description: Substance General Information containting Drug Substance (Active Ingredient) nomenclature (2.3.S.1.1) and Substance Structure (2.3.S.1.2) profile.
package_name: hl7.fhir.us.pq-cmc-fda
derivation: constraint
name: DrugSubstanceNomenclatureStructure
type: SubstanceDefinition
elements:
  supplier:
    type: Reference
    mustSupport: true
    refers: ['http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/supplier-organization']
    index: 4
  meta:
    elements:
      profile: {mustSupport: true, index: 0}
    required: [profile]
  name:
    short: Subtance Name
    constraint:
      cmc-name-preferred: {human: 'Name.preferred: at most one = true', source: 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-substance-nomenclature-structure', severity: error, expression: select(preferred = true).count() < 2}
    mustSupport: true
    index: 25
    elements:
      preferred: {short: True when the name type is Substance Name, mustSupport: true, index: 26}
    slicing:
      rules: closed
      description: Slice based on value pattern
      discriminator:
      - {path: type.coding, type: value}
      min: 1
      slices:
        sub:
          match:
            type:
              coding: {code: C97054, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy', display: Generic Name}
          schema:
            mustSupport: true
            index: 32
            elements:
              name: {short: Generic, mustSupport: true, index: 33}
              type:
                mustSupport: true
                index: 34
                elements:
                  coding:
                    mustSupport: true
                    pattern:
                      type: Coding
                      value: {code: C97054, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy', display: Generic Name}
                    index: 35
                required: [coding]
              preferred: {mustSupport: true, index: 36}
            required: [type]
        isbt:
          match:
            type:
              coding: {code: C95517, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy', display: ISBT-128 DIN}
          schema:
            mustSupport: true
            index: 77
            elements:
              name: {short: ISBT-128 DIN, mustSupport: true, index: 78}
              type:
                mustSupport: true
                index: 79
                elements:
                  coding:
                    mustSupport: true
                    pattern:
                      type: Coding
                      value: {code: C95517, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy', display: ISBT-128 DIN}
                    index: 80
                required: [coding]
              preferred: {mustSupport: true, index: 81}
            required: [type]
        cas:
          match:
            type:
              coding: {code: C54682, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy', display: CAS Number}
          schema:
            mustSupport: true
            index: 57
            elements:
              name: {short: CAS Number, mustSupport: true, index: 58}
              type:
                mustSupport: true
                index: 59
                elements:
                  coding:
                    mustSupport: true
                    pattern:
                      type: Coding
                      value: {code: C54682, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy', display: CAS Number}
                    index: 60
                required: [coding]
              preferred: {mustSupport: true, index: 61}
            required: [type]
        brand:
          match:
            type:
              coding: {code: C71898, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy', display: Brand}
          schema:
            mustSupport: true
            index: 37
            elements:
              name: {short: Brand, mustSupport: true, index: 38}
              type:
                mustSupport: true
                index: 39
                elements:
                  coding:
                    mustSupport: true
                    pattern:
                      type: Coding
                      value: {code: C71898, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy', display: Brand}
                    index: 40
                required: [coding]
              preferred: {mustSupport: true, index: 41}
            required: [type]
        usan:
          match:
            type:
              coding: {code: C96973, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy', display: USAN}
          schema:
            mustSupport: true
            index: 67
            elements:
              name: {short: USAN, mustSupport: true, index: 68}
              type:
                mustSupport: true
                index: 69
                elements:
                  coding:
                    mustSupport: true
                    pattern:
                      type: Coding
                      value: {code: C96973, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy', display: USAN}
                    index: 70
                required: [coding]
              preferred: {mustSupport: true, index: 71}
            required: [type]
        inn:
          match:
            type:
              coding: {code: C142585, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy', display: INN}
          schema:
            mustSupport: true
            index: 62
            elements:
              name: {short: INN, mustSupport: true, index: 63}
              type:
                mustSupport: true
                index: 64
                elements:
                  coding:
                    mustSupport: true
                    pattern:
                      type: Coding
                      value: {code: C142585, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy', display: INN}
                    index: 65
                required: [coding]
              preferred: {mustSupport: true, index: 66}
            required: [type]
        gsrs:
          match:
            type:
              coding: {code: C203355, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy', display: GSRS Preferred Term}
          schema:
            mustSupport: true
            index: 42
            elements:
              name: {short: GSRS Preferred Term, mustSupport: true, index: 43}
              type:
                mustSupport: true
                index: 44
                elements:
                  coding:
                    mustSupport: true
                    pattern:
                      type: Coding
                      value: {code: C203355, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy', display: GSRS Preferred Term}
                    index: 45
                required: [coding]
              preferred: {mustSupport: true, index: 46}
            required: [type]
        iupac:
          match:
            type:
              coding: {code: C203356, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy', display: IUPAC Name}
          schema:
            mustSupport: true
            index: 72
            elements:
              name: {short: IUPAC Name, mustSupport: true, index: 73}
              type:
                mustSupport: true
                index: 74
                elements:
                  coding:
                    mustSupport: true
                    pattern:
                      type: Coding
                      value: {code: C203356, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy', display: IUPAC Name}
                    index: 75
                required: [coding]
              preferred: {mustSupport: true, index: 76}
            required: [type]
        sys:
          match:
            type:
              coding: {code: C203357, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy', display: Systematic Name}
          schema:
            mustSupport: true
            index: 27
            elements:
              name: {short: Systematic, mustSupport: true, index: 28}
              type:
                mustSupport: true
                index: 29
                elements:
                  coding:
                    mustSupport: true
                    pattern:
                      type: Coding
                      value: {code: C203357, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy', display: Systematic Name}
                    index: 30
                required: [coding]
              preferred: {mustSupport: true, index: 31}
            required: [type]
        usp:
          match:
            type:
              coding: {code: C203358, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy', display: USP-NF Established Name}
          schema:
            mustSupport: true
            index: 47
            elements:
              name: {short: USP-NF Established Name, mustSupport: true, index: 48}
              type:
                mustSupport: true
                index: 49
                elements:
                  coding:
                    mustSupport: true
                    pattern:
                      type: Coding
                      value: {code: C203358, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy', display: USP-NF Established Name}
                    index: 50
                required: [coding]
              preferred: {mustSupport: true, index: 51}
            required: [type]
        comp:
          match:
            type:
              coding: {code: C203354, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy', display: Company ID/Code}
          schema:
            mustSupport: true
            index: 52
            elements:
              name: {short: Company ID/Code, mustSupport: true, index: 53}
              type:
                mustSupport: true
                index: 54
                elements:
                  coding:
                    pattern:
                      type: Coding
                      value: {code: C203354, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy', display: Company ID/Code}
                    index: 55
                required: [coding]
              preferred: {mustSupport: true, index: 56}
            required: [type]
  relationship:
    mustSupport: true
    index: 82
    elements:
      substanceDefinition:
        choices: []
        index: 84
        slicing:
          rules: open
          ordered: false
          discriminator:
          - {path: $this, type: type}
          min: null
          slices:
            substanceDefinitionReference:
              match: {}
              schema:
                short: The substance definition of a polyphorm of the Drug Substance
                choices: [substanceDefinitionReference]
                index: 86
              min: 0
              max: 1
      substanceDefinitionReference:
        short: The substance definition of a polyphorm of the Drug Substance
        refers: ['http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-polymorphic-form']
        type: Reference
        choiceOf: substanceDefinition
        index: 87
        slicing:
          slices:
            substanceDefinitionReference:
              match: {}
              schema:
                short: The substance definition of a polyphorm of the Drug Substance
                refers: ['http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-polymorphic-form']
                type: Reference
                choiceOf: substanceDefinition
                index: 87
              min: 0
              max: 1
      type:
        elements:
          text:
            short: Polymorph
            pattern: {type: String, value: Polymorph}
            index: 88
  classification:
    short: Substance Type
    binding: {strength: required, valueSet: 'http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/substance-classification'}
    mustSupport: true
    index: 2
  structure:
    mustSupport: true
    index: 9
    elements:
      molecularFormula: {short: Molecular Formula | Biopolymer Sequence, mustSupport: true, index: 10}
      technique:
        short: Substance Characterization Technique
        mustSupport: true
        index: 11
        elements:
          text: {mustSupport: true, index: 12}
        required: [text]
      representation:
        mustSupport: true
        index: 13
        elements:
          representation: {short: Drug Substance Structural Representation, mustSupport: true, index: 14}
          format:
            short: Structural Representation Type
            mustSupport: true
            index: 15
            elements:
              coding:
                binding: {strength: required, valueSet: 'http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-chemical-structure-datafile-type-terminology'}
                index: 16
          document:
            type: Reference
            short: Substance Structure Graphic
            mustSupport: true
            refers: ['http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-document-reference']
            index: 17
    required: [representation, technique]
  code:
    mustSupport: true
    index: 18
    elements:
      code:
        mustSupport: true
        index: 19
        elements:
          coding:
            index: 20
            slicing:
              rules: open
              discriminator:
              - {path: system, type: value}
              min: null
              slices:
                unii:
                  match: {system: 'http://fdasis.nlm.nih.gov'}
                  schema:
                    short: UNII
                    index: 21
                    elements:
                      system:
                        pattern: {type: Uri, value: 'http://fdasis.nlm.nih.gov'}
                        index: 22
                    required: [system]
                uniProt:
                  match: {system: 'https://www.uniprot.org'}
                  schema:
                    short: UniProt ID
                    index: 23
                    elements:
                      system:
                        pattern: {type: Uri, value: 'https://www.uniprot.org'}
                        index: 24
                    required: [system]
    required: [code]
  identifier: {short: optional user designated identifier, mustSupport: true, index: 1}
  molecularWeight:
    short: Molecular Weight
    mustSupport: true
    index: 5
    elements:
      amount:
        mustSupport: true
        index: 6
        elements:
          unit: {short: Molecular Weight UOM, index: 7}
          code:
            binding: {strength: required, valueSet: 'http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology'}
            mustSupport: true
            index: 8
        required: [code]
  manufacturer:
    type: Reference
    mustSupport: true
    refers: ['http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/mfg-test-site-organization']
    index: 3
package_version: 1.0.0-ballot
class: profile
kind: resource
url: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-substance-nomenclature-structure
base: http://hl7.org/fhir/StructureDefinition/SubstanceDefinition
version: 1.0.0-ballot
required: [structure, manufacturer, name, code, classification]