## Profile Comparison between http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-with-impurities vs http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-with-impurities

Left: | Drug Product Impurities (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-with-impurities)
Right: | Drug Product Impurities (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-with-impurities)

### Messages

Error | StructureDefinition.version | Values for version differ: '2.0.0-ballot' vs '2.0.0'
Information | StructureDefinition.date | Values for date differ: '2024-12-12T19:00:52+00:00' vs '2025-07-03T13:07:08+00:00'
Information | StructureDefinition.definition | Values for definition differ: 'A reference to a resource (by instance), or instead, a reference to a concept defined in a terminology or ontology (by class).' vs 'Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product. This includes process-related impurities and contaminants, product-related impurities including degradation products.'

### Metadata

Name | Value | Comments
--- | --- | ---
abstract | false |
baseDefinition | http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition |
copyright |  |
date | 2024-12-12T19:00:52+00:00 | 2025-07-03T13:07:08+00:00 | Values Differ
description | List of drug product impurities. Profile of Drug Product profile. |
experimental |  |
fhirVersion | 5.0.0 |
jurisdiction |  |
jurisdiction[0] | urn:iso:std:iso:3166#US |
kind | resource |
name | DrugProductwithImpurities |
publisher | HL7 International / Biomedical Research and Regulation |
purpose |  |
status | active |
title | Drug Product Impurities |
type | MedicinalProductDefinition |
url | http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-with-impurities |
version | 2.0.0-ballot | 2.0.0 | Values Differ

### Structure

Name | L Flags | L Card. | L Type | L Description & Constraints | R Flags | R Card. | R Type | R Description & Constraints | Comments
--- | --- | --- | --- | --- | --- | --- | --- | --- | ---
MedicinalProductDefinition |  | 0..* | MedicinalProductDefinition | Detailed definition of a medicinal product |  | 0..* | MedicinalProductDefinition | Detailed definition of a medicinal product |
id | Σ | 0..1 | id | Logical id of this artifact | Σ | 0..1 | id | Logical id of this artifact |
meta | Σ | 0..1 | Meta | Metadata about the resource | Σ | 0..1 | Meta | Metadata about the resource |
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ?!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
Additional Bindings | Purpose
?? | Starter
|  | 0..1 | code | Language of the resource content Binding: ?? (required): IETF language tag for a human language
Additional Bindings | Purpose
?? | Starter
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 |  | 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 |  | 0..* | Resource | Contained, inline Resources |
extension |  | 0..* | Extension | Additional content defined by implementations |  | 0..* | Extension | Additional content defined by implementations |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
identifier | Σ | 0..1 | Identifier | optional user designated 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. | 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). | 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 | 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. | ?!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 | Σ | 0..1 | dateTime | The date at which the given status became applicable |
description | Σ | 0..1 | markdown | General description of this product | Σ | 0..1 | markdown | General description of this product |
combinedPharmaceuticalDoseForm | S Σ | 1..1 | CodeableConcept | Product Dosage Form Binding: ?? (required) | S Σ | 1..1 | CodeableConcept | Product Dosage Form Binding: ?? (required) |
route | S Σ | 1..* | CodeableConcept | Route of Administration Binding: ?? (required) | 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 | 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 | 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). | 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. | 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. | 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. | 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 | 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 | 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 | 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. | 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 | S | 0..* | LiteralCodeableReference(Drug Substance Impurity) {b} | Product Impurity Binding: ?? (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. | S Σ | 0..* | LiteralCodeableReference(Drug Substance Impurity) {b} | Product Impurity 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 | 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) | 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 | Σ | 0..* | BackboneElement | A product specific contact, person (in a role), or an organization |
id |  | 0..1 | string | Unique id for inter-element referencing |  | 0..1 | string | Unique id for inter-element referencing |
extension |  | 0..* | Extension | Additional content defined by implementations |  | 0..* | Extension | Additional content defined by implementations |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!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. | 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 | 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 | 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. | 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. |
Slices for name | S Σ | 1..2 | BackboneElement | The product's name, including full name and possibly coded parts Slice: Unordered, Closed by value:type | S Σ | 1..2 | BackboneElement | The product's name, including full name and possibly coded parts Slice: Unordered, Closed by value:type |
id |  | 0..1 | string | Unique id for inter-element referencing |  | 0..1 | string | Unique id for inter-element referencing |
extension |  | 0..* | Extension | Additional content defined by implementations |  | 0..* | Extension | Additional content defined by implementations |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
productName | S Σ | 1..1 | string | The full product name | 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) | 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 | Σ | 0..* | BackboneElement | Coding words or phrases of the name |
id |  | 0..1 | string | Unique id for inter-element referencing |  | 0..1 | string | Unique id for inter-element referencing |
extension |  | 0..* | Extension | Additional content defined by implementations |  | 0..* | Extension | Additional content defined by implementations |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
part | Σ | 1..1 | string | A fragment of a product name | 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. | 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 | Σ | 0..* | BackboneElement | Country and jurisdiction where the name applies |
id |  | 0..1 | string | Unique id for inter-element referencing |  | 0..1 | string | Unique id for inter-element referencing |
extension |  | 0..* | Extension | Additional content defined by implementations |  | 0..* | Extension | Additional content defined by implementations |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!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 | Σ | 1..1 | CodeableConcept | Country code for where this name applies Binding: ?? (example): Jurisdiction codes |
jurisdiction | Σ | 0..1 | CodeableConcept | Jurisdiction code for where this name applies Binding: ?? (example): Jurisdiction codes | Σ | 0..1 | CodeableConcept | Jurisdiction 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
Additional Bindings | Purpose
?? | Starter
| Σ | 1..1 | CodeableConcept | Language code for this name Binding: ?? (required): IETF language tag for a human language
Additional Bindings | Purpose
?? | Starter
crossReference | Σ | 0..* | BackboneElement | Reference to another product, e.g. for linking authorised to investigational product | Σ | 0..* | BackboneElement | Reference to another product, e.g. for linking authorised to investigational product |
id |  | 0..1 | string | Unique id for inter-element referencing |  | 0..1 | string | Unique id for inter-element referencing |
extension |  | 0..* | Extension | Additional content defined by implementations |  | 0..* | Extension | Additional content defined by implementations |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
product | Σ | 1..1 | CodeableReference(MedicinalProductDefinition) | Reference to another product, e.g. for linking authorised to investigational product | Σ | 1..1 | CodeableReference(MedicinalProductDefinition) | Reference to another product, e.g. for linking authorised to investigational 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. | 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 | Σ | 0..* | BackboneElement | A manufacturing or administrative process for the medicinal product |
id |  | 0..1 | string | Unique id for inter-element referencing |  | 0..1 | string | Unique id for inter-element referencing |
extension |  | 0..* | Extension | Additional content defined by implementations |  | 0..* | Extension | Additional content defined by implementations |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!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 | 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 | 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 | 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. | 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" | Σ | 0..* | BackboneElement | Key product features such as "sugar free", "modified release" |
id |  | 0..1 | string | Unique id for inter-element referencing |  | 0..1 | string | Unique id for inter-element referencing |
extension |  | 0..* | Extension | Additional content defined by implementations |  | 0..* | Extension | Additional content defined by implementations |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!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. | 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 | CodeableConcept, markdown, Quantity, integer, date, boolean, Attachment | A value for the characteristic | Σ | 0..1 | CodeableConcept, markdown, Quantity, integer, date, boolean, Attachment | A value for the characteristic |
Documentation for this format