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: ContainerClosure

Container Closure for drug product referred to in Drug Product Description.

Usage:

• Use this Resource Profile: CMC eCTD 32P10 Document
• Refer to this Resource Profile: eCTD Product Description and Composition

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 PackagedProductDefinition

Name	Flags	Card.	Type	Description & Constraints
PackagedProductDefinition		0..*	PackagedProductDefinition	A medically related item or items, in a container or package
packageFor	S	1..1	LiteralReference(Drug Product Description) {b}	The product that this is a pack for
description	S	1..1	markdown	Container Closure System Description
attachedDocument	S	0..*	LiteralReference(Graphic Reference) {b}	Container Closure System Depiction
packaging	S	1..1	BackboneElement	A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap
type	S	1..1	CodeableConcept	The physical type of the container of the items
Slices for coding	S	2..2	Coding	Code defined by a terminology system Slice: Unordered, Closed by value:$this
coding:ContainerType	S	1..1	Coding	Container Type Binding: Container Type Terminology (required)
coding:ClosureType	S	1..1	Coding	Closure Type Binding: Closure Type Terminology (required)
quantity	S	0..1	integer	The quantity of this level of packaging in the package that contains it (with the outermost level being 1)
packaging	S	0..*		Allows containers (and parts of containers) within containers, still as a part of single packaged product
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
PackagedProductDefinition.packaging.type.coding:ContainerType	required	PqcmcContainerTypeTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-container-type-terminology from this IG
PackagedProductDefinition.packaging.type.coding:ClosureType	required	PqcmcClosureTypeTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-closure-type-terminology from this IG

Name	Flags	Card.	Type	Description & Constraints
PackagedProductDefinition		0..*	PackagedProductDefinition	A medically related item or items, in a container or package
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
packageFor	SΣ	1..1	LiteralReference(Drug Product Description) {b}	The product that this is a pack for
status	?!Σ	0..1	CodeableConcept	The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
description	SΣ	1..1	markdown	Container Closure System Description
attachedDocument	SΣ	0..*	LiteralReference(Graphic Reference) {b}	Container Closure System Depiction
packaging	SΣ	1..1	BackboneElement	A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	The physical type of the container of the items Binding: PackagingType (example): A high level categorisation of a package.
Slices for coding	SΣ	2..2	Coding	Code defined by a terminology system Slice: Unordered, Closed by value:$this
coding:ContainerType	SΣ	1..1	Coding	Container Type Binding: Container Type Terminology (required)
coding:ClosureType	SΣ	1..1	Coding	Closure Type Binding: Closure Type Terminology (required)
quantity	SΣ	0..1	integer	The quantity of this level of packaging in the package that contains it (with the outermost level being 1)
packaging	SΣ	0..*	See packaging (PackagedProductDefinition)	Allows containers (and parts of containers) within containers, still as a part of single packaged product
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
PackagedProductDefinition.status	preferred	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard
PackagedProductDefinition.packaging.type	example	PackagingType http://hl7.org/fhir/ValueSet/packaging-type from the FHIR Standard
PackagedProductDefinition.packaging.type.coding:ContainerType	required	PqcmcContainerTypeTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-container-type-terminology from this IG
PackagedProductDefinition.packaging.type.coding:ClosureType	required	PqcmcClosureTypeTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-closure-type-terminology from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	PackagedProductDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	PackagedProductDefinition	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	PackagedProductDefinition	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	PackagedProductDefinition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	PackagedProductDefinition	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
PackagedProductDefinition		0..*	PackagedProductDefinition	A medically related item or items, in a container or package
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
identifier	Σ	0..*	Identifier	A unique identifier for this package as whole - not for the content of the package
name	Σ	0..1	string	A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc
type	Σ	0..1	CodeableConcept	A high level category e.g. medicinal product, raw material, shipping container etc Binding: PackageType (example): A high level categorisation of a package.
packageFor	SΣ	1..1	LiteralReference(Drug Product Description) {b}	The product that this is a pack for
status	?!Σ	0..1	CodeableConcept	The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
statusDate	Σ	0..1	dateTime	The date at which the given status became applicable
containedItemQuantity	Σ	0..*	Quantity	A total of the complete count of contained items of a particular type/form, independent of sub-packaging or organization. This can be considered as the pack size. See also packaging.containedItem.amount (especially the long definition)
description	SΣ	1..1	markdown	Container Closure System Description
legalStatusOfSupply	Σ	0..*	BackboneElement	The legal status of supply of the packaged item as classified by the regulator
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	Σ	0..1	CodeableConcept	The actual status of supply. In what situation this package type may be supplied for use Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product
jurisdiction	Σ	0..1	CodeableConcept	The place where the legal status of supply applies Binding: JurisdictionValueSet (example): Jurisdiction codes
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
copackagedIndicator	Σ	0..1	boolean	Identifies if the drug product is supplied with another item such as a diluent or adjuvant
manufacturer	Σ	0..*	Reference(Organization)	Manufacturer of this package type (multiple means these are all possible manufacturers)
attachedDocument	SΣ	0..*	LiteralReference(Graphic Reference) {b}	Container Closure System Depiction
packaging	SΣ	1..1	BackboneElement	A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap
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
identifier	Σ	0..*	Identifier	An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier
type	SΣ	1..1	CodeableConcept	The physical type of the container of the items Binding: PackagingType (example): A high level categorisation of a package.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
Slices for coding	SΣ	2..2	Coding	Code defined by a terminology system Slice: Unordered, Closed by value:$this
coding:ContainerType	SΣ	1..1	Coding	Container Type Binding: Container Type Terminology (required)
coding:ClosureType	SΣ	1..1	Coding	Closure Type Binding: Closure Type Terminology (required)
text	Σ	0..1	string	Plain text representation of the concept
componentPart	Σ	0..1	boolean	Is this a part of the packaging (e.g. a cap or bottle stopper), rather than the packaging itself (e.g. a bottle or vial)
quantity	SΣ	0..1	integer	The quantity of this level of packaging in the package that contains it (with the outermost level being 1)
material	Σ	0..*	CodeableConcept	Material type of the package item Binding: PackageMaterial (example): A material used in the construction of packages and their components.
alternateMaterial	Σ	0..*	CodeableConcept	A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material Binding: PackageMaterial (example): A material used in the construction of packages and their components.
shelfLifeStorage	Σ	0..*	ProductShelfLife	Shelf Life and storage information
manufacturer	Σ	0..*	Reference(Organization)	Manufacturer of this packaging item (multiple means these are all potential manufacturers)
property	Σ	0..*	BackboneElement	General characteristics of this item
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
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
value[x]	Σ	0..1		A value for the characteristic
valueCodeableConcept			CodeableConcept
valueQuantity			Quantity
valueDate			date
valueBoolean			boolean
valueAttachment			Attachment
containedItem	Σ	0..*	BackboneElement	The item(s) within the packaging
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
item	Σ	1..1	CodeableReference(ManufacturedItemDefinition | DeviceDefinition | PackagedProductDefinition | BiologicallyDerivedProduct | NutritionProduct)	The actual item(s) of medication, as manufactured, or a device, or other medically related item (food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package
amount	Σ	0..1	Quantity	The number of this type of item within this packaging or for continuous items such as liquids it is the quantity (for example 25ml). See also PackagedProductDefinition.containedItemQuantity (especially the long definition)
packaging	SΣ	0..*	See packaging (PackagedProductDefinition)	Allows containers (and parts of containers) within containers, still as a part of single packaged product
characteristic	Σ	0..*	See property (PackagedProductDefinition)	Allows the key features to be recorded, such as "hospital pack", "nurse prescribable"
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
PackagedProductDefinition.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
PackagedProductDefinition.type	example	PackageType http://hl7.org/fhir/ValueSet/package-type from the FHIR Standard
PackagedProductDefinition.status	preferred	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard
PackagedProductDefinition.legalStatusOfSupply.code	example	LegalStatusOfSupply http://hl7.org/fhir/ValueSet/legal-status-of-supply from the FHIR Standard
PackagedProductDefinition.legalStatusOfSupply.jurisdiction	example	JurisdictionValueSet http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard
PackagedProductDefinition.packaging.type	example	PackagingType http://hl7.org/fhir/ValueSet/packaging-type from the FHIR Standard
PackagedProductDefinition.packaging.type.coding:ContainerType	required	PqcmcContainerTypeTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-container-type-terminology from this IG
PackagedProductDefinition.packaging.type.coding:ClosureType	required	PqcmcClosureTypeTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-closure-type-terminology from this IG
PackagedProductDefinition.packaging.material	example	PackageMaterial http://hl7.org/fhir/ValueSet/package-material from the FHIR Standard
PackagedProductDefinition.packaging.alternateMaterial	example	PackageMaterial http://hl7.org/fhir/ValueSet/package-material from the FHIR Standard
PackagedProductDefinition.packaging.property.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	PackagedProductDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	PackagedProductDefinition	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	PackagedProductDefinition	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	PackagedProductDefinition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	PackagedProductDefinition	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 PackagedProductDefinition

Summary

Mandatory: 6 elements
Must-Support: 10 elements

Structures

This structure refers to these other structures:

• Literal Reference (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference)
• Drug Product Description (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-description)
• Graphic Reference (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-graphic-reference)

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of PackagedProductDefinition.packaging.type.coding (Closed)

Differential View

This structure is derived from PackagedProductDefinition

Name	Flags	Card.	Type	Description & Constraints
PackagedProductDefinition		0..*	PackagedProductDefinition	A medically related item or items, in a container or package
packageFor	S	1..1	LiteralReference(Drug Product Description) {b}	The product that this is a pack for
description	S	1..1	markdown	Container Closure System Description
attachedDocument	S	0..*	LiteralReference(Graphic Reference) {b}	Container Closure System Depiction
packaging	S	1..1	BackboneElement	A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap
type	S	1..1	CodeableConcept	The physical type of the container of the items
Slices for coding	S	2..2	Coding	Code defined by a terminology system Slice: Unordered, Closed by value:$this
coding:ContainerType	S	1..1	Coding	Container Type Binding: Container Type Terminology (required)
coding:ClosureType	S	1..1	Coding	Closure Type Binding: Closure Type Terminology (required)
quantity	S	0..1	integer	The quantity of this level of packaging in the package that contains it (with the outermost level being 1)
packaging	S	0..*		Allows containers (and parts of containers) within containers, still as a part of single packaged product
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
PackagedProductDefinition.packaging.type.coding:ContainerType	required	PqcmcContainerTypeTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-container-type-terminology from this IG
PackagedProductDefinition.packaging.type.coding:ClosureType	required	PqcmcClosureTypeTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-closure-type-terminology from this IG

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
PackagedProductDefinition		0..*	PackagedProductDefinition	A medically related item or items, in a container or package
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
packageFor	SΣ	1..1	LiteralReference(Drug Product Description) {b}	The product that this is a pack for
status	?!Σ	0..1	CodeableConcept	The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
description	SΣ	1..1	markdown	Container Closure System Description
attachedDocument	SΣ	0..*	LiteralReference(Graphic Reference) {b}	Container Closure System Depiction
packaging	SΣ	1..1	BackboneElement	A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	The physical type of the container of the items Binding: PackagingType (example): A high level categorisation of a package.
Slices for coding	SΣ	2..2	Coding	Code defined by a terminology system Slice: Unordered, Closed by value:$this
coding:ContainerType	SΣ	1..1	Coding	Container Type Binding: Container Type Terminology (required)
coding:ClosureType	SΣ	1..1	Coding	Closure Type Binding: Closure Type Terminology (required)
quantity	SΣ	0..1	integer	The quantity of this level of packaging in the package that contains it (with the outermost level being 1)
packaging	SΣ	0..*	See packaging (PackagedProductDefinition)	Allows containers (and parts of containers) within containers, still as a part of single packaged product
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
PackagedProductDefinition.status	preferred	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard
PackagedProductDefinition.packaging.type	example	PackagingType http://hl7.org/fhir/ValueSet/packaging-type from the FHIR Standard
PackagedProductDefinition.packaging.type.coding:ContainerType	required	PqcmcContainerTypeTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-container-type-terminology from this IG
PackagedProductDefinition.packaging.type.coding:ClosureType	required	PqcmcClosureTypeTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-closure-type-terminology from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	PackagedProductDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	PackagedProductDefinition	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	PackagedProductDefinition	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	PackagedProductDefinition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	PackagedProductDefinition	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
PackagedProductDefinition		0..*	PackagedProductDefinition	A medically related item or items, in a container or package
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
identifier	Σ	0..*	Identifier	A unique identifier for this package as whole - not for the content of the package
name	Σ	0..1	string	A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc
type	Σ	0..1	CodeableConcept	A high level category e.g. medicinal product, raw material, shipping container etc Binding: PackageType (example): A high level categorisation of a package.
packageFor	SΣ	1..1	LiteralReference(Drug Product Description) {b}	The product that this is a pack for
status	?!Σ	0..1	CodeableConcept	The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
statusDate	Σ	0..1	dateTime	The date at which the given status became applicable
containedItemQuantity	Σ	0..*	Quantity	A total of the complete count of contained items of a particular type/form, independent of sub-packaging or organization. This can be considered as the pack size. See also packaging.containedItem.amount (especially the long definition)
description	SΣ	1..1	markdown	Container Closure System Description
legalStatusOfSupply	Σ	0..*	BackboneElement	The legal status of supply of the packaged item as classified by the regulator
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	Σ	0..1	CodeableConcept	The actual status of supply. In what situation this package type may be supplied for use Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product
jurisdiction	Σ	0..1	CodeableConcept	The place where the legal status of supply applies Binding: JurisdictionValueSet (example): Jurisdiction codes
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
copackagedIndicator	Σ	0..1	boolean	Identifies if the drug product is supplied with another item such as a diluent or adjuvant
manufacturer	Σ	0..*	Reference(Organization)	Manufacturer of this package type (multiple means these are all possible manufacturers)
attachedDocument	SΣ	0..*	LiteralReference(Graphic Reference) {b}	Container Closure System Depiction
packaging	SΣ	1..1	BackboneElement	A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap
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
identifier	Σ	0..*	Identifier	An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier
type	SΣ	1..1	CodeableConcept	The physical type of the container of the items Binding: PackagingType (example): A high level categorisation of a package.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
Slices for coding	SΣ	2..2	Coding	Code defined by a terminology system Slice: Unordered, Closed by value:$this
coding:ContainerType	SΣ	1..1	Coding	Container Type Binding: Container Type Terminology (required)
coding:ClosureType	SΣ	1..1	Coding	Closure Type Binding: Closure Type Terminology (required)
text	Σ	0..1	string	Plain text representation of the concept
componentPart	Σ	0..1	boolean	Is this a part of the packaging (e.g. a cap or bottle stopper), rather than the packaging itself (e.g. a bottle or vial)
quantity	SΣ	0..1	integer	The quantity of this level of packaging in the package that contains it (with the outermost level being 1)
material	Σ	0..*	CodeableConcept	Material type of the package item Binding: PackageMaterial (example): A material used in the construction of packages and their components.
alternateMaterial	Σ	0..*	CodeableConcept	A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material Binding: PackageMaterial (example): A material used in the construction of packages and their components.
shelfLifeStorage	Σ	0..*	ProductShelfLife	Shelf Life and storage information
manufacturer	Σ	0..*	Reference(Organization)	Manufacturer of this packaging item (multiple means these are all potential manufacturers)
property	Σ	0..*	BackboneElement	General characteristics of this item
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
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
value[x]	Σ	0..1		A value for the characteristic
valueCodeableConcept			CodeableConcept
valueQuantity			Quantity
valueDate			date
valueBoolean			boolean
valueAttachment			Attachment
containedItem	Σ	0..*	BackboneElement	The item(s) within the packaging
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
item	Σ	1..1	CodeableReference(ManufacturedItemDefinition | DeviceDefinition | PackagedProductDefinition | BiologicallyDerivedProduct | NutritionProduct)	The actual item(s) of medication, as manufactured, or a device, or other medically related item (food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package
amount	Σ	0..1	Quantity	The number of this type of item within this packaging or for continuous items such as liquids it is the quantity (for example 25ml). See also PackagedProductDefinition.containedItemQuantity (especially the long definition)
packaging	SΣ	0..*	See packaging (PackagedProductDefinition)	Allows containers (and parts of containers) within containers, still as a part of single packaged product
characteristic	Σ	0..*	See property (PackagedProductDefinition)	Allows the key features to be recorded, such as "hospital pack", "nurse prescribable"
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
PackagedProductDefinition.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
PackagedProductDefinition.type	example	PackageType http://hl7.org/fhir/ValueSet/package-type from the FHIR Standard
PackagedProductDefinition.status	preferred	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard
PackagedProductDefinition.legalStatusOfSupply.code	example	LegalStatusOfSupply http://hl7.org/fhir/ValueSet/legal-status-of-supply from the FHIR Standard
PackagedProductDefinition.legalStatusOfSupply.jurisdiction	example	JurisdictionValueSet http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard
PackagedProductDefinition.packaging.type	example	PackagingType http://hl7.org/fhir/ValueSet/packaging-type from the FHIR Standard
PackagedProductDefinition.packaging.type.coding:ContainerType	required	PqcmcContainerTypeTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-container-type-terminology from this IG
PackagedProductDefinition.packaging.type.coding:ClosureType	required	PqcmcClosureTypeTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-closure-type-terminology from this IG
PackagedProductDefinition.packaging.material	example	PackageMaterial http://hl7.org/fhir/ValueSet/package-material from the FHIR Standard
PackagedProductDefinition.packaging.alternateMaterial	example	PackageMaterial http://hl7.org/fhir/ValueSet/package-material from the FHIR Standard
PackagedProductDefinition.packaging.property.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	PackagedProductDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	PackagedProductDefinition	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	PackagedProductDefinition	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	PackagedProductDefinition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	PackagedProductDefinition	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 PackagedProductDefinition

Summary

Mandatory: 6 elements
Must-Support: 10 elements

Structures

This structure refers to these other structures:

• Literal Reference (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference)
• Drug Product Description (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-description)
• Graphic Reference (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-graphic-reference)

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of PackagedProductDefinition.packaging.type.coding (Closed)

Other representations of profile: CSV, Excel, Schematron