This page is part of the Pharmaceutical Quality (Industry) (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions

• Content
• Detailed Descriptions
• Mappings
• Examples

Resource Profile: Substance - Drug

This Substance profile represents identifying information about an actual batch of aubstance (an instance).

Usage:

• Use this Resource Profile: Bundle – Batch Analysis PQ, Bundle – Drug Reference Standards PQ, Bundle – Drug Stability PQ, Bundle – Drug Substance Batch Information PQ... Show 2 more, Bundle – Drug Substance Characterization PQ and Bundle - Product Process Validation PQ
• Refer to this Resource Profile: Extension - Batch Substance Batch PQ
• Examples for this Resource Profile: Substance/substance-drug-pq-ex1

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 Substance

Name	Flags	Card.	Type	Description & Constraints
Substance		0..*	Substance	A homogeneous material with a definite composition
identifier	S	0..*	Identifier	Unique identifier
status	S	0..1	code	active | inactive | entered-in-error
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
Substance		0..*	Substance	A homogeneous material with a definite composition
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..*	Identifier	Unique identifier
instance	?!Σ	1..1	boolean	Is this an instance of a substance or a kind of one
status	?!SΣ	0..1	code	active | inactive | entered-in-error Binding: FHIRSubstanceStatus (required): A code to indicate if the substance is actively used.
code	Σ	1..1	CodeableReference(SubstanceDefinition)	What substance this is Binding: SubstanceCode (example): Substance codes.
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
Substance.status	required	FHIRSubstanceStatus
Substance.code	example	SubstanceCode

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	Substance	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Substance	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	Substance	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	Substance	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Substance	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
Substance		0..*	Substance	A homogeneous material with a definite composition
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	SΣ	0..*	Identifier	Unique identifier
instance	?!Σ	1..1	boolean	Is this an instance of a substance or a kind of one
status	?!SΣ	0..1	code	active | inactive | entered-in-error Binding: FHIRSubstanceStatus (required): A code to indicate if the substance is actively used.
category	Σ	0..*	CodeableConcept	What class/type of substance this is Binding: SubstanceCategoryCodes (extensible): Category or classification of substance.
code	Σ	1..1	CodeableReference(SubstanceDefinition)	What substance this is Binding: SubstanceCode (example): Substance codes.
description	Σ	0..1	markdown	Textual description of the substance, comments
expiry	Σ	0..1	dateTime	When no longer valid to use
quantity	Σ	0..1	SimpleQuantity	Amount of substance in the package
ingredient	Σ	0..*	BackboneElement	Composition information about the substance
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
quantity	Σ	0..1	Ratio	Optional amount (concentration)
substance[x]	Σ	1..1		A component of the substance Binding: SubstanceCode (example): Substance Ingredient codes.
substanceCodeableConcept			CodeableConcept
substanceReference			Reference(Substance)
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
Substance.language	required	AllLanguages
Substance.status	required	FHIRSubstanceStatus
Substance.category	extensible	SubstanceCategoryCodes
Substance.code	example	SubstanceCode
Substance.ingredient.substance[x]	example	SubstanceCode

Constraints

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

Summary

Must-Support: 2 elements

Differential View

This structure is derived from Substance

Name	Flags	Card.	Type	Description & Constraints
Substance		0..*	Substance	A homogeneous material with a definite composition
identifier	S	0..*	Identifier	Unique identifier
status	S	0..1	code	active | inactive | entered-in-error
Documentation for this format

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
Substance		0..*	Substance	A homogeneous material with a definite composition
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..*	Identifier	Unique identifier
instance	?!Σ	1..1	boolean	Is this an instance of a substance or a kind of one
status	?!SΣ	0..1	code	active | inactive | entered-in-error Binding: FHIRSubstanceStatus (required): A code to indicate if the substance is actively used.
code	Σ	1..1	CodeableReference(SubstanceDefinition)	What substance this is Binding: SubstanceCode (example): Substance codes.
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
Substance.status	required	FHIRSubstanceStatus
Substance.code	example	SubstanceCode

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	Substance	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Substance	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	Substance	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	Substance	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Substance	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
Substance		0..*	Substance	A homogeneous material with a definite composition
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	SΣ	0..*	Identifier	Unique identifier
instance	?!Σ	1..1	boolean	Is this an instance of a substance or a kind of one
status	?!SΣ	0..1	code	active | inactive | entered-in-error Binding: FHIRSubstanceStatus (required): A code to indicate if the substance is actively used.
category	Σ	0..*	CodeableConcept	What class/type of substance this is Binding: SubstanceCategoryCodes (extensible): Category or classification of substance.
code	Σ	1..1	CodeableReference(SubstanceDefinition)	What substance this is Binding: SubstanceCode (example): Substance codes.
description	Σ	0..1	markdown	Textual description of the substance, comments
expiry	Σ	0..1	dateTime	When no longer valid to use
quantity	Σ	0..1	SimpleQuantity	Amount of substance in the package
ingredient	Σ	0..*	BackboneElement	Composition information about the substance
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
quantity	Σ	0..1	Ratio	Optional amount (concentration)
substance[x]	Σ	1..1		A component of the substance Binding: SubstanceCode (example): Substance Ingredient codes.
substanceCodeableConcept			CodeableConcept
substanceReference			Reference(Substance)
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
Substance.language	required	AllLanguages
Substance.status	required	FHIRSubstanceStatus
Substance.category	extensible	SubstanceCategoryCodes
Substance.code	example	SubstanceCode
Substance.ingredient.substance[x]	example	SubstanceCode

Constraints

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

Summary

Must-Support: 2 elements

Other representations of profile: CSV, Excel, Schematron