Intersection of http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component-substance and http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component-substance

This is the set of resources that conform to both Component Substance (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component-substance) and Component Substance (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component-substance).

Structure

Name	Flags	Card.	Type	Description & Constraints
SubstanceDefinition	C	0..*		The detailed description of a substance, typically at a level beyond what is used for prescribing dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources dom-3: 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 dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated dom-5: If a resource is contained in another resource, it SHALL NOT have a security label dom-6: A resource should have narrative for robust management cmc-when-unii-required: A UNII is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer'. A UniProt code is required for any of these categories: 'Protein' cmc-name-isbt: Name.type ISBT 128 required for blood products. cmc-source-material: IF raw material source type equals Microbial, Animal, Plant, Insect or Human THEN the 4 source related attributes are required and the manufacturer and supplier information is highly desirable.
meta	Σ	0..1	Meta	Metadata about the resource ele-1: All FHIR elements must have a @value or children
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created ele-1: All FHIR elements must have a @value or children
language		0..1	code	Language of the resource content Binding: ?? (required): IETF language tag for a human language ele-1: All FHIR elements must have a @value or children
text		0..1	Narrative	Text summary of the resource, for human interpretation ele-1: All FHIR elements must have a @value or children
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
identifier	Σ	0..1	Identifier	optional user designated identifier ele-1: All FHIR elements must have a @value or children
version	Σ	0..1	string	A business level version identifier of the substance ele-1: All FHIR elements must have a @value or children
status	Σ	0..1	CodeableConcept	Status of substance within the catalogue e.g. active, retired Binding: ?? (preferred): The lifecycle status of an artifact. ele-1: All FHIR elements must have a @value or children
classification	SΣ	1..1	CodeableConcept	Substance Type Binding: ?? (required) ele-1: All FHIR elements must have a @value or children
domain	Σ	0..1	CodeableConcept	If the substance applies to human or veterinary use Binding: ?? (example): Applicable domain for this product (e.g. human, veterinary). ele-1: All FHIR elements must have a @value or children
grade	Σ	1..*	CodeableConcept	Quality Standard Binding: ?? (required) ele-1: All FHIR elements must have a @value or children
description	Σ	0..1	markdown	Textual description of the substance ele-1: All FHIR elements must have a @value or children
informationSource	Σ	0..*	Reference(Citation)	Supporting literature ele-1: All FHIR elements must have a @value or children
note	Σ	0..*	Annotation	Textual comment about the substance's catalogue or registry record ele-1: All FHIR elements must have a @value or children
manufacturer	SΣ	0..1	LiteralReference(Basic Organization | #sd-cmc-organization-cmc-organization) {b}	The entity that creates, makes, produces or fabricates the substance ele-1: All FHIR elements must have a @value or children
supplier	SΣ	0..1	LiteralReference(Basic Organization | #sd-cmc-organization-cmc-organization) {b}	An entity that is the source for the substance. It may be different from the manufacturer ele-1: All FHIR elements must have a @value or children
moiety	Σ	0..*	BackboneElement	Moiety, for structural modifications ele-1: All FHIR elements must have a @value or children
extension		0..*	Extension	Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
role	Σ	0..1	CodeableConcept	Role that the moiety is playing ele-1: All FHIR elements must have a @value or children
identifier	Σ	0..1	Identifier	Identifier by which this moiety substance is known ele-1: All FHIR elements must have a @value or children
name	Σ	0..1	string	Textual name for this moiety substance ele-1: All FHIR elements must have a @value or children
stereochemistry	Σ	0..1	CodeableConcept	Stereochemistry type Binding: ?? (example): The optical rotation type of a substance. ele-1: All FHIR elements must have a @value or children
opticalActivity	Σ	0..1	CodeableConcept	Optical activity type Binding: ?? (example): The optical rotation type of a substance. ele-1: All FHIR elements must have a @value or children
molecularFormula	Σ	0..1	string	Molecular formula for this moiety (e.g. with the Hill system) ele-1: All FHIR elements must have a @value or children
amount[x]	Σ	0..1		Quantitative value for this moiety ele-1: All FHIR elements must have a @value or children
amountQuantity			Quantity
amountString			string
measurementType	Σ	0..1	CodeableConcept	The measurement type of the quantitative value Binding: ?? (example): The relationship between two substance types. ele-1: All FHIR elements must have a @value or children
characterization	Σ	0..*	BackboneElement	General specifications for this substance ele-1: All FHIR elements must have a @value or children
extension		0..*	Extension	Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
technique	Σ	0..1	CodeableConcept	The method used to find the characterization e.g. HPLC Binding: ?? (example): The method used to elucidate the characterization of the drug substance. ele-1: All FHIR elements must have a @value or children
form	Σ	0..1	CodeableConcept	Describes the nature of the chemical entity and explains, for instance, whether this is a base or a salt form Binding: ?? (example) ele-1: All FHIR elements must have a @value or children
description	Σ	0..1	markdown	The description or justification in support of the interpretation of the data file ele-1: All FHIR elements must have a @value or children
file	Σ	0..*	Attachment	The data produced by the analytical instrument or a pictorial representation of that data. Examples: a JCAMP, JDX, or ADX file, or a chromatogram or spectrum analysis ele-1: All FHIR elements must have a @value or children
property	Σ	0..*	BackboneElement	General specifications for this substance ele-1: All FHIR elements must have a @value or children
extension		0..*	Extension	Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
type	Σ	1..1	CodeableConcept	A code expressing the type of property Binding: ?? (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. ele-1: All FHIR elements must have a @value or children
value[x]	Σ	0..1		A value for the property ele-1: All FHIR elements must have a @value or children
valueCodeableConcept			CodeableConcept
valueQuantity			Quantity
valueDate			date
valueBoolean			boolean
valueAttachment			Attachment
referenceInformation	Σ	0..1	Reference(SubstanceReferenceInformation)	General information detailing this substance ele-1: All FHIR elements must have a @value or children
molecularWeight	Σ	0..*	BackboneElement	The average mass of a molecule of a compound ele-1: All FHIR elements must have a @value or children
extension		0..*	Extension	Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
method	Σ	0..1	CodeableConcept	The method by which the weight was determined Binding: ?? (example): The method by which the substance weight was measured. ele-1: All FHIR elements must have a @value or children
type	Σ	0..1	CodeableConcept	Type of molecular weight e.g. exact, average, weight average Binding: ?? (example): The type of substance weight measurement. ele-1: All FHIR elements must have a @value or children
amount	Σ	1..1	Quantity	Used to capture quantitative values for a variety of elements ele-1: All FHIR elements must have a @value or children
structure	ΣC	0..1	BackboneElement	Structural information ele-1: All FHIR elements must have a @value or children cmc-structure-representation-required: Either a file or string structure representation is required
extension		0..*	Extension	Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
stereochemistry	Σ	0..1	CodeableConcept	Stereochemistry type Binding: ?? (example): The optical rotation type of a substance. ele-1: All FHIR elements must have a @value or children
opticalActivity	Σ	0..1	CodeableConcept	Optical activity type Binding: ?? (example): The optical rotation type of a substance. ele-1: All FHIR elements must have a @value or children
molecularFormula	Σ	0..1	string	An expression which states the number and type of atoms present in a molecule of a substance ele-1: All FHIR elements must have a @value or children
molecularFormulaByMoiety	Σ	0..1	string	Specified per moiety according to the Hill system ele-1: All FHIR elements must have a @value or children
molecularWeight	Σ	0..1		The molecular weight or weight range ele-1: All FHIR elements must have a @value or children
technique	Σ	0..*	CodeableConcept	The method used to find the structure e.g. X-ray, NMR Binding: ?? (example): The method used to elucidate the structure of the drug substance. ele-1: All FHIR elements must have a @value or children
sourceDocument	Σ	0..*	Reference(DocumentReference)	Source of information for the structure ele-1: All FHIR elements must have a @value or children
representation	SΣ	0..*	BackboneElement	Impurity Structure Graphic | Impurity Structure Data File ele-1: All FHIR elements must have a @value or children
extension		0..*	Extension	Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
type	SΣ	1..1	CodeableConcept	The kind of structural representation (e.g. full, partial) Binding: ?? (required) ele-1: All FHIR elements must have a @value or children
representation	Σ	0..1	string	The structural representation as a text string in a standard format ele-1: All FHIR elements must have a @value or children
format	Σ	0..1	CodeableConcept	The format of the representation e.g. InChI, SMILES, MOLFILE (note: not the physical file format) Binding: ?? (example): A format of a substance representation. ele-1: All FHIR elements must have a @value or children
document	Σ	0..1	Reference(DocumentReference)	An attachment with the structural representation e.g. a structure graphic or AnIML file ele-1: All FHIR elements must have a @value or children
code	SΣ	1..*	BackboneElement	Codes associated with the substance ele-1: All FHIR elements must have a @value or children
extension		0..*	Extension	Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
code	Σ	0..1	CodeableConcept	The specific code ele-1: All FHIR elements must have a @value or children
status	Σ	0..1	CodeableConcept	Status of the code assignment, for example 'provisional', 'approved' Binding: ?? (preferred): The lifecycle status of an artifact. ele-1: All FHIR elements must have a @value or children
statusDate	Σ	0..1	dateTime	The date at which the code status was changed ele-1: All FHIR elements must have a @value or children
note	Σ	0..*	Annotation	Any comment can be provided in this field ele-1: All FHIR elements must have a @value or children
source	Σ	0..*	Reference(DocumentReference)	Supporting literature ele-1: All FHIR elements must have a @value or children
name	SΣC	1..*	BackboneElement	Substance Name ele-1: All FHIR elements must have a @value or children cmc-name-preferred: Name.preferred: at most one = true
extension		0..*	Extension	Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
name	Σ	1..1	string	The actual name ele-1: All FHIR elements must have a @value or children
type	Σ	0..1	CodeableConcept	Name type e.g. 'systematic', 'scientific, 'brand' Binding: ?? (required) ele-1: All FHIR elements must have a @value or children
status	Σ	0..1	CodeableConcept	The status of the name e.g. 'current', 'proposed' Binding: ?? (preferred): The lifecycle status of an artifact. ele-1: All FHIR elements must have a @value or children
preferred	SΣ	0..1	boolean	True when the name type is Substance Name ele-1: All FHIR elements must have a @value or children
language	Σ	0..*	CodeableConcept	Human language that the name is written in Binding: ?? (required): IETF language tag for a human language ele-1: All FHIR elements must have a @value or children
domain	Σ	0..*	CodeableConcept	The use context of this name e.g. as an active ingredient or as a food colour additive Binding: ?? (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. ele-1: All FHIR elements must have a @value or children
jurisdiction	Σ	0..*	CodeableConcept	The jurisdiction where this name applies Binding: ?? (example): Jurisdiction codes ele-1: All FHIR elements must have a @value or children
synonym	Σ	0..*		A synonym of this particular name, by which the substance is also known ele-1: All FHIR elements must have a @value or children
translation	Σ	0..*		A translation for this name into another human language ele-1: All FHIR elements must have a @value or children
official	Σ	0..*	BackboneElement	Details of the official nature of this name ele-1: All FHIR elements must have a @value or children
extension		0..*	Extension	Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
authority	Σ	0..1	CodeableConcept	Which authority uses this official name Binding: ?? (preferred): An authority that officates substance names. ele-1: All FHIR elements must have a @value or children
status	Σ	0..1	CodeableConcept	The status of the official name, for example 'draft', 'active' Binding: ?? (preferred): The lifecycle status of an artifact. ele-1: All FHIR elements must have a @value or children
date	Σ	0..1	dateTime	Date of official name change ele-1: All FHIR elements must have a @value or children
source	Σ	0..*	Reference(DocumentReference)	Supporting literature ele-1: All FHIR elements must have a @value or children
relationship	Σ	0..*	BackboneElement	A link between this substance and another ele-1: All FHIR elements must have a @value or children
extension		0..*	Extension	Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
substanceDefinition[x]	Σ	0..1		A pointer to another substance, as a resource or a representational code ele-1: All FHIR elements must have a @value or children
substanceDefinitionReference			Reference(SubstanceDefinition)
substanceDefinitionCodeableConcept			CodeableConcept
type	Σ	1..1	CodeableConcept	For example "salt to parent", "active moiety" Binding: ?? (example): The relationship between two substance types. ele-1: All FHIR elements must have a @value or children
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 ele-1: All FHIR elements must have a @value or children
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 ele-1: All FHIR elements must have a @value or children
amountQuantity			Quantity
amountRatio			Ratio
amountString			string
ratioHighLimitAmount	Σ	0..1	Ratio	For use when the numeric has an uncertain range ele-1: All FHIR elements must have a @value or children
comparator	Σ	0..1	CodeableConcept	An operator for the amount, for example "average", "approximately", "less than" Binding: ?? (example): The relationship between two substance types. ele-1: All FHIR elements must have a @value or children
source	Σ	0..*	Reference(DocumentReference)	Supporting literature ele-1: All FHIR elements must have a @value or children
nucleicAcid	Σ	0..1	Reference(SubstanceNucleicAcid)	Data items specific to nucleic acids ele-1: All FHIR elements must have a @value or children
polymer	Σ	0..1	Reference(SubstancePolymer)	Data items specific to polymers ele-1: All FHIR elements must have a @value or children
protein	Σ	0..1	Reference(SubstanceProtein)	Data items specific to proteins ele-1: All FHIR elements must have a @value or children
sourceMaterial	SΣ	0..1	BackboneElement	Material or taxonomic/anatomical source ele-1: All FHIR elements must have a @value or children
extension		0..*	Extension	Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
type	SΣ	0..1	CodeableConcept	Source Type Binding: ?? (required) ele-1: All FHIR elements must have a @value or children
genus	S	0..1	??, ??	Source Organism Genus Binding: ?? (example): The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name. ele-1: All FHIR elements must have a @value or children
species	S	0..1	??, ??	Source Organism Species Binding: ?? (example): A species of origin a substance raw material. ele-1: All FHIR elements must have a @value or children
part	S	0..1	??, ??	Source Organism Part Binding: ?? (example): An anatomical origin of the source material within an organism. ele-1: All FHIR elements must have a @value or children
countryOfOrigin	SΣ	0..1	CodeableConcept	Source Organism Country of Origin Binding: ?? (required) ele-1: All FHIR elements must have a @value or children
Documentation for this format