Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions

• Content
• Detailed Descriptions
• XML
• JSON

Resource Profile: Drug Product Batch Formula Ingredient

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

Usage:

• Use this Resource Profile: CMC eCTD 32P32 Document
• Refer to this Resource Profile: Drug Product Batch Formula

Formal Views of Profile Content

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

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

This structure is derived from Ingredient

Name	Flags	Card.	Type	Description & Constraints
Ingredient			Ingredient
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
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
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	S	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
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
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter Set
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	SΣ	0..1	Identifier	An identifier or code by which the ingredient can be referenced
status	?!Σ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
for	Σ	0..*	Reference(MedicinalProductDefinition | AdministrableProductDefinition | ManufacturedItemDefinition)	The product which this ingredient is a constituent part of
role	Σ	1..1	CodeableConcept	Purpose of the ingredient within the product, e.g. active, inactive Binding: IngredientRole (example): A classification of the ingredient identifying its purpose within the product, e.g. active, inactive.
function	Σ	0..*	CodeableConcept	Precise action within the drug product, e.g. antioxidant, alkalizing agent Binding: IngredientFunction (example): A classification of the ingredient identifying its precise purpose(s) in the drug product (beyond e.g. active/inactive).
group	Σ	0..1	CodeableConcept	A classification of the ingredient according to where in the physical item it tends to be used, such the outer shell of a tablet, inner body or ink
allergenicIndicator	ΣC	0..1	boolean	If the ingredient is a known or suspected allergen
comment		0..1	markdown	A place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on drying
manufacturer	Σ	0..*	BackboneElement	An organization that manufactures this ingredient
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
role	Σ	0..1	code	allowed | possible | actual Binding: IngredientManufacturerRole (required): The way in which this manufacturer is associated with the ingredient.
manufacturer	Σ	1..1	Reference(Organization)	An organization that manufactures this ingredient
substance	ΣC	1..1	BackboneElement	The substance that comprises this ingredient
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	S	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

This structure is derived from Ingredient

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)

Differential View

This structure is derived from Ingredient

Name	Flags	Card.	Type	Description & Constraints
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

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
Ingredient	C	0..*	Ingredient	An ingredient of a manufactured item or pharmaceutical product ing-1: If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource
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	S	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

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
Ingredient	C	0..*	Ingredient	An ingredient of a manufactured item or pharmaceutical product ing-1: If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter Set
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	SΣ	0..1	Identifier	An identifier or code by which the ingredient can be referenced
status	?!Σ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
for	Σ	0..*	Reference(MedicinalProductDefinition | AdministrableProductDefinition | ManufacturedItemDefinition)	The product which this ingredient is a constituent part of
role	Σ	1..1	CodeableConcept	Purpose of the ingredient within the product, e.g. active, inactive Binding: IngredientRole (example): A classification of the ingredient identifying its purpose within the product, e.g. active, inactive.
function	Σ	0..*	CodeableConcept	Precise action within the drug product, e.g. antioxidant, alkalizing agent Binding: IngredientFunction (example): A classification of the ingredient identifying its precise purpose(s) in the drug product (beyond e.g. active/inactive).
group	Σ	0..1	CodeableConcept	A classification of the ingredient according to where in the physical item it tends to be used, such the outer shell of a tablet, inner body or ink
allergenicIndicator	ΣC	0..1	boolean	If the ingredient is a known or suspected allergen
comment		0..1	markdown	A place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on drying
manufacturer	Σ	0..*	BackboneElement	An organization that manufactures this ingredient
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
role	Σ	0..1	code	allowed | possible | actual Binding: IngredientManufacturerRole (required): The way in which this manufacturer is associated with the ingredient.
manufacturer	Σ	1..1	Reference(Organization)	An organization that manufactures this ingredient
substance	ΣC	1..1	BackboneElement	The substance that comprises this ingredient
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	S	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

This structure is derived from Ingredient

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)

Other representations of profile: CSV, Excel, Schematron