Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions

• Content
• Detailed Descriptions
• XML
• JSON

Resource Profile: eCTD Product Description and Composition

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.

Usage:

• Use this Resource Profile: CMC eCTD 32P10 Document

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

• Differential Table
• Key Elements Table
• Snapshot Table
• Statistics/References
• All

This structure is derived from Composition

Name	Flags	Card.	Type	Description & Constraints
Composition			Composition
identifier	S	0..1	Identifier	Version-independent identifier for the Composition
status		1..1	code	registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown Required Pattern: final
type		1..1	CodeableConcept	Kind of composition (LOINC if possible) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use
code		1..1	code	Symbol in syntax defined by the system Fixed Value: ich_3.2.p.1
display		1..1	string	Representation defined by the system Fixed Value: Description and Composition of the Drug Product
author	S	1..1	LiteralReference(Basic Organization) {b}	Who and/or what authored the composition
title	S	1..1	string	Human Readable name/title
Slices for section	S	3..3	BackboneElement	Composition is broken into sections Slice: Unordered, Closed by value:code.text
section:All Slices				Content/Rules for all slices
title	S	1..1	string	Label for section (e.g. for ToC)
code	S	1..1	CodeableConcept	Classification of section (recommended)
section:ProductDescription	S	1..1	BackboneElement	Composition is broken into sections
code
text		1..1	string	Plain text representation of the concept Required Pattern: Product Description
entry	S	1..1	LiteralReference(Drug Product Description) {b}	A reference to data that supports this section
section:ProductComposition	S	1..1	BackboneElement	Composition is broken into sections
code
text		1..1	string	Plain text representation of the concept Required Pattern: Product Composition
entry	S	1..1	LiteralReference(Manufactured Drug Product) {b}	A reference to data that supports this section
section:ContainerClosure	S	1..1	BackboneElement	Composition is broken into sections
code
text		1..1	string	Plain text representation of the concept Required Pattern: Product Container Closure Description
entry	S	1..*	LiteralReference(ContainerClosure) {b}	A reference to data that supports this section
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
Composition		0..*	Composition	A set of resources composed into a single coherent clinical statement with clinical attestation
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	Version-independent identifier for the Composition
status	?!Σ	1..1	code	registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown Binding: CompositionStatus (required): The workflow/clinical status of the composition. Required Pattern: final
type	Σ	1..1	CodeableConcept	Kind of composition (LOINC if possible) Binding: FHIRDocumentTypeCodes (preferred): Type of a composition. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use
code		1..1	code	Symbol in syntax defined by the system Fixed Value: ich_3.2.p.1
display		1..1	string	Representation defined by the system Fixed Value: Description and Composition of the Drug Product
date	Σ	1..1	dateTime	Composition editing time
author	SΣ	1..1	LiteralReference(Basic Organization) {b}	Who and/or what authored the composition
title	SΣ	1..1	string	Human Readable name/title
Slices for section	SC	3..3	BackboneElement	Composition is broken into sections Slice: Unordered, Closed by value:code.text cmp-1: A section must contain at least one of text, entries, or sub-sections cmp-2: A section can only have an emptyReason if it is empty
section:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title	S	1..1	string	Label for section (e.g. for ToC)
code	S	1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:ProductDescription	SC	1..1	BackboneElement	Composition is broken into sections cmp-1: A section must contain at least one of text, entries, or sub-sections cmp-2: A section can only have an emptyReason if it is empty
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
entry	SC	1..1	LiteralReference(Drug Product Description) {b}	A reference to data that supports this section
section:ProductComposition	SC	1..1	BackboneElement	Composition is broken into sections cmp-1: A section must contain at least one of text, entries, or sub-sections cmp-2: A section can only have an emptyReason if it is empty
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
entry	SC	1..1	LiteralReference(Manufactured Drug Product) {b}	A reference to data that supports this section
section:ContainerClosure	SC	1..1	BackboneElement	Composition is broken into sections cmp-1: A section must contain at least one of text, entries, or sub-sections cmp-2: A section can only have an emptyReason if it is empty
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
entry	SC	1..*	LiteralReference(ContainerClosure) {b}	A reference to data that supports this section
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Composition.status	required	Pattern: final http://hl7.org/fhir/ValueSet/composition-status|5.0.0 from the FHIR Standard
Composition.type	preferred	Pattern: ich_3.2.p.1("Description and Composition of the Drug Product") http://hl7.org/fhir/ValueSet/doc-typecodes from the FHIR Standard
Composition.section.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
cmp-1	error	Composition.section, Composition.section:ProductDescription, Composition.section:ProductComposition, Composition.section:ContainerClosure	A section must contain at least one of text, entries, or sub-sections : text.exists() or entry.exists() or section.exists()
cmp-2	error	Composition.section, Composition.section:ProductDescription, Composition.section:ProductComposition, Composition.section:ContainerClosure	A section can only have an emptyReason if it is empty : emptyReason.empty() or entry.empty()
dom-2	error	Composition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Composition	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	Composition	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	Composition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Composition	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()

Name	Flags	Card.	Type	Description & Constraints
Composition		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
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter Set
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
url	Σ	0..1	uri	Canonical identifier for this Composition, represented as a URI (globally unique)
identifier	SΣ	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
status	?!Σ	1..1	code	registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown Binding: CompositionStatus (required): The workflow/clinical status of the composition. Required Pattern: final
type	Σ	1..1	CodeableConcept	Kind of composition (LOINC if possible) Binding: FHIRDocumentTypeCodes (preferred): Type of a composition. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: ich_3.2.p.1
display		1..1	string	Representation defined by the system Fixed Value: Description and Composition of the Drug Product
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
category	Σ	0..*	CodeableConcept	Categorization of Composition Binding: ReferencedItemCategoryValueSet (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
encounter	Σ	0..1	Reference(Encounter)	Context of the Composition
date	Σ	1..1	dateTime	Composition editing time
useContext	Σ	0..*	UsageContext	The context that the content is intended to support
author	SΣ	1..1	LiteralReference(Basic Organization) {b}	Who and/or what authored the composition
name	Σ	0..1	string	Name for this Composition (computer friendly)
title	SΣ	1..1	string	Human Readable name/title
note		0..*	Annotation	For any additional notes
attester		0..*	BackboneElement	Attests to accuracy of composition
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
mode		1..1	CodeableConcept	personal | professional | legal | official Binding: CompositionAttestationMode (preferred): The way in which a person authenticated a composition.
time		0..1	dateTime	When the composition was attested
party		0..1	Reference(Patient | RelatedPerson | Practitioner | PractitionerRole | Organization)	Who attested the composition
custodian	Σ	0..1	Reference(Organization)	Organization which maintains the composition
relatesTo		0..*	RelatedArtifact	Relationships to other compositions/documents
event	Σ	0..*	BackboneElement	The clinical service(s) being documented
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
period	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: v3 Code System ActCode (example): This list of codes represents the main clinical acts being documented.
Slices for section	SC	3..3	BackboneElement	Composition is broken into sections Slice: Unordered, Closed by value:code.text cmp-1: A section must contain at least one of text, entries, or sub-sections cmp-2: A section can only have an emptyReason if it is empty
section: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
title	S	1..1	string	Label for section (e.g. for ToC)
code	S	1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (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
focus		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
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:ProductDescription	SC	1..1	BackboneElement	Composition is broken into sections cmp-1: A section must contain at least one of text, entries, or sub-sections cmp-2: A section can only have an emptyReason if it is empty
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
title		0..1	string	Label for section (e.g. for ToC)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: Product Description
author		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
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	SC	1..1	LiteralReference(Drug Product Description) {b}	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:ProductComposition	SC	1..1	BackboneElement	Composition is broken into sections cmp-1: A section must contain at least one of text, entries, or sub-sections cmp-2: A section can only have an emptyReason if it is empty
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
title		0..1	string	Label for section (e.g. for ToC)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: Product Composition
author		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
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	SC	1..1	LiteralReference(Manufactured Drug Product) {b}	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:ContainerClosure	SC	1..1	BackboneElement	Composition is broken into sections cmp-1: A section must contain at least one of text, entries, or sub-sections cmp-2: A section can only have an emptyReason if it is empty
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
title		0..1	string	Label for section (e.g. for ToC)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: Product Container Closure Description
author		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
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	SC	1..*	LiteralReference(ContainerClosure) {b}	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Composition.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
Composition.status	required	Pattern: final http://hl7.org/fhir/ValueSet/composition-status|5.0.0 from the FHIR Standard
Composition.type	preferred	Pattern: ich_3.2.p.1("Description and Composition of the Drug Product") http://hl7.org/fhir/ValueSet/doc-typecodes from the FHIR Standard
Composition.category	example	ReferencedItemCategoryValueSet http://hl7.org/fhir/ValueSet/referenced-item-category from the FHIR Standard
Composition.attester.mode	preferred	CompositionAttestationMode http://hl7.org/fhir/ValueSet/composition-attestation-mode from the FHIR Standard
Composition.event.detail	example	ActCode http://terminology.hl7.org/ValueSet/v3-ActCode
Composition.section.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section.orderedBy	preferred	ListOrderCodes http://hl7.org/fhir/ValueSet/list-order from the FHIR Standard
Composition.section.emptyReason	preferred	ListEmptyReasons http://hl7.org/fhir/ValueSet/list-empty-reason from the FHIR Standard
Composition.section:ProductDescription.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:ProductDescription.orderedBy	preferred	ListOrderCodes http://hl7.org/fhir/ValueSet/list-order from the FHIR Standard
Composition.section:ProductDescription.emptyReason	preferred	ListEmptyReasons http://hl7.org/fhir/ValueSet/list-empty-reason from the FHIR Standard
Composition.section:ProductComposition.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:ProductComposition.orderedBy	preferred	ListOrderCodes http://hl7.org/fhir/ValueSet/list-order from the FHIR Standard
Composition.section:ProductComposition.emptyReason	preferred	ListEmptyReasons http://hl7.org/fhir/ValueSet/list-empty-reason from the FHIR Standard
Composition.section:ContainerClosure.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:ContainerClosure.orderedBy	preferred	ListOrderCodes http://hl7.org/fhir/ValueSet/list-order from the FHIR Standard
Composition.section:ContainerClosure.emptyReason	preferred	ListEmptyReasons http://hl7.org/fhir/ValueSet/list-empty-reason from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
cmp-1	error	Composition.section, Composition.section:ProductDescription, Composition.section:ProductComposition, Composition.section:ContainerClosure	A section must contain at least one of text, entries, or sub-sections : text.exists() or entry.exists() or section.exists()
cmp-2	error	Composition.section, Composition.section:ProductDescription, Composition.section:ProductComposition, Composition.section:ContainerClosure	A section can only have an emptyReason if it is empty : emptyReason.empty() or entry.empty()
dom-2	error	Composition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Composition	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	Composition	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	Composition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Composition	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()

This structure is derived from Composition

Summary

Mandatory: 8 elements(3 nested mandatory elements)
Must-Support: 12 elements

Structures

This structure refers to these other structures:

• Literal Reference (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference)
• Basic Organization (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization)
• Drug Product Description (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-description)
• Manufactured Drug Product (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part)
• ContainerClosure (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ContainerClosure)

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of Composition.section (Closed)

Differential View

This structure is derived from Composition

Name	Flags	Card.	Type	Description & Constraints
Composition			Composition
identifier	S	0..1	Identifier	Version-independent identifier for the Composition
status		1..1	code	registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown Required Pattern: final
type		1..1	CodeableConcept	Kind of composition (LOINC if possible) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use
code		1..1	code	Symbol in syntax defined by the system Fixed Value: ich_3.2.p.1
display		1..1	string	Representation defined by the system Fixed Value: Description and Composition of the Drug Product
author	S	1..1	LiteralReference(Basic Organization) {b}	Who and/or what authored the composition
title	S	1..1	string	Human Readable name/title
Slices for section	S	3..3	BackboneElement	Composition is broken into sections Slice: Unordered, Closed by value:code.text
section:All Slices				Content/Rules for all slices
title	S	1..1	string	Label for section (e.g. for ToC)
code	S	1..1	CodeableConcept	Classification of section (recommended)
section:ProductDescription	S	1..1	BackboneElement	Composition is broken into sections
code
text		1..1	string	Plain text representation of the concept Required Pattern: Product Description
entry	S	1..1	LiteralReference(Drug Product Description) {b}	A reference to data that supports this section
section:ProductComposition	S	1..1	BackboneElement	Composition is broken into sections
code
text		1..1	string	Plain text representation of the concept Required Pattern: Product Composition
entry	S	1..1	LiteralReference(Manufactured Drug Product) {b}	A reference to data that supports this section
section:ContainerClosure	S	1..1	BackboneElement	Composition is broken into sections
code
text		1..1	string	Plain text representation of the concept Required Pattern: Product Container Closure Description
entry	S	1..*	LiteralReference(ContainerClosure) {b}	A reference to data that supports this section
Documentation for this format

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
Composition		0..*	Composition	A set of resources composed into a single coherent clinical statement with clinical attestation
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	Version-independent identifier for the Composition
status	?!Σ	1..1	code	registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown Binding: CompositionStatus (required): The workflow/clinical status of the composition. Required Pattern: final
type	Σ	1..1	CodeableConcept	Kind of composition (LOINC if possible) Binding: FHIRDocumentTypeCodes (preferred): Type of a composition. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use
code		1..1	code	Symbol in syntax defined by the system Fixed Value: ich_3.2.p.1
display		1..1	string	Representation defined by the system Fixed Value: Description and Composition of the Drug Product
date	Σ	1..1	dateTime	Composition editing time
author	SΣ	1..1	LiteralReference(Basic Organization) {b}	Who and/or what authored the composition
title	SΣ	1..1	string	Human Readable name/title
Slices for section	SC	3..3	BackboneElement	Composition is broken into sections Slice: Unordered, Closed by value:code.text cmp-1: A section must contain at least one of text, entries, or sub-sections cmp-2: A section can only have an emptyReason if it is empty
section:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title	S	1..1	string	Label for section (e.g. for ToC)
code	S	1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:ProductDescription	SC	1..1	BackboneElement	Composition is broken into sections cmp-1: A section must contain at least one of text, entries, or sub-sections cmp-2: A section can only have an emptyReason if it is empty
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
entry	SC	1..1	LiteralReference(Drug Product Description) {b}	A reference to data that supports this section
section:ProductComposition	SC	1..1	BackboneElement	Composition is broken into sections cmp-1: A section must contain at least one of text, entries, or sub-sections cmp-2: A section can only have an emptyReason if it is empty
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
entry	SC	1..1	LiteralReference(Manufactured Drug Product) {b}	A reference to data that supports this section
section:ContainerClosure	SC	1..1	BackboneElement	Composition is broken into sections cmp-1: A section must contain at least one of text, entries, or sub-sections cmp-2: A section can only have an emptyReason if it is empty
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
entry	SC	1..*	LiteralReference(ContainerClosure) {b}	A reference to data that supports this section
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Composition.status	required	Pattern: final http://hl7.org/fhir/ValueSet/composition-status|5.0.0 from the FHIR Standard
Composition.type	preferred	Pattern: ich_3.2.p.1("Description and Composition of the Drug Product") http://hl7.org/fhir/ValueSet/doc-typecodes from the FHIR Standard
Composition.section.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
cmp-1	error	Composition.section, Composition.section:ProductDescription, Composition.section:ProductComposition, Composition.section:ContainerClosure	A section must contain at least one of text, entries, or sub-sections : text.exists() or entry.exists() or section.exists()
cmp-2	error	Composition.section, Composition.section:ProductDescription, Composition.section:ProductComposition, Composition.section:ContainerClosure	A section can only have an emptyReason if it is empty : emptyReason.empty() or entry.empty()
dom-2	error	Composition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Composition	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	Composition	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	Composition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Composition	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()

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
Composition		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
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter Set
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
url	Σ	0..1	uri	Canonical identifier for this Composition, represented as a URI (globally unique)
identifier	SΣ	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
status	?!Σ	1..1	code	registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown Binding: CompositionStatus (required): The workflow/clinical status of the composition. Required Pattern: final
type	Σ	1..1	CodeableConcept	Kind of composition (LOINC if possible) Binding: FHIRDocumentTypeCodes (preferred): Type of a composition. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: ich_3.2.p.1
display		1..1	string	Representation defined by the system Fixed Value: Description and Composition of the Drug Product
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
category	Σ	0..*	CodeableConcept	Categorization of Composition Binding: ReferencedItemCategoryValueSet (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
encounter	Σ	0..1	Reference(Encounter)	Context of the Composition
date	Σ	1..1	dateTime	Composition editing time
useContext	Σ	0..*	UsageContext	The context that the content is intended to support
author	SΣ	1..1	LiteralReference(Basic Organization) {b}	Who and/or what authored the composition
name	Σ	0..1	string	Name for this Composition (computer friendly)
title	SΣ	1..1	string	Human Readable name/title
note		0..*	Annotation	For any additional notes
attester		0..*	BackboneElement	Attests to accuracy of composition
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
mode		1..1	CodeableConcept	personal | professional | legal | official Binding: CompositionAttestationMode (preferred): The way in which a person authenticated a composition.
time		0..1	dateTime	When the composition was attested
party		0..1	Reference(Patient | RelatedPerson | Practitioner | PractitionerRole | Organization)	Who attested the composition
custodian	Σ	0..1	Reference(Organization)	Organization which maintains the composition
relatesTo		0..*	RelatedArtifact	Relationships to other compositions/documents
event	Σ	0..*	BackboneElement	The clinical service(s) being documented
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
period	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: v3 Code System ActCode (example): This list of codes represents the main clinical acts being documented.
Slices for section	SC	3..3	BackboneElement	Composition is broken into sections Slice: Unordered, Closed by value:code.text cmp-1: A section must contain at least one of text, entries, or sub-sections cmp-2: A section can only have an emptyReason if it is empty
section: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
title	S	1..1	string	Label for section (e.g. for ToC)
code	S	1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (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
focus		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
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:ProductDescription	SC	1..1	BackboneElement	Composition is broken into sections cmp-1: A section must contain at least one of text, entries, or sub-sections cmp-2: A section can only have an emptyReason if it is empty
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
title		0..1	string	Label for section (e.g. for ToC)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: Product Description
author		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
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	SC	1..1	LiteralReference(Drug Product Description) {b}	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:ProductComposition	SC	1..1	BackboneElement	Composition is broken into sections cmp-1: A section must contain at least one of text, entries, or sub-sections cmp-2: A section can only have an emptyReason if it is empty
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
title		0..1	string	Label for section (e.g. for ToC)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: Product Composition
author		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
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	SC	1..1	LiteralReference(Manufactured Drug Product) {b}	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:ContainerClosure	SC	1..1	BackboneElement	Composition is broken into sections cmp-1: A section must contain at least one of text, entries, or sub-sections cmp-2: A section can only have an emptyReason if it is empty
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
title		0..1	string	Label for section (e.g. for ToC)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: Product Container Closure Description
author		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
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	SC	1..*	LiteralReference(ContainerClosure) {b}	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Composition.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
Composition.status	required	Pattern: final http://hl7.org/fhir/ValueSet/composition-status|5.0.0 from the FHIR Standard
Composition.type	preferred	Pattern: ich_3.2.p.1("Description and Composition of the Drug Product") http://hl7.org/fhir/ValueSet/doc-typecodes from the FHIR Standard
Composition.category	example	ReferencedItemCategoryValueSet http://hl7.org/fhir/ValueSet/referenced-item-category from the FHIR Standard
Composition.attester.mode	preferred	CompositionAttestationMode http://hl7.org/fhir/ValueSet/composition-attestation-mode from the FHIR Standard
Composition.event.detail	example	ActCode http://terminology.hl7.org/ValueSet/v3-ActCode
Composition.section.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section.orderedBy	preferred	ListOrderCodes http://hl7.org/fhir/ValueSet/list-order from the FHIR Standard
Composition.section.emptyReason	preferred	ListEmptyReasons http://hl7.org/fhir/ValueSet/list-empty-reason from the FHIR Standard
Composition.section:ProductDescription.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:ProductDescription.orderedBy	preferred	ListOrderCodes http://hl7.org/fhir/ValueSet/list-order from the FHIR Standard
Composition.section:ProductDescription.emptyReason	preferred	ListEmptyReasons http://hl7.org/fhir/ValueSet/list-empty-reason from the FHIR Standard
Composition.section:ProductComposition.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:ProductComposition.orderedBy	preferred	ListOrderCodes http://hl7.org/fhir/ValueSet/list-order from the FHIR Standard
Composition.section:ProductComposition.emptyReason	preferred	ListEmptyReasons http://hl7.org/fhir/ValueSet/list-empty-reason from the FHIR Standard
Composition.section:ContainerClosure.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:ContainerClosure.orderedBy	preferred	ListOrderCodes http://hl7.org/fhir/ValueSet/list-order from the FHIR Standard
Composition.section:ContainerClosure.emptyReason	preferred	ListEmptyReasons http://hl7.org/fhir/ValueSet/list-empty-reason from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
cmp-1	error	Composition.section, Composition.section:ProductDescription, Composition.section:ProductComposition, Composition.section:ContainerClosure	A section must contain at least one of text, entries, or sub-sections : text.exists() or entry.exists() or section.exists()
cmp-2	error	Composition.section, Composition.section:ProductDescription, Composition.section:ProductComposition, Composition.section:ContainerClosure	A section can only have an emptyReason if it is empty : emptyReason.empty() or entry.empty()
dom-2	error	Composition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Composition	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	Composition	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	Composition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Composition	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()

This structure is derived from Composition

Summary

Mandatory: 8 elements(3 nested mandatory elements)
Must-Support: 12 elements

Structures

This structure refers to these other structures:

• Literal Reference (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference)
• Basic Organization (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization)
• Drug Product Description (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-description)
• Manufactured Drug Product (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part)
• ContainerClosure (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ContainerClosure)

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of Composition.section (Closed)

Other representations of profile: CSV, Excel, Schematron