Name	Flags	Card.	Type	Description & Constraints
Ingredient			Ingredient
meta
profile	S	0..1	canonical(StructureDefinition)	Profiles this resource claims to conform to
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
additional-info	S	0..1	markdown	Drug Product Component Additional Information URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
for		0..*	Reference(MedicinalProductDefinition | AdministrableProductDefinition | ManufacturedItemDefinition)	Reference to MedicinalProductDefinition
role		1..1	CodeableConcept	Purpose of the ingredient within the product, e.g. active, inactive Binding: Drug Product Component Function Category Terminology (required)
substance	C	1..1	BackboneElement	The substance that comprises this ingredient cmc-strength-type-cases1: IF Strength Type = Mass THEN Strength Numeric and Strength UOM are Mandatory cmc-strength-type-cases2: IF Strength Type = Activity THEN Strength Textual, Strength UOM ([arb'U]) and Strength Operator are applicable data elements. Strength Textual and Strength UOM will be Mandatory and Operator will be Optional. Codes 75765 [arb'U]; C45420 Activity.
code	S	1..1	CodeableReference(Component Substance)	Ingredient Substance
strength	S	1..1	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url
strengthFactors	S	1..1	(Complex)	Strength Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension
Slices for presentation[x]	S	1..1		The quantity of substance in the unit of presentation Slice: Unordered, Open by type:$this
presentationRatio			Ratio
presentationQuantity			Quantity
presentation[x]:presentationRatio	S	0..1	Ratio	The quantity of substance in the unit of presentation
numerator	S	1..1	Quantity	Numerator value
value	S	1..1	decimal	Product Ingredient Amount Numeric Numerator
unit	S	1..1	string	Product Ingredient Amount Numeric Numerator UOM
code	S	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
denominator	S	1..1	SimpleQuantity	Denominator value
value	S	1..1	decimal	Product Ingredient Amount Numeric Denominator
unit	S	1..1	string	Unit representation
code	S	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
presentation[x]:presentationQuantity	S	0..1	Quantity	The quantity of substance in the unit of presentation
value	S	1..1	decimal	Product Ingredient Amount Numeric
unit		1..1	string	Unit representation
code		1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
textPresentation	S	1..1	string	Strength Textual
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
Ingredient.role	required	PqcmcDrugProductComponentFunctionCategoryTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology from this IG
Ingredient.substance.strength.presentation[x]:presentationRatio.numerator.code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
Ingredient.substance.strength.presentation[x]:presentationRatio.denominator.code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
Ingredient.substance.strength.presentation[x]:presentationQuantity.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-strength-type-cases1	error	Ingredient.substance	IF Strength Type = Mass THEN Strength Numeric and Strength UOM are Mandatory : strength.extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension').extension('strengthType').value.where(value = 'C168628').exists() implies strength.ofType(Ratio).exists() or ((strength.ofType(Quantity).exists() and strength.ofType(Quantity).extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension').extension('strengthOperator').exists().not()))
cmc-strength-type-cases2	error	Ingredient.substance	IF Strength Type = Activity THEN Strength Textual, Strength UOM ([arb'U]) and Strength Operator are applicable data elements. Strength Textual and Strength UOM will be Mandatory and Operator will be Optional. Codes 75765 [arb'U]; C45420 Activity. : strength.extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension').extension('strengthType').value.where(value = 'C45420').exists() implies ((strength.ofType(Ratio).exists() and strength.ofType(Ratio).numerator.code = 'C75765').exists()) or ((strength.ofType(Quantity).exists() and strength.ofType(Quantity).code = 'C75765' ).exists())

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
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
additional-info	S	0..1	markdown	Drug Product Component Additional Information URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
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)	Reference to MedicinalProductDefinition
role	Σ	1..1	CodeableConcept	Purpose of the ingredient within the product, e.g. active, inactive Binding: Drug Product Component Function Category Terminology (required)
substance	ΣC	1..1	BackboneElement	The substance that comprises this ingredient cmc-strength-type-cases1: IF Strength Type = Mass THEN Strength Numeric and Strength UOM are Mandatory cmc-strength-type-cases2: IF Strength Type = Activity THEN Strength Textual, Strength UOM ([arb'U]) and Strength Operator are applicable data elements. Strength Textual and Strength UOM will be Mandatory and Operator will be Optional. Codes 75765 [arb'U]; C45420 Activity.
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	SΣC	1..1	CodeableReference(Component Substance)	Ingredient Substance Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
strength	SΣ	1..1	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url
strengthFactors	S	1..1	(Complex)	Strength Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Slices for presentation[x]	SΣ	1..1		The quantity of substance in the unit of presentation Slice: Unordered, Closed by type:$this
presentationRatio			Ratio
presentationQuantity			Quantity
presentation[x]:presentationRatio	SΣ	0..1	Ratio	The quantity of substance in the unit of presentation
numerator	SΣC	1..1	Quantity	Numerator value
value	SΣ	1..1	decimal	Product Ingredient Amount Numeric Numerator
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	Product Ingredient Amount Numeric Numerator UOM
code	SΣC	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
denominator	SΣC	1..1	SimpleQuantity	Denominator value
value	SΣ	1..1	decimal	Product Ingredient Amount Numeric Denominator
unit	SΣ	1..1	string	Unit representation
code	SΣC	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
presentation[x]:presentationQuantity	SΣ	0..1	Quantity	The quantity of substance in the unit of presentation
value	SΣ	1..1	decimal	Product Ingredient Amount Numeric
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	Σ	1..1	string	Unit representation
code	ΣC	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
textPresentation	SΣ	1..1	string	Strength Textual
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	required	PqcmcDrugProductComponentFunctionCategoryTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology from this IG
Ingredient.substance.code	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard
Ingredient.substance.strength.presentation[x]:presentationRatio.numerator.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
Ingredient.substance.strength.presentation[x]:presentationRatio.numerator.code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
Ingredient.substance.strength.presentation[x]:presentationRatio.denominator.code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
Ingredient.substance.strength.presentation[x]:presentationQuantity.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
Ingredient.substance.strength.presentation[x]:presentationQuantity.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-strength-type-cases1	error	Ingredient.substance	IF Strength Type = Mass THEN Strength Numeric and Strength UOM are Mandatory : strength.extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension').extension('strengthType').value.where(value = 'C168628').exists() implies strength.ofType(Ratio).exists() or ((strength.ofType(Quantity).exists() and strength.ofType(Quantity).extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension').extension('strengthOperator').exists().not()))
cmc-strength-type-cases2	error	Ingredient.substance	IF Strength Type = Activity THEN Strength Textual, Strength UOM ([arb'U]) and Strength Operator are applicable data elements. Strength Textual and Strength UOM will be Mandatory and Operator will be Optional. Codes 75765 [arb'U]; C45420 Activity. : strength.extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension').extension('strengthType').value.where(value = 'C45420').exists() implies ((strength.ofType(Ratio).exists() and strength.ofType(Ratio).numerator.code = 'C75765').exists()) or ((strength.ofType(Quantity).exists() and strength.ofType(Quantity).code = 'C75765' ).exists())
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
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
additional-info	S	0..1	markdown	Drug Product Component Additional Information URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..1	Identifier	An identifier or code by which the ingredient can be referenced
status	?!Σ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
for	Σ	0..*	Reference(MedicinalProductDefinition | AdministrableProductDefinition | ManufacturedItemDefinition)	Reference to MedicinalProductDefinition
role	Σ	1..1	CodeableConcept	Purpose of the ingredient within the product, e.g. active, inactive Binding: Drug Product Component Function Category Terminology (required)
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 cmc-strength-type-cases1: IF Strength Type = Mass THEN Strength Numeric and Strength UOM are Mandatory cmc-strength-type-cases2: IF Strength Type = Activity THEN Strength Textual, Strength UOM ([arb'U]) and Strength Operator are applicable data elements. Strength Textual and Strength UOM will be Mandatory and Operator will be Optional. Codes 75765 [arb'U]; C45420 Activity.
id		0..1	string	Unique id for inter-element referencing
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(Component Substance)	Ingredient Substance Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
strength	SΣ	1..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
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url
strengthFactors	S	1..1	(Complex)	Strength Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Slices for presentation[x]	SΣ	1..1		The quantity of substance in the unit of presentation Slice: Unordered, Closed by type:$this
presentationRatio			Ratio
presentationQuantity			Quantity
presentation[x]:presentationRatio	SΣ	0..1	Ratio	The quantity of substance in the unit of presentation
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
numerator	SΣC	1..1	Quantity	Numerator value
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	Product Ingredient Amount Numeric Numerator
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	Product Ingredient Amount Numeric Numerator UOM
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)
denominator	SΣC	1..1	SimpleQuantity	Denominator value
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	Product Ingredient Amount Numeric Denominator
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)
presentation[x]:presentationQuantity	SΣ	0..1	Quantity	The quantity of substance in the unit of presentation
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	Product Ingredient Amount Numeric
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	Σ	1..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	ΣC	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
textPresentation	SΣ	1..1	string	Strength Textual
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
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	required	PqcmcDrugProductComponentFunctionCategoryTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology from this IG
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.presentation[x]:presentationRatio.numerator.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
Ingredient.substance.strength.presentation[x]:presentationRatio.numerator.code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
Ingredient.substance.strength.presentation[x]:presentationRatio.denominator.code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
Ingredient.substance.strength.presentation[x]:presentationQuantity.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
Ingredient.substance.strength.presentation[x]:presentationQuantity.code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
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

Constraints

Id	Grade	Path(s)	Details	Requirements
cmc-strength-type-cases1	error	Ingredient.substance	IF Strength Type = Mass THEN Strength Numeric and Strength UOM are Mandatory : strength.extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension').extension('strengthType').value.where(value = 'C168628').exists() implies strength.ofType(Ratio).exists() or ((strength.ofType(Quantity).exists() and strength.ofType(Quantity).extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension').extension('strengthOperator').exists().not()))
cmc-strength-type-cases2	error	Ingredient.substance	IF Strength Type = Activity THEN Strength Textual, Strength UOM ([arb'U]) and Strength Operator are applicable data elements. Strength Textual and Strength UOM will be Mandatory and Operator will be Optional. Codes 75765 [arb'U]; C45420 Activity. : strength.extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension').extension('strengthType').value.where(value = 'C45420').exists() implies ((strength.ofType(Ratio).exists() and strength.ofType(Ratio).numerator.code = 'C75765').exists()) or ((strength.ofType(Quantity).exists() and strength.ofType(Quantity).code = 'C75765' ).exists())
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: 5 elements (11 nested mandatory elements)
Must-Support: 18 elements

Structures

This structure refers to these other structures:

• Component Substance (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component-substance)

Extensions

This structure refers to these extensions:

• http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
• http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension

Slices

This structure defines the following Slices:

• The element Ingredient.substance.strength.presentation[x] is sliced based on the value of type:$this

Name	Flags	Card.	Type	Description & Constraints
Ingredient			Ingredient
meta
profile	S	0..1	canonical(StructureDefinition)	Profiles this resource claims to conform to
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
additional-info	S	0..1	markdown	Drug Product Component Additional Information URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
for		0..*	Reference(MedicinalProductDefinition | AdministrableProductDefinition | ManufacturedItemDefinition)	Reference to MedicinalProductDefinition
role		1..1	CodeableConcept	Purpose of the ingredient within the product, e.g. active, inactive Binding: Drug Product Component Function Category Terminology (required)
substance	C	1..1	BackboneElement	The substance that comprises this ingredient cmc-strength-type-cases1: IF Strength Type = Mass THEN Strength Numeric and Strength UOM are Mandatory cmc-strength-type-cases2: IF Strength Type = Activity THEN Strength Textual, Strength UOM ([arb'U]) and Strength Operator are applicable data elements. Strength Textual and Strength UOM will be Mandatory and Operator will be Optional. Codes 75765 [arb'U]; C45420 Activity.
code	S	1..1	CodeableReference(Component Substance)	Ingredient Substance
strength	S	1..1	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url
strengthFactors	S	1..1	(Complex)	Strength Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension
Slices for presentation[x]	S	1..1		The quantity of substance in the unit of presentation Slice: Unordered, Open by type:$this
presentationRatio			Ratio
presentationQuantity			Quantity
presentation[x]:presentationRatio	S	0..1	Ratio	The quantity of substance in the unit of presentation
numerator	S	1..1	Quantity	Numerator value
value	S	1..1	decimal	Product Ingredient Amount Numeric Numerator
unit	S	1..1	string	Product Ingredient Amount Numeric Numerator UOM
code	S	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
denominator	S	1..1	SimpleQuantity	Denominator value
value	S	1..1	decimal	Product Ingredient Amount Numeric Denominator
unit	S	1..1	string	Unit representation
code	S	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
presentation[x]:presentationQuantity	S	0..1	Quantity	The quantity of substance in the unit of presentation
value	S	1..1	decimal	Product Ingredient Amount Numeric
unit		1..1	string	Unit representation
code		1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
textPresentation	S	1..1	string	Strength Textual
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
Ingredient.role	required	PqcmcDrugProductComponentFunctionCategoryTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology from this IG
Ingredient.substance.strength.presentation[x]:presentationRatio.numerator.code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
Ingredient.substance.strength.presentation[x]:presentationRatio.denominator.code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
Ingredient.substance.strength.presentation[x]:presentationQuantity.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-strength-type-cases1	error	Ingredient.substance	IF Strength Type = Mass THEN Strength Numeric and Strength UOM are Mandatory : strength.extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension').extension('strengthType').value.where(value = 'C168628').exists() implies strength.ofType(Ratio).exists() or ((strength.ofType(Quantity).exists() and strength.ofType(Quantity).extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension').extension('strengthOperator').exists().not()))
cmc-strength-type-cases2	error	Ingredient.substance	IF Strength Type = Activity THEN Strength Textual, Strength UOM ([arb'U]) and Strength Operator are applicable data elements. Strength Textual and Strength UOM will be Mandatory and Operator will be Optional. Codes 75765 [arb'U]; C45420 Activity. : strength.extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension').extension('strengthType').value.where(value = 'C45420').exists() implies ((strength.ofType(Ratio).exists() and strength.ofType(Ratio).numerator.code = 'C75765').exists()) or ((strength.ofType(Quantity).exists() and strength.ofType(Quantity).code = 'C75765' ).exists())

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
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
additional-info	S	0..1	markdown	Drug Product Component Additional Information URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
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)	Reference to MedicinalProductDefinition
role	Σ	1..1	CodeableConcept	Purpose of the ingredient within the product, e.g. active, inactive Binding: Drug Product Component Function Category Terminology (required)
substance	ΣC	1..1	BackboneElement	The substance that comprises this ingredient cmc-strength-type-cases1: IF Strength Type = Mass THEN Strength Numeric and Strength UOM are Mandatory cmc-strength-type-cases2: IF Strength Type = Activity THEN Strength Textual, Strength UOM ([arb'U]) and Strength Operator are applicable data elements. Strength Textual and Strength UOM will be Mandatory and Operator will be Optional. Codes 75765 [arb'U]; C45420 Activity.
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	SΣC	1..1	CodeableReference(Component Substance)	Ingredient Substance Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
strength	SΣ	1..1	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url
strengthFactors	S	1..1	(Complex)	Strength Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Slices for presentation[x]	SΣ	1..1		The quantity of substance in the unit of presentation Slice: Unordered, Closed by type:$this
presentationRatio			Ratio
presentationQuantity			Quantity
presentation[x]:presentationRatio	SΣ	0..1	Ratio	The quantity of substance in the unit of presentation
numerator	SΣC	1..1	Quantity	Numerator value
value	SΣ	1..1	decimal	Product Ingredient Amount Numeric Numerator
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	Product Ingredient Amount Numeric Numerator UOM
code	SΣC	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
denominator	SΣC	1..1	SimpleQuantity	Denominator value
value	SΣ	1..1	decimal	Product Ingredient Amount Numeric Denominator
unit	SΣ	1..1	string	Unit representation
code	SΣC	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
presentation[x]:presentationQuantity	SΣ	0..1	Quantity	The quantity of substance in the unit of presentation
value	SΣ	1..1	decimal	Product Ingredient Amount Numeric
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	Σ	1..1	string	Unit representation
code	ΣC	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
textPresentation	SΣ	1..1	string	Strength Textual
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	required	PqcmcDrugProductComponentFunctionCategoryTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology from this IG
Ingredient.substance.code	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard
Ingredient.substance.strength.presentation[x]:presentationRatio.numerator.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
Ingredient.substance.strength.presentation[x]:presentationRatio.numerator.code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
Ingredient.substance.strength.presentation[x]:presentationRatio.denominator.code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
Ingredient.substance.strength.presentation[x]:presentationQuantity.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
Ingredient.substance.strength.presentation[x]:presentationQuantity.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-strength-type-cases1	error	Ingredient.substance	IF Strength Type = Mass THEN Strength Numeric and Strength UOM are Mandatory : strength.extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension').extension('strengthType').value.where(value = 'C168628').exists() implies strength.ofType(Ratio).exists() or ((strength.ofType(Quantity).exists() and strength.ofType(Quantity).extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension').extension('strengthOperator').exists().not()))
cmc-strength-type-cases2	error	Ingredient.substance	IF Strength Type = Activity THEN Strength Textual, Strength UOM ([arb'U]) and Strength Operator are applicable data elements. Strength Textual and Strength UOM will be Mandatory and Operator will be Optional. Codes 75765 [arb'U]; C45420 Activity. : strength.extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension').extension('strengthType').value.where(value = 'C45420').exists() implies ((strength.ofType(Ratio).exists() and strength.ofType(Ratio).numerator.code = 'C75765').exists()) or ((strength.ofType(Quantity).exists() and strength.ofType(Quantity).code = 'C75765' ).exists())
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
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
additional-info	S	0..1	markdown	Drug Product Component Additional Information URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..1	Identifier	An identifier or code by which the ingredient can be referenced
status	?!Σ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
for	Σ	0..*	Reference(MedicinalProductDefinition | AdministrableProductDefinition | ManufacturedItemDefinition)	Reference to MedicinalProductDefinition
role	Σ	1..1	CodeableConcept	Purpose of the ingredient within the product, e.g. active, inactive Binding: Drug Product Component Function Category Terminology (required)
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 cmc-strength-type-cases1: IF Strength Type = Mass THEN Strength Numeric and Strength UOM are Mandatory cmc-strength-type-cases2: IF Strength Type = Activity THEN Strength Textual, Strength UOM ([arb'U]) and Strength Operator are applicable data elements. Strength Textual and Strength UOM will be Mandatory and Operator will be Optional. Codes 75765 [arb'U]; C45420 Activity.
id		0..1	string	Unique id for inter-element referencing
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(Component Substance)	Ingredient Substance Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
strength	SΣ	1..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
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url
strengthFactors	S	1..1	(Complex)	Strength Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Slices for presentation[x]	SΣ	1..1		The quantity of substance in the unit of presentation Slice: Unordered, Closed by type:$this
presentationRatio			Ratio
presentationQuantity			Quantity
presentation[x]:presentationRatio	SΣ	0..1	Ratio	The quantity of substance in the unit of presentation
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
numerator	SΣC	1..1	Quantity	Numerator value
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	Product Ingredient Amount Numeric Numerator
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	Product Ingredient Amount Numeric Numerator UOM
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)
denominator	SΣC	1..1	SimpleQuantity	Denominator value
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	Product Ingredient Amount Numeric Denominator
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)
presentation[x]:presentationQuantity	SΣ	0..1	Quantity	The quantity of substance in the unit of presentation
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	Product Ingredient Amount Numeric
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	Σ	1..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	ΣC	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
textPresentation	SΣ	1..1	string	Strength Textual
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
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	required	PqcmcDrugProductComponentFunctionCategoryTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology from this IG
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.presentation[x]:presentationRatio.numerator.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
Ingredient.substance.strength.presentation[x]:presentationRatio.numerator.code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
Ingredient.substance.strength.presentation[x]:presentationRatio.denominator.code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
Ingredient.substance.strength.presentation[x]:presentationQuantity.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
Ingredient.substance.strength.presentation[x]:presentationQuantity.code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
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

Constraints

Id	Grade	Path(s)	Details	Requirements
cmc-strength-type-cases1	error	Ingredient.substance	IF Strength Type = Mass THEN Strength Numeric and Strength UOM are Mandatory : strength.extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension').extension('strengthType').value.where(value = 'C168628').exists() implies strength.ofType(Ratio).exists() or ((strength.ofType(Quantity).exists() and strength.ofType(Quantity).extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension').extension('strengthOperator').exists().not()))
cmc-strength-type-cases2	error	Ingredient.substance	IF Strength Type = Activity THEN Strength Textual, Strength UOM ([arb'U]) and Strength Operator are applicable data elements. Strength Textual and Strength UOM will be Mandatory and Operator will be Optional. Codes 75765 [arb'U]; C45420 Activity. : strength.extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension').extension('strengthType').value.where(value = 'C45420').exists() implies ((strength.ofType(Ratio).exists() and strength.ofType(Ratio).numerator.code = 'C75765').exists()) or ((strength.ofType(Quantity).exists() and strength.ofType(Quantity).code = 'C75765' ).exists())
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: 5 elements (11 nested mandatory elements)
Must-Support: 18 elements

Structures

This structure refers to these other structures:

• Component Substance (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component-substance)

Extensions

This structure refers to these extensions:

• http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
• http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension

Slices

This structure defines the following Slices:

• The element Ingredient.substance.strength.presentation[x] is sliced based on the value of type:$this