## Profile Comparison between http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-batch-formula vs http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-batch-formula

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)

### Messages

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 '2025-07-03T13:07:08+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.'

### Metadata

Name | Value | Comments
--- | --- | ---
abstract | false |
baseDefinition | http://hl7.org/fhir/StructureDefinition/ManufacturedItemDefinition |
copyright |  |
date | 2024-12-12T19:00:52+00:00 | 2025-07-03T13:07:08+00:00 | Values Differ
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 | Values Differ

### Structure

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
Additional Bindings | Purpose
?? | Starter
|  | 0..1 | code | Language of the resource content Binding: ?? (required): IETF language tag for a human language
Additional Bindings | Purpose
?? | Starter
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements |  | 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 | S Σ | 0..1 | Identifier | optional user designated identifier | S Σ | 0..1 | Identifier | optional user designated identifier |
status | ?!S Σ | 1..1 | code | draft | active | retired | unknown Binding: ?? (required): The lifecycle status of an artifact. | ?!S Σ | 1..1 | code | draft | active | retired | unknown Binding: ?? (required): The lifecycle status of an artifact. |
name | S Σ | 1..1 | string | Product Non-proprietary Name | S Σ | 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 | S Σ | 0..* | LiteralReference(Basic Organization) {b} | Manufacturer of the item, one of several possible | S Σ | 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 | S Σ | 2..* | BackboneElement | General characteristics of this item Slice: Unordered, Closed by value:type.text | S Σ | 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 | S Σ | 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. | S Σ | 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 | S Σ | 1..1 | string | Plain text representation of the concept | S Σ | 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 | S Σ | 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 | S Σ | 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 | S Σ | 1..1 | CodeableConcept | Product Part Type Binding: ?? (required) | S Σ | 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 | S Σ | 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) | S Σ | 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 | S Σ | 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 | S Σ | 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 | S Σ | 0..* | CodeableConcept | Product Part Ingredient Physical Location Binding: ?? (required) | S Σ | 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 | S Σ | 1..1 | LiteralCodeableReference(Drug Product Batch Formula Ingredient) {b} | The ingredient that is the constituent of the given component |
Slices for property | S Σ | 1..* | BackboneElement | General characteristics of this component Slice: Unordered, Closed by value:type.text | S Σ | 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 | S Σ | 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. | S Σ | 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 | S Σ | 1..1 | string | Plain text representation of the concept | S Σ | 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 | S Σ | 0..* | See component (ManufacturedItemDefinition) | A component that this component contains or is made from | S Σ | 0..* | See component (ManufacturedItemDefinition) | A component that this component contains or is made from |
Documentation for this format