Pharmaceutical Quality (Industry)
1.0.0 - STU1 International flag

This page is part of the Pharmaceutical Quality (Industry) (v1.0.0: STU1) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version. For a full list of available versions, see the Directory of published versions

Resource Profile: SubstanceDrugPq - Detailed Descriptions

Active as of 2024-05-08

Definitions for the Substance-drug-pq resource profile.

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

0. Substance
2. Substance.extension
SlicingThis element introduces a set of slices on Substance.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 4. Substance.extension:medication-manufacturingBatch
    Slice Namemedication-manufacturingBatch
    Shortmedication-manufacturingBatch
    TypeExtension(Medication Manufacturing Batch) (Complex Extension)
    Must Supporttrue
    6. Substance.extension:batch-release-date
    Slice Namebatch-release-date
    Shortbatch-release-date
    TypeExtension(Extension - Batch Release Date PQ) (Extension Type: dateTime)
    Must Supporttrue
    8. Substance.extension:batch-retest-date
    Slice Namebatch-retest-date
    Shortbatch-retest-date
    TypeExtension(Extension - Batch Retest Date PQ) (Extension Type: dateTime)
    Must Supporttrue
    10. Substance.extension:manufacturing-process
    Slice Namemanufacturing-process
    Shortmanufacturing-process
    TypeExtension(Extension - Manufacturing Process PQ) (Extension Type: Reference(PlanDefinition - Drug PQ))
    Must Supporttrue
    12. Substance.extension:actual-yield
    Slice Nameactual-yield
    Shortactual-yield
    TypeExtension(Extension - Actual Yield PQ) (Extension Type: Quantity)
    Must Supporttrue
    14. Substance.extension:batch-derived-from
    Slice Namebatch-derived-from
    Shortbatch-derived-from
    TypeExtension(Extension - Batch Derived From PQ) (Extension Type: Reference)
    Must Supporttrue
    16. Substance.identifier
    NoteThis is a business identifier, not a resource identifier (see discussion)
    Must Supporttrue
    18. Substance.status
    Must Supporttrue

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

    0. Substance
    Definition

    A homogeneous material with a definite composition.

    ShortA homogeneous material with a definite composition
    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())
    2. Substance.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()))
    4. Substance.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
    6. Substance.extension
    Definition

    An Extension


    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.

    ShortExtensionAdditional 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())
    SlicingThis element introduces a set of slices on Substance.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
    • value @ url
    • 8. Substance.extension:medication-manufacturingBatch
      Slice Namemedication-manufacturingBatch
      Definition

      An Extension

      Shortmedication-manufacturingBatch
      Control0..1
      TypeExtension(Medication Manufacturing Batch) (Complex Extension)
      Is Modifierfalse
      Must Supporttrue
      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())
      10. Substance.extension:batch-release-date
      Slice Namebatch-release-date
      Definition

      An Extension

      Shortbatch-release-date
      Control0..*
      TypeExtension(Extension - Batch Release Date PQ) (Extension Type: dateTime)
      Is Modifierfalse
      Must Supporttrue
      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. Substance.extension:batch-retest-date
      Slice Namebatch-retest-date
      Definition

      An Extension

      Shortbatch-retest-date
      Control0..*
      TypeExtension(Extension - Batch Retest Date PQ) (Extension Type: dateTime)
      Is Modifierfalse
      Must Supporttrue
      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())
      14. Substance.extension:manufacturing-process
      Slice Namemanufacturing-process
      Definition

      An Extension

      Shortmanufacturing-process
      Control0..*
      TypeExtension(Extension - Manufacturing Process PQ) (Extension Type: Reference(PlanDefinition - Drug PQ))
      Is Modifierfalse
      Must Supporttrue
      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())
      16. Substance.extension:actual-yield
      Slice Nameactual-yield
      Definition

      An Extension

      Shortactual-yield
      Control0..*
      TypeExtension(Extension - Actual Yield PQ) (Extension Type: Quantity)
      Is Modifierfalse
      Must Supporttrue
      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())
      18. Substance.extension:batch-derived-from
      Slice Namebatch-derived-from
      Definition

      An Extension

      Shortbatch-derived-from
      Control0..*
      TypeExtension(Extension - Batch Derived From PQ) (Extension Type: Reference)
      Is Modifierfalse
      Must Supporttrue
      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())
      20. Substance.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())
      22. Substance.identifier
      Definition

      Unique identifier for the substance. For an instance, an identifier associated with the package/container (usually a label affixed directly).

      ShortUnique identifier
      NoteThis is a business identifier, not a resource identifier (see discussion)
      Control0..*
      TypeIdentifier
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      24. Substance.instance
      Definition

      A boolean to indicate if this an instance of a substance or a kind of one (a definition).

      ShortIs this an instance of a substance or a kind of one
      Control1..1
      Typeboolean
      Is Modifiertrue because Not known why this is labelled a modifier
      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()))
      26. Substance.status
      Definition

      A code to indicate if the substance is actively used.

      Shortactive | inactive | entered-in-error
      Control0..1
      BindingThe codes SHALL be taken from FHIRSubstanceStatushttp://hl7.org/fhir/ValueSet/substance-status|5.0.0
      (required to http://hl7.org/fhir/ValueSet/substance-status|5.0.0)

      A code to indicate if the substance is actively used.

      Typecode
      Is Modifiertrue because This element is labelled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
      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()))
      28. Substance.code
      Definition

      A code (or set of codes) that identify this substance.

      ShortWhat substance this is
      Comments

      This could be a reference to an externally defined code. It could also be a locally assigned code (e.g. a formulary), optionally with translations to the standard drug codes.

      Control1..1
      BindingFor example codes, see SubstanceCodehttp://hl7.org/fhir/ValueSet/substance-code
      (example to http://hl7.org/fhir/ValueSet/substance-code)

      Substance codes.

      TypeCodeableReference(SubstanceDefinition)
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      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. Substance
      Definition

      A homogeneous material with a definite composition.

      ShortA homogeneous material with a definite composition
      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())
      2. Substance.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. Substance.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. Substance.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. Substance.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()))
      10. Substance.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()))
      12. Substance.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
      14. Substance.extension
      Definition

      An Extension

      ShortExtension
      Control0..*
      TypeExtension
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      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 Substance.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
      • value @ url
      • 16. Substance.extension:medication-manufacturingBatch
        Slice Namemedication-manufacturingBatch
        Definition

        An Extension

        Shortmedication-manufacturingBatch
        Control0..1
        TypeExtension(Medication Manufacturing Batch) (Complex Extension)
        Is Modifierfalse
        Must Supporttrue
        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())
        18. Substance.extension:batch-release-date
        Slice Namebatch-release-date
        Definition

        An Extension

        Shortbatch-release-date
        Control0..*
        TypeExtension(Extension - Batch Release Date PQ) (Extension Type: dateTime)
        Is Modifierfalse
        Must Supporttrue
        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())
        20. Substance.extension:batch-retest-date
        Slice Namebatch-retest-date
        Definition

        An Extension

        Shortbatch-retest-date
        Control0..*
        TypeExtension(Extension - Batch Retest Date PQ) (Extension Type: dateTime)
        Is Modifierfalse
        Must Supporttrue
        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())
        22. Substance.extension:manufacturing-process
        Slice Namemanufacturing-process
        Definition

        An Extension

        Shortmanufacturing-process
        Control0..*
        TypeExtension(Extension - Manufacturing Process PQ) (Extension Type: Reference(PlanDefinition - Drug PQ))
        Is Modifierfalse
        Must Supporttrue
        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. Substance.extension:actual-yield
        Slice Nameactual-yield
        Definition

        An Extension

        Shortactual-yield
        Control0..*
        TypeExtension(Extension - Actual Yield PQ) (Extension Type: Quantity)
        Is Modifierfalse
        Must Supporttrue
        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())
        26. Substance.extension:batch-derived-from
        Slice Namebatch-derived-from
        Definition

        An Extension

        Shortbatch-derived-from
        Control0..*
        TypeExtension(Extension - Batch Derived From PQ) (Extension Type: Reference)
        Is Modifierfalse
        Must Supporttrue
        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())
        28. Substance.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())
        30. Substance.identifier
        Definition

        Unique identifier for the substance. For an instance, an identifier associated with the package/container (usually a label affixed directly).

        ShortUnique identifier
        NoteThis is a business identifier, not a resource identifier (see discussion)
        Control0..*
        TypeIdentifier
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        32. Substance.instance
        Definition

        A boolean to indicate if this an instance of a substance or a kind of one (a definition).

        ShortIs this an instance of a substance or a kind of one
        Control1..1
        Typeboolean
        Is Modifiertrue because Not known why this is labelled a modifier
        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()))
        34. Substance.status
        Definition

        A code to indicate if the substance is actively used.

        Shortactive | inactive | entered-in-error
        Control0..1
        BindingThe codes SHALL be taken from FHIRSubstanceStatus
        (required to http://hl7.org/fhir/ValueSet/substance-status|5.0.0)

        A code to indicate if the substance is actively used.

        Typecode
        Is Modifiertrue because This element is labelled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
        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()))
        36. Substance.category
        Definition

        A code that classifies the general type of substance. This is used for searching, sorting and display purposes.

        ShortWhat class/type of substance this is
        Comments

        The level of granularity is defined by the category concepts in the value set. More fine-grained filtering can be performed using the metadata and/or terminology hierarchy in Substance.code.

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

        Category or classification of substance.

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

        A code (or set of codes) that identify this substance.

        ShortWhat substance this is
        Comments

        This could be a reference to an externally defined code. It could also be a locally assigned code (e.g. a formulary), optionally with translations to the standard drug codes.

        Control1..1
        BindingFor example codes, see SubstanceCode
        (example to http://hl7.org/fhir/ValueSet/substance-code)

        Substance codes.

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

        A description of the substance - its appearance, handling requirements, and other usage notes.

        ShortTextual description of the substance, comments
        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()))
        42. Substance.expiry
        Definition

        When the substance is no longer valid to use. For some substances, a single arbitrary date is used for expiry.

        ShortWhen no longer valid to use
        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()))
        44. Substance.quantity
        Definition

        The amount of the substance.

        ShortAmount of substance in the package
        Control0..1
        TypeQuantity(SimpleQuantity)
        Is Modifierfalse
        Must Supportfalse
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        46. Substance.ingredient
        Definition

        A substance can be composed of other substances.

        ShortComposition information about the 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()))
        48. Substance.ingredient.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
        50. Substance.ingredient.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())
        52. Substance.ingredient.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())
        54. Substance.ingredient.quantity
        Definition

        The amount of the ingredient in the substance - a concentration ratio.

        ShortOptional amount (concentration)
        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()))
        56. Substance.ingredient.substance[x]
        Definition

        Another substance that is a component of this substance.

        ShortA component of the substance
        Control1..1
        BindingFor example codes, see SubstanceCode
        (example to http://hl7.org/fhir/ValueSet/substance-code)

        Substance Ingredient codes.

        TypeChoice of: CodeableConcept, Reference(Substance)
        [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()))