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

Messages

Metadata

Name	Value		Comments
abstract	false
baseDefinition	http://hl7.org/fhir/StructureDefinition/Ingredient
copyright
date	2024-12-12T19:00:52+00:00	2025-07-08T07:43:10+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	SΣ	0..1	Identifier	An identifier or code by which the ingredient can be referenced	SΣ	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	ΣC	0..1	boolean	If the ingredient is a known or suspected allergen	ΣC	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	ΣC	1..1	BackboneElement	The substance that comprises this ingredient	ΣC	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.	SΣC	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	SΣ	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	SΣ	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