description: Includes the identifying information of the drug product. Profile of Drug Product profile.
package_name: hl7.fhir.us.pq-cmc-fda
derivation: constraint
name: RoutineDrugProduct
type: MedicinalProductDefinition
elements:
  meta:
    elements:
      profile: {mustSupport: true, index: 0}
    required: [profile]
  identifier: {short: Optional user designated identifier, mustSupport: true, index: 1}
  combinedPharmaceuticalDoseForm:
    mustSupport: true
    index: 2
    elements:
      coding:
        elements:
          code:
            short: Product Dosage Form
            binding: {strength: required, valueSet: 'http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-pharmaceutical-dosage-form-terminology'}
            mustSupport: true
            index: 3
        required: [code]
  route:
    mustSupport: true
    index: 4
    elements:
      coding:
        elements:
          code:
            short: Product Route of Administration
            binding: {strength: required, valueSet: 'http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-drug-route-of-administration-terminology'}
            mustSupport: true
            index: 5
        required: [code]
  name:
    mustSupport: true
    array: true
    max: 2
    index: 6
    elements:
      productName: {mustSupport: true, index: 7}
      type: {mustSupport: true, index: 8}
      usage:
        elements:
          jurisdiction: {index: 9}
    required: [type]
    slicing:
      rules: open
      description: Require non-proprietary name. Parts required if present in the non-proprietary name
      discriminator:
      - {path: type, type: value}
      min: null
      max: 2
      slices:
        Proprietary:
          match:
            type:
              coding:
              - {code: PROP, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-product-name-types', display: Proprietary}
          schema:
            index: 10
            elements:
              type:
                pattern:
                  type: CodeableConcept
                  value:
                    coding:
                    - {code: PROP, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-product-name-types', display: Proprietary}
                index: 11
              part:
                mustSupport: true
                index: 12
                elements:
                  part: {mustSupport: true, index: 13}
                  type:
                    binding: {strength: required, valueSet: 'http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology'}
                    mustSupport: true
                    index: 14
              usage:
                elements:
                  jurisdiction: {index: 15}
        NonProprietary:
          match:
            type:
              coding:
              - {code: NON, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-product-name-types', display: Non-Proprietary}
          schema:
            _required: true
            index: 16
            elements:
              type:
                pattern:
                  type: CodeableConcept
                  value:
                    coding:
                    - {code: NON, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-product-name-types', display: Non-Proprietary}
                index: 17
              part:
                mustSupport: true
                array: true
                min: 2
                index: 18
                elements:
                  part: {mustSupport: true, index: 19}
                  type:
                    binding: {strength: required, valueSet: 'http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology'}
                    mustSupport: true
                    index: 20
                slicing:
                  rules: open
                  description: The scientific name part is required and all name parts if present
                  discriminator:
                  - {path: type, type: value}
                  min: 2
                  slices:
                    Scientific:
                      match:
                        type:
                          coding:
                          - {code: SCI, system: 'http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2'}
                      schema:
                        array: true
                        min: 1
                        _required: true
                        index: 21
                        elements:
                          type:
                            pattern:
                              type: CodeableConcept
                              value:
                                coding:
                                - {code: SCI, system: 'http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2'}
                            index: 22
                    Invented:
                      match:
                        type:
                          coding:
                          - {code: INV, system: 'http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2'}
                      schema:
                        array: true
                        index: 23
                        elements:
                          type:
                            pattern:
                              type: CodeableConcept
                              value:
                                coding:
                                - {code: INV, system: 'http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2'}
                            index: 24
                    Formulation:
                      match:
                        type:
                          coding:
                          - {code: FORMUL, system: 'http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2'}
                      schema:
                        array: true
                        index: 25
                        elements:
                          type:
                            pattern:
                              type: CodeableConcept
                              value:
                                coding:
                                - {code: FORMUL, system: 'http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2'}
                            index: 26
                    Strength:
                      match:
                        type:
                          coding:
                          - {code: STR, system: 'http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2'}
                      schema:
                        array: true
                        min: 1
                        _required: true
                        index: 27
                        elements:
                          type:
                            pattern:
                              type: CodeableConcept
                              value:
                                coding:
                                - {code: STR, system: 'http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2'}
                            index: 28
                    Container:
                      match:
                        type:
                          coding:
                          - {code: CON, system: 'http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2'}
                      schema:
                        array: true
                        index: 29
                        elements:
                          type:
                            pattern:
                              type: CodeableConcept
                              value:
                                coding:
                                - {code: CON, system: 'http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2'}
                            index: 30
                    Form:
                      match:
                        type:
                          coding:
                          - {code: FRM, system: 'http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2'}
                      schema:
                        array: true
                        index: 31
                        elements:
                          type:
                            pattern:
                              type: CodeableConcept
                              value:
                                coding:
                                - {code: FRM, system: 'http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2'}
                            index: 32
                    Device:
                      match:
                        type:
                          coding:
                          - {code: DEV, system: 'http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2'}
                      schema:
                        array: true
                        index: 33
                        elements:
                          type:
                            pattern:
                              type: CodeableConcept
                              value:
                                coding:
                                - {code: DEV, system: 'http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2'}
                            index: 34
              usage:
                elements:
                  jurisdiction: {index: 35}
package_version: 1.0.0-ballot
class: profile
kind: resource
url: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-product
base: http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition
version: 1.0.0-ballot
required: [combinedPharmaceuticalDoseForm, route]