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

Resource Profile: ExcipientRaw - Detailed Descriptions

Active as of 2024-04-04

Definitions for the pqcmc-excipient resource profile.

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

0. SubstanceDefinition
Invariantscmc-when-unii-required: A UNII is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer','Protein'. (classification.coding.where(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code in ('C48807' | 'C45305' | 'C706' | 'C48803' |'C17021') ).exists() implies code.code.text.exists())
cmc-name-isbt: Name.type ISBT 128 required for blood products. (classification.where(coding.where(code = '8' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy').exists()).exists() implies name.type.coding.exists(code = '226' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy'))
cmc-source-material: IF raw material source type equals Microbial, Animal, Plant, Insect or Human THEN the 4 source related attributes are required and the manufacturer and supplier information is highly desirable. (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()))
2. SubstanceDefinition.meta
4. SubstanceDefinition.meta.profile
Control1..1
Must Supporttrue
6. SubstanceDefinition.identifier
Shortoptional user designated identifier
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1
8. SubstanceDefinition.classification
Definition

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

ShortSubstance Type
Control1..?
BindingThe codes SHALL be taken from Substance Classification
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/substance-classification)
Must Supporttrue
10. SubstanceDefinition.grade
Definition

The established benchmark to which the component complies. [Source: SME Defined] Examples: USP/NF, EP, Company Standard

ShortQuality Standard
Control1..1
12. SubstanceDefinition.grade.coding
BindingThe codes SHALL be taken from Quality Benchmark Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology)
14. SubstanceDefinition.manufacturer
Control0..1
TypeReference(Manufacturing and/or Test Site Organization)
Must Supporttrue
16. SubstanceDefinition.supplier
Control0..1
TypeReference(Supplier Organization)
Must Supporttrue
18. SubstanceDefinition.code
Definition

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

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

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

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

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

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

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

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

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

      ShortGeneric Name
      Must Supporttrue
      40. SubstanceDefinition.name:sub.type
      Control1..?
      Must Supporttrue
      42. SubstanceDefinition.name:sub.type.coding
      Control1..1
      Must Supporttrue
      Pattern Value{
        "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "code" : "C97054",
        "display" : "Generic Name"
      }
      44. SubstanceDefinition.name:sub.preferred
      Must Supporttrue
      46. SubstanceDefinition.name:gsrs
      Slice Namegsrs
      Control0..1
      Must Supporttrue
      48. SubstanceDefinition.name:gsrs.name
      Definition

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

      ShortGSRS Preferred Term
      Must Supporttrue
      50. SubstanceDefinition.name:gsrs.type
      Control1..?
      Must Supporttrue
      52. SubstanceDefinition.name:gsrs.type.coding
      Control1..1
      Must Supporttrue
      Pattern Value{
        "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "code" : "C203355",
        "display" : "GSRS Preferred Term"
      }
      54. SubstanceDefinition.name:gsrs.preferred
      Must Supporttrue
      56. SubstanceDefinition.name:isbt
      Slice Nameisbt
      Control0..1
      Must Supporttrue
      58. SubstanceDefinition.name:isbt.name
      Definition

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

      ShortISBT-128 DIN
      Must Supporttrue
      60. SubstanceDefinition.name:isbt.type
      Control1..?
      Must Supporttrue
      62. SubstanceDefinition.name:isbt.type.coding
      Control1..1
      Must Supporttrue
      Pattern Value{
        "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "code" : "C95517",
        "display" : "ISBT-128 DIN"
      }
      64. SubstanceDefinition.name:isbt.preferred
      Must Supporttrue
      66. SubstanceDefinition.sourceMaterial
      Control1..?
      Must Supporttrue
      68. SubstanceDefinition.sourceMaterial.type
      Definition

      A classification that provides the origin of the raw material. [Source: SME Defined] Example: cat hair would be an Animal source type

      ShortSource Type
      Control1..?
      70. SubstanceDefinition.sourceMaterial.type.coding
      BindingThe codes SHALL be taken from Source Type Terminology
      (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-source-type-terminology)
      72. SubstanceDefinition.sourceMaterial.genus
      Must Supporttrue
      74. SubstanceDefinition.sourceMaterial.genus.coding
      Control0..0
      76. SubstanceDefinition.sourceMaterial.genus.text
      Definition

      The name, genus or genus and species of the organism from which the material is derived. [Source: SME Defined] Examples: Examples: human or Homo Sapiens, chicken, dog or canine, cow or bovine, rat or rattus.

      ShortSource Organism
      Control1..?
      78. SubstanceDefinition.sourceMaterial.species
      Definition

      The name, genus or genus and species of the organism from which the material is derived. [Source: SME Defined] Examples: Examples: human or Homo Sapiens, chicken, dog or canine, cow or bovine, rat or rattus.

      ShortSource Organism
      Must Supporttrue
      80. SubstanceDefinition.sourceMaterial.species.coding
      Control0..0
      82. SubstanceDefinition.sourceMaterial.species.text
      Control1..?
      84. SubstanceDefinition.sourceMaterial.part
      Definition

      A fragment of the source organism. [Source: SME Defined] Examples: secretions, material from a specific organ, tissue or portion of the organism such as liver, pancreas, blood or from bark or seed of a plant. IDMP 11238 definition & examples: Entity of anatomical origin of source material within an organism. Cartilage, Root and Stolon, whole plant is considered as a part, Aerial part of the plant, Leaf, Tuberous Root, whole animal

      ShortSource Organism Part
      Must Supporttrue
      86. SubstanceDefinition.sourceMaterial.part.coding
      Control0..0
      88. SubstanceDefinition.sourceMaterial.part.text
      Control1..?
      90. SubstanceDefinition.sourceMaterial.countryOfOrigin
      Definition

      The name of the country where the organism was reared. [Source: SME Defined]

      ShortSource Organism Country of Origin
      Control0..1
      Must Supporttrue
      Invariantscmc-iso-genc-overlap: Only country codes that are also member of GENC can be used. (coding.where( (system = 'urn:iso:std:iso:3166') and ( (code = 'ALA') or (code = 'PSE') or (code = 'SJM') or (code = 'UMI') ) ).exists().not())
      92. SubstanceDefinition.sourceMaterial.countryOfOrigin.coding
      Control1..1
      Must Supporttrue
      94. SubstanceDefinition.sourceMaterial.countryOfOrigin.coding.code
      Control1..?
      Must Supporttrue
      Invariantscmc-only-ISO-3166-1-alpha-3: Country must be a 3 letter country code ($this.length() = 3)

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

      0. SubstanceDefinition
      Definition

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

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

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

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

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

      ShortProfiles this resource claims to conform to
      Comments

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

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

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

      ShortA set of rules under which this content was created
      Comments

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

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

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

      ShortContained, inline Resources
      Comments

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

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

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

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

      ShortExtensions that cannot be ignored
      Comments

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

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

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

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

      Identifier by which this substance is known.

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

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


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

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

      The established benchmark to which the component complies. [Source: SME Defined] Examples: USP/NF, EP, Company Standard


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

      ShortQuality StandardThe quality standard, established benchmark, to which substance complies (e.g. USP/NF, BP)
      Control10..1*
      BindingFor example codes, see SubstanceGradehttp://hl7.org/fhir/ValueSet/substance-grade
      (example to http://hl7.org/fhir/ValueSet/substance-grade)

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

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

      A reference to a code defined by a terminology system.

      ShortCode defined by a terminology system
      Comments

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

      Control0..*
      BindingThe codes SHALL be taken from For codes, see Quality Benchmark Terminology
      (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology)
      TypeCoding
      Is Modifierfalse
      Summarytrue
      Requirements

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

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

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

      ShortThe entity that creates, makes, produces or fabricates the substance
      Control0..1*
      TypeReference(Manufacturing and/or Test Site Organization, Organization)
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      22. SubstanceDefinition.supplier
      Definition

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

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

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


      Codes associated with the substance.

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

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

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

      ShortExtensions that cannot be ignored even if unrecognized
      Comments

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

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

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

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

      The specific code.

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

      A reference to a code defined by a terminology system.

      ShortCode defined by a terminology system
      Comments

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

      Control0..*
      TypeCoding
      Is Modifierfalse
      Summarytrue
      Requirements

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

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

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


        A reference to a code defined by a terminology system.

        ShortUNIICode defined by a terminology system
        Comments

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

        Control0..1*
        TypeCoding
        Is Modifierfalse
        Summarytrue
        Requirements

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

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

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

        ShortIdentity of the terminology system
        Comments

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

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

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

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

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


        A reference to a code defined by a terminology system.

        ShortUniProt IDCode defined by a terminology system
        Comments

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

        Control0..1*
        TypeCoding
        Is Modifierfalse
        Summarytrue
        Requirements

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

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

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

        ShortIdentity of the terminology system
        Comments

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

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

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

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

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


        Names applicable to this substance.

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

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

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

          ShortExtensions that cannot be ignored even if unrecognized
          Comments

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

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

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

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

          The actual name.

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

          If this is the preferred name for this substance.

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

          Names applicable to this substance.

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

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

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

          ShortExtensions that cannot be ignored even if unrecognized
          Comments

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

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

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

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

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


          The actual name.

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

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

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

          The type of a name given to a substance.

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

          A reference to a code defined by a terminology system.

          ShortCode defined by a terminology system
          Comments

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

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

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

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

          If this is the preferred name for this substance.

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

          Names applicable to this substance.

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

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

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

          ShortExtensions that cannot be ignored even if unrecognized
          Comments

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

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

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

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

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


          The actual name.

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

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

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

          The type of a name given to a substance.

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

          A reference to a code defined by a terminology system.

          ShortCode defined by a terminology system
          Comments

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

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

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

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

          If this is the preferred name for this substance.

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

          Names applicable to this substance.

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

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

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

          ShortExtensions that cannot be ignored even if unrecognized
          Comments

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

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

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

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

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


          The actual name.

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

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

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

          The type of a name given to a substance.

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

          A reference to a code defined by a terminology system.

          ShortCode defined by a terminology system
          Comments

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

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

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

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

          If this is the preferred name for this substance.

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

          Material or taxonomic/anatomical source for the substance.

          ShortMaterial or taxonomic/anatomical source
          Control10..1
          TypeBackboneElement
          Is Modifierfalse
          Must Supporttrue
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          86. SubstanceDefinition.sourceMaterial.modifierExtension
          Definition

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

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

          ShortExtensions that cannot be ignored even if unrecognized
          Comments

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

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

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

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

          A classification that provides the origin of the raw material. [Source: SME Defined] Example: cat hair would be an Animal source type


          A classification that provides the origin of the raw material. Example: cat hair would be an Animal source type.

          ShortSource TypeClassification of the origin of the raw material. e.g. cat hair is an Animal source type
          Control10..1
          BindingFor example codes, see SourceMaterialTypehttp://hl7.org/fhir/ValueSet/substance-source-material-type
          (example to http://hl7.org/fhir/ValueSet/substance-source-material-type)

          A classification that provides the origin of the substance raw material.

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

          A reference to a code defined by a terminology system.

          ShortCode defined by a terminology system
          Comments

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

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

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

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

          The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name.

          ShortThe genus of an organism e.g. the Latin epithet of the plant/animal scientific name
          Control0..1
          BindingFor example codes, see SourceMaterialGenushttp://hl7.org/fhir/ValueSet/substance-source-material-genus
          (example to http://hl7.org/fhir/ValueSet/substance-source-material-genus)

          The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name.

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

          A reference to a code defined by a terminology system.

          ShortCode defined by a terminology system
          Comments

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

          Control0..0*
          TypeCoding
          Is Modifierfalse
          Summarytrue
          Requirements

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

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

          The name, genus or genus and species of the organism from which the material is derived. [Source: SME Defined] Examples: Examples: human or Homo Sapiens, chicken, dog or canine, cow or bovine, rat or rattus.


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

          ShortSource OrganismPlain text representation of the concept
          Comments

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

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

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

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

          The name, genus or genus and species of the organism from which the material is derived. [Source: SME Defined] Examples: Examples: human or Homo Sapiens, chicken, dog or canine, cow or bovine, rat or rattus.


          The species of an organism, typically referring to the Latin epithet of the species of the plant/animal.

          ShortSource OrganismThe species of an organism e.g. the Latin epithet of the species of the plant/animal
          Control0..1
          BindingFor example codes, see SourceMaterialSpecieshttp://hl7.org/fhir/ValueSet/substance-source-material-species
          (example to http://hl7.org/fhir/ValueSet/substance-source-material-species)

          A species of origin a substance raw material.

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

          A reference to a code defined by a terminology system.

          ShortCode defined by a terminology system
          Comments

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

          Control0..0*
          TypeCoding
          Is Modifierfalse
          Summarytrue
          Requirements

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

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

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

          ShortPlain text representation of the concept
          Comments

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

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

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

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

          A fragment of the source organism. [Source: SME Defined] Examples: secretions, material from a specific organ, tissue or portion of the organism such as liver, pancreas, blood or from bark or seed of a plant. IDMP 11238 definition & examples: Entity of anatomical origin of source material within an organism. Cartilage, Root and Stolon, whole plant is considered as a part, Aerial part of the plant, Leaf, Tuberous Root, whole animal


          An anatomical origin of the source material within an organism.

          ShortSource Organism PartAn anatomical origin of the source material within an organism
          Control0..1
          BindingFor example codes, see SourceMaterialParthttp://hl7.org/fhir/ValueSet/substance-source-material-part
          (example to http://hl7.org/fhir/ValueSet/substance-source-material-part)

          An anatomical origin of the source material within an organism.

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

          A reference to a code defined by a terminology system.

          ShortCode defined by a terminology system
          Comments

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

          Control0..0*
          TypeCoding
          Is Modifierfalse
          Summarytrue
          Requirements

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

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

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

          ShortPlain text representation of the concept
          Comments

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

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

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

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

          The name of the country where the organism was reared. [Source: SME Defined]


          The country or countries where the material is harvested.

          ShortSource Organism Country of OriginThe country or countries where the material is harvested
          Control0..1*
          BindingThe codes SHALL be taken from CountryValueSethttp://hl7.org/fhir/ValueSet/country|5.0.0
          (required to http://hl7.org/fhir/ValueSet/country|5.0.0)

          Jurisdiction codes

          TypeCodeableConcept
          Is Modifierfalse
          Must Supporttrue
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          cmc-iso-genc-overlap: Only country codes that are also member of GENC can be used. (coding.where( (system = 'urn:iso:std:iso:3166') and ( (code = 'ALA') or (code = 'PSE') or (code = 'SJM') or (code = 'UMI') ) ).exists().not())
          112. SubstanceDefinition.sourceMaterial.countryOfOrigin.coding
          Definition

          A reference to a code defined by a terminology system.

          ShortCode defined by a terminology system
          Comments

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

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

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

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

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

          ShortSymbol in syntax defined by the system
          Control10..1
          This element is affected by the following invariants: cod-1
          Typecode
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supporttrue
          Summarytrue
          Requirements

          Need to refer to a particular code in the system.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          cmc-only-ISO-3166-1-alpha-3: Country must be a 3 letter country code ($this.length() = 3)

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

          0. SubstanceDefinition
          Definition

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

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

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

          ShortLogical id of this artifact
          Comments

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

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

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

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

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

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

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

          ShortAdditional content defined by implementations
          Comments

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

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

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

            ShortVersion specific identifier
            Comments

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

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

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

            ShortWhen the resource version last changed
            Comments

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

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

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

            ShortIdentifies where the resource comes from
            Comments

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

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

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

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

            ShortProfiles this resource claims to conform to
            Comments

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

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

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

            ShortSecurity Labels applied to this resource
            Comments

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

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

            Security Labels from the Healthcare Privacy and Security Classification System.

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

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

            ShortTags applied to this resource
            Comments

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

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

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

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

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

            ShortA set of rules under which this content was created
            Comments

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

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

            The base language in which the resource is written.

            ShortLanguage of the resource content
            Comments

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

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

            IETF language tag for a human language

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

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

            ShortText summary of the resource, for human interpretation
            Comments

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

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

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

            ShortContained, inline Resources
            Comments

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

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

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

            ShortAdditional content defined by implementations
            Comments

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

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

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

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

            ShortExtensions that cannot be ignored
            Comments

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

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

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

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

            Identifier by which this substance is known.

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

            A business level version identifier of the substance.

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

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

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

            The lifecycle status of an artifact.

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

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

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

            If the substance applies to human or veterinary use.

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

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

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

            The established benchmark to which the component complies. [Source: SME Defined] Examples: USP/NF, EP, Company Standard

            ShortQuality Standard
            Control1..1
            BindingFor example codes, see SubstanceGrade
            (example to http://hl7.org/fhir/ValueSet/substance-grade)

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

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

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

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

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

            ShortAdditional content defined by implementations
            Comments

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

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

              A reference to a code defined by a terminology system.

              ShortCode defined by a terminology system
              Comments

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

              Control0..*
              BindingThe codes SHALL be taken from Quality Benchmark Terminology
              (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology)
              TypeCoding
              Is Modifierfalse
              Summarytrue
              Requirements

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

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

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

              ShortPlain text representation of the concept
              Comments

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

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

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

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

              Textual description of the substance.

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

              Supporting literature.

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

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

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

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

              ShortThe entity that creates, makes, produces or fabricates the substance
              Control0..1
              TypeReference(Manufacturing and/or Test Site Organization)
              Is Modifierfalse
              Must Supporttrue
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              62. SubstanceDefinition.supplier
              Definition

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

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

              Moiety, for structural modifications.

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

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

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

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

              ShortAdditional content defined by implementations
              Comments

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

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

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

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

              ShortExtensions that cannot be ignored even if unrecognized
              Comments

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

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

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

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

              Role that the moiety is playing.

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

              Identifier by which this moiety substance is known.

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

              Textual name for this moiety substance.

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

              Stereochemistry type.

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

              The optical rotation type of a substance.

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

              Optical activity type.

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

              The optical rotation type of a substance.

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

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

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

              Quantitative value for this moiety.

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

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

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

              The relationship between two substance types.

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

              General specifications for this substance.

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

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

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

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

              ShortAdditional content defined by implementations
              Comments

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

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

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

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

              ShortExtensions that cannot be ignored even if unrecognized
              Comments

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

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

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

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

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

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

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

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

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

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

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

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

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

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

              General specifications for this substance.

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

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

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

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

              ShortAdditional content defined by implementations
              Comments

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

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

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

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

              ShortExtensions that cannot be ignored even if unrecognized
              Comments

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

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

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

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

              A code expressing the type of property.

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

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

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

              A value for the property.

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

              General information detailing this substance.

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

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

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

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

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

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

              ShortAdditional content defined by implementations
              Comments

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

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

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

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

              ShortExtensions that cannot be ignored even if unrecognized
              Comments

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

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

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

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

              The method by which the molecular weight was determined.

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

              The method by which the substance weight was measured.

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

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

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

              The type of substance weight measurement.

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

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

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

              Structural information.

              ShortStructural information
              Control0..1
              TypeBackboneElement
              Is Modifierfalse
              Must Supportfalse
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              134. SubstanceDefinition.structure.id
              Definition

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

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

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

              ShortAdditional content defined by implementations
              Comments

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

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

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

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

              ShortExtensions that cannot be ignored even if unrecognized
              Comments

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

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

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

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

              Stereochemistry type.

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

              The optical rotation type of a substance.

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

              Optical activity type.

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

              The optical rotation type of a substance.

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

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

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

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

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

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

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

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

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

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

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

              The source of information about the structure.

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

              A depiction of the structure of the substance.

              ShortA depiction of the structure of the substance
              Control0..*
              TypeBackboneElement
              Is Modifierfalse
              Must Supportfalse
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              156. SubstanceDefinition.structure.representation.id
              Definition

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

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

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

              ShortAdditional content defined by implementations
              Comments

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

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

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

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

              ShortExtensions that cannot be ignored even if unrecognized
              Comments

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

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

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

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

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

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

              A format of a substance representation.

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

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

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

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

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

              A format of a substance representation.

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

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

              ShortAn attachment with the structural representation e.g. a structure graphic or AnIML file
              Control0..1
              TypeReference(DocumentReference)
              Is Modifierfalse
              Must Supportfalse
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              170. SubstanceDefinition.code
              Definition

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

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

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

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

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

              ShortAdditional content defined by implementations
              Comments

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

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

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

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

              ShortExtensions that cannot be ignored even if unrecognized
              Comments

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

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

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

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

              The specific code.

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

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

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

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

              ShortAdditional content defined by implementations
              Comments

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

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

                A reference to a code defined by a terminology system.

                ShortCode defined by a terminology system
                Comments

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

                Control0..*
                TypeCoding
                Is Modifierfalse
                Summarytrue
                Requirements

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

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

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

                  ShortUNII
                  Comments

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

                  Control0..1
                  TypeCoding
                  Is Modifierfalse
                  Summarytrue
                  Requirements

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

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

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

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

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

                  ShortAdditional content defined by implementations
                  Comments

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

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

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

                    ShortIdentity of the terminology system
                    Comments

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

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

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

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

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

                    ShortVersion of the system - if relevant
                    Comments

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

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

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

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

                    Need to refer to a particular code in the system.

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

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

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

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

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

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

                    ShortIf this coding was chosen directly by the user
                    Comments

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

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

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

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

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

                    ShortUniProt ID
                    Comments

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

                    Control0..1
                    TypeCoding
                    Is Modifierfalse
                    Summarytrue
                    Requirements

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

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

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

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

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

                    ShortAdditional content defined by implementations
                    Comments

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

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

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

                      ShortIdentity of the terminology system
                      Comments

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

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

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

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

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

                      ShortVersion of the system - if relevant
                      Comments

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

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

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

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

                      Need to refer to a particular code in the system.

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

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

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

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

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

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

                      ShortIf this coding was chosen directly by the user
                      Comments

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

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

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

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

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

                      ShortPlain text representation of the concept
                      Comments

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

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

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

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

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

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

                      The lifecycle status of an artifact.

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

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

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

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

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

                      Supporting literature.

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

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

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

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

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

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

                        ShortAdditional content defined by implementations
                        Comments

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

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

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

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

                        ShortExtensions that cannot be ignored even if unrecognized
                        Comments

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

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

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

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

                        The actual name.

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

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

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

                        The type of a name given to a substance.

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

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

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

                        The lifecycle status of an artifact.

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

                        If this is the preferred name for this substance.

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

                        Human language that the name is written in.

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

                        IETF language tag for a human language

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

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

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

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

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

                        The jurisdiction where this name applies.

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

                        Jurisdiction codes

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

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

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

                        A translation for this name into another human language.

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

                        Details of the official nature of this name.

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

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

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

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

                        ShortAdditional content defined by implementations
                        Comments

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

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

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

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

                        ShortExtensions that cannot be ignored even if unrecognized
                        Comments

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

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

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

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

                        Which authority uses this official name.

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

                        An authority that officates substance names.

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

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

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

                        The lifecycle status of an artifact.

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

                        Date of the official name change.

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

                        Supporting literature.

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

                        Names applicable to this substance.

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

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

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

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

                        ShortAdditional content defined by implementations
                        Comments

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

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

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

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

                        ShortExtensions that cannot be ignored even if unrecognized
                        Comments

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

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

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

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

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

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

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

                        ShortName type e.g. 'systematic', 'scientific, 'brand'
                        Control1..1
                        BindingFor example codes, see SubstanceNameType
                        (example to http://hl7.org/fhir/ValueSet/substance-name-type)

                        The type of a name given to a substance.

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

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

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

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

                        ShortAdditional content defined by implementations
                        Comments

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

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

                          A reference to a code defined by a terminology system.

                          ShortCode defined by a terminology system
                          Comments

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

                          Control1..1
                          TypeCoding
                          Is Modifierfalse
                          Must Supporttrue
                          Summarytrue
                          Requirements

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

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

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

                          ShortPlain text representation of the concept
                          Comments

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

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

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

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

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

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

                          The lifecycle status of an artifact.

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

                          If this is the preferred name for this substance.

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

                          Human language that the name is written in.

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

                          IETF language tag for a human language

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

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

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

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

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

                          The jurisdiction where this name applies.

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

                          Jurisdiction codes

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

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

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

                          A translation for this name into another human language.

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

                          Details of the official nature of this name.

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

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

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

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

                          ShortAdditional content defined by implementations
                          Comments

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

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

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

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

                          ShortExtensions that cannot be ignored even if unrecognized
                          Comments

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

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

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

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

                          Which authority uses this official name.

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

                          An authority that officates substance names.

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

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

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

                          The lifecycle status of an artifact.

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

                          Date of the official name change.

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

                          Supporting literature.

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

                          Names applicable to this substance.

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

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

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

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

                          ShortAdditional content defined by implementations
                          Comments

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

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

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

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

                          ShortExtensions that cannot be ignored even if unrecognized
                          Comments

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

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

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

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

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

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

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

                          ShortName type e.g. 'systematic', 'scientific, 'brand'
                          Control1..1
                          BindingFor example codes, see SubstanceNameType
                          (example to http://hl7.org/fhir/ValueSet/substance-name-type)

                          The type of a name given to a substance.

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

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

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

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

                          ShortAdditional content defined by implementations
                          Comments

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

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

                            A reference to a code defined by a terminology system.

                            ShortCode defined by a terminology system
                            Comments

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

                            Control1..1
                            TypeCoding
                            Is Modifierfalse
                            Must Supporttrue
                            Summarytrue
                            Requirements

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

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

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

                            ShortPlain text representation of the concept
                            Comments

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

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

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

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

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

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

                            The lifecycle status of an artifact.

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

                            If this is the preferred name for this substance.

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

                            Human language that the name is written in.

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

                            IETF language tag for a human language

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

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

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

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

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

                            The jurisdiction where this name applies.

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

                            Jurisdiction codes

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

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

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

                            A translation for this name into another human language.

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

                            Details of the official nature of this name.

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

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

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

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

                            ShortAdditional content defined by implementations
                            Comments

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

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

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

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

                            ShortExtensions that cannot be ignored even if unrecognized
                            Comments

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

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

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

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

                            Which authority uses this official name.

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

                            An authority that officates substance names.

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

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

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

                            The lifecycle status of an artifact.

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

                            Date of the official name change.

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

                            Supporting literature.

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

                            Names applicable to this substance.

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

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

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

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

                            ShortAdditional content defined by implementations
                            Comments

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

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

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

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

                            ShortExtensions that cannot be ignored even if unrecognized
                            Comments

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

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

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

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

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

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

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

                            ShortName type e.g. 'systematic', 'scientific, 'brand'
                            Control1..1
                            BindingFor example codes, see SubstanceNameType
                            (example to http://hl7.org/fhir/ValueSet/substance-name-type)

                            The type of a name given to a substance.

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

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

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

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

                            ShortAdditional content defined by implementations
                            Comments

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

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

                              A reference to a code defined by a terminology system.

                              ShortCode defined by a terminology system
                              Comments

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

                              Control1..1
                              TypeCoding
                              Is Modifierfalse
                              Must Supporttrue
                              Summarytrue
                              Requirements

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

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

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

                              ShortPlain text representation of the concept
                              Comments

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

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

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

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

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

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

                              The lifecycle status of an artifact.

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

                              If this is the preferred name for this substance.

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

                              Human language that the name is written in.

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

                              IETF language tag for a human language

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

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

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

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

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

                              The jurisdiction where this name applies.

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

                              Jurisdiction codes

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

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

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

                              A translation for this name into another human language.

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

                              Details of the official nature of this name.

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

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

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

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

                              ShortAdditional content defined by implementations
                              Comments

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

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

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

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

                              ShortExtensions that cannot be ignored even if unrecognized
                              Comments

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

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

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

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

                              Which authority uses this official name.

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

                              An authority that officates substance names.

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

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

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

                              The lifecycle status of an artifact.

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

                              Date of the official name change.

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

                              Supporting literature.

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

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

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

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

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

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

                              ShortAdditional content defined by implementations
                              Comments

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

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

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

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

                              ShortExtensions that cannot be ignored even if unrecognized
                              Comments

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

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

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

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

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

                              ShortA pointer to another substance, as a resource or a representational code
                              Control0..1
                              TypeChoice of: Reference(SubstanceDefinition), CodeableConcept
                              [x] NoteSee Choice of Data Types for further information about how to use [x]
                              Is Modifierfalse
                              Must Supportfalse
                              Summarytrue
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              430. SubstanceDefinition.relationship.type
                              Definition

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

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

                              The relationship between two substance types.

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

                              For example where an enzyme strongly bonds with a particular substance, this is a defining relationship for that enzyme, out of several possible substance relationships.

                              ShortFor example where an enzyme strongly bonds with a particular substance, this is a defining relationship for that enzyme, out of several possible relationships
                              Control0..1
                              Typeboolean
                              Is Modifierfalse
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Must Supportfalse
                              Summarytrue
                              Meaning if MissingIf this value is not present, there is no statement being made about whether this is a defining relationship or not. No inference can be made
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              434. SubstanceDefinition.relationship.amount[x]
                              Definition

                              A numeric factor for the relationship, for instance to express that the salt of a substance has some percentage of the active substance in relation to some other.

                              ShortA numeric factor for the relationship, e.g. that a substance salt has some percentage of active substance in relation to some other
                              Control0..1
                              TypeChoice of: Quantity, Ratio, string
                              [x] NoteSee Choice of Data Types for further information about how to use [x]
                              Is Modifierfalse
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Must Supportfalse
                              Summarytrue
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              436. SubstanceDefinition.relationship.ratioHighLimitAmount
                              Definition

                              For use when the numeric has an uncertain range.

                              ShortFor use when the numeric has an uncertain range
                              Control0..1
                              TypeRatio
                              Is Modifierfalse
                              Must Supportfalse
                              Summarytrue
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              438. SubstanceDefinition.relationship.comparator
                              Definition

                              An operator for the amount, for example "average", "approximately", "less than".

                              ShortAn operator for the amount, for example "average", "approximately", "less than"
                              Control0..1
                              BindingFor example codes, see SubstanceAmountType
                              (example to http://hl7.org/fhir/ValueSet/substance-amount-type)

                              The relationship between two substance types.

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

                              Supporting literature.

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

                              Data items specific to nucleic acids.

                              ShortData items specific to nucleic acids
                              Control0..1
                              TypeReference(SubstanceNucleicAcid)
                              Is Modifierfalse
                              Must Supportfalse
                              Summarytrue
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              444. SubstanceDefinition.polymer
                              Definition

                              Data items specific to polymers.

                              ShortData items specific to polymers
                              Control0..1
                              TypeReference(SubstancePolymer)
                              Is Modifierfalse
                              Must Supportfalse
                              Summarytrue
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              446. SubstanceDefinition.protein
                              Definition

                              Data items specific to proteins.

                              ShortData items specific to proteins
                              Control0..1
                              TypeReference(SubstanceProtein)
                              Is Modifierfalse
                              Must Supportfalse
                              Summarytrue
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              448. SubstanceDefinition.sourceMaterial
                              Definition

                              Material or taxonomic/anatomical source for the substance.

                              ShortMaterial or taxonomic/anatomical source
                              Control1..1
                              TypeBackboneElement
                              Is Modifierfalse
                              Must Supporttrue
                              Summarytrue
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              450. SubstanceDefinition.sourceMaterial.id
                              Definition

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

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

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

                              ShortAdditional content defined by implementations
                              Comments

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

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

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

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

                              ShortExtensions that cannot be ignored even if unrecognized
                              Comments

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

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

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

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

                              A classification that provides the origin of the raw material. [Source: SME Defined] Example: cat hair would be an Animal source type

                              ShortSource Type
                              Control1..1
                              BindingFor example codes, see SourceMaterialType
                              (example to http://hl7.org/fhir/ValueSet/substance-source-material-type)

                              A classification that provides the origin of the substance raw material.

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

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

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

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

                              ShortAdditional content defined by implementations
                              Comments

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

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

                                A reference to a code defined by a terminology system.

                                ShortCode defined by a terminology system
                                Comments

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

                                Control0..*
                                BindingThe codes SHALL be taken from Source Type Terminology
                                (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-source-type-terminology)
                                TypeCoding
                                Is Modifierfalse
                                Summarytrue
                                Requirements

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

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

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

                                ShortPlain text representation of the concept
                                Comments

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

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

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

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

                                The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name.

                                ShortThe genus of an organism e.g. the Latin epithet of the plant/animal scientific name
                                Control0..1
                                BindingFor example codes, see SourceMaterialGenus
                                (example to http://hl7.org/fhir/ValueSet/substance-source-material-genus)

                                The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name.

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

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

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

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

                                ShortAdditional content defined by implementations
                                Comments

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

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

                                  A reference to a code defined by a terminology system.

                                  ShortCode defined by a terminology system
                                  Comments

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

                                  Control0..0
                                  TypeCoding
                                  Is Modifierfalse
                                  Summarytrue
                                  Requirements

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

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

                                  The name, genus or genus and species of the organism from which the material is derived. [Source: SME Defined] Examples: Examples: human or Homo Sapiens, chicken, dog or canine, cow or bovine, rat or rattus.

                                  ShortSource Organism
                                  Comments

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

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

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

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

                                  The name, genus or genus and species of the organism from which the material is derived. [Source: SME Defined] Examples: Examples: human or Homo Sapiens, chicken, dog or canine, cow or bovine, rat or rattus.

                                  ShortSource Organism
                                  Control0..1
                                  BindingFor example codes, see SourceMaterialSpecies
                                  (example to http://hl7.org/fhir/ValueSet/substance-source-material-species)

                                  A species of origin a substance raw material.

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

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

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

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

                                  ShortAdditional content defined by implementations
                                  Comments

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

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

                                    A reference to a code defined by a terminology system.

                                    ShortCode defined by a terminology system
                                    Comments

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

                                    Control0..0
                                    TypeCoding
                                    Is Modifierfalse
                                    Summarytrue
                                    Requirements

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

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

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

                                    ShortPlain text representation of the concept
                                    Comments

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

                                    Control1..1
                                    Typestring
                                    Is Modifierfalse
                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                    Summarytrue
                                    Requirements

                                    The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    486. SubstanceDefinition.sourceMaterial.part
                                    Definition

                                    A fragment of the source organism. [Source: SME Defined] Examples: secretions, material from a specific organ, tissue or portion of the organism such as liver, pancreas, blood or from bark or seed of a plant. IDMP 11238 definition & examples: Entity of anatomical origin of source material within an organism. Cartilage, Root and Stolon, whole plant is considered as a part, Aerial part of the plant, Leaf, Tuberous Root, whole animal

                                    ShortSource Organism Part
                                    Control0..1
                                    BindingFor example codes, see SourceMaterialPart
                                    (example to http://hl7.org/fhir/ValueSet/substance-source-material-part)

                                    An anatomical origin of the source material within an organism.

                                    TypeCodeableConcept
                                    Is Modifierfalse
                                    Must Supporttrue
                                    Summarytrue
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    488. SubstanceDefinition.sourceMaterial.part.id
                                    Definition

                                    Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                    ShortUnique id for inter-element referencing
                                    Control0..1
                                    This element is affected by the following invariants: ele-1
                                    Typeid
                                    Is Modifierfalse
                                    XML FormatIn the XML format, this property is represented as an attribute.
                                    Summaryfalse
                                    490. SubstanceDefinition.sourceMaterial.part.extension
                                    Definition

                                    May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                    ShortAdditional content defined by implementations
                                    Comments

                                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                    Control0..*
                                    TypeExtension
                                    Is Modifierfalse
                                    Summaryfalse
                                    Alternate Namesextensions, user content
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                    SlicingThis element introduces a set of slices on SubstanceDefinition.sourceMaterial.part.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
                                    • value @ url
                                    • 492. SubstanceDefinition.sourceMaterial.part.coding
                                      Definition

                                      A reference to a code defined by a terminology system.

                                      ShortCode defined by a terminology system
                                      Comments

                                      Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                                      Control0..0
                                      TypeCoding
                                      Is Modifierfalse
                                      Summarytrue
                                      Requirements

                                      Allows for alternative encodings within a code system, and translations to other code systems.

                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      494. SubstanceDefinition.sourceMaterial.part.text
                                      Definition

                                      A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                                      ShortPlain text representation of the concept
                                      Comments

                                      Very often the text is the same as a displayName of one of the codings.

                                      Control1..1
                                      Typestring
                                      Is Modifierfalse
                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                      Summarytrue
                                      Requirements

                                      The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      496. SubstanceDefinition.sourceMaterial.countryOfOrigin
                                      Definition

                                      The name of the country where the organism was reared. [Source: SME Defined]

                                      ShortSource Organism Country of Origin
                                      Control0..1
                                      BindingThe codes SHALL be taken from CountryValueSet
                                      (required to http://hl7.org/fhir/ValueSet/country|5.0.0)

                                      Jurisdiction codes

                                      TypeCodeableConcept
                                      Is Modifierfalse
                                      Must Supporttrue
                                      Summarytrue
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      cmc-iso-genc-overlap: Only country codes that are also member of GENC can be used. (coding.where( (system = 'urn:iso:std:iso:3166') and ( (code = 'ALA') or (code = 'PSE') or (code = 'SJM') or (code = 'UMI') ) ).exists().not())
                                      498. SubstanceDefinition.sourceMaterial.countryOfOrigin.id
                                      Definition

                                      Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                      ShortUnique id for inter-element referencing
                                      Control0..1
                                      This element is affected by the following invariants: ele-1
                                      Typeid
                                      Is Modifierfalse
                                      XML FormatIn the XML format, this property is represented as an attribute.
                                      Summaryfalse
                                      500. SubstanceDefinition.sourceMaterial.countryOfOrigin.extension
                                      Definition

                                      May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                      ShortAdditional content defined by implementations
                                      Comments

                                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                      Control0..*
                                      TypeExtension
                                      Is Modifierfalse
                                      Summaryfalse
                                      Alternate Namesextensions, user content
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                      SlicingThis element introduces a set of slices on SubstanceDefinition.sourceMaterial.countryOfOrigin.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
                                      • value @ url
                                      • 502. SubstanceDefinition.sourceMaterial.countryOfOrigin.coding
                                        Definition

                                        A reference to a code defined by a terminology system.

                                        ShortCode defined by a terminology system
                                        Comments

                                        Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                                        Control1..1
                                        TypeCoding
                                        Is Modifierfalse
                                        Must Supporttrue
                                        Summarytrue
                                        Requirements

                                        Allows for alternative encodings within a code system, and translations to other code systems.

                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        504. SubstanceDefinition.sourceMaterial.countryOfOrigin.coding.id
                                        Definition

                                        Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                        ShortUnique id for inter-element referencing
                                        Control0..1
                                        This element is affected by the following invariants: ele-1
                                        Typeid
                                        Is Modifierfalse
                                        XML FormatIn the XML format, this property is represented as an attribute.
                                        Summaryfalse
                                        506. SubstanceDefinition.sourceMaterial.countryOfOrigin.coding.extension
                                        Definition

                                        May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                        ShortAdditional content defined by implementations
                                        Comments

                                        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                        Control0..*
                                        TypeExtension
                                        Is Modifierfalse
                                        Summaryfalse
                                        Alternate Namesextensions, user content
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                        SlicingThis element introduces a set of slices on SubstanceDefinition.sourceMaterial.countryOfOrigin.coding.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
                                        • value @ url
                                        • 508. SubstanceDefinition.sourceMaterial.countryOfOrigin.coding.system
                                          Definition

                                          The identification of the code system that defines the meaning of the symbol in the code.

                                          ShortIdentity of the terminology system
                                          Comments

                                          The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously.

                                          Control0..1
                                          Typeuri
                                          Is Modifierfalse
                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                          Summarytrue
                                          Requirements

                                          Need to be unambiguous about the source of the definition of the symbol.

                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          510. SubstanceDefinition.sourceMaterial.countryOfOrigin.coding.version
                                          Definition

                                          The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

                                          ShortVersion of the system - if relevant
                                          Comments

                                          Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

                                          NoteThis is a business versionId, not a resource version id (see discussion)
                                          Control0..1
                                          Typestring
                                          Is Modifierfalse
                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          512. SubstanceDefinition.sourceMaterial.countryOfOrigin.coding.code
                                          Definition

                                          A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

                                          ShortSymbol in syntax defined by the system
                                          Control1..1
                                          This element is affected by the following invariants: cod-1
                                          Typecode
                                          Is Modifierfalse
                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                          Must Supporttrue
                                          Summarytrue
                                          Requirements

                                          Need to refer to a particular code in the system.

                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          cmc-only-ISO-3166-1-alpha-3: Country must be a 3 letter country code ($this.length() = 3)
                                          514. SubstanceDefinition.sourceMaterial.countryOfOrigin.coding.display
                                          Definition

                                          A representation of the meaning of the code in the system, following the rules of the system.

                                          ShortRepresentation defined by the system
                                          Control0..1
                                          This element is affected by the following invariants: cod-1
                                          Typestring
                                          Is Modifierfalse
                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                          Summarytrue
                                          Requirements

                                          Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          516. SubstanceDefinition.sourceMaterial.countryOfOrigin.coding.userSelected
                                          Definition

                                          Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

                                          ShortIf this coding was chosen directly by the user
                                          Comments

                                          Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

                                          Control0..1
                                          Typeboolean
                                          Is Modifierfalse
                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                          Summarytrue
                                          Requirements

                                          This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          518. SubstanceDefinition.sourceMaterial.countryOfOrigin.text
                                          Definition

                                          A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                                          ShortPlain text representation of the concept
                                          Comments

                                          Very often the text is the same as a displayName of one of the codings.

                                          Control0..1
                                          Typestring
                                          Is Modifierfalse
                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                          Summarytrue
                                          Requirements

                                          The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))