description: Provides sufficient information to identify a drug substance. Profile on Drug Substance profile.
package_name: hl7.fhir.us.pq-cmc-fda
derivation: constraint
name: RoutineSubstanceDefinition
type: SubstanceDefinition
elements:
  identifier: {short: optional user designated identifier, mustSupport: true, index: 0}
  classification:
    short: Substance Type
    binding: {strength: required, valueSet: 'http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/substance-classification'}
    mustSupport: true
    index: 1
  grade:
    short: Quality Standard
    index: 2
    elements:
      coding:
        binding: {strength: required, valueSet: 'http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology'}
        index: 3
  manufacturer:
    type: Reference
    mustSupport: true
    refers: ['http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/mfg-test-site-organization']
    index: 4
  supplier:
    type: Reference
    mustSupport: true
    refers: ['http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/supplier-organization']
    index: 5
  code:
    mustSupport: true
    index: 6
    elements:
      code:
        mustSupport: true
        index: 7
        elements:
          coding:
            index: 8
            slicing:
              rules: open
              discriminator:
              - {path: system, type: value}
              min: null
              slices:
                unii:
                  match: {system: 'http://fdasis.nlm.nih.gov'}
                  schema:
                    short: UNII
                    index: 9
                    elements:
                      system:
                        pattern: {type: Uri, value: 'http://fdasis.nlm.nih.gov'}
                        index: 10
                    required: [system]
                uniProt:
                  match: {system: 'https://www.uniprot.org'}
                  schema:
                    short: UniProt ID
                    index: 11
                    elements:
                      system:
                        pattern: {type: Uri, value: 'https://www.uniprot.org'}
                        index: 12
                    required: [system]
    required: [code]
  name:
    short: Substance Name
    constraint:
      cmc-name-preferred: {human: 'Name.preferred: at most one = true', source: 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance', severity: error, expression: select(preferred = true).count() < 2}
    mustSupport: true
    index: 13
    elements:
      preferred: {short: True when the name type is Substance Name, mustSupport: true, index: 14}
    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: 15
            elements:
              name: {short: Generic Name, mustSupport: true, index: 16}
              type:
                mustSupport: true
                index: 17
                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: 18
                required: [coding]
              preferred: {mustSupport: true, index: 19}
            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: 20
            elements:
              name: {short: GSRS Preferred Term, mustSupport: true, index: 21}
              type:
                mustSupport: true
                index: 22
                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: 23
                required: [coding]
              preferred: {mustSupport: true, index: 24}
            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: 25
            elements:
              name: {short: ISBT-128 DIN, mustSupport: true, index: 26}
              type:
                mustSupport: true
                index: 27
                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: 28
                required: [coding]
              preferred: {mustSupport: true, index: 29}
            required: [type]
  sourceMaterial: {mustSupport: true, index: 30}
package_version: 1.0.0-ballot
class: profile
kind: resource
url: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance
base: http://hl7.org/fhir/StructureDefinition/SubstanceDefinition
version: 1.0.0-ballot
required: [grade, manufacturer, name, code, classification]