Union of http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance and http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance

This is the set of resources that conform to either of the profiles Drug Substance Handle (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance) and Drug Substance Handle (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance). E.g. what you have to deal with if you get resources conforming to one of them

Structure

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. SubstanceDefinition C0..*The detailed description of a substance, typically at a level beyond what is used for prescribing
Constraints: cmc-when-unii-required, cmc-name-isbt
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: ?? (required): IETF language tag for a human language
... text 0..1NarrativeText summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored
... identifier SΣ0..1Identifieroptional user designated identifier
... version Σ0..1stringA business level version identifier of the substance
... status Σ0..1CodeableConceptStatus of substance within the catalogue e.g. active, retired
Binding: ?? (preferred): The lifecycle status of an artifact.
... classification SΣ1..1CodeableConceptSubstance Type
Binding: ?? (required)
... domain Σ0..1CodeableConceptIf the substance applies to human or veterinary use
Binding: ?? (example): Applicable domain for this product (e.g. human, veterinary).
... grade Σ1..*CodeableConceptQuality Standard
Binding: ?? (required)
... description Σ0..1markdownTextual description of the substance
... informationSource Σ0..*Reference(Citation)Supporting literature
... note Σ0..*AnnotationTextual comment about the substance's catalogue or registry record
... manufacturer SΣ1..1LiteralReference(Basic Organization | #sd-cmc-organization-cmc-organization) {b}The entity that creates, makes, produces or fabricates the substance
... supplier SΣ0..1LiteralReference(Basic Organization | #sd-cmc-organization-cmc-organization) {b}An entity that is the source for the substance. It may be different from the manufacturer
... moiety Σ0..*BackboneElementMoiety, for structural modifications
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... role Σ0..1CodeableConceptRole that the moiety is playing
.... identifier Σ0..1IdentifierIdentifier by which this moiety substance is known
.... name Σ0..1stringTextual name for this moiety substance
.... stereochemistry Σ0..1CodeableConceptStereochemistry type
Binding: ?? (example): The optical rotation type of a substance.
.... opticalActivity Σ0..1CodeableConceptOptical activity type
Binding: ?? (example): The optical rotation type of a substance.
.... molecularFormula Σ0..1stringMolecular formula for this moiety (e.g. with the Hill system)
.... amount[x] Σ0..1Quantitative value for this moiety
..... amountQuantityQuantity
..... amountStringstring
.... measurementType Σ0..1CodeableConceptThe measurement type of the quantitative value
Binding: ?? (example): The relationship between two substance types.
... characterization Σ0..*BackboneElementGeneral specifications for this substance
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... technique Σ0..1CodeableConceptThe method used to find the characterization e.g. HPLC
Binding: ?? (example): The method used to elucidate the characterization of the drug substance.
.... form Σ0..1CodeableConceptDescribes the nature of the chemical entity and explains, for instance, whether this is a base or a salt form
Binding: ?? (example)
.... description Σ0..1markdownThe description or justification in support of the interpretation of the data file
.... file Σ0..*AttachmentThe 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
... property Σ0..*BackboneElementGeneral specifications for this substance
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type Σ1..1CodeableConceptA code expressing the type of property
Binding: ?? (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
.... value[x] Σ0..1A value for the property
..... valueCodeableConceptCodeableConcept
..... valueQuantityQuantity
..... valueDatedate
..... valueBooleanboolean
..... valueAttachmentAttachment
... referenceInformation Σ0..1Reference(SubstanceReferenceInformation)General information detailing this substance
... molecularWeight Σ0..*BackboneElementThe average mass of a molecule of a compound
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... method Σ0..1CodeableConceptThe method by which the weight was determined
Binding: ?? (example): The method by which the substance weight was measured.
.... type Σ0..1CodeableConceptType of molecular weight e.g. exact, average, weight average
Binding: ?? (example): The type of substance weight measurement.
.... amount Σ1..1QuantityUsed to capture quantitative values for a variety of elements
... structure Σ0..1BackboneElementStructural information
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... stereochemistry Σ0..1CodeableConceptStereochemistry type
Binding: ?? (example): The optical rotation type of a substance.
.... opticalActivity Σ0..1CodeableConceptOptical activity type
Binding: ?? (example): The optical rotation type of a substance.
.... molecularFormula Σ0..1stringAn expression which states the number and type of atoms present in a molecule of a substance
.... molecularFormulaByMoiety Σ0..1stringSpecified per moiety according to the Hill system
.... molecularWeight Σ0..1The molecular weight or weight range
.... technique Σ0..*CodeableConceptThe method used to find the structure e.g. X-ray, NMR
Binding: ?? (example): The method used to elucidate the structure of the drug substance.
.... sourceDocument Σ0..*Reference(DocumentReference)Source of information for the structure
.... representation Σ0..*BackboneElementA depiction of the structure of the substance
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... type Σ0..1CodeableConceptThe kind of structural representation (e.g. full, partial)
Binding: ?? (example): A format of a substance representation.
..... representation Σ0..1stringThe structural representation as a text string in a standard format
..... format Σ0..1CodeableConceptThe format of the representation e.g. InChI, SMILES, MOLFILE (note: not the physical file format)
Binding: ?? (example): A format of a substance representation.
..... document Σ0..1Reference(DocumentReference)An attachment with the structural representation e.g. a structure graphic or AnIML file
... code SΣ1..*BackboneElementCodes associated with the substance
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... code Σ0..1CodeableConceptThe specific code
.... status Σ0..1CodeableConceptStatus of the code assignment, for example 'provisional', 'approved'
Binding: ?? (preferred): The lifecycle status of an artifact.
.... statusDate Σ0..1dateTimeThe date at which the code status was changed
.... note Σ0..*AnnotationAny comment can be provided in this field
.... source Σ0..*Reference(DocumentReference)Supporting literature
... name SΣC1..*BackboneElementSubstance Name
Constraints: cmc-name-preferred
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... name Σ1..1stringThe actual name
.... type Σ0..1CodeableConceptName type e.g. 'systematic', 'scientific, 'brand'
Binding: ?? (required)
.... status Σ0..1CodeableConceptThe status of the name e.g. 'current', 'proposed'
Binding: ?? (preferred): The lifecycle status of an artifact.
.... preferred SΣ0..1booleanTrue when the name type is Substance Name
.... language Σ0..*CodeableConceptHuman language that the name is written in
Binding: ?? (required): IETF language tag for a human language
.... domain Σ0..*CodeableConceptThe use context of this name e.g. as an active ingredient or as a food colour additive
Binding: ?? (example): 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.
.... jurisdiction Σ0..*CodeableConceptThe jurisdiction where this name applies
Binding: ?? (example): Jurisdiction codes
.... synonym Σ0..*A synonym of this particular name, by which the substance is also known
.... translation Σ0..*A translation for this name into another human language
.... official Σ0..*BackboneElementDetails of the official nature of this name
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... authority Σ0..1CodeableConceptWhich authority uses this official name
Binding: ?? (preferred): An authority that officates substance names.
..... status Σ0..1CodeableConceptThe status of the official name, for example 'draft', 'active'
Binding: ?? (preferred): The lifecycle status of an artifact.
..... date Σ0..1dateTimeDate of official name change
.... source Σ0..*Reference(DocumentReference)Supporting literature
... relationship Σ0..*BackboneElementA link between this substance and another
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... substanceDefinition[x] Σ0..1A pointer to another substance, as a resource or a representational code
..... substanceDefinitionReferenceReference(SubstanceDefinition)
..... substanceDefinitionCodeableConceptCodeableConcept
.... type Σ1..1CodeableConceptFor example "salt to parent", "active moiety"
Binding: ?? (example): The relationship between two substance types.
.... isDefining Σ0..1booleanFor example where an enzyme strongly bonds with a particular substance, this is a defining relationship for that enzyme, out of several possible relationships
.... amount[x] Σ0..1A numeric factor for the relationship, e.g. that a substance salt has some percentage of active substance in relation to some other
..... amountQuantityQuantity
..... amountRatioRatio
..... amountStringstring
.... ratioHighLimitAmount Σ0..1RatioFor use when the numeric has an uncertain range
.... comparator Σ0..1CodeableConceptAn operator for the amount, for example "average", "approximately", "less than"
Binding: ?? (example): The relationship between two substance types.
.... source Σ0..*Reference(DocumentReference)Supporting literature
... nucleicAcid Σ0..1Reference(SubstanceNucleicAcid)Data items specific to nucleic acids
... polymer Σ0..1Reference(SubstancePolymer)Data items specific to polymers
... protein Σ0..1Reference(SubstanceProtein)Data items specific to proteins

doco Documentation for this format