Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.1.2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions

• Content
• Detailed Descriptions
• XML
• JSON

Resource Profile: Drug Product Batch Formula Ingredient

The amount details about the drug product ingredients in the batch. Use for Batch Formula.

Usage:

• Refer to this Resource Profile: Drug Product Batch Formula

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

• Differential Table
• Key Elements Table
• Snapshot Table
• Statistics/References
• All

This structure is derived from Ingredient

Name	Flags	Card.	Type	Description & Constraints
Ingredient			Ingredient
meta
profile	S	0..1	canonical(StructureDefinition)	Profiles this resource claims to conform to
identifier	S	0..1	Identifier	An identifier or code by which the ingredient can be referenced
substance
code	S	1..1	CodeableReference(Routine Drug Substance)	Ingredient Substance
Slices for strength	S	1..2	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity Slice: Unordered, Closed by value:concentrationQuantity.code
strength:Weight	SC	1..1	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity cmc-percent-quantity-ingredient: The Ingredient.substance.strength.concentration.code from PqcmcUnitsMeasureTerminology cannot be VolumeToVolume, WeightToVolume or WeightToWeight
Slices for concentration[x]		0..1	Ratio, RatioRange, CodeableConcept, Quantity	The strength per unitary volume (or mass) Slice: Unordered, Open by type:$this
concentration[x]:concentrationQuantity		0..1	Quantity	The strength per unitary volume (or mass)
value	S	1..1	decimal	Component Quantity Per Batch
unit	S	1..1	string	Unit representation
code	S	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
strength:VolumeToVolume	S	0..1	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity
Slices for concentration[x]		0..1	Ratio, RatioRange, CodeableConcept, Quantity	The strength per unitary volume (or mass) Slice: Unordered, Open by type:$this
concentration[x]:concentrationQuantity		0..1	Quantity	The strength per unitary volume (or mass)
value	S	1..1	decimal	Quantity Percent
code		0..1	code	Coded form of the unit Required Pattern: C48571
strength:WeightToVolume	S	0..1	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity
Slices for concentration[x]		0..1	Ratio, RatioRange, CodeableConcept, Quantity	The strength per unitary volume (or mass) Slice: Unordered, Open by type:$this
concentration[x]:concentrationQuantity		0..1	Quantity	The strength per unitary volume (or mass)
value	S	1..1	decimal	Quantity Percent
code		0..1	code	Coded form of the unit Required Pattern: C48527
strength:WeightToWeight	S	0..1	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity
Slices for concentration[x]		0..1	Ratio, RatioRange, CodeableConcept, Quantity	The strength per unitary volume (or mass) Slice: Unordered, Open by type:$this
concentration[x]:concentrationQuantity		0..1	Quantity	The strength per unitary volume (or mass)
value	S	1..1	decimal	Quantity Percent
code		0..1	code	Coded form of the unit Required Pattern: C48528
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
Ingredient.substance.strength:Weight.concentration[x]:concentrationQuantity.code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
cmc-percent-quantity-ingredient	error	Ingredient.substance.strength:Weight	The Ingredient.substance.strength.concentration.code from PqcmcUnitsMeasureTerminology cannot be VolumeToVolume, WeightToVolume or WeightToWeight : concentration.ofType(Quantity).code in ('C48527' | 'C48527' | 'C48528').count() = 0

Name	Flags	Card.	Type	Description & Constraints
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
meta	Σ	0..1	Meta	Metadata about the resource
profile	SΣ	0..1	canonical(StructureDefinition)	Profiles this resource claims to conform to
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	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: PublicationStatus (required): The lifecycle status of an artifact.
role	Σ	1..1	CodeableConcept	Purpose of the ingredient within the product, e.g. active, inactive Binding: IngredientRole (example): A classification of the ingredient identifying its purpose within the product, e.g. active, inactive.
substance	ΣC	1..1	BackboneElement	The substance that comprises this ingredient
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	SΣC	1..1	CodeableReference(Routine Drug Substance)	Ingredient Substance Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
Slices for strength	SΣ	1..2	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity Slice: Unordered, Closed by value:concentrationQuantity.code
strength:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
strength:Weight	SΣC	1..1	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity cmc-percent-quantity-ingredient: The Ingredient.substance.strength.concentration.code from PqcmcUnitsMeasureTerminology cannot be VolumeToVolume, WeightToVolume or WeightToWeight
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Slices for concentration[x]	Σ	0..1		The strength per unitary volume (or mass) Slice: Unordered, Open by type:$this
concentrationRatio			Ratio
concentrationRatioRange			RatioRange
concentrationCodeableConcept			CodeableConcept
concentrationQuantity			Quantity
concentration[x]:concentrationQuantity	Σ	0..1	Quantity	The strength per unitary volume (or mass)
value	SΣ	1..1	decimal	Component Quantity Per Batch
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	SΣ	1..1	string	Unit representation
code	SΣC	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
strength:VolumeToVolume	SΣ	0..1	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Slices for concentration[x]	Σ	0..1		The strength per unitary volume (or mass) Slice: Unordered, Open by type:$this
concentrationRatio			Ratio
concentrationRatioRange			RatioRange
concentrationCodeableConcept			CodeableConcept
concentrationQuantity			Quantity
concentration[x]:concentrationQuantity	Σ	0..1	Quantity	The strength per unitary volume (or mass)
value	SΣ	1..1	decimal	Quantity Percent
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
code	ΣC	0..1	code	Coded form of the unit Required Pattern: C48571
strength:WeightToVolume	SΣ	0..1	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Slices for concentration[x]	Σ	0..1		The strength per unitary volume (or mass) Slice: Unordered, Open by type:$this
concentrationRatio			Ratio
concentrationRatioRange			RatioRange
concentrationCodeableConcept			CodeableConcept
concentrationQuantity			Quantity
concentration[x]:concentrationQuantity	Σ	0..1	Quantity	The strength per unitary volume (or mass)
value	SΣ	1..1	decimal	Quantity Percent
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
code	ΣC	0..1	code	Coded form of the unit Required Pattern: C48527
strength:WeightToWeight	SΣ	0..1	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Slices for concentration[x]	Σ	0..1		The strength per unitary volume (or mass) Slice: Unordered, Open by type:$this
concentrationRatio			Ratio
concentrationRatioRange			RatioRange
concentrationCodeableConcept			CodeableConcept
concentrationQuantity			Quantity
concentration[x]:concentrationQuantity	Σ	0..1	Quantity	The strength per unitary volume (or mass)
value	SΣ	1..1	decimal	Quantity Percent
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
code	ΣC	0..1	code	Coded form of the unit Required Pattern: C48528
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Ingredient.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
Ingredient.role	example	IngredientRole http://hl7.org/fhir/ValueSet/ingredient-role from the FHIR Standard
Ingredient.substance.code	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard
Ingredient.substance.strength:Weight.concentration[x]:concentrationQuantity.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
Ingredient.substance.strength:Weight.concentration[x]:concentrationQuantity.code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
Ingredient.substance.strength:VolumeToVolume.concentration[x]:concentrationQuantity.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
Ingredient.substance.strength:WeightToVolume.concentration[x]:concentrationQuantity.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
Ingredient.substance.strength:WeightToWeight.concentration[x]:concentrationQuantity.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
cmc-percent-quantity-ingredient	error	Ingredient.substance.strength:Weight	The Ingredient.substance.strength.concentration.code from PqcmcUnitsMeasureTerminology cannot be VolumeToVolume, WeightToVolume or WeightToWeight : concentration.ofType(Quantity).code in ('C48527' | 'C48527' | 'C48528').count() = 0
dom-2	error	Ingredient	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Ingredient	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 : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	Ingredient	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	Ingredient	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Ingredient	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()
ing-1	error	Ingredient	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 : Ingredient.where(allergenicIndicator=true).count() + Ingredient.substance.code.reference.count() < 2

Name	Flags	Card.	Type	Description & Constraints
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
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
versionId	Σ	0..1	id	Version specific identifier
lastUpdated	Σ	0..1	instant	When the resource version last changed
source	Σ	0..1	uri	Identifies where the resource comes from
profile	SΣ	0..1	canonical(StructureDefinition)	Profiles this resource claims to conform to
security	Σ	0..*	Coding	Security Labels applied to this resource Binding: AllSecurityLabels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
tag	Σ	0..*	Coding	Tags applied to this resource Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter Set
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	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: PublicationStatus (required): The lifecycle status of an artifact.
for	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: IngredientRole (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: IngredientFunction (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
allergenicIndicator	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
manufacturer	Σ	0..*	BackboneElement	An organization that manufactures this ingredient
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
role	Σ	0..1	code	allowed | possible | actual Binding: IngredientManufacturerRole (required): The way in which this manufacturer is associated with the ingredient.
manufacturer	Σ	1..1	Reference(Organization)	An organization that manufactures this ingredient
substance	ΣC	1..1	BackboneElement	The substance that comprises this ingredient
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	SΣC	1..1	CodeableReference(Routine Drug Substance)	Ingredient Substance Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
Slices for strength	SΣ	1..2	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity Slice: Unordered, Closed by value:concentrationQuantity.code
strength:All Slices				Content/Rules for all slices
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
presentation[x]	Σ	0..1		The quantity of substance in the unit of presentation
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)
concentration[x]	Σ	0..1		The strength per unitary volume (or mass)
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)
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)
measurementPoint	Σ	0..1	string	When strength is measured at a particular point or distance
country	Σ	0..*	CodeableConcept	Where the strength range applies Binding: CountryValueSet (example): Jurisdiction codes
referenceStrength	Σ	0..*	BackboneElement	Strength expressed in terms of a reference substance
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
substance	Σ	1..1	CodeableReference(SubstanceDefinition)	Relevant reference substance Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
strength[x]	Σ	1..1		Strength expressed in terms of a reference substance
strengthRatio			Ratio
strengthRatioRange			RatioRange
strengthQuantity			Quantity
measurementPoint	Σ	0..1	string	When strength is measured at a particular point or distance
country	Σ	0..*	CodeableConcept	Where the strength range applies Binding: CountryValueSet (example): Jurisdiction codes
strength:Weight	SΣC	1..1	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity cmc-percent-quantity-ingredient: The Ingredient.substance.strength.concentration.code from PqcmcUnitsMeasureTerminology cannot be VolumeToVolume, WeightToVolume or WeightToWeight
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
presentation[x]	Σ	0..1		The quantity of substance in the unit of presentation
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)
Slices for concentration[x]	Σ	0..1		The strength per unitary volume (or mass) Slice: Unordered, Open by type:$this
concentrationRatio			Ratio
concentrationRatioRange			RatioRange
concentrationCodeableConcept			CodeableConcept
concentrationQuantity			Quantity
concentration[x]:concentrationQuantity	Σ	0..1	Quantity	The strength per unitary volume (or mass)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	SΣ	1..1	decimal	Component Quantity Per Batch
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	SΣ	1..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	SΣC	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
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)
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)
measurementPoint	Σ	0..1	string	When strength is measured at a particular point or distance
country	Σ	0..*	CodeableConcept	Where the strength range applies Binding: CountryValueSet (example): Jurisdiction codes
referenceStrength	Σ	0..*	BackboneElement	Strength expressed in terms of a reference substance
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
substance	Σ	1..1	CodeableReference(SubstanceDefinition)	Relevant reference substance Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
strength[x]	Σ	1..1		Strength expressed in terms of a reference substance
strengthRatio			Ratio
strengthRatioRange			RatioRange
strengthQuantity			Quantity
measurementPoint	Σ	0..1	string	When strength is measured at a particular point or distance
country	Σ	0..*	CodeableConcept	Where the strength range applies Binding: CountryValueSet (example): Jurisdiction codes
strength:VolumeToVolume	SΣ	0..1	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
presentation[x]	Σ	0..1		The quantity of substance in the unit of presentation
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)
Slices for concentration[x]	Σ	0..1		The strength per unitary volume (or mass) Slice: Unordered, Open by type:$this
concentrationRatio			Ratio
concentrationRatioRange			RatioRange
concentrationCodeableConcept			CodeableConcept
concentrationQuantity			Quantity
concentration[x]:concentrationQuantity	Σ	0..1	Quantity	The strength per unitary volume (or mass)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	SΣ	1..1	decimal	Quantity Percent
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	Σ	0..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	ΣC	0..1	code	Coded form of the unit Required Pattern: C48571
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)
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)
measurementPoint	Σ	0..1	string	When strength is measured at a particular point or distance
country	Σ	0..*	CodeableConcept	Where the strength range applies Binding: CountryValueSet (example): Jurisdiction codes
referenceStrength	Σ	0..*	BackboneElement	Strength expressed in terms of a reference substance
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
substance	Σ	1..1	CodeableReference(SubstanceDefinition)	Relevant reference substance Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
strength[x]	Σ	1..1		Strength expressed in terms of a reference substance
strengthRatio			Ratio
strengthRatioRange			RatioRange
strengthQuantity			Quantity
measurementPoint	Σ	0..1	string	When strength is measured at a particular point or distance
country	Σ	0..*	CodeableConcept	Where the strength range applies Binding: CountryValueSet (example): Jurisdiction codes
strength:WeightToVolume	SΣ	0..1	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
presentation[x]	Σ	0..1		The quantity of substance in the unit of presentation
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)
Slices for concentration[x]	Σ	0..1		The strength per unitary volume (or mass) Slice: Unordered, Open by type:$this
concentrationRatio			Ratio
concentrationRatioRange			RatioRange
concentrationCodeableConcept			CodeableConcept
concentrationQuantity			Quantity
concentration[x]:concentrationQuantity	Σ	0..1	Quantity	The strength per unitary volume (or mass)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	SΣ	1..1	decimal	Quantity Percent
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	Σ	0..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	ΣC	0..1	code	Coded form of the unit Required Pattern: C48527
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)
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)
measurementPoint	Σ	0..1	string	When strength is measured at a particular point or distance
country	Σ	0..*	CodeableConcept	Where the strength range applies Binding: CountryValueSet (example): Jurisdiction codes
referenceStrength	Σ	0..*	BackboneElement	Strength expressed in terms of a reference substance
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
substance	Σ	1..1	CodeableReference(SubstanceDefinition)	Relevant reference substance Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
strength[x]	Σ	1..1		Strength expressed in terms of a reference substance
strengthRatio			Ratio
strengthRatioRange			RatioRange
strengthQuantity			Quantity
measurementPoint	Σ	0..1	string	When strength is measured at a particular point or distance
country	Σ	0..*	CodeableConcept	Where the strength range applies Binding: CountryValueSet (example): Jurisdiction codes
strength:WeightToWeight	SΣ	0..1	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
presentation[x]	Σ	0..1		The quantity of substance in the unit of presentation
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)
Slices for concentration[x]	Σ	0..1		The strength per unitary volume (or mass) Slice: Unordered, Open by type:$this
concentrationRatio			Ratio
concentrationRatioRange			RatioRange
concentrationCodeableConcept			CodeableConcept
concentrationQuantity			Quantity
concentration[x]:concentrationQuantity	Σ	0..1	Quantity	The strength per unitary volume (or mass)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	SΣ	1..1	decimal	Quantity Percent
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	Σ	0..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	ΣC	0..1	code	Coded form of the unit Required Pattern: C48528
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)
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)
measurementPoint	Σ	0..1	string	When strength is measured at a particular point or distance
country	Σ	0..*	CodeableConcept	Where the strength range applies Binding: CountryValueSet (example): Jurisdiction codes
referenceStrength	Σ	0..*	BackboneElement	Strength expressed in terms of a reference substance
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
substance	Σ	1..1	CodeableReference(SubstanceDefinition)	Relevant reference substance Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
strength[x]	Σ	1..1		Strength expressed in terms of a reference substance
strengthRatio			Ratio
strengthRatioRange			RatioRange
strengthQuantity			Quantity
measurementPoint	Σ	0..1	string	When strength is measured at a particular point or distance
country	Σ	0..*	CodeableConcept	Where the strength range applies Binding: CountryValueSet (example): Jurisdiction codes
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Ingredient.meta.security	extensible	AllSecurityLabels http://hl7.org/fhir/ValueSet/security-labels from the FHIR Standard
Ingredient.meta.tag	example	CommonTags http://hl7.org/fhir/ValueSet/common-tags from the FHIR Standard
Ingredient.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
Ingredient.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
Ingredient.role	example	IngredientRole http://hl7.org/fhir/ValueSet/ingredient-role from the FHIR Standard
Ingredient.function	example	IngredientFunction http://hl7.org/fhir/ValueSet/ingredient-function from the FHIR Standard
Ingredient.manufacturer.role	required	IngredientManufacturerRole http://hl7.org/fhir/ValueSet/ingredient-manufacturer-role|5.0.0 from the FHIR Standard
Ingredient.substance.code	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard
Ingredient.substance.strength.country	example	CountryValueSet http://hl7.org/fhir/ValueSet/country from the FHIR Standard
Ingredient.substance.strength.referenceStrength.substance	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard
Ingredient.substance.strength.referenceStrength.country	example	CountryValueSet http://hl7.org/fhir/ValueSet/country from the FHIR Standard
Ingredient.substance.strength:Weight.concentration[x]:concentrationQuantity.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
Ingredient.substance.strength:Weight.concentration[x]:concentrationQuantity.code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
Ingredient.substance.strength:Weight.country	example	CountryValueSet http://hl7.org/fhir/ValueSet/country from the FHIR Standard
Ingredient.substance.strength:Weight.referenceStrength.substance	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard
Ingredient.substance.strength:Weight.referenceStrength.country	example	CountryValueSet http://hl7.org/fhir/ValueSet/country from the FHIR Standard
Ingredient.substance.strength:VolumeToVolume.concentration[x]:concentrationQuantity.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
Ingredient.substance.strength:VolumeToVolume.country	example	CountryValueSet http://hl7.org/fhir/ValueSet/country from the FHIR Standard
Ingredient.substance.strength:VolumeToVolume.referenceStrength.substance	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard
Ingredient.substance.strength:VolumeToVolume.referenceStrength.country	example	CountryValueSet http://hl7.org/fhir/ValueSet/country from the FHIR Standard
Ingredient.substance.strength:WeightToVolume.concentration[x]:concentrationQuantity.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
Ingredient.substance.strength:WeightToVolume.country	example	CountryValueSet http://hl7.org/fhir/ValueSet/country from the FHIR Standard
Ingredient.substance.strength:WeightToVolume.referenceStrength.substance	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard
Ingredient.substance.strength:WeightToVolume.referenceStrength.country	example	CountryValueSet http://hl7.org/fhir/ValueSet/country from the FHIR Standard
Ingredient.substance.strength:WeightToWeight.concentration[x]:concentrationQuantity.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
Ingredient.substance.strength:WeightToWeight.country	example	CountryValueSet http://hl7.org/fhir/ValueSet/country from the FHIR Standard
Ingredient.substance.strength:WeightToWeight.referenceStrength.substance	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard
Ingredient.substance.strength:WeightToWeight.referenceStrength.country	example	CountryValueSet http://hl7.org/fhir/ValueSet/country from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
cmc-percent-quantity-ingredient	error	Ingredient.substance.strength:Weight	The Ingredient.substance.strength.concentration.code from PqcmcUnitsMeasureTerminology cannot be VolumeToVolume, WeightToVolume or WeightToWeight : concentration.ofType(Quantity).code in ('C48527' | 'C48527' | 'C48528').count() = 0
dom-2	error	Ingredient	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Ingredient	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 : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	Ingredient	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	Ingredient	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Ingredient	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()
ing-1	error	Ingredient	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 : Ingredient.where(allergenicIndicator=true).count() + Ingredient.substance.code.reference.count() < 2

This structure is derived from Ingredient

Summary

Mandatory: 2 elements(6 nested mandatory elements)
Must-Support: 14 elements

Structures

This structure refers to these other structures:

• Routine Drug Substance (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance)

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of Ingredient.substance.strength (Closed)
• The element 1 is sliced based on the value of Ingredient.substance.strength.concentration[x]

Differential View

This structure is derived from Ingredient

Name	Flags	Card.	Type	Description & Constraints
Ingredient			Ingredient
meta
profile	S	0..1	canonical(StructureDefinition)	Profiles this resource claims to conform to
identifier	S	0..1	Identifier	An identifier or code by which the ingredient can be referenced
substance
code	S	1..1	CodeableReference(Routine Drug Substance)	Ingredient Substance
Slices for strength	S	1..2	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity Slice: Unordered, Closed by value:concentrationQuantity.code
strength:Weight	SC	1..1	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity cmc-percent-quantity-ingredient: The Ingredient.substance.strength.concentration.code from PqcmcUnitsMeasureTerminology cannot be VolumeToVolume, WeightToVolume or WeightToWeight
Slices for concentration[x]		0..1	Ratio, RatioRange, CodeableConcept, Quantity	The strength per unitary volume (or mass) Slice: Unordered, Open by type:$this
concentration[x]:concentrationQuantity		0..1	Quantity	The strength per unitary volume (or mass)
value	S	1..1	decimal	Component Quantity Per Batch
unit	S	1..1	string	Unit representation
code	S	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
strength:VolumeToVolume	S	0..1	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity
Slices for concentration[x]		0..1	Ratio, RatioRange, CodeableConcept, Quantity	The strength per unitary volume (or mass) Slice: Unordered, Open by type:$this
concentration[x]:concentrationQuantity		0..1	Quantity	The strength per unitary volume (or mass)
value	S	1..1	decimal	Quantity Percent
code		0..1	code	Coded form of the unit Required Pattern: C48571
strength:WeightToVolume	S	0..1	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity
Slices for concentration[x]		0..1	Ratio, RatioRange, CodeableConcept, Quantity	The strength per unitary volume (or mass) Slice: Unordered, Open by type:$this
concentration[x]:concentrationQuantity		0..1	Quantity	The strength per unitary volume (or mass)
value	S	1..1	decimal	Quantity Percent
code		0..1	code	Coded form of the unit Required Pattern: C48527
strength:WeightToWeight	S	0..1	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity
Slices for concentration[x]		0..1	Ratio, RatioRange, CodeableConcept, Quantity	The strength per unitary volume (or mass) Slice: Unordered, Open by type:$this
concentration[x]:concentrationQuantity		0..1	Quantity	The strength per unitary volume (or mass)
value	S	1..1	decimal	Quantity Percent
code		0..1	code	Coded form of the unit Required Pattern: C48528
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
Ingredient.substance.strength:Weight.concentration[x]:concentrationQuantity.code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
cmc-percent-quantity-ingredient	error	Ingredient.substance.strength:Weight	The Ingredient.substance.strength.concentration.code from PqcmcUnitsMeasureTerminology cannot be VolumeToVolume, WeightToVolume or WeightToWeight : concentration.ofType(Quantity).code in ('C48527' | 'C48527' | 'C48528').count() = 0

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
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
meta	Σ	0..1	Meta	Metadata about the resource
profile	SΣ	0..1	canonical(StructureDefinition)	Profiles this resource claims to conform to
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	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: PublicationStatus (required): The lifecycle status of an artifact.
role	Σ	1..1	CodeableConcept	Purpose of the ingredient within the product, e.g. active, inactive Binding: IngredientRole (example): A classification of the ingredient identifying its purpose within the product, e.g. active, inactive.
substance	ΣC	1..1	BackboneElement	The substance that comprises this ingredient
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	SΣC	1..1	CodeableReference(Routine Drug Substance)	Ingredient Substance Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
Slices for strength	SΣ	1..2	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity Slice: Unordered, Closed by value:concentrationQuantity.code
strength:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
strength:Weight	SΣC	1..1	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity cmc-percent-quantity-ingredient: The Ingredient.substance.strength.concentration.code from PqcmcUnitsMeasureTerminology cannot be VolumeToVolume, WeightToVolume or WeightToWeight
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Slices for concentration[x]	Σ	0..1		The strength per unitary volume (or mass) Slice: Unordered, Open by type:$this
concentrationRatio			Ratio
concentrationRatioRange			RatioRange
concentrationCodeableConcept			CodeableConcept
concentrationQuantity			Quantity
concentration[x]:concentrationQuantity	Σ	0..1	Quantity	The strength per unitary volume (or mass)
value	SΣ	1..1	decimal	Component Quantity Per Batch
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	SΣ	1..1	string	Unit representation
code	SΣC	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
strength:VolumeToVolume	SΣ	0..1	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Slices for concentration[x]	Σ	0..1		The strength per unitary volume (or mass) Slice: Unordered, Open by type:$this
concentrationRatio			Ratio
concentrationRatioRange			RatioRange
concentrationCodeableConcept			CodeableConcept
concentrationQuantity			Quantity
concentration[x]:concentrationQuantity	Σ	0..1	Quantity	The strength per unitary volume (or mass)
value	SΣ	1..1	decimal	Quantity Percent
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
code	ΣC	0..1	code	Coded form of the unit Required Pattern: C48571
strength:WeightToVolume	SΣ	0..1	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Slices for concentration[x]	Σ	0..1		The strength per unitary volume (or mass) Slice: Unordered, Open by type:$this
concentrationRatio			Ratio
concentrationRatioRange			RatioRange
concentrationCodeableConcept			CodeableConcept
concentrationQuantity			Quantity
concentration[x]:concentrationQuantity	Σ	0..1	Quantity	The strength per unitary volume (or mass)
value	SΣ	1..1	decimal	Quantity Percent
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
code	ΣC	0..1	code	Coded form of the unit Required Pattern: C48527
strength:WeightToWeight	SΣ	0..1	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Slices for concentration[x]	Σ	0..1		The strength per unitary volume (or mass) Slice: Unordered, Open by type:$this
concentrationRatio			Ratio
concentrationRatioRange			RatioRange
concentrationCodeableConcept			CodeableConcept
concentrationQuantity			Quantity
concentration[x]:concentrationQuantity	Σ	0..1	Quantity	The strength per unitary volume (or mass)
value	SΣ	1..1	decimal	Quantity Percent
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
code	ΣC	0..1	code	Coded form of the unit Required Pattern: C48528
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Ingredient.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
Ingredient.role	example	IngredientRole http://hl7.org/fhir/ValueSet/ingredient-role from the FHIR Standard
Ingredient.substance.code	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard
Ingredient.substance.strength:Weight.concentration[x]:concentrationQuantity.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
Ingredient.substance.strength:Weight.concentration[x]:concentrationQuantity.code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
Ingredient.substance.strength:VolumeToVolume.concentration[x]:concentrationQuantity.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
Ingredient.substance.strength:WeightToVolume.concentration[x]:concentrationQuantity.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
Ingredient.substance.strength:WeightToWeight.concentration[x]:concentrationQuantity.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
cmc-percent-quantity-ingredient	error	Ingredient.substance.strength:Weight	The Ingredient.substance.strength.concentration.code from PqcmcUnitsMeasureTerminology cannot be VolumeToVolume, WeightToVolume or WeightToWeight : concentration.ofType(Quantity).code in ('C48527' | 'C48527' | 'C48528').count() = 0
dom-2	error	Ingredient	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Ingredient	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 : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	Ingredient	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	Ingredient	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Ingredient	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()
ing-1	error	Ingredient	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 : Ingredient.where(allergenicIndicator=true).count() + Ingredient.substance.code.reference.count() < 2

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
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
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
versionId	Σ	0..1	id	Version specific identifier
lastUpdated	Σ	0..1	instant	When the resource version last changed
source	Σ	0..1	uri	Identifies where the resource comes from
profile	SΣ	0..1	canonical(StructureDefinition)	Profiles this resource claims to conform to
security	Σ	0..*	Coding	Security Labels applied to this resource Binding: AllSecurityLabels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
tag	Σ	0..*	Coding	Tags applied to this resource Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter Set
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	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: PublicationStatus (required): The lifecycle status of an artifact.
for	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: IngredientRole (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: IngredientFunction (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
allergenicIndicator	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
manufacturer	Σ	0..*	BackboneElement	An organization that manufactures this ingredient
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
role	Σ	0..1	code	allowed | possible | actual Binding: IngredientManufacturerRole (required): The way in which this manufacturer is associated with the ingredient.
manufacturer	Σ	1..1	Reference(Organization)	An organization that manufactures this ingredient
substance	ΣC	1..1	BackboneElement	The substance that comprises this ingredient
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	SΣC	1..1	CodeableReference(Routine Drug Substance)	Ingredient Substance Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
Slices for strength	SΣ	1..2	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity Slice: Unordered, Closed by value:concentrationQuantity.code
strength:All Slices				Content/Rules for all slices
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
presentation[x]	Σ	0..1		The quantity of substance in the unit of presentation
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)
concentration[x]	Σ	0..1		The strength per unitary volume (or mass)
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)
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)
measurementPoint	Σ	0..1	string	When strength is measured at a particular point or distance
country	Σ	0..*	CodeableConcept	Where the strength range applies Binding: CountryValueSet (example): Jurisdiction codes
referenceStrength	Σ	0..*	BackboneElement	Strength expressed in terms of a reference substance
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
substance	Σ	1..1	CodeableReference(SubstanceDefinition)	Relevant reference substance Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
strength[x]	Σ	1..1		Strength expressed in terms of a reference substance
strengthRatio			Ratio
strengthRatioRange			RatioRange
strengthQuantity			Quantity
measurementPoint	Σ	0..1	string	When strength is measured at a particular point or distance
country	Σ	0..*	CodeableConcept	Where the strength range applies Binding: CountryValueSet (example): Jurisdiction codes
strength:Weight	SΣC	1..1	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity cmc-percent-quantity-ingredient: The Ingredient.substance.strength.concentration.code from PqcmcUnitsMeasureTerminology cannot be VolumeToVolume, WeightToVolume or WeightToWeight
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
presentation[x]	Σ	0..1		The quantity of substance in the unit of presentation
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)
Slices for concentration[x]	Σ	0..1		The strength per unitary volume (or mass) Slice: Unordered, Open by type:$this
concentrationRatio			Ratio
concentrationRatioRange			RatioRange
concentrationCodeableConcept			CodeableConcept
concentrationQuantity			Quantity
concentration[x]:concentrationQuantity	Σ	0..1	Quantity	The strength per unitary volume (or mass)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	SΣ	1..1	decimal	Component Quantity Per Batch
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	SΣ	1..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	SΣC	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
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)
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)
measurementPoint	Σ	0..1	string	When strength is measured at a particular point or distance
country	Σ	0..*	CodeableConcept	Where the strength range applies Binding: CountryValueSet (example): Jurisdiction codes
referenceStrength	Σ	0..*	BackboneElement	Strength expressed in terms of a reference substance
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
substance	Σ	1..1	CodeableReference(SubstanceDefinition)	Relevant reference substance Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
strength[x]	Σ	1..1		Strength expressed in terms of a reference substance
strengthRatio			Ratio
strengthRatioRange			RatioRange
strengthQuantity			Quantity
measurementPoint	Σ	0..1	string	When strength is measured at a particular point or distance
country	Σ	0..*	CodeableConcept	Where the strength range applies Binding: CountryValueSet (example): Jurisdiction codes
strength:VolumeToVolume	SΣ	0..1	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
presentation[x]	Σ	0..1		The quantity of substance in the unit of presentation
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)
Slices for concentration[x]	Σ	0..1		The strength per unitary volume (or mass) Slice: Unordered, Open by type:$this
concentrationRatio			Ratio
concentrationRatioRange			RatioRange
concentrationCodeableConcept			CodeableConcept
concentrationQuantity			Quantity
concentration[x]:concentrationQuantity	Σ	0..1	Quantity	The strength per unitary volume (or mass)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	SΣ	1..1	decimal	Quantity Percent
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	Σ	0..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	ΣC	0..1	code	Coded form of the unit Required Pattern: C48571
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)
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)
measurementPoint	Σ	0..1	string	When strength is measured at a particular point or distance
country	Σ	0..*	CodeableConcept	Where the strength range applies Binding: CountryValueSet (example): Jurisdiction codes
referenceStrength	Σ	0..*	BackboneElement	Strength expressed in terms of a reference substance
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
substance	Σ	1..1	CodeableReference(SubstanceDefinition)	Relevant reference substance Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
strength[x]	Σ	1..1		Strength expressed in terms of a reference substance
strengthRatio			Ratio
strengthRatioRange			RatioRange
strengthQuantity			Quantity
measurementPoint	Σ	0..1	string	When strength is measured at a particular point or distance
country	Σ	0..*	CodeableConcept	Where the strength range applies Binding: CountryValueSet (example): Jurisdiction codes
strength:WeightToVolume	SΣ	0..1	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
presentation[x]	Σ	0..1		The quantity of substance in the unit of presentation
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)
Slices for concentration[x]	Σ	0..1		The strength per unitary volume (or mass) Slice: Unordered, Open by type:$this
concentrationRatio			Ratio
concentrationRatioRange			RatioRange
concentrationCodeableConcept			CodeableConcept
concentrationQuantity			Quantity
concentration[x]:concentrationQuantity	Σ	0..1	Quantity	The strength per unitary volume (or mass)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	SΣ	1..1	decimal	Quantity Percent
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	Σ	0..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	ΣC	0..1	code	Coded form of the unit Required Pattern: C48527
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)
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)
measurementPoint	Σ	0..1	string	When strength is measured at a particular point or distance
country	Σ	0..*	CodeableConcept	Where the strength range applies Binding: CountryValueSet (example): Jurisdiction codes
referenceStrength	Σ	0..*	BackboneElement	Strength expressed in terms of a reference substance
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
substance	Σ	1..1	CodeableReference(SubstanceDefinition)	Relevant reference substance Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
strength[x]	Σ	1..1		Strength expressed in terms of a reference substance
strengthRatio			Ratio
strengthRatioRange			RatioRange
strengthQuantity			Quantity
measurementPoint	Σ	0..1	string	When strength is measured at a particular point or distance
country	Σ	0..*	CodeableConcept	Where the strength range applies Binding: CountryValueSet (example): Jurisdiction codes
strength:WeightToWeight	SΣ	0..1	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
presentation[x]	Σ	0..1		The quantity of substance in the unit of presentation
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)
Slices for concentration[x]	Σ	0..1		The strength per unitary volume (or mass) Slice: Unordered, Open by type:$this
concentrationRatio			Ratio
concentrationRatioRange			RatioRange
concentrationCodeableConcept			CodeableConcept
concentrationQuantity			Quantity
concentration[x]:concentrationQuantity	Σ	0..1	Quantity	The strength per unitary volume (or mass)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	SΣ	1..1	decimal	Quantity Percent
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	Σ	0..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	ΣC	0..1	code	Coded form of the unit Required Pattern: C48528
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)
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)
measurementPoint	Σ	0..1	string	When strength is measured at a particular point or distance
country	Σ	0..*	CodeableConcept	Where the strength range applies Binding: CountryValueSet (example): Jurisdiction codes
referenceStrength	Σ	0..*	BackboneElement	Strength expressed in terms of a reference substance
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
substance	Σ	1..1	CodeableReference(SubstanceDefinition)	Relevant reference substance Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
strength[x]	Σ	1..1		Strength expressed in terms of a reference substance
strengthRatio			Ratio
strengthRatioRange			RatioRange
strengthQuantity			Quantity
measurementPoint	Σ	0..1	string	When strength is measured at a particular point or distance
country	Σ	0..*	CodeableConcept	Where the strength range applies Binding: CountryValueSet (example): Jurisdiction codes
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Ingredient.meta.security	extensible	AllSecurityLabels http://hl7.org/fhir/ValueSet/security-labels from the FHIR Standard
Ingredient.meta.tag	example	CommonTags http://hl7.org/fhir/ValueSet/common-tags from the FHIR Standard
Ingredient.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
Ingredient.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
Ingredient.role	example	IngredientRole http://hl7.org/fhir/ValueSet/ingredient-role from the FHIR Standard
Ingredient.function	example	IngredientFunction http://hl7.org/fhir/ValueSet/ingredient-function from the FHIR Standard
Ingredient.manufacturer.role	required	IngredientManufacturerRole http://hl7.org/fhir/ValueSet/ingredient-manufacturer-role|5.0.0 from the FHIR Standard
Ingredient.substance.code	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard
Ingredient.substance.strength.country	example	CountryValueSet http://hl7.org/fhir/ValueSet/country from the FHIR Standard
Ingredient.substance.strength.referenceStrength.substance	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard
Ingredient.substance.strength.referenceStrength.country	example	CountryValueSet http://hl7.org/fhir/ValueSet/country from the FHIR Standard
Ingredient.substance.strength:Weight.concentration[x]:concentrationQuantity.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
Ingredient.substance.strength:Weight.concentration[x]:concentrationQuantity.code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
Ingredient.substance.strength:Weight.country	example	CountryValueSet http://hl7.org/fhir/ValueSet/country from the FHIR Standard
Ingredient.substance.strength:Weight.referenceStrength.substance	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard
Ingredient.substance.strength:Weight.referenceStrength.country	example	CountryValueSet http://hl7.org/fhir/ValueSet/country from the FHIR Standard
Ingredient.substance.strength:VolumeToVolume.concentration[x]:concentrationQuantity.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
Ingredient.substance.strength:VolumeToVolume.country	example	CountryValueSet http://hl7.org/fhir/ValueSet/country from the FHIR Standard
Ingredient.substance.strength:VolumeToVolume.referenceStrength.substance	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard
Ingredient.substance.strength:VolumeToVolume.referenceStrength.country	example	CountryValueSet http://hl7.org/fhir/ValueSet/country from the FHIR Standard
Ingredient.substance.strength:WeightToVolume.concentration[x]:concentrationQuantity.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
Ingredient.substance.strength:WeightToVolume.country	example	CountryValueSet http://hl7.org/fhir/ValueSet/country from the FHIR Standard
Ingredient.substance.strength:WeightToVolume.referenceStrength.substance	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard
Ingredient.substance.strength:WeightToVolume.referenceStrength.country	example	CountryValueSet http://hl7.org/fhir/ValueSet/country from the FHIR Standard
Ingredient.substance.strength:WeightToWeight.concentration[x]:concentrationQuantity.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
Ingredient.substance.strength:WeightToWeight.country	example	CountryValueSet http://hl7.org/fhir/ValueSet/country from the FHIR Standard
Ingredient.substance.strength:WeightToWeight.referenceStrength.substance	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard
Ingredient.substance.strength:WeightToWeight.referenceStrength.country	example	CountryValueSet http://hl7.org/fhir/ValueSet/country from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
cmc-percent-quantity-ingredient	error	Ingredient.substance.strength:Weight	The Ingredient.substance.strength.concentration.code from PqcmcUnitsMeasureTerminology cannot be VolumeToVolume, WeightToVolume or WeightToWeight : concentration.ofType(Quantity).code in ('C48527' | 'C48527' | 'C48528').count() = 0
dom-2	error	Ingredient	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Ingredient	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 : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	Ingredient	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	Ingredient	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Ingredient	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()
ing-1	error	Ingredient	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 : Ingredient.where(allergenicIndicator=true).count() + Ingredient.substance.code.reference.count() < 2

This structure is derived from Ingredient

Summary

Mandatory: 2 elements(6 nested mandatory elements)
Must-Support: 14 elements

Structures

This structure refers to these other structures:

• Routine Drug Substance (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance)

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of Ingredient.substance.strength (Closed)
• The element 1 is sliced based on the value of Ingredient.substance.strength.concentration[x]