Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2

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

## Resource Profile: Drug Product Component

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component | Version: 2.0.0
Standards status: Trial-use | Maturity Level: 2 | Computable Name: DrugProductComponent
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.23

The amount details about the drug product components to define the product composition in a product unit. Use composition.

Usages:

- Use this Profile: CMC eCTD 32P10 Document
- Refer to this Profile: Manufactured Drug Product

### Formal Views of Profile Content

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

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

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
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.
for | Σ | 0..* | Reference(MedicinalProductDefinition | AdministrableProductDefinition | ManufacturedItemDefinition) | Reference to MedicinalProductDefinition
role | Σ | 1..1 | CodeableConcept | Purpose of the ingredient within the product, e.g. active, inactive Binding: Drug Product Component Function Category Terminology (required)
comment | S | 0..1 | markdown | Drug Product Component Additional Information
substance | Σ C | 1..1 | BackboneElement | The substance that comprises this ingredient Constraints: cmc-strength-type-cases2
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
code | S Σ C | 1..1 | LiteralCodeableReference(Component 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 | S Σ | 2..2 | BackboneElement | The quantity of substance, per presentation, or per volume or mass, and type of quantity Slice: Unordered, Closed by exists:textConcentration
strength:All Slices |  |  |  | Content/Rules for all slices
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
strength:amount | S Σ | 1..1 | BackboneElement | The quantity of substance, per presentation, or per volume or mass, and type of quantity
Slices for extension |  | 1..* | Extension | Extension Slice: Unordered, Open by value:url
extension:strengthFactors | S | 1..1 | CodeableConcept | Strength Type URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension Binding: Strength Type Terminology (required)
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
Slices for concentration[x] | S Σ | 1..1 |  | The strength per unitary volume (or mass) Slice: Unordered, Closed by type:$this
concentrationRatio |  |  | Ratio |
concentrationQuantity |  |  | Quantity |
concentration[x]:concentrationQuantity | S Σ | 0..1 | Quantity | The strength per unitary volume (or mass) Binding: Non-Percentage Units (required)
value | S Σ | 1..1 | decimal | Ingredient Total Amount Numeric
comparator | ?!S Σ | 0..1 | code | Ingredient Total Amount Operator Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit | Σ | 1..1 | string | Unit representation
concentration[x]:concentrationRatio | S Σ | 0..1 | Ratio | The strength per unitary volume (or mass)
numerator | S Σ C | 1..1 | Quantity | Numerator value Binding: Non-Percentage Units (required)
value | S Σ | 1..1 | decimal | Ingredient Total Amount Numeric Numerator
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit | Σ | 0..1 | string | Ingredient Total Amount Numeric Numerator UOM
code | S Σ C | 1..1 | code | Coded form of the unit
denominator | S Σ C | 1..1 | SimpleQuantity | Denominator value Binding: Non-Percentage Units (required)
value | S Σ | 1..1 | decimal | Ingredient Total Amount Numeric Denominator
unit | S Σ | 1..1 | string | Ingredient Total Amount Numeric Denominator UOM
code | S Σ C | 1..1 | code | Coded form of the unit
textConcentration | S Σ | 1..1 | string | Strength Textual
strength:percent | S Σ | 1..1 | 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
concentration[x] | S Σ | 1..1 | Quantity | The strength per unitary volume (or mass) Binding: Percentage Units (required)
value | S Σ | 1..1 | decimal | Ingredient Total Amount Content Percent
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
code | S Σ C | 1..1 | code | Ingredient Total Amount Content Percent UOM
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet | URI
Ingredient.status | required | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status|5.0.0` From the FHIR Standard
Ingredient.role | required | PqcmcDrugProductComponentFunctionCategoryTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology` From this IG
Ingredient.substance.code | example | SNOMEDCTSubstanceCodes `http://hl7.org/fhir/ValueSet/substance-codes` From the FHIR Standard
Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity | required | PqcmcNonPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units` From this IG
Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator | required | PqcmcNonPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units` From this IG
Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator | required | PqcmcNonPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units` From this IG
Ingredient.substance.strength:percent.concentration[x] | required | PqcmcPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units` From this IG
Ingredient.substance.strength:percent.concentration[x].comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard

#### Constraints

Id | Grade | Path(s) | Details | Requirements
cmc-strength-type-cases2 | error | Ingredient.substance | IF Strength Type = Activity THEN Strength Textual, Strength UOM ([arb'U]) and Strength Operator are applicable data elements. Strength Textual and Strength UOM will be Mandatory and Operator will be Optional. Codes 75765 [arb'U]; C45420 Activity. : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( strength .extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension') .extension.where( value.coding.where( code = 'C45420' and system = %system ).exists() ).exists() implies ( strength.presentation.ofType(Ratio).exists() and strength.presentation.numerator.where( code = '[arb\'U]' and system = 'http://unitsofmeasure.org' ) ) or ( strength.presentation.ofType(Quantity).exists() and strength.presentation.where( code = '[arb\'U]' and system = 'http://unitsofmeasure.org' ) )) |
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

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Ingredient |  |  | Ingredient |
for |  | 0..* | Reference(MedicinalProductDefinition | AdministrableProductDefinition | ManufacturedItemDefinition) | Reference to MedicinalProductDefinition
role |  | 1..1 | CodeableConcept | Purpose of the ingredient within the product, e.g. active, inactive Binding: Drug Product Component Function Category Terminology (required)
comment | S | 0..1 | markdown | Drug Product Component Additional Information
substance | C | 1..1 | BackboneElement | The substance that comprises this ingredient Constraints: cmc-strength-type-cases2
code | S | 1..1 | LiteralCodeableReference(Component 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 exists:textConcentration
strength:amount | S | 1..1 | BackboneElement | The quantity of substance, per presentation, or per volume or mass, and type of quantity
Slices for extension |  | 1..* | Extension | Extension Slice: Unordered, Open by value:url
extension:strengthFactors | S | 1..1 | CodeableConcept | Strength Type URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension Binding: Strength Type Terminology (required)
Slices for concentration[x] | S | 1..1 |  | The strength per unitary volume (or mass) Slice: Unordered, Open by type:$this
concentrationRatio |  |  | Ratio |
concentrationQuantity |  |  | Quantity |
concentration[x]:concentrationQuantity | S | 0..1 | Quantity | The strength per unitary volume (or mass) Binding: Non-Percentage Units (required)
value | S | 1..1 | decimal | Ingredient Total Amount Numeric
comparator | S | 0..1 | code | Ingredient Total Amount Operator
unit |  | 1..1 | string | Unit representation
concentration[x]:concentrationRatio | S | 0..1 | Ratio | The strength per unitary volume (or mass)
numerator | S | 1..1 | Quantity | Numerator value Binding: Non-Percentage Units (required)
value | S | 1..1 | decimal | Ingredient Total Amount Numeric Numerator
unit |  | 0..1 | string | Ingredient Total Amount Numeric Numerator UOM
code | S | 1..1 | code | Coded form of the unit
denominator | S | 1..1 | SimpleQuantity | Denominator value Binding: Non-Percentage Units (required)
value | S | 1..1 | decimal | Ingredient Total Amount Numeric Denominator
unit | S | 1..1 | string | Ingredient Total Amount Numeric Denominator UOM
code | S | 1..1 | code | Coded form of the unit
textConcentration | S | 1..1 | string | Strength Textual
strength:percent | S | 1..1 | BackboneElement | The quantity of substance, per presentation, or per volume or mass, and type of quantity
concentration[x] | S | 1..1 | Quantity | The strength per unitary volume (or mass) Binding: Percentage Units (required)
value | S | 1..1 | decimal | Ingredient Total Amount Content Percent
code | S | 1..1 | code | Ingredient Total Amount Content Percent UOM
textConcentration | S | 0..0 |  |
Documentation for this format

#### Terminology Bindings (Differential)

Path | Conformance | ValueSet | URI
Ingredient.role | required | PqcmcDrugProductComponentFunctionCategoryTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology` From this IG
Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity | required | PqcmcNonPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units` From this IG
Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator | required | PqcmcNonPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units` From this IG
Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator | required | PqcmcNonPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units` From this IG
Ingredient.substance.strength:percent.concentration[x] | required | PqcmcPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units` From this IG

#### Constraints

Id | Grade | Path(s) | Details | Requirements
cmc-strength-type-cases2 | error | Ingredient.substance | IF Strength Type = Activity THEN Strength Textual, Strength UOM ([arb'U]) and Strength Operator are applicable data elements. Strength Textual and Strength UOM will be Mandatory and Operator will be Optional. Codes 75765 [arb'U]; C45420 Activity. : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( strength .extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension') .extension.where( value.coding.where( code = 'C45420' and system = %system ).exists() ).exists() implies ( strength.presentation.ofType(Ratio).exists() and strength.presentation.numerator.where( code = '[arb\'U]' and system = 'http://unitsofmeasure.org' ) ) or ( strength.presentation.ofType(Quantity).exists() and strength.presentation.where( code = '[arb\'U]' and system = 'http://unitsofmeasure.org' ) )) |

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
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
language |  | 0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
Additional Bindings | Purpose
CommonLanguages | Starter
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 | Σ | 0..1 | Identifier | An identifier or code by which the ingredient can be referenced
status | ?!Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
for | Σ | 0..* | Reference(MedicinalProductDefinition | AdministrableProductDefinition | ManufacturedItemDefinition) | Reference to MedicinalProductDefinition
role | Σ | 1..1 | CodeableConcept | Purpose of the ingredient within the product, e.g. active, inactive Binding: Drug Product Component Function Category Terminology (required)
function | Σ | 0..* | CodeableConcept | Precise action within the drug product, e.g. antioxidant, alkalizing agent Binding: IngredientFunction (example): A classification of the ingredient identifying its precise purpose(s) in the drug product (beyond e.g. active/inactive).
group | Σ | 0..1 | CodeableConcept | A classification of the ingredient according to where in the physical item it tends to be used, such the outer shell of a tablet, inner body or ink
allergenicIndicator | Σ C | 0..1 | boolean | If the ingredient is a known or suspected allergen
comment | S | 0..1 | markdown | Drug Product Component Additional Information
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 | Σ C | 1..1 | BackboneElement | The substance that comprises this ingredient Constraints: cmc-strength-type-cases2
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
code | S Σ C | 1..1 | LiteralCodeableReference(Component 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 | S Σ | 2..2 | BackboneElement | The quantity of substance, per presentation, or per volume or mass, and type of quantity Slice: Unordered, Closed by exists:textConcentration
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:amount | S Σ | 1..1 | BackboneElement | The quantity of substance, per presentation, or per volume or mass, and type of quantity
id |  | 0..1 | string | Unique id for inter-element referencing
Slices for extension |  | 1..* | Extension | Extension Slice: Unordered, Open by value:url
extension:strengthFactors | S | 1..1 | CodeableConcept | Strength Type URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension Binding: Strength Type Terminology (required)
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)
Slices for concentration[x] | S Σ | 1..1 |  | The strength per unitary volume (or mass) Slice: Unordered, Closed by type:$this
concentrationRatio |  |  | Ratio |
concentrationQuantity |  |  | Quantity |
concentration[x]:concentrationQuantity | S Σ | 0..1 | Quantity | The strength per unitary volume (or mass) Binding: Non-Percentage Units (required)
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 | S Σ | 1..1 | decimal | Ingredient Total Amount Numeric
comparator | ?!S Σ | 0..1 | code | Ingredient Total Amount Operator Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit | Σ | 1..1 | string | Unit representation
system | Σ C | 0..1 | uri | System that defines coded unit form
code | Σ C | 0..1 | code | Coded form of the unit
concentration[x]:concentrationRatio | S Σ | 0..1 | Ratio | 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
numerator | S Σ C | 1..1 | Quantity | Numerator value Binding: Non-Percentage Units (required)
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 | S Σ | 1..1 | decimal | Ingredient Total Amount Numeric Numerator
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit | Σ | 0..1 | string | Ingredient Total Amount Numeric Numerator UOM
system | Σ C | 0..1 | uri | System that defines coded unit form
code | S Σ C | 1..1 | code | Coded form of the unit
denominator | S Σ C | 1..1 | SimpleQuantity | Denominator value Binding: Non-Percentage Units (required)
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 | S Σ | 1..1 | decimal | Ingredient Total Amount Numeric Denominator
unit | S Σ | 1..1 | string | Ingredient Total Amount Numeric Denominator UOM
system | Σ C | 0..1 | uri | System that defines coded unit form
code | S Σ C | 1..1 | code | Coded form of the unit
textConcentration | S Σ | 1..1 | string | Strength Textual
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 | S Σ | 1..1 | BackboneElement | The quantity of substance, per presentation, or per volume or mass, and type of quantity
id |  | 0..1 | string | Unique id for inter-element referencing
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] | S Σ | 1..1 | Quantity | The strength per unitary volume (or mass) Binding: Percentage Units (required)
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 | S Σ | 1..1 | decimal | Ingredient Total Amount Content Percent
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 | Σ C | 0..1 | uri | System that defines coded unit form
code | S Σ C | 1..1 | code | Ingredient Total Amount Content Percent UOM
basis | Σ | 0..1 | CodeableConcept | A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt)
measurementPoint | Σ | 0..1 | string | When strength is measured at a particular point or distance
country | Σ | 0..* | CodeableConcept | Where the strength range applies Binding: CountryValueSet (example): Jurisdiction codes
referenceStrength | Σ | 0..* | BackboneElement | Strength expressed in terms of a reference substance
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
substance | Σ | 1..1 | CodeableReference(SubstanceDefinition) | Relevant reference substance Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
strength[x] | Σ | 1..1 |  | Strength expressed in terms of a reference substance
strengthRatio |  |  | Ratio |
strengthRatioRange |  |  | RatioRange |
strengthQuantity |  |  | Quantity |
measurementPoint | Σ | 0..1 | string | When strength is measured at a particular point or distance
country | Σ | 0..* | CodeableConcept | Where the strength range applies Binding: CountryValueSet (example): Jurisdiction codes
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet | URI
Ingredient.language | required | AllLanguages `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` From the FHIR Standard
Ingredient.status | required | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status|5.0.0` From the FHIR Standard
Ingredient.role | required | PqcmcDrugProductComponentFunctionCategoryTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology` From this IG
Ingredient.function | example | IngredientFunction `http://hl7.org/fhir/ValueSet/ingredient-function` From the FHIR Standard
Ingredient.manufacturer.role | required | IngredientManufacturerRole `http://hl7.org/fhir/ValueSet/ingredient-manufacturer-role|5.0.0` From the FHIR Standard
Ingredient.substance.code | example | SNOMEDCTSubstanceCodes `http://hl7.org/fhir/ValueSet/substance-codes` From the FHIR Standard
Ingredient.substance.strength.country | example | CountryValueSet `http://hl7.org/fhir/ValueSet/country` From the FHIR Standard
Ingredient.substance.strength.referenceStrength.substance | example | SNOMEDCTSubstanceCodes `http://hl7.org/fhir/ValueSet/substance-codes` From the FHIR Standard
Ingredient.substance.strength.referenceStrength.country | example | CountryValueSet `http://hl7.org/fhir/ValueSet/country` From the FHIR Standard
Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity | required | PqcmcNonPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units` From this IG
Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator | required | PqcmcNonPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units` From this IG
Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator | required | PqcmcNonPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units` From this IG
Ingredient.substance.strength:amount.country | example | CountryValueSet `http://hl7.org/fhir/ValueSet/country` From the FHIR Standard
Ingredient.substance.strength:amount.referenceStrength.substance | example | SNOMEDCTSubstanceCodes `http://hl7.org/fhir/ValueSet/substance-codes` From the FHIR Standard
Ingredient.substance.strength:amount.referenceStrength.country | example | CountryValueSet `http://hl7.org/fhir/ValueSet/country` From the FHIR Standard
Ingredient.substance.strength:percent.concentration[x] | required | PqcmcPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units` From this IG
Ingredient.substance.strength:percent.concentration[x].comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
Ingredient.substance.strength:percent.country | example | CountryValueSet `http://hl7.org/fhir/ValueSet/country` From the FHIR Standard
Ingredient.substance.strength:percent.referenceStrength.substance | example | SNOMEDCTSubstanceCodes `http://hl7.org/fhir/ValueSet/substance-codes` From the FHIR Standard
Ingredient.substance.strength:percent.referenceStrength.country | example | CountryValueSet `http://hl7.org/fhir/ValueSet/country` From the FHIR Standard

#### Constraints

Id | Grade | Path(s) | Details | Requirements
cmc-strength-type-cases2 | error | Ingredient.substance | IF Strength Type = Activity THEN Strength Textual, Strength UOM ([arb'U]) and Strength Operator are applicable data elements. Strength Textual and Strength UOM will be Mandatory and Operator will be Optional. Codes 75765 [arb'U]; C45420 Activity. : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( strength .extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension') .extension.where( value.coding.where( code = 'C45420' and system = %system ).exists() ).exists() implies ( strength.presentation.ofType(Ratio).exists() and strength.presentation.numerator.where( code = '[arb\'U]' and system = 'http://unitsofmeasure.org' ) ) or ( strength.presentation.ofType(Quantity).exists() and strength.presentation.where( code = '[arb\'U]' and system = 'http://unitsofmeasure.org' ) )) |
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: 9 elements(9 nested mandatory elements)
Must-Support: 23 elements
Prohibited: 1 element

Structures

This structure refers to these other structures:

- Literal Coded Reference (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-codeable-reference)
- Component Substance (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component-substance)

Extensions

This structure refers to these extensions:

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

Slices

This structure defines the following Slices:

- The element 1 is sliced based on the value of Ingredient.substance.strength (Closed)
- The element 1 is sliced based on the value of Ingredient.substance.strength.concentration[x]

Maturity: 2

Key Elements View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
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.
for | Σ | 0..* | Reference(MedicinalProductDefinition | AdministrableProductDefinition | ManufacturedItemDefinition) | Reference to MedicinalProductDefinition
role | Σ | 1..1 | CodeableConcept | Purpose of the ingredient within the product, e.g. active, inactive Binding: Drug Product Component Function Category Terminology (required)
comment | S | 0..1 | markdown | Drug Product Component Additional Information
substance | Σ C | 1..1 | BackboneElement | The substance that comprises this ingredient Constraints: cmc-strength-type-cases2
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
code | S Σ C | 1..1 | LiteralCodeableReference(Component 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 | S Σ | 2..2 | BackboneElement | The quantity of substance, per presentation, or per volume or mass, and type of quantity Slice: Unordered, Closed by exists:textConcentration
strength:All Slices |  |  |  | Content/Rules for all slices
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
strength:amount | S Σ | 1..1 | BackboneElement | The quantity of substance, per presentation, or per volume or mass, and type of quantity
Slices for extension |  | 1..* | Extension | Extension Slice: Unordered, Open by value:url
extension:strengthFactors | S | 1..1 | CodeableConcept | Strength Type URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension Binding: Strength Type Terminology (required)
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
Slices for concentration[x] | S Σ | 1..1 |  | The strength per unitary volume (or mass) Slice: Unordered, Closed by type:$this
concentrationRatio |  |  | Ratio |
concentrationQuantity |  |  | Quantity |
concentration[x]:concentrationQuantity | S Σ | 0..1 | Quantity | The strength per unitary volume (or mass) Binding: Non-Percentage Units (required)
value | S Σ | 1..1 | decimal | Ingredient Total Amount Numeric
comparator | ?!S Σ | 0..1 | code | Ingredient Total Amount Operator Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit | Σ | 1..1 | string | Unit representation
concentration[x]:concentrationRatio | S Σ | 0..1 | Ratio | The strength per unitary volume (or mass)
numerator | S Σ C | 1..1 | Quantity | Numerator value Binding: Non-Percentage Units (required)
value | S Σ | 1..1 | decimal | Ingredient Total Amount Numeric Numerator
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit | Σ | 0..1 | string | Ingredient Total Amount Numeric Numerator UOM
code | S Σ C | 1..1 | code | Coded form of the unit
denominator | S Σ C | 1..1 | SimpleQuantity | Denominator value Binding: Non-Percentage Units (required)
value | S Σ | 1..1 | decimal | Ingredient Total Amount Numeric Denominator
unit | S Σ | 1..1 | string | Ingredient Total Amount Numeric Denominator UOM
code | S Σ C | 1..1 | code | Coded form of the unit
textConcentration | S Σ | 1..1 | string | Strength Textual
strength:percent | S Σ | 1..1 | 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
concentration[x] | S Σ | 1..1 | Quantity | The strength per unitary volume (or mass) Binding: Percentage Units (required)
value | S Σ | 1..1 | decimal | Ingredient Total Amount Content Percent
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
code | S Σ C | 1..1 | code | Ingredient Total Amount Content Percent UOM
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet | URI
Ingredient.status | required | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status|5.0.0` From the FHIR Standard
Ingredient.role | required | PqcmcDrugProductComponentFunctionCategoryTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology` From this IG
Ingredient.substance.code | example | SNOMEDCTSubstanceCodes `http://hl7.org/fhir/ValueSet/substance-codes` From the FHIR Standard
Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity | required | PqcmcNonPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units` From this IG
Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator | required | PqcmcNonPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units` From this IG
Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator | required | PqcmcNonPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units` From this IG
Ingredient.substance.strength:percent.concentration[x] | required | PqcmcPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units` From this IG
Ingredient.substance.strength:percent.concentration[x].comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard

#### Constraints

Id | Grade | Path(s) | Details | Requirements
cmc-strength-type-cases2 | error | Ingredient.substance | IF Strength Type = Activity THEN Strength Textual, Strength UOM ([arb'U]) and Strength Operator are applicable data elements. Strength Textual and Strength UOM will be Mandatory and Operator will be Optional. Codes 75765 [arb'U]; C45420 Activity. : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( strength .extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension') .extension.where( value.coding.where( code = 'C45420' and system = %system ).exists() ).exists() implies ( strength.presentation.ofType(Ratio).exists() and strength.presentation.numerator.where( code = '[arb\'U]' and system = 'http://unitsofmeasure.org' ) ) or ( strength.presentation.ofType(Quantity).exists() and strength.presentation.where( code = '[arb\'U]' and system = 'http://unitsofmeasure.org' ) )) |
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

This structure is derived from Ingredient

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Ingredient |  |  | Ingredient |
for |  | 0..* | Reference(MedicinalProductDefinition | AdministrableProductDefinition | ManufacturedItemDefinition) | Reference to MedicinalProductDefinition
role |  | 1..1 | CodeableConcept | Purpose of the ingredient within the product, e.g. active, inactive Binding: Drug Product Component Function Category Terminology (required)
comment | S | 0..1 | markdown | Drug Product Component Additional Information
substance | C | 1..1 | BackboneElement | The substance that comprises this ingredient Constraints: cmc-strength-type-cases2
code | S | 1..1 | LiteralCodeableReference(Component 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 exists:textConcentration
strength:amount | S | 1..1 | BackboneElement | The quantity of substance, per presentation, or per volume or mass, and type of quantity
Slices for extension |  | 1..* | Extension | Extension Slice: Unordered, Open by value:url
extension:strengthFactors | S | 1..1 | CodeableConcept | Strength Type URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension Binding: Strength Type Terminology (required)
Slices for concentration[x] | S | 1..1 |  | The strength per unitary volume (or mass) Slice: Unordered, Open by type:$this
concentrationRatio |  |  | Ratio |
concentrationQuantity |  |  | Quantity |
concentration[x]:concentrationQuantity | S | 0..1 | Quantity | The strength per unitary volume (or mass) Binding: Non-Percentage Units (required)
value | S | 1..1 | decimal | Ingredient Total Amount Numeric
comparator | S | 0..1 | code | Ingredient Total Amount Operator
unit |  | 1..1 | string | Unit representation
concentration[x]:concentrationRatio | S | 0..1 | Ratio | The strength per unitary volume (or mass)
numerator | S | 1..1 | Quantity | Numerator value Binding: Non-Percentage Units (required)
value | S | 1..1 | decimal | Ingredient Total Amount Numeric Numerator
unit |  | 0..1 | string | Ingredient Total Amount Numeric Numerator UOM
code | S | 1..1 | code | Coded form of the unit
denominator | S | 1..1 | SimpleQuantity | Denominator value Binding: Non-Percentage Units (required)
value | S | 1..1 | decimal | Ingredient Total Amount Numeric Denominator
unit | S | 1..1 | string | Ingredient Total Amount Numeric Denominator UOM
code | S | 1..1 | code | Coded form of the unit
textConcentration | S | 1..1 | string | Strength Textual
strength:percent | S | 1..1 | BackboneElement | The quantity of substance, per presentation, or per volume or mass, and type of quantity
concentration[x] | S | 1..1 | Quantity | The strength per unitary volume (or mass) Binding: Percentage Units (required)
value | S | 1..1 | decimal | Ingredient Total Amount Content Percent
code | S | 1..1 | code | Ingredient Total Amount Content Percent UOM
textConcentration | S | 0..0 |  |
Documentation for this format

#### Terminology Bindings (Differential)

Path | Conformance | ValueSet | URI
Ingredient.role | required | PqcmcDrugProductComponentFunctionCategoryTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology` From this IG
Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity | required | PqcmcNonPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units` From this IG
Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator | required | PqcmcNonPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units` From this IG
Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator | required | PqcmcNonPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units` From this IG
Ingredient.substance.strength:percent.concentration[x] | required | PqcmcPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units` From this IG

#### Constraints

Id | Grade | Path(s) | Details | Requirements
cmc-strength-type-cases2 | error | Ingredient.substance | IF Strength Type = Activity THEN Strength Textual, Strength UOM ([arb'U]) and Strength Operator are applicable data elements. Strength Textual and Strength UOM will be Mandatory and Operator will be Optional. Codes 75765 [arb'U]; C45420 Activity. : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( strength .extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension') .extension.where( value.coding.where( code = 'C45420' and system = %system ).exists() ).exists() implies ( strength.presentation.ofType(Ratio).exists() and strength.presentation.numerator.where( code = '[arb\'U]' and system = 'http://unitsofmeasure.org' ) ) or ( strength.presentation.ofType(Quantity).exists() and strength.presentation.where( code = '[arb\'U]' and system = 'http://unitsofmeasure.org' ) )) |

Snapshot View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
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
language |  | 0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
Additional Bindings | Purpose
CommonLanguages | Starter
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 | Σ | 0..1 | Identifier | An identifier or code by which the ingredient can be referenced
status | ?!Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
for | Σ | 0..* | Reference(MedicinalProductDefinition | AdministrableProductDefinition | ManufacturedItemDefinition) | Reference to MedicinalProductDefinition
role | Σ | 1..1 | CodeableConcept | Purpose of the ingredient within the product, e.g. active, inactive Binding: Drug Product Component Function Category Terminology (required)
function | Σ | 0..* | CodeableConcept | Precise action within the drug product, e.g. antioxidant, alkalizing agent Binding: IngredientFunction (example): A classification of the ingredient identifying its precise purpose(s) in the drug product (beyond e.g. active/inactive).
group | Σ | 0..1 | CodeableConcept | A classification of the ingredient according to where in the physical item it tends to be used, such the outer shell of a tablet, inner body or ink
allergenicIndicator | Σ C | 0..1 | boolean | If the ingredient is a known or suspected allergen
comment | S | 0..1 | markdown | Drug Product Component Additional Information
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 | Σ C | 1..1 | BackboneElement | The substance that comprises this ingredient Constraints: cmc-strength-type-cases2
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
code | S Σ C | 1..1 | LiteralCodeableReference(Component 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 | S Σ | 2..2 | BackboneElement | The quantity of substance, per presentation, or per volume or mass, and type of quantity Slice: Unordered, Closed by exists:textConcentration
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:amount | S Σ | 1..1 | BackboneElement | The quantity of substance, per presentation, or per volume or mass, and type of quantity
id |  | 0..1 | string | Unique id for inter-element referencing
Slices for extension |  | 1..* | Extension | Extension Slice: Unordered, Open by value:url
extension:strengthFactors | S | 1..1 | CodeableConcept | Strength Type URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension Binding: Strength Type Terminology (required)
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)
Slices for concentration[x] | S Σ | 1..1 |  | The strength per unitary volume (or mass) Slice: Unordered, Closed by type:$this
concentrationRatio |  |  | Ratio |
concentrationQuantity |  |  | Quantity |
concentration[x]:concentrationQuantity | S Σ | 0..1 | Quantity | The strength per unitary volume (or mass) Binding: Non-Percentage Units (required)
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 | S Σ | 1..1 | decimal | Ingredient Total Amount Numeric
comparator | ?!S Σ | 0..1 | code | Ingredient Total Amount Operator Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit | Σ | 1..1 | string | Unit representation
system | Σ C | 0..1 | uri | System that defines coded unit form
code | Σ C | 0..1 | code | Coded form of the unit
concentration[x]:concentrationRatio | S Σ | 0..1 | Ratio | 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
numerator | S Σ C | 1..1 | Quantity | Numerator value Binding: Non-Percentage Units (required)
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 | S Σ | 1..1 | decimal | Ingredient Total Amount Numeric Numerator
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit | Σ | 0..1 | string | Ingredient Total Amount Numeric Numerator UOM
system | Σ C | 0..1 | uri | System that defines coded unit form
code | S Σ C | 1..1 | code | Coded form of the unit
denominator | S Σ C | 1..1 | SimpleQuantity | Denominator value Binding: Non-Percentage Units (required)
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 | S Σ | 1..1 | decimal | Ingredient Total Amount Numeric Denominator
unit | S Σ | 1..1 | string | Ingredient Total Amount Numeric Denominator UOM
system | Σ C | 0..1 | uri | System that defines coded unit form
code | S Σ C | 1..1 | code | Coded form of the unit
textConcentration | S Σ | 1..1 | string | Strength Textual
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 | S Σ | 1..1 | BackboneElement | The quantity of substance, per presentation, or per volume or mass, and type of quantity
id |  | 0..1 | string | Unique id for inter-element referencing
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] | S Σ | 1..1 | Quantity | The strength per unitary volume (or mass) Binding: Percentage Units (required)
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 | S Σ | 1..1 | decimal | Ingredient Total Amount Content Percent
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 | Σ C | 0..1 | uri | System that defines coded unit form
code | S Σ C | 1..1 | code | Ingredient Total Amount Content Percent UOM
basis | Σ | 0..1 | CodeableConcept | A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt)
measurementPoint | Σ | 0..1 | string | When strength is measured at a particular point or distance
country | Σ | 0..* | CodeableConcept | Where the strength range applies Binding: CountryValueSet (example): Jurisdiction codes
referenceStrength | Σ | 0..* | BackboneElement | Strength expressed in terms of a reference substance
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
substance | Σ | 1..1 | CodeableReference(SubstanceDefinition) | Relevant reference substance Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
strength[x] | Σ | 1..1 |  | Strength expressed in terms of a reference substance
strengthRatio |  |  | Ratio |
strengthRatioRange |  |  | RatioRange |
strengthQuantity |  |  | Quantity |
measurementPoint | Σ | 0..1 | string | When strength is measured at a particular point or distance
country | Σ | 0..* | CodeableConcept | Where the strength range applies Binding: CountryValueSet (example): Jurisdiction codes
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet | URI
Ingredient.language | required | AllLanguages `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` From the FHIR Standard
Ingredient.status | required | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status|5.0.0` From the FHIR Standard
Ingredient.role | required | PqcmcDrugProductComponentFunctionCategoryTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology` From this IG
Ingredient.function | example | IngredientFunction `http://hl7.org/fhir/ValueSet/ingredient-function` From the FHIR Standard
Ingredient.manufacturer.role | required | IngredientManufacturerRole `http://hl7.org/fhir/ValueSet/ingredient-manufacturer-role|5.0.0` From the FHIR Standard
Ingredient.substance.code | example | SNOMEDCTSubstanceCodes `http://hl7.org/fhir/ValueSet/substance-codes` From the FHIR Standard
Ingredient.substance.strength.country | example | CountryValueSet `http://hl7.org/fhir/ValueSet/country` From the FHIR Standard
Ingredient.substance.strength.referenceStrength.substance | example | SNOMEDCTSubstanceCodes `http://hl7.org/fhir/ValueSet/substance-codes` From the FHIR Standard
Ingredient.substance.strength.referenceStrength.country | example | CountryValueSet `http://hl7.org/fhir/ValueSet/country` From the FHIR Standard
Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity | required | PqcmcNonPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units` From this IG
Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator | required | PqcmcNonPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units` From this IG
Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator | required | PqcmcNonPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units` From this IG
Ingredient.substance.strength:amount.country | example | CountryValueSet `http://hl7.org/fhir/ValueSet/country` From the FHIR Standard
Ingredient.substance.strength:amount.referenceStrength.substance | example | SNOMEDCTSubstanceCodes `http://hl7.org/fhir/ValueSet/substance-codes` From the FHIR Standard
Ingredient.substance.strength:amount.referenceStrength.country | example | CountryValueSet `http://hl7.org/fhir/ValueSet/country` From the FHIR Standard
Ingredient.substance.strength:percent.concentration[x] | required | PqcmcPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units` From this IG
Ingredient.substance.strength:percent.concentration[x].comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
Ingredient.substance.strength:percent.country | example | CountryValueSet `http://hl7.org/fhir/ValueSet/country` From the FHIR Standard
Ingredient.substance.strength:percent.referenceStrength.substance | example | SNOMEDCTSubstanceCodes `http://hl7.org/fhir/ValueSet/substance-codes` From the FHIR Standard
Ingredient.substance.strength:percent.referenceStrength.country | example | CountryValueSet `http://hl7.org/fhir/ValueSet/country` From the FHIR Standard

#### Constraints

Id | Grade | Path(s) | Details | Requirements
cmc-strength-type-cases2 | error | Ingredient.substance | IF Strength Type = Activity THEN Strength Textual, Strength UOM ([arb'U]) and Strength Operator are applicable data elements. Strength Textual and Strength UOM will be Mandatory and Operator will be Optional. Codes 75765 [arb'U]; C45420 Activity. : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( strength .extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension') .extension.where( value.coding.where( code = 'C45420' and system = %system ).exists() ).exists() implies ( strength.presentation.ofType(Ratio).exists() and strength.presentation.numerator.where( code = '[arb\'U]' and system = 'http://unitsofmeasure.org' ) ) or ( strength.presentation.ofType(Quantity).exists() and strength.presentation.where( code = '[arb\'U]' and system = 'http://unitsofmeasure.org' ) )) |
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: 9 elements(9 nested mandatory elements)
Must-Support: 23 elements
Prohibited: 1 element

Structures

This structure refers to these other structures:

- Literal Coded Reference (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-codeable-reference)
- Component Substance (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component-substance)

Extensions

This structure refers to these extensions:

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

Slices

This structure defines the following Slices:

- The element 1 is sliced based on the value of Ingredient.substance.strength (Closed)
- The element 1 is sliced based on the value of Ingredient.substance.strength.concentration[x]

Maturity: 2

Other representations of profile: CSV, Excel, Schematron