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

Messages

Metadata

Name	Value		Comments
abstract	false
baseDefinition	http://hl7.org/fhir/StructureDefinition/Ingredient
copyright
date	2024-12-11T13:47:08+00:00	2024-12-12T01:58:44+00:00	Values Differ
description	The amount details about the drug product components to define the product composition in a product unit. Use composition.
experimental
fhirVersion	5.0.0
jurisdiction
jurisdiction[0]	urn:iso:std:iso:3166#US
kind	resource
name	DrugProductComponent
publisher	HL7 International / Biomedical Research and Regulation
purpose
status	active
title	Drug Product Component
type	Ingredient
url	http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component
version	1.0.0	2.0.0-ballot	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 ing-1: If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource	C	0..*	Ingredient	An ingredient of a manufactured item or pharmaceutical product ing-1: If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource
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 Set		0..1	code	Language of the resource content Binding: ?? (required): IETF language tag for a human language Additional Bindings Purpose ?? Starter Set
text		0..1	Narrative	Text summary of the resource, for human interpretation		0..1	Narrative	Text summary of the resource, for human interpretation
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	An identifier or code by which the ingredient can be referenced	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)	Reference to MedicinalProductDefinition	Σ	0..*	Reference(MedicinalProductDefinition | AdministrableProductDefinition | ManufacturedItemDefinition)	Reference to MedicinalProductDefinition
role	Σ	1..1	CodeableConcept	Purpose of the ingredient within the product, e.g. active, inactive Binding: ?? (required)	Σ	1..1	CodeableConcept	Purpose of the ingredient within the product, e.g. active, inactive Binding: ?? (required)
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	S	0..1	markdown	Drug Product Component Additional Information	S	0..1	markdown	Drug Product Component Additional Information
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 cmc-strength-type-cases2: IF Strength Type = Activity THEN Strength Textual, Strength UOM ([arb'U]) and Strength Operator are applicable data elements. Strength Textual and Strength UOM will be Mandatory and Operator will be Optional. Codes 75765 [arb'U]; C45420 Activity.	ΣC	1..1	BackboneElement	The substance that comprises this ingredient cmc-strength-type-cases2: IF Strength Type = Activity THEN Strength Textual, Strength UOM ([arb'U]) and Strength Operator are applicable data elements. Strength Textual and Strength UOM will be Mandatory and Operator will be Optional. Codes 75765 [arb'U]; C45420 Activity.
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(Component Substance) {b}	Ingredient Substance Binding: ?? (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.	S	1..1	LiteralCodeableReference(Component 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 exists:textConcentration	SΣ	2..2	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity Slice: Unordered, Closed by exists:textConcentration
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