## Union of http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-description and http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-description

This is the set of resources that conform to either of the profiles Drug Product Description (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-description) and Drug Product Description (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-description). E.g. what you have to deal with if you get resources conforming to one of them

### Structure

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
MedicinalProductDefinition |  | 0..* |  | Detailed definition of a medicinal product
meta | Σ | 0..1 | Meta | Metadata about the resource
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
language |  | 0..1 | code | Language of the resource content Binding: ?? (required): IETF language tag for a human language
text |  | 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
contained |  | 0..* | Resource | Contained, inline Resources
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored
identifier | Σ | 0..1 | Identifier | optional user designated identifier
type | Σ | 0..1 | CodeableConcept | Regulatory type, e.g. Investigational or Authorized Binding: ?? (example): Overall defining type of this medicinal product.
domain | Σ | 0..1 | CodeableConcept | If this medicine applies to human or veterinary uses Binding: ?? (example): Applicable domain for this product (e.g. human, veterinary).
version | Σ | 0..1 | string | A business identifier relating to a specific version of the product
status | ?!Σ | 0..1 | CodeableConcept | The status within the lifecycle of this product record Binding: ?? (preferred): The lifecycle status of an artifact.
statusDate | Σ | 0..1 | dateTime | The date at which the given status became applicable
description | S Σ | 1..1 | markdown | Drug Product Description
combinedPharmaceuticalDoseForm | S Σ | 1..1 | CodeableConcept | Product Dosage Form Binding: ?? (required)
route | S Σ | 1..* | CodeableConcept | Route of Administration Binding: ?? (required)
indication | Σ | 0..1 | markdown | Description of indication(s) for this product, used when structured indications are not required
legalStatusOfSupply | Σ | 0..1 | CodeableConcept | The legal status of supply of the medicinal product as classified by the regulator Binding: ?? (example): The prescription supply types appropriate to a medicinal product
additionalMonitoringIndicator | Σ | 0..1 | CodeableConcept | Whether the Medicinal Product is subject to additional monitoring for regulatory reasons Binding: ?? (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring).
specialMeasures | Σ | 0..* | CodeableConcept | Whether the Medicinal Product is subject to special measures for regulatory reasons Binding: ?? (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies.
pediatricUseIndicator | Σ | 0..1 | CodeableConcept | If authorised for use in children Binding: ?? (example): Suitability for age groups, in particular children.
classification | Σ | 0..* | CodeableConcept | Allows the product to be classified by various systems Binding: ?? (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.
marketingStatus | Σ | 0..* | MarketingStatus | Marketing status of the medicinal product, in contrast to marketing authorization
packagedMedicinalProduct | Σ | 0..* | CodeableConcept | Package type for the product Binding: ?? (example): Types of medicinal product packs
comprisedOf | Σ | 0..* | Reference(ManufacturedItemDefinition | DeviceDefinition) | Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes
ingredient | Σ | 0..* | CodeableConcept | The ingredients of this medicinal product - when not detailed in other resources Binding: ?? (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
impurity | Σ | 0..* | CodeableReference(SubstanceDefinition) | Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product Binding: ?? (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
attachedDocument | Σ | 0..* | Reference(DocumentReference) | Additional documentation about the medicinal product
masterFile | Σ | 0..* | Reference(DocumentReference) | A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
contact | Σ | 0..* | BackboneElement | A product specific contact, person (in a role), or an organization
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | Σ | 0..1 | CodeableConcept | Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information Binding: ?? (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.
contact | Σ | 1..1 | Reference(Organization | PractitionerRole) | A product specific contact, person (in a role), or an organization
clinicalTrial | Σ | 0..* | Reference(ResearchStudy) | Clinical trials or studies that this product is involved in
code | Σ | 0..* | Coding | A code that this product is known by, within some formal terminology Binding: ?? (example): A coded concept that defines the type of a medication.
name | S Σ | 1..2 | BackboneElement | The product's name, including full name and possibly coded parts
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
productName | S Σ | 1..1 | string | The full product name
type | S Σ | 1..1 | CodeableConcept | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: ?? (required)
part | Σ | 0..* | BackboneElement | Coding words or phrases of the name
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
part | Σ | 1..1 | string | A fragment of a product name
type | Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: ?? (example): Type of part of a name for a Medicinal Product.
usage | Σ | 0..* | BackboneElement | Country and jurisdiction where the name applies
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
country | Σ | 1..1 | CodeableConcept | Country code for where this name applies Binding: ?? (example): Jurisdiction codes
language | Σ | 1..1 | CodeableConcept | Language code for this name Binding: ?? (required): IETF language tag for a human language
crossReference | S Σ | 0..* | BackboneElement | Reference to another product, e.g. for linking authorised to investigational product
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
product | S | 1..1 | LiteralCodeableReference(Drug Product Handle | #sd-pqcmc-drug-product-handle-pqcmc-drug-product-handle) {b} | Co-Packaged Product
type | Σ | 0..1 | CodeableConcept | The type of relationship, for instance branded to generic or virtual to actual product Binding: ?? (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.
operation | Σ | 0..* | BackboneElement | A manufacturing or administrative process for the medicinal product
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | Σ | 0..1 | CodeableReference(ActivityDefinition | PlanDefinition) | The type of manufacturing operation e.g. manufacturing itself, re-packaging
effectiveDate | Σ | 0..1 | Period | Date range of applicability
organization | Σ | 0..* | Reference(Organization) | The organization responsible for the particular process, e.g. the manufacturer or importer
confidentialityIndicator | Σ | 0..1 | CodeableConcept | Specifies whether this process is considered proprietary or confidential Binding: ?? (example): Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product.
characteristic | Σ | 0..* | BackboneElement | Key product features such as "sugar free", "modified release"
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ?? (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
value[x] | Σ | 0..1 |  | A value for the characteristic
valueCodeableConcept |  |  | CodeableConcept |
valueMarkdown |  |  | markdown |
valueQuantity |  |  | Quantity |
valueInteger |  |  | integer |
valueDate |  |  | date |
valueBoolean |  |  | boolean |
valueAttachment |  |  | Attachment |
Documentation for this format