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: RoutineSubstanceDefinition - Detailed Descriptions

Active as of 2024-04-04

Definitions for the pqcmc-routine-drug-substance 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'))
2. SubstanceDefinition.identifier
Shortoptional user designated identifier
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1
Must Supporttrue
4. 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.

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
6. SubstanceDefinition.grade
Definition

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

ShortQuality Standard
Control1..1
8. 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)
10. SubstanceDefinition.manufacturer
Control1..1
TypeReference(Manufacturing and/or Test Site Organization)
Must Supporttrue
12. SubstanceDefinition.supplier
Control0..1
TypeReference(Supplier Organization)
Must Supporttrue
14. SubstanceDefinition.code
Definition

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

Control1..?
Must Supporttrue
16. SubstanceDefinition.code.code
Control1..?
Must Supporttrue
18. 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
  • 20. 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
    22. SubstanceDefinition.code.code.coding:unii.system
    Control1..?
    Pattern Valuehttp://fdasis.nlm.nih.gov
    24. 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
    26. SubstanceDefinition.code.code.coding:uniProt.system
    Control1..?
    Pattern Valuehttps://www.uniprot.org
    28. 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
    • 30. SubstanceDefinition.name.preferred
      ShortTrue when the name type is Substance Name
      Must Supporttrue
      32. SubstanceDefinition.name:sub
      Slice Namesub
      Control0..1
      Must Supporttrue
      34. SubstanceDefinition.name:sub.name
      Definition

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

      ShortGeneric Name
      Must Supporttrue
      36. SubstanceDefinition.name:sub.type
      Control1..?
      Must Supporttrue
      38. 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"
      }
      40. SubstanceDefinition.name:sub.preferred
      Must Supporttrue
      42. SubstanceDefinition.name:gsrs
      Slice Namegsrs
      Control0..1
      Must Supporttrue
      44. SubstanceDefinition.name:gsrs.name
      Definition

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

      ShortGSRS Preferred Term
      Must Supporttrue
      46. SubstanceDefinition.name:gsrs.type
      Control1..?
      Must Supporttrue
      48. 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"
      }
      50. SubstanceDefinition.name:gsrs.preferred
      Must Supporttrue
      52. SubstanceDefinition.name:isbt
      Slice Nameisbt
      Control0..1
      Must Supporttrue
      54. 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
      56. SubstanceDefinition.name:isbt.type
      Control1..?
      Must Supporttrue
      58. 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"
      }
      60. SubstanceDefinition.name:isbt.preferred
      Must Supporttrue
      62. SubstanceDefinition.sourceMaterial
      Control0..0
      Must Supporttrue

      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'))
      2. 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()))
      4. 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
      6. 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())
      8. 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 Supporttrue
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      10. 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.


      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()))
      12. 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()))
      14. 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()))
      16. 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
      Control10..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()))
      18. 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()))
      20. 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()))
      22. 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())
      24. 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()))
      26. 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
      • 28. 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()))
        30. 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()))
        32. 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()))
        34. 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()))
        36. 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
        • 38. 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())
          40. 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()))
          42. 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()))
          44. 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()))
          46. 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())
          48. 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()))
          50. 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()))
          52. 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()))
          54. 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()))
          56. 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()))
          58. 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())
          60. 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()))
          62. 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()))
          64. 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()))
          66. 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()))
          68. 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()))
          70. 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())
          72. 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()))
          74. 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()))
          76. 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()))
          78. 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()))
          80. SubstanceDefinition.sourceMaterial
          Definition

          Material or taxonomic/anatomical source for the substance.

          ShortMaterial or taxonomic/anatomical source
          Control0..01
          TypeBackboneElement
          Is Modifierfalse
          Must Supporttrue
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

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

          0. 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'))
          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.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.language
          Definition

          The base language in which the resource is written.

          ShortLanguage of the resource content
          Comments

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

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

          IETF language tag for a human language

          Typecode
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          10. 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()))
          12. 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
          14. 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())
          16. 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())
          18. 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 Supporttrue
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          20. 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()))
          22. 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()))
          24. 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.

          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()))
          26. 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()))
          28. 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()))
          30. 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
          32. 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
          • 34. 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()))
            36. 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()))
            38. 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()))
            40. 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()))
            42. 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()))
            44. 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
            Control1..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()))
            46. 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()))
            48. 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()))
            50. 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
            52. 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())
            54. 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())
            56. 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()))
            58. 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()))
            60. 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()))
            62. 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()))
            64. 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()))
            66. 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()))
            68. 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()))
            70. 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()))
            72. 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()))
            74. 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
            76. 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())
            78. 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())
            80. 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()))
            82. 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()))
            84. 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()))
            86. 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()))
            88. 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()))
            90. 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
            92. 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())
            94. 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())
            96. 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()))
            98. 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()))
            100. 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()))
            102. 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()))
            104. 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
            106. 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())
            108. 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())
            110. 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()))
            112. 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()))
            114. 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()))
            116. 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()))
            118. 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
            120. 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())
            122. 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())
            124. 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()))
            126. 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()))
            128. 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()))
            130. 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()))
            132. 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()))
            134. 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()))
            136. 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()))
            138. 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()))
            140. 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
            142. 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())
            144. 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())
            146. 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()))
            148. 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()))
            150. 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()))
            152. 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()))
            154. 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()))
            156. 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
            158. 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())
            160. 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())
            162. 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()))
            164. 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
            166. 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
            • 168. 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
              • 170. 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()))
                172. 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
                174. 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
                • 176. 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()))
                  178. 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()))
                  180. 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()))
                  182. 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()))
                  184. 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()))
                  186. 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()))
                  188. 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
                  190. 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
                  • 192. 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()))
                    194. 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()))
                    196. 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()))
                    198. 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()))
                    200. 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()))
                    202. 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()))
                    204. 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()))
                    206. 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()))
                    208. 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()))
                    210. 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()))
                    212. 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
                    • 214. 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
                      216. 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())
                      218. 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())
                      220. 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()))
                      222. 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()))
                      224. 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()))
                      226. 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()))
                      228. 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()))
                      230. 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()))
                      232. 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()))
                      234. 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()))
                      236. 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()))
                      238. 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()))
                      240. 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
                      242. 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())
                      244. 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())
                      246. 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()))
                      248. 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()))
                      250. 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()))
                      252. 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()))
                      254. 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()))
                      256. 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
                      258. 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())
                      260. 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())
                      262. 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()))
                      264. 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()))
                      266. 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
                      268. 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
                      • 270. 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()))
                        272. 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()))
                        274. 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()))
                        276. 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()))
                        278. 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()))
                        280. 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()))
                        282. 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()))
                        284. 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()))
                        286. 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()))
                        288. 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()))
                        290. 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
                        292. 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())
                        294. 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())
                        296. 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()))
                        298. 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()))
                        300. 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()))
                        302. 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()))
                        304. 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()))
                        306. 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
                        308. 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())
                        310. 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())
                        312. 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()))
                        314. 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()))
                        316. 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
                        318. 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
                        • 320. 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()))
                          322. 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()))
                          324. 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()))
                          326. 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()))
                          328. 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()))
                          330. 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()))
                          332. 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()))
                          334. 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()))
                          336. 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()))
                          338. 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()))
                          340. 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
                          342. 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())
                          344. 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())
                          346. 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()))
                          348. 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()))
                          350. 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()))
                          352. 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()))
                          354. 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()))
                          356. 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
                          358. 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())
                          360. 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())
                          362. 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()))
                          364. 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()))
                          366. 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
                          368. 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
                          • 370. 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()))
                            372. 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()))
                            374. 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()))
                            376. 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()))
                            378. 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()))
                            380. 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()))
                            382. 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()))
                            384. 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()))
                            386. 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()))
                            388. 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()))
                            390. 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
                            392. 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())
                            394. 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())
                            396. 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()))
                            398. 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()))
                            400. 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()))
                            402. 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()))
                            404. 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()))
                            406. 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
                            408. 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())
                            410. 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())
                            412. 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()))
                            414. 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()))
                            416. 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()))
                            418. 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()))
                            420. 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()))
                            422. 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()))
                            424. 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()))
                            426. 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()))
                            428. 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()))
                            430. 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()))
                            432. SubstanceDefinition.sourceMaterial
                            Definition

                            Material or taxonomic/anatomical source for the substance.

                            ShortMaterial or taxonomic/anatomical source
                            Control0..0
                            TypeBackboneElement
                            Is Modifierfalse
                            Must Supporttrue
                            Summarytrue
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))