## Profile Comparison between http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient vs http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient

Left: | Drug Product Batch Formula Ingredient (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient)
Right: | Drug Product Batch Formula Ingredient (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient)

### 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 'A code or full resource that represents the ingredient's substance.'

### Metadata

Name | Value | Comments
--- | --- | ---
abstract | false |
baseDefinition | http://hl7.org/fhir/StructureDefinition/Ingredient |
copyright |  |
date | 2024-12-12T19:00:52+00:00 | 2025-07-03T13:07:08+00:00 | Values Differ
description | The amount details about the drug product ingredients in the batch. Use for Batch Formula. |
experimental |  |
fhirVersion | 5.0.0 |
jurisdiction |  |
jurisdiction[0] | urn:iso:std:iso:3166#US |
kind | resource |
name | DrugProductIngredient |
publisher | HL7 International / Biomedical Research and Regulation |
purpose |  |
status | active |
title | Drug Product Batch Formula Ingredient |
type | Ingredient |
url | http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient |
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
--- | --- | --- | --- | --- | --- | --- | --- | --- | ---
Ingredient | C | 0..* | Ingredient | An ingredient of a manufactured item or pharmaceutical product | C | 0..* | Ingredient | An ingredient of a manufactured item or pharmaceutical 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 | S Σ | 0..1 | Identifier | An identifier or code by which the ingredient can be referenced | S Σ | 0..1 | Identifier | An identifier or code by which the ingredient can be referenced |
status | ?!Σ | 1..1 | code | draft | active | retired | unknown Binding: ?? (required): The lifecycle status of an artifact. | ?!Σ | 1..1 | code | draft | active | retired | unknown Binding: ?? (required): The lifecycle status of an artifact. |
for | Σ | 0..* | Reference(MedicinalProductDefinition | AdministrableProductDefinition | ManufacturedItemDefinition) | The product which this ingredient is a constituent part of | Σ | 0..* | Reference(MedicinalProductDefinition | AdministrableProductDefinition | ManufacturedItemDefinition) | The product which this ingredient is a constituent part of |
role | Σ | 1..1 | CodeableConcept | Purpose of the ingredient within the product, e.g. active, inactive Binding: ?? (example): A classification of the ingredient identifying its purpose within the product, e.g. active, inactive. | Σ | 1..1 | CodeableConcept | Purpose of the ingredient within the product, e.g. active, inactive Binding: ?? (example): A classification of the ingredient identifying its purpose within the product, e.g. active, inactive. |
function | 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..* | 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). |
group | 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 | 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 |
allergenicIndicator | Σ C | 0..1 | boolean | If the ingredient is a known or suspected allergen | Σ C | 0..1 | boolean | If the ingredient is a known or suspected allergen |
comment |  | 0..1 | markdown | A place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on drying |  | 0..1 | markdown | A place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on drying |
manufacturer | Σ | 0..* | BackboneElement | An organization that manufactures this ingredient | Σ | 0..* | BackboneElement | An organization that manufactures this ingredient |
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 |
role | Σ | 0..1 | code | allowed | possible | actual Binding: ?? (required): The way in which this manufacturer is associated with the ingredient. | Σ | 0..1 | code | allowed | possible | actual Binding: ?? (required): The way in which this manufacturer is associated with the ingredient. |
manufacturer | Σ | 1..1 | Reference(Organization) | An organization that manufactures this ingredient | Σ | 1..1 | Reference(Organization) | An organization that manufactures this ingredient |
substance | Σ C | 1..1 | BackboneElement | The substance that comprises this ingredient | Σ C | 1..1 | BackboneElement | The substance that comprises this ingredient |
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 |
code | S | 1..1 | LiteralCodeableReference(Drug Substance Handle | Excipient Drug Substance) {b} | Ingredient Substance Binding: ?? (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. | S Σ C | 1..1 | LiteralCodeableReference(Drug Substance Handle | Excipient Drug Substance) {b} | Ingredient Substance Binding: ?? (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. |
Slices for strength | S Σ | 2..2 | BackboneElement | The quantity of substance, per presentation, or per volume or mass, and type of quantity Slice: Unordered, Closed by value:concentration.code | S Σ | 2..2 | BackboneElement | The quantity of substance, per presentation, or per volume or mass, and type of quantity Slice: Unordered, Closed by value:concentration.code |
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 |
presentation[x] | Σ | 0..1 | Ratio, RatioRange, CodeableConcept, Quantity | The quantity of substance in the unit of presentation | Σ | 0..1 | Ratio, RatioRange, CodeableConcept, Quantity | The quantity of substance in the unit of presentation |
textPresentation | 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 | string | Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio) |
concentration[x] | Σ | 0..1 | Ratio, RatioRange, CodeableConcept, Quantity | The strength per unitary volume (or mass) | Σ | 0..1 | Ratio, RatioRange, CodeableConcept, Quantity | The strength per unitary volume (or mass) |
textConcentration | 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 | string | Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio) |
basis | 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 | 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) |
measurementPoint | Σ | 0..1 | string | When strength is measured at a particular point or distance | Σ | 0..1 | string | When strength is measured at a particular point or distance |
country | Σ | 0..* | CodeableConcept | Where the strength range applies Binding: ?? (example): Jurisdiction codes | Σ | 0..* | CodeableConcept | Where the strength range applies Binding: ?? (example): Jurisdiction codes |
referenceStrength | Σ | 0..* | BackboneElement | Strength expressed in terms of a reference substance | Σ | 0..* | BackboneElement | Strength expressed in terms of a reference substance |
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 |
substance | 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 | CodeableReference(SubstanceDefinition) | Relevant reference substance Binding: ?? (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. |
strength[x] | Σ | 1..1 | Ratio, RatioRange, Quantity | Strength expressed in terms of a reference substance | Σ | 1..1 | Ratio, RatioRange, Quantity | Strength expressed in terms of a reference substance |
measurementPoint | Σ | 0..1 | string | When strength is measured at a particular point or distance | Σ | 0..1 | string | When strength is measured at a particular point or distance |
country | Σ | 0..* | CodeableConcept | Where the strength range applies Binding: ?? (example): Jurisdiction codes | Σ | 0..* | CodeableConcept | Where the strength range applies Binding: ?? (example): Jurisdiction codes |
Documentation for this format