Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0 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: DrugSubstanceNomenclatureStructure - Detailed Descriptions

Active as of 2024-10-30

Definitions for the pqcmc-drug-substance-nomenclature-structure resource profile.

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

0. SubstanceDefinition
Invariantscmc-when-unii-required: A UNII is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer'. A UniProt code is required for any of these categories: 'Protein' ((classification.coding.where(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and (code in ('C48807' | 'C45305' | 'C706' | 'C48803'))).exists() implies code.where( code.coding.exists(system = 'http://fdasis.nlm.nih.gov') ).exists()) and (classification.coding.where( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C17021' ).exists() implies code.where( code.coding.exists(system = 'https://www.uniprot.org') ).exists()))
cmc-name-isbt: Name.type ISBT 128 required for blood products. (classification.where(coding.where(code = '8' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy').exists()).exists() implies name.type.coding.exists(code = '226' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy'))
cmc-structure-required: A structure is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer','Protein'. (classification.coding.where(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code in ('C48807' | 'C45305' | 'C706' | 'C48803' |'C17021') ).exists() implies structure.exists())
cmc-substance-structure-graphic-required: A Substance Structure Graphic is required Required for Small Molecules. Equivalent to classification code equals 'Chemical'. ((classification.where(coding.where(code = '1' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy').exists()).exists()) implies structure.representation.exists())
2. SubstanceDefinition.identifier
Shortoptional user designated identifier
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1
Must Supporttrue
4. SubstanceDefinition.classification
Definition

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

ShortSubstance Type
Control1..1
BindingThe codes SHALL be taken from Substance Classification
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/substance-classification)
Must Supporttrue
6. SubstanceDefinition.manufacturer
Control1..1
TypeReference(Literal Reference)(Basic Organization)bundled
Must Supporttrue
8. SubstanceDefinition.supplier
Control0..1
TypeReference(Literal Reference)(Basic Organization)bundled
Must Supporttrue
10. 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. [Source: Merriam Webster]

ShortMolecular Weight
Control0..1
Must Supporttrue
12. SubstanceDefinition.molecularWeight.amount
BindingUnless not suitable, these codes SHALL be taken from Units Of Measure
(extensible to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure)
Must Supporttrue
14. SubstanceDefinition.molecularWeight.amount.unit
Definition

The labeled unit of measure for the molecular weight. [Source: Adapted for NCI EVS C117055]

ShortMolecular Weight UOM
16. SubstanceDefinition.molecularWeight.amount.code
Control1..?
Must Supporttrue
18. SubstanceDefinition.structure
Control1..?
Must Supporttrue
Invariantscmc-structure-representation-required: Either a file or string structure representation is required (representation.type.coding.where( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and (code in ('C45253' | 'C103240')) ).exists())
20. SubstanceDefinition.structure.molecularFormula
Definition

Molecular Formula: 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] Biopolymer Sequence: TBD

ShortMolecular Formula | Biopolymer Sequence
Must Supporttrue
22. 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
Control1..1
TypeCodeableConcept(Text Only Codeable Concept)
Must Supporttrue
24. SubstanceDefinition.structure.representation
ShortImpurity Structure Graphic | Impurity Structure Data File
Control1..?
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
  • 26. 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
    28. SubstanceDefinition.structure.representation:graphic
    Slice Namegraphic
    ShortA graphical, displayable depiction of the structure (e.g. an SVG, PNG)
    Control0..1
    30. SubstanceDefinition.structure.representation:graphic.type
    ShortGraphic
    Pattern Value{
      "coding" : [{
        "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "code" : "C54273"
      }]
    }
    32. 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
    34. SubstanceDefinition.structure.representation:structureFile
    Slice NamestructureFile
    Shortmachine-readable representation -- attached file
    Control0..*
    36. SubstanceDefinition.structure.representation:structureFile.type
    ShortStructure File
    Pattern Value{
      "coding" : [{
        "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "code" : "C103240"
      }]
    }
    38. SubstanceDefinition.structure.representation:structureFile.document
    ShortImpurity Chemical Structure Data (files, e.g. .SDF, .CIF)
    Control1..?
    TypeReference(Literal Reference)(Structure Data Reference)bundled
    Must Supporttrue
    40. SubstanceDefinition.structure.representation:structureString
    Slice NamestructureString
    Shortmachine-readable representation -- plain text
    Control0..*
    42. SubstanceDefinition.structure.representation:structureString.type
    ShortStructure Textual
    Pattern Value{
      "coding" : [{
        "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "code" : "C45253"
      }]
    }
    44. 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
    46. 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
    48. SubstanceDefinition.code
    Control1..?
    Must Supporttrue
    SlicingThis element introduces a set of slices on SubstanceDefinition.code. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ code.coding.system
    • 50. SubstanceDefinition.code:unii
      Slice Nameunii
      Definition

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

      ShortUNII
      Control0..1
      52. SubstanceDefinition.code:unii.code
      Control1..?
      Must Supporttrue
      54. SubstanceDefinition.code:unii.code.coding
      Control1..1
      Must Supporttrue
      56. SubstanceDefinition.code:unii.code.coding.system
      Control1..?
      Must Supporttrue
      Pattern Valuehttp://fdasis.nlm.nih.gov
      58. SubstanceDefinition.code:uniProt
      Slice NameuniProt
      Definition

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

      ShortUniProt ID
      Control0..1
      60. SubstanceDefinition.code:uniProt.code
      Control1..?
      Must Supporttrue
      62. SubstanceDefinition.code:uniProt.code.coding
      Control1..1
      Must Supporttrue
      64. SubstanceDefinition.code:uniProt.code.coding.system
      Control1..?
      Must Supporttrue
      Pattern Valuehttps://www.uniprot.org
      66. SubstanceDefinition.name
      Definition

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

      ShortSubtance 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
      • 68. 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)
        70. SubstanceDefinition.name.preferred
        ShortTrue when the name type is Substance Name
        Must Supporttrue
        72. SubstanceDefinition.name:sys
        Slice Namesys
        Control0..1
        Must Supporttrue
        74. SubstanceDefinition.name:sys.name
        Definition

        A name derived directly from the chemical structure. [Source: SME Defined]

        ShortSystematic
        Must Supporttrue
        76. SubstanceDefinition.name:sys.type
        Control1..?
        Must Supporttrue
        Pattern Value{
          "coding" : [{
            "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
            "code" : "C203357",
            "display" : "Systematic Name"
          }]
        }
        78. SubstanceDefinition.name:sys.preferred
        Must Supporttrue
        80. SubstanceDefinition.name:sub
        Slice Namesub
        Control0..1
        Must Supporttrue
        82. SubstanceDefinition.name:sub.name
        Definition

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

        ShortGeneric
        Must Supporttrue
        84. SubstanceDefinition.name:sub.type
        Control1..?
        Must Supporttrue
        Pattern Value{
          "coding" : [{
            "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
            "code" : "C97054",
            "display" : "Generic Name"
          }]
        }
        86. SubstanceDefinition.name:sub.preferred
        Must Supporttrue
        88. SubstanceDefinition.name:brand
        Slice Namebrand
        Control0..1
        Must Supporttrue
        90. SubstanceDefinition.name:brand.name
        Definition

        The part of the name or logo associated with a specific product or service identifying and distinguishing it from varieties of the same product or service marketed by competing companies.

        ShortBrand
        Must Supporttrue
        92. SubstanceDefinition.name:brand.type
        Control1..?
        Must Supporttrue
        Pattern Value{
          "coding" : [{
            "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
            "code" : "C71898",
            "display" : "Brand"
          }]
        }
        94. SubstanceDefinition.name:brand.preferred
        Must Supporttrue
        96. SubstanceDefinition.name:gsrs
        Slice Namegsrs
        Control0..1
        Must Supporttrue
        98. SubstanceDefinition.name:gsrs.name
        Definition

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

        ShortGSRS Preferred Term
        Must Supporttrue
        100. SubstanceDefinition.name:gsrs.type
        Control1..?
        Must Supporttrue
        Pattern Value{
          "coding" : [{
            "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
            "code" : "C203355",
            "display" : "GSRS Preferred Term"
          }]
        }
        102. SubstanceDefinition.name:gsrs.preferred
        Must Supporttrue
        104. SubstanceDefinition.name:usp
        Slice Nameusp
        Control0..1
        Must Supporttrue
        106. SubstanceDefinition.name:usp.name
        Definition

        A unique nonproprietary name assigned to drugs and biologics and assigned by the United States Pharmacopeia (USP) and excipients by the National Formulary (NF). [Source: SME Defined]

        ShortUSP-NF Established Name
        Must Supporttrue
        108. SubstanceDefinition.name:usp.type
        Control1..?
        Must Supporttrue
        Pattern Value{
          "coding" : [{
            "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
            "code" : "C203358",
            "display" : "USP-NF Established Name"
          }]
        }
        110. SubstanceDefinition.name:usp.preferred
        Must Supporttrue
        112. SubstanceDefinition.name:cas
        Slice Namecas
        Control0..1
        Must Supporttrue
        114. SubstanceDefinition.name:cas.name
        Definition

        Chemical Abstract Service (CAS) Registry Numbers (often referred to as CAS RNs or CAS Numbers) are used to provide identifiers for chemical substances. A CAS Registry Number itself has no inherent chemical significance but provides a way to identify a chemical substance or molecular structure when there are many possible systematic, generic, proprietary or trivial names. [Source: Adapted from CAS.org] Example: CAS [103-90-2]

        ShortCAS Number
        Must Supporttrue
        116. SubstanceDefinition.name:cas.type
        Control1..?
        Must Supporttrue
        Pattern Value{
          "coding" : [{
            "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
            "code" : "C54682",
            "display" : "CAS Number"
          }]
        }
        118. SubstanceDefinition.name:cas.preferred
        Must Supporttrue
        120. SubstanceDefinition.name:inn
        Slice Nameinn
        Control0..1
        Must Supporttrue
        122. SubstanceDefinition.name:inn.name
        Definition

        International Nonproprietary Names (INN) is a unique name that is globally recognized and is public property. A nonproprietary name is also known as a generic name. Note: International Nonproprietary Names (INN) facilitate the identification of pharmaceutical substances or active pharmaceutical ingredients [Source: http://www.who.int/medicines/services/inn/en/] Example: Paracetamol

        ShortINN
        Must Supporttrue
        124. SubstanceDefinition.name:inn.type
        Control1..?
        Must Supporttrue
        Pattern Value{
          "coding" : [{
            "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
            "code" : "C142585",
            "display" : "INN"
          }]
        }
        126. SubstanceDefinition.name:inn.preferred
        Must Supporttrue
        128. SubstanceDefinition.name:usan
        Slice Nameusan
        Control0..1
        Must Supporttrue
        130. SubstanceDefinition.name:usan.name
        Definition

        A unique nonproprietary name assigned to drugs and biologics and assigned by the United States Adopted Names Council [Source: SME Defined] Example: acetaminophen

        ShortUSAN
        Must Supporttrue
        132. SubstanceDefinition.name:usan.type
        Control1..?
        Must Supporttrue
        Pattern Value{
          "coding" : [{
            "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
            "code" : "C96973",
            "display" : "USAN"
          }]
        }
        134. SubstanceDefinition.name:usan.preferred
        Must Supporttrue
        136. SubstanceDefinition.name:iupac
        Slice Nameiupac
        Control0..1
        Must Supporttrue
        138. SubstanceDefinition.name:iupac.name
        Definition

        A name assigned to a chemical substance according to the systematic nomenclature rules defined by the International Union of Pure and Applied Chemistry (IUPAC) [Source: SME Defined] Example: N- (4-hydroxyphenyl)acetamide

        ShortIUPAC Name
        Must Supporttrue
        140. SubstanceDefinition.name:iupac.type
        Control1..?
        Must Supporttrue
        Pattern Value{
          "coding" : [{
            "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
            "code" : "C203356",
            "display" : "IUPAC Name"
          }]
        }
        142. SubstanceDefinition.name:iupac.preferred
        Must Supporttrue
        144. SubstanceDefinition.name:isbt
        Slice Nameisbt
        Control0..1
        Must Supporttrue
        146. 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
        148. SubstanceDefinition.name:isbt.type
        Control1..?
        Must Supporttrue
        Pattern Value{
          "coding" : [{
            "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
            "code" : "C95517",
            "display" : "ISBT-128 DIN"
          }]
        }
        150. SubstanceDefinition.name:isbt.preferred
        Must Supporttrue
        152. SubstanceDefinition.name:comp
        Slice Namecomp
        Control0..1
        Must Supporttrue
        154. SubstanceDefinition.name:comp.name
        Definition

        An internal identifier assigned by the sponsor to this drug substance. [Source: SME Defined]

        ShortCompany ID/Code
        Must Supporttrue
        156. SubstanceDefinition.name:comp.type
        Control1..?
        Must Supporttrue
        Pattern Value{
          "coding" : [{
            "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
            "code" : "C203354",
            "display" : "Company ID/Code"
          }]
        }
        158. SubstanceDefinition.name:comp.preferred
        Must Supporttrue
        160. SubstanceDefinition.relationship
        Must Supporttrue
        162. SubstanceDefinition.relationship.substanceDefinition[x]
        ShortThe substance definition of a polyphorm of the Drug Substance
        TypeReference(Literal Reference)(Polymorphic Form)bundled, CodeableConcept
        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
        164. SubstanceDefinition.relationship.type
        ShortPolymorph
        TypeCodeableConcept(Text Only Codeable Concept)
        166. SubstanceDefinition.relationship.type.text
        Pattern ValuePolymorph

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

        0. SubstanceDefinition
        Definition

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

        ShortThe detailed description of a substance, typically at a level beyond what is used for prescribing
        Control0..*
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
        dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
        dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
        dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
        dom-6: A resource should have narrative for robust management (text.`div`.exists())
        cmc-when-unii-required: A UNII is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer'. A UniProt code is required for any of these categories: 'Protein' ((classification.coding.where(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and (code in ('C48807' | 'C45305' | 'C706' | 'C48803'))).exists() implies code.where( code.coding.exists(system = 'http://fdasis.nlm.nih.gov') ).exists()) and (classification.coding.where( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C17021' ).exists() implies code.where( code.coding.exists(system = 'https://www.uniprot.org') ).exists()))
        cmc-name-isbt: Name.type ISBT 128 required for blood products. (classification.where(coding.where(code = '8' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy').exists()).exists() implies name.type.coding.exists(code = '226' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy'))
        cmc-structure-required: A structure is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer','Protein'. (classification.coding.where(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code in ('C48807' | 'C45305' | 'C706' | 'C48803' |'C17021') ).exists() implies structure.exists())
        cmc-substance-structure-graphic-required: A Substance Structure Graphic is required Required for Small Molecules. Equivalent to classification code equals 'Chemical'. ((classification.where(coding.where(code = '1' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy').exists()).exists()) implies structure.representation.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.classification
        Definition

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


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

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

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

        ShortThe entity that creates, makes, produces or fabricates the substance
        Control10..1*
        TypeReference(Literal Reference)(Basic Organization, Organization)bundled
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        14. SubstanceDefinition.supplier
        Definition

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

        ShortAn entity that is the source for the substance. It may be different from the manufacturer
        Control0..1*
        TypeReference(Literal Reference)(Basic Organization, Organization)bundled
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        16. 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. [Source: Merriam Webster]


        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.

        ShortMolecular WeightThe average mass of a molecule of a compound
        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()))
        18. 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())
        20. 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
        BindingUnless not suitable, these codes SHALL be taken from For codes, see Units Of Measure
        (extensible to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure)
        TypeQuantity
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        22. SubstanceDefinition.molecularWeight.amount.comparator
        Definition

        How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.

        Short< | <= | >= | > | ad - how to understand the value
        Control0..1
        BindingThe codes SHALL be taken from QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
        (required to http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0)

        How the Quantity should be understood and represented.

        Typecode
        Is Modifiertrue because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Summarytrue
        Requirements

        Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.

        Meaning if MissingIf there is no comparator, then there is no modification of the value
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        24. SubstanceDefinition.molecularWeight.amount.unit
        Definition

        The labeled unit of measure for the molecular weight. [Source: Adapted for NCI EVS C117055]


        A human-readable form of the unit.

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

        There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.

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

        A computer processable form of the unit in some unit representation system.

        ShortCoded form of the unit
        Comments

        The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.

        Control10..1
        This element is affected by the following invariants: qty-3
        Typecode
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Summarytrue
        Requirements

        Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.

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

        Structural information.

        ShortStructural information
        Control10..1
        TypeBackboneElement
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        cmc-structure-representation-required: Either a file or string structure representation is required (representation.type.coding.where( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and (code in ('C45253' | 'C103240')) ).exists())
        30. 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())
        32. SubstanceDefinition.structure.molecularFormula
        Definition

        Molecular Formula: 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] Biopolymer Sequence: TBD


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

        ShortMolecular Formula | Biopolymer SequenceAn 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()))
        34. 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.

        Control10..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()))
        36. 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
        Control10..*
        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
        • 38. 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())
          40. 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()))
          42. 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()))
          44. 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())
          46. 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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
              "code" : "C54273"
            }]
          }
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          48. 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()))
          50. 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()))
          52. 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())
          54. 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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
              "code" : "C103240"
            }]
          }
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          56. 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()))
          58. 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()))
          60. 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())
          62. 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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
              "code" : "C45253"
            }]
          }
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          64. 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()))
          66. 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()))
          68. SubstanceDefinition.code
          Definition

          Codes associated with the substance.

          ShortCodes associated with the substance
          Control10..*
          TypeBackboneElement
          Is Modifierfalse
          Must Supporttrue
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          SlicingThis element introduces a set of slices on SubstanceDefinition.code. The slices areUnordered and Open, and can be differentiated using the following discriminators:
          • value @ code.coding.system
          • 70. 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())
            72. SubstanceDefinition.code:unii
            Slice Nameunii
            Definition

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


            Codes associated with the substance.

            ShortUNIICodes associated with 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()))
            74. SubstanceDefinition.code:unii.modifierExtension
            Definition

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

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

            ShortExtensions that cannot be ignored even if unrecognized
            Comments

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

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

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

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

            The specific code.

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

            A reference to a code defined by a terminology system.

            ShortCode defined by a terminology system
            Comments

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

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

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

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

            Control10..1
            Typeuri
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supporttrue
            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()))
            82. SubstanceDefinition.code:uniProt
            Slice NameuniProt
            Definition

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


            Codes associated with the substance.

            ShortUniProt IDCodes associated with 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()))
            84. SubstanceDefinition.code:uniProt.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())
            86. SubstanceDefinition.code:uniProt.code
            Definition

            The specific code.

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

            A reference to a code defined by a terminology system.

            ShortCode defined by a terminology system
            Comments

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

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

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

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

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

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

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

            Substance Name is identified by its Substance Type. Substance 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.

            ShortSubtance 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
            • 94. 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())
              96. 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()))
              98. 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()))
              100. 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()))
              102. SubstanceDefinition.name:sys
              Slice Namesys
              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()))
              104. SubstanceDefinition.name:sys.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())
              106. SubstanceDefinition.name:sys.name
              Definition

              A name derived directly from the chemical structure. [Source: SME Defined]


              The actual name.

              ShortSystematicThe 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()))
              108. SubstanceDefinition.name:sys.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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
                  "code" : "C203357",
                  "display" : "Systematic Name"
                }]
              }
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              110. SubstanceDefinition.name:sys.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()))
              112. 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()))
              114. 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())
              116. SubstanceDefinition.name:sub.name
              Definition

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


              The actual name.

              ShortGenericThe 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()))
              118. 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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
                  "code" : "C97054",
                  "display" : "Generic Name"
                }]
              }
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              120. 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()))
              122. SubstanceDefinition.name:brand
              Slice Namebrand
              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()))
              124. SubstanceDefinition.name:brand.modifierExtension
              Definition

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

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

              ShortExtensions that cannot be ignored even if unrecognized
              Comments

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

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

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

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

              The part of the name or logo associated with a specific product or service identifying and distinguishing it from varieties of the same product or service marketed by competing companies.


              The actual name.

              ShortBrandThe 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()))
              128. SubstanceDefinition.name:brand.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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
                  "code" : "C71898",
                  "display" : "Brand"
                }]
              }
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              130. SubstanceDefinition.name:brand.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()))
              132. 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()))
              134. 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())
              136. 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()))
              138. 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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
                  "code" : "C203355",
                  "display" : "GSRS Preferred Term"
                }]
              }
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              140. 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()))
              142. SubstanceDefinition.name:usp
              Slice Nameusp
              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()))
              144. SubstanceDefinition.name:usp.modifierExtension
              Definition

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

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

              ShortExtensions that cannot be ignored even if unrecognized
              Comments

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

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

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

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

              A unique nonproprietary name assigned to drugs and biologics and assigned by the United States Pharmacopeia (USP) and excipients by the National Formulary (NF). [Source: SME Defined]


              The actual name.

              ShortUSP-NF Established 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()))
              148. SubstanceDefinition.name:usp.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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
                  "code" : "C203358",
                  "display" : "USP-NF Established Name"
                }]
              }
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              150. SubstanceDefinition.name:usp.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()))
              152. SubstanceDefinition.name:cas
              Slice Namecas
              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()))
              154. SubstanceDefinition.name:cas.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())
              156. SubstanceDefinition.name:cas.name
              Definition

              Chemical Abstract Service (CAS) Registry Numbers (often referred to as CAS RNs or CAS Numbers) are used to provide identifiers for chemical substances. A CAS Registry Number itself has no inherent chemical significance but provides a way to identify a chemical substance or molecular structure when there are many possible systematic, generic, proprietary or trivial names. [Source: Adapted from CAS.org] Example: CAS [103-90-2]


              The actual name.

              ShortCAS NumberThe 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()))
              158. SubstanceDefinition.name:cas.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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
                  "code" : "C54682",
                  "display" : "CAS Number"
                }]
              }
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              160. SubstanceDefinition.name:cas.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()))
              162. SubstanceDefinition.name:inn
              Slice Nameinn
              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()))
              164. SubstanceDefinition.name:inn.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())
              166. SubstanceDefinition.name:inn.name
              Definition

              International Nonproprietary Names (INN) is a unique name that is globally recognized and is public property. A nonproprietary name is also known as a generic name. Note: International Nonproprietary Names (INN) facilitate the identification of pharmaceutical substances or active pharmaceutical ingredients [Source: http://www.who.int/medicines/services/inn/en/] Example: Paracetamol


              The actual name.

              ShortINNThe 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()))
              168. SubstanceDefinition.name:inn.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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
                  "code" : "C142585",
                  "display" : "INN"
                }]
              }
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              170. SubstanceDefinition.name:inn.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()))
              172. SubstanceDefinition.name:usan
              Slice Nameusan
              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()))
              174. SubstanceDefinition.name:usan.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())
              176. SubstanceDefinition.name:usan.name
              Definition

              A unique nonproprietary name assigned to drugs and biologics and assigned by the United States Adopted Names Council [Source: SME Defined] Example: acetaminophen


              The actual name.

              ShortUSANThe 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()))
              178. SubstanceDefinition.name:usan.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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
                  "code" : "C96973",
                  "display" : "USAN"
                }]
              }
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              180. SubstanceDefinition.name:usan.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()))
              182. SubstanceDefinition.name:iupac
              Slice Nameiupac
              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()))
              184. SubstanceDefinition.name:iupac.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.name:iupac.name
              Definition

              A name assigned to a chemical substance according to the systematic nomenclature rules defined by the International Union of Pure and Applied Chemistry (IUPAC) [Source: SME Defined] Example: N- (4-hydroxyphenyl)acetamide


              The actual name.

              ShortIUPAC 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()))
              188. SubstanceDefinition.name:iupac.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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
                  "code" : "C203356",
                  "display" : "IUPAC Name"
                }]
              }
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              190. SubstanceDefinition.name:iupac.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()))
              192. 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()))
              194. 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())
              196. 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()))
              198. 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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
                  "code" : "C95517",
                  "display" : "ISBT-128 DIN"
                }]
              }
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              200. 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()))
              202. SubstanceDefinition.name:comp
              Slice Namecomp
              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()))
              204. SubstanceDefinition.name:comp.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())
              206. SubstanceDefinition.name:comp.name
              Definition

              An internal identifier assigned by the sponsor to this drug substance. [Source: SME Defined]


              The actual name.

              ShortCompany ID/CodeThe 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()))
              208. SubstanceDefinition.name:comp.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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
                  "code" : "C203354",
                  "display" : "Company ID/Code"
                }]
              }
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              210. SubstanceDefinition.name:comp.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()))
              212. 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 Supporttrue
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              214. 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())
              216. SubstanceDefinition.relationship.substanceDefinition[x]
              Definition

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

              ShortThe substance definition of a polyphorm of the Drug SubstanceA pointer to another substance, as a resource or a representational code
              Control0..1
              TypeReference(Literal Reference)(Polymorphic Form, SubstanceDefinition)bundled, 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()))
              218. SubstanceDefinition.relationship.type
              Definition

              A concept that may be defined by a formal reference to a terminology or ontology or may be provided by text.


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

              ShortPolymorphFor example "salt to parent", "active moiety"
              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.

              Control1..1
              BindingFor example codes, see SubstanceRelationshipTypehttp://hl7.org/fhir/ValueSet/substance-relationship-type
              (example to http://hl7.org/fhir/ValueSet/substance-relationship-type)

              The relationship between two substance types.

              TypeCodeableConcept(Text Only Codeable Concept)
              Is Modifierfalse
              Must Supportfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              220. SubstanceDefinition.relationship.type.text
              Definition

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

              ShortPlain text representation of the concept
              Comments

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

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

              Pattern ValuePolymorph
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

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

              0. SubstanceDefinition
              Definition

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

              ShortThe detailed description of a substance, typically at a level beyond what is used for prescribing
              Control0..*
              Is Modifierfalse
              Must Supportfalse
              Summaryfalse
              Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
              dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
              dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
              dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
              dom-6: A resource should have narrative for robust management (text.`div`.exists())
              cmc-when-unii-required: A UNII is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer'. A UniProt code is required for any of these categories: 'Protein' ((classification.coding.where(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and (code in ('C48807' | 'C45305' | 'C706' | 'C48803'))).exists() implies code.where( code.coding.exists(system = 'http://fdasis.nlm.nih.gov') ).exists()) and (classification.coding.where( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C17021' ).exists() implies code.where( code.coding.exists(system = 'https://www.uniprot.org') ).exists()))
              cmc-name-isbt: Name.type ISBT 128 required for blood products. (classification.where(coding.where(code = '8' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy').exists()).exists() implies name.type.coding.exists(code = '226' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy'))
              cmc-structure-required: A structure is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer','Protein'. (classification.coding.where(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code in ('C48807' | 'C45305' | 'C706' | 'C48803' |'C17021') ).exists() implies structure.exists())
              cmc-substance-structure-graphic-required: A Substance Structure Graphic is required Required for Small Molecules. Equivalent to classification code equals 'Chemical'. ((classification.where(coding.where(code = '1' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy').exists()).exists()) implies structure.representation.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 controlled vocabulary as provided by the prEN ISO 11238 - Health informatics identification of medicinal products - Structures and controlled vocabularies for drug substances to group drug substances at a relatively high level acording to the Substance and the Substance Preparation Model. [Source: Adapted from 'Logical model of the classification and identification of pharmaceutical and medicinal Products', HL7]

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

              If the substance applies to human or veterinary use.

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

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

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

              The 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
              Control1..1
              TypeReference(Literal Reference)(Basic Organization)bundled
              Is Modifierfalse
              Must Supporttrue
              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..1
              TypeReference(Literal Reference)(Basic Organization)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.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. [Source: Merriam Webster]

              ShortMolecular Weight
              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()))
              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
              BindingUnless not suitable, these codes SHALL be taken from Units Of Measure
              (extensible to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure)
              TypeQuantity
              Is Modifierfalse
              Must Supporttrue
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              108. SubstanceDefinition.molecularWeight.amount.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
              110. SubstanceDefinition.molecularWeight.amount.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.molecularWeight.amount.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
              • value @ url
              • 112. SubstanceDefinition.molecularWeight.amount.value
                Definition

                The value of the measured amount. The value includes an implicit precision in the presentation of the value.

                ShortNumerical value (with implicit precision)
                Comments

                The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).

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

                Precision is handled implicitly in almost all cases of measurement.

                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                114. SubstanceDefinition.molecularWeight.amount.comparator
                Definition

                How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.

                Short< | <= | >= | > | ad - how to understand the value
                Control0..1
                BindingThe codes SHALL be taken from QuantityComparator
                (required to http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0)

                How the Quantity should be understood and represented.

                Typecode
                Is Modifiertrue because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Summarytrue
                Requirements

                Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.

                Meaning if MissingIf there is no comparator, then there is no modification of the value
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                116. SubstanceDefinition.molecularWeight.amount.unit
                Definition

                The labeled unit of measure for the molecular weight. [Source: Adapted for NCI EVS C117055]

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

                There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.

                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                118. SubstanceDefinition.molecularWeight.amount.system
                Definition

                The identification of the system that provides the coded form of the unit.

                ShortSystem that defines coded unit form
                Control0..1
                This element is affected by the following invariants: qty-3
                Typeuri
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Summarytrue
                Requirements

                Need to know the system that defines the coded form of the unit.

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

                A computer processable form of the unit in some unit representation system.

                ShortCoded form of the unit
                Comments

                The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.

                Control1..1
                This element is affected by the following invariants: qty-3
                Typecode
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Must Supporttrue
                Summarytrue
                Requirements

                Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.

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

                Structural information.

                ShortStructural information
                Control1..1
                TypeBackboneElement
                Is Modifierfalse
                Must Supporttrue
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                cmc-structure-representation-required: Either a file or string structure representation is required (representation.type.coding.where( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and (code in ('C45253' | 'C103240')) ).exists())
                124. 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
                126. 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())
                128. 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())
                130. 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()))
                132. 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()))
                134. SubstanceDefinition.structure.molecularFormula
                Definition

                Molecular Formula: 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] Biopolymer Sequence: TBD

                ShortMolecular Formula | Biopolymer Sequence
                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()))
                136. 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()))
                138. 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()))
                140. 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.

                Control1..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()))
                142. 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()))
                144. SubstanceDefinition.structure.representation
                Definition

                A depiction of the structure of the substance.

                ShortImpurity Structure Graphic | Impurity Structure Data File
                Control1..*
                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
                • 146. 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
                  148. 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())
                  150. 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())
                  152. 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()))
                  154. 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()))
                  156. 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()))
                  158. 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()))
                  160. 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()))
                  162. 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
                  164. 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())
                  166. 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())
                  168. 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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
                      "code" : "C54273"
                    }]
                  }
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  170. 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()))
                  172. 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()))
                  174. 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()))
                  176. 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()))
                  178. 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
                  180. 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())
                  182. 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())
                  184. 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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
                      "code" : "C103240"
                    }]
                  }
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  186. 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()))
                  188. 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()))
                  190. 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()))
                  192. 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()))
                  194. 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
                  196. 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())
                  198. 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())
                  200. 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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
                      "code" : "C45253"
                    }]
                  }
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  202. 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()))
                  204. 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()))
                  206. 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()))
                  208. SubstanceDefinition.code
                  Definition

                  Codes associated with the substance.

                  ShortCodes associated with the substance
                  Control1..*
                  TypeBackboneElement
                  Is Modifierfalse
                  Must Supporttrue
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  SlicingThis element introduces a set of slices on SubstanceDefinition.code. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                  • value @ code.coding.system
                  • 210. 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
                    212. 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())
                    214. 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())
                    216. 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()))
                    218. 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()))
                    220. 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()))
                    222. 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()))
                    224. 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()))
                    226. SubstanceDefinition.code:unii
                    Slice Nameunii
                    Definition

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

                    ShortUNII
                    Control0..1
                    TypeBackboneElement
                    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:unii.id
                    Definition

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

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

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

                    ShortAdditional content defined by implementations
                    Comments

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

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

                    The specific code.

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

                      A reference to a code defined by a terminology system.

                      ShortCode defined by a terminology system
                      Comments

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

                      Control1..1
                      TypeCoding
                      Is Modifierfalse
                      Must Supporttrue
                      Summarytrue
                      Requirements

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

                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      242. SubstanceDefinition.code:unii.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
                      244. SubstanceDefinition.code:unii.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
                      • 246. SubstanceDefinition.code:unii.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.

                        Control1..1
                        Typeuri
                        Is Modifierfalse
                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                        Must Supporttrue
                        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()))
                        248. SubstanceDefinition.code:unii.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()))
                        250. SubstanceDefinition.code:unii.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()))
                        252. SubstanceDefinition.code:unii.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()))
                        254. SubstanceDefinition.code:unii.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()))
                        256. SubstanceDefinition.code:unii.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()))
                        258. SubstanceDefinition.code:unii.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()))
                        260. SubstanceDefinition.code:unii.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()))
                        262. SubstanceDefinition.code:unii.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()))
                        264. SubstanceDefinition.code:unii.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()))
                        266. SubstanceDefinition.code:uniProt
                        Slice NameuniProt
                        Definition

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

                        ShortUniProt ID
                        Control0..1
                        TypeBackboneElement
                        Is Modifierfalse
                        Must Supportfalse
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        268. SubstanceDefinition.code:uniProt.id
                        Definition

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

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

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

                        ShortAdditional content defined by implementations
                        Comments

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

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

                        The specific code.

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

                          A reference to a code defined by a terminology system.

                          ShortCode defined by a terminology system
                          Comments

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

                          Control1..1
                          TypeCoding
                          Is Modifierfalse
                          Must Supporttrue
                          Summarytrue
                          Requirements

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

                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          282. SubstanceDefinition.code:uniProt.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
                          284. SubstanceDefinition.code:uniProt.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
                          • 286. SubstanceDefinition.code:uniProt.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.

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

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

                            Pattern Valuehttps://www.uniprot.org
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            288. SubstanceDefinition.code:uniProt.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()))
                            290. SubstanceDefinition.code:uniProt.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()))
                            292. SubstanceDefinition.code:uniProt.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()))
                            294. SubstanceDefinition.code:uniProt.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()))
                            296. SubstanceDefinition.code:uniProt.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()))
                            298. SubstanceDefinition.code:uniProt.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()))
                            300. SubstanceDefinition.code:uniProt.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()))
                            302. SubstanceDefinition.code:uniProt.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()))
                            304. SubstanceDefinition.code:uniProt.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()))
                            306. SubstanceDefinition.name
                            Definition

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

                            ShortSubtance 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
                            • 308. 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
                              310. 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())
                              312. 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())
                              314. 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()))
                              316. 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()))
                              318. 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()))
                              320. 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()))
                              322. 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()))
                              324. 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()))
                              326. 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()))
                              328. 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()))
                              330. 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()))
                              332. SubstanceDefinition.name.official
                              Definition

                              Details of the official nature of this name.

                              ShortDetails of the official nature of this name
                              Control0..*
                              TypeBackboneElement