SPL Mapping FHIR R5 Implementation Guide, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.2.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-spl/ and changes regularly. See the Directory of published versions

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Resource Profile: SubmittedMedicinalProductIngredient

Details around the ingredients of a submitted medicinal product.

Usage:

• Use this Resource Profile: ProductSubmissionBundle
• Examples for this Resource Profile: Ingredient/AllopurinolUSPActiveIngredient, Ingredient/AllopurinolUSPIngredient1, Ingredient/AllopurinolUSPIngredient2, Ingredient/AllopurinolUSPIngredient3... Show 25 more, Ingredient/AllopurinolUSPIngredient4, Ingredient/AllopurinolUSPIngredient5, Ingredient/AllopurinolUSPIngredient6, Ingredient/Enbrel25mgSolutionActiveIngredient, Ingredient/Enbrel25mgSolutionIngredient1, Ingredient/Enbrel25mgSolutionIngredient2, Ingredient/Enbrel25mgSolutionIngredient3, Ingredient/Enbrel50mgSolutionActiveIngredient, Ingredient/Enbrel50mgSolutionIngredient1, Ingredient/Enbrel50mgSolutionIngredient2, Ingredient/Enbrel50mgSolutionIngredient3, Ingredient/EnbrelPowderActiveIngredient, Ingredient/EnbrelPowderIngredient1, Ingredient/EnbrelPowderIngredient2, Ingredient/EnbrelPowderIngredient3, Ingredient/EnbrelSterileSolutionIngredient1, Ingredient/EnbrelSterileSolutionIngredient2, Ingredient/LantusActiveIngredient, Ingredient/LantusIngredient1, Ingredient/LantusIngredient2, Ingredient/LantusIngredient3, Ingredient/LantusIngredient4, Ingredient/LantusIngredient5, Ingredient/LantusIngredient6 and Ingredient/LantusIngredient7

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
status		1..1	code	draft | active | retired | unknown Required Pattern: active
for	S	1..1	Reference(SubmittedManufacturedItem)	The product which this ingredient is a constituent part of
role	S	1..1	CodeableConcept	Purpose of the ingredient within the product, e.g. active, inactive Binding: RoleClassIngredientEntity (required)
substance	S	1..1	BackboneElement	The substance that comprises this ingredient
code	S	1..1	CodeableReference(SubmittedIngredientDefinition)	A code or full resource that represents the ingredient substance
strength	S	0..1	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity
presentation[x]	S	1..1	Ratio	The quantity of substance in the unit of presentation
referenceStrength	S	0..1	BackboneElement	Strength expressed in terms of a reference substance
substance	S	1..1	CodeableReference(SubstanceDefinition)	Relevant reference substance
concept	S	1..1	CodeableConcept	Reference to a concept (by class)
reference		0..0
strength[x]	S	1..1	Ratio	Strength expressed in terms of a reference substance
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
Ingredient.role	required	RoleClassIngredientEntity http://terminology.hl7.org/ValueSet/v3-RoleClassIngredientEntity

Name	Flags	Card.	Type	Description & Constraints
Ingredient	C	0..*	Ingredient	An ingredient of a manufactured item or pharmaceutical product dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated dom-5: If a resource is contained in another resource, it SHALL NOT have a security label dom-6: A resource should have narrative for robust management ing-1: If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created ele-1: All FHIR elements must have a @value or children
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
status	?!Σ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact. ele-1: All FHIR elements must have a @value or children Required Pattern: active
for	SΣ	1..1	Reference(SubmittedManufacturedItem)	The product which this ingredient is a constituent part of ele-1: All FHIR elements must have a @value or children
role	SΣ	1..1	CodeableConcept	Purpose of the ingredient within the product, e.g. active, inactive Binding: RoleClassIngredientEntity (required) ele-1: All FHIR elements must have a @value or children
substance	SΣC	1..1	BackboneElement	The substance that comprises this ingredient ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
code	SΣC	1..1	CodeableReference(SubmittedIngredientDefinition)	A code or full resource that represents the ingredient substance Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. ele-1: All FHIR elements must have a @value or children
strength	SΣ	0..1	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
presentation[x]	SΣ	1..1	Ratio	The quantity of substance in the unit of presentation ele-1: All FHIR elements must have a @value or children
referenceStrength	SΣ	0..1	BackboneElement	Strength expressed in terms of a reference substance ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
substance	SΣ	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. ele-1: All FHIR elements must have a @value or children
concept	SΣ	1..1	CodeableConcept	Reference to a concept (by class) ele-1: All FHIR elements must have a @value or children
strength[x]	SΣ	1..1	Ratio	Strength expressed in terms of a reference substance ele-1: All FHIR elements must have a @value or children
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Ingredient.status	required	Pattern: active http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
Ingredient.role	required	RoleClassIngredientEntity http://terminology.hl7.org/ValueSet/v3-RoleClassIngredientEntity
Ingredient.substance.code	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard
Ingredient.substance.strength.referenceStrength.substance	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes 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

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	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. Required Pattern: active
for	SΣ	1..1	Reference(SubmittedManufacturedItem)	The product which this ingredient is a constituent part of
role	SΣ	1..1	CodeableConcept	Purpose of the ingredient within the product, e.g. active, inactive Binding: RoleClassIngredientEntity (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	SΣC	1..1	BackboneElement	The substance that comprises this ingredient
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	SΣC	1..1	CodeableReference(SubmittedIngredientDefinition)	A code or full resource that represents the ingredient substance Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
strength	SΣ	0..1	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
presentation[x]	SΣ	1..1	Ratio	The quantity of substance in the unit of presentation
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	SΣ	0..1	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	SΣ	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.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
concept	SΣ	1..1	CodeableConcept	Reference to a concept (by class)
strength[x]	SΣ	1..1	Ratio	Strength expressed in terms of a reference substance
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 / Code	URI
Ingredient.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
Ingredient.status	required	Pattern: active http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
Ingredient.role	required	RoleClassIngredientEntity http://terminology.hl7.org/ValueSet/v3-RoleClassIngredientEntity
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

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: 1 element(2 nested mandatory elements)
Must-Support: 10 elements
Prohibited: 1 element

Structures

This structure refers to these other structures:

• SubmittedManufacturedItem (http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedManufacturedItem)
• SubmittedIngredientDefinition (http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedIngredientDefinition)

Maturity: 1

Differential View

This structure is derived from Ingredient

Name	Flags	Card.	Type	Description & Constraints
Ingredient			Ingredient
status		1..1	code	draft | active | retired | unknown Required Pattern: active
for	S	1..1	Reference(SubmittedManufacturedItem)	The product which this ingredient is a constituent part of
role	S	1..1	CodeableConcept	Purpose of the ingredient within the product, e.g. active, inactive Binding: RoleClassIngredientEntity (required)
substance	S	1..1	BackboneElement	The substance that comprises this ingredient
code	S	1..1	CodeableReference(SubmittedIngredientDefinition)	A code or full resource that represents the ingredient substance
strength	S	0..1	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity
presentation[x]	S	1..1	Ratio	The quantity of substance in the unit of presentation
referenceStrength	S	0..1	BackboneElement	Strength expressed in terms of a reference substance
substance	S	1..1	CodeableReference(SubstanceDefinition)	Relevant reference substance
concept	S	1..1	CodeableConcept	Reference to a concept (by class)
reference		0..0
strength[x]	S	1..1	Ratio	Strength expressed in terms of a reference substance
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
Ingredient.role	required	RoleClassIngredientEntity http://terminology.hl7.org/ValueSet/v3-RoleClassIngredientEntity

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
Ingredient	C	0..*	Ingredient	An ingredient of a manufactured item or pharmaceutical product dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated dom-5: If a resource is contained in another resource, it SHALL NOT have a security label dom-6: A resource should have narrative for robust management ing-1: If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created ele-1: All FHIR elements must have a @value or children
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
status	?!Σ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact. ele-1: All FHIR elements must have a @value or children Required Pattern: active
for	SΣ	1..1	Reference(SubmittedManufacturedItem)	The product which this ingredient is a constituent part of ele-1: All FHIR elements must have a @value or children
role	SΣ	1..1	CodeableConcept	Purpose of the ingredient within the product, e.g. active, inactive Binding: RoleClassIngredientEntity (required) ele-1: All FHIR elements must have a @value or children
substance	SΣC	1..1	BackboneElement	The substance that comprises this ingredient ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
code	SΣC	1..1	CodeableReference(SubmittedIngredientDefinition)	A code or full resource that represents the ingredient substance Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. ele-1: All FHIR elements must have a @value or children
strength	SΣ	0..1	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
presentation[x]	SΣ	1..1	Ratio	The quantity of substance in the unit of presentation ele-1: All FHIR elements must have a @value or children
referenceStrength	SΣ	0..1	BackboneElement	Strength expressed in terms of a reference substance ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
substance	SΣ	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. ele-1: All FHIR elements must have a @value or children
concept	SΣ	1..1	CodeableConcept	Reference to a concept (by class) ele-1: All FHIR elements must have a @value or children
strength[x]	SΣ	1..1	Ratio	Strength expressed in terms of a reference substance ele-1: All FHIR elements must have a @value or children
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Ingredient.status	required	Pattern: active http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
Ingredient.role	required	RoleClassIngredientEntity http://terminology.hl7.org/ValueSet/v3-RoleClassIngredientEntity
Ingredient.substance.code	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard
Ingredient.substance.strength.referenceStrength.substance	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes 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

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	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. Required Pattern: active
for	SΣ	1..1	Reference(SubmittedManufacturedItem)	The product which this ingredient is a constituent part of
role	SΣ	1..1	CodeableConcept	Purpose of the ingredient within the product, e.g. active, inactive Binding: RoleClassIngredientEntity (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	SΣC	1..1	BackboneElement	The substance that comprises this ingredient
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	SΣC	1..1	CodeableReference(SubmittedIngredientDefinition)	A code or full resource that represents the ingredient substance Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
strength	SΣ	0..1	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
presentation[x]	SΣ	1..1	Ratio	The quantity of substance in the unit of presentation
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	SΣ	0..1	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	SΣ	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.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
concept	SΣ	1..1	CodeableConcept	Reference to a concept (by class)
strength[x]	SΣ	1..1	Ratio	Strength expressed in terms of a reference substance
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 / Code	URI
Ingredient.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
Ingredient.status	required	Pattern: active http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
Ingredient.role	required	RoleClassIngredientEntity http://terminology.hl7.org/ValueSet/v3-RoleClassIngredientEntity
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

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: 1 element(2 nested mandatory elements)
Must-Support: 10 elements
Prohibited: 1 element

Structures

This structure refers to these other structures:

• SubmittedManufacturedItem (http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedManufacturedItem)
• SubmittedIngredientDefinition (http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedIngredientDefinition)

Maturity: 1

Other representations of profile: CSV, Excel, Schematron