined] Examples: SDF, MOLFILE, InChI file (small molecule), PDB, mmCIF (large molecules), HELM.


        The structural representation as a text string in a standard format.

        ShortDrug Substance Structural RepresentationThe structural representation as a text string in a standard format
        Control0..1
        Typestring
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        48. SubstanceDefinition.structure.representation.format
        Definition

        A format name or abbreviation that identifies a file structure. [Source: SME Defined] Examples: SMILES, MOLFILE, HELM, etc.


        The format of the representation e.g. InChI, SMILES, MOLFILE, CDX, SDF, PDB, mmCIF. The logical content type rather than the physical file format of a document.

        ShortStructural Representation TypeThe format of the representation e.g. InChI, SMILES, MOLFILE (note: not the physical file format)
        Control0..1
        BindingFor example codes, see SubstanceRepresentationFormathttp://hl7.org/fhir/ValueSet/substance-representation-format
        (example to http://hl7.org/fhir/ValueSet/substance-representation-format)

        A format of a substance representation.

        TypeCodeableConcept
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        50. SubstanceDefinition.structure.representation.format.coding
        Definition

        A reference to a code defined by a terminology system.

        ShortCode defined by a terminology system
        Comments

        Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

        Control0..*
        BindingThe codes SHALL be taken from For codes, see Chemical Structure Data File Type Terminology
        (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-chemical-structure-datafile-type-terminology)
        TypeCoding
        Is Modifierfalse
        Summarytrue
        Requirements

        Allows for alternative encodings within a code system, and translations to other code systems.

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        52. SubstanceDefinition.structure.representation.document
        Definition

        A pictorial representation of the structure of the drug substance. [Source: SME Defined] Note: Refer to the 'Acceptable File Formats for use in eCTD' Example: This is the representation of the molecule CH3OH, or the sequence SHLVEALALVAGERG.


        An attached file with the structural representation e.g. a molecular structure graphic of the substance, a JCAMP or AnIML file.

        ShortSubstance Structure GraphicAn attachment with the structural representation e.g. a structure graphic or AnIML file
        Control0..1
        TypeReference(Document Reference Attachment, DocumentReference)
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        54. SubstanceDefinition.code
        Definition

        Implementation Note: the cardinality represents the business rule for unii, uniprot, or some other code being required


        Codes associated with the substance.

        ShortCodes associated with the substance
        Control10..*
        TypeBackboneElement
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        56. SubstanceDefinition.code.modifierExtension
        Definition

        May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

        Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

        ShortExtensions that cannot be ignored even if unrecognized
        Comments

        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

        Control0..*
        TypeExtension
        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
        Summarytrue
        Requirements

        Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

        Alternate Namesextensions, user content, modifiers
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        58. SubstanceDefinition.code.code
        Definition

        The specific code.

        ShortThe specific code
        Control10..1
        TypeCodeableConcept
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        60. SubstanceDefinition.code.code.coding
        Definition

        A reference to a code defined by a terminology system.

        ShortCode defined by a terminology system
        Comments

        Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

        Control0..*
        TypeCoding
        Is Modifierfalse
        Summarytrue
        Requirements

        Allows for alternative encodings within a code system, and translations to other code systems.

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        SlicingThis element introduces a set of slices on SubstanceDefinition.code.code.coding. The slices are unordered and Open, and can be differentiated using the following discriminators:
        • value @ system
        • 62. SubstanceDefinition.code.code.coding:unii
          Slice Nameunii
          Definition

          The UNII is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. [Source: http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem-UniqueIngredientIdentifierUNII/] Example: 362O9ITL9D Note: If a UNII does not exist, please go to http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem-UniqueIngredientIdentifierUNII/


          A reference to a code defined by a terminology system.

          ShortUNIICode defined by a terminology system
          Comments

          Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

          Control0..1*
          TypeCoding
          Is Modifierfalse
          Summarytrue
          Requirements

          Allows for alternative encodings within a code system, and translations to other code systems.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          64. SubstanceDefinition.code.code.coding:unii.system
          Definition

          The identification of the code system that defines the meaning of the symbol in the code.

          ShortIdentity of the terminology system
          Comments

          The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously.

          Control10..1
          Typeuri
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Requirements

          Need to be unambiguous about the source of the definition of the symbol.

          Pattern Valuehttp://fdasis.nlm.nih.gov
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          66. SubstanceDefinition.code.code.coding:uniProt
          Slice NameuniProt
          Definition

          The UniProt ID is an index to the UniProt knowledgebase, a large resource of protein sequences and associated detailed annotation. It is accessible at https://www.uniprot.org/


          A reference to a code defined by a terminology system.

          ShortUniProt IDCode defined by a terminology system
          Comments

          Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

          Control0..1*
          TypeCoding
          Is Modifierfalse
          Summarytrue
          Requirements

          Allows for alternative encodings within a code system, and translations to other code systems.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          68. SubstanceDefinition.code.code.coding:uniProt.system
          Definition

          The identification of the code system that defines the meaning of the symbol in the code.

          ShortIdentity of the terminology system
          Comments

          The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously.

          Control10..1
          Typeuri
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Requirements

          Need to be unambiguous about the source of the definition of the symbol.

          Pattern Valuehttps://www.uniprot.org
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          70. SubstanceDefinition.name
          Definition

          Substance Name is identified by its Substance Type. Substance Type: Identifies the source that assigned the product ingredient name. [Source: SME Defined] Examples: GSRS Preferred Term, Systematic Name, INN, USP/NF


          Names applicable to this substance.

          ShortSubtance NameNames applicable to this substance
          Control10..*
          TypeBackboneElement
          Is Modifierfalse
          Must Supporttrue
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          cmc-name-preferred: Name.preferred: at most one = true (select(preferred = true).count() < 2)
          SlicingThis element introduces a set of slices on SubstanceDefinition.name. The slices are unordered and Closed, and can be differentiated using the following discriminators:
          • value @ type.coding
          • 72. SubstanceDefinition.name.modifierExtension
            Definition

            May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

            Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

            ShortExtensions that cannot be ignored even if unrecognized
            Comments

            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

            Control0..*
            TypeExtension
            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
            Summarytrue
            Requirements

            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

            Alternate Namesextensions, user content, modifiers
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            74. SubstanceDefinition.name.name
            Definition

            The actual name.

            ShortThe actual name
            Control1..1
            Typestring
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supportfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            76. SubstanceDefinition.name.preferred
            Definition

            If this is the preferred name for this substance.

            ShortTrue when the name type is Substance NameIf this is the preferred name for this substance
            Control0..1
            Typeboolean
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supporttrue
            Summarytrue
            Meaning if MissingIf this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            78. SubstanceDefinition.name:sys
            Slice Namesys
            Definition

            Names applicable to this substance.

            ShortNames applicable to this substance
            Control0..1*
            TypeBackboneElement
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            80. SubstanceDefinition.name:sys.modifierExtension
            Definition

            May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

            Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

            ShortExtensions that cannot be ignored even if unrecognized
            Comments

            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

            Control0..*
            TypeExtension
            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
            Summarytrue
            Requirements

            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

            Alternate Namesextensions, user content, modifiers
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            82. SubstanceDefinition.name:sys.name
            Definition

            A name derived directly from the chemical structure. [Source: SME Defined]


            The actual name.

            ShortSystematicThe actual name
            Control1..1
            Typestring
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            84. SubstanceDefinition.name:sys.type
            Definition

            Name type, for example 'systematic', 'scientific, 'brand'.

            ShortName type e.g. 'systematic', 'scientific, 'brand'
            Control10..1
            BindingFor example codes, see SubstanceNameTypehttp://hl7.org/fhir/ValueSet/substance-name-type
            (example to http://hl7.org/fhir/ValueSet/substance-name-type)

            The type of a name given to a substance.

            TypeCodeableConcept
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            86. SubstanceDefinition.name:sys.type.coding
            Definition

            A reference to a code defined by a terminology system.

            ShortCode defined by a terminology system
            Comments

            Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

            Control10..1*
            TypeCoding
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Requirements

            Allows for alternative encodings within a code system, and translations to other code systems.

            Pattern Value{
              "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
              "code" : "C203357",
              "display" : "Systematic Name"
            }
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            88. SubstanceDefinition.name:sys.preferred
            Definition

            If this is the preferred name for this substance.

            ShortIf this is the preferred name for this substance
            Control0..1
            Typeboolean
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supporttrue
            Summarytrue
            Meaning if MissingIf this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            90. SubstanceDefinition.name:sub
            Slice Namesub
            Definition

            Names applicable to this substance.

            ShortNames applicable to this substance
            Control0..1*
            TypeBackboneElement
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            92. SubstanceDefinition.name:sub.modifierExtension
            Definition

            May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

            Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

            ShortExtensions that cannot be ignored even if unrecognized
            Comments

            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

            Control0..*
            TypeExtension
            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
            Summarytrue
            Requirements

            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

            Alternate Namesextensions, user content, modifiers
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            94. SubstanceDefinition.name:sub.name
            Definition

            A non-branded nor registered name that meant for common use.


            The actual name.

            ShortGenericThe actual name
            Control1..1
            Typestring
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            96. SubstanceDefinition.name:sub.type
            Definition

            Name type, for example 'systematic', 'scientific, 'brand'.

            ShortName type e.g. 'systematic', 'scientific, 'brand'
            Control10..1
            BindingFor example codes, see SubstanceNameTypehttp://hl7.org/fhir/ValueSet/substance-name-type
            (example to http://hl7.org/fhir/ValueSet/substance-name-type)

            The type of a name given to a substance.

            TypeCodeableConcept
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            98. SubstanceDefinition.name:sub.type.coding
            Definition

            A reference to a code defined by a terminology system.

            ShortCode defined by a terminology system
            Comments

            Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

            Control10..1*
            TypeCoding
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Requirements

            Allows for alternative encodings within a code system, and translations to other code systems.

            Pattern Value{
              "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
              "code" : "C97054",
              "display" : "Generic Name"
            }
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            100. SubstanceDefinition.name:sub.preferred
            Definition

            If this is the preferred name for this substance.

            ShortIf this is the preferred name for this substance
            Control0..1
            Typeboolean
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supporttrue
            Summarytrue
            Meaning if MissingIf this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            102. SubstanceDefinition.name:brand
            Slice Namebrand
            Definition

            Names applicable to this substance.

            ShortNames applicable to this substance
            Control0..1*
            TypeBackboneElement
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            104. SubstanceDefinition.name:brand.modifierExtension
            Definition

            May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

            Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

            ShortExtensions that cannot be ignored even if unrecognized
            Comments

            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

            Control0..*
            TypeExtension
            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
            Summarytrue
            Requirements

            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

            Alternate Namesextensions, user content, modifiers
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            106. SubstanceDefinition.name:brand.name
            Definition

            The part of the name or logo associated with a specific product or service identifying and distinguishing it from varieties of the same product or service marketed by competing companies.


            The actual name.

            ShortBrandThe actual name
            Control1..1
            Typestring
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            108. SubstanceDefinition.name:brand.type
            Definition

            Name type, for example 'systematic', 'scientific, 'brand'.

            ShortName type e.g. 'systematic', 'scientific, 'brand'
            Control10..1
            BindingFor example codes, see SubstanceNameTypehttp://hl7.org/fhir/ValueSet/substance-name-type
            (example to http://hl7.org/fhir/ValueSet/substance-name-type)

            The type of a name given to a substance.

            TypeCodeableConcept
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            110. SubstanceDefinition.name:brand.type.coding
            Definition

            A reference to a code defined by a terminology system.

            ShortCode defined by a terminology system
            Comments

            Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

            Control10..1*
            TypeCoding
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Requirements

            Allows for alternative encodings within a code system, and translations to other code systems.

            Pattern Value{
              "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
              "code" : "C71898",
              "display" : "Brand"
            }
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            112. SubstanceDefinition.name:brand.preferred
            Definition

            If this is the preferred name for this substance.

            ShortIf this is the preferred name for this substance
            Control0..1
            Typeboolean
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supporttrue
            Summarytrue
            Meaning if MissingIf this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            114. SubstanceDefinition.name:gsrs
            Slice Namegsrs
            Definition

            Names applicable to this substance.

            ShortNames applicable to this substance
            Control0..1*
            TypeBackboneElement
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            116. SubstanceDefinition.name:gsrs.modifierExtension
            Definition

            May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

            Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

            ShortExtensions that cannot be ignored even if unrecognized
            Comments

            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

            Control0..*
            TypeExtension
            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
            Summarytrue
            Requirements

            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

            Alternate Namesextensions, user content, modifiers
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            118. SubstanceDefinition.name:gsrs.name
            Definition

            Default display name identified within FDA Global Substance Registration System (GSRS).


            The actual name.

            ShortGSRS Preferred TermThe actual name
            Control1..1
            Typestring
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            120. SubstanceDefinition.name:gsrs.type
            Definition

            Name type, for example 'systematic', 'scientific, 'brand'.

            ShortName type e.g. 'systematic', 'scientific, 'brand'
            Control10..1
            BindingFor example codes, see SubstanceNameTypehttp://hl7.org/fhir/ValueSet/substance-name-type
            (example to http://hl7.org/fhir/ValueSet/substance-name-type)

            The type of a name given to a substance.

            TypeCodeableConcept
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            122. SubstanceDefinition.name:gsrs.type.coding
            Definition

            A reference to a code defined by a terminology system.

            ShortCode defined by a terminology system
            Comments

            Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

            Control10..1*
            TypeCoding
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Requirements

            Allows for alternative encodings within a code system, and translations to other code systems.

            Pattern Value{
              "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
              "code" : "C203355",
              "display" : "GSRS Preferred Term"
            }
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            124. SubstanceDefinition.name:gsrs.preferred
            Definition

            If this is the preferred name for this substance.

            ShortIf this is the preferred name for this substance
            Control0..1
            Typeboolean
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supporttrue
            Summarytrue
            Meaning if MissingIf this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            126. SubstanceDefinition.name:usp
            Slice Nameusp
            Definition

            Names applicable to this substance.

            ShortNames applicable to this substance
            Control0..1*
            TypeBackboneElement
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            128. SubstanceDefinition.name:usp.modifierExtension
            Definition

            May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

            Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

            ShortExtensions that cannot be ignored even if unrecognized
            Comments

            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

            Control0..*
            TypeExtension
            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
            Summarytrue
            Requirements

            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

            Alternate Namesextensions, user content, modifiers
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            130. SubstanceDefinition.name:usp.name
            Definition

            A unique nonproprietary name assigned to drugs and biologics and assigned by the United States Pharmacopeia (USP) and excipients by the National Formulary (NF). [Source: SME Defined]


            The actual name.

            ShortUSP-NF Established NameThe actual name
            Control1..1
            Typestring
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            132. SubstanceDefinition.name:usp.type
            Definition

            Name type, for example 'systematic', 'scientific, 'brand'.

            ShortName type e.g. 'systematic', 'scientific, 'brand'
            Control10..1
            BindingFor example codes, see SubstanceNameTypehttp://hl7.org/fhir/ValueSet/substance-name-type
            (example to http://hl7.org/fhir/ValueSet/substance-name-type)

            The type of a name given to a substance.

            TypeCodeableConcept
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            134. SubstanceDefinition.name:usp.type.coding
            Definition

            A reference to a code defined by a terminology system.

            ShortCode defined by a terminology system
            Comments

            Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

            Control10..1*
            TypeCoding
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Requirements

            Allows for alternative encodings within a code system, and translations to other code systems.

            Pattern Value{
              "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
              "code" : "C203358",
              "display" : "USP-NF Established Name"
            }
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            136. SubstanceDefinition.name:usp.preferred
            Definition

            If this is the preferred name for this substance.

            ShortIf this is the preferred name for this substance
            Control0..1
            Typeboolean
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supporttrue
            Summarytrue
            Meaning if MissingIf this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            138. SubstanceDefinition.name:comp
            Slice Namecomp
            Definition

            Names applicable to this substance.

            ShortNames applicable to this substance
            Control0..1*
            TypeBackboneElement
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            140. SubstanceDefinition.name:comp.modifierExtension
            Definition

            May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

            Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

            ShortExtensions that cannot be ignored even if unrecognized
            Comments

            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

            Control0..*
            TypeExtension
            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
            Summarytrue
            Requirements

            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

            Alternate Namesextensions, user content, modifiers
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            142. SubstanceDefinition.name:comp.name
            Definition

            An internal identifier assigned by the sponsor to this drug substance. [Source: SME Defined]


            The actual name.

            ShortCompany ID/CodeThe actual name
            Control1..1
            Typestring
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            144. SubstanceDefinition.name:comp.type
            Definition

            Name type, for example 'systematic', 'scientific, 'brand'.

            ShortName type e.g. 'systematic', 'scientific, 'brand'
            Control10..1
            BindingFor example codes, see SubstanceNameTypehttp://hl7.org/fhir/ValueSet/substance-name-type
            (example to http://hl7.org/fhir/ValueSet/substance-name-type)

            The type of a name given to a substance.

            TypeCodeableConcept
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            146. SubstanceDefinition.name:comp.type.coding
            Definition

            A reference to a code defined by a terminology system.

            ShortCode defined by a terminology system
            Comments

            Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

            Control10..1*
            TypeCoding
            Is Modifierfalse
            Summarytrue
            Requirements

            Allows for alternative encodings within a code system, and translations to other code systems.

            Pattern Value{
              "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
              "code" : "C203354",
              "display" : "Company ID/Code"
            }
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            148. SubstanceDefinition.name:comp.preferred
            Definition

            If this is the preferred name for this substance.

            ShortIf this is the preferred name for this substance
            Control0..1
            Typeboolean
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supporttrue
            Summarytrue
            Meaning if MissingIf this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            150. SubstanceDefinition.name:cas
            Slice Namecas
            Definition

            Names applicable to this substance.

            ShortNames applicable to this substance
            Control0..1*
            TypeBackboneElement
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            152. SubstanceDefinition.name:cas.modifierExtension
            Definition

            May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

            Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

            ShortExtensions that cannot be ignored even if unrecognized
            Comments

            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

            Control0..*
            TypeExtension
            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
            Summarytrue
            Requirements

            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

            Alternate Namesextensions, user content, modifiers
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            154. SubstanceDefinition.name:cas.name
            Definition

            Chemical Abstract Service (CAS) Registry Numbers (often referred to as CAS RNs or CAS Numbers) are used to provide identifiers for chemical substances. A CAS Registry Number itself has no inherent chemical significance but provides a way to identify a chemical substance or molecular structure when there are many possible systematic, generic, proprietary or trivial names. [Source: Adapted from CAS.org] Example: CAS [103-90-2]


            The actual name.

            ShortCAS NumberThe actual name
            Control1..1
            Typestring
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            156. SubstanceDefinition.name:cas.type
            Definition

            Name type, for example 'systematic', 'scientific, 'brand'.

            ShortName type e.g. 'systematic', 'scientific, 'brand'
            Control10..1
            BindingFor example codes, see SubstanceNameTypehttp://hl7.org/fhir/ValueSet/substance-name-type
            (example to http://hl7.org/fhir/ValueSet/substance-name-type)

            The type of a name given to a substance.

            TypeCodeableConcept
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            158. SubstanceDefinition.name:cas.type.coding
            Definition

            A reference to a code defined by a terminology system.

            ShortCode defined by a terminology system
            Comments

            Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

            Control10..1*
            TypeCoding
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Requirements

            Allows for alternative encodings within a code system, and translations to other code systems.

            Pattern Value{
              "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
              "code" : "C54682",
              "display" : "CAS Number"
            }
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            160. SubstanceDefinition.name:cas.preferred
            Definition

            If this is the preferred name for this substance.

            ShortIf this is the preferred name for this substance
            Control0..1
            Typeboolean
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supporttrue
            Summarytrue
            Meaning if MissingIf this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            162. SubstanceDefinition.name:inn
            Slice Nameinn
            Definition

            Names applicable to this substance.

            ShortNames applicable to this substance
            Control0..1*
            TypeBackboneElement
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            164. SubstanceDefinition.name:inn.modifierExtension
            Definition

            May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

            Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

            ShortExtensions that cannot be ignored even if unrecognized
            Comments

            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

            Control0..*
            TypeExtension
            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
            Summarytrue
            Requirements

            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

            Alternate Namesextensions, user content, modifiers
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            166. SubstanceDefinition.name:inn.name
            Definition

            International Nonproprietary Names (INN) is a unique name that is globally recognized and is public property. A nonproprietary name is also known as a generic name. Note: International Nonproprietary Names (INN) facilitate the identification of pharmaceutical substances or active pharmaceutical ingredients [Source: http://www.who.int/medicines/services/inn/en/] Example: Paracetamol


            The actual name.

            ShortINNThe actual name
            Control1..1
            Typestring
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            168. SubstanceDefinition.name:inn.type
            Definition

            Name type, for example 'systematic', 'scientific, 'brand'.

            ShortName type e.g. 'systematic', 'scientific, 'brand'
            Control10..1
            BindingFor example codes, see SubstanceNameTypehttp://hl7.org/fhir/ValueSet/substance-name-type
            (example to http://hl7.org/fhir/ValueSet/substance-name-type)

            The type of a name given to a substance.

            TypeCodeableConcept
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            170. SubstanceDefinition.name:inn.type.coding
            Definition

            A reference to a code defined by a terminology system.

            ShortCode defined by a terminology system
            Comments

            Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

            Control10..1*
            TypeCoding
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Requirements

            Allows for alternative encodings within a code system, and translations to other code systems.

            Pattern Value{
              "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
              "code" : "C142585",
              "display" : "INN"
            }
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            172. SubstanceDefinition.name:inn.preferred
            Definition

            If this is the preferred name for this substance.

            ShortIf this is the preferred name for this substance
            Control0..1
            Typeboolean
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supporttrue
            Summarytrue
            Meaning if MissingIf this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            174. SubstanceDefinition.name:usan
            Slice Nameusan
            Definition

            Names applicable to this substance.

            ShortNames applicable to this substance
            Control0..1*
            TypeBackboneElement
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            176. SubstanceDefinition.name:usan.modifierExtension
            Definition

            May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

            Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

            ShortExtensions that cannot be ignored even if unrecognized
            Comments

            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

            Control0..*
            TypeExtension
            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
            Summarytrue
            Requirements

            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

            Alternate Namesextensions, user content, modifiers
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            178. SubstanceDefinition.name:usan.name
            Definition

            A unique nonproprietary name assigned to drugs and biologics and assigned by the United States Adopted Names Council [Source: SME Defined] Example: acetaminophen


            The actual name.

            ShortUSANThe actual name
            Control1..1
            Typestring
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            180. SubstanceDefinition.name:usan.type
            Definition

            Name type, for example 'systematic', 'scientific, 'brand'.

            ShortName type e.g. 'systematic', 'scientific, 'brand'
            Control10..1
            BindingFor example codes, see SubstanceNameTypehttp://hl7.org/fhir/ValueSet/substance-name-type
            (example to http://hl7.org/fhir/ValueSet/substance-name-type)

            The type of a name given to a substance.

            TypeCodeableConcept
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            182. SubstanceDefinition.name:usan.type.coding
            Definition

            A reference to a code defined by a terminology system.

            ShortCode defined by a terminology system
            Comments

            Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

            Control10..1*
            TypeCoding
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Requirements

            Allows for alternative encodings within a code system, and translations to other code systems.

            Pattern Value{
              "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
              "code" : "C96973",
              "display" : "USAN"
            }
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            184. SubstanceDefinition.name:usan.preferred
            Definition

            If this is the preferred name for this substance.

            ShortIf this is the preferred name for this substance
            Control0..1
            Typeboolean
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supporttrue
            Summarytrue
            Meaning if MissingIf this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            186. SubstanceDefinition.name:iupac
            Slice Nameiupac
            Definition

            Names applicable to this substance.

            ShortNames applicable to this substance
            Control0..1*
            TypeBackboneElement
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            188. SubstanceDefinition.name:iupac.modifierExtension
            Definition

            May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

            Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

            ShortExtensions that cannot be ignored even if unrecognized
            Comments

            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

            Control0..*
            TypeExtension
            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
            Summarytrue
            Requirements

            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

            Alternate Namesextensions, user content, modifiers
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            190. SubstanceDefinition.name:iupac.name
            Definition

            A name assigned to a chemical substance according to the systematic nomenclature rules defined by the International Union of Pure and Applied Chemistry (IUPAC) [Source: SME Defined] Example: N- (4-hydroxyphenyl)acetamide


            The actual name.

            ShortIUPAC NameThe actual name
            Control1..1
            Typestring
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            192. SubstanceDefinition.name:iupac.type
            Definition

            Name type, for example 'systematic', 'scientific, 'brand'.

            ShortName type e.g. 'systematic', 'scientific, 'brand'
            Control10..1
            BindingFor example codes, see SubstanceNameTypehttp://hl7.org/fhir/ValueSet/substance-name-type
            (example to http://hl7.org/fhir/ValueSet/substance-name-type)

            The type of a name given to a substance.

            TypeCodeableConcept
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            194. SubstanceDefinition.name:iupac.type.coding
            Definition

            A reference to a code defined by a terminology system.

            ShortCode defined by a terminology system
            Comments

            Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

            Control10..1*
            TypeCoding
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Requirements

            Allows for alternative encodings within a code system, and translations to other code systems.

            Pattern Value{
              "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
              "code" : "C203356",
              "display" : "IUPAC Name"
            }
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            196. SubstanceDefinition.name:iupac.preferred
            Definition

            If this is the preferred name for this substance.

            ShortIf this is the preferred name for this substance
            Control0..1
            Typeboolean
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supporttrue
            Summarytrue
            Meaning if MissingIf this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            198. SubstanceDefinition.name:isbt
            Slice Nameisbt
            Definition

            Names applicable to this substance.

            ShortNames applicable to this substance
            Control0..1*
            TypeBackboneElement
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            200. SubstanceDefinition.name:isbt.modifierExtension
            Definition

            May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

            Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

            ShortExtensions that cannot be ignored even if unrecognized
            Comments

            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

            Control0..*
            TypeExtension
            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
            Summarytrue
            Requirements

            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

            Alternate Namesextensions, user content, modifiers
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            202. SubstanceDefinition.name:isbt.name
            Definition

            It is the global standard for the terminology, identification, coding and labeling of medical products of human origin (including blood, cell, tissue, milk, and organ products). [Source: https://www.iccbba.org/]


            The actual name.

            ShortISBT-128 DINThe actual name
            Control1..1
            Typestring
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            204. SubstanceDefinition.name:isbt.type
            Definition

            Name type, for example 'systematic', 'scientific, 'brand'.

            ShortName type e.g. 'systematic', 'scientific, 'brand'
            Control10..1
            BindingFor example codes, see SubstanceNameTypehttp://hl7.org/fhir/ValueSet/substance-name-type
            (example to http://hl7.org/fhir/ValueSet/substance-name-type)

            The type of a name given to a substance.

            TypeCodeableConcept
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            206. SubstanceDefinition.name:isbt.type.coding
            Definition

            A reference to a code defined by a terminology system.

            ShortCode defined by a terminology system
            Comments

            Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

            Control10..1*
            TypeCoding
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Requirements

            Allows for alternative encodings within a code system, and translations to other code systems.

            Pattern Value{
              "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
              "code" : "C95517",
              "display" : "ISBT-128 DIN"
            }
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            208. SubstanceDefinition.name:isbt.preferred
            Definition

            If this is the preferred name for this substance.

            ShortIf this is the preferred name for this substance
            Control0..1
            Typeboolean
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supporttrue
            Summarytrue
            Meaning if MissingIf this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            210. SubstanceDefinition.relationship
            Definition

            A link between this substance and another, with details of the relationship.

            ShortA link between this substance and another
            Control0..*
            TypeBackboneElement
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            212. SubstanceDefinition.relationship.modifierExtension
            Definition

            May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

            Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

            ShortExtensions that cannot be ignored even if unrecognized
            Comments

            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

            Control0..*
            TypeExtension
            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
            Summarytrue
            Requirements

            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

            Alternate Namesextensions, user content, modifiers
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            214. SubstanceDefinition.relationship.substanceDefinition[x]
            Definition

            A pointer to another substance, as a resource or just a representational code.

            ShortA pointer to another substance, as a resource or a representational code
            Control0..1
            TypeChoice of: Reference(SubstanceDefinition), CodeableConcept
            [x] NoteSee Choice of Data Types for further information about how to use [x]
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            SlicingThis element introduces a set of slices on SubstanceDefinition.relationship.substanceDefinition[x]. The slices are unordered and Open, and can be differentiated using the following discriminators:
            • type @ $this
            • 216. SubstanceDefinition.relationship.substanceDefinition[x]:substanceDefinitionReference
              Slice NamesubstanceDefinitionReference
              Definition

              A pointer to another substance, as a resource or just a representational code.

              ShortThe substance definition of a polyphorm of the Drug SubstanceA pointer to another substance, as a resource or a representational code
              Control0..1
              TypeReference(Polymorphic Form, SubstanceDefinition), CodeableConcept
              [x] NoteSee Choice of Data Types for further information about how to use [x]
              Is Modifierfalse
              Must Supportfalse
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              218. SubstanceDefinition.relationship.type
              Definition

              For example "salt to parent", "active moiety", "starting material", "polymorph", "impurity of".

              ShortFor example "salt to parent", "active moiety"
              Control1..1
              BindingFor example codes, see SubstanceRelationshipTypehttp://hl7.org/fhir/ValueSet/substance-relationship-type
              (example to http://hl7.org/fhir/ValueSet/substance-relationship-type)

              The relationship between two substance types.

              TypeCodeableConcept
              Is Modifierfalse
              Must Supportfalse
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              220. SubstanceDefinition.relationship.type.text
              Definition

              A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

              ShortPolymorphPlain text representation of the concept
              Comments

              Very often the text is the same as a displayName of one of the codings.

              Control0..1
              Typestring
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Requirements

              The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

              Pattern ValuePolymorph
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

              Guidance on how to interpret the contents of this table can be found here

              0. SubstanceDefinition
              Definition

              The detailed description of a substance, typically at a level beyond what is used for prescribing.

              ShortThe detailed description of a substance, typically at a level beyond what is used for prescribing
              Control0..*
              Is Modifierfalse
              Must Supportfalse
              Summaryfalse
              Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
              dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
              dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
              dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
              dom-6: A resource should have narrative for robust management (text.`div`.exists())
              cmc-when-unii-required: A UNII is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer','Protein'. (classification.coding.where(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code in ('C48807' | 'C45305' | 'C706' | 'C48803' |'C17021') ).exists() implies code.code.text.exists())
              cmc-name-isbt: Name.type ISBT 128 required for blood products. (classification.where(coding.where(code = '8' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy').exists()).exists() implies name.type.coding.exists(code = '226' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy'))
              cmc-structure-required: A structure is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer','Protein'. (classification.coding.where(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code in ('C48807' | 'C45305' | 'C706' | 'C48803' |'C17021') ).exists() implies structure.exists())
              cmc-substance-structure-graphic-required: A Substance Structure Graphic is required Required for Small Molecules. Equivalent to classification code equals 'Chemical'. ((classification.where(coding.where(code = '1' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy').exists()).exists()) implies structure.representation.exists())
              2. SubstanceDefinition.id
              Definition

              The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

              ShortLogical id of this artifact
              Comments

              Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.

              Control0..1
              Typeid
              Is Modifierfalse
              Must Supportfalse
              Summarytrue
              4. SubstanceDefinition.meta
              Definition

              The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

              ShortMetadata about the resource
              Control0..1
              TypeMeta
              Is Modifierfalse
              Must Supportfalse
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              6. SubstanceDefinition.meta.id
              Definition

              Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

              ShortUnique id for inter-element referencing
              Control0..1
              This element is affected by the following invariants: ele-1
              Typeid
              Is Modifierfalse
              XML FormatIn the XML format, this property is represented as an attribute.
              Summaryfalse
              8. SubstanceDefinition.meta.extension
              Definition

              May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

              ShortAdditional content defined by implementations
              Comments

              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

              Control0..*
              TypeExtension
              Is Modifierfalse
              Summaryfalse
              Alternate Namesextensions, user content
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              SlicingThis element introduces a set of slices on SubstanceDefinition.meta.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
              • value @ url
              • 10. SubstanceDefinition.meta.versionId
                Definition

                The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted.

                ShortVersion specific identifier
                Comments

                The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes.

                Control0..1
                Typeid
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                12. SubstanceDefinition.meta.lastUpdated
                Definition

                When the resource last changed - e.g. when the version changed.

                ShortWhen the resource version last changed
                Comments

                This element is generally omitted in instances submitted in a PUT or POST. Instead, it is populated in the response instance and when retrieving information using a GET. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a read interaction.

                Control0..1
                Typeinstant
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                14. SubstanceDefinition.meta.source
                Definition

                A uri that identifies the source system of the resource. This provides a minimal amount of Provenance information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc.

                ShortIdentifies where the resource comes from
                Comments

                The exact use of the source (and the possible implied Provenance.entity.role and agent.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used. The source may correspond to Provenance.entity.what[x] or Provenance.agent.who[x], though it may be a more general or abstract reference.

                This element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL.

                Control0..1
                Typeuri
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                16. SubstanceDefinition.meta.profile
                Definition

                A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url.

                ShortProfiles this resource claims to conform to
                Comments

                It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.

                Control1..1
                Typecanonical(StructureDefinition)
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Must Supporttrue
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                18. SubstanceDefinition.meta.security
                Definition

                Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure.

                ShortSecurity Labels applied to this resource
                Comments

                The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored.

                Control0..*
                BindingUnless not suitable, these codes SHALL be taken from AllSecurityLabels
                (extensible to http://hl7.org/fhir/ValueSet/security-labels)

                Security Labels from the Healthcare Privacy and Security Classification System.

                TypeCoding
                Is Modifierfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                20. SubstanceDefinition.meta.tag
                Definition

                Tags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource.

                ShortTags applied to this resource
                Comments

                The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored.

                Control0..*
                BindingFor example codes, see CommonTags
                (example to http://hl7.org/fhir/ValueSet/common-tags)

                Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".

                TypeCoding
                Is Modifierfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                22. SubstanceDefinition.implicitRules
                Definition

                A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

                ShortA set of rules under which this content was created
                Comments

                Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.

                Control0..1
                Typeuri
                Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Must Supportfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                24. SubstanceDefinition.language
                Definition

                The base language in which the resource is written.

                ShortLanguage of the resource content
                Comments

                Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

                Control0..1
                BindingThe codes SHALL be taken from AllLanguages
                (required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0)

                IETF language tag for a human language

                Typecode
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Must Supportfalse
                Summaryfalse
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                26. SubstanceDefinition.text
                Definition

                A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

                ShortText summary of the resource, for human interpretation
                Comments

                Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

                Control0..1
                This element is affected by the following invariants: dom-6
                TypeNarrative
                Is Modifierfalse
                Must Supportfalse
                Summaryfalse
                Alternate Namesnarrative, html, xhtml, display
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                28. SubstanceDefinition.contained
                Definition

                These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

                ShortContained, inline Resources
                Comments

                This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.

                Control0..*
                This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
                TypeResource
                Is Modifierfalse
                Must Supportfalse
                Summaryfalse
                Alternate Namesinline resources, anonymous resources, contained resources
                30. SubstanceDefinition.extension
                Definition

                May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                ShortAdditional content defined by implementations
                Comments

                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                Control0..*
                TypeExtension
                Is Modifierfalse
                Must Supportfalse
                Summaryfalse
                Alternate Namesextensions, user content
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                32. SubstanceDefinition.modifierExtension
                Definition

                May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                ShortExtensions that cannot be ignored
                Comments

                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                Control0..*
                TypeExtension
                Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
                Must Supportfalse
                Summarytrue
                Requirements

                Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                Alternate Namesextensions, user content
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                34. SubstanceDefinition.identifier
                Definition

                Identifier by which this substance is known.

                Shortoptional user designated identifier
                NoteThis is a business identifier, not a resource identifier (see discussion)
                Control0..1
                TypeIdentifier
                Is Modifierfalse
                Must Supporttrue
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                36. SubstanceDefinition.version
                Definition

                A business level version identifier of the substance.

                ShortA business level version identifier of the substance
                NoteThis is a business versionId, not a resource version id (see discussion)
                Control0..1
                Typestring
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Must Supportfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                38. SubstanceDefinition.status
                Definition

                Status of substance within the catalogue e.g. active, retired.

                ShortStatus of substance within the catalogue e.g. active, retired
                Control0..1
                BindingThe codes SHOULD be taken from PublicationStatus
                (preferred to http://hl7.org/fhir/ValueSet/publication-status)

                The lifecycle status of an artifact.

                TypeCodeableConcept
                Is Modifierfalse
                Must Supportfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                40. SubstanceDefinition.classification
                Definition

                A controlled vocabulary as provided by the prEN ISO 11238 - Health informatics identification of medicinal products - Structures and controlled vocabularies for drug substances to group drug substances at a relatively high level acording to the Substance and the Substance Preparation Model. [Source: Adapted from 'Logical model of the classification and identification of pharmaceutical and medicinal Products', HL7]

                ShortSubstance Type
                Control1..*
                BindingThe codes SHALL be taken from Substance Classification
                (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/substance-classification)
                TypeCodeableConcept
                Is Modifierfalse
                Must Supporttrue
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                42. SubstanceDefinition.domain
                Definition

                If the substance applies to human or veterinary use.

                ShortIf the substance applies to human or veterinary use
                Control0..1
                BindingFor example codes, see MedicinalProductDomain
                (example to http://hl7.org/fhir/ValueSet/medicinal-product-domain)

                Applicable domain for this product (e.g. human, veterinary).

                TypeCodeableConcept
                Is Modifierfalse
                Must Supportfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                44. SubstanceDefinition.grade
                Definition

                The quality standard, established benchmark, to which substance complies (e.g. USP/NF, Ph. Eur, JP, BP, Company Standard).

                ShortThe quality standard, established benchmark, to which substance complies (e.g. USP/NF, BP)
                Control0..*
                BindingFor example codes, see SubstanceGrade
                (example to http://hl7.org/fhir/ValueSet/substance-grade)

                The quality standard, established benchmark, to which a substance complies

                TypeCodeableConcept
                Is Modifierfalse
                Must Supportfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                46. SubstanceDefinition.description
                Definition

                Textual description of the substance.

                ShortTextual description of the substance
                Control0..1
                Typemarkdown
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Must Supportfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                48. SubstanceDefinition.informationSource
                Definition

                Supporting literature.

                ShortSupporting literature
                Control0..*
                TypeReference(Citation)
                Is Modifierfalse
                Must Supportfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                50. SubstanceDefinition.note
                Definition

                Textual comment about the substance's catalogue or registry record.

                ShortTextual comment about the substance's catalogue or registry record
                Control0..*
                TypeAnnotation
                Is Modifierfalse
                Must Supportfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                52. SubstanceDefinition.manufacturer
                Definition

                The entity that creates, makes, produces or fabricates the substance. This is a set of potential manufacturers but is not necessarily comprehensive.

                ShortThe entity that creates, makes, produces or fabricates the substance
                Control1..1
                TypeReference(Manufacturing and/or Test Site Organization)
                Is Modifierfalse
                Must Supporttrue
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                54. SubstanceDefinition.supplier
                Definition

                An entity that is the source for the substance. It may be different from the manufacturer. Supplier is synonymous to a distributor.

                ShortAn entity that is the source for the substance. It may be different from the manufacturer
                Control0..1
                TypeReference(Supplier Organization)
                Is Modifierfalse
                Must Supporttrue
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                56. SubstanceDefinition.moiety
                Definition

                Moiety, for structural modifications.

                ShortMoiety, for structural modifications
                Control0..*
                TypeBackboneElement
                Is Modifierfalse
                Must Supportfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                58. SubstanceDefinition.moiety.id
                Definition

                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                ShortUnique id for inter-element referencing
                Control0..1
                This element is affected by the following invariants: ele-1
                Typestring
                Is Modifierfalse
                XML FormatIn the XML format, this property is represented as an attribute.
                Summaryfalse
                60. SubstanceDefinition.moiety.extension
                Definition

                May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                ShortAdditional content defined by implementations
                Comments

                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                Control0..*
                TypeExtension
                Is Modifierfalse
                Summaryfalse
                Alternate Namesextensions, user content
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                62. SubstanceDefinition.moiety.modifierExtension
                Definition

                May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                ShortExtensions that cannot be ignored even if unrecognized
                Comments

                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                Control0..*
                TypeExtension
                Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                Summarytrue
                Requirements

                Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                Alternate Namesextensions, user content, modifiers
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                64. SubstanceDefinition.moiety.role
                Definition

                Role that the moiety is playing.

                ShortRole that the moiety is playing
                Control0..1
                TypeCodeableConcept
                Is Modifierfalse
                Must Supportfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                66. SubstanceDefinition.moiety.identifier
                Definition

                Identifier by which this moiety substance is known.

                ShortIdentifier by which this moiety substance is known
                NoteThis is a business identifier, not a resource identifier (see discussion)
                Control0..1
                TypeIdentifier
                Is Modifierfalse
                Must Supportfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                68. SubstanceDefinition.moiety.name
                Definition

                Textual name for this moiety substance.

                ShortTextual name for this moiety substance
                Control0..1
                Typestring
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Must Supportfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                70. SubstanceDefinition.moiety.stereochemistry
                Definition

                Stereochemistry type.

                ShortStereochemistry type
                Control0..1
                BindingFor example codes, see Stereochemistry
                (example to http://hl7.org/fhir/ValueSet/substance-stereochemistry)

                The optical rotation type of a substance.

                TypeCodeableConcept
                Is Modifierfalse
                Must Supportfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                72. SubstanceDefinition.moiety.opticalActivity
                Definition

                Optical activity type.

                ShortOptical activity type
                Control0..1
                BindingFor example codes, see OpticalActivity
                (example to http://hl7.org/fhir/ValueSet/substance-optical-activity)

                The optical rotation type of a substance.

                TypeCodeableConcept
                Is Modifierfalse
                Must Supportfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                74. SubstanceDefinition.moiety.molecularFormula
                Definition

                Molecular formula for this moiety of this substance, typically using the Hill system.

                ShortMolecular formula for this moiety (e.g. with the Hill system)
                Control0..1
                Typestring
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Must Supportfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                76. SubstanceDefinition.moiety.amount[x]
                Definition

                Quantitative value for this moiety.

                ShortQuantitative value for this moiety
                Control0..1
                TypeChoice of: Quantity, string
                [x] NoteSee Choice of Data Types for further information about how to use [x]
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Must Supportfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                78. SubstanceDefinition.moiety.measurementType
                Definition

                The measurement type of the quantitative value. In capturing the actual relative amounts of substances or molecular fragments it may be necessary to indicate whether the amount refers to, for example, a mole ratio or weight ratio.

                ShortThe measurement type of the quantitative value
                Control0..1
                BindingFor example codes, see SubstanceAmountType
                (example to http://hl7.org/fhir/ValueSet/substance-amount-type)

                The relationship between two substance types.

                TypeCodeableConcept
                Is Modifierfalse
                Must Supportfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                80. SubstanceDefinition.characterization
                Definition

                General specifications for this substance.

                ShortGeneral specifications for this substance
                Control0..*
                TypeBackboneElement
                Is Modifierfalse
                Must Supportfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                82. SubstanceDefinition.characterization.id
                Definition

                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                ShortUnique id for inter-element referencing
                Control0..1
                This element is affected by the following invariants: ele-1
                Typestring
                Is Modifierfalse
                XML FormatIn the XML format, this property is represented as an attribute.
                Summaryfalse
                84. SubstanceDefinition.characterization.extension
                Definition

                May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                ShortAdditional content defined by implementations
                Comments

                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                Control0..*
                TypeExtension
                Is Modifierfalse
                Summaryfalse
                Alternate Namesextensions, user content
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                86. SubstanceDefinition.characterization.modifierExtension
                Definition

                May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                ShortExtensions that cannot be ignored even if unrecognized
                Comments

                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                Control0..*
                TypeExtension
                Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                Summarytrue
                Requirements

                Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                Alternate Namesextensions, user content, modifiers
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                88. SubstanceDefinition.characterization.technique
                Definition

                The method used to elucidate the characterization of the drug substance. Example: HPLC.

                ShortThe method used to find the characterization e.g. HPLC
                Control0..1
                BindingFor example codes, see StructureTechnique
                (example to http://hl7.org/fhir/ValueSet/substance-structure-technique)

                The method used to elucidate the characterization of the drug substance.

                TypeCodeableConcept
                Is Modifierfalse
                Must Supportfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                90. SubstanceDefinition.characterization.form
                Definition

                Describes the nature of the chemical entity and explains, for instance, whether this is a base or a salt form.

                ShortDescribes the nature of the chemical entity and explains, for instance, whether this is a base or a salt form
                Control0..1
                BindingFor example codes, see SubstanceForm
                (example to http://hl7.org/fhir/ValueSet/substance-form)
                TypeCodeableConcept
                Is Modifierfalse
                Must Supportfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                92. SubstanceDefinition.characterization.description
                Definition

                The description or justification in support of the interpretation of the data file.

                ShortThe description or justification in support of the interpretation of the data file
                Control0..1
                Typemarkdown
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Must Supportfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                94. SubstanceDefinition.characterization.file
                Definition

                The data produced by the analytical instrument or a pictorial representation of that data. Examples: a JCAMP, JDX, or ADX file, or a chromatogram or spectrum analysis.

                ShortThe data produced by the analytical instrument or a pictorial representation of that data. Examples: a JCAMP, JDX, or ADX file, or a chromatogram or spectrum analysis
                Control0..*
                TypeAttachment
                Is Modifierfalse
                Must Supportfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                96. SubstanceDefinition.property
                Definition

                General specifications for this substance.

                ShortGeneral specifications for this substance
                Control0..*
                TypeBackboneElement
                Is Modifierfalse
                Must Supportfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                98. SubstanceDefinition.property.id
                Definition

                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                ShortUnique id for inter-element referencing
                Control0..1
                This element is affected by the following invariants: ele-1
                Typestring
                Is Modifierfalse
                XML FormatIn the XML format, this property is represented as an attribute.
                Summaryfalse
                100. SubstanceDefinition.property.extension
                Definition

                May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                ShortAdditional content defined by implementations
                Comments

                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                Control0..*
                TypeExtension
                Is Modifierfalse
                Summaryfalse
                Alternate Namesextensions, user content
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                102. SubstanceDefinition.property.modifierExtension
                Definition

                May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                ShortExtensions that cannot be ignored even if unrecognized
                Comments

                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                Control0..*
                TypeExtension
                Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                Summarytrue
                Requirements

                Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                Alternate Namesextensions, user content, modifiers
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                104. SubstanceDefinition.property.type
                Definition

                A code expressing the type of property.

                ShortA code expressing the type of property
                Control1..1
                BindingFor example codes, see ProductCharacteristic
                (example to http://hl7.org/fhir/ValueSet/product-characteristic-codes)

                This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.

                TypeCodeableConcept
                Is Modifierfalse
                Must Supportfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                106. SubstanceDefinition.property.value[x]
                Definition

                A value for the property.

                ShortA value for the property
                Control0..1
                TypeChoice of: CodeableConcept, Quantity, date, boolean, Attachment
                [x] NoteSee Choice of Data Types for further information about how to use [x]
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Must Supportfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                108. SubstanceDefinition.referenceInformation
                Definition

                General information detailing this substance.

                ShortGeneral information detailing this substance
                Control0..1
                TypeReference(SubstanceReferenceInformation)
                Is Modifierfalse
                Must Supportfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                110. SubstanceDefinition.molecularWeight
                Definition

                The average mass of a molecule of a compound compared to ¹/₁₂ the mass of carbon 12 and calculated as the sum of the atomic weights of the constituent atoms. [Source: Merriam Webster]

                ShortMolecular Weight
                Control0..1
                TypeBackboneElement
                Is Modifierfalse
                Must Supporttrue
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                112. SubstanceDefinition.molecularWeight.id
                Definition

                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                ShortUnique id for inter-element referencing
                Control0..1
                This element is affected by the following invariants: ele-1
                Typestring
                Is Modifierfalse
                XML FormatIn the XML format, this property is represented as an attribute.
                Summaryfalse
                114. SubstanceDefinition.molecularWeight.extension
                Definition

                May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                ShortAdditional content defined by implementations
                Comments

                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                Control0..*
                TypeExtension
                Is Modifierfalse
                Summaryfalse
                Alternate Namesextensions, user content
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                116. SubstanceDefinition.molecularWeight.modifierExtension
                Definition

                May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                ShortExtensions that cannot be ignored even if unrecognized
                Comments

                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                Control0..*
                TypeExtension
                Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                Summarytrue
                Requirements

                Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                Alternate Namesextensions, user content, modifiers
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                118. SubstanceDefinition.molecularWeight.method
                Definition

                The method by which the molecular weight was determined.

                ShortThe method by which the weight was determined
                Control0..1
                BindingFor example codes, see WeightMethod
                (example to http://hl7.org/fhir/ValueSet/substance-weight-method)

                The method by which the substance weight was measured.

                TypeCodeableConcept
                Is Modifierfalse
                Must Supportfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                120. SubstanceDefinition.molecularWeight.type
                Definition

                Type of molecular weight such as exact, average (also known as. number average), weight average.

                ShortType of molecular weight e.g. exact, average, weight average
                Control0..1
                BindingFor example codes, see WeightType
                (example to http://hl7.org/fhir/ValueSet/substance-weight-type)

                The type of substance weight measurement.

                TypeCodeableConcept
                Is Modifierfalse
                Must Supportfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                122. SubstanceDefinition.molecularWeight.amount
                Definition

                Used to capture quantitative values for a variety of elements. If only limits are given, the arithmetic mean would be the average. If only a single definite value for a given element is given, it would be captured in this field.

                ShortUsed to capture quantitative values for a variety of elements
                Control1..1
                TypeQuantity
                Is Modifierfalse
                Must Supporttrue
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                124. SubstanceDefinition.molecularWeight.amount.id
                Definition

                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                ShortUnique id for inter-element referencing
                Control0..1
                This element is affected by the following invariants: ele-1
                Typeid
                Is Modifierfalse
                XML FormatIn the XML format, this property is represented as an attribute.
                Summaryfalse
                126. SubstanceDefinition.molecularWeight.amount.extension
                Definition

                May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                ShortAdditional content defined by implementations
                Comments

                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                Control0..*
                TypeExtension
                Is Modifierfalse
                Summaryfalse
                Alternate Namesextensions, user content
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                SlicingThis element introduces a set of slices on SubstanceDefinition.molecularWeight.amount.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
                • value @ url
                • 128. SubstanceDefinition.molecularWeight.amount.value
                  Definition

                  The value of the measured amount. The value includes an implicit precision in the presentation of the value.

                  ShortNumerical value (with implicit precision)
                  Comments

                  The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).

                  Control0..1
                  Typedecimal
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Summarytrue
                  Requirements

                  Precision is handled implicitly in almost all cases of measurement.

                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  130. SubstanceDefinition.molecularWeight.amount.comparator
                  Definition

                  How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.

                  Short< | <= | >= | > | ad - how to understand the value
                  Control0..1
                  BindingThe codes SHALL be taken from QuantityComparator
                  (required to http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0)

                  How the Quantity should be understood and represented.

                  Typecode
                  Is Modifiertrue because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Summarytrue
                  Requirements

                  Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.

                  Meaning if MissingIf there is no comparator, then there is no modification of the value
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  132. SubstanceDefinition.molecularWeight.amount.unit
                  Definition

                  The labeled unit of measure for the molecular weight. [Source: Adapted for NCI EVS C117055]

                  ShortMolecular Weight UOM
                  Control0..1
                  Typestring
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Summarytrue
                  Requirements

                  There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.

                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  134. SubstanceDefinition.molecularWeight.amount.system
                  Definition

                  The identification of the system that provides the coded form of the unit.

                  ShortSystem that defines coded unit form
                  Control0..1
                  This element is affected by the following invariants: qty-3
                  Typeuri
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Summarytrue
                  Requirements

                  Need to know the system that defines the coded form of the unit.

                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  136. SubstanceDefinition.molecularWeight.amount.code
                  Definition

                  A computer processable form of the unit in some unit representation system.

                  ShortCoded form of the unit
                  Comments

                  The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.

                  Control1..1
                  This element is affected by the following invariants: qty-3
                  BindingThe codes SHALL be taken from Units Of Measure Terminology
                  (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology)
                  Typecode
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Must Supporttrue
                  Summarytrue
                  Requirements

                  Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.

                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  138. SubstanceDefinition.structure
                  Definition

                  Structural information.

                  ShortStructural information
                  Control1..1
                  TypeBackboneElement
                  Is Modifierfalse
                  Must Supporttrue
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  140. SubstanceDefinition.structure.id
                  Definition

                  Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                  ShortUnique id for inter-element referencing
                  Control0..1
                  This element is affected by the following invariants: ele-1
                  Typestring
                  Is Modifierfalse
                  XML FormatIn the XML format, this property is represented as an attribute.
                  Summaryfalse
                  142. SubstanceDefinition.structure.extension
                  Definition

                  May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                  ShortAdditional content defined by implementations
                  Comments

                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                  Control0..*
                  TypeExtension
                  Is Modifierfalse
                  Summaryfalse
                  Alternate Namesextensions, user content
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                  144. SubstanceDefinition.structure.modifierExtension
                  Definition

                  May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                  Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                  ShortExtensions that cannot be ignored even if unrecognized
                  Comments

                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                  Control0..*
                  TypeExtension
                  Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                  Summarytrue
                  Requirements

                  Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                  Alternate Namesextensions, user content, modifiers
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                  146. SubstanceDefinition.structure.stereochemistry
                  Definition

                  Stereochemistry type.

                  ShortStereochemistry type
                  Control0..1
                  BindingFor example codes, see Stereochemistry
                  (example to http://hl7.org/fhir/ValueSet/substance-stereochemistry)

                  The optical rotation type of a substance.

                  TypeCodeableConcept
                  Is Modifierfalse
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  148. SubstanceDefinition.structure.opticalActivity
                  Definition

                  Optical activity type.

                  ShortOptical activity type
                  Control0..1
                  BindingFor example codes, see OpticalActivity
                  (example to http://hl7.org/fhir/ValueSet/substance-optical-activity)

                  The optical rotation type of a substance.

                  TypeCodeableConcept
                  Is Modifierfalse
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  150. SubstanceDefinition.structure.molecularFormula
                  Definition

                  Molecular Formula: An expression which states the number and type of atoms present in a molecule of a substance or sequence for biotechnology products. [Source: SME Defined] Biopolymer Sequence: TBD

                  ShortMolecular Formula | Biopolymer Sequence
                  Control0..1
                  Typestring
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Must Supporttrue
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  152. SubstanceDefinition.structure.molecularFormulaByMoiety
                  Definition

                  Specified per moiety according to the Hill system, i.e. first C, then H, then alphabetical, each moiety separated by a dot.

                  ShortSpecified per moiety according to the Hill system
                  Control0..1
                  Typestring
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  154. SubstanceDefinition.structure.molecularWeight
                  Definition

                  The molecular weight or weight range (for proteins, polymers or nucleic acids).

                  ShortThe molecular weight or weight range
                  Control0..1
                  TypeSee ttp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.molecularWeight
                  Is Modifierfalse
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  156. SubstanceDefinition.structure.technique
                  Definition

                  The technique used to elucidate the structure or characterization of the drug substance. [Source: SME Defined] Examples: x-ray, HPLC, NMR, peptide mapping, ligand binding assay.

                  ShortSubstance Characterization Technique
                  Control1..1
                  BindingFor example codes, see StructureTechnique
                  (example to http://hl7.org/fhir/ValueSet/substance-structure-technique)

                  The method used to elucidate the structure of the drug substance.

                  TypeCodeableConcept
                  Is Modifierfalse
                  Must Supporttrue
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  158. SubstanceDefinition.structure.technique.id
                  Definition

                  Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                  ShortUnique id for inter-element referencing
                  Control0..1
                  This element is affected by the following invariants: ele-1
                  Typeid
                  Is Modifierfalse
                  XML FormatIn the XML format, this property is represented as an attribute.
                  Summaryfalse
                  160. SubstanceDefinition.structure.technique.extension
                  Definition

                  May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                  ShortAdditional content defined by implementations
                  Comments

                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                  Control0..*
                  TypeExtension
                  Is Modifierfalse
                  Summaryfalse
                  Alternate Namesextensions, user content
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                  SlicingThis element introduces a set of slices on SubstanceDefinition.structure.technique.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
                  • value @ url
                  • 162. SubstanceDefinition.structure.technique.coding
                    Definition

                    A reference to a code defined by a terminology system.

                    ShortCode defined by a terminology system
                    Comments

                    Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                    Control0..*
                    TypeCoding
                    Is Modifierfalse
                    Summarytrue
                    Requirements

                    Allows for alternative encodings within a code system, and translations to other code systems.

                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    164. SubstanceDefinition.structure.technique.text
                    Definition

                    A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                    ShortPlain text representation of the concept
                    Comments

                    Very often the text is the same as a displayName of one of the codings.

                    Control1..1
                    Typestring
                    Is Modifierfalse
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Must Supporttrue
                    Summarytrue
                    Requirements

                    The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    166. SubstanceDefinition.structure.sourceDocument
                    Definition

                    The source of information about the structure.

                    ShortSource of information for the structure
                    Control0..*
                    TypeReference(DocumentReference)
                    Is Modifierfalse
                    Must Supportfalse
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    168. SubstanceDefinition.structure.representation
                    Definition

                    A depiction of the structure of the substance.

                    ShortA depiction of the structure of the substance
                    Control1..*
                    TypeBackboneElement
                    Is Modifierfalse
                    Must Supporttrue
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    170. SubstanceDefinition.structure.representation.id
                    Definition

                    Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                    ShortUnique id for inter-element referencing
                    Control0..1
                    This element is affected by the following invariants: ele-1
                    Typestring
                    Is Modifierfalse
                    XML FormatIn the XML format, this property is represented as an attribute.
                    Summaryfalse
                    172. SubstanceDefinition.structure.representation.extension
                    Definition

                    May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                    ShortAdditional content defined by implementations
                    Comments

                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                    Control0..*
                    TypeExtension
                    Is Modifierfalse
                    Summaryfalse
                    Alternate Namesextensions, user content
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                    174. SubstanceDefinition.structure.representation.modifierExtension
                    Definition

                    May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                    ShortExtensions that cannot be ignored even if unrecognized
                    Comments

                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                    Control0..*
                    TypeExtension
                    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                    Summarytrue
                    Requirements

                    Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                    Alternate Namesextensions, user content, modifiers
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                    176. SubstanceDefinition.structure.representation.type
                    Definition

                    The kind of structural representation (e.g. full, partial).

                    ShortThe kind of structural representation (e.g. full, partial)
                    Control0..1
                    BindingFor example codes, see SubstanceRepresentationType
                    (example to http://hl7.org/fhir/ValueSet/substance-representation-type)

                    A format of a substance representation.

                    TypeCodeableConcept
                    Is Modifierfalse
                    Must Supportfalse
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    178. SubstanceDefinition.structure.representation.representation
                    Definition

                    A machine-readable representation of the structure of the chemical. [Source: SME Defined] Examples: SDF, MOLFILE, InChI file (small molecule), PDB, mmCIF (large molecules), HELM.

                    ShortDrug Substance Structural Representation
                    Control0..1
                    Typestring
                    Is Modifierfalse
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Must Supporttrue
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    180. SubstanceDefinition.structure.representation.format
                    Definition

                    A format name or abbreviation that identifies a file structure. [Source: SME Defined] Examples: SMILES, MOLFILE, HELM, etc.

                    ShortStructural Representation Type
                    Control0..1
                    BindingFor example codes, see SubstanceRepresentationFormat
                    (example to http://hl7.org/fhir/ValueSet/substance-representation-format)

                    A format of a substance representation.

                    TypeCodeableConcept
                    Is Modifierfalse
                    Must Supporttrue
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    182. SubstanceDefinition.structure.representation.format.id
                    Definition

                    Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                    ShortUnique id for inter-element referencing
                    Control0..1
                    This element is affected by the following invariants: ele-1
                    Typeid
                    Is Modifierfalse
                    XML FormatIn the XML format, this property is represented as an attribute.
                    Summaryfalse
                    184. SubstanceDefinition.structure.representation.format.extension
                    Definition

                    May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                    ShortAdditional content defined by implementations
                    Comments

                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                    Control0..*
                    TypeExtension
                    Is Modifierfalse
                    Summaryfalse
                    Alternate Namesextensions, user content
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                    SlicingThis element introduces a set of slices on SubstanceDefinition.structure.representation.format.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
                    • value @ url
                    • 186. SubstanceDefinition.structure.representation.format.coding
                      Definition

                      A reference to a code defined by a terminology system.

                      ShortCode defined by a terminology system
                      Comments

                      Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                      Control0..*
                      BindingThe codes SHALL be taken from Chemical Structure Data File Type Terminology
                      (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-chemical-structure-datafile-type-terminology)
                      TypeCoding
                      Is Modifierfalse
                      Summarytrue
                      Requirements

                      Allows for alternative encodings within a code system, and translations to other code systems.

                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      188. SubstanceDefinition.structure.representation.format.text
                      Definition

                      A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                      ShortPlain text representation of the concept
                      Comments

                      Very often the text is the same as a displayName of one of the codings.

                      Control0..1
                      Typestring
                      Is Modifierfalse
                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                      Summarytrue
                      Requirements

                      The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      190. SubstanceDefinition.structure.representation.document
                      Definition

                      A pictorial representation of the structure of the drug substance. [Source: SME Defined] Note: Refer to the 'Acceptable File Formats for use in eCTD' Example: This is the representation of the molecule CH3OH, or the sequence SHLVEALALVAGERG.

                      ShortSubstance Structure Graphic
                      Control0..1
                      TypeReference(Document Reference Attachment)
                      Is Modifierfalse
                      Must Supporttrue
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      192. SubstanceDefinition.code
                      Definition

                      Implementation Note: the cardinality represents the business rule for unii, uniprot, or some other code being required

                      ShortCodes associated with the substance
                      Control1..*
                      TypeBackboneElement
                      Is Modifierfalse
                      Must Supporttrue
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      194. SubstanceDefinition.code.id
                      Definition

                      Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                      ShortUnique id for inter-element referencing
                      Control0..1
                      This element is affected by the following invariants: ele-1
                      Typestring
                      Is Modifierfalse
                      XML FormatIn the XML format, this property is represented as an attribute.
                      Summaryfalse
                      196. SubstanceDefinition.code.extension
                      Definition

                      May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                      ShortAdditional content defined by implementations
                      Comments

                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                      Control0..*
                      TypeExtension
                      Is Modifierfalse
                      Summaryfalse
                      Alternate Namesextensions, user content
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                      198. SubstanceDefinition.code.modifierExtension
                      Definition

                      May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                      Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                      ShortExtensions that cannot be ignored even if unrecognized
                      Comments

                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                      Control0..*
                      TypeExtension
                      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                      Summarytrue
                      Requirements

                      Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                      Alternate Namesextensions, user content, modifiers
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                      200. SubstanceDefinition.code.code
                      Definition

                      The specific code.

                      ShortThe specific code
                      Control1..1
                      TypeCodeableConcept
                      Is Modifierfalse
                      Must Supporttrue
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      202. SubstanceDefinition.code.code.id
                      Definition

                      Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                      ShortUnique id for inter-element referencing
                      Control0..1
                      This element is affected by the following invariants: ele-1
                      Typeid
                      Is Modifierfalse
                      XML FormatIn the XML format, this property is represented as an attribute.
                      Summaryfalse
                      204. SubstanceDefinition.code.code.extension
                      Definition

                      May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                      ShortAdditional content defined by implementations
                      Comments

                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                      Control0..*
                      TypeExtension
                      Is Modifierfalse
                      Summaryfalse
                      Alternate Namesextensions, user content
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                      SlicingThis element introduces a set of slices on SubstanceDefinition.code.code.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
                      • value @ url
                      • 206. SubstanceDefinition.code.code.coding
                        Definition

                        A reference to a code defined by a terminology system.

                        ShortCode defined by a terminology system
                        Comments

                        Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                        Control0..*
                        TypeCoding
                        Is Modifierfalse
                        Summarytrue
                        Requirements

                        Allows for alternative encodings within a code system, and translations to other code systems.

                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        SlicingThis element introduces a set of slices on SubstanceDefinition.code.code.coding. The slices are unordered and Open, and can be differentiated using the following discriminators:
                        • value @ system
                        • 208. SubstanceDefinition.code.code.coding:unii
                          Slice Nameunii
                          Definition

                          The UNII is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. [Source: http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem-UniqueIngredientIdentifierUNII/] Example: 362O9ITL9D Note: If a UNII does not exist, please go to http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem-UniqueIngredientIdentifierUNII/

                          ShortUNII
                          Comments

                          Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                          Control0..1
                          TypeCoding
                          Is Modifierfalse
                          Summarytrue
                          Requirements

                          Allows for alternative encodings within a code system, and translations to other code systems.

                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          210. SubstanceDefinition.code.code.coding:unii.id
                          Definition

                          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                          ShortUnique id for inter-element referencing
                          Control0..1
                          This element is affected by the following invariants: ele-1
                          Typeid
                          Is Modifierfalse
                          XML FormatIn the XML format, this property is represented as an attribute.
                          Summaryfalse
                          212. SubstanceDefinition.code.code.coding:unii.extension
                          Definition

                          May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                          ShortAdditional content defined by implementations
                          Comments

                          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                          Control0..*
                          TypeExtension
                          Is Modifierfalse
                          Summaryfalse
                          Alternate Namesextensions, user content
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                          SlicingThis element introduces a set of slices on SubstanceDefinition.code.code.coding.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
                          • value @ url
                          • 214. SubstanceDefinition.code.code.coding:unii.system
                            Definition

                            The identification of the code system that defines the meaning of the symbol in the code.

                            ShortIdentity of the terminology system
                            Comments

                            The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously.

                            Control1..1
                            Typeuri
                            Is Modifierfalse
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Summarytrue
                            Requirements

                            Need to be unambiguous about the source of the definition of the symbol.

                            Pattern Valuehttp://fdasis.nlm.nih.gov
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            216. SubstanceDefinition.code.code.coding:unii.version
                            Definition

                            The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

                            ShortVersion of the system - if relevant
                            Comments

                            Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

                            NoteThis is a business versionId, not a resource version id (see discussion)
                            Control0..1
                            Typestring
                            Is Modifierfalse
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Summarytrue
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            218. SubstanceDefinition.code.code.coding:unii.code
                            Definition

                            A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

                            ShortSymbol in syntax defined by the system
                            Control0..1
                            This element is affected by the following invariants: cod-1
                            Typecode
                            Is Modifierfalse
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Summarytrue
                            Requirements

                            Need to refer to a particular code in the system.

                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            220. SubstanceDefinition.code.code.coding:unii.display
                            Definition

                            A representation of the meaning of the code in the system, following the rules of the system.

                            ShortRepresentation defined by the system
                            Control0..1
                            This element is affected by the following invariants: cod-1
                            Typestring
                            Is Modifierfalse
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Summarytrue
                            Requirements

                            Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            222. SubstanceDefinition.code.code.coding:unii.userSelected
                            Definition

                            Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

                            ShortIf this coding was chosen directly by the user
                            Comments

                            Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

                            Control0..1
                            Typeboolean
                            Is Modifierfalse
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Summarytrue
                            Requirements

                            This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            224. SubstanceDefinition.code.code.coding:uniProt
                            Slice NameuniProt
                            Definition

                            The UniProt ID is an index to the UniProt knowledgebase, a large resource of protein sequences and associated detailed annotation. It is accessible at https://www.uniprot.org/

                            ShortUniProt ID
                            Comments

                            Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                            Control0..1
                            TypeCoding
                            Is Modifierfalse
                            Summarytrue
                            Requirements

                            Allows for alternative encodings within a code system, and translations to other code systems.

                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            226. SubstanceDefinition.code.code.coding:uniProt.id
                            Definition

                            Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                            ShortUnique id for inter-element referencing
                            Control0..1
                            This element is affected by the following invariants: ele-1
                            Typeid
                            Is Modifierfalse
                            XML FormatIn the XML format, this property is represented as an attribute.
                            Summaryfalse
                            228. SubstanceDefinition.code.code.coding:uniProt.extension
                            Definition

                            May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                            ShortAdditional content defined by implementations
                            Comments

                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                            Control0..*
                            TypeExtension
                            Is Modifierfalse
                            Summaryfalse
                            Alternate Namesextensions, user content
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                            SlicingThis element introduces a set of slices on SubstanceDefinition.code.code.coding.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
                            • value @ url
                            • 230. SubstanceDefinition.code.code.coding:uniProt.system
                              Definition

                              The identification of the code system that defines the meaning of the symbol in the code.

                              ShortIdentity of the terminology system
                              Comments

                              The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously.

                              Control1..1
                              Typeuri
                              Is Modifierfalse
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Summarytrue
                              Requirements

                              Need to be unambiguous about the source of the definition of the symbol.

                              Pattern Valuehttps://www.uniprot.org
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              232. SubstanceDefinition.code.code.coding:uniProt.version
                              Definition

                              The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

                              ShortVersion of the system - if relevant
                              Comments

                              Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

                              NoteThis is a business versionId, not a resource version id (see discussion)
                              Control0..1
                              Typestring
                              Is Modifierfalse
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Summarytrue
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              234. SubstanceDefinition.code.code.coding:uniProt.code
                              Definition

                              A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

                              ShortSymbol in syntax defined by the system
                              Control0..1
                              This element is affected by the following invariants: cod-1
                              Typecode
                              Is Modifierfalse
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Summarytrue
                              Requirements

                              Need to refer to a particular code in the system.

                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              236. SubstanceDefinition.code.code.coding:uniProt.display
                              Definition

                              A representation of the meaning of the code in the system, following the rules of the system.

                              ShortRepresentation defined by the system
                              Control0..1
                              This element is affected by the following invariants: cod-1
                              Typestring
                              Is Modifierfalse
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Summarytrue
                              Requirements

                              Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              238. SubstanceDefinition.code.code.coding:uniProt.userSelected
                              Definition

                              Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

                              ShortIf this coding was chosen directly by the user
                              Comments

                              Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

                              Control0..1
                              Typeboolean
                              Is Modifierfalse
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Summarytrue
                              Requirements

                              This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              240. SubstanceDefinition.code.code.text
                              Definition

                              A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                              ShortPlain text representation of the concept
                              Comments

                              Very often the text is the same as a displayName of one of the codings.

                              Control0..1
                              Typestring
                              Is Modifierfalse
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Summarytrue
                              Requirements

                              The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              242. SubstanceDefinition.code.status
                              Definition

                              Status of the code assignment, for example 'provisional', 'approved'.

                              ShortStatus of the code assignment, for example 'provisional', 'approved'
                              Control0..1
                              BindingThe codes SHOULD be taken from PublicationStatus
                              (preferred to http://hl7.org/fhir/ValueSet/publication-status)

                              The lifecycle status of an artifact.

                              TypeCodeableConcept
                              Is Modifierfalse
                              Must Supportfalse
                              Summarytrue
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              244. SubstanceDefinition.code.statusDate
                              Definition

                              The date at which the code status was changed as part of the terminology maintenance.

                              ShortThe date at which the code status was changed
                              Control0..1
                              TypedateTime
                              Is Modifierfalse
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Must Supportfalse
                              Summarytrue
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              246. SubstanceDefinition.code.note
                              Definition

                              Any comment can be provided in this field, if necessary.

                              ShortAny comment can be provided in this field
                              Control0..*
                              TypeAnnotation
                              Is Modifierfalse
                              Must Supportfalse
                              Summarytrue
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              248. SubstanceDefinition.code.source
                              Definition

                              Supporting literature.

                              ShortSupporting literature
                              Control0..*
                              TypeReference(DocumentReference)
                              Is Modifierfalse
                              Must Supportfalse
                              Summarytrue
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              250. SubstanceDefinition.name
                              Definition

                              Substance Name is identified by its Substance Type. Substance Type: Identifies the source that assigned the product ingredient name. [Source: SME Defined] Examples: GSRS Preferred Term, Systematic Name, INN, USP/NF

                              ShortSubtance Name
                              Control1..*
                              TypeBackboneElement
                              Is Modifierfalse
                              Must Supporttrue
                              Summarytrue
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              cmc-name-preferred: Name.preferred: at most one = true (select(preferred = true).count() < 2)
                              SlicingThis element introduces a set of slices on SubstanceDefinition.name. The slices are unordered and Closed, and can be differentiated using the following discriminators:
                              • value @ type.coding
                              • 252. SubstanceDefinition.name.id
                                Definition

                                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                ShortUnique id for inter-element referencing
                                Control0..1
                                This element is affected by the following invariants: ele-1
                                Typestring
                                Is Modifierfalse
                                XML FormatIn the XML format, this property is represented as an attribute.
                                Summaryfalse
                                254. SubstanceDefinition.name.extension
                                Definition

                                May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                ShortAdditional content defined by implementations
                                Comments

                                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                Control0..*
                                TypeExtension
                                Is Modifierfalse
                                Summaryfalse
                                Alternate Namesextensions, user content
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                256. SubstanceDefinition.name.modifierExtension
                                Definition

                                May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                ShortExtensions that cannot be ignored even if unrecognized
                                Comments

                                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                Control0..*
                                TypeExtension
                                Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                Summarytrue
                                Requirements

                                Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                Alternate Namesextensions, user content, modifiers
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                258. SubstanceDefinition.name.name
                                Definition

                                The actual name.

                                ShortThe actual name
                                Control1..1
                                Typestring
                                Is Modifierfalse
                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                Must Supportfalse
                                Summarytrue
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                260. SubstanceDefinition.name.type
                                Definition

                                Name type, for example 'systematic', 'scientific, 'brand'.

                                ShortName type e.g. 'systematic', 'scientific, 'brand'
                                Control0..1
                                BindingFor example codes, see SubstanceNameType
                                (example to http://hl7.org/fhir/ValueSet/substance-name-type)

                                The type of a name given to a substance.

                                TypeCodeableConcept
                                Is Modifierfalse
                                Must Supportfalse
                                Summarytrue
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                262. SubstanceDefinition.name.status
                                Definition

                                The status of the name, for example 'current', 'proposed'.

                                ShortThe status of the name e.g. 'current', 'proposed'
                                Control0..1
                                BindingThe codes SHOULD be taken from PublicationStatus
                                (preferred to http://hl7.org/fhir/ValueSet/publication-status)

                                The lifecycle status of an artifact.

                                TypeCodeableConcept
                                Is Modifierfalse
                                Must Supportfalse
                                Summarytrue
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                264. SubstanceDefinition.name.preferred
                                Definition

                                If this is the preferred name for this substance.

                                ShortTrue when the name type is Substance Name
                                Control0..1
                                Typeboolean
                                Is Modifierfalse
                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                Must Supporttrue
                                Summarytrue
                                Meaning if MissingIf this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                266. SubstanceDefinition.name.language
                                Definition

                                Human language that the name is written in.

                                ShortHuman language that the name is written in
                                Control0..*
                                BindingThe codes SHALL be taken from AllLanguages
                                (required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0)

                                IETF language tag for a human language

                                TypeCodeableConcept
                                Is Modifierfalse
                                Must Supportfalse
                                Summarytrue
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                268. SubstanceDefinition.name.domain
                                Definition

                                The use context of this name for example if there is a different name a drug active ingredient as opposed to a food colour additive.

                                ShortThe use context of this name e.g. as an active ingredient or as a food colour additive
                                Control0..*
                                BindingFor example codes, see SubstanceNameDomain
                                (example to http://hl7.org/fhir/ValueSet/substance-name-domain)

                                The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive.

                                TypeCodeableConcept
                                Is Modifierfalse
                                Must Supportfalse
                                Summarytrue
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                270. SubstanceDefinition.name.jurisdiction
                                Definition

                                The jurisdiction where this name applies.

                                ShortThe jurisdiction where this name applies
                                Control0..*
                                BindingFor example codes, see JurisdictionValueSet
                                (example to http://hl7.org/fhir/ValueSet/jurisdiction)

                                Jurisdiction codes

                                TypeCodeableConcept
                                Is Modifierfalse
                                Must Supportfalse
                                Summarytrue
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                272. SubstanceDefinition.name.synonym
                                Definition

                                A synonym of this particular name, by which the substance is also known.

                                ShortA synonym of this particular name, by which the substance is also known
                                Control0..*
                                TypeSee ttp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name
                                Is Modifierfalse
                                Must Supportfalse
                                Summarytrue
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                274. SubstanceDefinition.name.translation
                                Definition

                                A translation for this name into another human language.

                                ShortA translation for this name into another human language
                                Control0..*
                                TypeSee ttp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name
                                Is Modifierfalse
                                Must Supportfalse
                                Summarytrue
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                276. SubstanceDefinition.name.official
                                Definition

                                Details of the official nature of this name.

                                ShortDetails of the official nature of this name
                                Control0..*
                                TypeBackboneElement
                                Is Modifierfalse
                                Must Supportfalse
                                Summarytrue
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                278. SubstanceDefinition.name.official.id
                                Definition

                                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                ShortUnique id for inter-element referencing
                                Control0..1
                                This element is affected by the following invariants: ele-1
                                Typestring
                                Is Modifierfalse
                                XML FormatIn the XML format, this property is represented as an attribute.
                                Summaryfalse
                                280. SubstanceDefinition.name.official.extension
                                Definition

                                May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                ShortAdditional content defined by implementations
                                Comments

                                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                Control0..*
                                TypeExtension
                                Is Modifierfalse
                                Summaryfalse
                                Alternate Namesextensions, user content
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                282. SubstanceDefinition.name.official.modifierExtension
                                Definition

                                May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                ShortExtensions that cannot be ignored even if unrecognized
                                Comments

                                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                Control0..*
                                TypeExtension
                                Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                Summarytrue
                                Requirements

                                Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                Alternate Namesextensions, user content, modifiers
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                284. SubstanceDefinition.name.official.authority
                                Definition

                                Which authority uses this official name.

                                ShortWhich authority uses this official name
                                Control0..1
                                BindingThe codes SHOULD be taken from SubstanceNameAuthority
                                (preferred to http://hl7.org/fhir/ValueSet/substance-name-authority)

                                An authority that officates substance names.

                                TypeCodeableConcept
                                Is Modifierfalse
                                Must Supportfalse
                                Summarytrue
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                286. SubstanceDefinition.name.official.status
                                Definition

                                The status of the official name, for example 'draft', 'active', 'retired'.

                                ShortThe status of the official name, for example 'draft', 'active'
                                Control0..1
                                BindingThe codes SHOULD be taken from PublicationStatus
                                (preferred to http://hl7.org/fhir/ValueSet/publication-status)

                                The lifecycle status of an artifact.

                                TypeCodeableConcept
                                Is Modifierfalse
                                Must Supportfalse
                                Summarytrue
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                288. SubstanceDefinition.name.official.date
                                Definition

                                Date of the official name change.

                                ShortDate of official name change
                                Control0..1
                                TypedateTime
                                Is Modifierfalse
                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                Must Supportfalse
                                Summarytrue
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                290. SubstanceDefinition.name.source
                                Definition

                                Supporting literature.

                                ShortSupporting literature
                                Control0..*
                                TypeReference(DocumentReference)
                                Is Modifierfalse
                                Must Supportfalse
                                Summarytrue
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                292. SubstanceDefinition.name:sys
                                Slice Namesys
                                Definition

                                Names applicable to this substance.

                                ShortNames applicable to this substance
                                Control0..1
                                TypeBackboneElement
                                Is Modifierfalse
                                Must Supporttrue
                                Summarytrue
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                294. SubstanceDefinition.name:sys.id
                                Definition

                                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                ShortUnique id for inter-element referencing
                                Control0..1
                                This element is affected by the following invariants: ele-1
                                Typestring
                                Is Modifierfalse
                                XML FormatIn the XML format, this property is represented as an attribute.
                                Summaryfalse
                                296. SubstanceDefinition.name:sys.extension
                                Definition

                                May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                ShortAdditional content defined by implementations
                                Comments

                                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                Control0..*
                                TypeExtension
                                Is Modifierfalse
                                Summaryfalse
                                Alternate Namesextensions, user content
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                298. SubstanceDefinition.name:sys.modifierExtension
                                Definition

                                May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                ShortExtensions that cannot be ignored even if unrecognized
                                Comments

                                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                Control0..*
                                TypeExtension
                                Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                Summarytrue
                                Requirements

                                Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                Alternate Namesextensions, user content, modifiers
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                300. SubstanceDefinition.name:sys.name
                                Definition

                                A name derived directly from the chemical structure. [Source: SME Defined]

                                ShortSystematic
                                Control1..1
                                Typestring
                                Is Modifierfalse
                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                Must Supporttrue
                                Summarytrue
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                302. SubstanceDefinition.name:sys.type
                                Definition

                                Name type, for example 'systematic', 'scientific, 'brand'.

                                ShortName type e.g. 'systematic', 'scientific, 'brand'
                                Control1..1
                                BindingFor example codes, see SubstanceNameType
                                (example to http://hl7.org/fhir/ValueSet/substance-name-type)

                                The type of a name given to a substance.

                                TypeCodeableConcept
                                Is Modifierfalse
                                Must Supporttrue
                                Summarytrue
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                304. SubstanceDefinition.name:sys.type.id
                                Definition

                                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                ShortUnique id for inter-element referencing
                                Control0..1
                                This element is affected by the following invariants: ele-1
                                Typeid
                                Is Modifierfalse
                                XML FormatIn the XML format, this property is represented as an attribute.
                                Summaryfalse
                                306. SubstanceDefinition.name:sys.type.extension
                                Definition

                                May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                ShortAdditional content defined by implementations
                                Comments

                                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                Control0..*
                                TypeExtension
                                Is Modifierfalse
                                Summaryfalse
                                Alternate Namesextensions, user content
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                SlicingThis element introduces a set of slices on SubstanceDefinition.name.type.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
                                • value @ url
                                • 308. SubstanceDefinition.name:sys.type.coding
                                  Definition

                                  A reference to a code defined by a terminology system.

                                  ShortCode defined by a terminology system
                                  Comments

                                  Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                                  Control1..1
                                  TypeCoding
                                  Is Modifierfalse
                                  Must Supporttrue
                                  Summarytrue
                                  Requirements

                                  Allows for alternative encodings within a code system, and translations to other code systems.

                                  Pattern Value{
                                    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
                                    "code" : "C203357",
                                    "display" : "Systematic Name"
                                  }
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  310. SubstanceDefinition.name:sys.type.text
                                  Definition

                                  A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                                  ShortPlain text representation of the concept
                                  Comments

                                  Very often the text is the same as a displayName of one of the codings.

                                  Control0..1
                                  Typestring
                                  Is Modifierfalse
                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                  Summarytrue
                                  Requirements

                                  The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  312. SubstanceDefinition.name:sys.status
                                  Definition

                                  The status of the name, for example 'current', 'proposed'.

                                  ShortThe status of the name e.g. 'current', 'proposed'
                                  Control0..1
                                  BindingThe codes SHOULD be taken from PublicationStatus
                                  (preferred to http://hl7.org/fhir/ValueSet/publication-status)

                                  The lifecycle status of an artifact.

                                  TypeCodeableConcept
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  314. SubstanceDefinition.name:sys.preferred
                                  Definition

                                  If this is the preferred name for this substance.

                                  ShortIf this is the preferred name for this substance
                                  Control0..1
                                  Typeboolean
                                  Is Modifierfalse
                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                  Must Supporttrue
                                  Summarytrue
                                  Meaning if MissingIf this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  316. SubstanceDefinition.name:sys.language
                                  Definition

                                  Human language that the name is written in.

                                  ShortHuman language that the name is written in
                                  Control0..*
                                  BindingThe codes SHALL be taken from AllLanguages
                                  (required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0)

                                  IETF language tag for a human language

                                  TypeCodeableConcept
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  318. SubstanceDefinition.name:sys.domain
                                  Definition

                                  The use context of this name for example if there is a different name a drug active ingredient as opposed to a food colour additive.

                                  ShortThe use context of this name e.g. as an active ingredient or as a food colour additive
                                  Control0..*
                                  BindingFor example codes, see SubstanceNameDomain
                                  (example to http://hl7.org/fhir/ValueSet/substance-name-domain)

                                  The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive.

                                  TypeCodeableConcept
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  320. SubstanceDefinition.name:sys.jurisdiction
                                  Definition

                                  The jurisdiction where this name applies.

                                  ShortThe jurisdiction where this name applies
                                  Control0..*
                                  BindingFor example codes, see JurisdictionValueSet
                                  (example to http://hl7.org/fhir/ValueSet/jurisdiction)

                                  Jurisdiction codes

                                  TypeCodeableConcept
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  322. SubstanceDefinition.name:sys.synonym
                                  Definition

                                  A synonym of this particular name, by which the substance is also known.

                                  ShortA synonym of this particular name, by which the substance is also known
                                  Control0..*
                                  TypeSee ttp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  324. SubstanceDefinition.name:sys.translation
                                  Definition

                                  A translation for this name into another human language.

                                  ShortA translation for this name into another human language
                                  Control0..*
                                  TypeSee ttp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  326. SubstanceDefinition.name:sys.official
                                  Definition

                                  Details of the official nature of this name.

                                  ShortDetails of the official nature of this name
                                  Control0..*
                                  TypeBackboneElement
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  328. SubstanceDefinition.name:sys.official.id
                                  Definition

                                  Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                  ShortUnique id for inter-element referencing
                                  Control0..1
                                  This element is affected by the following invariants: ele-1
                                  Typestring
                                  Is Modifierfalse
                                  XML FormatIn the XML format, this property is represented as an attribute.
                                  Summaryfalse
                                  330. SubstanceDefinition.name:sys.official.extension
                                  Definition

                                  May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                  ShortAdditional content defined by implementations
                                  Comments

                                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                  Control0..*
                                  TypeExtension
                                  Is Modifierfalse
                                  Summaryfalse
                                  Alternate Namesextensions, user content
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                  332. SubstanceDefinition.name:sys.official.modifierExtension
                                  Definition

                                  May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                  Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                  ShortExtensions that cannot be ignored even if unrecognized
                                  Comments

                                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                  Control0..*
                                  TypeExtension
                                  Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                  Summarytrue
                                  Requirements

                                  Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                  Alternate Namesextensions, user content, modifiers
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                  334. SubstanceDefinition.name:sys.official.authority
                                  Definition

                                  Which authority uses this official name.

                                  ShortWhich authority uses this official name
                                  Control0..1
                                  BindingThe codes SHOULD be taken from SubstanceNameAuthority
                                  (preferred to http://hl7.org/fhir/ValueSet/substance-name-authority)

                                  An authority that officates substance names.

                                  TypeCodeableConcept
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  336. SubstanceDefinition.name:sys.official.status
                                  Definition

                                  The status of the official name, for example 'draft', 'active', 'retired'.

                                  ShortThe status of the official name, for example 'draft', 'active'
                                  Control0..1
                                  BindingThe codes SHOULD be taken from PublicationStatus
                                  (preferred to http://hl7.org/fhir/ValueSet/publication-status)

                                  The lifecycle status of an artifact.

                                  TypeCodeableConcept
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  338. SubstanceDefinition.name:sys.official.date
                                  Definition

                                  Date of the official name change.

                                  ShortDate of official name change
                                  Control0..1
                                  TypedateTime
                                  Is Modifierfalse
                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  340. SubstanceDefinition.name:sys.source
                                  Definition

                                  Supporting literature.

                                  ShortSupporting literature
                                  Control0..*
                                  TypeReference(DocumentReference)
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  342. SubstanceDefinition.name:sub
                                  Slice Namesub
                                  Definition

                                  Names applicable to this substance.

                                  ShortNames applicable to this substance
                                  Control0..1
                                  TypeBackboneElement
                                  Is Modifierfalse
                                  Must Supporttrue
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  344. SubstanceDefinition.name:sub.id
                                  Definition

                                  Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                  ShortUnique id for inter-element referencing
                                  Control0..1
                                  This element is affected by the following invariants: ele-1
                                  Typestring
                                  Is Modifierfalse
                                  XML FormatIn the XML format, this property is represented as an attribute.
                                  Summaryfalse
                                  346. SubstanceDefinition.name:sub.extension
                                  Definition

                                  May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                  ShortAdditional content defined by implementations
                                  Comments

                                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                  Control0..*
                                  TypeExtension
                                  Is Modifierfalse
                                  Summaryfalse
                                  Alternate Namesextensions, user content
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                  348. SubstanceDefinition.name:sub.modifierExtension
                                  Definition

                                  May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                  Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                  ShortExtensions that cannot be ignored even if unrecognized
                                  Comments

                                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                  Control0..*
                                  TypeExtension
                                  Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                  Summarytrue
                                  Requirements

                                  Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                  Alternate Namesextensions, user content, modifiers
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                  350. SubstanceDefinition.name:sub.name
                                  Definition

                                  A non-branded nor registered name that meant for common use.

                                  ShortGeneric
                                  Control1..1
                                  Typestring
                                  Is Modifierfalse
                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                  Must Supporttrue
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  352. SubstanceDefinition.name:sub.type
                                  Definition

                                  Name type, for example 'systematic', 'scientific, 'brand'.

                                  ShortName type e.g. 'systematic', 'scientific, 'brand'
                                  Control1..1
                                  BindingFor example codes, see SubstanceNameType
                                  (example to http://hl7.org/fhir/ValueSet/substance-name-type)

                                  The type of a name given to a substance.

                                  TypeCodeableConcept
                                  Is Modifierfalse
                                  Must Supporttrue
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  354. SubstanceDefinition.name:sub.type.id
                                  Definition

                                  Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                  ShortUnique id for inter-element referencing
                                  Control0..1
                                  This element is affected by the following invariants: ele-1
                                  Typeid
                                  Is Modifierfalse
                                  XML FormatIn the XML format, this property is represented as an attribute.
                                  Summaryfalse
                                  356. SubstanceDefinition.name:sub.type.extension
                                  Definition

                                  May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                  ShortAdditional content defined by implementations
                                  Comments

                                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                  Control0..*
                                  TypeExtension
                                  Is Modifierfalse
                                  Summaryfalse
                                  Alternate Namesextensions, user content
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                  SlicingThis element introduces a set of slices on SubstanceDefinition.name.type.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
                                  • value @ url
                                  • 358. SubstanceDefinition.name:sub.type.coding
                                    Definition

                                    A reference to a code defined by a terminology system.

                                    ShortCode defined by a terminology system
                                    Comments

                                    Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                                    Control1..1
                                    TypeCoding
                                    Is Modifierfalse
                                    Must Supporttrue
                                    Summarytrue
                                    Requirements

                                    Allows for alternative encodings within a code system, and translations to other code systems.

                                    Pattern Value{
                                      "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
                                      "code" : "C97054",
                                      "display" : "Generic Name"
                                    }
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    360. SubstanceDefinition.name:sub.type.text
                                    Definition

                                    A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                                    ShortPlain text representation of the concept
                                    Comments

                                    Very often the text is the same as a displayName of one of the codings.

                                    Control0..1
                                    Typestring
                                    Is Modifierfalse
                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                    Summarytrue
                                    Requirements

                                    The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    362. SubstanceDefinition.name:sub.status
                                    Definition

                                    The status of the name, for example 'current', 'proposed'.

                                    ShortThe status of the name e.g. 'current', 'proposed'
                                    Control0..1
                                    BindingThe codes SHOULD be taken from PublicationStatus
                                    (preferred to http://hl7.org/fhir/ValueSet/publication-status)

                                    The lifecycle status of an artifact.

                                    TypeCodeableConcept
                                    Is Modifierfalse
                                    Must Supportfalse
                                    Summarytrue
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    364. SubstanceDefinition.name:sub.preferred
                                    Definition

                                    If this is the preferred name for this substance.

                                    ShortIf this is the preferred name for this substance
                                    Control0..1
                                    Typeboolean
                                    Is Modifierfalse
                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                    Must Supporttrue
                                    Summarytrue
                                    Meaning if MissingIf this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    366. SubstanceDefinition.name:sub.language
                                    Definition

                                    Human language that the name is written in.

                                    ShortHuman language that the name is written in
                                    Control0..*
                                    BindingThe codes SHALL be taken from AllLanguages
                                    (required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0)

                                    IETF language tag for a human language

                                    TypeCodeableConcept
                                    Is Modifierfalse
                                    Must Supportfalse
                                    Summarytrue
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    368. SubstanceDefinition.name:sub.domain
                                    Definition

                                    The use context of this name for example if there is a different name a drug active ingredient as opposed to a food colour additive.

                                    ShortThe use context of this name e.g. as an active ingredient or as a food colour additive
                                    Control0..*
                                    BindingFor example codes, see SubstanceNameDomain
                                    (example to http://hl7.org/fhir/ValueSet/substance-name-domain)

                                    The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive.

                                    TypeCodeableConcept
                                    Is Modifierfalse
                                    Must Supportfalse
                                    Summarytrue
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    370. SubstanceDefinition.name:sub.jurisdiction
                                    Definition

                                    The jurisdiction where this name applies.

                                    ShortThe jurisdiction where this name applies
                                    Control0..*
                                    BindingFor example codes, see JurisdictionValueSet
                                    (example to http://hl7.org/fhir/ValueSet/jurisdiction)

                                    Jurisdiction codes

                                    TypeCodeableConcept
                                    Is Modifierfalse
                                    Must Supportfalse
                                    Summarytrue
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    372. SubstanceDefinition.name:sub.synonym
                                    Definition

                                    A synonym of this particular name, by which the substance is also known.

                                    ShortA synonym of this particular name, by which the substance is also known
                                    Control0..*
                                    TypeSee ttp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name
                                    Is Modifierfalse
                                    Must Supportfalse
                                    Summarytrue
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    374. SubstanceDefinition.name:sub.translation
                                    Definition

                                    A translation for this name into another human language.

                                    ShortA translation for this name into another human language
                                    Control0..*
                                    TypeSee ttp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name
                                    Is Modifierfalse
                                    Must Supportfalse
                                    Summarytrue
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    376. SubstanceDefinition.name:sub.official
                                    Definition

                                    Details of the official nature of this name.

                                    ShortDetails of the official nature of this name
                                    Control0..*
                                    TypeBackboneElement
                                    Is Modifierfalse
                                    Must Supportfalse
                                    Summarytrue
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    378. SubstanceDefinition.name:sub.official.id
                                    Definition

                                    Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                    ShortUnique id for inter-element referencing
                                    Control0..1
                                    This element is affected by the following invariants: ele-1
                                    Typestring
                                    Is Modifierfalse
                                    XML FormatIn the XML format, this property is represented as an attribute.
                                    Summaryfalse
                                    380. SubstanceDefinition.name:sub.official.extension
                                    Definition

                                    May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                    ShortAdditional content defined by implementations
                                    Comments

                                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                    Control0..*
                                    TypeExtension
                                    Is Modifierfalse
                                    Summaryfalse
                                    Alternate Namesextensions, user content
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                    382. SubstanceDefinition.name:sub.official.modifierExtension
                                    Definition

                                    May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                    ShortExtensions that cannot be ignored even if unrecognized
                                    Comments

                                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                    Control0..*
                                    TypeExtension
                                    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                    Summarytrue
                                    Requirements

                                    Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                    Alternate Namesextensions, user content, modifiers
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                    384. SubstanceDefinition.name:sub.official.authority
                                    Definition

                                    Which authority uses this official name.

                                    ShortWhich authority uses this official name
                                    Control0..1
                                    BindingThe codes SHOULD be taken from SubstanceNameAuthority
                                    (preferred to http://hl7.org/fhir/ValueSet/substance-name-authority)

                                    An authority that officates substance names.

                                    TypeCodeableConcept
                                    Is Modifierfalse
                                    Must Supportfalse
                                    Summarytrue
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    386. SubstanceDefinition.name:sub.official.status
                                    Definition

                                    The status of the official name, for example 'draft', 'active', 'retired'.

                                    ShortThe status of the official name, for example 'draft', 'active'
                                    Control0..1
                                    BindingThe codes SHOULD be taken from PublicationStatus
                                    (preferred to http://hl7.org/fhir/ValueSet/publication-status)

                                    The lifecycle status of an artifact.

                                    TypeCodeableConcept
                                    Is Modifierfalse
                                    Must Supportfalse
                                    Summarytrue
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    388. SubstanceDefinition.name:sub.official.date
                                    Definition

                                    Date of the official name change.

                                    ShortDate of official name change
                                    Control0..1
                                    TypedateTime
                                    Is Modifierfalse
                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                    Must Supportfalse
                                    Summarytrue
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    390. SubstanceDefinition.name:sub.source
                                    Definition

                                    Supporting literature.

                                    ShortSupporting literature
                                    Control0..*
                                    TypeReference(DocumentReference)
                                    Is Modifierfalse
                                    Must Supportfalse
                                    Summarytrue
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    392. SubstanceDefinition.name:brand
                                    Slice Namebrand
                                    Definition

                                    Names applicable to this substance.

                                    ShortNames applicable to this substance
                                    Control0..1
                                    TypeBackboneElement
                                    Is Modifierfalse
                                    Must Supporttrue
                                    Summarytrue
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    394. SubstanceDefinition.name:brand.id
                                    Definition

                                    Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                    ShortUnique id for inter-element referencing
                                    Control0..1
                                    This element is affected by the following invariants: ele-1
                                    Typestring
                                    Is Modifierfalse
                                    XML FormatIn the XML format, this property is represented as an attribute.
                                    Summaryfalse
                                    396. SubstanceDefinition.name:brand.extension
                                    Definition

                                    May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                    ShortAdditional content defined by implementations
                                    Comments

                                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                    Control0..*
                                    TypeExtension
                                    Is Modifierfalse
                                    Summaryfalse
                                    Alternate Namesextensions, user content
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                    398. SubstanceDefinition.name:brand.modifierExtension
                                    Definition

                                    May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                    ShortExtensions that cannot be ignored even if unrecognized
                                    Comments

                                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                    Control0..*
                                    TypeExtension
                                    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                    Summarytrue
                                    Requirements

                                    Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                    Alternate Namesextensions, user content, modifiers
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                    400. SubstanceDefinition.name:brand.name
                                    Definition

                                    The part of the name or logo associated with a specific product or service identifying and distinguishing it from varieties of the same product or service marketed by competing companies.

                                    ShortBrand
                                    Control1..1
                                    Typestring
                                    Is Modifierfalse
                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                    Must Supporttrue
                                    Summarytrue
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    402. SubstanceDefinition.name:brand.type
                                    Definition

                                    Name type, for example 'systematic', 'scientific, 'brand'.

                                    ShortName type e.g. 'systematic', 'scientific, 'brand'
                                    Control1..1
                                    BindingFor example codes, see SubstanceNameType
                                    (example to http://hl7.org/fhir/ValueSet/substance-name-type)

                                    The type of a name given to a substance.

                                    TypeCodeableConcept
                                    Is Modifierfalse
                                    Must Supporttrue
                                    Summarytrue
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    404. SubstanceDefinition.name:brand.type.id
                                    Definition

                                    Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                    ShortUnique id for inter-element referencing
                                    Control0..1
                                    This element is affected by the following invariants: ele-1
                                    Typeid
                                    Is Modifierfalse
                                    XML FormatIn the XML format, this property is represented as an attribute.
                                    Summaryfalse
                                    406. SubstanceDefinition.name:brand.type.extension
                                    Definition

                                    May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                    ShortAdditional content defined by implementations
                                    Comments

                                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                    Control0..*
                                    TypeExtension
                                    Is Modifierfalse
                                    Summaryfalse
                                    Alternate Namesextensions, user content
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                    SlicingThis element introduces a set of slices on SubstanceDefinition.name.type.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
                                    • value @ url
                                    • 408. SubstanceDefinition.name:brand.type.coding
                                      Definition

                                      A reference to a code defined by a terminology system.

                                      ShortCode defined by a terminology system
                                      Comments

                                      Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                                      Control1..1
                                      TypeCoding
                                      Is Modifierfalse
                                      Must Supporttrue
                                      Summarytrue
                                      Requirements

                                      Allows for alternative encodings within a code system, and translations to other code systems.

                                      Pattern Value{
                                        "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
                                        "code" : "C71898",
                                        "display" : "Brand"
                                      }
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      410. SubstanceDefinition.name:brand.type.text
                                      Definition

                                      A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                                      ShortPlain text representation of the concept
                                      Comments

                                      Very often the text is the same as a displayName of one of the codings.

                                      Control0..1
                                      Typestring
                                      Is Modifierfalse
                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                      Summarytrue
                                      Requirements

                                      The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      412. SubstanceDefinition.name:brand.status
                                      Definition

                                      The status of the name, for example 'current', 'proposed'.

                                      ShortThe status of the name e.g. 'current', 'proposed'
                                      Control0..1
                                      BindingThe codes SHOULD be taken from PublicationStatus
                                      (preferred to http://hl7.org/fhir/ValueSet/publication-status)

                                      The lifecycle status of an artifact.

                                      TypeCodeableConcept
                                      Is Modifierfalse
                                      Must Supportfalse
                                      Summarytrue
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      414. SubstanceDefinition.name:brand.preferred
                                      Definition

                                      If this is the preferred name for this substance.

                                      ShortIf this is the preferred name for this substance
                                      Control0..1
                                      Typeboolean
                                      Is Modifierfalse
                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                      Must Supporttrue
                                      Summarytrue
                                      Meaning if MissingIf this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      416. SubstanceDefinition.name:brand.language
                                      Definition

                                      Human language that the name is written in.

                                      ShortHuman language that the name is written in
                                      Control0..*
                                      BindingThe codes SHALL be taken from AllLanguages
                                      (required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0)

                                      IETF language tag for a human language

                                      TypeCodeableConcept
                                      Is Modifierfalse
                                      Must Supportfalse
                                      Summarytrue
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      418. SubstanceDefinition.name:brand.domain
                                      Definition

                                      The use context of this name for example if there is a different name a drug active ingredient as opposed to a food colour additive.

                                      ShortThe use context of this name e.g. as an active ingredient or as a food colour additive
                                      Control0..*
                                      BindingFor example codes, see SubstanceNameDomain
                                      (example to http://hl7.org/fhir/ValueSet/substance-name-domain)

                                      The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive.

                                      TypeCodeableConcept
                                      Is Modifierfalse
                                      Must Supportfalse
                                      Summarytrue
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      420. SubstanceDefinition.name:brand.jurisdiction
                                      Definition

                                      The jurisdiction where this name applies.

                                      ShortThe jurisdiction where this name applies
                                      Control0..*
                                      BindingFor example codes, see JurisdictionValueSet
                                      (example to http://hl7.org/fhir/ValueSet/jurisdiction)

                                      Jurisdiction codes

                                      TypeCodeableConcept
                                      Is Modifierfalse
                                      Must Supportfalse
                                      Summarytrue
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      422. SubstanceDefinition.name:brand.synonym
                                      Definition

                                      A synonym of this particular name, by which the substance is also known.

                                      ShortA synonym of this particular name, by which the substance is also known
                                      Control0..*
                                      TypeSee ttp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name
                                      Is Modifierfalse
                                      Must Supportfalse
                                      Summarytrue
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      424. SubstanceDefinition.name:brand.translation
                                      Definition

                                      A translation for this name into another human language.

                                      ShortA translation for this name into another human language
                                      Control0..*
                                      TypeSee ttp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name
                                      Is Modifierfalse
                                      Must Supportfalse
                                      Summarytrue
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      426. SubstanceDefinition.name:brand.official
                                      Definition

                                      Details of the official nature of this name.

                                      ShortDetails of the official nature of this name
                                      Control0..*
                                      TypeBackboneElement
                                      Is Modifierfalse
                                      Must Supportfalse
                                      Summarytrue
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      428. SubstanceDefinition.name:brand.official.id
                                      Definition

                                      Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                      ShortUnique id for inter-element referencing
                                      Control0..1
                                      This element is affected by the following invariants: ele-1
                                      Typestring
                                      Is Modifierfalse
                                      XML FormatIn the XML format, this property is represented as an attribute.
                                      Summaryfalse
                                      430. SubstanceDefinition.name:brand.official.extension
                                      Definition

                                      May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                      ShortAdditional content defined by implementations
                                      Comments

                                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                      Control0..*
                                      TypeExtension
                                      Is Modifierfalse
                                      Summaryfalse
                                      Alternate Namesextensions, user content
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                      432. SubstanceDefinition.name:brand.official.modifierExtension
                                      Definition

                                      May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                      Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                      ShortExtensions that cannot be ignored even if unrecognized
                                      Comments

                                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                      Control0..*
                                      TypeExtension
                                      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                      Summarytrue
                                      Requirements

                                      Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                      Alternate Namesextensions, user content, modifiers
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                      434. SubstanceDefinition.name:brand.official.authority
                                      Definition

                                      Which authority uses this official name.

                                      ShortWhich authority uses this official name
                                      Control0..1
                                      BindingThe codes SHOULD be taken from SubstanceNameAuthority
                                      (preferred to http://hl7.org/fhir/ValueSet/substance-name-authority)

                                      An authority that officates substance names.

                                      TypeCodeableConcept
                                      Is Modifierfalse
                                      Must Supportfalse
                                      Summarytrue
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      436. SubstanceDefinition.name:brand.official.status
                                      Definition

                                      The status of the official name, for example 'draft', 'active', 'retired'.

                                      ShortThe status of the official name, for example 'draft', 'active'
                                      Control0..1
                                      BindingThe codes SHOULD be taken from PublicationStatus
                                      (preferred to http://hl7.org/fhir/ValueSet/publication-status)

                                      The lifecycle status of an artifact.

                                      TypeCodeableConcept
                                      Is Modifierfalse
                                      Must Supportfalse
                                      Summarytrue
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      438. SubstanceDefinition.name:brand.official.date
                                      Definition

                                      Date of the official name change.

                                      ShortDate of official name change
                                      Control0..1
                                      TypedateTime
                                      Is Modifierfalse
                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                      Must Supportfalse
                                      Summarytrue
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      440. SubstanceDefinition.name:brand.source
                                      Definition

                                      Supporting literature.

                                      ShortSupporting literature
                                      Control0..*
                                      TypeReference(DocumentReference)
                                      Is Modifierfalse
                                      Must Supportfalse
                                      Summarytrue
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      442. SubstanceDefinition.name:gsrs
                                      Slice Namegsrs
                                      Definition

                                      Names applicable to this substance.

                                      ShortNames applicable to this substance
                                      Control0..1
                                      TypeBackboneElement
                                      Is Modifierfalse
                                      Must Supporttrue
                                      Summarytrue
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      444. SubstanceDefinition.name:gsrs.id
                                      Definition

                                      Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                      ShortUnique id for inter-element referencing
                                      Control0..1
                                      This element is affected by the following invariants: ele-1
                                      Typestring
                                      Is Modifierfalse
                                      XML FormatIn the XML format, this property is represented as an attribute.
                                      Summaryfalse
                                      446. SubstanceDefinition.name:gsrs.extension
                                      Definition

                                      May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                      ShortAdditional content defined by implementations
                                      Comments

                                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                      Control0..*
                                      TypeExtension
                                      Is Modifierfalse
                                      Summaryfalse
                                      Alternate Namesextensions, user content
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                      448. SubstanceDefinition.name:gsrs.modifierExtension
                                      Definition

                                      May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                      Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                      ShortExtensions that cannot be ignored even if unrecognized
                                      Comments

                                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                      Control0..*
                                      TypeExtension
                                      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                      Summarytrue
                                      Requirements

                                      Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                      Alternate Namesextensions, user content, modifiers
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                      450. SubstanceDefinition.name:gsrs.name
                                      Definition

                                      Default display name identified within FDA Global Substance Registration System (GSRS).

                                      ShortGSRS Preferred Term
                                      Control1..1
                                      Typestring
                                      Is Modifierfalse
                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                      Must Supporttrue
                                      Summarytrue
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      452. SubstanceDefinition.name:gsrs.type
                                      Definition

                                      Name type, for example 'systematic', 'scientific, 'brand'.

                                      ShortName type e.g. 'systematic', 'scientific, 'brand'
                                      Control1..1
                                      BindingFor example codes, see SubstanceNameType
                                      (example to http://hl7.org/fhir/ValueSet/substance-name-type)

                                      The type of a name given to a substance.

                                      TypeCodeableConcept
                                      Is Modifierfalse
                                      Must Supporttrue
                                      Summarytrue
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      454. SubstanceDefinition.name:gsrs.type.id
                                      Definition

                                      Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                      ShortUnique id for inter-element referencing
                                      Control0..1
                                      This element is affected by the following invariants: ele-1
                                      Typeid
                                      Is Modifierfalse
                                      XML FormatIn the XML format, this property is represented as an attribute.
                                      Summaryfalse
                                      456. SubstanceDefinition.name:gsrs.type.extension
                                      Definition

                                      May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                      ShortAdditional content defined by implementations
                                      Comments

                                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                      Control0..*
                                      TypeExtension
                                      Is Modifierfalse
                                      Summaryfalse
                                      Alternate Namesextensions, user content
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                      SlicingThis element introduces a set of slices on SubstanceDefinition.name.type.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
                                      • value @ url
                                      • 458. SubstanceDefinition.name:gsrs.type.coding
                                        Definition

                                        A reference to a code defined by a terminology system.

                                        ShortCode defined by a terminology system
                                        Comments

                                        Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                                        Control1..1
                                        TypeCoding
                                        Is Modifierfalse
                                        Must Supporttrue
                                        Summarytrue
                                        Requirements

                                        Allows for alternative encodings within a code system, and translations to other code systems.

                                        Pattern Value{
                                          "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
                                          "code" : "C203355",
                                          "display" : "GSRS Preferred Term"
                                        }
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        460. SubstanceDefinition.name:gsrs.type.text
                                        Definition

                                        A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                                        ShortPlain text representation of the concept
                                        Comments

                                        Very often the text is the same as a displayName of one of the codings.

                                        Control0..1
                                        Typestring
                                        Is Modifierfalse
                                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                        Summarytrue
                                        Requirements

                                        The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        462. SubstanceDefinition.name:gsrs.status
                                        Definition

                                        The status of the name, for example 'current', 'proposed'.

                                        ShortThe status of the name e.g. 'current', 'proposed'
                                        Control0..1
                                        BindingThe codes SHOULD be taken from PublicationStatus
                                        (preferred to http://hl7.org/fhir/ValueSet/publication-status)

                                        The lifecycle status of an artifact.

                                        TypeCodeableConcept
                                        Is Modifierfalse
                                        Must Supportfalse
                                        Summarytrue
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        464. SubstanceDefinition.name:gsrs.preferred
                                        Definition

                                        If this is the preferred name for this substance.

                                        ShortIf this is the preferred name for this substance
                                        Control0..1
                                        Typeboolean
                                        Is Modifierfalse
                                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                        Must Supporttrue
                                        Summarytrue
                                        Meaning if MissingIf this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        466. SubstanceDefinition.name:gsrs.language
                                        Definition

                                        Human language that the name is written in.

                                        ShortHuman language that the name is written in
                                        Control0..*
                                        BindingThe codes SHALL be taken from AllLanguages
                                        (required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0)

                                        IETF language tag for a human language

                                        TypeCodeableConcept
                                        Is Modifierfalse
                                        Must Supportfalse
                                        Summarytrue
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        468. SubstanceDefinition.name:gsrs.domain
                                        Definition

                                        The use context of this name for example if there is a different name a drug active ingredient as opposed to a food colour additive.

                                        ShortThe use context of this name e.g. as an active ingredient or as a food colour additive
                                        Control0..*
                                        BindingFor example codes, see SubstanceNameDomain
                                        (example to http://hl7.org/fhir/ValueSet/substance-name-domain)

                                        The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive.

                                        TypeCodeableConcept
                                        Is Modifierfalse
                                        Must Supportfalse
                                        Summarytrue
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        470. SubstanceDefinition.name:gsrs.jurisdiction
                                        Definition

                                        The jurisdiction where this name applies.

                                        ShortThe jurisdiction where this name applies
                                        Control0..*
                                        BindingFor example codes, see JurisdictionValueSet
                                        (example to http://hl7.org/fhir/ValueSet/jurisdiction)

                                        Jurisdiction codes

                                        TypeCodeableConcept
                                        Is Modifierfalse
                                        Must Supportfalse
                                        Summarytrue
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        472. SubstanceDefinition.name:gsrs.synonym
                                        Definition

                                        A synonym of this particular name, by which the substance is also known.

                                        ShortA synonym of this particular name, by which the substance is also known
                                        Control0..*
                                        TypeSee ttp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name
                                        Is Modifierfalse
                                        Must Supportfalse
                                        Summarytrue
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        474. SubstanceDefinition.name:gsrs.translation
                                        Definition

                                        A translation for this name into another human language.

                                        ShortA translation for this name into another human language
                                        Control0..*
                                        TypeSee ttp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name
                                        Is Modifierfalse
                                        Must Supportfalse
                                        Summarytrue
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        476. SubstanceDefinition.name:gsrs.official
                                        Definition

                                        Details of the official nature of this name.

                                        ShortDetails of the official nature of this name
                                        Control0..*
                                        TypeBackboneElement
                                        Is Modifierfalse
                                        Must Supportfalse
                                        Summarytrue
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        478. SubstanceDefinition.name:gsrs.official.id
                                        Definition

                                        Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                        ShortUnique id for inter-element referencing
                                        Control0..1
                                        This element is affected by the following invariants: ele-1
                                        Typestring
                                        Is Modifierfalse
                                        XML FormatIn the XML format, this property is represented as an attribute.
                                        Summaryfalse
                                        480. SubstanceDefinition.name:gsrs.official.extension
                                        Definition

                                        May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                        ShortAdditional content defined by implementations
                                        Comments

                                        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                        Control0..*
                                        TypeExtension
                                        Is Modifierfalse
                                        Summaryfalse
                                        Alternate Namesextensions, user content
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                        482. SubstanceDefinition.name:gsrs.official.modifierExtension
                                        Definition

                                        May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                        Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                        ShortExtensions that cannot be ignored even if unrecognized
                                        Comments

                                        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                        Control0..*
                                        TypeExtension
                                        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                        Summarytrue
                                        Requirements

                                        Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                        Alternate Namesextensions, user content, modifiers
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                        484. SubstanceDefinition.name:gsrs.official.authority
                                        Definition

                                        Which authority uses this official name.

                                        ShortWhich authority uses this official name
                                        Control0..1
                                        BindingThe codes SHOULD be taken from SubstanceNameAuthority
                                        (preferred to http://hl7.org/fhir/ValueSet/substance-name-authority)

                                        An authority that officates substance names.

                                        TypeCodeableConcept
                                        Is Modifierfalse
                                        Must Supportfalse
                                        Summarytrue
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        486. SubstanceDefinition.name:gsrs.official.status
                                        Definition

                                        The status of the official name, for example 'draft', 'active', 'retired'.

                                        ShortThe status of the official name, for example 'draft', 'active'
                                        Control0..1
                                        BindingThe codes SHOULD be taken from PublicationStatus
                                        (preferred to http://hl7.org/fhir/ValueSet/publication-status)

                                        The lifecycle status of an artifact.

                                        TypeCodeableConcept
                                        Is Modifierfalse
                                        Must Supportfalse
                                        Summarytrue
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        488. SubstanceDefinition.name:gsrs.official.date
                                        Definition

                                        Date of the official name change.

                                        ShortDate of official name change
                                        Control0..1
                                        TypedateTime
                                        Is Modifierfalse
                                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                        Must Supportfalse
                                        Summarytrue
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        490. SubstanceDefinition.name:gsrs.source
                                        Definition

                                        Supporting literature.

                                        ShortSupporting literature
                                        Control0..*
                                        TypeReference(DocumentReference)
                                        Is Modifierfalse
                                        Must Supportfalse
                                        Summarytrue
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        492. SubstanceDefinition.name:usp
                                        Slice Nameusp
                                        Definition

                                        Names applicable to this substance.

                                        ShortNames applicable to this substance
                                        Control0..1
                                        TypeBackboneElement
                                        Is Modifierfalse
                                        Must Supporttrue
                                        Summarytrue
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        494. SubstanceDefinition.name:usp.id
                                        Definition

                                        Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                        ShortUnique id for inter-element referencing
                                        Control0..1
                                        This element is affected by the following invariants: ele-1
                                        Typestring
                                        Is Modifierfalse
                                        XML FormatIn the XML format, this property is represented as an attribute.
                                        Summaryfalse
                                        496. SubstanceDefinition.name:usp.extension
                                        Definition

                                        May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                        ShortAdditional content defined by implementations
                                        Comments

                                        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                        Control0..*
                                        TypeExtension
                                        Is Modifierfalse
                                        Summaryfalse
                                        Alternate Namesextensions, user content
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                        498. SubstanceDefinition.name:usp.modifierExtension
                                        Definition

                                        May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                        Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                        ShortExtensions that cannot be ignored even if unrecognized
                                        Comments

                                        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                        Control0..*
                                        TypeExtension
                                        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                        Summarytrue
                                        Requirements

                                        Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                        Alternate Namesextensions, user content, modifiers
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                        500. SubstanceDefinition.name:usp.name
                                        Definition

                                        A unique nonproprietary name assigned to drugs and biologics and assigned by the United States Pharmacopeia (USP) and excipients by the National Formulary (NF). [Source: SME Defined]

                                        ShortUSP-NF Established Name
                                        Control1..1
                                        Typestring
                                        Is Modifierfalse
                                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                        Must Supporttrue
                                        Summarytrue
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        502. SubstanceDefinition.name:usp.type
                                        Definition

                                        Name type, for example 'systematic', 'scientific, 'brand'.

                                        ShortName type e.g. 'systematic', 'scientific, 'brand'
                                        Control1..1
                                        BindingFor example codes, see SubstanceNameType
                                        (example to http://hl7.org/fhir/ValueSet/substance-name-type)

                                        The type of a name given to a substance.

                                        TypeCodeableConcept
                                        Is Modifierfalse
                                        Must Supporttrue
                                        Summarytrue
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        504. SubstanceDefinition.name:usp.type.id
                                        Definition

                                        Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                        ShortUnique id for inter-element referencing
                                        Control0..1
                                        This element is affected by the following invariants: ele-1
                                        Typeid
                                        Is Modifierfalse
                                        XML FormatIn the XML format, this property is represented as an attribute.
                                        Summaryfalse
                                        506. SubstanceDefinition.name:usp.type.extension
                                        Definition

                                        May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                        ShortAdditional content defined by implementations
                                        Comments

                                        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                        Control0..*
                                        TypeExtension
                                        Is Modifierfalse
                                        Summaryfalse
                                        Alternate Namesextensions, user content
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                        SlicingThis element introduces a set of slices on SubstanceDefinition.name.type.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
                                        • value @ url
                                        • 508. SubstanceDefinition.name:usp.type.coding
                                          Definition

                                          A reference to a code defined by a terminology system.

                                          ShortCode defined by a terminology system
                                          Comments

                                          Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                                          Control1..1
                                          TypeCoding
                                          Is Modifierfalse
                                          Must Supporttrue
                                          Summarytrue
                                          Requirements

                                          Allows for alternative encodings within a code system, and translations to other code systems.

                                          Pattern Value{
                                            "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
                                            "code" : "C203358",
                                            "display" : "USP-NF Established Name"
                                          }
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          510. SubstanceDefinition.name:usp.type.text
                                          Definition

                                          A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                                          ShortPlain text representation of the concept
                                          Comments

                                          Very often the text is the same as a displayName of one of the codings.

                                          Control0..1
                                          Typestring
                                          Is Modifierfalse
                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                          Summarytrue
                                          Requirements

                                          The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          512. SubstanceDefinition.name:usp.status
                                          Definition

                                          The status of the name, for example 'current', 'proposed'.

                                          ShortThe status of the name e.g. 'current', 'proposed'
                                          Control0..1
                                          BindingThe codes SHOULD be taken from PublicationStatus
                                          (preferred to http://hl7.org/fhir/ValueSet/publication-status)

                                          The lifecycle status of an artifact.

                                          TypeCodeableConcept
                                          Is Modifierfalse
                                          Must Supportfalse
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          514. SubstanceDefinition.name:usp.preferred
                                          Definition

                                          If this is the preferred name for this substance.

                                          ShortIf this is the preferred name for this substance
                                          Control0..1
                                          Typeboolean
                                          Is Modifierfalse
                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                          Must Supporttrue
                                          Summarytrue
                                          Meaning if MissingIf this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          516. SubstanceDefinition.name:usp.language
                                          Definition

                                          Human language that the name is written in.

                                          ShortHuman language that the name is written in
                                          Control0..*
                                          BindingThe codes SHALL be taken from AllLanguages
                                          (required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0)

                                          IETF language tag for a human language

                                          TypeCodeableConcept
                                          Is Modifierfalse
                                          Must Supportfalse
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          518. SubstanceDefinition.name:usp.domain
                                          Definition

                                          The use context of this name for example if there is a different name a drug active ingredient as opposed to a food colour additive.

                                          ShortThe use context of this name e.g. as an active ingredient or as a food colour additive
                                          Control0..*
                                          BindingFor example codes, see SubstanceNameDomain
                                          (example to http://hl7.org/fhir/ValueSet/substance-name-domain)

                                          The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive.

                                          TypeCodeableConcept
                                          Is Modifierfalse
                                          Must Supportfalse
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          520. SubstanceDefinition.name:usp.jurisdiction
                                          Definition

                                          The jurisdiction where this name applies.

                                          ShortThe jurisdiction where this name applies
                                          Control0..*
                                          BindingFor example codes, see JurisdictionValueSet
                                          (example to http://hl7.org/fhir/ValueSet/jurisdiction)

                                          Jurisdiction codes

                                          TypeCodeableConcept
                                          Is Modifierfalse
                                          Must Supportfalse
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          522. SubstanceDefinition.name:usp.synonym
                                          Definition

                                          A synonym of this particular name, by which the substance is also known.

                                          ShortA synonym of this particular name, by which the substance is also known
                                          Control0..*
                                          TypeSee ttp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name
                                          Is Modifierfalse
                                          Must Supportfalse
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          524. SubstanceDefinition.name:usp.translation
                                          Definition

                                          A translation for this name into another human language.

                                          ShortA translation for this name into another human language
                                          Control0..*
                                          TypeSee ttp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name
                                          Is Modifierfalse
                                          Must Supportfalse
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          526. SubstanceDefinition.name:usp.official
                                          Definition

                                          Details of the official nature of this name.

                                          ShortDetails of the official nature of this name
                                          Control0..*
                                          TypeBackboneElement
                                          Is Modifierfalse
                                          Must Supportfalse
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          528. SubstanceDefinition.name:usp.official.id
                                          Definition

                                          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                          ShortUnique id for inter-element referencing
                                          Control0..1
                                          This element is affected by the following invariants: ele-1
                                          Typestring
                                          Is Modifierfalse
                                          XML FormatIn the XML format, this property is represented as an attribute.
                                          Summaryfalse
                                          530. SubstanceDefinition.name:usp.official.extension
                                          Definition

                                          May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                          ShortAdditional content defined by implementations
                                          Comments

                                          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                          Control0..*
                                          TypeExtension
                                          Is Modifierfalse
                                          Summaryfalse
                                          Alternate Namesextensions, user content
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                          532. SubstanceDefinition.name:usp.official.modifierExtension
                                          Definition

                                          May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                          Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                          ShortExtensions that cannot be ignored even if unrecognized
                                          Comments

                                          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                          Control0..*
                                          TypeExtension
                                          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                          Summarytrue
                                          Requirements

                                          Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                          Alternate Namesextensions, user content, modifiers
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                          534. SubstanceDefinition.name:usp.official.authority
                                          Definition

                                          Which authority uses this official name.

                                          ShortWhich authority uses this official name
                                          Control0..1
                                          BindingThe codes SHOULD be taken from SubstanceNameAuthority
                                          (preferred to http://hl7.org/fhir/ValueSet/substance-name-authority)

                                          An authority that officates substance names.

                                          TypeCodeableConcept
                                          Is Modifierfalse
                                          Must Supportfalse
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          536. SubstanceDefinition.name:usp.official.status
                                          Definition

                                          The status of the official name, for example 'draft', 'active', 'retired'.

                                          ShortThe status of the official name, for example 'draft', 'active'
                                          Control0..1
                                          BindingThe codes SHOULD be taken from PublicationStatus
                                          (preferred to http://hl7.org/fhir/ValueSet/publication-status)

                                          The lifecycle status of an artifact.

                                          TypeCodeableConcept
                                          Is Modifierfalse
                                          Must Supportfalse
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          538. SubstanceDefinition.name:usp.official.date
                                          Definition

                                          Date of the official name change.

                                          ShortDate of official name change
                                          Control0..1
                                          TypedateTime
                                          Is Modifierfalse
                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                          Must Supportfalse
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          540. SubstanceDefinition.name:usp.source
                                          Definition

                                          Supporting literature.

                                          ShortSupporting literature
                                          Control0..*
                                          TypeReference(DocumentReference)
                                          Is Modifierfalse
                                          Must Supportfalse
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          542. SubstanceDefinition.name:comp
                                          Slice Namecomp
                                          Definition

                                          Names applicable to this substance.

                                          ShortNames applicable to this substance
                                          Control0..1
                                          TypeBackboneElement
                                          Is Modifierfalse
                                          Must Supporttrue
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          544. SubstanceDefinition.name:comp.id
                                          Definition

                                          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                          ShortUnique id for inter-element referencing
                                          Control0..1
                                          This element is affected by the following invariants: ele-1
                                          Typestring
                                          Is Modifierfalse
                                          XML FormatIn the XML format, this property is represented as an attribute.
                                          Summaryfalse
                                          546. SubstanceDefinition.name:comp.extension
                                          Definition

                                          May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                          ShortAdditional content defined by implementations
                                          Comments

                                          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                          Control0..*
                                          TypeExtension
                                          Is Modifierfalse
                                          Summaryfalse
                                          Alternate Namesextensions, user content
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                          548. SubstanceDefinition.name:comp.modifierExtension
                                          Definition

                                          May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                          Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                          ShortExtensions that cannot be ignored even if unrecognized
                                          Comments

                                          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                          Control0..*
                                          TypeExtension
                                          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                          Summarytrue
                                          Requirements

                                          Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                          Alternate Namesextensions, user content, modifiers
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                          550. SubstanceDefinition.name:comp.name
                                          Definition

                                          An internal identifier assigned by the sponsor to this drug substance. [Source: SME Defined]

                                          ShortCompany ID/Code
                                          Control1..1
                                          Typestring
                                          Is Modifierfalse
                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                          Must Supporttrue
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          552. SubstanceDefinition.name:comp.type
                                          Definition

                                          Name type, for example 'systematic', 'scientific, 'brand'.

                                          ShortName type e.g. 'systematic', 'scientific, 'brand'
                                          Control1..1
                                          BindingFor example codes, see SubstanceNameType
                                          (example to http://hl7.org/fhir/ValueSet/substance-name-type)

                                          The type of a name given to a substance.

                                          TypeCodeableConcept
                                          Is Modifierfalse
                                          Must Supporttrue
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          554. SubstanceDefinition.name:comp.type.id
                                          Definition

                                          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                          ShortUnique id for inter-element referencing
                                          Control0..1
                                          This element is affected by the following invariants: ele-1
                                          Typeid
                                          Is Modifierfalse
                                          XML FormatIn the XML format, this property is represented as an attribute.
                                          Summaryfalse
                                          556. SubstanceDefinition.name:comp.type.extension
                                          Definition

                                          May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                          ShortAdditional content defined by implementations
                                          Comments

                                          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                          Control0..*
                                          TypeExtension
                                          Is Modifierfalse
                                          Summaryfalse
                                          Alternate Namesextensions, user content
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                          SlicingThis element introduces a set of slices on SubstanceDefinition.name.type.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
                                          • value @ url
                                          • 558. SubstanceDefinition.name:comp.type.coding
                                            Definition

                                            A reference to a code defined by a terminology system.

                                            ShortCode defined by a terminology system
                                            Comments

                                            Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                                            Control1..1
                                            TypeCoding
                                            Is Modifierfalse
                                            Summarytrue
                                            Requirements

                                            Allows for alternative encodings within a code system, and translations to other code systems.

                                            Pattern Value{
                                              "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
                                              "code" : "C203354",
                                              "display" : "Company ID/Code"
                                            }
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            560. SubstanceDefinition.name:comp.type.text
                                            Definition

                                            A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                                            ShortPlain text representation of the concept
                                            Comments

                                            Very often the text is the same as a displayName of one of the codings.

                                            Control0..1
                                            Typestring
                                            Is Modifierfalse
                                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                            Summarytrue
                                            Requirements

                                            The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            562. SubstanceDefinition.name:comp.status
                                            Definition

                                            The status of the name, for example 'current', 'proposed'.

                                            ShortThe status of the name e.g. 'current', 'proposed'
                                            Control0..1
                                            BindingThe codes SHOULD be taken from PublicationStatus
                                            (preferred to http://hl7.org/fhir/ValueSet/publication-status)

                                            The lifecycle status of an artifact.

                                            TypeCodeableConcept
                                            Is Modifierfalse
                                            Must Supportfalse
                                            Summarytrue
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            564. SubstanceDefinition.name:comp.preferred
                                            Definition

                                            If this is the preferred name for this substance.

                                            ShortIf this is the preferred name for this substance
                                            Control0..1
                                            Typeboolean
                                            Is Modifierfalse
                                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                            Must Supporttrue
                                            Summarytrue
                                            Meaning if MissingIf this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            566. SubstanceDefinition.name:comp.language
                                            Definition

                                            Human language that the name is written in.

                                            ShortHuman language that the name is written in
                                            Control0..*
                                            BindingThe codes SHALL be taken from AllLanguages
                                            (required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0)

                                            IETF language tag for a human language

                                            TypeCodeableConcept
                                            Is Modifierfalse
                                            Must Supportfalse
                                            Summarytrue
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            568. SubstanceDefinition.name:comp.domain
                                            Definition

                                            The use context of this name for example if there is a different name a drug active ingredient as opposed to a food colour additive.

                                            ShortThe use context of this name e.g. as an active ingredient or as a food colour additive
                                            Control0..*
                                            BindingFor example codes, see SubstanceNameDomain
                                            (example to http://hl7.org/fhir/ValueSet/substance-name-domain)

                                            The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive.

                                            TypeCodeableConcept
                                            Is Modifierfalse
                                            Must Supportfalse
                                            Summarytrue
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            570. SubstanceDefinition.name:comp.jurisdiction
                                            Definition

                                            The jurisdiction where this name applies.

                                            ShortThe jurisdiction where this name applies
                                            Control0..*
                                            BindingFor example codes, see JurisdictionValueSet
                                            (example to http://hl7.org/fhir/ValueSet/jurisdiction)

                                            Jurisdiction codes

                                            TypeCodeableConcept
                                            Is Modifierfalse
                                            Must Supportfalse
                                            Summarytrue
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            572. SubstanceDefinition.name:comp.synonym
                                            Definition

                                            A synonym of this particular name, by which the substance is also known.

                                            ShortA synonym of this particular name, by which the substance is also known
                                            Control0..*
                                            TypeSee ttp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name
                                            Is Modifierfalse
                                            Must Supportfalse
                                            Summarytrue
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            574. SubstanceDefinition.name:comp.translation
                                            Definition

                                            A translation for this name into another human language.

                                            ShortA translation for this name into another human language
                                            Control0..*
                                            TypeSee ttp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name
                                            Is Modifierfalse
                                            Must Supportfalse
                                            Summarytrue
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            576. SubstanceDefinition.name:comp.official
                                            Definition

                                            Details of the official nature of this name.

                                            ShortDetails of the official nature of this name
                                            Control0..*
                                            TypeBackboneElement
                                            Is Modifierfalse
                                            Must Supportfalse
                                            Summarytrue
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            578. SubstanceDefinition.name:comp.official.id
                                            Definition

                                            Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                            ShortUnique id for inter-element referencing
                                            Control0..1
                                            This element is affected by the following invariants: ele-1
                                            Typestring
                                            Is Modifierfalse
                                            XML FormatIn the XML format, this property is represented as an attribute.
                                            Summaryfalse
                                            580. SubstanceDefinition.name:comp.official.extension
                                            Definition

                                            May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                            ShortAdditional content defined by implementations
                                            Comments

                                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                            Control0..*
                                            TypeExtension
                                            Is Modifierfalse
                                            Summaryfalse
                                            Alternate Namesextensions, user content
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                            582. SubstanceDefinition.name:comp.official.modifierExtension
                                            Definition

                                            May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                            Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                            ShortExtensions that cannot be ignored even if unrecognized
                                            Comments

                                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                            Control0..*
                                            TypeExtension
                                            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                            Summarytrue
                                            Requirements

                                            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                            Alternate Namesextensions, user content, modifiers
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                            584. SubstanceDefinition.name:comp.official.authority
                                            Definition

                                            Which authority uses this official name.

                                            ShortWhich authority uses this official name
                                            Control0..1
                                            BindingThe codes SHOULD be taken from SubstanceNameAuthority
                                            (preferred to http://hl7.org/fhir/ValueSet/substance-name-authority)

                                            An authority that officates substance names.

                                            TypeCodeableConcept
                                            Is Modifierfalse
                                            Must Supportfalse
                                            Summarytrue
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            586. SubstanceDefinition.name:comp.official.status
                                            Definition

                                            The status of the official name, for example 'draft', 'active', 'retired'.

                                            ShortThe status of the official name, for example 'draft', 'active'
                                            Control0..1
                                            BindingThe codes SHOULD be taken from PublicationStatus
                                            (preferred to http://hl7.org/fhir/ValueSet/publication-status)

                                            The lifecycle status of an artifact.

                                            TypeCodeableConcept
                                            Is Modifierfalse
                                            Must Supportfalse
                                            Summarytrue
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            588. SubstanceDefinition.name:comp.official.date
                                            Definition

                                            Date of the official name change.

                                            ShortDate of official name change
                                            Control0..1
                                            TypedateTime
                                            Is Modifierfalse
                                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                            Must Supportfalse
                                            Summarytrue
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            590. SubstanceDefinition.name:comp.source
                                            Definition

                                            Supporting literature.

                                            ShortSupporting literature
                                            Control0..*
                                            TypeReference(DocumentReference)
                                            Is Modifierfalse
                                            Must Supportfalse
                                            Summarytrue
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            592. SubstanceDefinition.name:cas
                                            Slice Namecas
                                            Definition

                                            Names applicable to this substance.

                                            ShortNames applicable to this substance
                                            Control0..1
                                            TypeBackboneElement
                                            Is Modifierfalse
                                            Must Supporttrue
                                            Summarytrue
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            594. SubstanceDefinition.name:cas.id
                                            Definition

                                            Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                            ShortUnique id for inter-element referencing
                                            Control0..1
                                            This element is affected by the following invariants: ele-1
                                            Typestring
                                            Is Modifierfalse
                                            XML FormatIn the XML format, this property is represented as an attribute.
                                            Summaryfalse
                                            596. SubstanceDefinition.name:cas.extension
                                            Definition

                                            May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                            ShortAdditional content defined by implementations
                                            Comments

                                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                            Control0..*
                                            TypeExtension
                                            Is Modifierfalse
                                            Summaryfalse
                                            Alternate Namesextensions, user content
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                            598. SubstanceDefinition.name:cas.modifierExtension
                                            Definition

                                            May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                            Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                            ShortExtensions that cannot be ignored even if unrecognized
                                            Comments

                                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                            Control0..*
                                            TypeExtension
                                            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                            Summarytrue
                                            Requirements

                                            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                            Alternate Namesextensions, user content, modifiers
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                            600. SubstanceDefinition.name:cas.name
                                            Definition

                                            Chemical Abstract Service (CAS) Registry Numbers (often referred to as CAS RNs or CAS Numbers) are used to provide identifiers for chemical substances. A CAS Registry Number itself has no inherent chemical significance but provides a way to identify a chemical substance or molecular structure when there are many possible systematic, generic, proprietary or trivial names. [Source: Adapted from CAS.org] Example: CAS [103-90-2]

                                            ShortCAS Number
                                            Control1..1
                                            Typestring
                                            Is Modifierfalse
                                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                            Must Supporttrue
                                            Summarytrue
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            602. SubstanceDefinition.name:cas.type
                                            Definition

                                            Name type, for example 'systematic', 'scientific, 'brand'.

                                            ShortName type e.g. 'systematic', 'scientific, 'brand'
                                            Control1..1
                                            BindingFor example codes, see SubstanceNameType
                                            (example to http://hl7.org/fhir/ValueSet/substance-name-type)

                                            The type of a name given to a substance.

                                            TypeCodeableConcept
                                            Is Modifierfalse
                                            Must Supporttrue
                                            Summarytrue
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            604. SubstanceDefinition.name:cas.type.id
                                            Definition

                                            Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                            ShortUnique id for inter-element referencing
                                            Control0..1
                                            This element is affected by the following invariants: ele-1
                                            Typeid
                                            Is Modifierfalse
                                            XML FormatIn the XML format, this property is represented as an attribute.
                                            Summaryfalse
                                            606. SubstanceDefinition.name:cas.type.extension
                                            Definition

                                            May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                            ShortAdditional content defined by implementations
                                            Comments

                                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                            Control0..*
                                            TypeExtension
                                            Is Modifierfalse
                                            Summaryfalse
                                            Alternate Namesextensions, user content
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                            SlicingThis element introduces a set of slices on SubstanceDefinition.name.type.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
                                            • value @ url
                                            • 608. SubstanceDefinition.name:cas.type.coding
                                              Definition

                                              A reference to a code defined by a terminology system.

                                              ShortCode defined by a terminology system
                                              Comments

                                              Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                                              Control1..1
                                              TypeCoding
                                              Is Modifierfalse
                                              Must Supporttrue
                                              Summarytrue
                                              Requirements

                                              Allows for alternative encodings within a code system, and translations to other code systems.

                                              Pattern Value{
                                                "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
                                                "code" : "C54682",
                                                "display" : "CAS Number"
                                              }
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              610. SubstanceDefinition.name:cas.type.text
                                              Definition

                                              A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                                              ShortPlain text representation of the concept
                                              Comments

                                              Very often the text is the same as a displayName of one of the codings.

                                              Control0..1
                                              Typestring
                                              Is Modifierfalse
                                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                              Summarytrue
                                              Requirements

                                              The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              612. SubstanceDefinition.name:cas.status
                                              Definition

                                              The status of the name, for example 'current', 'proposed'.

                                              ShortThe status of the name e.g. 'current', 'proposed'
                                              Control0..1
                                              BindingThe codes SHOULD be taken from PublicationStatus
                                              (preferred to http://hl7.org/fhir/ValueSet/publication-status)

                                              The lifecycle status of an artifact.

                                              TypeCodeableConcept
                                              Is Modifierfalse
                                              Must Supportfalse
                                              Summarytrue
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              614. SubstanceDefinition.name:cas.preferred
                                              Definition

                                              If this is the preferred name for this substance.

                                              ShortIf this is the preferred name for this substance
                                              Control0..1
                                              Typeboolean
                                              Is Modifierfalse
                                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                              Must Supporttrue
                                              Summarytrue
                                              Meaning if MissingIf this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              616. SubstanceDefinition.name:cas.language
                                              Definition

                                              Human language that the name is written in.

                                              ShortHuman language that the name is written in
                                              Control0..*
                                              BindingThe codes SHALL be taken from AllLanguages
                                              (required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0)

                                              IETF language tag for a human language

                                              TypeCodeableConcept
                                              Is Modifierfalse
                                              Must Supportfalse
                                              Summarytrue
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              618. SubstanceDefinition.name:cas.domain
                                              Definition

                                              The use context of this name for example if there is a different name a drug active ingredient as opposed to a food colour additive.

                                              ShortThe use context of this name e.g. as an active ingredient or as a food colour additive
                                              Control0..*
                                              BindingFor example codes, see SubstanceNameDomain
                                              (example to http://hl7.org/fhir/ValueSet/substance-name-domain)

                                              The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive.

                                              TypeCodeableConcept
                                              Is Modifierfalse
                                              Must Supportfalse
                                              Summarytrue
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              620. SubstanceDefinition.name:cas.jurisdiction
                                              Definition

                                              The jurisdiction where this name applies.

                                              ShortThe jurisdiction where this name applies
                                              Control0..*
                                              BindingFor example codes, see JurisdictionValueSet
                                              (example to http://hl7.org/fhir/ValueSet/jurisdiction)

                                              Jurisdiction codes

                                              TypeCodeableConcept
                                              Is Modifierfalse
                                              Must Supportfalse
                                              Summarytrue
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              622. SubstanceDefinition.name:cas.synonym
                                              Definition

                                              A synonym of this particular name, by which the substance is also known.

                                              ShortA synonym of this particular name, by which the substance is also known
                                              Control0..*
                                              TypeSee ttp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name
                                              Is Modifierfalse
                                              Must Supportfalse
                                              Summarytrue
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              624. SubstanceDefinition.name:cas.translation
                                              Definition

                                              A translation for this name into another human language.

                                              ShortA translation for this name into another human language
                                              Control0..*
                                              TypeSee ttp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name
                                              Is Modifierfalse
                                              Must Supportfalse
                                              Summarytrue
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              626. SubstanceDefinition.name:cas.official
                                              Definition

                                              Details of the official nature of this name.

                                              ShortDetails of the official nature of this name
                                              Control0..*
                                              TypeBackboneElement
                                              Is Modifierfalse
                                              Must Supportfalse
                                              Summarytrue
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              628. SubstanceDefinition.name:cas.official.id
                                              Definition

                                              Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                              ShortUnique id for inter-element referencing
                                              Control0..1
                                              This element is affected by the following invariants: ele-1
                                              Typestring
                                              Is Modifierfalse
                                              XML FormatIn the XML format, this property is represented as an attribute.
                                              Summaryfalse
                                              630. SubstanceDefinition.name:cas.official.extension
                                              Definition

                                              May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                              ShortAdditional content defined by implementations
                                              Comments

                                              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                              Control0..*
                                              TypeExtension
                                              Is Modifierfalse
                                              Summaryfalse
                                              Alternate Namesextensions, user content
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                              632. SubstanceDefinition.name:cas.official.modifierExtension
                                              Definition

                                              May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                              Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                              ShortExtensions that cannot be ignored even if unrecognized
                                              Comments

                                              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                              Control0..*
                                              TypeExtension
                                              Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                              Summarytrue
                                              Requirements

                                              Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                              Alternate Namesextensions, user content, modifiers
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                              634. SubstanceDefinition.name:cas.official.authority
                                              Definition

                                              Which authority uses this official name.

                                              ShortWhich authority uses this official name
                                              Control0..1
                                              BindingThe codes SHOULD be taken from SubstanceNameAuthority
                                              (preferred to http://hl7.org/fhir/ValueSet/substance-name-authority)

                                              An authority that officates substance names.

                                              TypeCodeableConcept
                                              Is Modifierfalse
                                              Must Supportfalse
                                              Summarytrue
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              636. SubstanceDefinition.name:cas.official.status
                                              Definition

                                              The status of the official name, for example 'draft', 'active', 'retired'.

                                              ShortThe status of the official name, for example 'draft', 'active'
                                              Control0..1
                                              BindingThe codes SHOULD be taken from PublicationStatus
                                              (preferred to http://hl7.org/fhir/ValueSet/publication-status)

                                              The lifecycle status of an artifact.

                                              TypeCodeableConcept
                                              Is Modifierfalse
                                              Must Supportfalse
                                              Summarytrue
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              638. SubstanceDefinition.name:cas.official.date
                                              Definition

                                              Date of the official name change.

                                              ShortDate of official name change
                                              Control0..1
                                              TypedateTime
                                              Is Modifierfalse
                                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                              Must Supportfalse
                                              Summarytrue
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              640. SubstanceDefinition.name:cas.source
                                              Definition

                                              Supporting literature.

                                              ShortSupporting literature
                                              Control0..*
                                              TypeReference(DocumentReference)
                                              Is Modifierfalse
                                              Must Supportfalse
                                              Summarytrue
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              642. SubstanceDefinition.name:inn
                                              Slice Nameinn
                                              Definition

                                              Names applicable to this substance.

                                              ShortNames applicable to this substance
                                              Control0..1
                                              TypeBackboneElement
                                              Is Modifierfalse
                                              Must Supporttrue
                                              Summarytrue
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              644. SubstanceDefinition.name:inn.id
                                              Definition

                                              Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                              ShortUnique id for inter-element referencing
                                              Control0..1
                                              This element is affected by the following invariants: ele-1
                                              Typestring
                                              Is Modifierfalse
                                              XML FormatIn the XML format, this property is represented as an attribute.
                                              Summaryfalse
                                              646. SubstanceDefinition.name:inn.extension
                                              Definition

                                              May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                              ShortAdditional content defined by implementations
                                              Comments

                                              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                              Control0..*
                                              TypeExtension
                                              Is Modifierfalse
                                              Summaryfalse
                                              Alternate Namesextensions, user content
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                              648. SubstanceDefinition.name:inn.modifierExtension
                                              Definition

                                              May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                              Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                              ShortExtensions that cannot be ignored even if unrecognized
                                              Comments

                                              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                              Control0..*
                                              TypeExtension
                                              Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                              Summarytrue
                                              Requirements

                                              Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                              Alternate Namesextensions, user content, modifiers
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                              650. SubstanceDefinition.name:inn.name
                                              Definition

                                              International Nonproprietary Names (INN) is a unique name that is globally recognized and is public property. A nonproprietary name is also known as a generic name. Note: International Nonproprietary Names (INN) facilitate the identification of pharmaceutical substances or active pharmaceutical ingredients [Source: http://www.who.int/medicines/services/inn/en/] Example: Paracetamol

                                              ShortINN
                                              Control1..1
                                              Typestring
                                              Is Modifierfalse
                                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                              Must Supporttrue
                                              Summarytrue
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              652. SubstanceDefinition.name:inn.type
                                              Definition

                                              Name type, for example 'systematic', 'scientific, 'brand'.

                                              ShortName type e.g. 'systematic', 'scientific, 'brand'
                                              Control1..1
                                              BindingFor example codes, see SubstanceNameType
                                              (example to http://hl7.org/fhir/ValueSet/substance-name-type)

                                              The type of a name given to a substance.

                                              TypeCodeableConcept
                                              Is Modifierfalse
                                              Must Supporttrue
                                              Summarytrue
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              654. SubstanceDefinition.name:inn.type.id
                                              Definition

                                              Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                              ShortUnique id for inter-element referencing
                                              Control0..1
                                              This element is affected by the following invariants: ele-1
                                              Typeid
                                              Is Modifierfalse
                                              XML FormatIn the XML format, this property is represented as an attribute.
                                              Summaryfalse
                                              656. SubstanceDefinition.name:inn.type.extension
                                              Definition

                                              May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                              ShortAdditional content defined by implementations
                                              Comments

                                              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                              Control0..*
                                              TypeExtension
                                              Is Modifierfalse
                                              Summaryfalse
                                              Alternate Namesextensions, user content
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                              SlicingThis element introduces a set of slices on SubstanceDefinition.name.type.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
                                              • value @ url
                                              • 658. SubstanceDefinition.name:inn.type.coding
                                                Definition

                                                A reference to a code defined by a terminology system.

                                                ShortCode defined by a terminology system
                                                Comments

                                                Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                                                Control1..1
                                                TypeCoding
                                                Is Modifierfalse
                                                Must Supporttrue
                                                Summarytrue
                                                Requirements

                                                Allows for alternative encodings within a code system, and translations to other code systems.

                                                Pattern Value{
                                                  "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
                                                  "code" : "C142585",
                                                  "display" : "INN"
                                                }
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                660. SubstanceDefinition.name:inn.type.text
                                                Definition

                                                A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                                                ShortPlain text representation of the concept
                                                Comments

                                                Very often the text is the same as a displayName of one of the codings.

                                                Control0..1
                                                Typestring
                                                Is Modifierfalse
                                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                Summarytrue
                                                Requirements

                                                The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                662. SubstanceDefinition.name:inn.status
                                                Definition

                                                The status of the name, for example 'current', 'proposed'.

                                                ShortThe status of the name e.g. 'current', 'proposed'
                                                Control0..1
                                                BindingThe codes SHOULD be taken from PublicationStatus
                                                (preferred to http://hl7.org/fhir/ValueSet/publication-status)

                                                The lifecycle status of an artifact.

                                                TypeCodeableConcept
                                                Is Modifierfalse
                                                Must Supportfalse
                                                Summarytrue
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                664. SubstanceDefinition.name:inn.preferred
                                                Definition

                                                If this is the preferred name for this substance.

                                                ShortIf this is the preferred name for this substance
                                                Control0..1
                                                Typeboolean
                                                Is Modifierfalse
                                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                Must Supporttrue
                                                Summarytrue
                                                Meaning if MissingIf this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                666. SubstanceDefinition.name:inn.language
                                                Definition

                                                Human language that the name is written in.

                                                ShortHuman language that the name is written in
                                                Control0..*
                                                BindingThe codes SHALL be taken from AllLanguages
                                                (required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0)

                                                IETF language tag for a human language

                                                TypeCodeableConcept
                                                Is Modifierfalse
                                                Must Supportfalse
                                                Summarytrue
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                668. SubstanceDefinition.name:inn.domain
                                                Definition

                                                The use context of this name for example if there is a different name a drug active ingredient as opposed to a food colour additive.

                                                ShortThe use context of this name e.g. as an active ingredient or as a food colour additive
                                                Control0..*
                                                BindingFor example codes, see SubstanceNameDomain
                                                (example to http://hl7.org/fhir/ValueSet/substance-name-domain)

                                                The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive.

                                                TypeCodeableConcept
                                                Is Modifierfalse
                                                Must Supportfalse
                                                Summarytrue
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                670. SubstanceDefinition.name:inn.jurisdiction
                                                Definition

                                                The jurisdiction where this name applies.

                                                ShortThe jurisdiction where this name applies
                                                Control0..*
                                                BindingFor example codes, see JurisdictionValueSet
                                                (example to http://hl7.org/fhir/ValueSet/jurisdiction)

                                                Jurisdiction codes

                                                TypeCodeableConcept
                                                Is Modifierfalse
                                                Must Supportfalse
                                                Summarytrue
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                672. SubstanceDefinition.name:inn.synonym
                                                Definition

                                                A synonym of this particular name, by which the substance is also known.

                                                ShortA synonym of this particular name, by which the substance is also known
                                                Control0..*
                                                TypeSee ttp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name
                                                Is Modifierfalse
                                                Must Supportfalse
                                                Summarytrue
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                674. SubstanceDefinition.name:inn.translation
                                                Definition

                                                A translation for this name into another human language.

                                                ShortA translation for this name into another human language
                                                Control0..*
                                                TypeSee ttp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name
                                                Is Modifierfalse
                                                Must Supportfalse
                                                Summarytrue
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                676. SubstanceDefinition.name:inn.official
                                                Definition

                                                Details of the official nature of this name.

                                                ShortDetails of the official nature of this name
                                                Control0..*
                                                TypeBackboneElement
                                                Is Modifierfalse
                                                Must Supportfalse
                                                Summarytrue
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                678. SubstanceDefinition.name:inn.official.id
                                                Definition

                                                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                ShortUnique id for inter-element referencing
                                                Control0..1
                                                This element is affected by the following invariants: ele-1
                                                Typestring
                                                Is Modifierfalse
                                                XML FormatIn the XML format, this property is represented as an attribute.
                                                Summaryfalse
                                                680. SubstanceDefinition.name:inn.official.extension
                                                Definition

                                                May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                ShortAdditional content defined by implementations
                                                Comments

                                                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                Control0..*
                                                TypeExtension
                                                Is Modifierfalse
                                                Summaryfalse
                                                Alternate Namesextensions, user content
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                682. SubstanceDefinition.name:inn.official.modifierExtension
                                                Definition

                                                May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                ShortExtensions that cannot be ignored even if unrecognized
                                                Comments

                                                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                Control0..*
                                                TypeExtension
                                                Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                Summarytrue
                                                Requirements

                                                Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                Alternate Namesextensions, user content, modifiers
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                684. SubstanceDefinition.name:inn.official.authority
                                                Definition

                                                Which authority uses this official name.

                                                ShortWhich authority uses this official name
                                                Control0..1
                                                BindingThe codes SHOULD be taken from SubstanceNameAuthority
                                                (preferred to http://hl7.org/fhir/ValueSet/substance-name-authority)

                                                An authority that officates substance names.

                                                TypeCodeableConcept
                                                Is Modifierfalse
                                                Must Supportfalse
                                                Summarytrue
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                686. SubstanceDefinition.name:inn.official.status
                                                Definition

                                                The status of the official name, for example 'draft', 'active', 'retired'.

                                                ShortThe status of the official name, for example 'draft', 'active'
                                                Control0..1
                                                BindingThe codes SHOULD be taken from PublicationStatus
                                                (preferred to http://hl7.org/fhir/ValueSet/publication-status)

                                                The lifecycle status of an artifact.

                                                TypeCodeableConcept
                                                Is Modifierfalse
                                                Must Supportfalse
                                                Summarytrue
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                688. SubstanceDefinition.name:inn.official.date
                                                Definition

                                                Date of the official name change.

                                                ShortDate of official name change
                                                Control0..1
                                                TypedateTime
                                                Is Modifierfalse
                                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                Must Supportfalse
                                                Summarytrue
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                690. SubstanceDefinition.name:inn.source
                                                Definition

                                                Supporting literature.

                                                ShortSupporting literature
                                                Control0..*
                                                TypeReference(DocumentReference)
                                                Is Modifierfalse
                                                Must Supportfalse
                                                Summarytrue
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                692. SubstanceDefinition.name:usan
                                                Slice Nameusan
                                                Definition

                                                Names applicable to this substance.

                                                ShortNames applicable to this substance
                                                Control0..1
                                                TypeBackboneElement
                                                Is Modifierfalse
                                                Must Supporttrue
                                                Summarytrue
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                694. SubstanceDefinition.name:usan.id
                                                Definition

                                                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                ShortUnique id for inter-element referencing
                                                Control0..1
                                                This element is affected by the following invariants: ele-1
                                                Typestring
                                                Is Modifierfalse
                                                XML FormatIn the XML format, this property is represented as an attribute.
                                                Summaryfalse
                                                696. SubstanceDefinition.name:usan.extension
                                                Definition

                                                May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                ShortAdditional content defined by implementations
                                                Comments

                                                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                Control0..*
                                                TypeExtension
                                                Is Modifierfalse
                                                Summaryfalse
                                                Alternate Namesextensions, user content
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                698. SubstanceDefinition.name:usan.modifierExtension
                                                Definition

                                                May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                ShortExtensions that cannot be ignored even if unrecognized
                                                Comments

                                                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                Control0..*
                                                TypeExtension
                                                Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                Summarytrue
                                                Requirements

                                                Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                Alternate Namesextensions, user content, modifiers
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                700. SubstanceDefinition.name:usan.name
                                                Definition

                                                A unique nonproprietary name assigned to drugs and biologics and assigned by the United States Adopted Names Council [Source: SME Defined] Example: acetaminophen

                                                ShortUSAN
                                                Control1..1
                                                Typestring
                                                Is Modifierfalse
                                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                Must Supporttrue
                                                Summarytrue
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                702. SubstanceDefinition.name:usan.type
                                                Definition

                                                Name type, for example 'systematic', 'scientific, 'brand'.

                                                ShortName type e.g. 'systematic', 'scientific, 'brand'
                                                Control1..1
                                                BindingFor example codes, see SubstanceNameType
                                                (example to http://hl7.org/fhir/ValueSet/substance-name-type)

                                                The type of a name given to a substance.

                                                TypeCodeableConcept
                                                Is Modifierfalse
                                                Must Supporttrue
                                                Summarytrue
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                704. SubstanceDefinition.name:usan.type.id
                                                Definition

                                                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                ShortUnique id for inter-element referencing
                                                Control0..1
                                                This element is affected by the following invariants: ele-1
                                                Typeid
                                                Is Modifierfalse
                                                XML FormatIn the XML format, this property is represented as an attribute.
                                                Summaryfalse
                                                706. SubstanceDefinition.name:usan.type.extension
                                                Definition

                                                May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                ShortAdditional content defined by implementations
                                                Comments

                                                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                Control0..*
                                                TypeExtension
                                                Is Modifierfalse
                                                Summaryfalse
                                                Alternate Namesextensions, user content
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                SlicingThis element introduces a set of slices on SubstanceDefinition.name.type.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
                                                • value @ url
                                                • 708. SubstanceDefinition.name:usan.type.coding
                                                  Definition

                                                  A reference to a code defined by a terminology system.

                                                  ShortCode defined by a terminology system
                                                  Comments

                                                  Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                                                  Control1..1
                                                  TypeCoding
                                                  Is Modifierfalse
                                                  Must Supporttrue
                                                  Summarytrue
                                                  Requirements

                                                  Allows for alternative encodings within a code system, and translations to other code systems.

                                                  Pattern Value{
                                                    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
                                                    "code" : "C96973",
                                                    "display" : "USAN"
                                                  }
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  710. SubstanceDefinition.name:usan.type.text
                                                  Definition

                                                  A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                                                  ShortPlain text representation of the concept
                                                  Comments

                                                  Very often the text is the same as a displayName of one of the codings.

                                                  Control0..1
                                                  Typestring
                                                  Is Modifierfalse
                                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                  Summarytrue
                                                  Requirements

                                                  The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  712. SubstanceDefinition.name:usan.status
                                                  Definition

                                                  The status of the name, for example 'current', 'proposed'.

                                                  ShortThe status of the name e.g. 'current', 'proposed'
                                                  Control0..1
                                                  BindingThe codes SHOULD be taken from PublicationStatus
                                                  (preferred to http://hl7.org/fhir/ValueSet/publication-status)

                                                  The lifecycle status of an artifact.

                                                  TypeCodeableConcept
                                                  Is Modifierfalse
                                                  Must Supportfalse
                                                  Summarytrue
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  714. SubstanceDefinition.name:usan.preferred
                                                  Definition

                                                  If this is the preferred name for this substance.

                                                  ShortIf this is the preferred name for this substance
                                                  Control0..1
                                                  Typeboolean
                                                  Is Modifierfalse
                                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                  Must Supporttrue
                                                  Summarytrue
                                                  Meaning if MissingIf this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  716. SubstanceDefinition.name:usan.language
                                                  Definition

                                                  Human language that the name is written in.

                                                  ShortHuman language that the name is written in
                                                  Control0..*
                                                  BindingThe codes SHALL be taken from AllLanguages
                                                  (required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0)

                                                  IETF language tag for a human language

                                                  TypeCodeableConcept
                                                  Is Modifierfalse
                                                  Must Supportfalse
                                                  Summarytrue
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  718. SubstanceDefinition.name:usan.domain
                                                  Definition

                                                  The use context of this name for example if there is a different name a drug active ingredient as opposed to a food colour additive.

                                                  ShortThe use context of this name e.g. as an active ingredient or as a food colour additive
                                                  Control0..*
                                                  BindingFor example codes, see SubstanceNameDomain
                                                  (example to http://hl7.org/fhir/ValueSet/substance-name-domain)

                                                  The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive.

                                                  TypeCodeableConcept
                                                  Is Modifierfalse
                                                  Must Supportfalse
                                                  Summarytrue
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  720. SubstanceDefinition.name:usan.jurisdiction
                                                  Definition

                                                  The jurisdiction where this name applies.

                                                  ShortThe jurisdiction where this name applies
                                                  Control0..*
                                                  BindingFor example codes, see JurisdictionValueSet
                                                  (example to http://hl7.org/fhir/ValueSet/jurisdiction)

                                                  Jurisdiction codes

                                                  TypeCodeableConcept
                                                  Is Modifierfalse
                                                  Must Supportfalse
                                                  Summarytrue
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  722. SubstanceDefinition.name:usan.synonym
                                                  Definition

                                                  A synonym of this particular name, by which the substance is also known.

                                                  ShortA synonym of this particular name, by which the substance is also known
                                                  Control0..*
                                                  TypeSee ttp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name
                                                  Is Modifierfalse
                                                  Must Supportfalse
                                                  Summarytrue
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  724. SubstanceDefinition.name:usan.translation
                                                  Definition

                                                  A translation for this name into another human language.

                                                  ShortA translation for this name into another human language
                                                  Control0..*
                                                  TypeSee ttp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name
                                                  Is Modifierfalse
                                                  Must Supportfalse
                                                  Summarytrue
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  726. SubstanceDefinition.name:usan.official
                                                  Definition

                                                  Details of the official nature of this name.

                                                  ShortDetails of the official nature of this name
                                                  Control0..*
                                                  TypeBackboneElement
                                                  Is Modifierfalse
                                                  Must Supportfalse
                                                  Summarytrue
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  728. SubstanceDefinition.name:usan.official.id
                                                  Definition

                                                  Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                  ShortUnique id for inter-element referencing
                                                  Control0..1
                                                  This element is affected by the following invariants: ele-1
                                                  Typestring
                                                  Is Modifierfalse
                                                  XML FormatIn the XML format, this property is represented as an attribute.
                                                  Summaryfalse
                                                  730. SubstanceDefinition.name:usan.official.extension
                                                  Definition

                                                  May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                  ShortAdditional content defined by implementations
                                                  Comments

                                                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                  Control0..*
                                                  TypeExtension
                                                  Is Modifierfalse
                                                  Summaryfalse
                                                  Alternate Namesextensions, user content
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                  732. SubstanceDefinition.name:usan.official.modifierExtension
                                                  Definition

                                                  May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                  Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                  ShortExtensions that cannot be ignored even if unrecognized
                                                  Comments

                                                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                  Control0..*
                                                  TypeExtension
                                                  Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                  Summarytrue
                                                  Requirements

                                                  Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                  Alternate Namesextensions, user content, modifiers
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                  734. SubstanceDefinition.name:usan.official.authority
                                                  Definition

                                                  Which authority uses this official name.

                                                  ShortWhich authority uses this official name
                                                  Control0..1
                                                  BindingThe codes SHOULD be taken from SubstanceNameAuthority
                                                  (preferred to http://hl7.org/fhir/ValueSet/substance-name-authority)

                                                  An authority that officates substance names.

                                                  TypeCodeableConcept
                                                  Is Modifierfalse
                                                  Must Supportfalse
                                                  Summarytrue
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  736. SubstanceDefinition.name:usan.official.status
                                                  Definition

                                                  The status of the official name, for example 'draft', 'active', 'retired'.

                                                  ShortThe status of the official name, for example 'draft', 'active'
                                                  Control0..1
                                                  BindingThe codes SHOULD be taken from PublicationStatus
                                                  (preferred to http://hl7.org/fhir/ValueSet/publication-status)

                                                  The lifecycle status of an artifact.

                                                  TypeCodeableConcept
                                                  Is Modifierfalse
                                                  Must Supportfalse
                                                  Summarytrue
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  738. SubstanceDefinition.name:usan.official.date
                                                  Definition

                                                  Date of the official name change.

                                                  ShortDate of official name change
                                                  Control0..1
                                                  TypedateTime
                                                  Is Modifierfalse
                                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                  Must Supportfalse
                                                  Summarytrue
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  740. SubstanceDefinition.name:usan.source
                                                  Definition

                                                  Supporting literature.

                                                  ShortSupporting literature
                                                  Control0..*
                                                  TypeReference(DocumentReference)
                                                  Is Modifierfalse
                                                  Must Supportfalse
                                                  Summarytrue
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  742. SubstanceDefinition.name:iupac
                                                  Slice Nameiupac
                                                  Definition

                                                  Names applicable to this substance.

                                                  ShortNames applicable to this substance
                                                  Control0..1
                                                  TypeBackboneElement
                                                  Is Modifierfalse
                                                  Must Supporttrue
                                                  Summarytrue
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  744. SubstanceDefinition.name:iupac.id
                                                  Definition

                                                  Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                  ShortUnique id for inter-element referencing
                                                  Control0..1
                                                  This element is affected by the following invariants: ele-1
                                                  Typestring
                                                  Is Modifierfalse
                                                  XML FormatIn the XML format, this property is represented as an attribute.
                                                  Summaryfalse
                                                  746. SubstanceDefinition.name:iupac.extension
                                                  Definition

                                                  May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                  ShortAdditional content defined by implementations
                                                  Comments

                                                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                  Control0..*
                                                  TypeExtension
                                                  Is Modifierfalse
                                                  Summaryfalse
                                                  Alternate Namesextensions, user content
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                  748. SubstanceDefinition.name:iupac.modifierExtension
                                                  Definition

                                                  May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                  Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                  ShortExtensions that cannot be ignored even if unrecognized
                                                  Comments

                                                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                  Control0..*
                                                  TypeExtension
                                                  Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                  Summarytrue
                                                  Requirements

                                                  Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                  Alternate Namesextensions, user content, modifiers
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                  750. SubstanceDefinition.name:iupac.name
                                                  Definition

                                                  A name assigned to a chemical substance according to the systematic nomenclature rules defined by the International Union of Pure and Applied Chemistry (IUPAC) [Source: SME Defined] Example: N- (4-hydroxyphenyl)acetamide

                                                  ShortIUPAC Name
                                                  Control1..1
                                                  Typestring
                                                  Is Modifierfalse
                                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                  Must Supporttrue
                                                  Summarytrue
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  752. SubstanceDefinition.name:iupac.type
                                                  Definition

                                                  Name type, for example 'systematic', 'scientific, 'brand'.

                                                  ShortName type e.g. 'systematic', 'scientific, 'brand'
                                                  Control1..1
                                                  BindingFor example codes, see SubstanceNameType
                                                  (example to http://hl7.org/fhir/ValueSet/substance-name-type)

                                                  The type of a name given to a substance.

                                                  TypeCodeableConcept
                                                  Is Modifierfalse
                                                  Must Supporttrue
                                                  Summarytrue
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  754. SubstanceDefinition.name:iupac.type.id
                                                  Definition

                                                  Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                  ShortUnique id for inter-element referencing
                                                  Control0..1
                                                  This element is affected by the following invariants: ele-1
                                                  Typeid
                                                  Is Modifierfalse
                                                  XML FormatIn the XML format, this property is represented as an attribute.
                                                  Summaryfalse
                                                  756. SubstanceDefinition.name:iupac.type.extension
                                                  Definition

                                                  May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                  ShortAdditional content defined by implementations
                                                  Comments

                                                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                  Control0..*
                                                  TypeExtension
                                                  Is Modifierfalse
                                                  Summaryfalse
                                                  Alternate Namesextensions, user content
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                  SlicingThis element introduces a set of slices on SubstanceDefinition.name.type.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
                                                  • value @ url
                                                  • 758. SubstanceDefinition.name:iupac.type.coding
                                                    Definition

                                                    A reference to a code defined by a terminology system.

                                                    ShortCode defined by a terminology system
                                                    Comments

                                                    Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                                                    Control1..1
                                                    TypeCoding
                                                    Is Modifierfalse
                                                    Must Supporttrue
                                                    Summarytrue
                                                    Requirements

                                                    Allows for alternative encodings within a code system, and translations to other code systems.

                                                    Pattern Value{
                                                      "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
                                                      "code" : "C203356",
                                                      "display" : "IUPAC Name"
                                                    }
                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    760. SubstanceDefinition.name:iupac.type.text
                                                    Definition

                                                    A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                                                    ShortPlain text representation of the concept
                                                    Comments

                                                    Very often the text is the same as a displayName of one of the codings.

                                                    Control0..1
                                                    Typestring
                                                    Is Modifierfalse
                                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                    Summarytrue
                                                    Requirements

                                                    The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    762. SubstanceDefinition.name:iupac.status
                                                    Definition

                                                    The status of the name, for example 'current', 'proposed'.

                                                    ShortThe status of the name e.g. 'current', 'proposed'
                                                    Control0..1
                                                    BindingThe codes SHOULD be taken from PublicationStatus
                                                    (preferred to http://hl7.org/fhir/ValueSet/publication-status)

                                                    The lifecycle status of an artifact.

                                                    TypeCodeableConcept
                                                    Is Modifierfalse
                                                    Must Supportfalse
                                                    Summarytrue
                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    764. SubstanceDefinition.name:iupac.preferred
                                                    Definition

                                                    If this is the preferred name for this substance.

                                                    ShortIf this is the preferred name for this substance
                                                    Control0..1
                                                    Typeboolean
                                                    Is Modifierfalse
                                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                    Must Supporttrue
                                                    Summarytrue
                                                    Meaning if MissingIf this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made
                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    766. SubstanceDefinition.name:iupac.language
                                                    Definition

                                                    Human language that the name is written in.

                                                    ShortHuman language that the name is written in
                                                    Control0..*
                                                    BindingThe codes SHALL be taken from AllLanguages
                                                    (required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0)

                                                    IETF language tag for a human language

                                                    TypeCodeableConcept
                                                    Is Modifierfalse
                                                    Must Supportfalse
                                                    Summarytrue
                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    768. SubstanceDefinition.name:iupac.domain
                                                    Definition

                                                    The use context of this name for example if there is a different name a drug active ingredient as opposed to a food colour additive.

                                                    ShortThe use context of this name e.g. as an active ingredient or as a food colour additive
                                                    Control0..*
                                                    BindingFor example codes, see SubstanceNameDomain
                                                    (example to http://hl7.org/fhir/ValueSet/substance-name-domain)

                                                    The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive.

                                                    TypeCodeableConcept
                                                    Is Modifierfalse
                                                    Must Supportfalse
                                                    Summarytrue
                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    770. SubstanceDefinition.name:iupac.jurisdiction
                                                    Definition

                                                    The jurisdiction where this name applies.

                                                    ShortThe jurisdiction where this name applies
                                                    Control0..*
                                                    BindingFor example codes, see JurisdictionValueSet
                                                    (example to http://hl7.org/fhir/ValueSet/jurisdiction)

                                                    Jurisdiction codes

                                                    TypeCodeableConcept
                                                    Is Modifierfalse
                                                    Must Supportfalse
                                                    Summarytrue
                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    772. SubstanceDefinition.name:iupac.synonym
                                                    Definition

                                                    A synonym of this particular name, by which the substance is also known.

                                                    ShortA synonym of this particular name, by which the substance is also known
                                                    Control0..*
                                                    TypeSee ttp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name
                                                    Is Modifierfalse
                                                    Must Supportfalse
                                                    Summarytrue
                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    774. SubstanceDefinition.name:iupac.translation
                                                    Definition

                                                    A translation for this name into another human language.

                                                    ShortA translation for this name into another human language
                                                    Control0..*
                                                    TypeSee ttp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name
                                                    Is Modifierfalse
                                                    Must Supportfalse
                                                    Summarytrue
                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    776. SubstanceDefinition.name:iupac.official
                                                    Definition

                                                    Details of the official nature of this name.

                                                    ShortDetails of the official nature of this name
                                                    Control0..*
                                                    TypeBackboneElement
                                                    Is Modifierfalse
                                                    Must Supportfalse
                                                    Summarytrue
                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    778. SubstanceDefinition.name:iupac.official.id
                                                    Definition

                                                    Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                    ShortUnique id for inter-element referencing
                                                    Control0..1
                                                    This element is affected by the following invariants: ele-1
                                                    Typestring
                                                    Is Modifierfalse
                                                    XML FormatIn the XML format, this property is represented as an attribute.
                                                    Summaryfalse
                                                    780. SubstanceDefinition.name:iupac.official.extension
                                                    Definition

                                                    May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                    ShortAdditional content defined by implementations
                                                    Comments

                                                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                    Control0..*
                                                    TypeExtension
                                                    Is Modifierfalse
                                                    Summaryfalse
                                                    Alternate Namesextensions, user content
                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                    782. SubstanceDefinition.name:iupac.official.modifierExtension
                                                    Definition

                                                    May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                    ShortExtensions that cannot be ignored even if unrecognized
                                                    Comments

                                                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                    Control0..*
                                                    TypeExtension
                                                    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                    Summarytrue
                                                    Requirements

                                                    Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                    Alternate Namesextensions, user content, modifiers
                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                    784. SubstanceDefinition.name:iupac.official.authority
                                                    Definition

                                                    Which authority uses this official name.

                                                    ShortWhich authority uses this official name
                                                    Control0..1
                                                    BindingThe codes SHOULD be taken from SubstanceNameAuthority
                                                    (preferred to http://hl7.org/fhir/ValueSet/substance-name-authority)

                                                    An authority that officates substance names.

                                                    TypeCodeableConcept
                                                    Is Modifierfalse
                                                    Must Supportfalse
                                                    Summarytrue
                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    786. SubstanceDefinition.name:iupac.official.status
                                                    Definition

                                                    The status of the official name, for example 'draft', 'active', 'retired'.

                                                    ShortThe status of the official name, for example 'draft', 'active'
                                                    Control0..1
                                                    BindingThe codes SHOULD be taken from PublicationStatus
                                                    (preferred to http://hl7.org/fhir/ValueSet/publication-status)

                                                    The lifecycle status of an artifact.

                                                    TypeCodeableConcept
                                                    Is Modifierfalse
                                                    Must Supportfalse
                                                    Summarytrue
                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    788. SubstanceDefinition.name:iupac.official.date
                                                    Definition

                                                    Date of the official name change.

                                                    ShortDate of official name change
                                                    Control0..1
                                                    TypedateTime
                                                    Is Modifierfalse
                                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                    Must Supportfalse
                                                    Summarytrue
                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    790. SubstanceDefinition.name:iupac.source
                                                    Definition

                                                    Supporting literature.

                                                    ShortSupporting literature
                                                    Control0..*
                                                    TypeReference(DocumentReference)
                                                    Is Modifierfalse
                                                    Must Supportfalse
                                                    Summarytrue
                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    792. SubstanceDefinition.name:isbt
                                                    Slice Nameisbt
                                                    Definition

                                                    Names applicable to this substance.

                                                    ShortNames applicable to this substance
                                                    Control0..1
                                                    TypeBackboneElement
                                                    Is Modifierfalse
                                                    Must Supporttrue
                                                    Summarytrue
                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    794. SubstanceDefinition.name:isbt.id
                                                    Definition

                                                    Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                    ShortUnique id for inter-element referencing
                                                    Control0..1
                                                    This element is affected by the following invariants: ele-1
                                                    Typestring
                                                    Is Modifierfalse
                                                    XML FormatIn the XML format, this property is represented as an attribute.
                                                    Summaryfalse
                                                    796. SubstanceDefinition.name:isbt.extension
                                                    Definition

                                                    May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                    ShortAdditional content defined by implementations
                                                    Comments

                                                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                    Control0..*
                                                    TypeExtension
                                                    Is Modifierfalse
                                                    Summaryfalse
                                                    Alternate Namesextensions, user content
                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                    798. SubstanceDefinition.name:isbt.modifierExtension
                                                    Definition

                                                    May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                    ShortExtensions that cannot be ignored even if unrecognized
                                                    Comments

                                                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                    Control0..*
                                                    TypeExtension
                                                    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                    Summarytrue
                                                    Requirements

                                                    Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                    Alternate Namesextensions, user content, modifiers
                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                    800. SubstanceDefinition.name:isbt.name
                                                    Definition

                                                    It is the global standard for the terminology, identification, coding and labeling of medical products of human origin (including blood, cell, tissue, milk, and organ products). [Source: https://www.iccbba.org/]

                                                    ShortISBT-128 DIN
                                                    Control1..1
                                                    Typestring
                                                    Is Modifierfalse
                                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                    Must Supporttrue
                                                    Summarytrue
                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    802. SubstanceDefinition.name:isbt.type
                                                    Definition

                                                    Name type, for example 'systematic', 'scientific, 'brand'.

                                                    ShortName type e.g. 'systematic', 'scientific, 'brand'
                                                    Control1..1
                                                    BindingFor example codes, see SubstanceNameType
                                                    (example to http://hl7.org/fhir/ValueSet/substance-name-type)

                                                    The type of a name given to a substance.

                                                    TypeCodeableConcept
                                                    Is Modifierfalse
                                                    Must Supporttrue
                                                    Summarytrue
                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    804. SubstanceDefinition.name:isbt.type.id
                                                    Definition

                                                    Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                    ShortUnique id for inter-element referencing
                                                    Control0..1
                                                    This element is affected by the following invariants: ele-1
                                                    Typeid
                                                    Is Modifierfalse
                                                    XML FormatIn the XML format, this property is represented as an attribute.
                                                    Summaryfalse
                                                    806. SubstanceDefinition.name:isbt.type.extension
                                                    Definition

                                                    May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                    ShortAdditional content defined by implementations
                                                    Comments

                                                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                    Control0..*
                                                    TypeExtension
                                                    Is Modifierfalse
                                                    Summaryfalse
                                                    Alternate Namesextensions, user content
                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                    SlicingThis element introduces a set of slices on SubstanceDefinition.name.type.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
                                                    • value @ url
                                                    • 808. SubstanceDefinition.name:isbt.type.coding
                                                      Definition

                                                      A reference to a code defined by a terminology system.

                                                      ShortCode defined by a terminology system
                                                      Comments

                                                      Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                                                      Control1..1
                                                      TypeCoding
                                                      Is Modifierfalse
                                                      Must Supporttrue
                                                      Summarytrue
                                                      Requirements

                                                      Allows for alternative encodings within a code system, and translations to other code systems.

                                                      Pattern Value{
                                                        "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
                                                        "code" : "C95517",
                                                        "display" : "ISBT-128 DIN"
                                                      }
                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      810. SubstanceDefinition.name:isbt.type.text
                                                      Definition

                                                      A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                                                      ShortPlain text representation of the concept
                                                      Comments

                                                      Very often the text is the same as a displayName of one of the codings.

                                                      Control0..1
                                                      Typestring
                                                      Is Modifierfalse
                                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                      Summarytrue
                                                      Requirements

                                                      The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      812. SubstanceDefinition.name:isbt.status
                                                      Definition

                                                      The status of the name, for example 'current', 'proposed'.

                                                      ShortThe status of the name e.g. 'current', 'proposed'
                                                      Control0..1
                                                      BindingThe codes SHOULD be taken from PublicationStatus
                                                      (preferred to http://hl7.org/fhir/ValueSet/publication-status)

                                                      The lifecycle status of an artifact.

                                                      TypeCodeableConcept
                                                      Is Modifierfalse
                                                      Must Supportfalse
                                                      Summarytrue
                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      814. SubstanceDefinition.name:isbt.preferred
                                                      Definition

                                                      If this is the preferred name for this substance.

                                                      ShortIf this is the preferred name for this substance
                                                      Control0..1
                                                      Typeboolean
                                                      Is Modifierfalse
                                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                      Must Supporttrue
                                                      Summarytrue
                                                      Meaning if MissingIf this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made
                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      816. SubstanceDefinition.name:isbt.language
                                                      Definition

                                                      Human language that the name is written in.

                                                      ShortHuman language that the name is written in
                                                      Control0..*
                                                      BindingThe codes SHALL be taken from AllLanguages
                                                      (required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0)

                                                      IETF language tag for a human language

                                                      TypeCodeableConcept
                                                      Is Modifierfalse
                                                      Must Supportfalse
                                                      Summarytrue
                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      818. SubstanceDefinition.name:isbt.domain
                                                      Definition

                                                      The use context of this name for example if there is a different name a drug active ingredient as opposed to a food colour additive.

                                                      ShortThe use context of this name e.g. as an active ingredient or as a food colour additive
                                                      Control0..*
                                                      BindingFor example codes, see SubstanceNameDomain
                                                      (example to http://hl7.org/fhir/ValueSet/substance-name-domain)

                                                      The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive.

                                                      TypeCodeableConcept
                                                      Is Modifierfalse
                                                      Must Supportfalse
                                                      Summarytrue
                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      820. SubstanceDefinition.name:isbt.jurisdiction
                                                      Definition

                                                      The jurisdiction where this name applies.

                                                      ShortThe jurisdiction where this name applies
                                                      Control0..*
                                                      BindingFor example codes, see JurisdictionValueSet
                                                      (example to http://hl7.org/fhir/ValueSet/jurisdiction)

                                                      Jurisdiction codes

                                                      TypeCodeableConcept
                                                      Is Modifierfalse
                                                      Must Supportfalse
                                                      Summarytrue
                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      822. SubstanceDefinition.name:isbt.synonym
                                                      Definition

                                                      A synonym of this particular name, by which the substance is also known.

                                                      ShortA synonym of this particular name, by which the substance is also known
                                                      Control0..*
                                                      TypeSee ttp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name
                                                      Is Modifierfalse
                                                      Must Supportfalse
                                                      Summarytrue
                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      824. SubstanceDefinition.name:isbt.translation
                                                      Definition

                                                      A translation for this name into another human language.

                                                      ShortA translation for this name into another human language
                                                      Control0..*
                                                      TypeSee ttp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name
                                                      Is Modifierfalse
                                                      Must Supportfalse
                                                      Summarytrue
                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      826. SubstanceDefinition.name:isbt.official
                                                      Definition

                                                      Details of the official nature of this name.

                                                      ShortDetails of the official nature of this name
                                                      Control0..*
                                                      TypeBackboneElement
                                                      Is Modifierfalse
                                                      Must Supportfalse
                                                      Summarytrue
                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      828. SubstanceDefinition.name:isbt.official.id
                                                      Definition

                                                      Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                      ShortUnique id for inter-element referencing
                                                      Control0..1
                                                      This element is affected by the following invariants: ele-1
                                                      Typestring
                                                      Is Modifierfalse
                                                      XML FormatIn the XML format, this property is represented as an attribute.
                                                      Summaryfalse
                                                      830. SubstanceDefinition.name:isbt.official.extension
                                                      Definition

                                                      May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                      ShortAdditional content defined by implementations
                                                      Comments

                                                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                      Control0..*
                                                      TypeExtension
                                                      Is Modifierfalse
                                                      Summaryfalse
                                                      Alternate Namesextensions, user content
                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                      832. SubstanceDefinition.name:isbt.official.modifierExtension
                                                      Definition

                                                      May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                      Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                      ShortExtensions that cannot be ignored even if unrecognized
                                                      Comments

                                                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                      Control0..*
                                                      TypeExtension
                                                      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                      Summarytrue
                                                      Requirements

                                                      Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                      Alternate Namesextensions, user content, modifiers
                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                      834. SubstanceDefinition.name:isbt.official.authority
                                                      Definition

                                                      Which authority uses this official name.

                                                      ShortWhich authority uses this official name
                                                      Control0..1
                                                      BindingThe codes SHOULD be taken from SubstanceNameAuthority
                                                      (preferred to http://hl7.org/fhir/ValueSet/substance-name-authority)

                                                      An authority that officates substance names.

                                                      TypeCodeableConcept
                                                      Is Modifierfalse
                                                      Must Supportfalse
                                                      Summarytrue
                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      836. SubstanceDefinition.name:isbt.official.status
                                                      Definition

                                                      The status of the official name, for example 'draft', 'active', 'retired'.

                                                      ShortThe status of the official name, for example 'draft', 'active'
                                                      Control0..1
                                                      BindingThe codes SHOULD be taken from PublicationStatus
                                                      (preferred to http://hl7.org/fhir/ValueSet/publication-status)

                                                      The lifecycle status of an artifact.

                                                      TypeCodeableConcept
                                                      Is Modifierfalse
                                                      Must Supportfalse
                                                      Summarytrue
                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      838. SubstanceDefinition.name:isbt.official.date
                                                      Definition

                                                      Date of the official name change.

                                                      ShortDate of official name change
                                                      Control0..1
                                                      TypedateTime
                                                      Is Modifierfalse
                                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                      Must Supportfalse
                                                      Summarytrue
                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      840. SubstanceDefinition.name:isbt.source
                                                      Definition

                                                      Supporting literature.

                                                      ShortSupporting literature
                                                      Control0..*
                                                      TypeReference(DocumentReference)
                                                      Is Modifierfalse
                                                      Must Supportfalse
                                                      Summarytrue
                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      842. SubstanceDefinition.relationship
                                                      Definition

                                                      A link between this substance and another, with details of the relationship.

                                                      ShortA link between this substance and another
                                                      Control0..*
                                                      TypeBackboneElement
                                                      Is Modifierfalse
                                                      Must Supporttrue
                                                      Summarytrue
                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      844. SubstanceDefinition.relationship.id
                                                      Definition

                                                      Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                      ShortUnique id for inter-element referencing
                                                      Control0..1
                                                      This element is affected by the following invariants: ele-1
                                                      Typestring
                                                      Is Modifierfalse
                                                      XML FormatIn the XML format, this property is represented as an attribute.
                                                      Summaryfalse
                                                      846. SubstanceDefinition.relationship.extension
                                                      Definition

                                                      May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                      ShortAdditional content defined by implementations
                                                      Comments

                                                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                      Control0..*
                                                      TypeExtension
                                                      Is Modifierfalse
                                                      Summaryfalse
                                                      Alternate Namesextensions, user content
                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                      848. SubstanceDefinition.relationship.modifierExtension
                                                      Definition

                                                      May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                      Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                      ShortExtensions that cannot be ignored even if unrecognized
                                                      Comments

                                                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                      Control0..*
                                                      TypeExtension
                                                      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                      Summarytrue
                                                      Requirements

                                                      Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                      Alternate Namesextensions, user content, modifiers
                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                      850. SubstanceDefinition.relationship.substanceDefinition[x]
                                                      Definition

                                                      A pointer to another substance, as a resource or just a representational code.

                                                      ShortA pointer to another substance, as a resource or a representational code
                                                      Control0..1
                                                      TypeChoice of: Reference(SubstanceDefinition), CodeableConcept
                                                      [x] NoteSee Choice of Data Types for further information about how to use [x]
                                                      Is Modifierfalse
                                                      Must Supportfalse
                                                      Summarytrue
                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      SlicingThis element introduces a set of slices on SubstanceDefinition.relationship.substanceDefinition[x]. The slices are unordered and Open, and can be differentiated using the following discriminators:
                                                      • type @ $this
                                                      • 852. SubstanceDefinition.relationship.substanceDefinition[x]:substanceDefinitionReference
                                                        Slice NamesubstanceDefinitionReference
                                                        Definition

                                                        A pointer to another substance, as a resource or just a representational code.

                                                        ShortThe substance definition of a polyphorm of the Drug Substance
                                                        Control0..1
                                                        TypeReference(Polymorphic Form)
                                                        [x] NoteSee Choice of Data Types for further information about how to use [x]
                                                        Is Modifierfalse
                                                        Must Supportfalse
                                                        Summarytrue
                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                        854. SubstanceDefinition.relationship.type
                                                        Definition

                                                        For example "salt to parent", "active moiety", "starting material", "polymorph", "impurity of".

                                                        ShortFor example "salt to parent", "active moiety"
                                                        Control1..1
                                                        BindingFor example codes, see SubstanceRelationshipType
                                                        (example to http://hl7.org/fhir/ValueSet/substance-relationship-type)

                                                        The relationship between two substance types.

                                                        TypeCodeableConcept
                                                        Is Modifierfalse
                                                        Must Supportfalse
                                                        Summarytrue
                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                        856. SubstanceDefinition.relationship.type.id
                                                        Definition

                                                        Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                        ShortUnique id for inter-element referencing
                                                        Control0..1
                                                        This element is affected by the following invariants: ele-1
                                                        Typeid
                                                        Is Modifierfalse
                                                        XML FormatIn the XML format, this property is represented as an attribute.
                                                        Summaryfalse
                                                        858. SubstanceDefinition.relationship.type.extension
                                                        Definition

                                                        May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                        ShortAdditional content defined by implementations
                                                        Comments

                                                        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                        Control0..*
                                                        TypeExtension
                                                        Is Modifierfalse
                                                        Summaryfalse
                                                        Alternate Namesextensions, user content
                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                        SlicingThis element introduces a set of slices on SubstanceDefinition.relationship.type.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
                                                        • value @ url
                                                        • 860. SubstanceDefinition.relationship.type.coding
                                                          Definition

                                                          A reference to a code defined by a terminology system.

                                                          ShortCode defined by a terminology system
                                                          Comments

                                                          Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                                                          Control0..*
                                                          TypeCoding
                                                          Is Modifierfalse
                                                          Summarytrue
                                                          Requirements

                                                          Allows for alternative encodings within a code system, and translations to other code systems.

                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          862. SubstanceDefinition.relationship.type.text
                                                          Definition

                                                          A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                                                          ShortPolymorph
                                                          Comments

                                                          Very often the text is the same as a displayName of one of the codings.

                                                          Control0..1
                                                          Typestring
                                                          Is Modifierfalse
                                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                          Summarytrue
                                                          Requirements

                                                          The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                                                          Pattern ValuePolymorph
                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          864. SubstanceDefinition.relationship.isDefining
                                                          Definition

                                                          For example where an enzyme strongly bonds with a particular substance, this is a defining relationship for that enzyme, out of several possible substance relationships.

                                                          ShortFor example where an enzyme strongly bonds with a particular substance, this is a defining relationship for that enzyme, out of several possible relationships
                                                          Control0..1
                                                          Typeboolean
                                                          Is Modifierfalse
                                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                          Must Supportfalse
                                                          Summarytrue
                                                          Meaning if MissingIf this value is not present, there is no statement being made about whether this is a defining relationship or not. No inference can be made
                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          866. SubstanceDefinition.relationship.amount[x]
                                                          Definition

                                                          A numeric factor for the relationship, for instance to express that the salt of a substance has some percentage of the active substance in relation to some other.

                                                          ShortA numeric factor for the relationship, e.g. that a substance salt has some percentage of active substance in relation to some other
                                                          Control0..1
                                                          TypeChoice of: Quantity, Ratio, string
                                                          [x] NoteSee Choice of Data Types for further information about how to use [x]
                                                          Is Modifierfalse
                                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                          Must Supportfalse
                                                          Summarytrue
                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          868. SubstanceDefinition.relationship.ratioHighLimitAmount
                                                          Definition

                                                          For use when the numeric has an uncertain range.

                                                          ShortFor use when the numeric has an uncertain range
                                                          Control0..1
                                                          TypeRatio
                                                          Is Modifierfalse
                                                          Must Supportfalse
                                                          Summarytrue
                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          870. SubstanceDefinition.relationship.comparator
                                                          Definition

                                                          An operator for the amount, for example "average", "approximately", "less than".

                                                          ShortAn operator for the amount, for example "average", "approximately", "less than"
                                                          Control0..1
                                                          BindingFor example codes, see SubstanceAmountType
                                                          (example to http://hl7.org/fhir/ValueSet/substance-amount-type)

                                                          The relationship between two substance types.

                                                          TypeCodeableConcept
                                                          Is Modifierfalse
                                                          Must Supportfalse
                                                          Summarytrue
                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          872. SubstanceDefinition.relationship.source
                                                          Definition

                                                          Supporting literature.

                                                          ShortSupporting literature
                                                          Control0..*
                                                          TypeReference(DocumentReference)
                                                          Is Modifierfalse
                                                          Must Supportfalse
                                                          Summarytrue
                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          874. SubstanceDefinition.nucleicAcid
                                                          Definition

                                                          Data items specific to nucleic acids.

                                                          ShortData items specific to nucleic acids
                                                          Control0..1
                                                          TypeReference(SubstanceNucleicAcid)
                                                          Is Modifierfalse
                                                          Must Supportfalse
                                                          Summarytrue
                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          876. SubstanceDefinition.polymer
                                                          Definition

                                                          Data items specific to polymers.

                                                          ShortData items specific to polymers
                                                          Control0..1
                                                          TypeReference(SubstancePolymer)
                                                          Is Modifierfalse
                                                          Must Supportfalse
                                                          Summarytrue
                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          878. SubstanceDefinition.protein
                                                          Definition

                                                          Data items specific to proteins.

                                                          ShortData items specific to proteins
                                                          Control0..1
                                                          TypeReference(SubstanceProtein)
                                                          Is Modifierfalse
                                                          Must Supportfalse
                                                          Summarytrue
                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          880. SubstanceDefinition.sourceMaterial
                                                          Definition

                                                          Material or taxonomic/anatomical source for the substance.

                                                          ShortMaterial or taxonomic/anatomical source
                                                          Control0..1
                                                          TypeBackboneElement
                                                          Is Modifierfalse
                                                          Must Supportfalse
                                                          Summarytrue
                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          882. SubstanceDefinition.sourceMaterial.id
                                                          Definition

                                                          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                          ShortUnique id for inter-element referencing
                                                          Control0..1
                                                          This element is affected by the following invariants: ele-1
                                                          Typestring
                                                          Is Modifierfalse
                                                          XML FormatIn the XML format, this property is represented as an attribute.
                                                          Summaryfalse
                                                          884. SubstanceDefinition.sourceMaterial.extension
                                                          Definition

                                                          May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                          ShortAdditional content defined by implementations
                                                          Comments

                                                          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                          Control0..*
                                                          TypeExtension
                                                          Is Modifierfalse
                                                          Summaryfalse
                                                          Alternate Namesextensions, user content
                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                          886. SubstanceDefinition.sourceMaterial.modifierExtension
                                                          Definition

                                                          May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                          Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                          ShortExtensions that cannot be ignored even if unrecognized
                                                          Comments

                                                          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                          Control0..*
                                                          TypeExtension
                                                          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                          Summarytrue
                                                          Requirements

                                                          Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                          Alternate Namesextensions, user content, modifiers
                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                          888. SubstanceDefinition.sourceMaterial.type
                                                          Definition

                                                          A classification that provides the origin of the raw material. Example: cat hair would be an Animal source type.

                                                          ShortClassification of the origin of the raw material. e.g. cat hair is an Animal source type
                                                          Control0..1
                                                          BindingFor example codes, see SourceMaterialType
                                                          (example to http://hl7.org/fhir/ValueSet/substance-source-material-type)

                                                          A classification that provides the origin of the substance raw material.

                                                          TypeCodeableConcept
                                                          Is Modifierfalse
                                                          Must Supportfalse
                                                          Summarytrue
                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          890. SubstanceDefinition.sourceMaterial.genus
                                                          Definition

                                                          The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name.

                                                          ShortThe genus of an organism e.g. the Latin epithet of the plant/animal scientific name
                                                          Control0..1
                                                          BindingFor example codes, see SourceMaterialGenus
                                                          (example to http://hl7.org/fhir/ValueSet/substance-source-material-genus)

                                                          The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name.

                                                          TypeCodeableConcept
                                                          Is Modifierfalse
                                                          Must Supportfalse
                                                          Summarytrue
                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          892. SubstanceDefinition.sourceMaterial.species
                                                          Definition

                                                          The species of an organism, typically referring to the Latin epithet of the species of the plant/animal.

                                                          ShortThe species of an organism e.g. the Latin epithet of the species of the plant/animal
                                                          Control0..1
                                                          BindingFor example codes, see SourceMaterialSpecies
                                                          (example to http://hl7.org/fhir/ValueSet/substance-source-material-species)

                                                          A species of origin a substance raw material.

                                                          TypeCodeableConcept
                                                          Is Modifierfalse
                                                          Must Supportfalse
                                                          Summarytrue
                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          894. SubstanceDefinition.sourceMaterial.part
                                                          Definition

                                                          An anatomical origin of the source material within an organism.

                                                          ShortAn anatomical origin of the source material within an organism
                                                          Control0..1
                                                          BindingFor example codes, see SourceMaterialPart
                                                          (example to http://hl7.org/fhir/ValueSet/substance-source-material-part)

                                                          An anatomical origin of the source material within an organism.

                                                          TypeCodeableConcept
                                                          Is Modifierfalse
                                                          Must Supportfalse
                                                          Summarytrue
                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          896. SubstanceDefinition.sourceMaterial.countryOfOrigin
                                                          Definition

                                                          The country or countries where the material is harvested.

                                                          ShortThe country or countries where the material is harvested
                                                          Control0..*
                                                          BindingThe codes SHALL be taken from CountryValueSet
                                                          (required to http://hl7.org/fhir/ValueSet/country|5.0.0)

                                                          Jurisdiction codes

                                                          TypeCodeableConcept
                                                          Is Modifierfalse
                                                          Must Supportfalse
                                                          Summarytrue
                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))