abstractbaseDefinitioncopyrightdate- Values Differ
descriptionexperimentalfhirVersionjurisdiction
jurisdiction[0]kindnamepublisherpurposestatustitletypeurlversion- Values Differ
| Left: | Drug Product Batch Formula (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-batch-formula) |
| Right: | Drug Product Batch Formula (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-batch-formula) |
| Error | StructureDefinition.version | Values for version differ: '2.0.0-ballot' vs '2.0.0' |
| Information | StructureDefinition.date | Values for date differ: '2024-12-12T19:00:52+00:00' vs '2025-07-08T07:43:10+00:00' |
| Information | StructureDefinition.short | Values for short differ: 'Reference to a resource or a concept' vs 'The ingredient that is the constituent of the given component' |
| Information | StructureDefinition.definition | Values for definition differ: 'A reference to a resource (by instance), or instead, a reference to a concept defined in a terminology or ontology (by class).' vs 'The ingredient that is the constituent of the given component.' |
| Name | Value | Comments | |
|---|---|---|---|
| abstract | false | ||
| baseDefinition | http://hl7.org/fhir/StructureDefinition/ManufacturedItemDefinition | ||
| copyright | |||
| date | 2024-12-12T19:00:52+00:00 | 2025-07-08T07:43:10+00:00 |
|
| description | Listing of all components of the dosage form to be used in the manufacture, their amounts on a per batch basis, including overages, and reference to their quality standards. | ||
| experimental | |||
| fhirVersion | 5.0.0 | ||
| jurisdiction | |||
| jurisdiction[0] | urn:iso:std:iso:3166#US | ||
| kind | resource | ||
| name | BatchFormula | ||
| publisher | HL7 International / Biomedical Research and Regulation | ||
| purpose | |||
| status | active | ||
| title | Drug Product Batch Formula | ||
| type | ManufacturedItemDefinition | ||
| url | http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-batch-formula | ||
| version | 2.0.0-ballot | 2.0.0 |
|
| Name | L Flags | L Card. | L Type | L Description & Constraints | R Flags | R Card. | R Type | R Description & Constraints | Comments | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
 ManufacturedItemDefinition | 0..* | ManufacturedItemDefinition | The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product | 0..* | ManufacturedItemDefinition | The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product | |||||||||||
 id | Σ | 0..1 | id | Logical id of this artifact | Σ | 0..1 | id | Logical id of this artifact | |||||||||
| meta | Σ | 0..1 | Meta | Metadata about the resource | Σ | 0..1 | Meta | Metadata about the resource | |||||||||
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ?!Σ | 0..1 | uri | A set of rules under which this content was created | |||||||||
| language | 0..1 | code | Language of the resource content Binding: ?? (required): IETF language tag for a human language
| 0..1 | code | Language of the resource content Binding: ?? (required): IETF language tag for a human language
| |||||||||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements | 0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements | |||||||||||
| contained | 0..* | Resource | Contained, inline Resources | 0..* | Resource | Contained, inline Resources | |||||||||||
 extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
 modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | |||||||||
| identifier | SΣ | 0..1 | Identifier | optional user designated identifier | SΣ | 0..1 | Identifier | optional user designated identifier | |||||||||
| status | ?!SΣ | 1..1 | code | draft | active | retired | unknown Binding: ?? (required): The lifecycle status of an artifact. | ?!SΣ | 1..1 | code | draft | active | retired | unknown Binding: ?? (required): The lifecycle status of an artifact. | |||||||||
| name | SΣ | 1..1 | string | Product Non-proprietary Name | SΣ | 1..1 | string | Product Non-proprietary Name | |||||||||
| manufacturedDoseForm | Σ | 1..1 | CodeableConcept | Dose form as manufactured (before any necessary transformation) Binding: ?? (required) | Σ | 1..1 | CodeableConcept | Dose form as manufactured (before any necessary transformation) Binding: ?? (required) | |||||||||
| unitOfPresentation | Σ | 0..1 | CodeableConcept | The “real-world” units in which the quantity of the item is described Binding: ?? (example): The presentation type in which an administrable medicinal product is given to a patient. | Σ | 0..1 | CodeableConcept | The “real-world” units in which the quantity of the item is described Binding: ?? (example): The presentation type in which an administrable medicinal product is given to a patient. | |||||||||
| manufacturer | SΣ | 0..* | LiteralReference(Basic Organization) {b} | Manufacturer of the item, one of several possible | SΣ | 0..* | LiteralReference(Basic Organization) {b} | Manufacturer of the item, one of several possible | |||||||||
| marketingStatus | Σ | 0..* | MarketingStatus | Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated | Σ | 0..* | MarketingStatus | Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated | |||||||||
| ingredient | Σ | 0..* | CodeableConcept | The ingredients of this manufactured item. Only needed if these are not specified by incoming references from the Ingredient resource Binding: ?? (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. | Σ | 0..* | CodeableConcept | The ingredients of this manufactured item. Only needed if these are not specified by incoming references from the Ingredient resource Binding: ?? (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. | |||||||||
 Slices for property | SΣ | 2..* | BackboneElement | General characteristics of this item Slice: Unordered, Closed by value:type.text | SΣ | 2..* | BackboneElement | General characteristics of this item Slice: Unordered, Closed by value:type.text | |||||||||
 id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
| type | SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ?? (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. | SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ?? (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. | |||||||||
| id | 0..1 | id | Unique id for inter-element referencing | 0..1 | id | Unique id for inter-element referencing | |||||||||||
| Slices for extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||||||||
| coding | Σ | 0..* | Coding | Code defined by a terminology system | Σ | 0..* | Coding | Code defined by a terminology system | |||||||||
| text | SΣ | 1..1 | string | Plain text representation of the concept | SΣ | 1..1 | string | Plain text representation of the concept | |||||||||
| value[x] | Σ | 0..1 | CodeableConcept, Quantity, date, boolean, markdown, Attachment, Reference(Binary) | A value for the characteristic | Σ | 0..1 | CodeableConcept, Quantity, date, boolean, markdown, Attachment, Reference(Binary) | A value for the characteristic | |||||||||
 component | SΣ | 1..* | BackboneElement | Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup | SΣ | 1..* | BackboneElement | Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup | |||||||||
 id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
| type | SΣ | 1..1 | CodeableConcept | Product Part Type Binding: ?? (required) | SΣ | 1..1 | CodeableConcept | Product Part Type Binding: ?? (required) | |||||||||
| function | Σ | 0..* | CodeableConcept | The function of this component within the item e.g. delivers active ingredient, masks taste | Σ | 0..* | CodeableConcept | The function of this component within the item e.g. delivers active ingredient, masks taste | |||||||||
| Slices for amount | Σ | 2..2 | Quantity | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Closed by value:code | Σ | 2..2 | Quantity | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Closed by value:code | |||||||||
| constituent | SΣ | 1..* | BackboneElement | A reference to a constituent of the manufactured item as a whole, linked here so that its component location within the item can be indicated. This not where the item's ingredient are primarily stated (for which see Ingredient.for or ManufacturedItemDefinition.ingredient) | SΣ | 1..* | BackboneElement | A reference to a constituent of the manufactured item as a whole, linked here so that its component location within the item can be indicated. This not where the item's ingredient are primarily stated (for which see Ingredient.for or ManufacturedItemDefinition.ingredient) | |||||||||
| id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
| Slices for amount | SΣ | 2..2 | Quantity | The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Closed by value:code | SΣ | 2..2 | Quantity | The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Closed by value:code | |||||||||
| location | SΣ | 0..* | CodeableConcept | Product Part Ingredient Physical Location Binding: ?? (required) | SΣ | 0..* | CodeableConcept | Product Part Ingredient Physical Location Binding: ?? (required) | |||||||||
| function | Σ | 0..* | CodeableConcept | The function of this constituent within the component e.g. binder | Σ | 0..* | CodeableConcept | The function of this constituent within the component e.g. binder | |||||||||
| hasIngredient | S | 1..1 | LiteralCodeableReference(Drug Product Batch Formula Ingredient) {b} | Reference to a resource or a concept | SΣ | 1..1 | LiteralCodeableReference(Drug Product Batch Formula Ingredient) {b} | The ingredient that is the constituent of the given component | |||||||||
| Slices for property | SΣ | 1..* | BackboneElement | General characteristics of this component Slice: Unordered, Closed by value:type.text | SΣ | 1..* | BackboneElement | General characteristics of this component Slice: Unordered, Closed by value:type.text | |||||||||
| id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
| type | SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ?? (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. | SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ?? (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. | |||||||||
| id | 0..1 | id | Unique id for inter-element referencing | 0..1 | id | Unique id for inter-element referencing | |||||||||||
| Slices for extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||||||||
| coding | Σ | 0..* | Coding | Code defined by a terminology system | Σ | 0..* | Coding | Code defined by a terminology system | |||||||||
| text | SΣ | 1..1 | string | Plain text representation of the concept | SΣ | 1..1 | string | Plain text representation of the concept | |||||||||
| value[x] | Σ | 0..1 | CodeableConcept, Quantity, date, boolean, markdown, Attachment, Reference(Binary) | A value for the characteristic | Σ | 0..1 | CodeableConcept, Quantity, date, boolean, markdown, Attachment, Reference(Binary) | A value for the characteristic | |||||||||
 component | SΣ | 0..* | See component (ManufacturedItemDefinition) | A component that this component contains or is made from | SΣ | 0..* | See component (ManufacturedItemDefinition) | A component that this component contains or is made from | |||||||||
| Documentation for this format | |||||||||||||||||