## Profile Comparison between http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32p10 vs http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32p10

Left: | eCTD Product Description and Composition (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32p10)
Right: | eCTD Product Description and Composition (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32p10)

### 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'

### Metadata

Name | Value | Comments
--- | --- | ---
abstract | false |
baseDefinition | http://hl7.org/fhir/StructureDefinition/Composition |
copyright |  |
date | 2024-12-12T19:00:52+00:00 | 2025-07-03T13:07:08+00:00 | Values Differ
description | The fields needed to represent the Product Description, Container Closure and Composition of the Drug Product to be included under the 3.2.P.1 heading of the eCTD. References Sponsor Organization, Drug Product Description, and Product Container Closure System. |
experimental |  |
fhirVersion | 5.0.0 |
jurisdiction |  |
jurisdiction[0] | urn:iso:std:iso:3166#US |
kind | resource |
name | EctdComposition32P10 |
publisher | HL7 International / Biomedical Research and Regulation |
purpose |  |
status | active |
title | eCTD Product Description and Composition |
type | Composition |
url | http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32p10 |
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
--- | --- | --- | --- | --- | --- | --- | --- | --- | ---
Composition |  | 0..* | Composition | A set of resources composed into a single coherent clinical statement with clinical attestation |  | 0..* | Composition | A set of resources composed into a single coherent clinical statement with clinical attestation |
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 |
url | Σ | 0..1 | uri | Canonical identifier for this Composition, represented as a URI (globally unique) | Σ | 0..1 | uri | Canonical identifier for this Composition, represented as a URI (globally unique) |
identifier | S Σ | 0..1 | Identifier | Version-independent identifier for the Composition | S Σ | 0..1 | Identifier | Version-independent identifier for the Composition |
version | Σ | 0..1 | string | An explicitly assigned identifer of a variation of the content in the Composition | Σ | 0..1 | string | An explicitly assigned identifer of a variation of the content in the Composition |
status | ?!Σ | 1..1 | code | registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown Binding: ?? (required): The workflow/clinical status of the composition. Required Pattern: final | ?!Σ | 1..1 | code | registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown Binding: ?? (required): The workflow/clinical status of the composition. Required Pattern: final |
type | Σ | 1..1 | CodeableConcept | Kind of composition (LOINC if possible) Binding: ?? (preferred): Type of a composition. Required Pattern: {"coding":[{"system":"http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use","code":"ich_3.2.p.1","display":"Description and Composition of the Drug Product"}]} | Σ | 1..1 | CodeableConcept | Kind of composition (LOINC if possible) Binding: ?? (preferred): Type of a composition. Required Pattern: {"coding":[{"system":"http://terminology.hl7.org/CodeSystem/ICHContextOfUse","code":"ich_3.2.p.1","display":"m3.2.p.1 description and composition of the drug product"}]} |
category | Σ | 0..* | CodeableConcept | Categorization of Composition Binding: ?? (example): High-level kind of a clinical document at a macro level. | Σ | 0..* | CodeableConcept | Categorization of Composition Binding: ?? (example): High-level kind of a clinical document at a macro level. |
subject | Σ | 0..* | Reference(Resource) | Who and/or what the composition is about | Σ | 0..* | Reference(Resource) | Who and/or what the composition is about |
encounter | Σ | 0..1 | Reference(Encounter) | Context of the Composition | Σ | 0..1 | Reference(Encounter) | Context of the Composition |
date | Σ | 1..1 | dateTime | Composition editing time | Σ | 1..1 | dateTime | Composition editing time |
useContext | Σ | 0..* | UsageContext | The context that the content is intended to support | Σ | 0..* | UsageContext | The context that the content is intended to support |
author | S Σ | 1..1 | LiteralReference(Basic Organization) {b} | Who and/or what authored the composition | S Σ | 1..1 | LiteralReference(Basic Organization) {b} | Who and/or what authored the composition |
name | Σ | 0..1 | string | Name for this Composition (computer friendly) | Σ | 0..1 | string | Name for this Composition (computer friendly) |
title | S Σ | 1..1 | string | Human Readable name/title | S Σ | 1..1 | string | Human Readable name/title |
note |  | 0..* | Annotation | For any additional notes |  | 0..* | Annotation | For any additional notes |
attester |  | 0..* | BackboneElement | Attests to accuracy of composition |  | 0..* | BackboneElement | Attests to accuracy of composition |
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 |
mode |  | 1..1 | CodeableConcept | personal | professional | legal | official Binding: ?? (preferred): The way in which a person authenticated a composition. |  | 1..1 | CodeableConcept | personal | professional | legal | official Binding: ?? (preferred): The way in which a person authenticated a composition. |
time |  | 0..1 | dateTime | When the composition was attested |  | 0..1 | dateTime | When the composition was attested |
party |  | 0..1 | Reference(Patient | RelatedPerson | Practitioner | PractitionerRole | Organization) | Who attested the composition |  | 0..1 | Reference(Patient | RelatedPerson | Practitioner | PractitionerRole | Organization) | Who attested the composition |
custodian | Σ | 0..1 | Reference(Organization) | Organization which maintains the composition | Σ | 0..1 | Reference(Organization) | Organization which maintains the composition |
relatesTo |  | 0..* | RelatedArtifact | Relationships to other compositions/documents |  | 0..* | RelatedArtifact | Relationships to other compositions/documents |
event | Σ | 0..* | BackboneElement | The clinical service(s) being documented | Σ | 0..* | BackboneElement | The clinical service(s) being documented |
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 |
period | Σ | 0..1 | Period | The period covered by the documentation | Σ | 0..1 | Period | The period covered by the documentation |
detail | Σ | 0..* | CodeableReference(Resource) | The event(s) being documented, as code(s), reference(s), or both Binding: ?? (example): This list of codes represents the main clinical acts being documented. | Σ | 0..* | CodeableReference(Resource) | The event(s) being documented, as code(s), reference(s), or both Binding: ?? (example): This list of codes represents the main clinical acts being documented. |
Slices for section | S C | 3..3 | BackboneElement | Composition is broken into sections Slice: Unordered, Closed by value:code.text | S C | 3..3 | BackboneElement | Composition is broken into sections Slice: Unordered, Closed by value:code.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 |
title | S | 1..1 | string | Label for section (e.g. for ToC) | S | 1..1 | string | Label for section (e.g. for ToC) |
code | S | 1..1 | CodeableConcept | Classification of section (recommended) Binding: ?? (example): Classification of a section of a composition/document. | S | 1..1 | CodeableConcept | Classification of section (recommended) Binding: ?? (example): Classification of a section of a composition/document. |
author |  | 0..* | Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) | Who and/or what authored the section |  | 0..* | Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) | Who and/or what authored the section |
focus |  | 0..1 | Reference(Resource) | Who/what the section is about, when it is not about the subject of composition |  | 0..1 | Reference(Resource) | Who/what the section is about, when it is not about the subject of composition |
text | C | 0..1 | Narrative | Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements | C | 0..1 | Narrative | Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements |
orderedBy |  | 0..1 | CodeableConcept | Order of section entries Binding: ?? (preferred): What order applies to the items in the entry. |  | 0..1 | CodeableConcept | Order of section entries Binding: ?? (preferred): What order applies to the items in the entry. |
entry | C | 0..* | Reference(Resource) | A reference to data that supports this section | C | 0..* | Reference(Resource) | A reference to data that supports this section |
emptyReason | C | 0..1 | CodeableConcept | Why the section is empty Binding: ?? (preferred): If a section is empty, why it is empty. | C | 0..1 | CodeableConcept | Why the section is empty Binding: ?? (preferred): If a section is empty, why it is empty. |
section |  | 0..* | See section (Composition) | Nested Section |  | 0..* | See section (Composition) | Nested Section |
Documentation for this format