Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Ingredient	C	0..*	Ingredient	An ingredient of a manufactured item or pharmaceutical product Constraints: ing-1
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	LiteralCodeableReference(Drug Substance Handle | Excipient Drug Substance) {b}	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	2..2	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity Slice: Unordered, Closed by value:concentration.code
strength:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
strength:perBatch	SΣ	1..1	BackboneElement	Ingredient Total per Batch
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
concentration[x]	SΣ	1..1	Quantity	The strength per unitary volume (or mass)
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
code	SΣC	1..1	code	Coded form of the unit Binding: Non-Percentage Units (required)
strength:percent	SΣ	1..1	BackboneElement	Ingredient percent of Total Batch
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
concentration[x]	SΣ	1..1	Quantity	The strength per unitary volume (or mass)
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
code	SΣC	1..1	code	Coded form of the unit Binding: Percentage Units (required)
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:perBatch.concentration[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 From the FHIR Standard
Ingredient.substance.strength:perBatch.concentration[x].code	required	PqcmcNonPercentageUnits http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units From this IG
Ingredient.substance.strength:percent.concentration[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 From the FHIR Standard
Ingredient.substance.strength:percent.concentration[x].code	required	PqcmcPercentageUnits http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units From this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
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    Filter: Bindings Constraints Obligations
Ingredient			Ingredient
identifier	S	0..1	Identifier	An identifier or code by which the ingredient can be referenced
substance
code	S	1..1	LiteralCodeableReference(Drug Substance Handle | Excipient Drug Substance) {b}	Ingredient Substance
Slices for strength	S	2..2	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity Slice: Unordered, Closed by value:concentration.code
strength:perBatch	S	1..1	BackboneElement	Ingredient Total per Batch
concentration[x]	S	1..1	Quantity	The strength per unitary volume (or mass)
code	S	1..1	code	Coded form of the unit Binding: Non-Percentage Units (required)
strength:percent	S	1..1	BackboneElement	Ingredient percent of Total Batch
concentration[x]	S	1..1	Quantity	The strength per unitary volume (or mass)
code	S	1..1	code	Coded form of the unit Binding: Percentage Units (required)
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
Ingredient.substance.strength:perBatch.concentration[x].code	required	PqcmcNonPercentageUnits http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units From this IG
Ingredient.substance.strength:percent.concentration[x].code	required	PqcmcPercentageUnits http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units From this IG

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Ingredient	C	0..*	Ingredient	An ingredient of a manufactured item or pharmaceutical product Constraints: ing-1
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
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
text		0..1	Narrative	Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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	LiteralCodeableReference(Drug Substance Handle | Excipient Drug Substance) {b}	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	2..2	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity Slice: Unordered, Closed by value:concentration.code
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:perBatch	SΣ	1..1	BackboneElement	Ingredient Total per Batch
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]	SΣ	1..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	Σ	0..1	decimal	Numerical value (with implicit precision)
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	SΣC	1..1	code	Coded form of the unit Binding: Non-Percentage Units (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:percent	SΣ	1..1	BackboneElement	Ingredient percent of Total Batch
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]	SΣ	1..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	Σ	0..1	decimal	Numerical value (with implicit precision)
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	SΣC	1..1	code	Coded form of the unit Binding: Percentage Units (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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
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:perBatch.concentration[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 From the FHIR Standard
Ingredient.substance.strength:perBatch.concentration[x].code	required	PqcmcNonPercentageUnits http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units From this IG
Ingredient.substance.strength:perBatch.country	example	CountryValueSet http://hl7.org/fhir/ValueSet/country From the FHIR Standard
Ingredient.substance.strength:perBatch.referenceStrength.substance	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes From the FHIR Standard
Ingredient.substance.strength:perBatch.referenceStrength.country	example	CountryValueSet http://hl7.org/fhir/ValueSet/country From the FHIR Standard
Ingredient.substance.strength:percent.concentration[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 From the FHIR Standard
Ingredient.substance.strength:percent.concentration[x].code	required	PqcmcPercentageUnits http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units From this IG
Ingredient.substance.strength:percent.country	example	CountryValueSet http://hl7.org/fhir/ValueSet/country From the FHIR Standard
Ingredient.substance.strength:percent.referenceStrength.substance	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes From the FHIR Standard
Ingredient.substance.strength:percent.referenceStrength.country	example	CountryValueSet http://hl7.org/fhir/ValueSet/country From the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
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

Summary

Mandatory: 6 elements
Must-Support: 9 elements

Structures

This structure refers to these other structures:

• Literal Coded Reference (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-codeable-reference)
• Drug Substance Handle (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance)
• Excipient Drug Substance (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient)

Slices

This structure defines the following Slices:

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

Maturity: 2

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Ingredient	C	0..*	Ingredient	An ingredient of a manufactured item or pharmaceutical product Constraints: ing-1
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	LiteralCodeableReference(Drug Substance Handle | Excipient Drug Substance) {b}	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	2..2	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity Slice: Unordered, Closed by value:concentration.code
strength:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
strength:perBatch	SΣ	1..1	BackboneElement	Ingredient Total per Batch
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
concentration[x]	SΣ	1..1	Quantity	The strength per unitary volume (or mass)
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
code	SΣC	1..1	code	Coded form of the unit Binding: Non-Percentage Units (required)
strength:percent	SΣ	1..1	BackboneElement	Ingredient percent of Total Batch
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
concentration[x]	SΣ	1..1	Quantity	The strength per unitary volume (or mass)
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
code	SΣC	1..1	code	Coded form of the unit Binding: Percentage Units (required)
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:perBatch.concentration[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 From the FHIR Standard
Ingredient.substance.strength:perBatch.concentration[x].code	required	PqcmcNonPercentageUnits http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units From this IG
Ingredient.substance.strength:percent.concentration[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 From the FHIR Standard
Ingredient.substance.strength:percent.concentration[x].code	required	PqcmcPercentageUnits http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units From this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
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    Filter: Bindings Constraints Obligations
Ingredient			Ingredient
identifier	S	0..1	Identifier	An identifier or code by which the ingredient can be referenced
substance
code	S	1..1	LiteralCodeableReference(Drug Substance Handle | Excipient Drug Substance) {b}	Ingredient Substance
Slices for strength	S	2..2	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity Slice: Unordered, Closed by value:concentration.code
strength:perBatch	S	1..1	BackboneElement	Ingredient Total per Batch
concentration[x]	S	1..1	Quantity	The strength per unitary volume (or mass)
code	S	1..1	code	Coded form of the unit Binding: Non-Percentage Units (required)
strength:percent	S	1..1	BackboneElement	Ingredient percent of Total Batch
concentration[x]	S	1..1	Quantity	The strength per unitary volume (or mass)
code	S	1..1	code	Coded form of the unit Binding: Percentage Units (required)
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
Ingredient.substance.strength:perBatch.concentration[x].code	required	PqcmcNonPercentageUnits http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units From this IG
Ingredient.substance.strength:percent.concentration[x].code	required	PqcmcPercentageUnits http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units From this IG

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Ingredient	C	0..*	Ingredient	An ingredient of a manufactured item or pharmaceutical product Constraints: ing-1
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
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
text		0..1	Narrative	Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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	LiteralCodeableReference(Drug Substance Handle | Excipient Drug Substance) {b}	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	2..2	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity Slice: Unordered, Closed by value:concentration.code
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:perBatch	SΣ	1..1	BackboneElement	Ingredient Total per Batch
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]	SΣ	1..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	Σ	0..1	decimal	Numerical value (with implicit precision)
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	SΣC	1..1	code	Coded form of the unit Binding: Non-Percentage Units (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:percent	SΣ	1..1	BackboneElement	Ingredient percent of Total Batch
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]	SΣ	1..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	Σ	0..1	decimal	Numerical value (with implicit precision)
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	SΣC	1..1	code	Coded form of the unit Binding: Percentage Units (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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
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:perBatch.concentration[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 From the FHIR Standard
Ingredient.substance.strength:perBatch.concentration[x].code	required	PqcmcNonPercentageUnits http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units From this IG
Ingredient.substance.strength:perBatch.country	example	CountryValueSet http://hl7.org/fhir/ValueSet/country From the FHIR Standard
Ingredient.substance.strength:perBatch.referenceStrength.substance	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes From the FHIR Standard
Ingredient.substance.strength:perBatch.referenceStrength.country	example	CountryValueSet http://hl7.org/fhir/ValueSet/country From the FHIR Standard
Ingredient.substance.strength:percent.concentration[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 From the FHIR Standard
Ingredient.substance.strength:percent.concentration[x].code	required	PqcmcPercentageUnits http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units From this IG
Ingredient.substance.strength:percent.country	example	CountryValueSet http://hl7.org/fhir/ValueSet/country From the FHIR Standard
Ingredient.substance.strength:percent.referenceStrength.substance	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes From the FHIR Standard
Ingredient.substance.strength:percent.referenceStrength.country	example	CountryValueSet http://hl7.org/fhir/ValueSet/country From the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
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

Summary

Mandatory: 6 elements
Must-Support: 9 elements

Structures

This structure refers to these other structures:

• Literal Coded Reference (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-codeable-reference)
• Drug Substance Handle (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance)
• Excipient Drug Substance (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient)

Slices

This structure defines the following Slices:

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

Maturity: 2