SPL Mapping FHIR Implementation Guide
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SPL Mapping FHIR Implementation Guide, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-spl/ and changes regularly. See the Directory of published versions

Resource Profile: SubmittedIngredientDefinition

Official URL: http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedIngredientDefinition Version: 0.1.0
Standards status: Trial-use Maturity Level: 1 Computable Name: SubmittedIngredientDefinition

Used to represent an substance’s active moiety.

Usage:

Formal Views of Profile Content

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

This structure is derived from SubstanceDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. SubstanceDefinition SubstanceDefinition
... identifier S 1..* Identifier Identifier by which this substance is known
... moiety S 1..2 BackboneElement Moiety, for structural modifications
.... identifier S 1..1 Identifier Identifier by which this moiety substance is known
.... name S 1..1 string Textual name for this moiety substance
... name S 1..1 BackboneElement Names applicable to this substance
.... name S 1..1 string The actual name

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. SubstanceDefinition 0..* SubstanceDefinition The detailed description of a substance, typically at a level beyond what is used for prescribing
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier SΣ 1..* Identifier Identifier by which this substance is known
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... identifier SΣ 1..1 Identifier Identifier by which this moiety substance is known
.... name SΣ 1..1 string Textual name for this moiety substance
... name SΣ 1..1 BackboneElement Names applicable to this substance
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... name SΣ 1..1 string The actual name

doco Documentation for this format

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorSubstanceDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorSubstanceDefinitionIf 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.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorSubstanceDefinitionIf 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-5errorSubstanceDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceSubstanceDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
NameFlagsCard.TypeDescription & Constraintsdoco
.. SubstanceDefinition 0..* SubstanceDefinition The detailed description of a substance, typically at a level beyond what is used for prescribing
... 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: CommonLanguages (preferred): IETF language tag

Additional BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
dom-r4b: Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier SΣ 1..* Identifier Identifier by which this substance is known
... version Σ 0..1 string A business level version identifier of the substance
... status Σ 0..1 CodeableConcept Status of substance within the catalogue e.g. active, retired
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

... classification Σ 0..* CodeableConcept A categorization, high level e.g. polymer or nucleic acid, or food, chemical, biological, or lower e.g. polymer linear or branch chain, or type of impurity
... domain Σ 0..1 CodeableConcept If the substance applies to human or veterinary use
Binding: MedicinalProductDomain (example): Applicable domain for this product (e.g. human, veterinary).

... grade Σ 0..* CodeableConcept The quality standard, established benchmark, to which substance complies (e.g. USP/NF, BP)
Binding: SubstanceGrade (example): The quality standard, established benchmark, to which a substance complies


... description Σ 0..1 markdown Textual description of the substance
... informationSource Σ 0..* Reference(Citation) Supporting literature
... note Σ 0..* Annotation Textual comment about the substance's catalogue or registry record
... manufacturer Σ 0..* Reference(Organization) The entity that creates, makes, produces or fabricates the substance
... supplier Σ 0..* Reference(Organization) An entity that is the source for the substance. It may be different from the manufacturer
... moiety SΣ 1..2 BackboneElement Moiety, for structural modifications
.... 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
.... role Σ 0..1 CodeableConcept Role that the moiety is playing
.... identifier SΣ 1..1 Identifier Identifier by which this moiety substance is known
.... name SΣ 1..1 string Textual name for this moiety substance
.... stereochemistry Σ 0..1 CodeableConcept Stereochemistry type
Binding: Stereochemistry (example): The optical rotation type of a substance.

.... opticalActivity Σ 0..1 CodeableConcept Optical activity type
Binding: OpticalActivity (example): The optical rotation type of a substance.

.... molecularFormula Σ 0..1 string Molecular formula for this moiety (e.g. with the Hill system)
.... amount[x] Σ 0..1 Quantitative value for this moiety
..... amountQuantity Quantity
..... amountString string
.... measurementType Σ 0..1 CodeableConcept The measurement type of the quantitative value
Binding: SubstanceAmountType (example): The relationship between two substance types.

... property Σ 0..* BackboneElement General specifications for this 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
.... type Σ 1..1 CodeableConcept A code expressing the type of property
Binding: product-characteristic-codes (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 property
..... valueCodeableConcept CodeableConcept
..... valueQuantity Quantity
..... valueDate date
..... valueBoolean boolean
..... valueAttachment Attachment
... molecularWeight Σ 0..* BackboneElement The molecular weight or weight range
.... 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
.... method Σ 0..1 CodeableConcept The method by which the weight was determined
Binding: WeightMethod (example): The method by which the substance weight was measured.

.... type Σ 0..1 CodeableConcept Type of molecular weight e.g. exact, average, weight average
Binding: WeightType (example): The type of substance weight measurement.

.... amount Σ 1..1 Quantity Used to capture quantitative values for a variety of elements
... structure Σ 0..1 BackboneElement Structural information
.... 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
.... stereochemistry Σ 0..1 CodeableConcept Stereochemistry type
Binding: Stereochemistry (example): The optical rotation type of a substance.

.... opticalActivity Σ 0..1 CodeableConcept Optical activity type
Binding: OpticalActivity (example): The optical rotation type of a substance.

.... molecularFormula Σ 0..1 string Molecular formula (e.g. using the Hill system)
.... molecularFormulaByMoiety Σ 0..1 string Specified per moiety according to the Hill system
.... molecularWeight Σ 0..1 See molecularWeight (SubstanceDefinition) The molecular weight or weight range
.... technique Σ 0..* CodeableConcept The method used to find the structure e.g. X-ray, NMR
Binding: StructureTechnique (example): The method used to elucidate the structure or characterization of the drug substance.


.... sourceDocument Σ 0..* Reference(DocumentReference) Source of information for the structure
.... representation Σ 0..* BackboneElement A depiction of the structure or characterization of 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
..... type Σ 0..1 CodeableConcept The kind of structural representation (e.g. full, partial)
Binding: SubstanceRepresentationType (example): A format of a substance representation.

..... representation Σ 0..1 string The structural representation or characterization as a text string in a standard format
..... format Σ 0..1 CodeableConcept The format of the representation e.g. InChI, SMILES, MOLFILE (note: not the physical file format)
Binding: SubstanceRepresentationFormat (example): A format of a substance representation.

..... document Σ 0..1 Reference(DocumentReference) An attachment with the structural representation e.g. a structure graphic or AnIML file
... code Σ 0..* BackboneElement Codes associated with 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
.... code Σ 0..1 CodeableConcept The specific code
.... status Σ 0..1 CodeableConcept Status of the code assignment, for example 'provisional', 'approved'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

.... statusDate Σ 0..1 dateTime The date at which the code status was changed
.... note Σ 0..* Annotation Any comment can be provided in this field
.... source Σ 0..* Reference(DocumentReference) Supporting literature
... name SΣ 1..1 BackboneElement Names applicable to this 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
.... name SΣ 1..1 string The actual name
.... type Σ 0..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'
Binding: SubstanceNameType (example): The type of a name given to a substance.

.... status Σ 0..1 CodeableConcept The status of the name e.g. 'current', 'proposed'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

.... preferred Σ 0..1 boolean If this is the preferred name for this substance
.... language Σ 0..* CodeableConcept Human language that the name is written in
Binding: CommonLanguages (preferred): IETF language tag

Additional BindingsPurpose
AllLanguages Max Binding

.... domain Σ 0..* CodeableConcept The use context of this name e.g. as an active ingredient or as a food colour additive
Binding: SubstanceNameDomain (example): The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive.


.... jurisdiction Σ 0..* CodeableConcept The jurisdiction where this name applies
Binding: Jurisdiction ValueSet (example): Jurisdiction codes


.... synonym Σ 0..* See name (SubstanceDefinition) A synonym of this particular name, by which the substance is also known
.... translation Σ 0..* See name (SubstanceDefinition) A translation for this name into another human language
.... official Σ 0..* BackboneElement Details of the official nature of this name
..... 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
..... authority Σ 0..1 CodeableConcept Which authority uses this official name
Binding: SubstanceNameAuthority (preferred): An authority that officates substance names.

..... status Σ 0..1 CodeableConcept The status of the official name, for example 'draft', 'active'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

..... date Σ 0..1 dateTime Date of official name change
.... source Σ 0..* Reference(DocumentReference) Supporting literature
... relationship Σ 0..* BackboneElement A link between this substance and another
.... 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
.... substanceDefinition[x] Σ 0..1 A pointer to another substance, as a resource or a representational code
..... substanceDefinitionReference Reference(SubstanceDefinition)
..... substanceDefinitionCodeableConcept CodeableConcept
.... type Σ 1..1 CodeableConcept For example "salt to parent", "active moiety"
Binding: SubstanceRelationshipType (example): The relationship between two substance types.

.... isDefining Σ 0..1 boolean For example where an enzyme strongly bonds with a particular substance, this is a defining relationship for that enzyme, out of several possible relationships
.... amount[x] Σ 0..1 A numeric factor for the relationship, e.g. that a substance salt has some percentage of active substance in relation to some other
..... amountQuantity Quantity
..... amountRatio Ratio
..... amountString string
.... ratioHighLimitAmount Σ 0..1 Ratio For use when the numeric has an uncertain range
.... comparator Σ 0..1 CodeableConcept An operator for the amount, for example "average", "approximately", "less than"
Binding: SubstanceAmountType (example): The relationship between two substance types.

.... source Σ 0..* Reference(DocumentReference) Supporting literature
... sourceMaterial Σ 0..1 BackboneElement Material or taxonomic/anatomical source
.... 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 0..1 CodeableConcept Classification of the origin of the raw material. e.g. cat hair is an Animal source type
Binding: SourceMaterialType (example): A classification that provides the origin of the substance raw material.

.... genus Σ 0..1 CodeableConcept The genus of an organism e.g. the Latin epithet of the plant/animal scientific name
Binding: SourceMaterialGenus (example): The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name.

.... species Σ 0..1 CodeableConcept The species of an organism e.g. the Latin epithet of the species of the plant/animal
Binding: SourceMaterialSpecies (example): A species of origin a substance raw material.

.... part Σ 0..1 CodeableConcept An anatomical origin of the source material within an organism
Binding: SourceMaterialPart (example): An anatomical origin of the source material within an organism.

.... countryOfOrigin Σ 0..* CodeableConcept The country or countries where the material is harvested
Binding: Country ValueSet (required): Jurisdiction codes



doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
SubstanceDefinition.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
SubstanceDefinition.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
SubstanceDefinition.domainexampleMedicinalProductDomain
http://hl7.org/fhir/ValueSet/medicinal-product-domain
from the FHIR Standard
SubstanceDefinition.gradeexampleSubstanceGrade
http://hl7.org/fhir/ValueSet/substance-grade
from the FHIR Standard
SubstanceDefinition.moiety.stereochemistryexampleStereochemistry
http://hl7.org/fhir/ValueSet/substance-stereochemistry
from the FHIR Standard
SubstanceDefinition.moiety.opticalActivityexampleOpticalActivity
http://hl7.org/fhir/ValueSet/substance-optical-activity
from the FHIR Standard
SubstanceDefinition.moiety.measurementTypeexampleSubstanceAmountType
http://hl7.org/fhir/ValueSet/substance-amount-type
from the FHIR Standard
SubstanceDefinition.property.typeexamplehttp://hl7.org/fhir/ValueSet/product-characteristic-codes
http://hl7.org/fhir/ValueSet/product-characteristic-codes
SubstanceDefinition.molecularWeight.methodexampleWeightMethod
http://hl7.org/fhir/ValueSet/substance-weight-method
from the FHIR Standard
SubstanceDefinition.molecularWeight.typeexampleWeightType
http://hl7.org/fhir/ValueSet/substance-weight-type
from the FHIR Standard
SubstanceDefinition.structure.stereochemistryexampleStereochemistry
http://hl7.org/fhir/ValueSet/substance-stereochemistry
from the FHIR Standard
SubstanceDefinition.structure.opticalActivityexampleOpticalActivity
http://hl7.org/fhir/ValueSet/substance-optical-activity
from the FHIR Standard
SubstanceDefinition.structure.techniqueexampleStructureTechnique
http://hl7.org/fhir/ValueSet/substance-structure-technique
from the FHIR Standard
SubstanceDefinition.structure.representation.typeexampleSubstanceRepresentationType
http://hl7.org/fhir/ValueSet/substance-representation-type
from the FHIR Standard
SubstanceDefinition.structure.representation.formatexampleSubstanceRepresentationFormat
http://hl7.org/fhir/ValueSet/substance-representation-format
from the FHIR Standard
SubstanceDefinition.code.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
SubstanceDefinition.name.typeexampleSubstanceNameType
http://hl7.org/fhir/ValueSet/substance-name-type
from the FHIR Standard
SubstanceDefinition.name.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
SubstanceDefinition.name.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
SubstanceDefinition.name.domainexampleSubstanceNameDomain
http://hl7.org/fhir/ValueSet/substance-name-domain
from the FHIR Standard
SubstanceDefinition.name.jurisdictionexampleJurisdiction ValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
SubstanceDefinition.name.official.authoritypreferredSubstanceNameAuthority
http://hl7.org/fhir/ValueSet/substance-name-authority
from the FHIR Standard
SubstanceDefinition.name.official.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
SubstanceDefinition.relationship.typeexampleSubstanceRelationshipType
http://hl7.org/fhir/ValueSet/substance-relationship-type
from the FHIR Standard
SubstanceDefinition.relationship.comparatorexampleSubstanceAmountType
http://hl7.org/fhir/ValueSet/substance-amount-type
from the FHIR Standard
SubstanceDefinition.sourceMaterial.typeexampleSourceMaterialType
http://hl7.org/fhir/ValueSet/substance-source-material-type
from the FHIR Standard
SubstanceDefinition.sourceMaterial.genusexampleSourceMaterialGenus
http://hl7.org/fhir/ValueSet/substance-source-material-genus
from the FHIR Standard
SubstanceDefinition.sourceMaterial.speciesexampleSourceMaterialSpecies
http://hl7.org/fhir/ValueSet/substance-source-material-species
from the FHIR Standard
SubstanceDefinition.sourceMaterial.partexampleSourceMaterialPart
http://hl7.org/fhir/ValueSet/substance-source-material-part
from the FHIR Standard
SubstanceDefinition.sourceMaterial.countryOfOriginrequiredCountry ValueSet
http://hl7.org/fhir/ValueSet/country|4.3.0
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorSubstanceDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorSubstanceDefinitionIf 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.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorSubstanceDefinitionIf 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-5errorSubstanceDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceSubstanceDefinitionA resource should have narrative for robust management
: text.`div`.exists()
dom-r4bwarningSubstanceDefinition.containedContaining new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems
: ($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic)
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from SubstanceDefinition

Summary

Mandatory: 5 elements
Must-Support: 6 elements

Maturity: 1

Differential View

This structure is derived from SubstanceDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. SubstanceDefinition SubstanceDefinition
... identifier S 1..* Identifier Identifier by which this substance is known
... moiety S 1..2 BackboneElement Moiety, for structural modifications
.... identifier S 1..1 Identifier Identifier by which this moiety substance is known
.... name S 1..1 string Textual name for this moiety substance
... name S 1..1 BackboneElement Names applicable to this substance
.... name S 1..1 string The actual name

doco Documentation for this format

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. SubstanceDefinition 0..* SubstanceDefinition The detailed description of a substance, typically at a level beyond what is used for prescribing
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier SΣ 1..* Identifier Identifier by which this substance is known
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... identifier SΣ 1..1 Identifier Identifier by which this moiety substance is known
.... name SΣ 1..1 string Textual name for this moiety substance
... name SΣ 1..1 BackboneElement Names applicable to this substance
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... name SΣ 1..1 string The actual name

doco Documentation for this format

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorSubstanceDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorSubstanceDefinitionIf 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.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorSubstanceDefinitionIf 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-5errorSubstanceDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceSubstanceDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. SubstanceDefinition 0..* SubstanceDefinition The detailed description of a substance, typically at a level beyond what is used for prescribing
... 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: CommonLanguages (preferred): IETF language tag

Additional BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
dom-r4b: Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier SΣ 1..* Identifier Identifier by which this substance is known
... version Σ 0..1 string A business level version identifier of the substance
... status Σ 0..1 CodeableConcept Status of substance within the catalogue e.g. active, retired
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

... classification Σ 0..* CodeableConcept A categorization, high level e.g. polymer or nucleic acid, or food, chemical, biological, or lower e.g. polymer linear or branch chain, or type of impurity
... domain Σ 0..1 CodeableConcept If the substance applies to human or veterinary use
Binding: MedicinalProductDomain (example): Applicable domain for this product (e.g. human, veterinary).

... grade Σ 0..* CodeableConcept The quality standard, established benchmark, to which substance complies (e.g. USP/NF, BP)
Binding: SubstanceGrade (example): The quality standard, established benchmark, to which a substance complies


... description Σ 0..1 markdown Textual description of the substance
... informationSource Σ 0..* Reference(Citation) Supporting literature
... note Σ 0..* Annotation Textual comment about the substance's catalogue or registry record
... manufacturer Σ 0..* Reference(Organization) The entity that creates, makes, produces or fabricates the substance
... supplier Σ 0..* Reference(Organization) An entity that is the source for the substance. It may be different from the manufacturer
... moiety SΣ 1..2 BackboneElement Moiety, for structural modifications
.... 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
.... role Σ 0..1 CodeableConcept Role that the moiety is playing
.... identifier SΣ 1..1 Identifier Identifier by which this moiety substance is known
.... name SΣ 1..1 string Textual name for this moiety substance
.... stereochemistry Σ 0..1 CodeableConcept Stereochemistry type
Binding: Stereochemistry (example): The optical rotation type of a substance.

.... opticalActivity Σ 0..1 CodeableConcept Optical activity type
Binding: OpticalActivity (example): The optical rotation type of a substance.

.... molecularFormula Σ 0..1 string Molecular formula for this moiety (e.g. with the Hill system)
.... amount[x] Σ 0..1 Quantitative value for this moiety
..... amountQuantity Quantity
..... amountString string
.... measurementType Σ 0..1 CodeableConcept The measurement type of the quantitative value
Binding: SubstanceAmountType (example): The relationship between two substance types.

... property Σ 0..* BackboneElement General specifications for this 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
.... type Σ 1..1 CodeableConcept A code expressing the type of property
Binding: product-characteristic-codes (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 property
..... valueCodeableConcept CodeableConcept
..... valueQuantity Quantity
..... valueDate date
..... valueBoolean boolean
..... valueAttachment Attachment
... molecularWeight Σ 0..* BackboneElement The molecular weight or weight range
.... 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
.... method Σ 0..1 CodeableConcept The method by which the weight was determined
Binding: WeightMethod (example): The method by which the substance weight was measured.

.... type Σ 0..1 CodeableConcept Type of molecular weight e.g. exact, average, weight average
Binding: WeightType (example): The type of substance weight measurement.

.... amount Σ 1..1 Quantity Used to capture quantitative values for a variety of elements
... structure Σ 0..1 BackboneElement Structural information
.... 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
.... stereochemistry Σ 0..1 CodeableConcept Stereochemistry type
Binding: Stereochemistry (example): The optical rotation type of a substance.

.... opticalActivity Σ 0..1 CodeableConcept Optical activity type
Binding: OpticalActivity (example): The optical rotation type of a substance.

.... molecularFormula Σ 0..1 string Molecular formula (e.g. using the Hill system)
.... molecularFormulaByMoiety Σ 0..1 string Specified per moiety according to the Hill system
.... molecularWeight Σ 0..1 See molecularWeight (SubstanceDefinition) The molecular weight or weight range
.... technique Σ 0..* CodeableConcept The method used to find the structure e.g. X-ray, NMR
Binding: StructureTechnique (example): The method used to elucidate the structure or characterization of the drug substance.


.... sourceDocument Σ 0..* Reference(DocumentReference) Source of information for the structure
.... representation Σ 0..* BackboneElement A depiction of the structure or characterization of 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
..... type Σ 0..1 CodeableConcept The kind of structural representation (e.g. full, partial)
Binding: SubstanceRepresentationType (example): A format of a substance representation.

..... representation Σ 0..1 string The structural representation or characterization as a text string in a standard format
..... format Σ 0..1 CodeableConcept The format of the representation e.g. InChI, SMILES, MOLFILE (note: not the physical file format)
Binding: SubstanceRepresentationFormat (example): A format of a substance representation.

..... document Σ 0..1 Reference(DocumentReference) An attachment with the structural representation e.g. a structure graphic or AnIML file
... code Σ 0..* BackboneElement Codes associated with 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
.... code Σ 0..1 CodeableConcept The specific code
.... status Σ 0..1 CodeableConcept Status of the code assignment, for example 'provisional', 'approved'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

.... statusDate Σ 0..1 dateTime The date at which the code status was changed
.... note Σ 0..* Annotation Any comment can be provided in this field
.... source Σ 0..* Reference(DocumentReference) Supporting literature
... name SΣ 1..1 BackboneElement Names applicable to this 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
.... name SΣ 1..1 string The actual name
.... type Σ 0..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'
Binding: SubstanceNameType (example): The type of a name given to a substance.

.... status Σ 0..1 CodeableConcept The status of the name e.g. 'current', 'proposed'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

.... preferred Σ 0..1 boolean If this is the preferred name for this substance
.... language Σ 0..* CodeableConcept Human language that the name is written in
Binding: CommonLanguages (preferred): IETF language tag

Additional BindingsPurpose
AllLanguages Max Binding

.... domain Σ 0..* CodeableConcept The use context of this name e.g. as an active ingredient or as a food colour additive
Binding: SubstanceNameDomain (example): The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive.


.... jurisdiction Σ 0..* CodeableConcept The jurisdiction where this name applies
Binding: Jurisdiction ValueSet (example): Jurisdiction codes


.... synonym Σ 0..* See name (SubstanceDefinition) A synonym of this particular name, by which the substance is also known
.... translation Σ 0..* See name (SubstanceDefinition) A translation for this name into another human language
.... official Σ 0..* BackboneElement Details of the official nature of this name
..... 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
..... authority Σ 0..1 CodeableConcept Which authority uses this official name
Binding: SubstanceNameAuthority (preferred): An authority that officates substance names.

..... status Σ 0..1 CodeableConcept The status of the official name, for example 'draft', 'active'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

..... date Σ 0..1 dateTime Date of official name change
.... source Σ 0..* Reference(DocumentReference) Supporting literature
... relationship Σ 0..* BackboneElement A link between this substance and another
.... 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
.... substanceDefinition[x] Σ 0..1 A pointer to another substance, as a resource or a representational code
..... substanceDefinitionReference Reference(SubstanceDefinition)
..... substanceDefinitionCodeableConcept CodeableConcept
.... type Σ 1..1 CodeableConcept For example "salt to parent", "active moiety"
Binding: SubstanceRelationshipType (example): The relationship between two substance types.

.... isDefining Σ 0..1 boolean For example where an enzyme strongly bonds with a particular substance, this is a defining relationship for that enzyme, out of several possible relationships
.... amount[x] Σ 0..1 A numeric factor for the relationship, e.g. that a substance salt has some percentage of active substance in relation to some other
..... amountQuantity Quantity
..... amountRatio Ratio
..... amountString string
.... ratioHighLimitAmount Σ 0..1 Ratio For use when the numeric has an uncertain range
.... comparator Σ 0..1 CodeableConcept An operator for the amount, for example "average", "approximately", "less than"
Binding: SubstanceAmountType (example): The relationship between two substance types.

.... source Σ 0..* Reference(DocumentReference) Supporting literature
... sourceMaterial Σ 0..1 BackboneElement Material or taxonomic/anatomical source
.... 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 0..1 CodeableConcept Classification of the origin of the raw material. e.g. cat hair is an Animal source type
Binding: SourceMaterialType (example): A classification that provides the origin of the substance raw material.

.... genus Σ 0..1 CodeableConcept The genus of an organism e.g. the Latin epithet of the plant/animal scientific name
Binding: SourceMaterialGenus (example): The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name.

.... species Σ 0..1 CodeableConcept The species of an organism e.g. the Latin epithet of the species of the plant/animal
Binding: SourceMaterialSpecies (example): A species of origin a substance raw material.

.... part Σ 0..1 CodeableConcept An anatomical origin of the source material within an organism
Binding: SourceMaterialPart (example): An anatomical origin of the source material within an organism.

.... countryOfOrigin Σ 0..* CodeableConcept The country or countries where the material is harvested
Binding: Country ValueSet (required): Jurisdiction codes



doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
SubstanceDefinition.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
SubstanceDefinition.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
SubstanceDefinition.domainexampleMedicinalProductDomain
http://hl7.org/fhir/ValueSet/medicinal-product-domain
from the FHIR Standard
SubstanceDefinition.gradeexampleSubstanceGrade
http://hl7.org/fhir/ValueSet/substance-grade
from the FHIR Standard
SubstanceDefinition.moiety.stereochemistryexampleStereochemistry
http://hl7.org/fhir/ValueSet/substance-stereochemistry
from the FHIR Standard
SubstanceDefinition.moiety.opticalActivityexampleOpticalActivity
http://hl7.org/fhir/ValueSet/substance-optical-activity
from the FHIR Standard
SubstanceDefinition.moiety.measurementTypeexampleSubstanceAmountType
http://hl7.org/fhir/ValueSet/substance-amount-type
from the FHIR Standard
SubstanceDefinition.property.typeexamplehttp://hl7.org/fhir/ValueSet/product-characteristic-codes
http://hl7.org/fhir/ValueSet/product-characteristic-codes
SubstanceDefinition.molecularWeight.methodexampleWeightMethod
http://hl7.org/fhir/ValueSet/substance-weight-method
from the FHIR Standard
SubstanceDefinition.molecularWeight.typeexampleWeightType
http://hl7.org/fhir/ValueSet/substance-weight-type
from the FHIR Standard
SubstanceDefinition.structure.stereochemistryexampleStereochemistry
http://hl7.org/fhir/ValueSet/substance-stereochemistry
from the FHIR Standard
SubstanceDefinition.structure.opticalActivityexampleOpticalActivity
http://hl7.org/fhir/ValueSet/substance-optical-activity
from the FHIR Standard
SubstanceDefinition.structure.techniqueexampleStructureTechnique
http://hl7.org/fhir/ValueSet/substance-structure-technique
from the FHIR Standard
SubstanceDefinition.structure.representation.typeexampleSubstanceRepresentationType
http://hl7.org/fhir/ValueSet/substance-representation-type
from the FHIR Standard
SubstanceDefinition.structure.representation.formatexampleSubstanceRepresentationFormat
http://hl7.org/fhir/ValueSet/substance-representation-format
from the FHIR Standard
SubstanceDefinition.code.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
SubstanceDefinition.name.typeexampleSubstanceNameType
http://hl7.org/fhir/ValueSet/substance-name-type
from the FHIR Standard
SubstanceDefinition.name.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
SubstanceDefinition.name.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
SubstanceDefinition.name.domainexampleSubstanceNameDomain
http://hl7.org/fhir/ValueSet/substance-name-domain
from the FHIR Standard
SubstanceDefinition.name.jurisdictionexampleJurisdiction ValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
SubstanceDefinition.name.official.authoritypreferredSubstanceNameAuthority
http://hl7.org/fhir/ValueSet/substance-name-authority
from the FHIR Standard
SubstanceDefinition.name.official.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
SubstanceDefinition.relationship.typeexampleSubstanceRelationshipType
http://hl7.org/fhir/ValueSet/substance-relationship-type
from the FHIR Standard
SubstanceDefinition.relationship.comparatorexampleSubstanceAmountType
http://hl7.org/fhir/ValueSet/substance-amount-type
from the FHIR Standard
SubstanceDefinition.sourceMaterial.typeexampleSourceMaterialType
http://hl7.org/fhir/ValueSet/substance-source-material-type
from the FHIR Standard
SubstanceDefinition.sourceMaterial.genusexampleSourceMaterialGenus
http://hl7.org/fhir/ValueSet/substance-source-material-genus
from the FHIR Standard
SubstanceDefinition.sourceMaterial.speciesexampleSourceMaterialSpecies
http://hl7.org/fhir/ValueSet/substance-source-material-species
from the FHIR Standard
SubstanceDefinition.sourceMaterial.partexampleSourceMaterialPart
http://hl7.org/fhir/ValueSet/substance-source-material-part
from the FHIR Standard
SubstanceDefinition.sourceMaterial.countryOfOriginrequiredCountry ValueSet
http://hl7.org/fhir/ValueSet/country|4.3.0
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorSubstanceDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorSubstanceDefinitionIf 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.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorSubstanceDefinitionIf 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-5errorSubstanceDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceSubstanceDefinitionA resource should have narrative for robust management
: text.`div`.exists()
dom-r4bwarningSubstanceDefinition.containedContaining new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems
: ($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic)
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from SubstanceDefinition

Summary

Mandatory: 5 elements
Must-Support: 6 elements

Maturity: 1

 

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