Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions

Resource Profile: Excipient Drug Substance

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient Version: 1.0.0-ballot
Active as of 2024-04-04 Computable Name: ExcipientRaw
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.27

Provides sufficient information to identify an inactive substance and raw materials and its source when stability data is required in the submission.

Usage:

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

This structure is derived from SubstanceDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. SubstanceDefinition C 0..* SubstanceDefinition The detailed description of a substance, typically at a level beyond what is used for prescribing
cmc-when-unii-required: A UNII is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer','Protein'.
cmc-name-isbt: Name.type ISBT 128 required for blood products.
cmc-source-material: IF raw material source type equals Microbial, Animal, Plant, Insect or Human THEN the 4 source related attributes are required and the manufacturer and supplier information is highly desirable.
... meta
.... profile S 1..1 canonical(StructureDefinition) Profiles this resource claims to conform to
... identifier 0..1 Identifier optional user designated identifier
... classification S 1..* CodeableConcept Substance Type
Binding: Substance Classification (required)
.... coding 0..* Coding Code defined by a terminology system
Binding: Quality Benchmark Terminology (required)
... manufacturer S 0..1 Reference(Manufacturing and/or Test Site Organization) The entity that creates, makes, produces or fabricates the substance
... supplier S 0..1 Reference(Supplier Organization) An entity that is the source for the substance. It may be different from the manufacturer
... code S 1..* BackboneElement Codes associated with the substance
.... code S 1..1 CodeableConcept The specific code
..... Slices for coding 0..* Coding Code defined by a terminology system
Slice: Unordered, Open by value:system
...... coding:unii 0..1 Coding UNII
....... system 1..1 uri Identity of the terminology system
Required Pattern: http://fdasis.nlm.nih.gov
...... coding:uniProt 0..1 Coding UniProt ID
....... system 1..1 uri Identity of the terminology system
Required Pattern: https://www.uniprot.org
... Slices for name SC 1..* BackboneElement Substance Name
Slice: Unordered, Closed by value:type.coding
cmc-name-preferred: Name.preferred: at most one = true
.... name:All Slices Content/Rules for all slices
..... preferred S 0..1 boolean True when the name type is Substance Name
.... name:sub S 0..1 BackboneElement Names applicable to this substance
..... name S 1..1 string Generic Name
..... type S 1..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'
...... coding S 1..1 Coding Code defined by a terminology system
Required Pattern: At least the following
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C97054
....... display 1..1 string Representation defined by the system
Fixed Value: Generic Name
..... preferred S 0..1 boolean If this is the preferred name for this substance
.... name:gsrs S 0..1 BackboneElement Names applicable to this substance
..... name S 1..1 string GSRS Preferred Term
..... type S 1..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'
...... coding S 1..1 Coding Code defined by a terminology system
Required Pattern: At least the following
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C203355
....... display 1..1 string Representation defined by the system
Fixed Value: GSRS Preferred Term
..... preferred S 0..1 boolean If this is the preferred name for this substance
.... name:isbt S 0..1 BackboneElement Names applicable to this substance
..... name S 1..1 string ISBT-128 DIN
..... type S 1..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'
...... coding S 1..1 Coding Code defined by a terminology system
Required Pattern: At least the following
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C95517
....... display 1..1 string Representation defined by the system
Fixed Value: ISBT-128 DIN
..... preferred S 0..1 boolean If this is the preferred name for this substance
... sourceMaterial S 1..1 BackboneElement Material or taxonomic/anatomical source
.... type 1..1 CodeableConcept Source Type
..... coding 0..* Coding Code defined by a terminology system
Binding: Source Type Terminology (required)
.... genus S 0..1 CodeableConcept The genus of an organism e.g. the Latin epithet of the plant/animal scientific name
..... coding 0..0
..... text 1..1 string Source Organism
.... species S 0..1 CodeableConcept Source Organism
..... coding 0..0
..... text 1..1 string Plain text representation of the concept
.... part S 0..1 CodeableConcept Source Organism Part
..... coding 0..0
..... text 1..1 string Plain text representation of the concept
.... countryOfOrigin SC 0..1 CodeableConcept Source Organism Country of Origin
cmc-iso-genc-overlap: Only country codes that are also member of GENC can be used.
..... coding S 1..1 Coding Code defined by a terminology system
...... code SC 1..1 code Symbol in syntax defined by the system
cmc-only-ISO-3166-1-alpha-3: Country must be a 3 letter country code

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
SubstanceDefinition.classificationrequiredSubstanceClassification
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/substance-classification
from this IG
SubstanceDefinition.grade.codingrequiredPqcmcQualityBenchmarkTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology
from this IG
SubstanceDefinition.sourceMaterial.type.codingrequiredPqcmcSourceTypeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-source-type-terminology
from this IG

Constraints

IdGradePath(s)DetailsRequirements
cmc-iso-genc-overlaperrorSubstanceDefinition.sourceMaterial.countryOfOriginOnly country codes that are also member of GENC can be used.
: coding.where( (system = 'urn:iso:std:iso:3166') and ( (code = 'ALA') or (code = 'PSE') or (code = 'SJM') or (code = 'UMI') ) ).exists().not()
cmc-name-isbterrorSubstanceDefinitionName.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-name-preferrederrorSubstanceDefinition.nameName.preferred: at most one = true
: select(preferred = true).count() < 2
cmc-only-ISO-3166-1-alpha-3errorSubstanceDefinition.sourceMaterial.countryOfOrigin.coding.codeCountry must be a 3 letter country code
: $this.length() = 3
cmc-source-materialerrorSubstanceDefinitionIF raw material source type equals Microbial, Animal, Plant, Insect or Human THEN the 4 source related attributes are required and the manufacturer and supplier information is highly desirable.
: sourceMaterial.type.coding.where(system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and code in ('C14182' | 'C14225' | 'C14227' | 'C14329' | 'C14258')).exists() implies (sourceMaterial.genus.exists() and sourceMaterial.species.exists() and sourceMaterial.part.exists() and sourceMaterial.countryOfOrigin.exists())
cmc-when-unii-requirederrorSubstanceDefinitionA 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()
NameFlagsCard.TypeDescription & Constraintsdoco
.. SubstanceDefinition C 0..* SubstanceDefinition The detailed description of a substance, typically at a level beyond what is used for prescribing
cmc-when-unii-required: A UNII is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer','Protein'.
cmc-name-isbt: Name.type ISBT 128 required for blood products.
cmc-source-material: IF raw material source type equals Microbial, Animal, Plant, Insect or Human THEN the 4 source related attributes are required and the manufacturer and supplier information is highly desirable.
... meta Σ 0..1 Meta Metadata about the resource
.... profile SΣ 1..1 canonical(StructureDefinition) Profiles this resource claims to conform to
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... identifier Σ 0..1 Identifier optional user designated identifier
... classification SΣ 1..* CodeableConcept Substance Type
Binding: Substance Classification (required)
... grade Σ 1..1 CodeableConcept Quality Standard
Binding: SubstanceGrade (example): The quality standard, established benchmark, to which a substance complies


.... coding Σ 0..* Coding Code defined by a terminology system
Binding: Quality Benchmark Terminology (required)
... manufacturer SΣ 0..1 Reference(Manufacturing and/or Test Site Organization) The entity that creates, makes, produces or fabricates the substance
... supplier SΣ 0..1 Reference(Supplier Organization) An entity that is the source for the substance. It may be different from the manufacturer
... code SΣ 1..* BackboneElement Codes associated with the substance
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code SΣ 1..1 CodeableConcept The specific code
..... Slices for coding Σ 0..* Coding Code defined by a terminology system
Slice: Unordered, Open by value:system
...... coding:unii Σ 0..1 Coding UNII
....... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://fdasis.nlm.nih.gov
...... coding:uniProt Σ 0..1 Coding UniProt ID
....... system Σ 1..1 uri Identity of the terminology system
Required Pattern: https://www.uniprot.org
... Slices for name SΣC 1..* BackboneElement Substance Name
Slice: Unordered, Closed by value:type.coding
cmc-name-preferred: Name.preferred: at most one = true
.... name:All Slices Content/Rules for all slices
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... name Σ 1..1 string The actual name
..... preferred SΣ 0..1 boolean True when the name type is Substance Name
.... name:sub SΣ 0..1 BackboneElement Names applicable to this substance
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... name SΣ 1..1 string Generic Name
..... type SΣ 1..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'
Binding: SubstanceNameType (example): The type of a name given to a substance.

...... coding SΣ 1..1 Coding Code defined by a terminology system

Required Pattern: At least the following
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C97054
....... display 1..1 string Representation defined by the system
Fixed Value: Generic Name
..... preferred SΣ 0..1 boolean If this is the preferred name for this substance
.... name:gsrs SΣ 0..1 BackboneElement Names applicable to this substance
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... name SΣ 1..1 string GSRS Preferred Term
..... type SΣ 1..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'
Binding: SubstanceNameType (example): The type of a name given to a substance.

...... coding SΣ 1..1 Coding Code defined by a terminology system

Required Pattern: At least the following
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C203355
....... display 1..1 string Representation defined by the system
Fixed Value: GSRS Preferred Term
..... preferred SΣ 0..1 boolean If this is the preferred name for this substance
.... name:isbt SΣ 0..1 BackboneElement Names applicable to this substance
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... name SΣ 1..1 string ISBT-128 DIN
..... type SΣ 1..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'
Binding: SubstanceNameType (example): The type of a name given to a substance.

...... coding SΣ 1..1 Coding Code defined by a terminology system

Required Pattern: At least the following
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C95517
....... display 1..1 string Representation defined by the system
Fixed Value: ISBT-128 DIN
..... preferred SΣ 0..1 boolean If this is the preferred name for this substance
... sourceMaterial SΣ 1..1 BackboneElement Material or taxonomic/anatomical source
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type Σ 1..1 CodeableConcept Source Type
Binding: SourceMaterialType (example): A classification that provides the origin of the substance raw material.

..... coding Σ 0..* Coding Code defined by a terminology system
Binding: Source Type Terminology (required)
.... genus SΣ 0..1 CodeableConcept The genus of an organism e.g. the Latin epithet of the plant/animal scientific name
Binding: SourceMaterialGenus (example): The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name.

..... text Σ 1..1 string Source Organism
.... species SΣ 0..1 CodeableConcept Source Organism
Binding: SourceMaterialSpecies (example): A species of origin a substance raw material.

..... text Σ 1..1 string Plain text representation of the concept
.... part SΣ 0..1 CodeableConcept Source Organism Part
Binding: SourceMaterialPart (example): An anatomical origin of the source material within an organism.

..... text Σ 1..1 string Plain text representation of the concept
.... countryOfOrigin SΣC 0..1 CodeableConcept Source Organism Country of Origin
Binding: CountryValueSet (required): Jurisdiction codes


cmc-iso-genc-overlap: Only country codes that are also member of GENC can be used.
..... coding SΣ 1..1 Coding Code defined by a terminology system
...... code SΣC 1..1 code Symbol in syntax defined by the system
cmc-only-ISO-3166-1-alpha-3: Country must be a 3 letter country code

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
SubstanceDefinition.classificationrequiredSubstanceClassification
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/substance-classification
from this IG
SubstanceDefinition.gradeexampleSubstanceGrade
http://hl7.org/fhir/ValueSet/substance-grade
from the FHIR Standard
SubstanceDefinition.grade.codingrequiredPqcmcQualityBenchmarkTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology
from this IG
SubstanceDefinition.name:sub.typeexampleSubstanceNameType
http://hl7.org/fhir/ValueSet/substance-name-type
from the FHIR Standard
SubstanceDefinition.name:gsrs.typeexampleSubstanceNameType
http://hl7.org/fhir/ValueSet/substance-name-type
from the FHIR Standard
SubstanceDefinition.name:isbt.typeexampleSubstanceNameType
http://hl7.org/fhir/ValueSet/substance-name-type
from the FHIR Standard
SubstanceDefinition.sourceMaterial.typeexampleSourceMaterialType
http://hl7.org/fhir/ValueSet/substance-source-material-type
from the FHIR Standard
SubstanceDefinition.sourceMaterial.type.codingrequiredPqcmcSourceTypeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-source-type-terminology
from this IG
SubstanceDefinition.sourceMaterial.genusexampleSourceMaterialGenus
http://hl7.org/fhir/ValueSet/substance-source-material-genus
from the FHIR Standard
SubstanceDefinition.sourceMaterial.speciesexampleSourceMaterialSpecies
http://hl7.org/fhir/ValueSet/substance-source-material-species
from the FHIR Standard
SubstanceDefinition.sourceMaterial.partexampleSourceMaterialPart
http://hl7.org/fhir/ValueSet/substance-source-material-part
from the FHIR Standard
SubstanceDefinition.sourceMaterial.countryOfOriginrequiredCountryValueSet
http://hl7.org/fhir/ValueSet/country|5.0.0
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
cmc-iso-genc-overlaperrorSubstanceDefinition.sourceMaterial.countryOfOriginOnly country codes that are also member of GENC can be used.
: coding.where( (system = 'urn:iso:std:iso:3166') and ( (code = 'ALA') or (code = 'PSE') or (code = 'SJM') or (code = 'UMI') ) ).exists().not()
cmc-name-isbterrorSubstanceDefinitionName.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-name-preferrederrorSubstanceDefinition.nameName.preferred: at most one = true
: select(preferred = true).count() < 2
cmc-only-ISO-3166-1-alpha-3errorSubstanceDefinition.sourceMaterial.countryOfOrigin.coding.codeCountry must be a 3 letter country code
: $this.length() = 3
cmc-source-materialerrorSubstanceDefinitionIF raw material source type equals Microbial, Animal, Plant, Insect or Human THEN the 4 source related attributes are required and the manufacturer and supplier information is highly desirable.
: sourceMaterial.type.coding.where(system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and code in ('C14182' | 'C14225' | 'C14227' | 'C14329' | 'C14258')).exists() implies (sourceMaterial.genus.exists() and sourceMaterial.species.exists() and sourceMaterial.part.exists() and sourceMaterial.countryOfOrigin.exists())
cmc-when-unii-requirederrorSubstanceDefinitionA 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()
dom-2errorSubstanceDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorSubstanceDefinitionIf 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-4errorSubstanceDefinitionIf 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-5errorSubstanceDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceSubstanceDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
NameFlagsCard.TypeDescription & Constraintsdoco
.. SubstanceDefinition C 0..* SubstanceDefinition The detailed description of a substance, typically at a level beyond what is used for prescribing
cmc-when-unii-required: A UNII is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer','Protein'.
cmc-name-isbt: Name.type ISBT 128 required for blood products.
cmc-source-material: IF raw material source type equals Microbial, Animal, Plant, Insect or Human THEN the 4 source related attributes are required and the manufacturer and supplier information is highly desirable.
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... versionId Σ 0..1 id Version specific identifier
.... lastUpdated Σ 0..1 instant When the resource version last changed
.... source Σ 0..1 uri Identifies where the resource comes from
.... profile SΣ 1..1 canonical(StructureDefinition) Profiles this resource claims to conform to
.... security Σ 0..* Coding Security Labels applied to this resource
Binding: AllSecurityLabels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.


.... tag Σ 0..* Coding Tags applied to this resource
Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".


... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..1 Identifier optional user designated identifier
... version Σ 0..1 string A business level version identifier of the substance
... status Σ 0..1 CodeableConcept Status of substance within the catalogue e.g. active, retired
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

... classification SΣ 1..* CodeableConcept Substance Type
Binding: Substance Classification (required)
... domain Σ 0..1 CodeableConcept If the substance applies to human or veterinary use
Binding: MedicinalProductDomain (example): Applicable domain for this product (e.g. human, veterinary).

... grade Σ 1..1 CodeableConcept Quality Standard
Binding: SubstanceGrade (example): The quality standard, established benchmark, to which a substance complies


.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 0..* Coding Code defined by a terminology system
Binding: Quality Benchmark Terminology (required)
.... text Σ 0..1 string Plain text representation of the concept
... description Σ 0..1 markdown Textual description of the substance
... informationSource Σ 0..* Reference(Citation) Supporting literature
... note Σ 0..* Annotation Textual comment about the substance's catalogue or registry record
... manufacturer SΣ 0..1 Reference(Manufacturing and/or Test Site Organization) The entity that creates, makes, produces or fabricates the substance
... supplier SΣ 0..1 Reference(Supplier Organization) An entity that is the source for the substance. It may be different from the manufacturer
... moiety Σ 0..* BackboneElement Moiety, for structural modifications
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... role Σ 0..1 CodeableConcept Role that the moiety is playing
.... identifier Σ 0..1 Identifier Identifier by which this moiety substance is known
.... name Σ 0..1 string Textual name for this moiety substance
.... stereochemistry Σ 0..1 CodeableConcept Stereochemistry type
Binding: Stereochemistry (example): The optical rotation type of a substance.

.... opticalActivity Σ 0..1 CodeableConcept Optical activity type
Binding: OpticalActivity (example): The optical rotation type of a substance.

.... molecularFormula Σ 0..1 string Molecular formula for this moiety (e.g. with the Hill system)
.... amount[x] Σ 0..1 Quantitative value for this moiety
..... amountQuantity Quantity
..... amountString string
.... measurementType Σ 0..1 CodeableConcept The measurement type of the quantitative value
Binding: SubstanceAmountType (example): The relationship between two substance types.

... characterization Σ 0..* BackboneElement General specifications for this substance
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... technique Σ 0..1 CodeableConcept The method used to find the characterization e.g. HPLC
Binding: StructureTechnique (example): The method used to elucidate the characterization of the drug substance.

.... form Σ 0..1 CodeableConcept Describes the nature of the chemical entity and explains, for instance, whether this is a base or a salt form
Binding: SubstanceForm (example)
.... description Σ 0..1 markdown The description or justification in support of the interpretation of the data file
.... file Σ 0..* Attachment 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
... property Σ 0..* BackboneElement General specifications for this substance
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type Σ 1..1 CodeableConcept A code expressing the type of property
Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.

.... value[x] Σ 0..1 A value for the property
..... valueCodeableConcept CodeableConcept
..... valueQuantity Quantity
..... valueDate date
..... valueBoolean boolean
..... valueAttachment Attachment
... referenceInformation Σ 0..1 Reference(SubstanceReferenceInformation) General information detailing this substance
... molecularWeight Σ 0..* BackboneElement The average mass of a molecule of a compound
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... method Σ 0..1 CodeableConcept The method by which the weight was determined
Binding: WeightMethod (example): The method by which the substance weight was measured.

.... type Σ 0..1 CodeableConcept Type of molecular weight e.g. exact, average, weight average
Binding: WeightType (example): The type of substance weight measurement.

.... amount Σ 1..1 Quantity Used to capture quantitative values for a variety of elements
... structure Σ 0..1 BackboneElement Structural information
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... stereochemistry Σ 0..1 CodeableConcept Stereochemistry type
Binding: Stereochemistry (example): The optical rotation type of a substance.

.... opticalActivity Σ 0..1 CodeableConcept Optical activity type
Binding: OpticalActivity (example): The optical rotation type of a substance.

.... molecularFormula Σ 0..1 string An expression which states the number and type of atoms present in a molecule of a substance
.... molecularFormulaByMoiety Σ 0..1 string Specified per moiety according to the Hill system
.... molecularWeight Σ 0..1 See molecularWeight (SubstanceDefinition) The molecular weight or weight range
.... technique Σ 0..* CodeableConcept The method used to find the structure e.g. X-ray, NMR
Binding: StructureTechnique (example): The method used to elucidate the structure of the drug substance.


.... sourceDocument Σ 0..* Reference(DocumentReference) Source of information for the structure
.... representation Σ 0..* BackboneElement A depiction of the structure of the substance
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type Σ 0..1 CodeableConcept The kind of structural representation (e.g. full, partial)
Binding: SubstanceRepresentationType (example): A format of a substance representation.

..... representation Σ 0..1 string The structural representation as a text string in a standard format
..... format Σ 0..1 CodeableConcept The format of the representation e.g. InChI, SMILES, MOLFILE (note: not the physical file format)
Binding: SubstanceRepresentationFormat (example): A format of a substance representation.

..... document Σ 0..1 Reference(DocumentReference) An attachment with the structural representation e.g. a structure graphic or AnIML file
... code SΣ 1..* BackboneElement Codes associated with the substance
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code SΣ 1..1 CodeableConcept The specific code
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... Slices for coding Σ 0..* Coding Code defined by a terminology system
Slice: Unordered, Open by value:system
...... coding:unii Σ 0..1 Coding UNII
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://fdasis.nlm.nih.gov
....... version Σ 0..1 string Version of the system - if relevant
....... code ΣC 0..1 code Symbol in syntax defined by the system
....... display ΣC 0..1 string Representation defined by the system
....... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
...... coding:uniProt Σ 0..1 Coding UniProt ID
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ 1..1 uri Identity of the terminology system
Required Pattern: https://www.uniprot.org
....... version Σ 0..1 string Version of the system - if relevant
....... code ΣC 0..1 code Symbol in syntax defined by the system
....... display ΣC 0..1 string Representation defined by the system
....... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... text Σ 0..1 string Plain text representation of the concept
.... status Σ 0..1 CodeableConcept Status of the code assignment, for example 'provisional', 'approved'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

.... statusDate Σ 0..1 dateTime The date at which the code status was changed
.... note Σ 0..* Annotation Any comment can be provided in this field
.... source Σ 0..* Reference(DocumentReference) Supporting literature
... Slices for name SΣC 1..* BackboneElement Substance Name
Slice: Unordered, Closed by value:type.coding
cmc-name-preferred: Name.preferred: at most one = true
.... name:All Slices Content/Rules for all slices
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... name Σ 1..1 string The actual name
..... type Σ 0..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'
Binding: SubstanceNameType (example): The type of a name given to a substance.

..... status Σ 0..1 CodeableConcept The status of the name e.g. 'current', 'proposed'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

..... preferred SΣ 0..1 boolean True when the name type is Substance Name
..... language Σ 0..* CodeableConcept Human language that the name is written in
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set

..... domain Σ 0..* CodeableConcept The use context of this name e.g. as an active ingredient or as a food colour additive
Binding: SubstanceNameDomain (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 Σ 0..* CodeableConcept The jurisdiction where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes


..... synonym Σ 0..* See name (SubstanceDefinition) A synonym of this particular name, by which the substance is also known
..... translation Σ 0..* See name (SubstanceDefinition) A translation for this name into another human language
..... official Σ 0..* BackboneElement Details of the official nature of this name
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... authority Σ 0..1 CodeableConcept Which authority uses this official name
Binding: SubstanceNameAuthority (preferred): An authority that officates substance names.

...... status Σ 0..1 CodeableConcept The status of the official name, for example 'draft', 'active'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

...... date Σ 0..1 dateTime Date of official name change
..... source Σ 0..* Reference(DocumentReference) Supporting literature
.... name:sub SΣ 0..1 BackboneElement Names applicable to this substance
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... name SΣ 1..1 string Generic Name
..... type SΣ 1..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'
Binding: SubstanceNameType (example): The type of a name given to a substance.

...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding SΣ 1..1 Coding Code defined by a terminology system

Required Pattern: At least the following
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C97054
....... display 1..1 string Representation defined by the system
Fixed Value: Generic Name
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... status Σ 0..1 CodeableConcept The status of the name e.g. 'current', 'proposed'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

..... preferred SΣ 0..1 boolean If this is the preferred name for this substance
..... language Σ 0..* CodeableConcept Human language that the name is written in
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set

..... domain Σ 0..* CodeableConcept The use context of this name e.g. as an active ingredient or as a food colour additive
Binding: SubstanceNameDomain (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 Σ 0..* CodeableConcept The jurisdiction where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes


..... synonym Σ 0..* See name (SubstanceDefinition) A synonym of this particular name, by which the substance is also known
..... translation Σ 0..* See name (SubstanceDefinition) A translation for this name into another human language
..... official Σ 0..* BackboneElement Details of the official nature of this name
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... authority Σ 0..1 CodeableConcept Which authority uses this official name
Binding: SubstanceNameAuthority (preferred): An authority that officates substance names.

...... status Σ 0..1 CodeableConcept The status of the official name, for example 'draft', 'active'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

...... date Σ 0..1 dateTime Date of official name change
..... source Σ 0..* Reference(DocumentReference) Supporting literature
.... name:gsrs SΣ 0..1 BackboneElement Names applicable to this substance
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... name SΣ 1..1 string GSRS Preferred Term
..... type SΣ 1..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'
Binding: SubstanceNameType (example): The type of a name given to a substance.

...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding SΣ 1..1 Coding Code defined by a terminology system

Required Pattern: At least the following
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C203355
....... display 1..1 string Representation defined by the system
Fixed Value: GSRS Preferred Term
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... status Σ 0..1 CodeableConcept The status of the name e.g. 'current', 'proposed'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

..... preferred SΣ 0..1 boolean If this is the preferred name for this substance
..... language Σ 0..* CodeableConcept Human language that the name is written in
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set

..... domain Σ 0..* CodeableConcept The use context of this name e.g. as an active ingredient or as a food colour additive
Binding: SubstanceNameDomain (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 Σ 0..* CodeableConcept The jurisdiction where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes


..... synonym Σ 0..* See name (SubstanceDefinition) A synonym of this particular name, by which the substance is also known
..... translation Σ 0..* See name (SubstanceDefinition) A translation for this name into another human language
..... official Σ 0..* BackboneElement Details of the official nature of this name
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... authority Σ 0..1 CodeableConcept Which authority uses this official name
Binding: SubstanceNameAuthority (preferred): An authority that officates substance names.

...... status Σ 0..1 CodeableConcept The status of the official name, for example 'draft', 'active'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

...... date Σ 0..1 dateTime Date of official name change
..... source Σ 0..* Reference(DocumentReference) Supporting literature
.... name:isbt SΣ 0..1 BackboneElement Names applicable to this substance
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... name SΣ 1..1 string ISBT-128 DIN
..... type SΣ 1..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'
Binding: SubstanceNameType (example): The type of a name given to a substance.

...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding SΣ 1..1 Coding Code defined by a terminology system

Required Pattern: At least the following
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C95517
....... display 1..1 string Representation defined by the system
Fixed Value: ISBT-128 DIN
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... status Σ 0..1 CodeableConcept The status of the name e.g. 'current', 'proposed'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

..... preferred SΣ 0..1 boolean If this is the preferred name for this substance
..... language Σ 0..* CodeableConcept Human language that the name is written in
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set

..... domain Σ 0..* CodeableConcept The use context of this name e.g. as an active ingredient or as a food colour additive
Binding: SubstanceNameDomain (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 Σ 0..* CodeableConcept The jurisdiction where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes


..... synonym Σ 0..* See name (SubstanceDefinition) A synonym of this particular name, by which the substance is also known
..... translation Σ 0..* See name (SubstanceDefinition) A translation for this name into another human language
..... official Σ 0..* BackboneElement Details of the official nature of this name
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... authority Σ 0..1 CodeableConcept Which authority uses this official name
Binding: SubstanceNameAuthority (preferred): An authority that officates substance names.

...... status Σ 0..1 CodeableConcept The status of the official name, for example 'draft', 'active'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

...... date Σ 0..1 dateTime Date of official name change
..... source Σ 0..* Reference(DocumentReference) Supporting literature
... relationship Σ 0..* BackboneElement A link between this substance and another
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... substanceDefinition[x] Σ 0..1 A pointer to another substance, as a resource or a representational code
..... substanceDefinitionReference Reference(SubstanceDefinition)
..... substanceDefinitionCodeableConcept CodeableConcept
.... type Σ 1..1 CodeableConcept For example "salt to parent", "active moiety"
Binding: SubstanceRelationshipType (example): The relationship between two substance types.

.... isDefining Σ 0..1 boolean For 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] Σ 0..1 A numeric factor for the relationship, e.g. that a substance salt has some percentage of active substance in relation to some other
..... amountQuantity Quantity
..... amountRatio Ratio
..... amountString string
.... ratioHighLimitAmount Σ 0..1 Ratio For use when the numeric has an uncertain range
.... comparator Σ 0..1 CodeableConcept An operator for the amount, for example "average", "approximately", "less than"
Binding: SubstanceAmountType (example): The relationship between two substance types.

.... source Σ 0..* Reference(DocumentReference) Supporting literature
... nucleicAcid Σ 0..1 Reference(SubstanceNucleicAcid) Data items specific to nucleic acids
... polymer Σ 0..1 Reference(SubstancePolymer) Data items specific to polymers
... protein Σ 0..1 Reference(SubstanceProtein) Data items specific to proteins
... sourceMaterial SΣ 1..1 BackboneElement Material or taxonomic/anatomical source
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type Σ 1..1 CodeableConcept Source Type
Binding: SourceMaterialType (example): A classification that provides the origin of the substance raw material.

..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 0..* Coding Code defined by a terminology system
Binding: Source Type Terminology (required)
..... text Σ 0..1 string Plain text representation of the concept
.... genus SΣ 0..1 CodeableConcept The genus of an organism e.g. the Latin epithet of the plant/animal scientific name
Binding: SourceMaterialGenus (example): The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name.

..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... text Σ 1..1 string Source Organism
.... species SΣ 0..1 CodeableConcept Source Organism
Binding: SourceMaterialSpecies (example): A species of origin a substance raw material.

..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... text Σ 1..1 string Plain text representation of the concept
.... part SΣ 0..1 CodeableConcept Source Organism Part
Binding: SourceMaterialPart (example): An anatomical origin of the source material within an organism.

..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... text Σ 1..1 string Plain text representation of the concept
.... countryOfOrigin SΣC 0..1 CodeableConcept Source Organism Country of Origin
Binding: CountryValueSet (required): Jurisdiction codes


cmc-iso-genc-overlap: Only country codes that are also member of GENC can be used.
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding SΣ 1..1 Coding Code defined by a terminology system
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 0..1 uri Identity of the terminology system
...... version Σ 0..1 string Version of the system - if relevant
...... code SΣC 1..1 code Symbol in syntax defined by the system
cmc-only-ISO-3166-1-alpha-3: Country must be a 3 letter country code
...... display ΣC 0..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... text Σ 0..1 string Plain text representation of the concept

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
SubstanceDefinition.meta.securityextensibleAllSecurityLabels
http://hl7.org/fhir/ValueSet/security-labels
from the FHIR Standard
SubstanceDefinition.meta.tagexampleCommonTags
http://hl7.org/fhir/ValueSet/common-tags
from the FHIR Standard
SubstanceDefinition.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
SubstanceDefinition.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.classificationrequiredSubstanceClassification
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/substance-classification
from this IG
SubstanceDefinition.domainexampleMedicinalProductDomain
http://hl7.org/fhir/ValueSet/medicinal-product-domain
from the FHIR Standard
SubstanceDefinition.gradeexampleSubstanceGrade
http://hl7.org/fhir/ValueSet/substance-grade
from the FHIR Standard
SubstanceDefinition.grade.codingrequiredPqcmcQualityBenchmarkTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology
from this IG
SubstanceDefinition.moiety.stereochemistryexampleStereochemistry
http://hl7.org/fhir/ValueSet/substance-stereochemistry
from the FHIR Standard
SubstanceDefinition.moiety.opticalActivityexampleOpticalActivity
http://hl7.org/fhir/ValueSet/substance-optical-activity
from the FHIR Standard
SubstanceDefinition.moiety.measurementTypeexampleSubstanceAmountType
http://hl7.org/fhir/ValueSet/substance-amount-type
from the FHIR Standard
SubstanceDefinition.characterization.techniqueexampleStructureTechnique
http://hl7.org/fhir/ValueSet/substance-structure-technique
from the FHIR Standard
SubstanceDefinition.characterization.formexampleSubstanceForm
http://hl7.org/fhir/ValueSet/substance-form
from the FHIR Standard
SubstanceDefinition.property.typeexampleProductCharacteristic
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard
SubstanceDefinition.molecularWeight.methodexampleWeightMethod
http://hl7.org/fhir/ValueSet/substance-weight-method
from the FHIR Standard
SubstanceDefinition.molecularWeight.typeexampleWeightType
http://hl7.org/fhir/ValueSet/substance-weight-type
from the FHIR Standard
SubstanceDefinition.structure.stereochemistryexampleStereochemistry
http://hl7.org/fhir/ValueSet/substance-stereochemistry
from the FHIR Standard
SubstanceDefinition.structure.opticalActivityexampleOpticalActivity
http://hl7.org/fhir/ValueSet/substance-optical-activity
from the FHIR Standard
SubstanceDefinition.structure.techniqueexampleStructureTechnique
http://hl7.org/fhir/ValueSet/substance-structure-technique
from the FHIR Standard
SubstanceDefinition.structure.representation.typeexampleSubstanceRepresentationType
http://hl7.org/fhir/ValueSet/substance-representation-type
from the FHIR Standard
SubstanceDefinition.structure.representation.formatexampleSubstanceRepresentationFormat
http://hl7.org/fhir/ValueSet/substance-representation-format
from the FHIR Standard
SubstanceDefinition.code.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.name.typeexampleSubstanceNameType
http://hl7.org/fhir/ValueSet/substance-name-type
from the FHIR Standard
SubstanceDefinition.name.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.name.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
SubstanceDefinition.name.domainexampleSubstanceNameDomain
http://hl7.org/fhir/ValueSet/substance-name-domain
from the FHIR Standard
SubstanceDefinition.name.jurisdictionexampleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
SubstanceDefinition.name.official.authoritypreferredSubstanceNameAuthority
http://hl7.org/fhir/ValueSet/substance-name-authority
from the FHIR Standard
SubstanceDefinition.name.official.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.name:sub.typeexampleSubstanceNameType
http://hl7.org/fhir/ValueSet/substance-name-type
from the FHIR Standard
SubstanceDefinition.name:sub.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.name:sub.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
SubstanceDefinition.name:sub.domainexampleSubstanceNameDomain
http://hl7.org/fhir/ValueSet/substance-name-domain
from the FHIR Standard
SubstanceDefinition.name:sub.jurisdictionexampleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
SubstanceDefinition.name:sub.official.authoritypreferredSubstanceNameAuthority
http://hl7.org/fhir/ValueSet/substance-name-authority
from the FHIR Standard
SubstanceDefinition.name:sub.official.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.name:gsrs.typeexampleSubstanceNameType
http://hl7.org/fhir/ValueSet/substance-name-type
from the FHIR Standard
SubstanceDefinition.name:gsrs.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.name:gsrs.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
SubstanceDefinition.name:gsrs.domainexampleSubstanceNameDomain
http://hl7.org/fhir/ValueSet/substance-name-domain
from the FHIR Standard
SubstanceDefinition.name:gsrs.jurisdictionexampleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
SubstanceDefinition.name:gsrs.official.authoritypreferredSubstanceNameAuthority
http://hl7.org/fhir/ValueSet/substance-name-authority
from the FHIR Standard
SubstanceDefinition.name:gsrs.official.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.name:isbt.typeexampleSubstanceNameType
http://hl7.org/fhir/ValueSet/substance-name-type
from the FHIR Standard
SubstanceDefinition.name:isbt.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.name:isbt.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
SubstanceDefinition.name:isbt.domainexampleSubstanceNameDomain
http://hl7.org/fhir/ValueSet/substance-name-domain
from the FHIR Standard
SubstanceDefinition.name:isbt.jurisdictionexampleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
SubstanceDefinition.name:isbt.official.authoritypreferredSubstanceNameAuthority
http://hl7.org/fhir/ValueSet/substance-name-authority
from the FHIR Standard
SubstanceDefinition.name:isbt.official.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.relationship.typeexampleSubstanceRelationshipType
http://hl7.org/fhir/ValueSet/substance-relationship-type
from the FHIR Standard
SubstanceDefinition.relationship.comparatorexampleSubstanceAmountType
http://hl7.org/fhir/ValueSet/substance-amount-type
from the FHIR Standard
SubstanceDefinition.sourceMaterial.typeexampleSourceMaterialType
http://hl7.org/fhir/ValueSet/substance-source-material-type
from the FHIR Standard
SubstanceDefinition.sourceMaterial.type.codingrequiredPqcmcSourceTypeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-source-type-terminology
from this IG
SubstanceDefinition.sourceMaterial.genusexampleSourceMaterialGenus
http://hl7.org/fhir/ValueSet/substance-source-material-genus
from the FHIR Standard
SubstanceDefinition.sourceMaterial.speciesexampleSourceMaterialSpecies
http://hl7.org/fhir/ValueSet/substance-source-material-species
from the FHIR Standard
SubstanceDefinition.sourceMaterial.partexampleSourceMaterialPart
http://hl7.org/fhir/ValueSet/substance-source-material-part
from the FHIR Standard
SubstanceDefinition.sourceMaterial.countryOfOriginrequiredCountryValueSet
http://hl7.org/fhir/ValueSet/country|5.0.0
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
cmc-iso-genc-overlaperrorSubstanceDefinition.sourceMaterial.countryOfOriginOnly country codes that are also member of GENC can be used.
: coding.where( (system = 'urn:iso:std:iso:3166') and ( (code = 'ALA') or (code = 'PSE') or (code = 'SJM') or (code = 'UMI') ) ).exists().not()
cmc-name-isbterrorSubstanceDefinitionName.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-name-preferrederrorSubstanceDefinition.nameName.preferred: at most one = true
: select(preferred = true).count() < 2
cmc-only-ISO-3166-1-alpha-3errorSubstanceDefinition.sourceMaterial.countryOfOrigin.coding.codeCountry must be a 3 letter country code
: $this.length() = 3
cmc-source-materialerrorSubstanceDefinitionIF raw material source type equals Microbial, Animal, Plant, Insect or Human THEN the 4 source related attributes are required and the manufacturer and supplier information is highly desirable.
: sourceMaterial.type.coding.where(system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and code in ('C14182' | 'C14225' | 'C14227' | 'C14329' | 'C14258')).exists() implies (sourceMaterial.genus.exists() and sourceMaterial.species.exists() and sourceMaterial.part.exists() and sourceMaterial.countryOfOrigin.exists())
cmc-when-unii-requirederrorSubstanceDefinitionA 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()
dom-2errorSubstanceDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorSubstanceDefinitionIf 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-4errorSubstanceDefinitionIf 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-5errorSubstanceDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceSubstanceDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from SubstanceDefinition

Summary

Mandatory: 7 elements(14 nested mandatory elements)
Must-Support: 30 elements
Prohibited: 3 elements

Structures

This structure refers to these other structures:

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of SubstanceDefinition.code.code.coding
  • The element 1 is sliced based on the value of SubstanceDefinition.name (Closed)

Differential View

This structure is derived from SubstanceDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. SubstanceDefinition C 0..* SubstanceDefinition The detailed description of a substance, typically at a level beyond what is used for prescribing
cmc-when-unii-required: A UNII is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer','Protein'.
cmc-name-isbt: Name.type ISBT 128 required for blood products.
cmc-source-material: IF raw material source type equals Microbial, Animal, Plant, Insect or Human THEN the 4 source related attributes are required and the manufacturer and supplier information is highly desirable.
... meta
.... profile S 1..1 canonical(StructureDefinition) Profiles this resource claims to conform to
... identifier 0..1 Identifier optional user designated identifier
... classification S 1..* CodeableConcept Substance Type
Binding: Substance Classification (required)
.... coding 0..* Coding Code defined by a terminology system
Binding: Quality Benchmark Terminology (required)
... manufacturer S 0..1 Reference(Manufacturing and/or Test Site Organization) The entity that creates, makes, produces or fabricates the substance
... supplier S 0..1 Reference(Supplier Organization) An entity that is the source for the substance. It may be different from the manufacturer
... code S 1..* BackboneElement Codes associated with the substance
.... code S 1..1 CodeableConcept The specific code
..... Slices for coding 0..* Coding Code defined by a terminology system
Slice: Unordered, Open by value:system
...... coding:unii 0..1 Coding UNII
....... system 1..1 uri Identity of the terminology system
Required Pattern: http://fdasis.nlm.nih.gov
...... coding:uniProt 0..1 Coding UniProt ID
....... system 1..1 uri Identity of the terminology system
Required Pattern: https://www.uniprot.org
... Slices for name SC 1..* BackboneElement Substance Name
Slice: Unordered, Closed by value:type.coding
cmc-name-preferred: Name.preferred: at most one = true
.... name:All Slices Content/Rules for all slices
..... preferred S 0..1 boolean True when the name type is Substance Name
.... name:sub S 0..1 BackboneElement Names applicable to this substance
..... name S 1..1 string Generic Name
..... type S 1..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'
...... coding S 1..1 Coding Code defined by a terminology system
Required Pattern: At least the following
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C97054
....... display 1..1 string Representation defined by the system
Fixed Value: Generic Name
..... preferred S 0..1 boolean If this is the preferred name for this substance
.... name:gsrs S 0..1 BackboneElement Names applicable to this substance
..... name S 1..1 string GSRS Preferred Term
..... type S 1..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'
...... coding S 1..1 Coding Code defined by a terminology system
Required Pattern: At least the following
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C203355
....... display 1..1 string Representation defined by the system
Fixed Value: GSRS Preferred Term
..... preferred S 0..1 boolean If this is the preferred name for this substance
.... name:isbt S 0..1 BackboneElement Names applicable to this substance
..... name S 1..1 string ISBT-128 DIN
..... type S 1..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'
...... coding S 1..1 Coding Code defined by a terminology system
Required Pattern: At least the following
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C95517
....... display 1..1 string Representation defined by the system
Fixed Value: ISBT-128 DIN
..... preferred S 0..1 boolean If this is the preferred name for this substance
... sourceMaterial S 1..1 BackboneElement Material or taxonomic/anatomical source
.... type 1..1 CodeableConcept Source Type
..... coding 0..* Coding Code defined by a terminology system
Binding: Source Type Terminology (required)
.... genus S 0..1 CodeableConcept The genus of an organism e.g. the Latin epithet of the plant/animal scientific name
..... coding 0..0
..... text 1..1 string Source Organism
.... species S 0..1 CodeableConcept Source Organism
..... coding 0..0
..... text 1..1 string Plain text representation of the concept
.... part S 0..1 CodeableConcept Source Organism Part
..... coding 0..0
..... text 1..1 string Plain text representation of the concept
.... countryOfOrigin SC 0..1 CodeableConcept Source Organism Country of Origin
cmc-iso-genc-overlap: Only country codes that are also member of GENC can be used.
..... coding S 1..1 Coding Code defined by a terminology system
...... code SC 1..1 code Symbol in syntax defined by the system
cmc-only-ISO-3166-1-alpha-3: Country must be a 3 letter country code

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
SubstanceDefinition.classificationrequiredSubstanceClassification
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/substance-classification
from this IG
SubstanceDefinition.grade.codingrequiredPqcmcQualityBenchmarkTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology
from this IG
SubstanceDefinition.sourceMaterial.type.codingrequiredPqcmcSourceTypeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-source-type-terminology
from this IG

Constraints

IdGradePath(s)DetailsRequirements
cmc-iso-genc-overlaperrorSubstanceDefinition.sourceMaterial.countryOfOriginOnly country codes that are also member of GENC can be used.
: coding.where( (system = 'urn:iso:std:iso:3166') and ( (code = 'ALA') or (code = 'PSE') or (code = 'SJM') or (code = 'UMI') ) ).exists().not()
cmc-name-isbterrorSubstanceDefinitionName.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-name-preferrederrorSubstanceDefinition.nameName.preferred: at most one = true
: select(preferred = true).count() < 2
cmc-only-ISO-3166-1-alpha-3errorSubstanceDefinition.sourceMaterial.countryOfOrigin.coding.codeCountry must be a 3 letter country code
: $this.length() = 3
cmc-source-materialerrorSubstanceDefinitionIF raw material source type equals Microbial, Animal, Plant, Insect or Human THEN the 4 source related attributes are required and the manufacturer and supplier information is highly desirable.
: sourceMaterial.type.coding.where(system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and code in ('C14182' | 'C14225' | 'C14227' | 'C14329' | 'C14258')).exists() implies (sourceMaterial.genus.exists() and sourceMaterial.species.exists() and sourceMaterial.part.exists() and sourceMaterial.countryOfOrigin.exists())
cmc-when-unii-requirederrorSubstanceDefinitionA 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()

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. SubstanceDefinition C 0..* SubstanceDefinition The detailed description of a substance, typically at a level beyond what is used for prescribing
cmc-when-unii-required: A UNII is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer','Protein'.
cmc-name-isbt: Name.type ISBT 128 required for blood products.
cmc-source-material: IF raw material source type equals Microbial, Animal, Plant, Insect or Human THEN the 4 source related attributes are required and the manufacturer and supplier information is highly desirable.
... meta Σ 0..1 Meta Metadata about the resource
.... profile SΣ 1..1 canonical(StructureDefinition) Profiles this resource claims to conform to
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... identifier Σ 0..1 Identifier optional user designated identifier
... classification SΣ 1..* CodeableConcept Substance Type
Binding: Substance Classification (required)
... grade Σ 1..1 CodeableConcept Quality Standard
Binding: SubstanceGrade (example): The quality standard, established benchmark, to which a substance complies


.... coding Σ 0..* Coding Code defined by a terminology system
Binding: Quality Benchmark Terminology (required)
... manufacturer SΣ 0..1 Reference(Manufacturing and/or Test Site Organization) The entity that creates, makes, produces or fabricates the substance
... supplier SΣ 0..1 Reference(Supplier Organization) An entity that is the source for the substance. It may be different from the manufacturer
... code SΣ 1..* BackboneElement Codes associated with the substance
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code SΣ 1..1 CodeableConcept The specific code
..... Slices for coding Σ 0..* Coding Code defined by a terminology system
Slice: Unordered, Open by value:system
...... coding:unii Σ 0..1 Coding UNII
....... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://fdasis.nlm.nih.gov
...... coding:uniProt Σ 0..1 Coding UniProt ID
....... system Σ 1..1 uri Identity of the terminology system
Required Pattern: https://www.uniprot.org
... Slices for name SΣC 1..* BackboneElement Substance Name
Slice: Unordered, Closed by value:type.coding
cmc-name-preferred: Name.preferred: at most one = true
.... name:All Slices Content/Rules for all slices
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... name Σ 1..1 string The actual name
..... preferred SΣ 0..1 boolean True when the name type is Substance Name
.... name:sub SΣ 0..1 BackboneElement Names applicable to this substance
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... name SΣ 1..1 string Generic Name
..... type SΣ 1..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'
Binding: SubstanceNameType (example): The type of a name given to a substance.

...... coding SΣ 1..1 Coding Code defined by a terminology system

Required Pattern: At least the following
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C97054
....... display 1..1 string Representation defined by the system
Fixed Value: Generic Name
..... preferred SΣ 0..1 boolean If this is the preferred name for this substance
.... name:gsrs SΣ 0..1 BackboneElement Names applicable to this substance
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... name SΣ 1..1 string GSRS Preferred Term
..... type SΣ 1..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'
Binding: SubstanceNameType (example): The type of a name given to a substance.

...... coding SΣ 1..1 Coding Code defined by a terminology system

Required Pattern: At least the following
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C203355
....... display 1..1 string Representation defined by the system
Fixed Value: GSRS Preferred Term
..... preferred SΣ 0..1 boolean If this is the preferred name for this substance
.... name:isbt SΣ 0..1 BackboneElement Names applicable to this substance
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... name SΣ 1..1 string ISBT-128 DIN
..... type SΣ 1..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'
Binding: SubstanceNameType (example): The type of a name given to a substance.

...... coding SΣ 1..1 Coding Code defined by a terminology system

Required Pattern: At least the following
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C95517
....... display 1..1 string Representation defined by the system
Fixed Value: ISBT-128 DIN
..... preferred SΣ 0..1 boolean If this is the preferred name for this substance
... sourceMaterial SΣ 1..1 BackboneElement Material or taxonomic/anatomical source
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type Σ 1..1 CodeableConcept Source Type
Binding: SourceMaterialType (example): A classification that provides the origin of the substance raw material.

..... coding Σ 0..* Coding Code defined by a terminology system
Binding: Source Type Terminology (required)
.... genus SΣ 0..1 CodeableConcept The genus of an organism e.g. the Latin epithet of the plant/animal scientific name
Binding: SourceMaterialGenus (example): The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name.

..... text Σ 1..1 string Source Organism
.... species SΣ 0..1 CodeableConcept Source Organism
Binding: SourceMaterialSpecies (example): A species of origin a substance raw material.

..... text Σ 1..1 string Plain text representation of the concept
.... part SΣ 0..1 CodeableConcept Source Organism Part
Binding: SourceMaterialPart (example): An anatomical origin of the source material within an organism.

..... text Σ 1..1 string Plain text representation of the concept
.... countryOfOrigin SΣC 0..1 CodeableConcept Source Organism Country of Origin
Binding: CountryValueSet (required): Jurisdiction codes


cmc-iso-genc-overlap: Only country codes that are also member of GENC can be used.
..... coding SΣ 1..1 Coding Code defined by a terminology system
...... code SΣC 1..1 code Symbol in syntax defined by the system
cmc-only-ISO-3166-1-alpha-3: Country must be a 3 letter country code

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
SubstanceDefinition.classificationrequiredSubstanceClassification
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/substance-classification
from this IG
SubstanceDefinition.gradeexampleSubstanceGrade
http://hl7.org/fhir/ValueSet/substance-grade
from the FHIR Standard
SubstanceDefinition.grade.codingrequiredPqcmcQualityBenchmarkTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology
from this IG
SubstanceDefinition.name:sub.typeexampleSubstanceNameType
http://hl7.org/fhir/ValueSet/substance-name-type
from the FHIR Standard
SubstanceDefinition.name:gsrs.typeexampleSubstanceNameType
http://hl7.org/fhir/ValueSet/substance-name-type
from the FHIR Standard
SubstanceDefinition.name:isbt.typeexampleSubstanceNameType
http://hl7.org/fhir/ValueSet/substance-name-type
from the FHIR Standard
SubstanceDefinition.sourceMaterial.typeexampleSourceMaterialType
http://hl7.org/fhir/ValueSet/substance-source-material-type
from the FHIR Standard
SubstanceDefinition.sourceMaterial.type.codingrequiredPqcmcSourceTypeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-source-type-terminology
from this IG
SubstanceDefinition.sourceMaterial.genusexampleSourceMaterialGenus
http://hl7.org/fhir/ValueSet/substance-source-material-genus
from the FHIR Standard
SubstanceDefinition.sourceMaterial.speciesexampleSourceMaterialSpecies
http://hl7.org/fhir/ValueSet/substance-source-material-species
from the FHIR Standard
SubstanceDefinition.sourceMaterial.partexampleSourceMaterialPart
http://hl7.org/fhir/ValueSet/substance-source-material-part
from the FHIR Standard
SubstanceDefinition.sourceMaterial.countryOfOriginrequiredCountryValueSet
http://hl7.org/fhir/ValueSet/country|5.0.0
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
cmc-iso-genc-overlaperrorSubstanceDefinition.sourceMaterial.countryOfOriginOnly country codes that are also member of GENC can be used.
: coding.where( (system = 'urn:iso:std:iso:3166') and ( (code = 'ALA') or (code = 'PSE') or (code = 'SJM') or (code = 'UMI') ) ).exists().not()
cmc-name-isbterrorSubstanceDefinitionName.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-name-preferrederrorSubstanceDefinition.nameName.preferred: at most one = true
: select(preferred = true).count() < 2
cmc-only-ISO-3166-1-alpha-3errorSubstanceDefinition.sourceMaterial.countryOfOrigin.coding.codeCountry must be a 3 letter country code
: $this.length() = 3
cmc-source-materialerrorSubstanceDefinitionIF raw material source type equals Microbial, Animal, Plant, Insect or Human THEN the 4 source related attributes are required and the manufacturer and supplier information is highly desirable.
: sourceMaterial.type.coding.where(system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and code in ('C14182' | 'C14225' | 'C14227' | 'C14329' | 'C14258')).exists() implies (sourceMaterial.genus.exists() and sourceMaterial.species.exists() and sourceMaterial.part.exists() and sourceMaterial.countryOfOrigin.exists())
cmc-when-unii-requirederrorSubstanceDefinitionA 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()
dom-2errorSubstanceDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorSubstanceDefinitionIf 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-4errorSubstanceDefinitionIf 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-5errorSubstanceDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceSubstanceDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. SubstanceDefinition C 0..* SubstanceDefinition The detailed description of a substance, typically at a level beyond what is used for prescribing
cmc-when-unii-required: A UNII is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer','Protein'.
cmc-name-isbt: Name.type ISBT 128 required for blood products.
cmc-source-material: IF raw material source type equals Microbial, Animal, Plant, Insect or Human THEN the 4 source related attributes are required and the manufacturer and supplier information is highly desirable.
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... versionId Σ 0..1 id Version specific identifier
.... lastUpdated Σ 0..1 instant When the resource version last changed
.... source Σ 0..1 uri Identifies where the resource comes from
.... profile SΣ 1..1 canonical(StructureDefinition) Profiles this resource claims to conform to
.... security Σ 0..* Coding Security Labels applied to this resource
Binding: AllSecurityLabels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.


.... tag Σ 0..* Coding Tags applied to this resource
Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".


... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..1 Identifier optional user designated identifier
... version Σ 0..1 string A business level version identifier of the substance
... status Σ 0..1 CodeableConcept Status of substance within the catalogue e.g. active, retired
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

... classification SΣ 1..* CodeableConcept Substance Type
Binding: Substance Classification (required)
... domain Σ 0..1 CodeableConcept If the substance applies to human or veterinary use
Binding: MedicinalProductDomain (example): Applicable domain for this product (e.g. human, veterinary).

... grade Σ 1..1 CodeableConcept Quality Standard
Binding: SubstanceGrade (example): The quality standard, established benchmark, to which a substance complies


.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 0..* Coding Code defined by a terminology system
Binding: Quality Benchmark Terminology (required)
.... text Σ 0..1 string Plain text representation of the concept
... description Σ 0..1 markdown Textual description of the substance
... informationSource Σ 0..* Reference(Citation) Supporting literature
... note Σ 0..* Annotation Textual comment about the substance's catalogue or registry record
... manufacturer SΣ 0..1 Reference(Manufacturing and/or Test Site Organization) The entity that creates, makes, produces or fabricates the substance
... supplier SΣ 0..1 Reference(Supplier Organization) An entity that is the source for the substance. It may be different from the manufacturer
... moiety Σ 0..* BackboneElement Moiety, for structural modifications
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... role Σ 0..1 CodeableConcept Role that the moiety is playing
.... identifier Σ 0..1 Identifier Identifier by which this moiety substance is known
.... name Σ 0..1 string Textual name for this moiety substance
.... stereochemistry Σ 0..1 CodeableConcept Stereochemistry type
Binding: Stereochemistry (example): The optical rotation type of a substance.

.... opticalActivity Σ 0..1 CodeableConcept Optical activity type
Binding: OpticalActivity (example): The optical rotation type of a substance.

.... molecularFormula Σ 0..1 string Molecular formula for this moiety (e.g. with the Hill system)
.... amount[x] Σ 0..1 Quantitative value for this moiety
..... amountQuantity Quantity
..... amountString string
.... measurementType Σ 0..1 CodeableConcept The measurement type of the quantitative value
Binding: SubstanceAmountType (example): The relationship between two substance types.

... characterization Σ 0..* BackboneElement General specifications for this substance
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... technique Σ 0..1 CodeableConcept The method used to find the characterization e.g. HPLC
Binding: StructureTechnique (example): The method used to elucidate the characterization of the drug substance.

.... form Σ 0..1 CodeableConcept Describes the nature of the chemical entity and explains, for instance, whether this is a base or a salt form
Binding: SubstanceForm (example)
.... description Σ 0..1 markdown The description or justification in support of the interpretation of the data file
.... file Σ 0..* Attachment 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
... property Σ 0..* BackboneElement General specifications for this substance
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type Σ 1..1 CodeableConcept A code expressing the type of property
Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.

.... value[x] Σ 0..1 A value for the property
..... valueCodeableConcept CodeableConcept
..... valueQuantity Quantity
..... valueDate date
..... valueBoolean boolean
..... valueAttachment Attachment
... referenceInformation Σ 0..1 Reference(SubstanceReferenceInformation) General information detailing this substance
... molecularWeight Σ 0..* BackboneElement The average mass of a molecule of a compound
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... method Σ 0..1 CodeableConcept The method by which the weight was determined
Binding: WeightMethod (example): The method by which the substance weight was measured.

.... type Σ 0..1 CodeableConcept Type of molecular weight e.g. exact, average, weight average
Binding: WeightType (example): The type of substance weight measurement.

.... amount Σ 1..1 Quantity Used to capture quantitative values for a variety of elements
... structure Σ 0..1 BackboneElement Structural information
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... stereochemistry Σ 0..1 CodeableConcept Stereochemistry type
Binding: Stereochemistry (example): The optical rotation type of a substance.

.... opticalActivity Σ 0..1 CodeableConcept Optical activity type
Binding: OpticalActivity (example): The optical rotation type of a substance.

.... molecularFormula Σ 0..1 string An expression which states the number and type of atoms present in a molecule of a substance
.... molecularFormulaByMoiety Σ 0..1 string Specified per moiety according to the Hill system
.... molecularWeight Σ 0..1 See molecularWeight (SubstanceDefinition) The molecular weight or weight range
.... technique Σ 0..* CodeableConcept The method used to find the structure e.g. X-ray, NMR
Binding: StructureTechnique (example): The method used to elucidate the structure of the drug substance.


.... sourceDocument Σ 0..* Reference(DocumentReference) Source of information for the structure
.... representation Σ 0..* BackboneElement A depiction of the structure of the substance
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type Σ 0..1 CodeableConcept The kind of structural representation (e.g. full, partial)
Binding: SubstanceRepresentationType (example): A format of a substance representation.

..... representation Σ 0..1 string The structural representation as a text string in a standard format
..... format Σ 0..1 CodeableConcept The format of the representation e.g. InChI, SMILES, MOLFILE (note: not the physical file format)
Binding: SubstanceRepresentationFormat (example): A format of a substance representation.

..... document Σ 0..1 Reference(DocumentReference) An attachment with the structural representation e.g. a structure graphic or AnIML file
... code SΣ 1..* BackboneElement Codes associated with the substance
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code SΣ 1..1 CodeableConcept The specific code
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... Slices for coding Σ 0..* Coding Code defined by a terminology system
Slice: Unordered, Open by value:system
...... coding:unii Σ 0..1 Coding UNII
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://fdasis.nlm.nih.gov
....... version Σ 0..1 string Version of the system - if relevant
....... code ΣC 0..1 code Symbol in syntax defined by the system
....... display ΣC 0..1 string Representation defined by the system
....... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
...... coding:uniProt Σ 0..1 Coding UniProt ID
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ 1..1 uri Identity of the terminology system
Required Pattern: https://www.uniprot.org
....... version Σ 0..1 string Version of the system - if relevant
....... code ΣC 0..1 code Symbol in syntax defined by the system
....... display ΣC 0..1 string Representation defined by the system
....... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... text Σ 0..1 string Plain text representation of the concept
.... status Σ 0..1 CodeableConcept Status of the code assignment, for example 'provisional', 'approved'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

.... statusDate Σ 0..1 dateTime The date at which the code status was changed
.... note Σ 0..* Annotation Any comment can be provided in this field
.... source Σ 0..* Reference(DocumentReference) Supporting literature
... Slices for name SΣC 1..* BackboneElement Substance Name
Slice: Unordered, Closed by value:type.coding
cmc-name-preferred: Name.preferred: at most one = true
.... name:All Slices Content/Rules for all slices
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... name Σ 1..1 string The actual name
..... type Σ 0..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'
Binding: SubstanceNameType (example): The type of a name given to a substance.

..... status Σ 0..1 CodeableConcept The status of the name e.g. 'current', 'proposed'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

..... preferred SΣ 0..1 boolean True when the name type is Substance Name
..... language Σ 0..* CodeableConcept Human language that the name is written in
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set

..... domain Σ 0..* CodeableConcept The use context of this name e.g. as an active ingredient or as a food colour additive
Binding: SubstanceNameDomain (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 Σ 0..* CodeableConcept The jurisdiction where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes


..... synonym Σ 0..* See name (SubstanceDefinition) A synonym of this particular name, by which the substance is also known
..... translation Σ 0..* See name (SubstanceDefinition) A translation for this name into another human language
..... official Σ 0..* BackboneElement Details of the official nature of this name
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... authority Σ 0..1 CodeableConcept Which authority uses this official name
Binding: SubstanceNameAuthority (preferred): An authority that officates substance names.

...... status Σ 0..1 CodeableConcept The status of the official name, for example 'draft', 'active'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

...... date Σ 0..1 dateTime Date of official name change
..... source Σ 0..* Reference(DocumentReference) Supporting literature
.... name:sub SΣ 0..1 BackboneElement Names applicable to this substance
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... name SΣ 1..1 string Generic Name
..... type SΣ 1..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'
Binding: SubstanceNameType (example): The type of a name given to a substance.

...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding SΣ 1..1 Coding Code defined by a terminology system

Required Pattern: At least the following
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C97054
....... display 1..1 string Representation defined by the system
Fixed Value: Generic Name
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... status Σ 0..1 CodeableConcept The status of the name e.g. 'current', 'proposed'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

..... preferred SΣ 0..1 boolean If this is the preferred name for this substance
..... language Σ 0..* CodeableConcept Human language that the name is written in
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set

..... domain Σ 0..* CodeableConcept The use context of this name e.g. as an active ingredient or as a food colour additive
Binding: SubstanceNameDomain (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 Σ 0..* CodeableConcept The jurisdiction where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes


..... synonym Σ 0..* See name (SubstanceDefinition) A synonym of this particular name, by which the substance is also known
..... translation Σ 0..* See name (SubstanceDefinition) A translation for this name into another human language
..... official Σ 0..* BackboneElement Details of the official nature of this name
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... authority Σ 0..1 CodeableConcept Which authority uses this official name
Binding: SubstanceNameAuthority (preferred): An authority that officates substance names.

...... status Σ 0..1 CodeableConcept The status of the official name, for example 'draft', 'active'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

...... date Σ 0..1 dateTime Date of official name change
..... source Σ 0..* Reference(DocumentReference) Supporting literature
.... name:gsrs SΣ 0..1 BackboneElement Names applicable to this substance
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... name SΣ 1..1 string GSRS Preferred Term
..... type SΣ 1..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'
Binding: SubstanceNameType (example): The type of a name given to a substance.

...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding SΣ 1..1 Coding Code defined by a terminology system

Required Pattern: At least the following
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C203355
....... display 1..1 string Representation defined by the system
Fixed Value: GSRS Preferred Term
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... status Σ 0..1 CodeableConcept The status of the name e.g. 'current', 'proposed'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

..... preferred SΣ 0..1 boolean If this is the preferred name for this substance
..... language Σ 0..* CodeableConcept Human language that the name is written in
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set

..... domain Σ 0..* CodeableConcept The use context of this name e.g. as an active ingredient or as a food colour additive
Binding: SubstanceNameDomain (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 Σ 0..* CodeableConcept The jurisdiction where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes


..... synonym Σ 0..* See name (SubstanceDefinition) A synonym of this particular name, by which the substance is also known
..... translation Σ 0..* See name (SubstanceDefinition) A translation for this name into another human language
..... official Σ 0..* BackboneElement Details of the official nature of this name
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... authority Σ 0..1 CodeableConcept Which authority uses this official name
Binding: SubstanceNameAuthority (preferred): An authority that officates substance names.

...... status Σ 0..1 CodeableConcept The status of the official name, for example 'draft', 'active'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

...... date Σ 0..1 dateTime Date of official name change
..... source Σ 0..* Reference(DocumentReference) Supporting literature
.... name:isbt SΣ 0..1 BackboneElement Names applicable to this substance
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... name SΣ 1..1 string ISBT-128 DIN
..... type SΣ 1..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'
Binding: SubstanceNameType (example): The type of a name given to a substance.

...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding SΣ 1..1 Coding Code defined by a terminology system

Required Pattern: At least the following
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C95517
....... display 1..1 string Representation defined by the system
Fixed Value: ISBT-128 DIN
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... status Σ 0..1 CodeableConcept The status of the name e.g. 'current', 'proposed'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

..... preferred SΣ 0..1 boolean If this is the preferred name for this substance
..... language Σ 0..* CodeableConcept Human language that the name is written in
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set

..... domain Σ 0..* CodeableConcept The use context of this name e.g. as an active ingredient or as a food colour additive
Binding: SubstanceNameDomain (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 Σ 0..* CodeableConcept The jurisdiction where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes


..... synonym Σ 0..* See name (SubstanceDefinition) A synonym of this particular name, by which the substance is also known
..... translation Σ 0..* See name (SubstanceDefinition) A translation for this name into another human language
..... official Σ 0..* BackboneElement Details of the official nature of this name
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... authority Σ 0..1 CodeableConcept Which authority uses this official name
Binding: SubstanceNameAuthority (preferred): An authority that officates substance names.

...... status Σ 0..1 CodeableConcept The status of the official name, for example 'draft', 'active'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

...... date Σ 0..1 dateTime Date of official name change
..... source Σ 0..* Reference(DocumentReference) Supporting literature
... relationship Σ 0..* BackboneElement A link between this substance and another
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... substanceDefinition[x] Σ 0..1 A pointer to another substance, as a resource or a representational code
..... substanceDefinitionReference Reference(SubstanceDefinition)
..... substanceDefinitionCodeableConcept CodeableConcept
.... type Σ 1..1 CodeableConcept For example "salt to parent", "active moiety"
Binding: SubstanceRelationshipType (example): The relationship between two substance types.

.... isDefining Σ 0..1 boolean For 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] Σ 0..1 A numeric factor for the relationship, e.g. that a substance salt has some percentage of active substance in relation to some other
..... amountQuantity Quantity
..... amountRatio Ratio
..... amountString string
.... ratioHighLimitAmount Σ 0..1 Ratio For use when the numeric has an uncertain range
.... comparator Σ 0..1 CodeableConcept An operator for the amount, for example "average", "approximately", "less than"
Binding: SubstanceAmountType (example): The relationship between two substance types.

.... source Σ 0..* Reference(DocumentReference) Supporting literature
... nucleicAcid Σ 0..1 Reference(SubstanceNucleicAcid) Data items specific to nucleic acids
... polymer Σ 0..1 Reference(SubstancePolymer) Data items specific to polymers
... protein Σ 0..1 Reference(SubstanceProtein) Data items specific to proteins
... sourceMaterial SΣ 1..1 BackboneElement Material or taxonomic/anatomical source
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type Σ 1..1 CodeableConcept Source Type
Binding: SourceMaterialType (example): A classification that provides the origin of the substance raw material.

..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 0..* Coding Code defined by a terminology system
Binding: Source Type Terminology (required)
..... text Σ 0..1 string Plain text representation of the concept
.... genus SΣ 0..1 CodeableConcept The genus of an organism e.g. the Latin epithet of the plant/animal scientific name
Binding: SourceMaterialGenus (example): The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name.

..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... text Σ 1..1 string Source Organism
.... species SΣ 0..1 CodeableConcept Source Organism
Binding: SourceMaterialSpecies (example): A species of origin a substance raw material.

..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... text Σ 1..1 string Plain text representation of the concept
.... part SΣ 0..1 CodeableConcept Source Organism Part
Binding: SourceMaterialPart (example): An anatomical origin of the source material within an organism.

..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... text Σ 1..1 string Plain text representation of the concept
.... countryOfOrigin SΣC 0..1 CodeableConcept Source Organism Country of Origin
Binding: CountryValueSet (required): Jurisdiction codes


cmc-iso-genc-overlap: Only country codes that are also member of GENC can be used.
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding SΣ 1..1 Coding Code defined by a terminology system
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 0..1 uri Identity of the terminology system
...... version Σ 0..1 string Version of the system - if relevant
...... code SΣC 1..1 code Symbol in syntax defined by the system
cmc-only-ISO-3166-1-alpha-3: Country must be a 3 letter country code
...... display ΣC 0..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... text Σ 0..1 string Plain text representation of the concept

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
SubstanceDefinition.meta.securityextensibleAllSecurityLabels
http://hl7.org/fhir/ValueSet/security-labels
from the FHIR Standard
SubstanceDefinition.meta.tagexampleCommonTags
http://hl7.org/fhir/ValueSet/common-tags
from the FHIR Standard
SubstanceDefinition.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
SubstanceDefinition.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.classificationrequiredSubstanceClassification
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/substance-classification
from this IG
SubstanceDefinition.domainexampleMedicinalProductDomain
http://hl7.org/fhir/ValueSet/medicinal-product-domain
from the FHIR Standard
SubstanceDefinition.gradeexampleSubstanceGrade
http://hl7.org/fhir/ValueSet/substance-grade
from the FHIR Standard
SubstanceDefinition.grade.codingrequiredPqcmcQualityBenchmarkTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology
from this IG
SubstanceDefinition.moiety.stereochemistryexampleStereochemistry
http://hl7.org/fhir/ValueSet/substance-stereochemistry
from the FHIR Standard
SubstanceDefinition.moiety.opticalActivityexampleOpticalActivity
http://hl7.org/fhir/ValueSet/substance-optical-activity
from the FHIR Standard
SubstanceDefinition.moiety.measurementTypeexampleSubstanceAmountType
http://hl7.org/fhir/ValueSet/substance-amount-type
from the FHIR Standard
SubstanceDefinition.characterization.techniqueexampleStructureTechnique
http://hl7.org/fhir/ValueSet/substance-structure-technique
from the FHIR Standard
SubstanceDefinition.characterization.formexampleSubstanceForm
http://hl7.org/fhir/ValueSet/substance-form
from the FHIR Standard
SubstanceDefinition.property.typeexampleProductCharacteristic
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard
SubstanceDefinition.molecularWeight.methodexampleWeightMethod
http://hl7.org/fhir/ValueSet/substance-weight-method
from the FHIR Standard
SubstanceDefinition.molecularWeight.typeexampleWeightType
http://hl7.org/fhir/ValueSet/substance-weight-type
from the FHIR Standard
SubstanceDefinition.structure.stereochemistryexampleStereochemistry
http://hl7.org/fhir/ValueSet/substance-stereochemistry
from the FHIR Standard
SubstanceDefinition.structure.opticalActivityexampleOpticalActivity
http://hl7.org/fhir/ValueSet/substance-optical-activity
from the FHIR Standard
SubstanceDefinition.structure.techniqueexampleStructureTechnique
http://hl7.org/fhir/ValueSet/substance-structure-technique
from the FHIR Standard
SubstanceDefinition.structure.representation.typeexampleSubstanceRepresentationType
http://hl7.org/fhir/ValueSet/substance-representation-type
from the FHIR Standard
SubstanceDefinition.structure.representation.formatexampleSubstanceRepresentationFormat
http://hl7.org/fhir/ValueSet/substance-representation-format
from the FHIR Standard
SubstanceDefinition.code.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.name.typeexampleSubstanceNameType
http://hl7.org/fhir/ValueSet/substance-name-type
from the FHIR Standard
SubstanceDefinition.name.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.name.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
SubstanceDefinition.name.domainexampleSubstanceNameDomain
http://hl7.org/fhir/ValueSet/substance-name-domain
from the FHIR Standard
SubstanceDefinition.name.jurisdictionexampleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
SubstanceDefinition.name.official.authoritypreferredSubstanceNameAuthority
http://hl7.org/fhir/ValueSet/substance-name-authority
from the FHIR Standard
SubstanceDefinition.name.official.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.name:sub.typeexampleSubstanceNameType
http://hl7.org/fhir/ValueSet/substance-name-type
from the FHIR Standard
SubstanceDefinition.name:sub.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.name:sub.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
SubstanceDefinition.name:sub.domainexampleSubstanceNameDomain
http://hl7.org/fhir/ValueSet/substance-name-domain
from the FHIR Standard
SubstanceDefinition.name:sub.jurisdictionexampleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
SubstanceDefinition.name:sub.official.authoritypreferredSubstanceNameAuthority
http://hl7.org/fhir/ValueSet/substance-name-authority
from the FHIR Standard
SubstanceDefinition.name:sub.official.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.name:gsrs.typeexampleSubstanceNameType
http://hl7.org/fhir/ValueSet/substance-name-type
from the FHIR Standard
SubstanceDefinition.name:gsrs.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.name:gsrs.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
SubstanceDefinition.name:gsrs.domainexampleSubstanceNameDomain
http://hl7.org/fhir/ValueSet/substance-name-domain
from the FHIR Standard
SubstanceDefinition.name:gsrs.jurisdictionexampleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
SubstanceDefinition.name:gsrs.official.authoritypreferredSubstanceNameAuthority
http://hl7.org/fhir/ValueSet/substance-name-authority
from the FHIR Standard
SubstanceDefinition.name:gsrs.official.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.name:isbt.typeexampleSubstanceNameType
http://hl7.org/fhir/ValueSet/substance-name-type
from the FHIR Standard
SubstanceDefinition.name:isbt.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.name:isbt.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
SubstanceDefinition.name:isbt.domainexampleSubstanceNameDomain
http://hl7.org/fhir/ValueSet/substance-name-domain
from the FHIR Standard
SubstanceDefinition.name:isbt.jurisdictionexampleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
SubstanceDefinition.name:isbt.official.authoritypreferredSubstanceNameAuthority
http://hl7.org/fhir/ValueSet/substance-name-authority
from the FHIR Standard
SubstanceDefinition.name:isbt.official.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.relationship.typeexampleSubstanceRelationshipType
http://hl7.org/fhir/ValueSet/substance-relationship-type
from the FHIR Standard
SubstanceDefinition.relationship.comparatorexampleSubstanceAmountType
http://hl7.org/fhir/ValueSet/substance-amount-type
from the FHIR Standard
SubstanceDefinition.sourceMaterial.typeexampleSourceMaterialType
http://hl7.org/fhir/ValueSet/substance-source-material-type
from the FHIR Standard
SubstanceDefinition.sourceMaterial.type.codingrequiredPqcmcSourceTypeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-source-type-terminology
from this IG
SubstanceDefinition.sourceMaterial.genusexampleSourceMaterialGenus
http://hl7.org/fhir/ValueSet/substance-source-material-genus
from the FHIR Standard
SubstanceDefinition.sourceMaterial.speciesexampleSourceMaterialSpecies
http://hl7.org/fhir/ValueSet/substance-source-material-species
from the FHIR Standard
SubstanceDefinition.sourceMaterial.partexampleSourceMaterialPart
http://hl7.org/fhir/ValueSet/substance-source-material-part
from the FHIR Standard
SubstanceDefinition.sourceMaterial.countryOfOriginrequiredCountryValueSet
http://hl7.org/fhir/ValueSet/country|5.0.0
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
cmc-iso-genc-overlaperrorSubstanceDefinition.sourceMaterial.countryOfOriginOnly country codes that are also member of GENC can be used.
: coding.where( (system = 'urn:iso:std:iso:3166') and ( (code = 'ALA') or (code = 'PSE') or (code = 'SJM') or (code = 'UMI') ) ).exists().not()
cmc-name-isbterrorSubstanceDefinitionName.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-name-preferrederrorSubstanceDefinition.nameName.preferred: at most one = true
: select(preferred = true).count() < 2
cmc-only-ISO-3166-1-alpha-3errorSubstanceDefinition.sourceMaterial.countryOfOrigin.coding.codeCountry must be a 3 letter country code
: $this.length() = 3
cmc-source-materialerrorSubstanceDefinitionIF raw material source type equals Microbial, Animal, Plant, Insect or Human THEN the 4 source related attributes are required and the manufacturer and supplier information is highly desirable.
: sourceMaterial.type.coding.where(system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and code in ('C14182' | 'C14225' | 'C14227' | 'C14329' | 'C14258')).exists() implies (sourceMaterial.genus.exists() and sourceMaterial.species.exists() and sourceMaterial.part.exists() and sourceMaterial.countryOfOrigin.exists())
cmc-when-unii-requirederrorSubstanceDefinitionA 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()
dom-2errorSubstanceDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorSubstanceDefinitionIf 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-4errorSubstanceDefinitionIf 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-5errorSubstanceDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceSubstanceDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from SubstanceDefinition

Summary

Mandatory: 7 elements(14 nested mandatory elements)
Must-Support: 30 elements
Prohibited: 3 elements

Structures

This structure refers to these other structures:

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of SubstanceDefinition.code.code.coding
  • The element 1 is sliced based on the value of SubstanceDefinition.name (Closed)

 

Other representations of profile: CSV, Excel, Schematron