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 1.1.6 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-dp-ingredient | Version: 1.1.6 | |||
Active as of 2024-09-22 | Computable Name: DrugProductIngredient | |||
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.43 |
The amount details about the drug product ingredients in the batch. Use for Batch Formula.
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 | |||
meta | ||||
profile | S | 0..1 | canonical(StructureDefinition) | Profiles this resource claims to conform to |
identifier | S | 0..1 | Identifier | An identifier or code by which the ingredient can be referenced |
substance | ||||
code | S | 1..1 | CodeableReference(Drug Substance Handle | Excipient Drug Substance) | Ingredient Substance |
Slices for strength | S | 2..2 | BackboneElement | The quantity of substance, per presentation, or per volume or mass, and type of quantity Slice: Unordered, Closed by value:concentration.code |
strength:perBatch | S | 1..1 | BackboneElement | Ingredient Total per Batch |
concentration[x] | S | 1..1 | Quantity | The strength per unitary volume (or mass) |
code | S | 1..1 | code | Coded form of the unit Binding: Non-Percentage Units (required) |
strength:percent | S | 1..1 | BackboneElement | Ingredient percent of Total Batch |
concentration[x] | S | 1..1 | Quantity | The strength per unitary volume (or mass) |
code | S | 1..1 | code | Coded form of the unit Binding: Percentage Units (required) |
Documentation for this format |
Path | Conformance | ValueSet | URI |
Ingredient.substance.strength:perBatch.concentration[x].code | required | PqcmcNonPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units from this IG | |
Ingredient.substance.strength:percent.concentration[x].code | required | PqcmcPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units from this IG |
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 |
meta | Σ | 0..1 | Meta | Metadata about the resource |
profile | SΣ | 0..1 | canonical(StructureDefinition) | Profiles this resource claims to conform to |
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 |
identifier | SΣ | 0..1 | Identifier | An identifier or code by which the ingredient can be referenced |
status | ?!Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact. |
role | Σ | 1..1 | CodeableConcept | Purpose of the ingredient within the product, e.g. active, inactive Binding: IngredientRole (example): A classification of the ingredient identifying its purpose within the product, e.g. active, inactive. |
substance | ΣC | 1..1 | BackboneElement | The substance that comprises this ingredient |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
code | SΣC | 1..1 | CodeableReference(Drug Substance Handle | Excipient Drug Substance) | Ingredient Substance Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. |
Slices for strength | SΣ | 2..2 | BackboneElement | The quantity of substance, per presentation, or per volume or mass, and type of quantity Slice: Unordered, Closed by value:concentration.code |
strength:All Slices | Content/Rules for all slices | |||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
strength:perBatch | SΣ | 1..1 | BackboneElement | Ingredient Total per Batch |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
concentration[x] | SΣ | 1..1 | Quantity | The strength per unitary volume (or mass) |
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. |
code | SΣC | 1..1 | code | Coded form of the unit Binding: Non-Percentage Units (required) |
strength:percent | SΣ | 1..1 | BackboneElement | Ingredient percent of Total Batch |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
concentration[x] | SΣ | 1..1 | Quantity | The strength per unitary volume (or mass) |
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. |
code | SΣC | 1..1 | code | Coded form of the unit Binding: Percentage Units (required) |
Documentation for this format |
Path | Conformance | ValueSet | URI |
Ingredient.status | required | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard | |
Ingredient.role | example | IngredientRolehttp://hl7.org/fhir/ValueSet/ingredient-role from the FHIR Standard | |
Ingredient.substance.code | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard | |
Ingredient.substance.strength:perBatch.concentration[x].comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard | |
Ingredient.substance.strength:perBatch.concentration[x].code | required | PqcmcNonPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units from this IG | |
Ingredient.substance.strength:percent.concentration[x].comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard | |
Ingredient.substance.strength:percent.concentration[x].code | required | PqcmcPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units from this IG |
Id | Grade | Path(s) | Details | Requirements |
dom-2 | error | Ingredient | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | Ingredient | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
dom-4 | error | Ingredient | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
dom-5 | error | Ingredient | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | Ingredient | A resource should have narrative for robust management : text.`div`.exists() | |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
ing-1 | error | Ingredient | If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource : Ingredient.where(allergenicIndicator=true).count() + Ingredient.substance.code.reference.count() < 2 |
Name | Flags | Card. | Type | Description & Constraints | ||||
---|---|---|---|---|---|---|---|---|
Ingredient | C | 0..* | Ingredient | An ingredient of a manufactured item or pharmaceutical product ing-1: If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource | ||||
id | Σ | 0..1 | id | Logical id of this artifact | ||||
meta | Σ | 0..1 | Meta | Metadata about the resource | ||||
id | 0..1 | id | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
versionId | Σ | 0..1 | id | Version specific identifier | ||||
lastUpdated | Σ | 0..1 | instant | When the resource version last changed | ||||
source | Σ | 0..1 | uri | Identifies where the resource comes from | ||||
profile | SΣ | 0..1 | canonical(StructureDefinition) | Profiles this resource claims to conform to | ||||
security | Σ | 0..* | Coding | Security Labels applied to this resource Binding: AllSecurityLabels (extensible): Security Labels from the Healthcare Privacy and Security Classification System. | ||||
tag | Σ | 0..* | Coding | Tags applied to this resource Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones". | ||||
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 | SΣ | 0..1 | Identifier | An identifier or code by which the ingredient can be referenced | ||||
status | ?!Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact. | ||||
for | Σ | 0..* | Reference(MedicinalProductDefinition | AdministrableProductDefinition | ManufacturedItemDefinition) | The product which this ingredient is a constituent part of | ||||
role | Σ | 1..1 | CodeableConcept | Purpose of the ingredient within the product, e.g. active, inactive Binding: IngredientRole (example): A classification of the ingredient identifying its purpose within the product, e.g. active, inactive. | ||||
function | Σ | 0..* | CodeableConcept | Precise action within the drug product, e.g. antioxidant, alkalizing agent Binding: IngredientFunction (example): A classification of the ingredient identifying its precise purpose(s) in the drug product (beyond e.g. active/inactive). | ||||
group | Σ | 0..1 | CodeableConcept | A classification of the ingredient according to where in the physical item it tends to be used, such the outer shell of a tablet, inner body or ink | ||||
allergenicIndicator | ΣC | 0..1 | boolean | If the ingredient is a known or suspected allergen | ||||
comment | 0..1 | markdown | A place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on drying | |||||
manufacturer | Σ | 0..* | BackboneElement | An organization that manufactures this ingredient | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
role | Σ | 0..1 | code | allowed | possible | actual Binding: IngredientManufacturerRole (required): The way in which this manufacturer is associated with the ingredient. | ||||
manufacturer | Σ | 1..1 | Reference(Organization) | An organization that manufactures this ingredient | ||||
substance | ΣC | 1..1 | BackboneElement | The substance that comprises this ingredient | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
code | SΣC | 1..1 | CodeableReference(Drug Substance Handle | Excipient Drug Substance) | Ingredient Substance Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. | ||||
Slices for strength | SΣ | 2..2 | BackboneElement | The quantity of substance, per presentation, or per volume or mass, and type of quantity Slice: Unordered, Closed by value:concentration.code | ||||
strength:All Slices | Content/Rules for all slices | |||||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
presentation[x] | Σ | 0..1 | The quantity of substance in the unit of presentation | |||||
presentationRatio | Ratio | |||||||
presentationRatioRange | RatioRange | |||||||
presentationCodeableConcept | CodeableConcept | |||||||
presentationQuantity | Quantity | |||||||
textPresentation | Σ | 0..1 | string | Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio) | ||||
concentration[x] | Σ | 0..1 | The strength per unitary volume (or mass) | |||||
concentrationRatio | Ratio | |||||||
concentrationRatioRange | RatioRange | |||||||
concentrationCodeableConcept | CodeableConcept | |||||||
concentrationQuantity | Quantity | |||||||
textConcentration | Σ | 0..1 | string | Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio) | ||||
basis | Σ | 0..1 | CodeableConcept | A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt) | ||||
measurementPoint | Σ | 0..1 | string | When strength is measured at a particular point or distance | ||||
country | Σ | 0..* | CodeableConcept | Where the strength range applies Binding: CountryValueSet (example): Jurisdiction codes | ||||
referenceStrength | Σ | 0..* | BackboneElement | Strength expressed in terms of a reference substance | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
substance | Σ | 1..1 | CodeableReference(SubstanceDefinition) | Relevant reference substance Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. | ||||
strength[x] | Σ | 1..1 | Strength expressed in terms of a reference substance | |||||
strengthRatio | Ratio | |||||||
strengthRatioRange | RatioRange | |||||||
strengthQuantity | Quantity | |||||||
measurementPoint | Σ | 0..1 | string | When strength is measured at a particular point or distance | ||||
country | Σ | 0..* | CodeableConcept | Where the strength range applies Binding: CountryValueSet (example): Jurisdiction codes | ||||
strength:perBatch | SΣ | 1..1 | BackboneElement | Ingredient Total per Batch | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
presentation[x] | Σ | 0..1 | The quantity of substance in the unit of presentation | |||||
presentationRatio | Ratio | |||||||
presentationRatioRange | RatioRange | |||||||
presentationCodeableConcept | CodeableConcept | |||||||
presentationQuantity | Quantity | |||||||
textPresentation | Σ | 0..1 | string | Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio) | ||||
concentration[x] | SΣ | 1..1 | Quantity | The strength per unitary volume (or mass) | ||||
id | 0..1 | id | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
value | Σ | 0..1 | decimal | Numerical value (with implicit precision) | ||||
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. | ||||
unit | Σ | 0..1 | string | Unit representation | ||||
system | ΣC | 0..1 | uri | System that defines coded unit form | ||||
code | SΣC | 1..1 | code | Coded form of the unit Binding: Non-Percentage Units (required) | ||||
textConcentration | Σ | 0..1 | string | Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio) | ||||
basis | Σ | 0..1 | CodeableConcept | A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt) | ||||
measurementPoint | Σ | 0..1 | string | When strength is measured at a particular point or distance | ||||
country | Σ | 0..* | CodeableConcept | Where the strength range applies Binding: CountryValueSet (example): Jurisdiction codes | ||||
referenceStrength | Σ | 0..* | BackboneElement | Strength expressed in terms of a reference substance | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
substance | Σ | 1..1 | CodeableReference(SubstanceDefinition) | Relevant reference substance Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. | ||||
strength[x] | Σ | 1..1 | Strength expressed in terms of a reference substance | |||||
strengthRatio | Ratio | |||||||
strengthRatioRange | RatioRange | |||||||
strengthQuantity | Quantity | |||||||
measurementPoint | Σ | 0..1 | string | When strength is measured at a particular point or distance | ||||
country | Σ | 0..* | CodeableConcept | Where the strength range applies Binding: CountryValueSet (example): Jurisdiction codes | ||||
strength:percent | SΣ | 1..1 | BackboneElement | Ingredient percent of Total Batch | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
presentation[x] | Σ | 0..1 | The quantity of substance in the unit of presentation | |||||
presentationRatio | Ratio | |||||||
presentationRatioRange | RatioRange | |||||||
presentationCodeableConcept | CodeableConcept | |||||||
presentationQuantity | Quantity | |||||||
textPresentation | Σ | 0..1 | string | Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio) | ||||
concentration[x] | SΣ | 1..1 | Quantity | The strength per unitary volume (or mass) | ||||
id | 0..1 | id | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
value | Σ | 0..1 | decimal | Numerical value (with implicit precision) | ||||
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. | ||||
unit | Σ | 0..1 | string | Unit representation | ||||
system | ΣC | 0..1 | uri | System that defines coded unit form | ||||
code | SΣC | 1..1 | code | Coded form of the unit Binding: Percentage Units (required) | ||||
textConcentration | Σ | 0..1 | string | Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio) | ||||
basis | Σ | 0..1 | CodeableConcept | A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt) | ||||
measurementPoint | Σ | 0..1 | string | When strength is measured at a particular point or distance | ||||
country | Σ | 0..* | CodeableConcept | Where the strength range applies Binding: CountryValueSet (example): Jurisdiction codes | ||||
referenceStrength | Σ | 0..* | BackboneElement | Strength expressed in terms of a reference substance | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
substance | Σ | 1..1 | CodeableReference(SubstanceDefinition) | Relevant reference substance Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. | ||||
strength[x] | Σ | 1..1 | Strength expressed in terms of a reference substance | |||||
strengthRatio | Ratio | |||||||
strengthRatioRange | RatioRange | |||||||
strengthQuantity | Quantity | |||||||
measurementPoint | Σ | 0..1 | string | When strength is measured at a particular point or distance | ||||
country | Σ | 0..* | CodeableConcept | Where the strength range applies Binding: CountryValueSet (example): Jurisdiction codes | ||||
Documentation for this format |
Path | Conformance | ValueSet | URI |
Ingredient.meta.security | extensible | AllSecurityLabelshttp://hl7.org/fhir/ValueSet/security-labels from the FHIR Standard | |
Ingredient.meta.tag | example | CommonTagshttp://hl7.org/fhir/ValueSet/common-tags from the FHIR Standard | |
Ingredient.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard | |
Ingredient.status | required | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard | |
Ingredient.role | example | IngredientRolehttp://hl7.org/fhir/ValueSet/ingredient-role from the FHIR Standard | |
Ingredient.function | example | IngredientFunctionhttp://hl7.org/fhir/ValueSet/ingredient-function from the FHIR Standard | |
Ingredient.manufacturer.role | required | IngredientManufacturerRolehttp://hl7.org/fhir/ValueSet/ingredient-manufacturer-role|5.0.0 from the FHIR Standard | |
Ingredient.substance.code | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard | |
Ingredient.substance.strength.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/country from the FHIR Standard | |
Ingredient.substance.strength.referenceStrength.substance | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard | |
Ingredient.substance.strength.referenceStrength.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/country from the FHIR Standard | |
Ingredient.substance.strength:perBatch.concentration[x].comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard | |
Ingredient.substance.strength:perBatch.concentration[x].code | required | PqcmcNonPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units from this IG | |
Ingredient.substance.strength:perBatch.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/country from the FHIR Standard | |
Ingredient.substance.strength:perBatch.referenceStrength.substance | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard | |
Ingredient.substance.strength:perBatch.referenceStrength.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/country from the FHIR Standard | |
Ingredient.substance.strength:percent.concentration[x].comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard | |
Ingredient.substance.strength:percent.concentration[x].code | required | PqcmcPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units from this IG | |
Ingredient.substance.strength:percent.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/country from the FHIR Standard | |
Ingredient.substance.strength:percent.referenceStrength.substance | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard | |
Ingredient.substance.strength:percent.referenceStrength.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/country from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
dom-2 | error | Ingredient | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | Ingredient | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
dom-4 | error | Ingredient | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
dom-5 | error | Ingredient | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | Ingredient | A resource should have narrative for robust management : text.`div`.exists() | |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
ing-1 | error | Ingredient | If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource : Ingredient.where(allergenicIndicator=true).count() + Ingredient.substance.code.reference.count() < 2 |
This structure is derived from Ingredient
Summary
Mandatory: 6 elements
Must-Support: 10 elements
Structures
This structure refers to these other structures:
Slices
This structure defines the following Slices:
Differential View
This structure is derived from Ingredient
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Ingredient | Ingredient | |||
meta | ||||
profile | S | 0..1 | canonical(StructureDefinition) | Profiles this resource claims to conform to |
identifier | S | 0..1 | Identifier | An identifier or code by which the ingredient can be referenced |
substance | ||||
code | S | 1..1 | CodeableReference(Drug Substance Handle | Excipient Drug Substance) | Ingredient Substance |
Slices for strength | S | 2..2 | BackboneElement | The quantity of substance, per presentation, or per volume or mass, and type of quantity Slice: Unordered, Closed by value:concentration.code |
strength:perBatch | S | 1..1 | BackboneElement | Ingredient Total per Batch |
concentration[x] | S | 1..1 | Quantity | The strength per unitary volume (or mass) |
code | S | 1..1 | code | Coded form of the unit Binding: Non-Percentage Units (required) |
strength:percent | S | 1..1 | BackboneElement | Ingredient percent of Total Batch |
concentration[x] | S | 1..1 | Quantity | The strength per unitary volume (or mass) |
code | S | 1..1 | code | Coded form of the unit Binding: Percentage Units (required) |
Documentation for this format |
Path | Conformance | ValueSet | URI |
Ingredient.substance.strength:perBatch.concentration[x].code | required | PqcmcNonPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units from this IG | |
Ingredient.substance.strength:percent.concentration[x].code | required | PqcmcPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units from this IG |
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 |
meta | Σ | 0..1 | Meta | Metadata about the resource |
profile | SΣ | 0..1 | canonical(StructureDefinition) | Profiles this resource claims to conform to |
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 |
identifier | SΣ | 0..1 | Identifier | An identifier or code by which the ingredient can be referenced |
status | ?!Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact. |
role | Σ | 1..1 | CodeableConcept | Purpose of the ingredient within the product, e.g. active, inactive Binding: IngredientRole (example): A classification of the ingredient identifying its purpose within the product, e.g. active, inactive. |
substance | ΣC | 1..1 | BackboneElement | The substance that comprises this ingredient |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
code | SΣC | 1..1 | CodeableReference(Drug Substance Handle | Excipient Drug Substance) | Ingredient Substance Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. |
Slices for strength | SΣ | 2..2 | BackboneElement | The quantity of substance, per presentation, or per volume or mass, and type of quantity Slice: Unordered, Closed by value:concentration.code |
strength:All Slices | Content/Rules for all slices | |||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
strength:perBatch | SΣ | 1..1 | BackboneElement | Ingredient Total per Batch |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
concentration[x] | SΣ | 1..1 | Quantity | The strength per unitary volume (or mass) |
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. |
code | SΣC | 1..1 | code | Coded form of the unit Binding: Non-Percentage Units (required) |
strength:percent | SΣ | 1..1 | BackboneElement | Ingredient percent of Total Batch |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
concentration[x] | SΣ | 1..1 | Quantity | The strength per unitary volume (or mass) |
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. |
code | SΣC | 1..1 | code | Coded form of the unit Binding: Percentage Units (required) |
Documentation for this format |
Path | Conformance | ValueSet | URI |
Ingredient.status | required | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard | |
Ingredient.role | example | IngredientRolehttp://hl7.org/fhir/ValueSet/ingredient-role from the FHIR Standard | |
Ingredient.substance.code | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard | |
Ingredient.substance.strength:perBatch.concentration[x].comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard | |
Ingredient.substance.strength:perBatch.concentration[x].code | required | PqcmcNonPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units from this IG | |
Ingredient.substance.strength:percent.concentration[x].comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard | |
Ingredient.substance.strength:percent.concentration[x].code | required | PqcmcPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units from this IG |
Id | Grade | Path(s) | Details | Requirements |
dom-2 | error | Ingredient | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | Ingredient | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
dom-4 | error | Ingredient | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
dom-5 | error | Ingredient | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | Ingredient | A resource should have narrative for robust management : text.`div`.exists() | |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
ing-1 | error | Ingredient | If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource : Ingredient.where(allergenicIndicator=true).count() + Ingredient.substance.code.reference.count() < 2 |
Snapshot View
Name | Flags | Card. | Type | Description & Constraints | ||||
---|---|---|---|---|---|---|---|---|
Ingredient | C | 0..* | Ingredient | An ingredient of a manufactured item or pharmaceutical product ing-1: If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource | ||||
id | Σ | 0..1 | id | Logical id of this artifact | ||||
meta | Σ | 0..1 | Meta | Metadata about the resource | ||||
id | 0..1 | id | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
versionId | Σ | 0..1 | id | Version specific identifier | ||||
lastUpdated | Σ | 0..1 | instant | When the resource version last changed | ||||
source | Σ | 0..1 | uri | Identifies where the resource comes from | ||||
profile | SΣ | 0..1 | canonical(StructureDefinition) | Profiles this resource claims to conform to | ||||
security | Σ | 0..* | Coding | Security Labels applied to this resource Binding: AllSecurityLabels (extensible): Security Labels from the Healthcare Privacy and Security Classification System. | ||||
tag | Σ | 0..* | Coding | Tags applied to this resource Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones". | ||||
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 | SΣ | 0..1 | Identifier | An identifier or code by which the ingredient can be referenced | ||||
status | ?!Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact. | ||||
for | Σ | 0..* | Reference(MedicinalProductDefinition | AdministrableProductDefinition | ManufacturedItemDefinition) | The product which this ingredient is a constituent part of | ||||
role | Σ | 1..1 | CodeableConcept | Purpose of the ingredient within the product, e.g. active, inactive Binding: IngredientRole (example): A classification of the ingredient identifying its purpose within the product, e.g. active, inactive. | ||||
function | Σ | 0..* | CodeableConcept | Precise action within the drug product, e.g. antioxidant, alkalizing agent Binding: IngredientFunction (example): A classification of the ingredient identifying its precise purpose(s) in the drug product (beyond e.g. active/inactive). | ||||
group | Σ | 0..1 | CodeableConcept | A classification of the ingredient according to where in the physical item it tends to be used, such the outer shell of a tablet, inner body or ink | ||||
allergenicIndicator | ΣC | 0..1 | boolean | If the ingredient is a known or suspected allergen | ||||
comment | 0..1 | markdown | A place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on drying | |||||
manufacturer | Σ | 0..* | BackboneElement | An organization that manufactures this ingredient | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
role | Σ | 0..1 | code | allowed | possible | actual Binding: IngredientManufacturerRole (required): The way in which this manufacturer is associated with the ingredient. | ||||
manufacturer | Σ | 1..1 | Reference(Organization) | An organization that manufactures this ingredient | ||||
substance | ΣC | 1..1 | BackboneElement | The substance that comprises this ingredient | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
code | SΣC | 1..1 | CodeableReference(Drug Substance Handle | Excipient Drug Substance) | Ingredient Substance Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. | ||||
Slices for strength | SΣ | 2..2 | BackboneElement | The quantity of substance, per presentation, or per volume or mass, and type of quantity Slice: Unordered, Closed by value:concentration.code | ||||
strength:All Slices | Content/Rules for all slices | |||||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
presentation[x] | Σ | 0..1 | The quantity of substance in the unit of presentation | |||||
presentationRatio | Ratio | |||||||
presentationRatioRange | RatioRange | |||||||
presentationCodeableConcept | CodeableConcept | |||||||
presentationQuantity | Quantity | |||||||
textPresentation | Σ | 0..1 | string | Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio) | ||||
concentration[x] | Σ | 0..1 | The strength per unitary volume (or mass) | |||||
concentrationRatio | Ratio | |||||||
concentrationRatioRange | RatioRange | |||||||
concentrationCodeableConcept | CodeableConcept | |||||||
concentrationQuantity | Quantity | |||||||
textConcentration | Σ | 0..1 | string | Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio) | ||||
basis | Σ | 0..1 | CodeableConcept | A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt) | ||||
measurementPoint | Σ | 0..1 | string | When strength is measured at a particular point or distance | ||||
country | Σ | 0..* | CodeableConcept | Where the strength range applies Binding: CountryValueSet (example): Jurisdiction codes | ||||
referenceStrength | Σ | 0..* | BackboneElement | Strength expressed in terms of a reference substance | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
substance | Σ | 1..1 | CodeableReference(SubstanceDefinition) | Relevant reference substance Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. | ||||
strength[x] | Σ | 1..1 | Strength expressed in terms of a reference substance | |||||
strengthRatio | Ratio | |||||||
strengthRatioRange | RatioRange | |||||||
strengthQuantity | Quantity | |||||||
measurementPoint | Σ | 0..1 | string | When strength is measured at a particular point or distance | ||||
country | Σ | 0..* | CodeableConcept | Where the strength range applies Binding: CountryValueSet (example): Jurisdiction codes | ||||
strength:perBatch | SΣ | 1..1 | BackboneElement | Ingredient Total per Batch | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
presentation[x] | Σ | 0..1 | The quantity of substance in the unit of presentation | |||||
presentationRatio | Ratio | |||||||
presentationRatioRange | RatioRange | |||||||
presentationCodeableConcept | CodeableConcept | |||||||
presentationQuantity | Quantity | |||||||
textPresentation | Σ | 0..1 | string | Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio) | ||||
concentration[x] | SΣ | 1..1 | Quantity | The strength per unitary volume (or mass) | ||||
id | 0..1 | id | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
value | Σ | 0..1 | decimal | Numerical value (with implicit precision) | ||||
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. | ||||
unit | Σ | 0..1 | string | Unit representation | ||||
system | ΣC | 0..1 | uri | System that defines coded unit form | ||||
code | SΣC | 1..1 | code | Coded form of the unit Binding: Non-Percentage Units (required) | ||||
textConcentration | Σ | 0..1 | string | Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio) | ||||
basis | Σ | 0..1 | CodeableConcept | A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt) | ||||
measurementPoint | Σ | 0..1 | string | When strength is measured at a particular point or distance | ||||
country | Σ | 0..* | CodeableConcept | Where the strength range applies Binding: CountryValueSet (example): Jurisdiction codes | ||||
referenceStrength | Σ | 0..* | BackboneElement | Strength expressed in terms of a reference substance | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
substance | Σ | 1..1 | CodeableReference(SubstanceDefinition) | Relevant reference substance Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. | ||||
strength[x] | Σ | 1..1 | Strength expressed in terms of a reference substance | |||||
strengthRatio | Ratio | |||||||
strengthRatioRange | RatioRange | |||||||
strengthQuantity | Quantity | |||||||
measurementPoint | Σ | 0..1 | string | When strength is measured at a particular point or distance | ||||
country | Σ | 0..* | CodeableConcept | Where the strength range applies Binding: CountryValueSet (example): Jurisdiction codes | ||||
strength:percent | SΣ | 1..1 | BackboneElement | Ingredient percent of Total Batch | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
presentation[x] | Σ | 0..1 | The quantity of substance in the unit of presentation | |||||
presentationRatio | Ratio | |||||||
presentationRatioRange | RatioRange | |||||||
presentationCodeableConcept | CodeableConcept | |||||||
presentationQuantity | Quantity | |||||||
textPresentation | Σ | 0..1 | string | Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio) | ||||
concentration[x] | SΣ | 1..1 | Quantity | The strength per unitary volume (or mass) | ||||
id | 0..1 | id | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
value | Σ | 0..1 | decimal | Numerical value (with implicit precision) | ||||
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. | ||||
unit | Σ | 0..1 | string | Unit representation | ||||
system | ΣC | 0..1 | uri | System that defines coded unit form | ||||
code | SΣC | 1..1 | code | Coded form of the unit Binding: Percentage Units (required) | ||||
textConcentration | Σ | 0..1 | string | Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio) | ||||
basis | Σ | 0..1 | CodeableConcept | A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt) | ||||
measurementPoint | Σ | 0..1 | string | When strength is measured at a particular point or distance | ||||
country | Σ | 0..* | CodeableConcept | Where the strength range applies Binding: CountryValueSet (example): Jurisdiction codes | ||||
referenceStrength | Σ | 0..* | BackboneElement | Strength expressed in terms of a reference substance | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
substance | Σ | 1..1 | CodeableReference(SubstanceDefinition) | Relevant reference substance Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. | ||||
strength[x] | Σ | 1..1 | Strength expressed in terms of a reference substance | |||||
strengthRatio | Ratio | |||||||
strengthRatioRange | RatioRange | |||||||
strengthQuantity | Quantity | |||||||
measurementPoint | Σ | 0..1 | string | When strength is measured at a particular point or distance | ||||
country | Σ | 0..* | CodeableConcept | Where the strength range applies Binding: CountryValueSet (example): Jurisdiction codes | ||||
Documentation for this format |
Path | Conformance | ValueSet | URI |
Ingredient.meta.security | extensible | AllSecurityLabelshttp://hl7.org/fhir/ValueSet/security-labels from the FHIR Standard | |
Ingredient.meta.tag | example | CommonTagshttp://hl7.org/fhir/ValueSet/common-tags from the FHIR Standard | |
Ingredient.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard | |
Ingredient.status | required | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard | |
Ingredient.role | example | IngredientRolehttp://hl7.org/fhir/ValueSet/ingredient-role from the FHIR Standard | |
Ingredient.function | example | IngredientFunctionhttp://hl7.org/fhir/ValueSet/ingredient-function from the FHIR Standard | |
Ingredient.manufacturer.role | required | IngredientManufacturerRolehttp://hl7.org/fhir/ValueSet/ingredient-manufacturer-role|5.0.0 from the FHIR Standard | |
Ingredient.substance.code | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard | |
Ingredient.substance.strength.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/country from the FHIR Standard | |
Ingredient.substance.strength.referenceStrength.substance | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard | |
Ingredient.substance.strength.referenceStrength.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/country from the FHIR Standard | |
Ingredient.substance.strength:perBatch.concentration[x].comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard | |
Ingredient.substance.strength:perBatch.concentration[x].code | required | PqcmcNonPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units from this IG | |
Ingredient.substance.strength:perBatch.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/country from the FHIR Standard | |
Ingredient.substance.strength:perBatch.referenceStrength.substance | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard | |
Ingredient.substance.strength:perBatch.referenceStrength.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/country from the FHIR Standard | |
Ingredient.substance.strength:percent.concentration[x].comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard | |
Ingredient.substance.strength:percent.concentration[x].code | required | PqcmcPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units from this IG | |
Ingredient.substance.strength:percent.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/country from the FHIR Standard | |
Ingredient.substance.strength:percent.referenceStrength.substance | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard | |
Ingredient.substance.strength:percent.referenceStrength.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/country from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
dom-2 | error | Ingredient | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | Ingredient | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
dom-4 | error | Ingredient | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
dom-5 | error | Ingredient | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | Ingredient | A resource should have narrative for robust management : text.`div`.exists() | |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
ing-1 | error | Ingredient | If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource : Ingredient.where(allergenicIndicator=true).count() + Ingredient.substance.code.reference.count() < 2 |
This structure is derived from Ingredient
Summary
Mandatory: 6 elements
Must-Support: 10 elements
Structures
This structure refers to these other structures:
Slices
This structure defines the following Slices:
Other representations of profile: CSV, Excel, Schematron