Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2 United States of America flag

This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v2.0.0: STU2) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version. For a full list of available versions, see the Directory of published versions

Resource Profile: Drug Product Batch Formula Ingredient

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient Version: 2.0.0
Standards status: Trial-use Maturity Level: 2 Computable Name: DrugProductIngredient
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.43

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

Usages:

Formal Views of Profile Content

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

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
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... status ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.
... role Σ 1..1 CodeableConcept Purpose of the ingredient within the product, e.g. active, inactive
Binding: IngredientRole (example): A classification of the ingredient identifying its purpose within the product, e.g. active, inactive.
... substance ΣC 1..1 BackboneElement The substance that comprises this ingredient
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code SΣC 1..1 LiteralCodeableReference(Drug Substance Handle | Excipient Drug Substance) {b} Ingredient Substance
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
.... Slices for strength SΣ 2..2 BackboneElement The quantity of substance, per presentation, or per volume or mass, and type of quantity
Slice: Unordered, Closed by value:concentration.code
..... strength:All Slices Content/Rules for all slices
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... strength:perBatch SΣ 1..1 BackboneElement Ingredient Total per Batch
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... concentration[x] SΣ 1..1 Quantity The strength per unitary volume (or mass)
....... comparator ?!Σ 0..1 code < | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.
....... code SΣC 1..1 code Coded form of the unit
Binding: Non-Percentage Units (required)
..... strength:percent SΣ 1..1 BackboneElement Ingredient percent of Total Batch
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... concentration[x] SΣ 1..1 Quantity The strength per unitary volume (or mass)
....... comparator ?!Σ 0..1 code < | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.
....... code SΣC 1..1 code Coded form of the unit
Binding: Percentage Units (required)

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Ingredient.statusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
From the FHIR Standard
Ingredient.roleexampleIngredientRole
http://hl7.org/fhir/ValueSet/ingredient-role
From the FHIR Standard
Ingredient.substance.codeexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
From the FHIR Standard
Ingredient.substance.strength:perBatch.concentration[x].comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
From the FHIR Standard
Ingredient.substance.strength:perBatch.concentration[x].coderequiredPqcmcNonPercentageUnits
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units
From this IG
Ingredient.substance.strength:percent.concentration[x].comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
From the FHIR Standard
Ingredient.substance.strength:percent.concentration[x].coderequiredPqcmcPercentageUnits
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units
From this IG

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorIngredientIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorIngredientIf 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-4errorIngredientIf 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-5errorIngredientIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceIngredientA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ing-1errorIngredientIf 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

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. 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)

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
Ingredient.substance.strength:perBatch.concentration[x].coderequiredPqcmcNonPercentageUnits
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units
From this IG
Ingredient.substance.strength:percent.concentration[x].coderequiredPqcmcPercentageUnits
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units
From 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
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier SΣ 0..1 Identifier An identifier or code by which the ingredient can be referenced
... status ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.
... for Σ 0..* Reference(MedicinalProductDefinition | AdministrableProductDefinition | ManufacturedItemDefinition) The product which this ingredient is a constituent part of
... role Σ 1..1 CodeableConcept Purpose of the ingredient within the product, e.g. active, inactive
Binding: IngredientRole (example): A classification of the ingredient identifying its purpose within the product, e.g. active, inactive.
... function Σ 0..* CodeableConcept Precise action within the drug product, e.g. antioxidant, alkalizing agent
Binding: IngredientFunction (example): A classification of the ingredient identifying its precise purpose(s) in the drug product (beyond e.g. active/inactive).
... group Σ 0..1 CodeableConcept A classification of the ingredient according to where in the physical item it tends to be used, such the outer shell of a tablet, inner body or ink
... allergenicIndicator ΣC 0..1 boolean If the ingredient is a known or suspected allergen
... comment 0..1 markdown A place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on drying
... manufacturer Σ 0..* BackboneElement An organization that manufactures this ingredient
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... role Σ 0..1 code allowed | possible | actual
Binding: IngredientManufacturerRole (required): The way in which this manufacturer is associated with the ingredient.
.... manufacturer Σ 1..1 Reference(Organization) An organization that manufactures this ingredient
... substance ΣC 1..1 BackboneElement The substance that comprises this ingredient
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code SΣC 1..1 LiteralCodeableReference(Drug Substance Handle | Excipient Drug Substance) {b} Ingredient Substance
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
.... Slices for strength SΣ 2..2 BackboneElement The quantity of substance, per presentation, or per volume or mass, and type of quantity
Slice: Unordered, Closed by value:concentration.code
..... strength:All Slices Content/Rules for all slices
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... presentation[x] Σ 0..1 The quantity of substance in the unit of presentation
....... presentationRatio Ratio
....... presentationRatioRange RatioRange
....... presentationCodeableConcept CodeableConcept
....... presentationQuantity Quantity
...... textPresentation Σ 0..1 string Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)
...... concentration[x] Σ 0..1 The strength per unitary volume (or mass)
....... concentrationRatio Ratio
....... concentrationRatioRange RatioRange
....... concentrationCodeableConcept CodeableConcept
....... concentrationQuantity Quantity
...... textConcentration Σ 0..1 string Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio)
...... basis Σ 0..1 CodeableConcept A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt)
...... measurementPoint Σ 0..1 string When strength is measured at a particular point or distance
...... country Σ 0..* CodeableConcept Where the strength range applies
Binding: CountryValueSet (example): Jurisdiction codes
...... referenceStrength Σ 0..* BackboneElement Strength expressed in terms of a reference substance
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... substance Σ 1..1 CodeableReference(SubstanceDefinition) Relevant reference substance
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
....... strength[x] Σ 1..1 Strength expressed in terms of a reference substance
........ strengthRatio Ratio
........ strengthRatioRange RatioRange
........ strengthQuantity Quantity
....... measurementPoint Σ 0..1 string When strength is measured at a particular point or distance
....... country Σ 0..* CodeableConcept Where the strength range applies
Binding: CountryValueSet (example): Jurisdiction codes
..... strength:perBatch SΣ 1..1 BackboneElement Ingredient Total per Batch
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... presentation[x] Σ 0..1 The quantity of substance in the unit of presentation
....... presentationRatio Ratio
....... presentationRatioRange RatioRange
....... presentationCodeableConcept CodeableConcept
....... presentationQuantity Quantity
...... textPresentation Σ 0..1 string Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)
...... concentration[x] SΣ 1..1 Quantity The strength per unitary volume (or mass)
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... value Σ 0..1 decimal Numerical value (with implicit precision)
....... comparator ?!Σ 0..1 code < | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.
....... unit Σ 0..1 string Unit representation
....... system ΣC 0..1 uri System that defines coded unit form
....... code SΣC 1..1 code Coded form of the unit
Binding: Non-Percentage Units (required)
...... textConcentration Σ 0..1 string Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio)
...... basis Σ 0..1 CodeableConcept A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt)
...... measurementPoint Σ 0..1 string When strength is measured at a particular point or distance
...... country Σ 0..* CodeableConcept Where the strength range applies
Binding: CountryValueSet (example): Jurisdiction codes
...... referenceStrength Σ 0..* BackboneElement Strength expressed in terms of a reference substance
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... substance Σ 1..1 CodeableReference(SubstanceDefinition) Relevant reference substance
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
....... strength[x] Σ 1..1 Strength expressed in terms of a reference substance
........ strengthRatio Ratio
........ strengthRatioRange RatioRange
........ strengthQuantity Quantity
....... measurementPoint Σ 0..1 string When strength is measured at a particular point or distance
....... country Σ 0..* CodeableConcept Where the strength range applies
Binding: CountryValueSet (example): Jurisdiction codes
..... strength:percent SΣ 1..1 BackboneElement Ingredient percent of Total Batch
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... presentation[x] Σ 0..1 The quantity of substance in the unit of presentation
....... presentationRatio Ratio
....... presentationRatioRange RatioRange
....... presentationCodeableConcept CodeableConcept
....... presentationQuantity Quantity
...... textPresentation Σ 0..1 string Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)
...... concentration[x] SΣ 1..1 Quantity The strength per unitary volume (or mass)
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... value Σ 0..1 decimal Numerical value (with implicit precision)
....... comparator ?!Σ 0..1 code < | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.
....... unit Σ 0..1 string Unit representation
....... system ΣC 0..1 uri System that defines coded unit form
....... code SΣC 1..1 code Coded form of the unit
Binding: Percentage Units (required)
...... textConcentration Σ 0..1 string Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio)
...... basis Σ 0..1 CodeableConcept A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt)
...... measurementPoint Σ 0..1 string When strength is measured at a particular point or distance
...... country Σ 0..* CodeableConcept Where the strength range applies
Binding: CountryValueSet (example): Jurisdiction codes
...... referenceStrength Σ 0..* BackboneElement Strength expressed in terms of a reference substance
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... substance Σ 1..1 CodeableReference(SubstanceDefinition) Relevant reference substance
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
....... strength[x] Σ 1..1 Strength expressed in terms of a reference substance
........ strengthRatio Ratio
........ strengthRatioRange RatioRange
........ strengthQuantity Quantity
....... measurementPoint Σ 0..1 string When strength is measured at a particular point or distance
....... country Σ 0..* CodeableConcept Where the strength range applies
Binding: CountryValueSet (example): Jurisdiction codes

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Ingredient.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
From the FHIR Standard
Ingredient.statusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
From the FHIR Standard
Ingredient.roleexampleIngredientRole
http://hl7.org/fhir/ValueSet/ingredient-role
From the FHIR Standard
Ingredient.functionexampleIngredientFunction
http://hl7.org/fhir/ValueSet/ingredient-function
From the FHIR Standard
Ingredient.manufacturer.rolerequiredIngredientManufacturerRole
http://hl7.org/fhir/ValueSet/ingredient-manufacturer-role|5.0.0
From the FHIR Standard
Ingredient.substance.codeexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
From the FHIR Standard
Ingredient.substance.strength.countryexampleCountryValueSet
http://hl7.org/fhir/ValueSet/country
From the FHIR Standard
Ingredient.substance.strength.referenceStrength.substanceexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
From the FHIR Standard
Ingredient.substance.strength.referenceStrength.countryexampleCountryValueSet
http://hl7.org/fhir/ValueSet/country
From the FHIR Standard
Ingredient.substance.strength:perBatch.concentration[x].comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
From the FHIR Standard
Ingredient.substance.strength:perBatch.concentration[x].coderequiredPqcmcNonPercentageUnits
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units
From this IG
Ingredient.substance.strength:perBatch.countryexampleCountryValueSet
http://hl7.org/fhir/ValueSet/country
From the FHIR Standard
Ingredient.substance.strength:perBatch.referenceStrength.substanceexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
From the FHIR Standard
Ingredient.substance.strength:perBatch.referenceStrength.countryexampleCountryValueSet
http://hl7.org/fhir/ValueSet/country
From the FHIR Standard
Ingredient.substance.strength:percent.concentration[x].comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
From the FHIR Standard
Ingredient.substance.strength:percent.concentration[x].coderequiredPqcmcPercentageUnits
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units
From this IG
Ingredient.substance.strength:percent.countryexampleCountryValueSet
http://hl7.org/fhir/ValueSet/country
From the FHIR Standard
Ingredient.substance.strength:percent.referenceStrength.substanceexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
From the FHIR Standard
Ingredient.substance.strength:percent.referenceStrength.countryexampleCountryValueSet
http://hl7.org/fhir/ValueSet/country
From the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorIngredientIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorIngredientIf 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-4errorIngredientIf 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-5errorIngredientIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceIngredientA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ing-1errorIngredientIf 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:

Slices

This structure defines the following Slices:

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

Maturity: 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
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... status ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.
... role Σ 1..1 CodeableConcept Purpose of the ingredient within the product, e.g. active, inactive
Binding: IngredientRole (example): A classification of the ingredient identifying its purpose within the product, e.g. active, inactive.
... substance ΣC 1..1 BackboneElement The substance that comprises this ingredient
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code SΣC 1..1 LiteralCodeableReference(Drug Substance Handle | Excipient Drug Substance) {b} Ingredient Substance
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
.... Slices for strength SΣ 2..2 BackboneElement The quantity of substance, per presentation, or per volume or mass, and type of quantity
Slice: Unordered, Closed by value:concentration.code
..... strength:All Slices Content/Rules for all slices
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... strength:perBatch SΣ 1..1 BackboneElement Ingredient Total per Batch
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... concentration[x] SΣ 1..1 Quantity The strength per unitary volume (or mass)
....... comparator ?!Σ 0..1 code < | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.
....... code SΣC 1..1 code Coded form of the unit
Binding: Non-Percentage Units (required)
..... strength:percent SΣ 1..1 BackboneElement Ingredient percent of Total Batch
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... concentration[x] SΣ 1..1 Quantity The strength per unitary volume (or mass)
....... comparator ?!Σ 0..1 code < | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.
....... code SΣC 1..1 code Coded form of the unit
Binding: Percentage Units (required)

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Ingredient.statusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
From the FHIR Standard
Ingredient.roleexampleIngredientRole
http://hl7.org/fhir/ValueSet/ingredient-role
From the FHIR Standard
Ingredient.substance.codeexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
From the FHIR Standard
Ingredient.substance.strength:perBatch.concentration[x].comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
From the FHIR Standard
Ingredient.substance.strength:perBatch.concentration[x].coderequiredPqcmcNonPercentageUnits
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units
From this IG
Ingredient.substance.strength:percent.concentration[x].comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
From the FHIR Standard
Ingredient.substance.strength:percent.concentration[x].coderequiredPqcmcPercentageUnits
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units
From this IG

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorIngredientIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorIngredientIf 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-4errorIngredientIf 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-5errorIngredientIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceIngredientA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ing-1errorIngredientIf 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

This structure is derived from Ingredient

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. 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)

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
Ingredient.substance.strength:perBatch.concentration[x].coderequiredPqcmcNonPercentageUnits
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units
From this IG
Ingredient.substance.strength:percent.concentration[x].coderequiredPqcmcPercentageUnits
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units
From this IG

Snapshot View

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
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier SΣ 0..1 Identifier An identifier or code by which the ingredient can be referenced
... status ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.
... for Σ 0..* Reference(MedicinalProductDefinition | AdministrableProductDefinition | ManufacturedItemDefinition) The product which this ingredient is a constituent part of
... role Σ 1..1 CodeableConcept Purpose of the ingredient within the product, e.g. active, inactive
Binding: IngredientRole (example): A classification of the ingredient identifying its purpose within the product, e.g. active, inactive.
... function Σ 0..* CodeableConcept Precise action within the drug product, e.g. antioxidant, alkalizing agent
Binding: IngredientFunction (example): A classification of the ingredient identifying its precise purpose(s) in the drug product (beyond e.g. active/inactive).
... group Σ 0..1 CodeableConcept A classification of the ingredient according to where in the physical item it tends to be used, such the outer shell of a tablet, inner body or ink
... allergenicIndicator ΣC 0..1 boolean If the ingredient is a known or suspected allergen
... comment 0..1 markdown A place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on drying
... manufacturer Σ 0..* BackboneElement An organization that manufactures this ingredient
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... role Σ 0..1 code allowed | possible | actual
Binding: IngredientManufacturerRole (required): The way in which this manufacturer is associated with the ingredient.
.... manufacturer Σ 1..1 Reference(Organization) An organization that manufactures this ingredient
... substance ΣC 1..1 BackboneElement The substance that comprises this ingredient
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code SΣC 1..1 LiteralCodeableReference(Drug Substance Handle | Excipient Drug Substance) {b} Ingredient Substance
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
.... Slices for strength SΣ 2..2 BackboneElement The quantity of substance, per presentation, or per volume or mass, and type of quantity
Slice: Unordered, Closed by value:concentration.code
..... strength:All Slices Content/Rules for all slices
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... presentation[x] Σ 0..1 The quantity of substance in the unit of presentation
....... presentationRatio Ratio
....... presentationRatioRange RatioRange
....... presentationCodeableConcept CodeableConcept
....... presentationQuantity Quantity
...... textPresentation Σ 0..1 string Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)
...... concentration[x] Σ 0..1 The strength per unitary volume (or mass)
....... concentrationRatio Ratio
....... concentrationRatioRange RatioRange
....... concentrationCodeableConcept CodeableConcept
....... concentrationQuantity Quantity
...... textConcentration Σ 0..1 string Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio)
...... basis Σ 0..1 CodeableConcept A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt)
...... measurementPoint Σ 0..1 string When strength is measured at a particular point or distance
...... country Σ 0..* CodeableConcept Where the strength range applies
Binding: CountryValueSet (example): Jurisdiction codes
...... referenceStrength Σ 0..* BackboneElement Strength expressed in terms of a reference substance
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... substance Σ 1..1 CodeableReference(SubstanceDefinition) Relevant reference substance
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
....... strength[x] Σ 1..1 Strength expressed in terms of a reference substance
........ strengthRatio Ratio
........ strengthRatioRange RatioRange
........ strengthQuantity Quantity
....... measurementPoint Σ 0..1 string When strength is measured at a particular point or distance
....... country Σ 0..* CodeableConcept Where the strength range applies
Binding: CountryValueSet (example): Jurisdiction codes
..... strength:perBatch SΣ 1..1 BackboneElement Ingredient Total per Batch
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... presentation[x] Σ 0..1 The quantity of substance in the unit of presentation
....... presentationRatio Ratio
....... presentationRatioRange RatioRange
....... presentationCodeableConcept CodeableConcept
....... presentationQuantity Quantity
...... textPresentation Σ 0..1 string Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)
...... concentration[x] SΣ 1..1 Quantity The strength per unitary volume (or mass)
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... value Σ 0..1 decimal Numerical value (with implicit precision)
....... comparator ?!Σ 0..1 code < | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.
....... unit Σ 0..1 string Unit representation
....... system ΣC 0..1 uri System that defines coded unit form
....... code SΣC 1..1 code Coded form of the unit
Binding: Non-Percentage Units (required)
...... textConcentration Σ 0..1 string Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio)
...... basis Σ 0..1 CodeableConcept A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt)
...... measurementPoint Σ 0..1 string When strength is measured at a particular point or distance
...... country Σ 0..* CodeableConcept Where the strength range applies
Binding: CountryValueSet (example): Jurisdiction codes
...... referenceStrength Σ 0..* BackboneElement Strength expressed in terms of a reference substance
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... substance Σ 1..1 CodeableReference(SubstanceDefinition) Relevant reference substance
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
....... strength[x] Σ 1..1 Strength expressed in terms of a reference substance
........ strengthRatio Ratio
........ strengthRatioRange RatioRange
........ strengthQuantity Quantity
....... measurementPoint Σ 0..1 string When strength is measured at a particular point or distance
....... country Σ 0..* CodeableConcept Where the strength range applies
Binding: CountryValueSet (example): Jurisdiction codes
..... strength:percent SΣ 1..1 BackboneElement Ingredient percent of Total Batch
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... presentation[x] Σ 0..1 The quantity of substance in the unit of presentation
....... presentationRatio Ratio
....... presentationRatioRange RatioRange
....... presentationCodeableConcept CodeableConcept
....... presentationQuantity Quantity
...... textPresentation Σ 0..1 string Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)
...... concentration[x] SΣ 1..1 Quantity The strength per unitary volume (or mass)
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... value Σ 0..1 decimal Numerical value (with implicit precision)
....... comparator ?!Σ 0..1 code < | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.
....... unit Σ 0..1 string Unit representation
....... system ΣC 0..1 uri System that defines coded unit form
....... code SΣC 1..1 code Coded form of the unit
Binding: Percentage Units (required)
...... textConcentration Σ 0..1 string Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio)
...... basis Σ 0..1 CodeableConcept A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt)
...... measurementPoint Σ 0..1 string When strength is measured at a particular point or distance
...... country Σ 0..* CodeableConcept Where the strength range applies
Binding: CountryValueSet (example): Jurisdiction codes
...... referenceStrength Σ 0..* BackboneElement Strength expressed in terms of a reference substance
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... substance Σ 1..1 CodeableReference(SubstanceDefinition) Relevant reference substance
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
....... strength[x] Σ 1..1 Strength expressed in terms of a reference substance
........ strengthRatio Ratio
........ strengthRatioRange RatioRange
........ strengthQuantity Quantity
....... measurementPoint Σ 0..1 string When strength is measured at a particular point or distance
....... country Σ 0..* CodeableConcept Where the strength range applies
Binding: CountryValueSet (example): Jurisdiction codes

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Ingredient.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
From the FHIR Standard
Ingredient.statusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
From the FHIR Standard
Ingredient.roleexampleIngredientRole
http://hl7.org/fhir/ValueSet/ingredient-role
From the FHIR Standard
Ingredient.functionexampleIngredientFunction
http://hl7.org/fhir/ValueSet/ingredient-function
From the FHIR Standard
Ingredient.manufacturer.rolerequiredIngredientManufacturerRole
http://hl7.org/fhir/ValueSet/ingredient-manufacturer-role|5.0.0
From the FHIR Standard
Ingredient.substance.codeexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
From the FHIR Standard
Ingredient.substance.strength.countryexampleCountryValueSet
http://hl7.org/fhir/ValueSet/country
From the FHIR Standard
Ingredient.substance.strength.referenceStrength.substanceexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
From the FHIR Standard
Ingredient.substance.strength.referenceStrength.countryexampleCountryValueSet
http://hl7.org/fhir/ValueSet/country
From the FHIR Standard
Ingredient.substance.strength:perBatch.concentration[x].comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
From the FHIR Standard
Ingredient.substance.strength:perBatch.concentration[x].coderequiredPqcmcNonPercentageUnits
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units
From this IG
Ingredient.substance.strength:perBatch.countryexampleCountryValueSet
http://hl7.org/fhir/ValueSet/country
From the FHIR Standard
Ingredient.substance.strength:perBatch.referenceStrength.substanceexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
From the FHIR Standard
Ingredient.substance.strength:perBatch.referenceStrength.countryexampleCountryValueSet
http://hl7.org/fhir/ValueSet/country
From the FHIR Standard
Ingredient.substance.strength:percent.concentration[x].comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
From the FHIR Standard
Ingredient.substance.strength:percent.concentration[x].coderequiredPqcmcPercentageUnits
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units
From this IG
Ingredient.substance.strength:percent.countryexampleCountryValueSet
http://hl7.org/fhir/ValueSet/country
From the FHIR Standard
Ingredient.substance.strength:percent.referenceStrength.substanceexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
From the FHIR Standard
Ingredient.substance.strength:percent.referenceStrength.countryexampleCountryValueSet
http://hl7.org/fhir/ValueSet/country
From the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorIngredientIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorIngredientIf 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-4errorIngredientIf 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-5errorIngredientIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceIngredientA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ing-1errorIngredientIf 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:

Slices

This structure defines the following Slices:

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

Maturity: 2

 

Other representations of profile: CSV, Excel, Schematron