Pharmaceutical Quality (Industry)
1.0.0 - STU1 International flag

Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-dx-pq/ and changes regularly. See the Directory of published versions

Resource Profile: Ingredient - Drug Pq

Official URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Ingredient-drug-pq Version: 1.0.0
Active as of 2026-05-10 Computable Name: IngredientDrugPq
Other Identifiers: OID:2.16.840.1.113883.4.642.40.41.42.65

This Ingredient profile represents the active ingredient(s) of a drug substance or product. It references one SubstanceDefinition resource and can include the strength or concentration of that substance.

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description Differentials, Snapshots, and other representations.

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Ingredient C 0..* Ingredient An ingredient of a manufactured item or pharmaceutical product
Constraints: ing-1
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:novel-excipient S 0..1 boolean novel-excipient
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-novel-excipient-pq
.... extension:suitability-for-use S 0..1 string suitability-for-use
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-suitability-for-use-pq
... 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 (preferred)
.... Slices for extension Content/Rules for all slices
..... extension:data-absent-reason S 0..1 code data-absent-reason
URL: http://hl7.org/fhir/StructureDefinition/data-absent-reason
Binding: DataAbsentReason (required)
... function Σ 0..* CodeableConcept Precise action within the drug product, e.g. antioxidant, alkalizing agent
Binding: Ingredient Function (preferred): A classification of the ingredient identifying its precise purpose(s) in the drug product. This extends the Ingredient.role to add more detail. Example: antioxidant, alkalizing agent.
... substance ΣC 1..1 BackboneElement The substance that comprises this ingredient
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code SΣC 1..1 CodeableReference(SubstanceDefinition - Component Substance Drug PQ) Ingredient Substance
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
.... strength Σ 0..* BackboneElement The quantity of substance, per presentation, or per volume or mass, and type of quantity
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... referenceStrength SΣ 0..* BackboneElement Strength expressed in terms of a reference substance
...... 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

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Ingredient.status Base required PublicationStatus 📍5.0.0 FHIR Std.
Ingredient.role Base preferred Ingredient Role 📦5.0.0 FHIR Std.
Ingredient.function Base preferred Ingredient Function 📦1.0.0 This IG
Ingredient.substance.​code Base example SNOMED CT Substance Codes 📍5.0.0 FHIR Std.
Ingredient.substance.​strength.referenceStrength.​substance Base example SNOMED CT Substance Codes 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
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

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Ingredient Ingredient
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:novel-excipient S 0..1 boolean novel-excipient
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-novel-excipient-pq
.... extension:suitability-for-use S 0..1 string suitability-for-use
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-suitability-for-use-pq
... identifier S 0..1 Identifier An identifier or code by which the ingredient can be referenced
... role 1..1 CodeableConcept Purpose of the ingredient within the product, e.g. active, inactive
Binding: IngredientRole (preferred)
.... Slices for extension Content/Rules for all slices
..... extension:data-absent-reason S 0..1 code data-absent-reason
URL: http://hl7.org/fhir/StructureDefinition/data-absent-reason
Binding: DataAbsentReason (required)
... substance
.... code S 1..1 CodeableReference(SubstanceDefinition - Component Substance Drug PQ) Ingredient Substance
.... strength
..... referenceStrength S 0..* BackboneElement Strength expressed in terms of a reference substance

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
Ingredient.role Base preferred Ingredient Role 📦5.0.0 FHIR Std.
Ingredient.function Base preferred Ingredient Function 📦1.0.0 This IG
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Ingredient C 0..* Ingredient An ingredient of a manufactured item or pharmaceutical product
Constraints: ing-1
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:novel-excipient S 0..1 boolean novel-excipient
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-novel-excipient-pq
.... extension:suitability-for-use S 0..1 string suitability-for-use
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-suitability-for-use-pq
... 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 (preferred)
.... id 0..1 id Unique id for inter-element referencing
.... Slices for extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... extension:data-absent-reason S 0..1 code data-absent-reason
URL: http://hl7.org/fhir/StructureDefinition/data-absent-reason
Binding: DataAbsentReason (required)
.... coding Σ 0..* Coding Code defined by a terminology system
.... text Σ 0..1 string Plain text representation of the concept
... function Σ 0..* CodeableConcept Precise action within the drug product, e.g. antioxidant, alkalizing agent
Binding: Ingredient Function (preferred): A classification of the ingredient identifying its precise purpose(s) in the drug product. This extends the Ingredient.role to add more detail. Example: antioxidant, alkalizing agent.
... group Σ 0..1 CodeableConcept A classification of the ingredient according to where in the physical item it tends to be used, such the outer shell of a tablet, inner body or ink
... allergenicIndicator ΣC 0..1 boolean If the ingredient is a known or suspected allergen
... comment 0..1 markdown A place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on drying
... manufacturer Σ 0..* BackboneElement An organization that manufactures this ingredient
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... role Σ 0..1 code allowed | possible | actual
Binding: IngredientManufacturerRole (required): The way in which this manufacturer is associated with the ingredient.
.... manufacturer Σ 1..1 Reference(Organization) An organization that manufactures this ingredient
... substance ΣC 1..1 BackboneElement The substance that comprises this ingredient
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code SΣC 1..1 CodeableReference(SubstanceDefinition - Component Substance Drug PQ) Ingredient Substance
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
.... strength Σ 0..* BackboneElement The quantity of substance, per presentation, or per volume or mass, and type of quantity
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... presentation[x] Σ 0..1 The quantity of substance in the unit of presentation
...... presentationRatio Ratio
...... presentationRatioRange RatioRange
...... presentationCodeableConcept CodeableConcept
...... presentationQuantity Quantity
..... textPresentation Σ 0..1 string Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)
..... 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..* 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

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Ingredient.language Base required All Languages 📍5.0.0 FHIR Std.
Ingredient.status Base required PublicationStatus 📍5.0.0 FHIR Std.
Ingredient.role Base preferred Ingredient Role 📦5.0.0 FHIR Std.
Ingredient.function Base preferred Ingredient Function 📦1.0.0 This IG
Ingredient.manufacturer.​role Base required Ingredient Manufacturer Role 📍5.0.0 FHIR Std.
Ingredient.substance.​code Base example SNOMED CT Substance Codes 📍5.0.0 FHIR Std.
Ingredient.substance.​strength.country Base example Country ValueSet 📍5.0.0 FHIR Std.
Ingredient.substance.​strength.referenceStrength.​substance Base example SNOMED CT Substance Codes 📍5.0.0 FHIR Std.
Ingredient.substance.​strength.referenceStrength.​country Base example Country ValueSet 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
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

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Ingredient C 0..* Ingredient An ingredient of a manufactured item or pharmaceutical product
Constraints: ing-1
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:novel-excipient S 0..1 boolean novel-excipient
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-novel-excipient-pq
.... extension:suitability-for-use S 0..1 string suitability-for-use
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-suitability-for-use-pq
... 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 (preferred)
.... Slices for extension Content/Rules for all slices
..... extension:data-absent-reason S 0..1 code data-absent-reason
URL: http://hl7.org/fhir/StructureDefinition/data-absent-reason
Binding: DataAbsentReason (required)
... function Σ 0..* CodeableConcept Precise action within the drug product, e.g. antioxidant, alkalizing agent
Binding: Ingredient Function (preferred): A classification of the ingredient identifying its precise purpose(s) in the drug product. This extends the Ingredient.role to add more detail. Example: antioxidant, alkalizing agent.
... substance ΣC 1..1 BackboneElement The substance that comprises this ingredient
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code SΣC 1..1 CodeableReference(SubstanceDefinition - Component Substance Drug PQ) Ingredient Substance
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
.... strength Σ 0..* BackboneElement The quantity of substance, per presentation, or per volume or mass, and type of quantity
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... referenceStrength SΣ 0..* BackboneElement Strength expressed in terms of a reference substance
...... 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

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Ingredient.status Base required PublicationStatus 📍5.0.0 FHIR Std.
Ingredient.role Base preferred Ingredient Role 📦5.0.0 FHIR Std.
Ingredient.function Base preferred Ingredient Function 📦1.0.0 This IG
Ingredient.substance.​code Base example SNOMED CT Substance Codes 📍5.0.0 FHIR Std.
Ingredient.substance.​strength.referenceStrength.​substance Base example SNOMED CT Substance Codes 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
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

Differential View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Ingredient Ingredient
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:novel-excipient S 0..1 boolean novel-excipient
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-novel-excipient-pq
.... extension:suitability-for-use S 0..1 string suitability-for-use
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-suitability-for-use-pq
... identifier S 0..1 Identifier An identifier or code by which the ingredient can be referenced
... role 1..1 CodeableConcept Purpose of the ingredient within the product, e.g. active, inactive
Binding: IngredientRole (preferred)
.... Slices for extension Content/Rules for all slices
..... extension:data-absent-reason S 0..1 code data-absent-reason
URL: http://hl7.org/fhir/StructureDefinition/data-absent-reason
Binding: DataAbsentReason (required)
... substance
.... code S 1..1 CodeableReference(SubstanceDefinition - Component Substance Drug PQ) Ingredient Substance
.... strength
..... referenceStrength S 0..* BackboneElement Strength expressed in terms of a reference substance

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
Ingredient.role Base preferred Ingredient Role 📦5.0.0 FHIR Std.
Ingredient.function Base preferred Ingredient Function 📦1.0.0 This IG

Snapshot ViewView

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Ingredient C 0..* Ingredient An ingredient of a manufactured item or pharmaceutical product
Constraints: ing-1
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:novel-excipient S 0..1 boolean novel-excipient
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-novel-excipient-pq
.... extension:suitability-for-use S 0..1 string suitability-for-use
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-suitability-for-use-pq
... 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 (preferred)
.... id 0..1 id Unique id for inter-element referencing
.... Slices for extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... extension:data-absent-reason S 0..1 code data-absent-reason
URL: http://hl7.org/fhir/StructureDefinition/data-absent-reason
Binding: DataAbsentReason (required)
.... coding Σ 0..* Coding Code defined by a terminology system
.... text Σ 0..1 string Plain text representation of the concept
... function Σ 0..* CodeableConcept Precise action within the drug product, e.g. antioxidant, alkalizing agent
Binding: Ingredient Function (preferred): A classification of the ingredient identifying its precise purpose(s) in the drug product. This extends the Ingredient.role to add more detail. Example: antioxidant, alkalizing agent.
... group Σ 0..1 CodeableConcept A classification of the ingredient according to where in the physical item it tends to be used, such the outer shell of a tablet, inner body or ink
... allergenicIndicator ΣC 0..1 boolean If the ingredient is a known or suspected allergen
... comment 0..1 markdown A place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on drying
... manufacturer Σ 0..* BackboneElement An organization that manufactures this ingredient
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... role Σ 0..1 code allowed | possible | actual
Binding: IngredientManufacturerRole (required): The way in which this manufacturer is associated with the ingredient.
.... manufacturer Σ 1..1 Reference(Organization) An organization that manufactures this ingredient
... substance ΣC 1..1 BackboneElement The substance that comprises this ingredient
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code SΣC 1..1 CodeableReference(SubstanceDefinition - Component Substance Drug PQ) Ingredient Substance
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
.... strength Σ 0..* BackboneElement The quantity of substance, per presentation, or per volume or mass, and type of quantity
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... presentation[x] Σ 0..1 The quantity of substance in the unit of presentation
...... presentationRatio Ratio
...... presentationRatioRange RatioRange
...... presentationCodeableConcept CodeableConcept
...... presentationQuantity Quantity
..... textPresentation Σ 0..1 string Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)
..... 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..* 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

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Ingredient.language Base required All Languages 📍5.0.0 FHIR Std.
Ingredient.status Base required PublicationStatus 📍5.0.0 FHIR Std.
Ingredient.role Base preferred Ingredient Role 📦5.0.0 FHIR Std.
Ingredient.function Base preferred Ingredient Function 📦1.0.0 This IG
Ingredient.manufacturer.​role Base required Ingredient Manufacturer Role 📍5.0.0 FHIR Std.
Ingredient.substance.​code Base example SNOMED CT Substance Codes 📍5.0.0 FHIR Std.
Ingredient.substance.​strength.country Base example Country ValueSet 📍5.0.0 FHIR Std.
Ingredient.substance.​strength.referenceStrength.​substance Base example SNOMED CT Substance Codes 📍5.0.0 FHIR Std.
Ingredient.substance.​strength.referenceStrength.​country Base example Country ValueSet 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
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

 

Other representations of profile: CSV, Excel, Schematron