Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2

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 2.0.0 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: 2.0.0
Standards status: Trial-use | Maturity Level: 2 | 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.

Usages:

- Use this Profile: CMC eCTD 32P32 Document, CMC eCTD 32S23 Document and CMC eCTD SP4151 Document
- Refer to this Profile: Drug Product Batch Formula Ingredient and Quality Specification

### Formal Views of Profile Content

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

- Key Elements Table
- Differential Table
- Snapshot Table
- Statistics/References
- All

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
SubstanceDefinition | C | 0..* | SubstanceDefinition | The detailed description of a substance, typically at a level beyond what is used for prescribing Constraints: cmc-when-unii-required, cmc-name-isbt, cmc-source-material
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
contained |  | 0..* | Resource | Contained, inline Resources
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored
identifier | Σ | 0..1 | Identifier | optional user designated identifier
classification | S Σ | 1..1 | CodeableConcept | Substance Type Binding: Substance Classification (required)
grade | Σ | 1..* | CodeableConcept | Quality Standard Binding: Quality Benchmark Terminology (required)
manufacturer | S Σ | 0..* | LiteralReference(Basic Organization) {b} | The entity that creates, makes, produces or fabricates the substance
supplier | S Σ | 0..1 | LiteralReference(Basic Organization) {b} | An entity that is the source for the substance. It may be different from the manufacturer
Slices for code | S Σ | 1..* | BackboneElement | Codes associated with the substance Slice: Unordered, Open by value:code.coding.system
code:All Slices |  |  |  | Content/Rules for all slices
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
code:unii | S Σ | 0..1 | BackboneElement | UNII
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
code | S Σ | 1..1 | CodeableConcept | The specific code
coding | S Σ | 1..1 | Coding | Code defined by a terminology system
system | S Σ | 1..1 | uri | Identity of the terminology system Required Pattern: http://fdasis.nlm.nih.gov
code:uniProt | S Σ | 0..1 | BackboneElement | UniProt ID
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
code | S Σ | 1..1 | CodeableConcept | The specific code
coding | S Σ | 1..1 | Coding | Code defined by a terminology system
system | S Σ | 1..1 | uri | Identity of the terminology system Required Pattern: http://terminology.hl7.org/NamingSystem/UniProt
Slices for name | S Σ C | 1..* | BackboneElement | Substance Name Slice: Unordered, Closed by value:type Constraints: cmc-name-preferred
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
type | Σ | 0..1 | CodeableConcept | Name type e.g. 'systematic', 'scientific, 'brand' Binding: Substance Name Type (required)
preferred | S Σ | 0..1 | boolean | True when the name type is Substance Name
name:sub | S Σ | 0..1 | BackboneElement | Names applicable to this substance
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
name | S Σ | 1..1 | string | Generic Name
type | S Σ | 1..1 | CodeableConcept | Name type e.g. 'systematic', 'scientific, 'brand' Binding: Substance Name Type (required) Required Pattern: At least the following
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
coding |  | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex)
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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
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 |  | 0..1 | string | Plain text representation of the concept
preferred | S Σ | 0..1 | boolean | True when the name type is Substance Name
name:gsrs | S Σ | 0..1 | BackboneElement | Names applicable to this substance
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
name | S Σ | 1..1 | string | GSRS Preferred Term
type | S Σ | 1..1 | CodeableConcept | Name type e.g. 'systematic', 'scientific, 'brand' Binding: Substance Name Type (required) Required Pattern: At least the following
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
coding |  | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex)
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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
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 |  | 0..1 | string | Plain text representation of the concept
preferred | S Σ | 0..1 | boolean | True when the name type is Substance Name
name:isbt | S Σ | 0..1 | BackboneElement | Names applicable to this substance
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
name | S Σ | 1..1 | string | ISBT-128 DIN
type | S Σ | 1..1 | CodeableConcept | Name type e.g. 'systematic', 'scientific, 'brand' Binding: Substance Name Type (required) Required Pattern: At least the following
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
coding |  | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex)
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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
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 |  | 0..1 | string | Plain text representation of the concept
preferred | S Σ | 0..1 | boolean | True when the name type is Substance Name
sourceMaterial | S Σ | 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: Source Type Terminology (required)
genus | S Σ | 0..1 | CodeableConceptTextOnly | Source Organism Genus Binding: SourceMaterialGenus (example): The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name.
species | S Σ | 0..1 | CodeableConceptTextOnly | Source Organism Species Binding: SourceMaterialSpecies (example): A species of origin a substance raw material.
part | S Σ | 0..1 | CodeableConceptTextOnly | Source Organism Part Binding: SourceMaterialPart (example): An anatomical origin of the source material within an organism.
countryOfOrigin | S Σ | 0..1 | CodeableConcept | Source Organism Country of Origin Binding: GENC and ISO 3166 Intersection (required)
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet / Code | URI
SubstanceDefinition.classification | required | SubstanceClassification `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/substance-classification` From this IG
SubstanceDefinition.grade | required | PqcmcQualityBenchmarkTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology` From this IG
SubstanceDefinition.name.type | required | PqcmcSubstanceNameType `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type` From this IG
SubstanceDefinition.name:sub.type | required | Pattern Value: C97054("Generic Name") `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type` From this IG
SubstanceDefinition.name:gsrs.type | required | Pattern Value: C203355("GSRS Preferred Term") `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type` From this IG
SubstanceDefinition.name:isbt.type | required | Pattern Value: C95517("ISBT-128 DIN") `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type` From this IG
SubstanceDefinition.sourceMaterial.type | required | PqcmcSourceTypeTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-source-type-terminology` From this IG
SubstanceDefinition.sourceMaterial.genus | example | SourceMaterialGenus `http://hl7.org/fhir/ValueSet/substance-source-material-genus` From the FHIR Standard
SubstanceDefinition.sourceMaterial.species | example | SourceMaterialSpecies `http://hl7.org/fhir/ValueSet/substance-source-material-species` From the FHIR Standard
SubstanceDefinition.sourceMaterial.part | example | SourceMaterialPart `http://hl7.org/fhir/ValueSet/substance-source-material-part` From the FHIR Standard
SubstanceDefinition.sourceMaterial.countryOfOrigin | required | PqcmcGENCAndISOIntersect `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-genc-and-iso-intersect` From this IG

#### Constraints

Id | Grade | Path(s) | Details | Requirements
cmc-name-isbt | error | SubstanceDefinition | Name.type ISBT 128 required for blood products. : classification.where(coding.where(code = '8' and system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').exists()).exists() implies name.type.coding.exists(code = '226' and system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl') |
cmc-name-preferred | error | SubstanceDefinition.name | Name.preferred: at most one = true : select(preferred = true).count() < 2 |
cmc-source-material | error | SubstanceDefinition | 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. : 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-required | error | SubstanceDefinition | A UNII is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer'. A UniProt code is required for any of these categories: 'Protein' : (classification.coding.where(system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and (code in ('C48807' | 'C45305' | 'C706' | 'C48803'))).exists() implies code.where( code.coding.exists(system = 'http://fdasis.nlm.nih.gov') ).exists()) and (classification.coding.where( system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and code = 'C17021' ).exists() implies code.where( code.coding.exists(system = 'http://terminology.hl7.org/NamingSystem/UniProt') ).exists()) |
dom-2 | error | SubstanceDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-3 | error | SubstanceDefinition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() |
dom-4 | error | SubstanceDefinition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() |
dom-5 | error | SubstanceDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() |
dom-6 | best practice | SubstanceDefinition | A resource should have narrative for robust management : text.`div`.exists() |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |

This structure is derived from SubstanceDefinition

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
SubstanceDefinition | C | 0..* | SubstanceDefinition | The detailed description of a substance, typically at a level beyond what is used for prescribing Constraints: cmc-when-unii-required, cmc-name-isbt, cmc-source-material
identifier |  | 0..1 | Identifier | optional user designated identifier
classification | S | 1..1 | CodeableConcept | Substance Type Binding: Substance Classification (required)
grade |  | 1..* | CodeableConcept | Quality Standard Binding: Quality Benchmark Terminology (required)
manufacturer | S | 0..* | LiteralReference(Basic Organization) {b} | The entity that creates, makes, produces or fabricates the substance
supplier | S | 0..1 | LiteralReference(Basic Organization) {b} | An entity that is the source for the substance. It may be different from the manufacturer
Slices for code | S | 1..* | BackboneElement | Codes associated with the substance Slice: Unordered, Open by value:code.coding.system
code:unii | S | 0..1 | BackboneElement | UNII
code | S | 1..1 | CodeableConcept | The specific code
coding | S | 1..1 | Coding | Code defined by a terminology system
system | S | 1..1 | uri | Identity of the terminology system Required Pattern: http://fdasis.nlm.nih.gov
code:uniProt | S | 0..1 | BackboneElement | UniProt ID
code | S | 1..1 | CodeableConcept | The specific code
coding | S | 1..1 | Coding | Code defined by a terminology system
system | S | 1..1 | uri | Identity of the terminology system Required Pattern: http://terminology.hl7.org/NamingSystem/UniProt
Slices for name | S C | 1..* | BackboneElement | Substance Name Slice: Unordered, Closed by value:type Constraints: cmc-name-preferred
name:All Slices |  |  |  | Content/Rules for all slices
type |  | 0..1 | CodeableConcept | Name type e.g. 'systematic', 'scientific, 'brand' Binding: Substance Name Type (required)
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' Required Pattern: At least the following
coding |  | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex)
system |  | 1..1 | uri | Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
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 | True when the name type is Substance Name
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' Required Pattern: At least the following
coding |  | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex)
system |  | 1..1 | uri | Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
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 | True when the name type is Substance Name
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' Required Pattern: At least the following
coding |  | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex)
system |  | 1..1 | uri | Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
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 | True when the name type is Substance Name
sourceMaterial | S | 1..1 | BackboneElement | Material or taxonomic/anatomical source
type |  | 1..1 | CodeableConcept | Source Type Binding: Source Type Terminology (required)
genus | S | 0..1 | CodeableConceptTextOnly | Source Organism Genus
species | S | 0..1 | CodeableConceptTextOnly | Source Organism Species
part | S | 0..1 | CodeableConceptTextOnly | Source Organism Part
countryOfOrigin | S | 0..1 | CodeableConcept | Source Organism Country of Origin Binding: GENC and ISO 3166 Intersection (required)
Documentation for this format

#### Terminology Bindings (Differential)

Path | Conformance | ValueSet | URI
SubstanceDefinition.classification | required | SubstanceClassification `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/substance-classification` From this IG
SubstanceDefinition.grade | required | PqcmcQualityBenchmarkTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology` From this IG
SubstanceDefinition.name.type | required | PqcmcSubstanceNameType `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type` From this IG
SubstanceDefinition.sourceMaterial.type | required | PqcmcSourceTypeTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-source-type-terminology` From this IG
SubstanceDefinition.sourceMaterial.countryOfOrigin | required | PqcmcGENCAndISOIntersect `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-genc-and-iso-intersect` From this IG

#### Constraints

Id | Grade | Path(s) | Details | Requirements
cmc-name-isbt | error | SubstanceDefinition | Name.type ISBT 128 required for blood products. : classification.where(coding.where(code = '8' and system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').exists()).exists() implies name.type.coding.exists(code = '226' and system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl') |
cmc-name-preferred | error | SubstanceDefinition.name | Name.preferred: at most one = true : select(preferred = true).count() < 2 |
cmc-source-material | error | SubstanceDefinition | 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. : 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-required | error | SubstanceDefinition | A UNII is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer'. A UniProt code is required for any of these categories: 'Protein' : (classification.coding.where(system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and (code in ('C48807' | 'C45305' | 'C706' | 'C48803'))).exists() implies code.where( code.coding.exists(system = 'http://fdasis.nlm.nih.gov') ).exists()) and (classification.coding.where( system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and code = 'C17021' ).exists() implies code.where( code.coding.exists(system = 'http://terminology.hl7.org/NamingSystem/UniProt') ).exists()) |

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
SubstanceDefinition | C | 0..* | SubstanceDefinition | The detailed description of a substance, typically at a level beyond what is used for prescribing Constraints: cmc-when-unii-required, cmc-name-isbt, cmc-source-material
id | Σ | 0..1 | id | Logical id of this artifact
meta | Σ | 0..1 | Meta | Metadata about the resource
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 Bindings | Purpose
CommonLanguages | Starter
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
contained |  | 0..* | 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 | S Σ | 1..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..* | CodeableConcept | Quality Standard Binding: Quality Benchmark Terminology (required)
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 | S Σ | 0..* | LiteralReference(Basic Organization) {b} | The entity that creates, makes, produces or fabricates the substance
supplier | S Σ | 0..1 | LiteralReference(Basic Organization) {b} | 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
Slices for code | S Σ | 1..* | BackboneElement | Codes associated with the substance Slice: Unordered, Open by value:code.coding.system
code: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
code | Σ | 0..1 | CodeableConcept | The specific code
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
code:unii | S Σ | 0..1 | BackboneElement | UNII
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 | S Σ | 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
coding | S Σ | 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 | S 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 | Σ C | 0..1 | code | Symbol in syntax defined by the system
display | Σ C | 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
code:uniProt | S Σ | 0..1 | BackboneElement | UniProt ID
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 | S Σ | 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
coding | S Σ | 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 | S Σ | 1..1 | uri | Identity of the terminology system Required Pattern: http://terminology.hl7.org/NamingSystem/UniProt
version | Σ | 0..1 | string | Version of the system - if relevant
code | Σ C | 0..1 | code | Symbol in syntax defined by the system
display | Σ C | 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 | S Σ C | 1..* | BackboneElement | Substance Name Slice: Unordered, Closed by value:type Constraints: cmc-name-preferred
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: Substance Name Type (required)
status | Σ | 0..1 | CodeableConcept | The status of the name e.g. 'current', 'proposed' Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
preferred | S Σ | 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 Bindings | Purpose
CommonLanguages | Starter
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 | S Σ | 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 | S Σ | 1..1 | string | Generic Name
type | S Σ | 1..1 | CodeableConcept | Name type e.g. 'systematic', 'scientific, 'brand' Binding: Substance Name Type (required) Required Pattern: At least the following
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
coding |  | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex)
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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
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 |  | 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 | S Σ | 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 Bindings | Purpose
CommonLanguages | Starter
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 | S Σ | 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 | S Σ | 1..1 | string | GSRS Preferred Term
type | S Σ | 1..1 | CodeableConcept | Name type e.g. 'systematic', 'scientific, 'brand' Binding: Substance Name Type (required) Required Pattern: At least the following
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
coding |  | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex)
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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
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 |  | 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 | S Σ | 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 Bindings | Purpose
CommonLanguages | Starter
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 | S Σ | 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 | S Σ | 1..1 | string | ISBT-128 DIN
type | S Σ | 1..1 | CodeableConcept | Name type e.g. 'systematic', 'scientific, 'brand' Binding: Substance Name Type (required) Required Pattern: At least the following
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
coding |  | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex)
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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
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 |  | 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 | S Σ | 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 Bindings | Purpose
CommonLanguages | Starter
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 | S Σ | 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: Source Type Terminology (required)
genus | S Σ | 0..1 | CodeableConceptTextOnly | Source Organism Genus Binding: SourceMaterialGenus (example): The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name.
species | S Σ | 0..1 | CodeableConceptTextOnly | Source Organism Species Binding: SourceMaterialSpecies (example): A species of origin a substance raw material.
part | S Σ | 0..1 | CodeableConceptTextOnly | Source Organism Part Binding: SourceMaterialPart (example): An anatomical origin of the source material within an organism.
countryOfOrigin | S Σ | 0..1 | CodeableConcept | Source Organism Country of Origin Binding: GENC and ISO 3166 Intersection (required)
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet / Code | URI
SubstanceDefinition.language | required | AllLanguages `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` From the FHIR Standard
SubstanceDefinition.status | preferred | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status` From the FHIR Standard
SubstanceDefinition.classification | required | SubstanceClassification `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/substance-classification` From this IG
SubstanceDefinition.domain | example | MedicinalProductDomain `http://hl7.org/fhir/ValueSet/medicinal-product-domain` From the FHIR Standard
SubstanceDefinition.grade | required | PqcmcQualityBenchmarkTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology` From this IG
SubstanceDefinition.moiety.stereochemistry | example | Stereochemistry `http://hl7.org/fhir/ValueSet/substance-stereochemistry` From the FHIR Standard
SubstanceDefinition.moiety.opticalActivity | example | OpticalActivity `http://hl7.org/fhir/ValueSet/substance-optical-activity` From the FHIR Standard
SubstanceDefinition.moiety.measurementType | example | SubstanceAmountType `http://hl7.org/fhir/ValueSet/substance-amount-type` From the FHIR Standard
SubstanceDefinition.characterization.technique | example | StructureTechnique `http://hl7.org/fhir/ValueSet/substance-structure-technique` From the FHIR Standard
SubstanceDefinition.characterization.form | example | SubstanceForm `http://hl7.org/fhir/ValueSet/substance-form` From the FHIR Standard
SubstanceDefinition.property.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
SubstanceDefinition.molecularWeight.method | example | WeightMethod `http://hl7.org/fhir/ValueSet/substance-weight-method` From the FHIR Standard
SubstanceDefinition.molecularWeight.type | example | WeightType `http://hl7.org/fhir/ValueSet/substance-weight-type` From the FHIR Standard
SubstanceDefinition.structure.stereochemistry | example | Stereochemistry `http://hl7.org/fhir/ValueSet/substance-stereochemistry` From the FHIR Standard
SubstanceDefinition.structure.opticalActivity | example | OpticalActivity `http://hl7.org/fhir/ValueSet/substance-optical-activity` From the FHIR Standard
SubstanceDefinition.structure.technique | example | StructureTechnique `http://hl7.org/fhir/ValueSet/substance-structure-technique` From the FHIR Standard
SubstanceDefinition.structure.representation.type | example | SubstanceRepresentationType `http://hl7.org/fhir/ValueSet/substance-representation-type` From the FHIR Standard
SubstanceDefinition.structure.representation.format | example | SubstanceRepresentationFormat `http://hl7.org/fhir/ValueSet/substance-representation-format` From the FHIR Standard
SubstanceDefinition.code.status | preferred | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status` From the FHIR Standard
SubstanceDefinition.code:unii.status | preferred | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status` From the FHIR Standard
SubstanceDefinition.code:uniProt.status | preferred | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status` From the FHIR Standard
SubstanceDefinition.name.type | required | PqcmcSubstanceNameType `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type` From this IG
SubstanceDefinition.name.status | preferred | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status` From the FHIR Standard
SubstanceDefinition.name.language | required | AllLanguages `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` From the FHIR Standard
SubstanceDefinition.name.domain | example | SubstanceNameDomain `http://hl7.org/fhir/ValueSet/substance-name-domain` From the FHIR Standard
SubstanceDefinition.name.jurisdiction | example | JurisdictionValueSet `http://hl7.org/fhir/ValueSet/jurisdiction` From the FHIR Standard
SubstanceDefinition.name.official.authority | preferred | SubstanceNameAuthority `http://hl7.org/fhir/ValueSet/substance-name-authority` From the FHIR Standard
SubstanceDefinition.name.official.status | preferred | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status` From the FHIR Standard
SubstanceDefinition.name:sub.type | required | Pattern Value: C97054("Generic Name") `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type` From this IG
SubstanceDefinition.name:sub.status | preferred | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status` From the FHIR Standard
SubstanceDefinition.name:sub.language | required | AllLanguages `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` From the FHIR Standard
SubstanceDefinition.name:sub.domain | example | SubstanceNameDomain `http://hl7.org/fhir/ValueSet/substance-name-domain` From the FHIR Standard
SubstanceDefinition.name:sub.jurisdiction | example | JurisdictionValueSet `http://hl7.org/fhir/ValueSet/jurisdiction` From the FHIR Standard
SubstanceDefinition.name:sub.official.authority | preferred | SubstanceNameAuthority `http://hl7.org/fhir/ValueSet/substance-name-authority` From the FHIR Standard
SubstanceDefinition.name:sub.official.status | preferred | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status` From the FHIR Standard
SubstanceDefinition.name:gsrs.type | required | Pattern Value: C203355("GSRS Preferred Term") `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type` From this IG
SubstanceDefinition.name:gsrs.status | preferred | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status` From the FHIR Standard
SubstanceDefinition.name:gsrs.language | required | AllLanguages `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` From the FHIR Standard
SubstanceDefinition.name:gsrs.domain | example | SubstanceNameDomain `http://hl7.org/fhir/ValueSet/substance-name-domain` From the FHIR Standard
SubstanceDefinition.name:gsrs.jurisdiction | example | JurisdictionValueSet `http://hl7.org/fhir/ValueSet/jurisdiction` From the FHIR Standard
SubstanceDefinition.name:gsrs.official.authority | preferred | SubstanceNameAuthority `http://hl7.org/fhir/ValueSet/substance-name-authority` From the FHIR Standard
SubstanceDefinition.name:gsrs.official.status | preferred | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status` From the FHIR Standard
SubstanceDefinition.name:isbt.type | required | Pattern Value: C95517("ISBT-128 DIN") `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type` From this IG
SubstanceDefinition.name:isbt.status | preferred | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status` From the FHIR Standard
SubstanceDefinition.name:isbt.language | required | AllLanguages `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` From the FHIR Standard
SubstanceDefinition.name:isbt.domain | example | SubstanceNameDomain `http://hl7.org/fhir/ValueSet/substance-name-domain` From the FHIR Standard
SubstanceDefinition.name:isbt.jurisdiction | example | JurisdictionValueSet `http://hl7.org/fhir/ValueSet/jurisdiction` From the FHIR Standard
SubstanceDefinition.name:isbt.official.authority | preferred | SubstanceNameAuthority `http://hl7.org/fhir/ValueSet/substance-name-authority` From the FHIR Standard
SubstanceDefinition.name:isbt.official.status | preferred | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status` From the FHIR Standard
SubstanceDefinition.relationship.type | example | SubstanceRelationshipType `http://hl7.org/fhir/ValueSet/substance-relationship-type` From the FHIR Standard
SubstanceDefinition.relationship.comparator | example | SubstanceAmountType `http://hl7.org/fhir/ValueSet/substance-amount-type` From the FHIR Standard
SubstanceDefinition.sourceMaterial.type | required | PqcmcSourceTypeTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-source-type-terminology` From this IG
SubstanceDefinition.sourceMaterial.genus | example | SourceMaterialGenus `http://hl7.org/fhir/ValueSet/substance-source-material-genus` From the FHIR Standard
SubstanceDefinition.sourceMaterial.species | example | SourceMaterialSpecies `http://hl7.org/fhir/ValueSet/substance-source-material-species` From the FHIR Standard
SubstanceDefinition.sourceMaterial.part | example | SourceMaterialPart `http://hl7.org/fhir/ValueSet/substance-source-material-part` From the FHIR Standard
SubstanceDefinition.sourceMaterial.countryOfOrigin | required | PqcmcGENCAndISOIntersect `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-genc-and-iso-intersect` From this IG

#### Constraints

Id | Grade | Path(s) | Details | Requirements
cmc-name-isbt | error | SubstanceDefinition | Name.type ISBT 128 required for blood products. : classification.where(coding.where(code = '8' and system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').exists()).exists() implies name.type.coding.exists(code = '226' and system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl') |
cmc-name-preferred | error | SubstanceDefinition.name | Name.preferred: at most one = true : select(preferred = true).count() < 2 |
cmc-source-material | error | SubstanceDefinition | 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. : 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-required | error | SubstanceDefinition | A UNII is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer'. A UniProt code is required for any of these categories: 'Protein' : (classification.coding.where(system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and (code in ('C48807' | 'C45305' | 'C706' | 'C48803'))).exists() implies code.where( code.coding.exists(system = 'http://fdasis.nlm.nih.gov') ).exists()) and (classification.coding.where( system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and code = 'C17021' ).exists() implies code.where( code.coding.exists(system = 'http://terminology.hl7.org/NamingSystem/UniProt') ).exists()) |
dom-2 | error | SubstanceDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-3 | error | SubstanceDefinition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() |
dom-4 | error | SubstanceDefinition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() |
dom-5 | error | SubstanceDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() |
dom-6 | best practice | SubstanceDefinition | A resource should have narrative for robust management : text.`div`.exists() |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |

This structure is derived from SubstanceDefinition

Summary

Mandatory: 6 elements(9 nested mandatory elements)
Must-Support: 31 elements

Structures

This structure refers to these other structures:

- Literal Reference (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference)
- Basic Organization (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization)
- Text Only Codeable Concept (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only)

Slices

This structure defines the following Slices:

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

Maturity: 2

Key Elements View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
SubstanceDefinition | C | 0..* | SubstanceDefinition | The detailed description of a substance, typically at a level beyond what is used for prescribing Constraints: cmc-when-unii-required, cmc-name-isbt, cmc-source-material
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
contained |  | 0..* | Resource | Contained, inline Resources
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored
identifier | Σ | 0..1 | Identifier | optional user designated identifier
classification | S Σ | 1..1 | CodeableConcept | Substance Type Binding: Substance Classification (required)
grade | Σ | 1..* | CodeableConcept | Quality Standard Binding: Quality Benchmark Terminology (required)
manufacturer | S Σ | 0..* | LiteralReference(Basic Organization) {b} | The entity that creates, makes, produces or fabricates the substance
supplier | S Σ | 0..1 | LiteralReference(Basic Organization) {b} | An entity that is the source for the substance. It may be different from the manufacturer
Slices for code | S Σ | 1..* | BackboneElement | Codes associated with the substance Slice: Unordered, Open by value:code.coding.system
code:All Slices |  |  |  | Content/Rules for all slices
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
code:unii | S Σ | 0..1 | BackboneElement | UNII
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
code | S Σ | 1..1 | CodeableConcept | The specific code
coding | S Σ | 1..1 | Coding | Code defined by a terminology system
system | S Σ | 1..1 | uri | Identity of the terminology system Required Pattern: http://fdasis.nlm.nih.gov
code:uniProt | S Σ | 0..1 | BackboneElement | UniProt ID
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
code | S Σ | 1..1 | CodeableConcept | The specific code
coding | S Σ | 1..1 | Coding | Code defined by a terminology system
system | S Σ | 1..1 | uri | Identity of the terminology system Required Pattern: http://terminology.hl7.org/NamingSystem/UniProt
Slices for name | S Σ C | 1..* | BackboneElement | Substance Name Slice: Unordered, Closed by value:type Constraints: cmc-name-preferred
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
type | Σ | 0..1 | CodeableConcept | Name type e.g. 'systematic', 'scientific, 'brand' Binding: Substance Name Type (required)
preferred | S Σ | 0..1 | boolean | True when the name type is Substance Name
name:sub | S Σ | 0..1 | BackboneElement | Names applicable to this substance
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
name | S Σ | 1..1 | string | Generic Name
type | S Σ | 1..1 | CodeableConcept | Name type e.g. 'systematic', 'scientific, 'brand' Binding: Substance Name Type (required) Required Pattern: At least the following
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
coding |  | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex)
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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
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 |  | 0..1 | string | Plain text representation of the concept
preferred | S Σ | 0..1 | boolean | True when the name type is Substance Name
name:gsrs | S Σ | 0..1 | BackboneElement | Names applicable to this substance
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
name | S Σ | 1..1 | string | GSRS Preferred Term
type | S Σ | 1..1 | CodeableConcept | Name type e.g. 'systematic', 'scientific, 'brand' Binding: Substance Name Type (required) Required Pattern: At least the following
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
coding |  | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex)
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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
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 |  | 0..1 | string | Plain text representation of the concept
preferred | S Σ | 0..1 | boolean | True when the name type is Substance Name
name:isbt | S Σ | 0..1 | BackboneElement | Names applicable to this substance
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
name | S Σ | 1..1 | string | ISBT-128 DIN
type | S Σ | 1..1 | CodeableConcept | Name type e.g. 'systematic', 'scientific, 'brand' Binding: Substance Name Type (required) Required Pattern: At least the following
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
coding |  | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex)
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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
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 |  | 0..1 | string | Plain text representation of the concept
preferred | S Σ | 0..1 | boolean | True when the name type is Substance Name
sourceMaterial | S Σ | 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: Source Type Terminology (required)
genus | S Σ | 0..1 | CodeableConceptTextOnly | Source Organism Genus Binding: SourceMaterialGenus (example): The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name.
species | S Σ | 0..1 | CodeableConceptTextOnly | Source Organism Species Binding: SourceMaterialSpecies (example): A species of origin a substance raw material.
part | S Σ | 0..1 | CodeableConceptTextOnly | Source Organism Part Binding: SourceMaterialPart (example): An anatomical origin of the source material within an organism.
countryOfOrigin | S Σ | 0..1 | CodeableConcept | Source Organism Country of Origin Binding: GENC and ISO 3166 Intersection (required)
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet / Code | URI
SubstanceDefinition.classification | required | SubstanceClassification `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/substance-classification` From this IG
SubstanceDefinition.grade | required | PqcmcQualityBenchmarkTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology` From this IG
SubstanceDefinition.name.type | required | PqcmcSubstanceNameType `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type` From this IG
SubstanceDefinition.name:sub.type | required | Pattern Value: C97054("Generic Name") `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type` From this IG
SubstanceDefinition.name:gsrs.type | required | Pattern Value: C203355("GSRS Preferred Term") `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type` From this IG
SubstanceDefinition.name:isbt.type | required | Pattern Value: C95517("ISBT-128 DIN") `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type` From this IG
SubstanceDefinition.sourceMaterial.type | required | PqcmcSourceTypeTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-source-type-terminology` From this IG
SubstanceDefinition.sourceMaterial.genus | example | SourceMaterialGenus `http://hl7.org/fhir/ValueSet/substance-source-material-genus` From the FHIR Standard
SubstanceDefinition.sourceMaterial.species | example | SourceMaterialSpecies `http://hl7.org/fhir/ValueSet/substance-source-material-species` From the FHIR Standard
SubstanceDefinition.sourceMaterial.part | example | SourceMaterialPart `http://hl7.org/fhir/ValueSet/substance-source-material-part` From the FHIR Standard
SubstanceDefinition.sourceMaterial.countryOfOrigin | required | PqcmcGENCAndISOIntersect `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-genc-and-iso-intersect` From this IG

#### Constraints

Id | Grade | Path(s) | Details | Requirements
cmc-name-isbt | error | SubstanceDefinition | Name.type ISBT 128 required for blood products. : classification.where(coding.where(code = '8' and system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').exists()).exists() implies name.type.coding.exists(code = '226' and system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl') |
cmc-name-preferred | error | SubstanceDefinition.name | Name.preferred: at most one = true : select(preferred = true).count() < 2 |
cmc-source-material | error | SubstanceDefinition | 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. : 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-required | error | SubstanceDefinition | A UNII is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer'. A UniProt code is required for any of these categories: 'Protein' : (classification.coding.where(system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and (code in ('C48807' | 'C45305' | 'C706' | 'C48803'))).exists() implies code.where( code.coding.exists(system = 'http://fdasis.nlm.nih.gov') ).exists()) and (classification.coding.where( system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and code = 'C17021' ).exists() implies code.where( code.coding.exists(system = 'http://terminology.hl7.org/NamingSystem/UniProt') ).exists()) |
dom-2 | error | SubstanceDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-3 | error | SubstanceDefinition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() |
dom-4 | error | SubstanceDefinition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() |
dom-5 | error | SubstanceDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() |
dom-6 | best practice | SubstanceDefinition | A resource should have narrative for robust management : text.`div`.exists() |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |

Differential View

This structure is derived from SubstanceDefinition

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
SubstanceDefinition | C | 0..* | SubstanceDefinition | The detailed description of a substance, typically at a level beyond what is used for prescribing Constraints: cmc-when-unii-required, cmc-name-isbt, cmc-source-material
identifier |  | 0..1 | Identifier | optional user designated identifier
classification | S | 1..1 | CodeableConcept | Substance Type Binding: Substance Classification (required)
grade |  | 1..* | CodeableConcept | Quality Standard Binding: Quality Benchmark Terminology (required)
manufacturer | S | 0..* | LiteralReference(Basic Organization) {b} | The entity that creates, makes, produces or fabricates the substance
supplier | S | 0..1 | LiteralReference(Basic Organization) {b} | An entity that is the source for the substance. It may be different from the manufacturer
Slices for code | S | 1..* | BackboneElement | Codes associated with the substance Slice: Unordered, Open by value:code.coding.system
code:unii | S | 0..1 | BackboneElement | UNII
code | S | 1..1 | CodeableConcept | The specific code
coding | S | 1..1 | Coding | Code defined by a terminology system
system | S | 1..1 | uri | Identity of the terminology system Required Pattern: http://fdasis.nlm.nih.gov
code:uniProt | S | 0..1 | BackboneElement | UniProt ID
code | S | 1..1 | CodeableConcept | The specific code
coding | S | 1..1 | Coding | Code defined by a terminology system
system | S | 1..1 | uri | Identity of the terminology system Required Pattern: http://terminology.hl7.org/NamingSystem/UniProt
Slices for name | S C | 1..* | BackboneElement | Substance Name Slice: Unordered, Closed by value:type Constraints: cmc-name-preferred
name:All Slices |  |  |  | Content/Rules for all slices
type |  | 0..1 | CodeableConcept | Name type e.g. 'systematic', 'scientific, 'brand' Binding: Substance Name Type (required)
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' Required Pattern: At least the following
coding |  | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex)
system |  | 1..1 | uri | Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
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 | True when the name type is Substance Name
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' Required Pattern: At least the following
coding |  | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex)
system |  | 1..1 | uri | Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
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 | True when the name type is Substance Name
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' Required Pattern: At least the following
coding |  | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex)
system |  | 1..1 | uri | Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
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 | True when the name type is Substance Name
sourceMaterial | S | 1..1 | BackboneElement | Material or taxonomic/anatomical source
type |  | 1..1 | CodeableConcept | Source Type Binding: Source Type Terminology (required)
genus | S | 0..1 | CodeableConceptTextOnly | Source Organism Genus
species | S | 0..1 | CodeableConceptTextOnly | Source Organism Species
part | S | 0..1 | CodeableConceptTextOnly | Source Organism Part
countryOfOrigin | S | 0..1 | CodeableConcept | Source Organism Country of Origin Binding: GENC and ISO 3166 Intersection (required)
Documentation for this format

#### Terminology Bindings (Differential)

Path | Conformance | ValueSet | URI
SubstanceDefinition.classification | required | SubstanceClassification `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/substance-classification` From this IG
SubstanceDefinition.grade | required | PqcmcQualityBenchmarkTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology` From this IG
SubstanceDefinition.name.type | required | PqcmcSubstanceNameType `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type` From this IG
SubstanceDefinition.sourceMaterial.type | required | PqcmcSourceTypeTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-source-type-terminology` From this IG
SubstanceDefinition.sourceMaterial.countryOfOrigin | required | PqcmcGENCAndISOIntersect `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-genc-and-iso-intersect` From this IG

#### Constraints

Id | Grade | Path(s) | Details | Requirements
cmc-name-isbt | error | SubstanceDefinition | Name.type ISBT 128 required for blood products. : classification.where(coding.where(code = '8' and system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').exists()).exists() implies name.type.coding.exists(code = '226' and system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl') |
cmc-name-preferred | error | SubstanceDefinition.name | Name.preferred: at most one = true : select(preferred = true).count() < 2 |
cmc-source-material | error | SubstanceDefinition | 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. : 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-required | error | SubstanceDefinition | A UNII is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer'. A UniProt code is required for any of these categories: 'Protein' : (classification.coding.where(system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and (code in ('C48807' | 'C45305' | 'C706' | 'C48803'))).exists() implies code.where( code.coding.exists(system = 'http://fdasis.nlm.nih.gov') ).exists()) and (classification.coding.where( system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and code = 'C17021' ).exists() implies code.where( code.coding.exists(system = 'http://terminology.hl7.org/NamingSystem/UniProt') ).exists()) |

Snapshot View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
SubstanceDefinition | C | 0..* | SubstanceDefinition | The detailed description of a substance, typically at a level beyond what is used for prescribing Constraints: cmc-when-unii-required, cmc-name-isbt, cmc-source-material
id | Σ | 0..1 | id | Logical id of this artifact
meta | Σ | 0..1 | Meta | Metadata about the resource
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 Bindings | Purpose
CommonLanguages | Starter
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
contained |  | 0..* | 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 | S Σ | 1..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..* | CodeableConcept | Quality Standard Binding: Quality Benchmark Terminology (required)
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 | S Σ | 0..* | LiteralReference(Basic Organization) {b} | The entity that creates, makes, produces or fabricates the substance
supplier | S Σ | 0..1 | LiteralReference(Basic Organization) {b} | 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
Slices for code | S Σ | 1..* | BackboneElement | Codes associated with the substance Slice: Unordered, Open by value:code.coding.system
code: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
code | Σ | 0..1 | CodeableConcept | The specific code
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
code:unii | S Σ | 0..1 | BackboneElement | UNII
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 | S Σ | 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
coding | S Σ | 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 | S 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 | Σ C | 0..1 | code | Symbol in syntax defined by the system
display | Σ C | 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
code:uniProt | S Σ | 0..1 | BackboneElement | UniProt ID
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 | S Σ | 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
coding | S Σ | 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 | S Σ | 1..1 | uri | Identity of the terminology system Required Pattern: http://terminology.hl7.org/NamingSystem/UniProt
version | Σ | 0..1 | string | Version of the system - if relevant
code | Σ C | 0..1 | code | Symbol in syntax defined by the system
display | Σ C | 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 | S Σ C | 1..* | BackboneElement | Substance Name Slice: Unordered, Closed by value:type Constraints: cmc-name-preferred
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: Substance Name Type (required)
status | Σ | 0..1 | CodeableConcept | The status of the name e.g. 'current', 'proposed' Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
preferred | S Σ | 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 Bindings | Purpose
CommonLanguages | Starter
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 | S Σ | 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 | S Σ | 1..1 | string | Generic Name
type | S Σ | 1..1 | CodeableConcept | Name type e.g. 'systematic', 'scientific, 'brand' Binding: Substance Name Type (required) Required Pattern: At least the following
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
coding |  | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex)
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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
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 |  | 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 | S Σ | 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 Bindings | Purpose
CommonLanguages | Starter
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 | S Σ | 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 | S Σ | 1..1 | string | GSRS Preferred Term
type | S Σ | 1..1 | CodeableConcept | Name type e.g. 'systematic', 'scientific, 'brand' Binding: Substance Name Type (required) Required Pattern: At least the following
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
coding |  | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex)
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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
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 |  | 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 | S Σ | 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 Bindings | Purpose
CommonLanguages | Starter
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 | S Σ | 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 | S Σ | 1..1 | string | ISBT-128 DIN
type | S Σ | 1..1 | CodeableConcept | Name type e.g. 'systematic', 'scientific, 'brand' Binding: Substance Name Type (required) Required Pattern: At least the following
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
coding |  | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex)
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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
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 |  | 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 | S Σ | 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 Bindings | Purpose
CommonLanguages | Starter
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 | S Σ | 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: Source Type Terminology (required)
genus | S Σ | 0..1 | CodeableConceptTextOnly | Source Organism Genus Binding: SourceMaterialGenus (example): The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name.
species | S Σ | 0..1 | CodeableConceptTextOnly | Source Organism Species Binding: SourceMaterialSpecies (example): A species of origin a substance raw material.
part | S Σ | 0..1 | CodeableConceptTextOnly | Source Organism Part Binding: SourceMaterialPart (example): An anatomical origin of the source material within an organism.
countryOfOrigin | S Σ | 0..1 | CodeableConcept | Source Organism Country of Origin Binding: GENC and ISO 3166 Intersection (required)
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet / Code | URI
SubstanceDefinition.language | required | AllLanguages `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` From the FHIR Standard
SubstanceDefinition.status | preferred | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status` From the FHIR Standard
SubstanceDefinition.classification | required | SubstanceClassification `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/substance-classification` From this IG
SubstanceDefinition.domain | example | MedicinalProductDomain `http://hl7.org/fhir/ValueSet/medicinal-product-domain` From the FHIR Standard
SubstanceDefinition.grade | required | PqcmcQualityBenchmarkTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology` From this IG
SubstanceDefinition.moiety.stereochemistry | example | Stereochemistry `http://hl7.org/fhir/ValueSet/substance-stereochemistry` From the FHIR Standard
SubstanceDefinition.moiety.opticalActivity | example | OpticalActivity `http://hl7.org/fhir/ValueSet/substance-optical-activity` From the FHIR Standard
SubstanceDefinition.moiety.measurementType | example | SubstanceAmountType `http://hl7.org/fhir/ValueSet/substance-amount-type` From the FHIR Standard
SubstanceDefinition.characterization.technique | example | StructureTechnique `http://hl7.org/fhir/ValueSet/substance-structure-technique` From the FHIR Standard
SubstanceDefinition.characterization.form | example | SubstanceForm `http://hl7.org/fhir/ValueSet/substance-form` From the FHIR Standard
SubstanceDefinition.property.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
SubstanceDefinition.molecularWeight.method | example | WeightMethod `http://hl7.org/fhir/ValueSet/substance-weight-method` From the FHIR Standard
SubstanceDefinition.molecularWeight.type | example | WeightType `http://hl7.org/fhir/ValueSet/substance-weight-type` From the FHIR Standard
SubstanceDefinition.structure.stereochemistry | example | Stereochemistry `http://hl7.org/fhir/ValueSet/substance-stereochemistry` From the FHIR Standard
SubstanceDefinition.structure.opticalActivity | example | OpticalActivity `http://hl7.org/fhir/ValueSet/substance-optical-activity` From the FHIR Standard
SubstanceDefinition.structure.technique | example | StructureTechnique `http://hl7.org/fhir/ValueSet/substance-structure-technique` From the FHIR Standard
SubstanceDefinition.structure.representation.type | example | SubstanceRepresentationType `http://hl7.org/fhir/ValueSet/substance-representation-type` From the FHIR Standard
SubstanceDefinition.structure.representation.format | example | SubstanceRepresentationFormat `http://hl7.org/fhir/ValueSet/substance-representation-format` From the FHIR Standard
SubstanceDefinition.code.status | preferred | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status` From the FHIR Standard
SubstanceDefinition.code:unii.status | preferred | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status` From the FHIR Standard
SubstanceDefinition.code:uniProt.status | preferred | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status` From the FHIR Standard
SubstanceDefinition.name.type | required | PqcmcSubstanceNameType `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type` From this IG
SubstanceDefinition.name.status | preferred | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status` From the FHIR Standard
SubstanceDefinition.name.language | required | AllLanguages `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` From the FHIR Standard
SubstanceDefinition.name.domain | example | SubstanceNameDomain `http://hl7.org/fhir/ValueSet/substance-name-domain` From the FHIR Standard
SubstanceDefinition.name.jurisdiction | example | JurisdictionValueSet `http://hl7.org/fhir/ValueSet/jurisdiction` From the FHIR Standard
SubstanceDefinition.name.official.authority | preferred | SubstanceNameAuthority `http://hl7.org/fhir/ValueSet/substance-name-authority` From the FHIR Standard
SubstanceDefinition.name.official.status | preferred | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status` From the FHIR Standard
SubstanceDefinition.name:sub.type | required | Pattern Value: C97054("Generic Name") `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type` From this IG
SubstanceDefinition.name:sub.status | preferred | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status` From the FHIR Standard
SubstanceDefinition.name:sub.language | required | AllLanguages `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` From the FHIR Standard
SubstanceDefinition.name:sub.domain | example | SubstanceNameDomain `http://hl7.org/fhir/ValueSet/substance-name-domain` From the FHIR Standard
SubstanceDefinition.name:sub.jurisdiction | example | JurisdictionValueSet `http://hl7.org/fhir/ValueSet/jurisdiction` From the FHIR Standard
SubstanceDefinition.name:sub.official.authority | preferred | SubstanceNameAuthority `http://hl7.org/fhir/ValueSet/substance-name-authority` From the FHIR Standard
SubstanceDefinition.name:sub.official.status | preferred | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status` From the FHIR Standard
SubstanceDefinition.name:gsrs.type | required | Pattern Value: C203355("GSRS Preferred Term") `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type` From this IG
SubstanceDefinition.name:gsrs.status | preferred | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status` From the FHIR Standard
SubstanceDefinition.name:gsrs.language | required | AllLanguages `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` From the FHIR Standard
SubstanceDefinition.name:gsrs.domain | example | SubstanceNameDomain `http://hl7.org/fhir/ValueSet/substance-name-domain` From the FHIR Standard
SubstanceDefinition.name:gsrs.jurisdiction | example | JurisdictionValueSet `http://hl7.org/fhir/ValueSet/jurisdiction` From the FHIR Standard
SubstanceDefinition.name:gsrs.official.authority | preferred | SubstanceNameAuthority `http://hl7.org/fhir/ValueSet/substance-name-authority` From the FHIR Standard
SubstanceDefinition.name:gsrs.official.status | preferred | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status` From the FHIR Standard
SubstanceDefinition.name:isbt.type | required | Pattern Value: C95517("ISBT-128 DIN") `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type` From this IG
SubstanceDefinition.name:isbt.status | preferred | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status` From the FHIR Standard
SubstanceDefinition.name:isbt.language | required | AllLanguages `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` From the FHIR Standard
SubstanceDefinition.name:isbt.domain | example | SubstanceNameDomain `http://hl7.org/fhir/ValueSet/substance-name-domain` From the FHIR Standard
SubstanceDefinition.name:isbt.jurisdiction | example | JurisdictionValueSet `http://hl7.org/fhir/ValueSet/jurisdiction` From the FHIR Standard
SubstanceDefinition.name:isbt.official.authority | preferred | SubstanceNameAuthority `http://hl7.org/fhir/ValueSet/substance-name-authority` From the FHIR Standard
SubstanceDefinition.name:isbt.official.status | preferred | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status` From the FHIR Standard
SubstanceDefinition.relationship.type | example | SubstanceRelationshipType `http://hl7.org/fhir/ValueSet/substance-relationship-type` From the FHIR Standard
SubstanceDefinition.relationship.comparator | example | SubstanceAmountType `http://hl7.org/fhir/ValueSet/substance-amount-type` From the FHIR Standard
SubstanceDefinition.sourceMaterial.type | required | PqcmcSourceTypeTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-source-type-terminology` From this IG
SubstanceDefinition.sourceMaterial.genus | example | SourceMaterialGenus `http://hl7.org/fhir/ValueSet/substance-source-material-genus` From the FHIR Standard
SubstanceDefinition.sourceMaterial.species | example | SourceMaterialSpecies `http://hl7.org/fhir/ValueSet/substance-source-material-species` From the FHIR Standard
SubstanceDefinition.sourceMaterial.part | example | SourceMaterialPart `http://hl7.org/fhir/ValueSet/substance-source-material-part` From the FHIR Standard
SubstanceDefinition.sourceMaterial.countryOfOrigin | required | PqcmcGENCAndISOIntersect `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-genc-and-iso-intersect` From this IG

#### Constraints

Id | Grade | Path(s) | Details | Requirements
cmc-name-isbt | error | SubstanceDefinition | Name.type ISBT 128 required for blood products. : classification.where(coding.where(code = '8' and system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').exists()).exists() implies name.type.coding.exists(code = '226' and system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl') |
cmc-name-preferred | error | SubstanceDefinition.name | Name.preferred: at most one = true : select(preferred = true).count() < 2 |
cmc-source-material | error | SubstanceDefinition | 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. : 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-required | error | SubstanceDefinition | A UNII is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer'. A UniProt code is required for any of these categories: 'Protein' : (classification.coding.where(system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and (code in ('C48807' | 'C45305' | 'C706' | 'C48803'))).exists() implies code.where( code.coding.exists(system = 'http://fdasis.nlm.nih.gov') ).exists()) and (classification.coding.where( system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and code = 'C17021' ).exists() implies code.where( code.coding.exists(system = 'http://terminology.hl7.org/NamingSystem/UniProt') ).exists()) |
dom-2 | error | SubstanceDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-3 | error | SubstanceDefinition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() |
dom-4 | error | SubstanceDefinition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() |
dom-5 | error | SubstanceDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() |
dom-6 | best practice | SubstanceDefinition | A resource should have narrative for robust management : text.`div`.exists() |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |

This structure is derived from SubstanceDefinition

Summary

Mandatory: 6 elements(9 nested mandatory elements)
Must-Support: 31 elements

Structures

This structure refers to these other structures:

- Literal Reference (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference)
- Basic Organization (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization)
- Text Only Codeable Concept (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only)

Slices

This structure defines the following Slices:

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

Maturity: 2

Other representations of profile: CSV, Excel, Schematron