Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - 2025Jan
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - 2025Jan
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions
| Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component | Version: 2.0.0-ballot | |||
| Active as of 2024-12-04 | 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.
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from Ingredient
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  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 cmc-strength-type-cases2: 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. |
  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 | |
  strengthFactors |
S | 1..1 | CodeableConcept | Strength Extension 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 | ||||
| Path | Conformance | ValueSet | URI |
| Ingredient.role | required | PqcmcDrugProductComponentFunctionCategoryTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminologyfrom this IG | |
| Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity | required | PqcmcNonPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-unitsfrom this IG | |
| Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator | required | PqcmcNonPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-unitsfrom this IG | |
| Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator | required | PqcmcNonPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-unitsfrom this IG | |
| Ingredient.substance.strength:percent.concentration[x] | required | PqcmcPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-unitsfrom this IG |
| 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 |
|---|---|---|---|---|
| Ingredient |
C | 0..* | Ingredient | An ingredient of a manufactured item or pharmaceutical product ing-1: If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource |
 implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
| contained |
0..* | Resource | Contained, inline Resources | |
 modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored |
| 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 |
ΣC | 1..1 | BackboneElement | The substance that comprises this ingredient cmc-strength-type-cases2: 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. |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| code |
S | 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 |
SΣ | 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 |
SΣ | 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 | |
| strengthFactors |
S | 1..1 | CodeableConcept | Strength Extension 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] |
SΣ | 1..1 | The strength per unitary volume (or mass) Slice: Unordered, Closed by type:$this | |
| concentrationRatio |
Ratio | |||
| concentrationQuantity |
Quantity | |||
| concentration[x]:concentrationQuantity |
SΣ | 0..1 | Quantity | The strength per unitary volume (or mass) Binding: Non-Percentage Units (required) |
| value |
SΣ | 1..1 | decimal | Ingredient Total Amount Numeric |
| comparator |
?!SΣ | 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 |
SΣ | 0..1 | Ratio | The strength per unitary volume (or mass) |
| numerator |
SΣC | 1..1 | Quantity | Numerator value Binding: Non-Percentage Units (required) |
| value |
SΣ | 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 |
SΣC | 1..1 | code | Coded form of the unit |
| denominator |
SΣC | 1..1 | SimpleQuantity | Denominator value Binding: Non-Percentage Units (required) |
| value |
SΣ | 1..1 | decimal | Ingredient Total Amount Numeric Denominator |
| unit |
SΣ | 1..1 | string | Ingredient Total Amount Numeric Denominator UOM |
| code |
SΣC | 1..1 | code | Coded form of the unit |
| textConcentration |
SΣ | 1..1 | string | Strength Textual |
| strength:percent |
SΣ | 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] |
SΣ | 1..1 | Quantity | The strength per unitary volume (or mass) Binding: Percentage Units (required) |
| value |
SΣ | 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 |
SΣC | 1..1 | code | Ingredient Total Amount Content Percent UOM |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| Ingredient.status | required | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status|5.0.0from the FHIR Standard | |
| Ingredient.role | required | PqcmcDrugProductComponentFunctionCategoryTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminologyfrom this IG | |
| Ingredient.substance.code | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codesfrom the FHIR Standard | |
| Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity | required | PqcmcNonPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-unitsfrom this IG | |
| Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0from the FHIR Standard | |
| Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator | required | PqcmcNonPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-unitsfrom this IG | |
| Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0from the FHIR Standard | |
| Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator | required | PqcmcNonPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-unitsfrom this IG | |
| Ingredient.substance.strength:percent.concentration[x] | required | PqcmcPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-unitsfrom this IG | |
| Ingredient.substance.strength:percent.concentration[x].comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0from the FHIR Standard |
| 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 |
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| Ingredient |
C | 0..* | Ingredient | An ingredient of a manufactured item or pharmaceutical product ing-1: If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource | ||||
| id |
Σ | 0..1 | id | Logical id of this artifact | ||||
| meta |
Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language |
0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
| |||||
| text |
0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained |
0..* | Resource | Contained, inline Resources | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier |
Σ | 0..1 | Identifier | An identifier or code by which the ingredient can be referenced | ||||
| status |
?!Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact. | ||||
| 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 |
ΣC | 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 |
ΣC | 1..1 | BackboneElement | The substance that comprises this ingredient cmc-strength-type-cases2: 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. | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| code |
S | 1..1 | LiteralCodeableReference(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 |
SΣ | 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 |
SΣ | 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 | |||||
| strengthFactors |
S | 1..1 | CodeableConcept | Strength Extension 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] |
SΣ | 1..1 | The strength per unitary volume (or mass) Slice: Unordered, Closed by type:$this | |||||
| concentrationRatio |
Ratio | |||||||
| concentrationQuantity |
Quantity | |||||||
| concentration[x]:concentrationQuantity |
SΣ | 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 |
SΣ | 1..1 | decimal | Ingredient Total Amount Numeric | ||||
| comparator |
?!SΣ | 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 |
ΣC | 0..1 | uri | System that defines coded unit form | ||||
| code |
ΣC | 0..1 | code | Coded form of the unit | ||||
| concentration[x]:concentrationRatio |
SΣ | 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 |
SΣC | 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 |
SΣ | 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 |
ΣC | 0..1 | uri | System that defines coded unit form | ||||
| code |
SΣC | 1..1 | code | Coded form of the unit | ||||
| denominator |
SΣC | 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 |
SΣ | 1..1 | decimal | Ingredient Total Amount Numeric Denominator | ||||
| unit |
SΣ | 1..1 | string | Ingredient Total Amount Numeric Denominator UOM | ||||
| system |
ΣC | 0..1 | uri | System that defines coded unit form | ||||
| code |
SΣC | 1..1 | code | Coded form of the unit | ||||
| textConcentration |
SΣ | 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 |
SΣ | 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] |
SΣ | 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 |
SΣ | 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 |
ΣC | 0..1 | uri | System that defines coded unit form | ||||
| code |
SΣC | 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 | ||||||||
| Path | Conformance | ValueSet | URI |
| Ingredient.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| Ingredient.status | required | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status|5.0.0from the FHIR Standard | |
| Ingredient.role | required | PqcmcDrugProductComponentFunctionCategoryTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminologyfrom this IG | |
| Ingredient.function | example | IngredientFunctionhttp://hl7.org/fhir/ValueSet/ingredient-functionfrom the FHIR Standard | |
| Ingredient.manufacturer.role | required | IngredientManufacturerRolehttp://hl7.org/fhir/ValueSet/ingredient-manufacturer-role|5.0.0from the FHIR Standard | |
| Ingredient.substance.code | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codesfrom the FHIR Standard | |
| Ingredient.substance.strength.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/countryfrom the FHIR Standard | |
| Ingredient.substance.strength.referenceStrength.substance | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codesfrom the FHIR Standard | |
| Ingredient.substance.strength.referenceStrength.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/countryfrom the FHIR Standard | |
| Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity | required | PqcmcNonPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-unitsfrom this IG | |
| Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0from the FHIR Standard | |
| Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator | required | PqcmcNonPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-unitsfrom this IG | |
| Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0from the FHIR Standard | |
| Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator | required | PqcmcNonPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-unitsfrom this IG | |
| Ingredient.substance.strength:amount.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/countryfrom the FHIR Standard | |
| Ingredient.substance.strength:amount.referenceStrength.substance | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codesfrom the FHIR Standard | |
| Ingredient.substance.strength:amount.referenceStrength.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/countryfrom the FHIR Standard | |
| Ingredient.substance.strength:percent.concentration[x] | required | PqcmcPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-unitsfrom this IG | |
| Ingredient.substance.strength:percent.concentration[x].comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0from the FHIR Standard | |
| Ingredient.substance.strength:percent.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/countryfrom the FHIR Standard | |
| Ingredient.substance.strength:percent.referenceStrength.substance | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codesfrom the FHIR Standard | |
| Ingredient.substance.strength:percent.referenceStrength.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/countryfrom the FHIR Standard |
| 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:
Extensions
This structure refers to these extensions:
Slices
This structure defines the following Slices:
Differential View
This structure is derived from Ingredient
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| 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 cmc-strength-type-cases2: 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. |
| 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 | |
| strengthFactors |
S | 1..1 | CodeableConcept | Strength Extension 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 | ||||
| Path | Conformance | ValueSet | URI |
| Ingredient.role | required | PqcmcDrugProductComponentFunctionCategoryTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminologyfrom this IG | |
| Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity | required | PqcmcNonPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-unitsfrom this IG | |
| Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator | required | PqcmcNonPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-unitsfrom this IG | |
| Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator | required | PqcmcNonPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-unitsfrom this IG | |
| Ingredient.substance.strength:percent.concentration[x] | required | PqcmcPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-unitsfrom this IG |
| 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' ) )) |
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Ingredient |
C | 0..* | Ingredient | An ingredient of a manufactured item or pharmaceutical product ing-1: If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource |
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
| contained |
0..* | Resource | Contained, inline Resources | |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored |
| 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 |
ΣC | 1..1 | BackboneElement | The substance that comprises this ingredient cmc-strength-type-cases2: 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. |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| code |
S | 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 |
SΣ | 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 |
SΣ | 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 | |
| strengthFactors |
S | 1..1 | CodeableConcept | Strength Extension 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] |
SΣ | 1..1 | The strength per unitary volume (or mass) Slice: Unordered, Closed by type:$this | |
| concentrationRatio |
Ratio | |||
| concentrationQuantity |
Quantity | |||
| concentration[x]:concentrationQuantity |
SΣ | 0..1 | Quantity | The strength per unitary volume (or mass) Binding: Non-Percentage Units (required) |
| value |
SΣ | 1..1 | decimal | Ingredient Total Amount Numeric |
| comparator |
?!SΣ | 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 |
SΣ | 0..1 | Ratio | The strength per unitary volume (or mass) |
| numerator |
SΣC | 1..1 | Quantity | Numerator value Binding: Non-Percentage Units (required) |
| value |
SΣ | 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 |
SΣC | 1..1 | code | Coded form of the unit |
| denominator |
SΣC | 1..1 | SimpleQuantity | Denominator value Binding: Non-Percentage Units (required) |
| value |
SΣ | 1..1 | decimal | Ingredient Total Amount Numeric Denominator |
| unit |
SΣ | 1..1 | string | Ingredient Total Amount Numeric Denominator UOM |
| code |
SΣC | 1..1 | code | Coded form of the unit |
| textConcentration |
SΣ | 1..1 | string | Strength Textual |
| strength:percent |
SΣ | 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] |
SΣ | 1..1 | Quantity | The strength per unitary volume (or mass) Binding: Percentage Units (required) |
| value |
SΣ | 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 |
SΣC | 1..1 | code | Ingredient Total Amount Content Percent UOM |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| Ingredient.status | required | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status|5.0.0from the FHIR Standard | |
| Ingredient.role | required | PqcmcDrugProductComponentFunctionCategoryTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminologyfrom this IG | |
| Ingredient.substance.code | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codesfrom the FHIR Standard | |
| Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity | required | PqcmcNonPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-unitsfrom this IG | |
| Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0from the FHIR Standard | |
| Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator | required | PqcmcNonPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-unitsfrom this IG | |
| Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0from the FHIR Standard | |
| Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator | required | PqcmcNonPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-unitsfrom this IG | |
| Ingredient.substance.strength:percent.concentration[x] | required | PqcmcPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-unitsfrom this IG | |
| Ingredient.substance.strength:percent.concentration[x].comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0from the FHIR Standard |
| 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 |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| Ingredient |
C | 0..* | Ingredient | An ingredient of a manufactured item or pharmaceutical product ing-1: If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource | ||||
| id |
Σ | 0..1 | id | Logical id of this artifact | ||||
| meta |
Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language |
0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
| |||||
| text |
0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained |
0..* | Resource | Contained, inline Resources | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier |
Σ | 0..1 | Identifier | An identifier or code by which the ingredient can be referenced | ||||
| status |
?!Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact. | ||||
| 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 |
ΣC | 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 |
ΣC | 1..1 | BackboneElement | The substance that comprises this ingredient cmc-strength-type-cases2: 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. | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| code |
S | 1..1 | LiteralCodeableReference(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 |
SΣ | 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 |
SΣ | 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 | |||||
| strengthFactors |
S | 1..1 | CodeableConcept | Strength Extension 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] |
SΣ | 1..1 | The strength per unitary volume (or mass) Slice: Unordered, Closed by type:$this | |||||
| concentrationRatio |
Ratio | |||||||
| concentrationQuantity |
Quantity | |||||||
| concentration[x]:concentrationQuantity |
SΣ | 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 |
SΣ | 1..1 | decimal | Ingredient Total Amount Numeric | ||||
| comparator |
?!SΣ | 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 |
ΣC | 0..1 | uri | System that defines coded unit form | ||||
| code |
ΣC | 0..1 | code | Coded form of the unit | ||||
| concentration[x]:concentrationRatio |
SΣ | 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 |
SΣC | 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 |
SΣ | 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 |
ΣC | 0..1 | uri | System that defines coded unit form | ||||
| code |
SΣC | 1..1 | code | Coded form of the unit | ||||
| denominator |
SΣC | 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 |
SΣ | 1..1 | decimal | Ingredient Total Amount Numeric Denominator | ||||
| unit |
SΣ | 1..1 | string | Ingredient Total Amount Numeric Denominator UOM | ||||
| system |
ΣC | 0..1 | uri | System that defines coded unit form | ||||
| code |
SΣC | 1..1 | code | Coded form of the unit | ||||
| textConcentration |
SΣ | 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 |
SΣ | 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] |
SΣ | 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 |
SΣ | 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 |
ΣC | 0..1 | uri | System that defines coded unit form | ||||
| code |
SΣC | 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 | ||||||||
| Path | Conformance | ValueSet | URI |
| Ingredient.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| Ingredient.status | required | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status|5.0.0from the FHIR Standard | |
| Ingredient.role | required | PqcmcDrugProductComponentFunctionCategoryTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminologyfrom this IG | |
| Ingredient.function | example | IngredientFunctionhttp://hl7.org/fhir/ValueSet/ingredient-functionfrom the FHIR Standard | |
| Ingredient.manufacturer.role | required | IngredientManufacturerRolehttp://hl7.org/fhir/ValueSet/ingredient-manufacturer-role|5.0.0from the FHIR Standard | |
| Ingredient.substance.code | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codesfrom the FHIR Standard | |
| Ingredient.substance.strength.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/countryfrom the FHIR Standard | |
| Ingredient.substance.strength.referenceStrength.substance | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codesfrom the FHIR Standard | |
| Ingredient.substance.strength.referenceStrength.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/countryfrom the FHIR Standard | |
| Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity | required | PqcmcNonPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-unitsfrom this IG | |
| Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0from the FHIR Standard | |
| Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator | required | PqcmcNonPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-unitsfrom this IG | |
| Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0from the FHIR Standard | |
| Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator | required | PqcmcNonPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-unitsfrom this IG | |
| Ingredient.substance.strength:amount.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/countryfrom the FHIR Standard | |
| Ingredient.substance.strength:amount.referenceStrength.substance | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codesfrom the FHIR Standard | |
| Ingredient.substance.strength:amount.referenceStrength.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/countryfrom the FHIR Standard | |
| Ingredient.substance.strength:percent.concentration[x] | required | PqcmcPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-unitsfrom this IG | |
| Ingredient.substance.strength:percent.concentration[x].comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0from the FHIR Standard | |
| Ingredient.substance.strength:percent.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/countryfrom the FHIR Standard | |
| Ingredient.substance.strength:percent.referenceStrength.substance | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codesfrom the FHIR Standard | |
| Ingredient.substance.strength:percent.referenceStrength.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/countryfrom the FHIR Standard |
| 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:
Extensions
This structure refers to these extensions:
Slices
This structure defines the following Slices:
Other representations of profile: CSV, Excel, Schematron
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#2.0.0-ballot based on FHIR 5.0.0. Generated 2024-12-04
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