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 2.0.0-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: PolymorphicForm - Detailed Descriptions

Active as of 2024-12-12

Definitions for the pqcmc-polymorphic-form resource profile.

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

0. SubstanceDefinition
2. SubstanceDefinition.identifier
Shortoptional user designated identifier
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1
Must Supporttrue
4. SubstanceDefinition.structure
Must Supporttrue
Invariantscmc-structure-representation-required: Either a file or string structure representation is required (representation.type.coding.where( system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and (code in ('C45253' | 'C103240')) ).exists())
6. SubstanceDefinition.structure.molecularFormula
Definition

An expression which states the number and type of atoms present in a molecule of a substance or sequence for biotechnology products. [Source: SME Defined]

ShortMolecular Formula
Must Supporttrue
8. SubstanceDefinition.structure.technique
Definition

The technique used to elucidate the structure or characterisation of the drug substance. [Source: SME Defined] Examples: x-ray, HPLC, NMR, peptide mapping, ligand binding assay.

ShortSubstance Characterisation Technique
Control0..1
TypeCodeableConcept(Text Only Codeable Concept)
Must Supporttrue
10. SubstanceDefinition.structure.representation
ShortImpurity Structure Graphic | Impurity Structure Data File
Must Supporttrue
SlicingThis element introduces a set of slices on SubstanceDefinition.structure.representation. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
  • value @ type
  • 12. SubstanceDefinition.structure.representation.type
    Control1..?
    BindingThe codes SHALL be taken from Representation Types
    (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-representation-types)
    Must Supporttrue
    14. SubstanceDefinition.structure.representation:graphic
    Slice Namegraphic
    ShortA graphical, displayable depiction of the structure (e.g. an SVG, PNG)
    Control0..1
    16. SubstanceDefinition.structure.representation:graphic.type
    ShortGraphic
    Pattern Value{
      "coding" : [{
        "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
        "code" : "C54273"
      }]
    }
    18. SubstanceDefinition.structure.representation:graphic.document
    Definition

    A pictorial representation of the structure of the impurity substance. [Source: SME Defined] Note: Refer to the 'Acceptable File Formats for use in eCTD' Example: This is the representation of the molecule CH3OH, or the sequence SHLVEALALVAGERG.

    ShortImpurity Structure Graphic
    Control1..?
    TypeReference(Literal Reference)(Graphic Reference)bundled
    20. SubstanceDefinition.structure.representation:structureFile
    Slice NamestructureFile
    Shortmachine-readable representation -- attached file
    Control0..*
    22. SubstanceDefinition.structure.representation:structureFile.type
    ShortStructure File
    Pattern Value{
      "coding" : [{
        "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
        "code" : "C103240"
      }]
    }
    24. SubstanceDefinition.structure.representation:structureFile.document
    ShortImpurity Chemical Structure Data (files, e.g. .SDF, .CIF)
    Control1..?
    TypeReference(Literal Reference)(Structure Data Reference)bundled
    Must Supporttrue
    26. SubstanceDefinition.structure.representation:structureString
    Slice NamestructureString
    Shortmachine-readable representation -- plain text
    Control0..*
    28. SubstanceDefinition.structure.representation:structureString.type
    ShortStructure Textual
    Pattern Value{
      "coding" : [{
        "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
        "code" : "C45253"
      }]
    }
    30. SubstanceDefinition.structure.representation:structureString.representation
    Definition

    A machine-readable representation of the structure of the chemical. [Source: SME Defined] Examples: SMILES, INCHI

    ShortImpurity Chemical Structure Data (short, plain text representations, e.g. SMILES)
    Control1..?
    Must Supporttrue
    32. SubstanceDefinition.structure.representation:structureString.format
    ShortDrug Substance Impurity Method Type
    Control1..?
    BindingThe codes SHALL be taken from Chemical Structure Data File Type Terminology
    (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-chemical-structure-datafile-type-terminology)
    Must Supporttrue
    34. SubstanceDefinition.code
    Control0..1
    Must Supporttrue
    36. SubstanceDefinition.code.code
    38. SubstanceDefinition.code.code.coding
    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
    40. SubstanceDefinition.code.code.coding.system
    Pattern Valuehttp://fdasis.nlm.nih.gov
    42. 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 areUnordered and Closed, and can be differentiated using the following discriminators:
    • value @ type
    • 44. SubstanceDefinition.name.type
      BindingThe codes SHALL be taken from Substance Name Type
      (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type)
      46. SubstanceDefinition.name.preferred
      ShortTrue when the name type is Substance Name
      Must Supporttrue
      48. SubstanceDefinition.name:sub
      Slice Namesub
      Control0..1
      Must Supporttrue
      50. SubstanceDefinition.name:sub.name
      Definition

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

      ShortGeneric Name
      Must Supporttrue
      52. SubstanceDefinition.name:sub.type
      Control1..?
      Must Supporttrue
      Pattern Value{
        "coding" : [{
          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
          "code" : "C97054",
          "display" : "Generic Name"
        }]
      }
      54. SubstanceDefinition.name:sub.preferred
      Must Supporttrue
      56. SubstanceDefinition.name:gsrs
      Slice Namegsrs
      Control0..1
      Must Supporttrue
      58. SubstanceDefinition.name:gsrs.name
      Definition

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

      ShortGSRS Preferred Term
      Must Supporttrue
      60. SubstanceDefinition.name:gsrs.type
      Control1..?
      Must Supporttrue
      Pattern Value{
        "coding" : [{
          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
          "code" : "C203355",
          "display" : "GSRS Preferred Term"
        }]
      }
      62. SubstanceDefinition.name:gsrs.preferred
      Must Supporttrue
      64. SubstanceDefinition.name:isbt
      Slice Nameisbt
      Control0..1
      Must Supporttrue
      66. 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
      68. SubstanceDefinition.name:isbt.type
      Control1..?
      Must Supporttrue
      Pattern Value{
        "coding" : [{
          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
          "code" : "C95517",
          "display" : "ISBT-128 DIN"
        }]
      }
      70. SubstanceDefinition.name:isbt.preferred
      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())
      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.structure
      Definition

      Structural information.

      ShortStructural information
      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()))
      cmc-structure-representation-required: Either a file or string structure representation is required (representation.type.coding.where( system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and (code in ('C45253' | 'C103240')) ).exists())
      12. 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())
      14. SubstanceDefinition.structure.molecularFormula
      Definition

      An expression which states the number and type of atoms present in a molecule of a substance or sequence for biotechnology products. [Source: SME Defined]


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

      ShortMolecular FormulaAn 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 Supporttrue
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      16. SubstanceDefinition.structure.technique
      Definition

      The technique used to elucidate the structure or characterisation of the drug substance. [Source: SME Defined] Examples: x-ray, HPLC, NMR, peptide mapping, ligand binding assay.


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

      ShortSubstance Characterisation TechniqueThe method used to find the structure e.g. X-ray, NMR
      Comments

      Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

      Control0..1*
      BindingFor example codes, see StructureTechniquehttp://hl7.org/fhir/ValueSet/substance-structure-technique
      (example to http://hl7.org/fhir/ValueSet/substance-structure-technique)

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

      TypeCodeableConcept(Text Only Codeable Concept)
      Is Modifierfalse
      Must Supporttrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      18. SubstanceDefinition.structure.representation
      Definition

      A depiction of the structure of the substance.

      ShortImpurity Structure Graphic | Impurity Structure Data FileA depiction of the structure of the substance
      Control0..*
      TypeBackboneElement
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      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.structure.representation. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
      • value @ type
      • 20. 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())
        22. SubstanceDefinition.structure.representation.type
        Definition

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

        ShortThe kind of structural representation (e.g. full, partial)
        Control10..1
        BindingThe codes SHALL be taken from For example codes, see Representation Typeshttp://hl7.org/fhir/ValueSet/substance-representation-type
        (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-representation-types)
        TypeCodeableConcept
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        24. SubstanceDefinition.structure.representation:graphic
        Slice Namegraphic
        Definition

        A depiction of the structure of the substance.

        ShortA graphical, displayable depiction of the structure (e.g. an SVG, PNG)A depiction of the structure of the substance
        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()))
        26. SubstanceDefinition.structure.representation:graphic.modifierExtension
        Definition

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

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

        ShortExtensions that cannot be ignored even if unrecognized
        Comments

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

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

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

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

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

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

        A format of a substance representation.

        TypeCodeableConcept
        Is Modifierfalse
        Must Supportfalse
        Summarytrue
        Pattern Value{
          "coding" : [{
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code" : "C54273"
          }]
        }
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        30. SubstanceDefinition.structure.representation:graphic.document
        Definition

        A pictorial representation of the structure of the impurity substance. [Source: SME Defined] Note: Refer to the 'Acceptable File Formats for use in eCTD' Example: This is the representation of the molecule CH3OH, or the sequence SHLVEALALVAGERG.


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

        ShortImpurity Structure GraphicAn attachment with the structural representation e.g. a structure graphic or AnIML file
        Control10..1
        TypeReference(Literal Reference)(Graphic Reference, DocumentReference)bundled
        Is Modifierfalse
        Must Supportfalse
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        32. SubstanceDefinition.structure.representation:structureFile
        Slice NamestructureFile
        Definition

        A depiction of the structure of the substance.

        Shortmachine-readable representation -- attached fileA 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()))
        34. SubstanceDefinition.structure.representation:structureFile.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())
        36. SubstanceDefinition.structure.representation:structureFile.type
        Definition

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

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

        A format of a substance representation.

        TypeCodeableConcept
        Is Modifierfalse
        Must Supportfalse
        Summarytrue
        Pattern Value{
          "coding" : [{
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code" : "C103240"
          }]
        }
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        38. SubstanceDefinition.structure.representation:structureFile.document
        Definition

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

        ShortImpurity Chemical Structure Data (files, e.g. .SDF, .CIF)An attachment with the structural representation e.g. a structure graphic or AnIML file
        Control10..1
        TypeReference(Literal Reference)(Structure Data Reference, DocumentReference)bundled
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        40. SubstanceDefinition.structure.representation:structureString
        Slice NamestructureString
        Definition

        A depiction of the structure of the substance.

        Shortmachine-readable representation -- plain textA 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()))
        42. SubstanceDefinition.structure.representation:structureString.modifierExtension
        Definition

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

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

        ShortExtensions that cannot be ignored even if unrecognized
        Comments

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

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

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

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

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

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

        A format of a substance representation.

        TypeCodeableConcept
        Is Modifierfalse
        Must Supportfalse
        Summarytrue
        Pattern Value{
          "coding" : [{
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code" : "C45253"
          }]
        }
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        46. SubstanceDefinition.structure.representation:structureString.representation
        Definition

        A machine-readable representation of the structure of the chemical. [Source: SME Defined] Examples: SMILES, INCHI


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

        ShortImpurity Chemical Structure Data (short, plain text representations, e.g. SMILES)The structural representation as a text string in a standard format
        Control10..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()))
        48. SubstanceDefinition.structure.representation:structureString.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.

        ShortDrug Substance Impurity Method TypeThe format of the representation e.g. InChI, SMILES, MOLFILE (note: not the physical file format)
        Control10..1
        BindingThe codes SHALL be taken from For example codes, see Chemical Structure Data File Type Terminologyhttp://hl7.org/fhir/ValueSet/substance-representation-format
        (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-chemical-structure-datafile-type-terminology)
        TypeCodeableConcept
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        50. SubstanceDefinition.code
        Definition

        Codes associated with the substance.

        ShortCodes associated with the 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()))
        52. 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())
        54. 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 areUnordered and Closed, and can be differentiated using the following discriminators:
        • value @ type
        • 56. 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())
          58. 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()))
          60. SubstanceDefinition.name.type
          Definition

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

          ShortName type e.g. 'systematic', 'scientific, 'brand'
          Control0..1
          BindingThe codes SHALL be taken from For example codes, see Substance Name Typehttp://hl7.org/fhir/ValueSet/substance-name-type
          (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type)
          TypeCodeableConcept
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          62. 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()))
          64. 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()))
          66. 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())
          68. 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()))
          70. 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
          Pattern Value{
            "coding" : [{
              "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
              "code" : "C97054",
              "display" : "Generic Name"
            }]
          }
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          72. 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()))
          74. 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()))
          76. 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())
          78. 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()))
          80. 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
          Pattern Value{
            "coding" : [{
              "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
              "code" : "C203355",
              "display" : "GSRS Preferred Term"
            }]
          }
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          82. 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()))
          84. 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()))
          86. 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())
          88. 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()))
          90. 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
          Pattern Value{
            "coding" : [{
              "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
              "code" : "C95517",
              "display" : "ISBT-128 DIN"
            }]
          }
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          92. 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()))

          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())
          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 version Id, 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 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).

          ShortA 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
          Control0..*
          TypeCodeableConcept
          Is Modifierfalse
          Must Supportfalse
          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 quality standard, established benchmark, to which substance complies (e.g. USP/NF, Ph. Eur, JP, BP, Company Standard).

          ShortThe quality standard, established benchmark, to which substance complies (e.g. USP/NF, BP)
          Control0..*
          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.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()))
          32. 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()))
          34. 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()))
          36. SubstanceDefinition.manufacturer
          Definition

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

          ShortThe entity that creates, makes, produces or fabricates the substance
          Control0..*
          TypeReference(Organization)
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          38. 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..*
          TypeReference(Organization)
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          40. 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()))
          42. 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
          44. 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())
          46. 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())
          48. 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()))
          50. 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()))
          52. 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()))
          54. 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()))
          56. 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()))
          58. 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()))
          60. SubstanceDefinition.moiety.amount[x]
          Definition

          Quantitative value for this moiety.

          ShortQuantitative value for this moiety
          Control0..1
          TypeChoice of: Quantity, string
          [x] NoteSeeChoice of Data Typesfor 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()))
          62. 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()))
          64. 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()))
          66. 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
          68. 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())
          70. 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())
          72. 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()))
          74. 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()))
          76. 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()))
          78. 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()))
          80. 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()))
          82. 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
          84. 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())
          86. 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())
          88. 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()))
          90. 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] NoteSeeChoice of Data Typesfor 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()))
          92. 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()))
          94. 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()))
          96. 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
          98. 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())
          100. 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())
          102. 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()))
          104. 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()))
          106. 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()))
          108. SubstanceDefinition.structure
          Definition

          Structural information.

          ShortStructural information
          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()))
          cmc-structure-representation-required: Either a file or string structure representation is required (representation.type.coding.where( system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and (code in ('C45253' | 'C103240')) ).exists())
          110. 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
          112. 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())
          114. 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())
          116. 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()))
          118. 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()))
          120. SubstanceDefinition.structure.molecularFormula
          Definition

          An expression which states the number and type of atoms present in a molecule of a substance or sequence for biotechnology products. [Source: SME Defined]

          ShortMolecular Formula
          Control0..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()))
          122. 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()))
          124. SubstanceDefinition.structure.molecularWeight
          Definition

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

          ShortThe molecular weight or weight range
          Control0..1
          TypeSeettp://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()))
          126. SubstanceDefinition.structure.technique
          Definition

          The technique used to elucidate the structure or characterisation of the drug substance. [Source: SME Defined] Examples: x-ray, HPLC, NMR, peptide mapping, ligand binding assay.

          ShortSubstance Characterisation Technique
          Comments

          Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

          Control0..1
          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(Text Only Codeable Concept)
          Is Modifierfalse
          Must Supporttrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          128. 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()))
          130. SubstanceDefinition.structure.representation
          Definition

          A depiction of the structure of the substance.

          ShortImpurity Structure Graphic | Impurity Structure Data File
          Control0..*
          TypeBackboneElement
          Is Modifierfalse
          Must Supporttrue
          Summarytrue
          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.structure.representation. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
          • value @ type
          • 132. 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
            134. 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())
            136. 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())
            138. SubstanceDefinition.structure.representation.type
            Definition

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

            ShortThe kind of structural representation (e.g. full, partial)
            Control1..1
            BindingThe codes SHALL be taken from Representation Types
            (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-representation-types)
            TypeCodeableConcept
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            140. 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()))
            142. 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()))
            144. 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()))
            146. SubstanceDefinition.structure.representation:graphic
            Slice Namegraphic
            Definition

            A depiction of the structure of the substance.

            ShortA graphical, displayable depiction of the structure (e.g. an SVG, PNG)
            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()))
            148. SubstanceDefinition.structure.representation:graphic.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
            150. SubstanceDefinition.structure.representation:graphic.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())
            152. SubstanceDefinition.structure.representation:graphic.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())
            154. SubstanceDefinition.structure.representation:graphic.type
            Definition

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

            ShortGraphic
            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
            Pattern Value{
              "coding" : [{
                "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code" : "C54273"
              }]
            }
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            156. SubstanceDefinition.structure.representation:graphic.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()))
            158. SubstanceDefinition.structure.representation:graphic.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()))
            160. SubstanceDefinition.structure.representation:graphic.document
            Definition

            A pictorial representation of the structure of the impurity substance. [Source: SME Defined] Note: Refer to the 'Acceptable File Formats for use in eCTD' Example: This is the representation of the molecule CH3OH, or the sequence SHLVEALALVAGERG.

            ShortImpurity Structure Graphic
            Control1..1
            TypeReference(Literal Reference)(Graphic Reference)bundled
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            162. SubstanceDefinition.structure.representation:structureFile
            Slice NamestructureFile
            Definition

            A depiction of the structure of the substance.

            Shortmachine-readable representation -- attached file
            Control0..*
            TypeBackboneElement
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            164. SubstanceDefinition.structure.representation:structureFile.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
            166. SubstanceDefinition.structure.representation:structureFile.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())
            168. SubstanceDefinition.structure.representation:structureFile.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())
            170. SubstanceDefinition.structure.representation:structureFile.type
            Definition

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

            ShortStructure File
            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
            Pattern Value{
              "coding" : [{
                "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code" : "C103240"
              }]
            }
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            172. SubstanceDefinition.structure.representation:structureFile.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()))
            174. SubstanceDefinition.structure.representation:structureFile.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()))
            176. SubstanceDefinition.structure.representation:structureFile.document
            Definition

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

            ShortImpurity Chemical Structure Data (files, e.g. .SDF, .CIF)
            Control1..1
            TypeReference(Literal Reference)(Structure Data Reference)bundled
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            178. SubstanceDefinition.structure.representation:structureString
            Slice NamestructureString
            Definition

            A depiction of the structure of the substance.

            Shortmachine-readable representation -- plain text
            Control0..*
            TypeBackboneElement
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            180. SubstanceDefinition.structure.representation:structureString.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
            182. SubstanceDefinition.structure.representation:structureString.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())
            184. SubstanceDefinition.structure.representation:structureString.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())
            186. SubstanceDefinition.structure.representation:structureString.type
            Definition

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

            ShortStructure Textual
            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
            Pattern Value{
              "coding" : [{
                "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code" : "C45253"
              }]
            }
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            188. SubstanceDefinition.structure.representation:structureString.representation
            Definition

            A machine-readable representation of the structure of the chemical. [Source: SME Defined] Examples: SMILES, INCHI

            ShortImpurity Chemical Structure Data (short, plain text representations, e.g. SMILES)
            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()))
            190. SubstanceDefinition.structure.representation:structureString.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.

            ShortDrug Substance Impurity Method Type
            Control1..1
            BindingThe codes SHALL be taken from Chemical Structure Data File Type Terminology
            (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-chemical-structure-datafile-type-terminology)
            TypeCodeableConcept
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            192. SubstanceDefinition.structure.representation:structureString.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()))
            194. SubstanceDefinition.code
            Definition

            Codes associated with the substance.

            ShortCodes associated with the 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()))
            196. 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
            198. 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())
            200. 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())
            202. SubstanceDefinition.code.code
            Definition

            The specific code.

            ShortThe specific code
            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()))
            204. 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
            206. 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 areUnordered and Open, and can be differentiated using the following discriminators:
            • value @ url
            • 208. SubstanceDefinition.code.code.coding
              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..*
              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()))
              210. SubstanceDefinition.code.code.coding.id
              Definition

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

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

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

              ShortAdditional content defined by implementations
              Comments

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

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

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

                ShortIdentity of the terminology system
                Comments

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

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

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

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

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

                ShortVersion of the system - if relevant
                Comments

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

                NoteThis is a business version Id, 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()))
                218. SubstanceDefinition.code.code.coding.code
                Definition

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

                ShortSymbol in syntax defined by the system
                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()))
                220. SubstanceDefinition.code.code.coding.display
                Definition

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

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

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

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

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

                ShortIf this coding was chosen directly by the user
                Comments

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

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

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

                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                224. 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()))
                226. 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()))
                228. 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()))
                230. 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()))
                232. 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()))
                234. 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 areUnordered and Closed, and can be differentiated using the following discriminators:
                • value @ type
                • 236. 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
                  238. 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())
                  240. 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())
                  242. 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()))
                  244. SubstanceDefinition.name.type
                  Definition

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

                  ShortName type e.g. 'systematic', 'scientific, 'brand'
                  Control0..1
                  BindingThe codes SHALL be taken from Substance Name Type
                  (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type)
                  TypeCodeableConcept
                  Is Modifierfalse
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  246. SubstanceDefinition.name.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()))
                  248. 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()))
                  250. 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()))
                  252. 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()))
                  254. 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()))
                  256. 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..*
                  TypeSeettp://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()))
                  258. SubstanceDefinition.name.translation
                  Definition

                  A translation for this name into another human language.

                  ShortA translation for this name into another human language
                  Control0..*
                  TypeSeettp://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()))
                  260. 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()))
                  262. 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
                  264. 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())
                  266. 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())
                  268. 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()))
                  270. 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()))
                  272. 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()))
                  274. 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()))
                  276. 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()))
                  278. 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
                  280. 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())
                  282. 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())
                  284. 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()))
                  286. 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
                  Pattern Value{
                    "coding" : [{
                      "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                      "code" : "C97054",
                      "display" : "Generic Name"
                    }]
                  }
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  288. SubstanceDefinition.name:sub.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()))
                  290. 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()))
                  292. 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()))
                  294. 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()))
                  296. 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()))
                  298. 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..*
                  TypeSeettp://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()))
                  300. SubstanceDefinition.name:sub.translation
                  Definition

                  A translation for this name into another human language.

                  ShortA translation for this name into another human language
                  Control0..*
                  TypeSeettp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name
                  Is Modifierfalse
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  302. SubstanceDefinition.name:sub.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()))
                  304. 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
                  306. 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())
                  308. 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())
                  310. 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()))
                  312. 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()))
                  314. 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()))
                  316. 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()))
                  318. 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()))
                  320. 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
                  322. 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())
                  324. 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())
                  326. 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()))
                  328. 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
                  Pattern Value{
                    "coding" : [{
                      "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                      "code" : "C203355",
                      "display" : "GSRS Preferred Term"
                    }]
                  }
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  330. 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()))
                  332. 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()))
                  334. 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()))
                  336. 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()))
                  338. 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()))
                  340. 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..*
                  TypeSeettp://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()))
                  342. SubstanceDefinition.name:gsrs.translation
                  Definition

                  A translation for this name into another human language.

                  ShortA translation for this name into another human language
                  Control0..*
                  TypeSeettp://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()))
                  344. 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()))
                  346. 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
                  348. 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())
                  350. 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())
                  352. 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()))
                  354. 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()))
                  356. 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()))
                  358. 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()))
                  360. 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()))
                  362. 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
                  364. 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())
                  366. 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())
                  368. 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()))
                  370. 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
                  Pattern Value{
                    "coding" : [{
                      "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                      "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.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()))
                  374. 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()))
                  376. 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()))
                  378. 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()))
                  380. 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()))
                  382. 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..*
                  TypeSeettp://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()))
                  384. SubstanceDefinition.name:isbt.translation
                  Definition

                  A translation for this name into another human language.

                  ShortA translation for this name into another human language
                  Control0..*
                  TypeSeettp://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.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()))
                  388. 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
                  390. 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())
                  392. 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())
                  394. 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()))
                  396. 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()))
                  398. 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()))
                  400. 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()))
                  402. 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()))
                  404. 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
                  406. 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())
                  408. 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())
                  410. 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] NoteSeeChoice of Data Typesfor 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()))
                  412. 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()))
                  414. 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()))
                  416. 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] NoteSeeChoice of Data Typesfor 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()))
                  418. 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()))
                  420. 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()))
                  422. 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()))
                  424. 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()))
                  426. 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()))
                  428. 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()))
                  430. SubstanceDefinition.sourceMaterial
                  Definition

                  Material or taxonomic/anatomical source for the substance.

                  ShortMaterial or taxonomic/anatomical source
                  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()))
                  432. SubstanceDefinition.sourceMaterial.id
                  Definition

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

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

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

                  ShortAdditional content defined by implementations
                  Comments

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

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

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

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

                  ShortExtensions that cannot be ignored even if unrecognized
                  Comments

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

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

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

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

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

                  ShortClassification of the origin of the raw material. e.g. cat hair is an Animal source type
                  Control0..1
                  BindingFor example codes, see SourceMaterialType
                  (example to http://hl7.org/fhir/ValueSet/substance-source-material-type)

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

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

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

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

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

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

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

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

                  A species of origin a substance raw material.

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

                  An anatomical origin of the source material within an organism.

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

                  An anatomical origin of the source material within an organism.

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

                  The country or countries where the material is harvested.

                  ShortThe country or countries where the material is harvested
                  Control0..*
                  BindingThe codes SHALL be taken from CountryValueSet
                  (required to http://hl7.org/fhir/ValueSet/country|5.0.0)

                  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()))