Union of http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component and http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component

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

Structure

Name	Flags	Card.	Type	Description & Constraints
Ingredient	C	0..*		An ingredient of a manufactured item or pharmaceutical product dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated dom-5: If a resource is contained in another resource, it SHALL NOT have a security label dom-6: A resource should have narrative for robust management 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
meta	Σ	0..1	Meta	Metadata about the resource ele-1: All FHIR elements must have a @value or children
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created ele-1: All FHIR elements must have a @value or children
language		0..1	code	Language of the resource content Binding: ?? (required): IETF language tag for a human language ele-1: All FHIR elements must have a @value or children
text		0..1	Narrative	Text summary of the resource, for human interpretation ele-1: All FHIR elements must have a @value or children
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
identifier	Σ	0..1	Identifier	An identifier or code by which the ingredient can be referenced ele-1: All FHIR elements must have a @value or children
status	?!Σ	1..1	code	draft | active | retired | unknown Binding: ?? (required): The lifecycle status of an artifact. ele-1: All FHIR elements must have a @value or children
for	Σ	0..*	Reference(MedicinalProductDefinition | AdministrableProductDefinition | ManufacturedItemDefinition)	Reference to MedicinalProductDefinition ele-1: All FHIR elements must have a @value or children
role	Σ	1..1	CodeableConcept	Purpose of the ingredient within the product, e.g. active, inactive Binding: ?? (required) ele-1: All FHIR elements must have a @value or children
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). ele-1: All FHIR elements must have a @value or children
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 ele-1: All FHIR elements must have a @value or children
allergenicIndicator	Σ	0..1	boolean	If the ingredient is a known or suspected allergen ele-1: All FHIR elements must have a @value or children
comment	S	0..1	markdown	Drug Product Component Additional Information ele-1: All FHIR elements must have a @value or children
manufacturer	Σ	0..*	BackboneElement	An organization that manufactures this ingredient ele-1: All FHIR elements must have a @value or children
extension		0..*	Extension	Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
role	Σ	0..1	code	allowed | possible | actual Binding: ?? (required): The way in which this manufacturer is associated with the ingredient. ele-1: All FHIR elements must have a @value or children
manufacturer	Σ	1..1	Reference(Organization)	An organization that manufactures this ingredient ele-1: All FHIR elements must have a @value or children
substance	ΣC	1..1	BackboneElement	The substance that comprises this ingredient ele-1: All FHIR elements must have a @value or children 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.
extension		0..*	Extension	Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
code	S	1..1	LiteralCodeableReference(Component Substance | #sd-pqcmc-component-substance-pqcmc-component-substance) {b}	Ingredient Substance Binding: ?? (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. ele-1: All FHIR elements must have a @value or children
strength	SΣ	2..2	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity ele-1: All FHIR elements must have a @value or children
extension		0..*	Extension	Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
presentation[x]	Σ	0..1		The quantity of substance in the unit of presentation ele-1: All FHIR elements must have a @value or children
presentationRatio			Ratio
presentationRatioRange			RatioRange
presentationCodeableConcept			CodeableConcept
presentationQuantity			Quantity
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) ele-1: All FHIR elements must have a @value or children
concentration[x]	Σ	0..1		The strength per unitary volume (or mass) ele-1: All FHIR elements must have a @value or children
concentrationRatio			Ratio
concentrationRatioRange			RatioRange
concentrationCodeableConcept			CodeableConcept
concentrationQuantity			Quantity
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) ele-1: All FHIR elements must have a @value or children
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) ele-1: All FHIR elements must have a @value or children
measurementPoint	Σ	0..1	string	When strength is measured at a particular point or distance ele-1: All FHIR elements must have a @value or children
country	Σ	0..*	CodeableConcept	Where the strength range applies Binding: ?? (example): Jurisdiction codes ele-1: All FHIR elements must have a @value or children
referenceStrength	Σ	0..*	BackboneElement	Strength expressed in terms of a reference substance ele-1: All FHIR elements must have a @value or children
extension		0..*	Extension	Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
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. ele-1: All FHIR elements must have a @value or children
strength[x]	Σ	1..1		Strength expressed in terms of a reference substance ele-1: All FHIR elements must have a @value or children
strengthRatio			Ratio
strengthRatioRange			RatioRange
strengthQuantity			Quantity
measurementPoint	Σ	0..1	string	When strength is measured at a particular point or distance ele-1: All FHIR elements must have a @value or children
country	Σ	0..*	CodeableConcept	Where the strength range applies Binding: ?? (example): Jurisdiction codes ele-1: All FHIR elements must have a @value or children
Documentation for this format