description: The fields needed to represent the Product Description, Container Closure and Composition of the Drug Product to be included under the 3.2.P.1 heading of the eCTD. References Sponsor Organization, Drug Product Description, and Product Container Closure System.
package_name: hl7.fhir.us.pq
derivation: constraint
name: EctdComposition32P10
type: Composition
elements:
  identifier: {mustSupport: true, index: 0}
  status:
    pattern: {type: Code, value: final}
    index: 1
  type:
    pattern:
      type: CodeableConcept
      value:
        coding:
        - {code: ich_3.2.p.1, system: 'http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use', display: Description and Composition of the Drug Product}
    index: 2
  author:
    type: Reference
    mustSupport: true
    refers: ['http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization']
    index: 3
  title: {mustSupport: true, index: 4}
  section:
    mustSupport: true
    array: true
    min: 3
    max: 3
    index: 5
    elements:
      title: {mustSupport: true, index: 6}
      code: {mustSupport: true, index: 7}
    required: [title, code]
    slicing:
      rules: closed
      description: Slice based on the ectd document sections.
      discriminator:
      - {path: code.text, type: value}
      min: 3
      max: 3
      slices:
        ProductDescription:
          match:
            code: {text: Product Description}
          schema:
            mustSupport: true
            _required: true
            index: 8
            elements:
              code:
                elements:
                  text:
                    pattern: {type: String, value: Product Description}
                    index: 9
                required: [text]
              entry:
                type: Reference
                mustSupport: true
                refers: ['http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-description']
                index: 10
            required: [entry]
        ProductComposition:
          match:
            code: {text: Product Composition}
          schema:
            mustSupport: true
            _required: true
            index: 11
            elements:
              code:
                elements:
                  text:
                    pattern: {type: String, value: Product Composition}
                    index: 12
                required: [text]
              entry:
                type: Reference
                mustSupport: true
                refers: ['http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part']
                index: 13
            required: [entry]
        ContainerClosure:
          match:
            code: {text: Product Container Closure Description}
          schema:
            mustSupport: true
            _required: true
            index: 14
            elements:
              code:
                elements:
                  text:
                    pattern: {type: String, value: Product Container Closure Description}
                    index: 15
                required: [text]
              entry:
                type: Reference
                mustSupport: true
                refers: ['http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ContainerClosure']
                index: 16
            required: [entry]
package_version: cmc-fda-2.0.0-ballot
class: profile
kind: resource
url: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32p10
base: http://hl7.org/fhir/StructureDefinition/Composition
version: 2.0.0-ballot