This is the set of resources that conform to both Drug Product Component (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component) and Drug Product Component (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component).
Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() |
---|---|---|---|---|
![]() ![]() | C | 0..* | An ingredient of a manufactured item or pharmaceutical product Constraints: ing-1 | |
![]() ![]() ![]() | Σ | 0..1 | Meta | Metadata about the resource |
![]() ![]() ![]() | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
![]() ![]() ![]() | 0..1 | code | Language of the resource content Binding: ?? (required): IETF language tag for a human language | |
![]() ![]() ![]() | 0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements | |
![]() ![]() ![]() | 0..* | Resource | Contained, inline Resources | |
![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations | |
![]() ![]() ![]() | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
![]() ![]() ![]() | Σ | 0..1 | Identifier | An identifier or code by which the ingredient can be referenced |
![]() ![]() ![]() | ?!Σ | 1..1 | code | draft | active | retired | unknown Binding: ?? (required): The lifecycle status of an artifact. |
![]() ![]() ![]() | Σ | 0..* | Reference(MedicinalProductDefinition | AdministrableProductDefinition | ManufacturedItemDefinition) | Reference to MedicinalProductDefinition |
![]() ![]() ![]() | Σ | 1..1 | CodeableConcept | Purpose of the ingredient within the product, e.g. active, inactive Binding: ?? (required) |
![]() ![]() ![]() | Σ | 0..* | CodeableConcept | Precise action within the drug product, e.g. antioxidant, alkalizing agent Binding: ?? (example): A classification of the ingredient identifying its precise purpose(s) in the drug product (beyond e.g. active/inactive). |
![]() ![]() ![]() | Σ | 0..1 | CodeableConcept | A classification of the ingredient according to where in the physical item it tends to be used, such the outer shell of a tablet, inner body or ink |
![]() ![]() ![]() | Σ | 0..1 | boolean | If the ingredient is a known or suspected allergen |
![]() ![]() ![]() | S | 0..1 | markdown | Drug Product Component Additional Information |
![]() ![]() ![]() | Σ | 0..* | BackboneElement | An organization that manufactures this ingredient |
![]() ![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations | |
![]() ![]() ![]() ![]() | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
![]() ![]() ![]() ![]() | Σ | 0..1 | code | allowed | possible | actual Binding: ?? (required): The way in which this manufacturer is associated with the ingredient. |
![]() ![]() ![]() ![]() | Σ | 1..1 | Reference(Organization) | An organization that manufactures this ingredient |
![]() ![]() ![]() | ΣC | 1..1 | BackboneElement | The substance that comprises this ingredient Constraints: cmc-strength-type-cases2 |
![]() ![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations | |
![]() ![]() ![]() ![]() | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
![]() ![]() ![]() ![]() | S | 1..1 | LiteralCodeableReference(Component Substance | #sd-pqcmc-component-substance-pqcmc-component-substance) {b} | Ingredient Substance Binding: ?? (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. |
![]() ![]() ![]() ![]() | SΣ | 2..2 | BackboneElement | The quantity of substance, per presentation, or per volume or mass, and type of quantity |
![]() ![]() ![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations | |
![]() ![]() ![]() ![]() ![]() | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
![]() ![]() ![]() ![]() ![]() | Σ | 0..1 | The quantity of substance in the unit of presentation | |
![]() ![]() ![]() ![]() ![]() ![]() | Ratio | |||
![]() ![]() ![]() ![]() ![]() ![]() | RatioRange | |||
![]() ![]() ![]() ![]() ![]() ![]() | CodeableConcept | |||
![]() ![]() ![]() ![]() ![]() ![]() | Quantity | |||
![]() ![]() ![]() ![]() ![]() | Σ | 0..1 | string | Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio) |
![]() ![]() ![]() ![]() ![]() | Σ | 0..1 | The strength per unitary volume (or mass) | |
![]() ![]() ![]() ![]() ![]() ![]() | Ratio | |||
![]() ![]() ![]() ![]() ![]() ![]() | RatioRange | |||
![]() ![]() ![]() ![]() ![]() ![]() | CodeableConcept | |||
![]() ![]() ![]() ![]() ![]() ![]() | Quantity | |||
![]() ![]() ![]() ![]() ![]() | Σ | 0..1 | string | Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio) |
![]() ![]() ![]() ![]() ![]() | Σ | 0..1 | CodeableConcept | A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt) |
![]() ![]() ![]() ![]() ![]() | Σ | 0..1 | string | When strength is measured at a particular point or distance |
![]() ![]() ![]() ![]() ![]() | Σ | 0..* | CodeableConcept | Where the strength range applies Binding: ?? (example): Jurisdiction codes |
![]() ![]() ![]() ![]() ![]() | Σ | 0..* | BackboneElement | Strength expressed in terms of a reference substance |
![]() ![]() ![]() ![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations | |
![]() ![]() ![]() ![]() ![]() ![]() | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
![]() ![]() ![]() ![]() ![]() ![]() | Σ | 1..1 | CodeableReference(SubstanceDefinition) | Relevant reference substance Binding: ?? (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. |
![]() ![]() ![]() ![]() ![]() ![]() | Σ | 1..1 | Strength expressed in terms of a reference substance | |
![]() ![]() ![]() ![]() ![]() ![]() ![]() | Ratio | |||
![]() ![]() ![]() ![]() ![]() ![]() ![]() | RatioRange | |||
![]() ![]() ![]() ![]() ![]() ![]() ![]() | Quantity | |||
![]() ![]() ![]() ![]() ![]() ![]() | Σ | 0..1 | string | When strength is measured at a particular point or distance |
![]() ![]() ![]() ![]() ![]() ![]() | Σ | 0..* | CodeableConcept | Where the strength range applies Binding: ?? (example): Jurisdiction codes |
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