Profile Comparison between http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-product vs http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-handle

Messages

Metadata

Name	Value		Comments
abstract	false
baseDefinition	http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition
copyright
date	2024-04-08T17:51:06+00:00	2024-12-11T13:47:08+00:00	Values Differ
description	Includes the identifying information of the drug product. Profile of Drug Product profile.	Includes the essential identifying information of the drug product required to link to other profiles about the product in the eCTD structure.	Values Differ
experimental
fhirVersion	5.0.0
jurisdiction
jurisdiction[0]	urn:iso:std:iso:3166#US
kind	resource
name	RoutineDrugProduct	DrugProductHandle	Values Differ
publisher	HL7 International / Biomedical Research and Regulation
purpose
status	active
title	Routine Drug Product	Drug Product Handle	Values Differ
type	MedicinalProductDefinition
url	http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-product	http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-handle	Values Differ
version	1.0.0-ballot	1.0.0	Values Differ

Structure

Name	L Flags	L Card.	L Type	L Description & Constraints	R Flags	R Card.	R Type	R Description & Constraints	Comments
MedicinalProductDefinition		0..*	MedicinalProductDefinition	Detailed definition of a medicinal product		0..*	MedicinalProductDefinition	Detailed definition of a medicinal product
id	Σ	0..1	id	Logical id of this artifact	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource	Σ	0..1	Meta	Metadata about the resource
id		0..1	id	Unique id for inter-element referencing					Removed this element
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url					Removed this element
versionId	Σ	0..1	id	Version specific identifier					Removed this element
lastUpdated	Σ	0..1	instant	When the resource version last changed					Removed this element
source	Σ	0..1	uri	Identifies where the resource comes from					Removed this element
profile	SΣ	1..1	canonical(StructureDefinition)	Profiles this resource claims to conform to					Removed this element
security	Σ	0..*	Coding	Security Labels applied to this resource Binding: ?? (extensible): Security Labels from the Healthcare Privacy and Security Classification System.					Removed this element
tag	Σ	0..*	Coding	Tags applied to this resource Binding: ?? (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".					Removed this element
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: ?? (required): IETF language tag for a human language Additional Bindings Purpose ?? Starter Set		0..1	code	Language of the resource content Binding: ?? (required): IETF language tag for a human language Additional Bindings Purpose ?? Starter Set
text		0..1	Narrative	Text summary of the resource, for human interpretation		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	SΣ	0..1	Identifier	Optional user designated identifier	SΣ	0..1	Identifier	Optional user designated identifier
type	Σ	0..1	CodeableConcept	Regulatory type, e.g. Investigational or Authorized Binding: ?? (example): Overall defining type of this medicinal product.	Σ	0..1	CodeableConcept	Regulatory type, e.g. Investigational or Authorized Binding: ?? (example): Overall defining type of this medicinal product.
domain	Σ	0..1	CodeableConcept	If this medicine applies to human or veterinary uses Binding: ?? (example): Applicable domain for this product (e.g. human, veterinary).	Σ	0..1	CodeableConcept	If this medicine applies to human or veterinary uses Binding: ?? (example): Applicable domain for this product (e.g. human, veterinary).
version	Σ	0..1	string	A business identifier relating to a specific version of the product	Σ	0..1	string	A business identifier relating to a specific version of the product
status	?!Σ	0..1	CodeableConcept	The status within the lifecycle of this product record Binding: ?? (preferred): The lifecycle status of an artifact.	?!Σ	0..1	CodeableConcept	The status within the lifecycle of this product record Binding: ?? (preferred): The lifecycle status of an artifact.
statusDate	Σ	0..1	dateTime	The date at which the given status became applicable	Σ	0..1	dateTime	The date at which the given status became applicable
description	Σ	0..1	markdown	General description of this product	SΣ	0..0			Elements differ in definition for mustSupport: 'false' vs 'true' Element maximum cardinalities differ: '1' vs '0'
combinedPharmaceuticalDoseForm	SΣ	1..1	CodeableConcept	The dose form for a single part product, or combined form of a multiple part product Binding: ?? (example): Dose forms for a product as a whole, considering all individual parts, but before any mixing	SΣ	1..1	CodeableConcept	Product Dosage Form Binding: ?? (required)
id		0..1	id	Unique id for inter-element referencing					Removed this element
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url					Removed this element
coding	Σ	0..*	Coding	Code defined by a terminology system					Removed this element
text	Σ	0..1	string	Plain text representation of the concept					Removed this element
route	SΣ	1..*	CodeableConcept	The path by which the product is taken into or makes contact with the body Binding: ?? (example): A code specifying the route or physiological path of administration of a therapeutic agent into or onto a patient's body.	SΣ	1..*	CodeableConcept	Route of Administration Binding: ?? (required)
id		0..1	id	Unique id for inter-element referencing					Removed this element
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url					Removed this element
coding	Σ	0..*	Coding	Code defined by a terminology system					Removed this element
text	Σ	0..1	string	Plain text representation of the concept					Removed this element
indication	Σ	0..1	markdown	Description of indication(s) for this product, used when structured indications are not required	Σ	0..1	markdown	Description of indication(s) for this product, used when structured indications are not required
legalStatusOfSupply	Σ	0..1	CodeableConcept	The legal status of supply of the medicinal product as classified by the regulator Binding: ?? (example): The prescription supply types appropriate to a medicinal product	Σ	0..1	CodeableConcept	The legal status of supply of the medicinal product as classified by the regulator Binding: ?? (example): The prescription supply types appropriate to a medicinal product
additionalMonitoringIndicator	Σ	0..1	CodeableConcept	Whether the Medicinal Product is subject to additional monitoring for regulatory reasons Binding: ?? (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring).	Σ	0..1	CodeableConcept	Whether the Medicinal Product is subject to additional monitoring for regulatory reasons Binding: ?? (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring).
specialMeasures	Σ	0..*	CodeableConcept	Whether the Medicinal Product is subject to special measures for regulatory reasons Binding: ?? (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies.	Σ	0..*	CodeableConcept	Whether the Medicinal Product is subject to special measures for regulatory reasons Binding: ?? (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies.
pediatricUseIndicator	Σ	0..1	CodeableConcept	If authorised for use in children Binding: ?? (example): Suitability for age groups, in particular children.	Σ	0..1	CodeableConcept	If authorised for use in children Binding: ?? (example): Suitability for age groups, in particular children.
classification	Σ	0..*	CodeableConcept	Allows the product to be classified by various systems Binding: ?? (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.	Σ	0..*	CodeableConcept	Allows the product to be classified by various systems Binding: ?? (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.
marketingStatus	Σ	0..*	MarketingStatus	Marketing status of the medicinal product, in contrast to marketing authorization	Σ	0..*	MarketingStatus	Marketing status of the medicinal product, in contrast to marketing authorization
packagedMedicinalProduct	Σ	0..*	CodeableConcept	Package type for the product Binding: ?? (example): Types of medicinal product packs	Σ	0..*	CodeableConcept	Package type for the product Binding: ?? (example): Types of medicinal product packs
comprisedOf	Σ	0..*	Reference(ManufacturedItemDefinition | DeviceDefinition)	Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes	Σ	0..*	Reference(ManufacturedItemDefinition | DeviceDefinition)	Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes
ingredient	Σ	0..*	CodeableConcept	The ingredients of this medicinal product - when not detailed in other resources Binding: ?? (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.	Σ	0..*	CodeableConcept	The ingredients of this medicinal product - when not detailed in other resources Binding: ?? (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
impurity	Σ	0..*	CodeableReference(SubstanceDefinition)	Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product Binding: ?? (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.	Σ	0..*	CodeableReference(SubstanceDefinition)	Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product Binding: ?? (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
attachedDocument	Σ	0..*	Reference(DocumentReference)	Additional documentation about the medicinal product	Σ	0..*	Reference(DocumentReference)	Additional documentation about the medicinal product
masterFile	Σ	0..*	Reference(DocumentReference)	A master file for the medicinal product (e.g. Pharmacovigilance System Master File)	Σ	0..*	Reference(DocumentReference)	A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
contact	Σ	0..*	BackboneElement	A product specific contact, person (in a role), or an organization	Σ	0..*	BackboneElement	A product specific contact, person (in a role), or an organization
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	0..1	CodeableConcept	Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information Binding: ?? (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.	Σ	0..1	CodeableConcept	Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information Binding: ?? (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.
contact	Σ	1..1	Reference(Organization | PractitionerRole)	A product specific contact, person (in a role), or an organization	Σ	1..1	Reference(Organization | PractitionerRole)	A product specific contact, person (in a role), or an organization
clinicalTrial	Σ	0..*	Reference(ResearchStudy)	Clinical trials or studies that this product is involved in	Σ	0..*	Reference(ResearchStudy)	Clinical trials or studies that this product is involved in
code	Σ	0..*	Coding	A code that this product is known by, within some formal terminology Binding: ?? (example): A coded concept that defines the type of a medication.	Σ	0..*	Coding	A code that this product is known by, within some formal terminology Binding: ?? (example): A coded concept that defines the type of a medication.
Slices for name	SΣ	1..2	BackboneElement	The product's name, including full name and possibly coded parts Slice: Unordered, Open by value:type	SΣ	1..2	BackboneElement	The product's name, including full name and possibly coded parts Slice: Unordered, Closed by value:type
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
productName	SΣ	1..1	string	The full product name	SΣ	1..1	string	The full product name
type	SΣ	1..1	CodeableConcept	Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: ?? (example): Type of a name for a Medicinal Product.	SΣ	1..1	CodeableConcept	Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: ?? (required)
part	Σ	0..*	BackboneElement	Coding words or phrases of the name	Σ	0..*	BackboneElement	Coding words or phrases of the name
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
part	Σ	1..1	string	A fragment of a product name	Σ	1..1	string	A fragment of a product name
type	Σ	1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Binding: ?? (example): Type of part of a name for a Medicinal Product.	Σ	1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Binding: ?? (example): Type of part of a name for a Medicinal Product.
usage	Σ	0..*	BackboneElement	Country and jurisdiction where the name applies	Σ	0..*	BackboneElement	Country and jurisdiction where the name applies
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
country	Σ	1..1	CodeableConcept	Country code for where this name applies Binding: ?? (example): Jurisdiction codes	Σ	1..1	CodeableConcept	Country code for where this name applies Binding: ?? (example): Jurisdiction codes
jurisdiction	Σ	0..0			Σ	0..0
language	Σ	1..1	CodeableConcept	Language code for this name Binding: ?? (required): IETF language tag for a human language Additional Bindings Purpose ?? Starter Set	Σ	1..1	CodeableConcept	Language code for this name Binding: ?? (required): IETF language tag for a human language Additional Bindings Purpose ?? Starter Set
crossReference	Σ	0..*	BackboneElement	Reference to another product, e.g. for linking authorised to investigational product	SΣ	0..0			Elements differ in definition for mustSupport: 'false' vs 'true' Element maximum cardinalities differ: '2147483647' vs '0'
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
product	Σ	1..1	CodeableReference(MedicinalProductDefinition)	Reference to another product, e.g. for linking authorised to investigational product	Σ	1..1	CodeableReference(MedicinalProductDefinition)	Reference to another product, e.g. for linking authorised to investigational product
type	Σ	0..1	CodeableConcept	The type of relationship, for instance branded to generic or virtual to actual product Binding: ?? (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.	Σ	0..1	CodeableConcept	The type of relationship, for instance branded to generic or virtual to actual product Binding: ?? (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.
operation	Σ	0..*	BackboneElement	A manufacturing or administrative process for the medicinal product	Σ	0..*	BackboneElement	A manufacturing or administrative process for the medicinal product
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	0..1	CodeableReference(ActivityDefinition | PlanDefinition)	The type of manufacturing operation e.g. manufacturing itself, re-packaging	Σ	0..1	CodeableReference(ActivityDefinition | PlanDefinition)	The type of manufacturing operation e.g. manufacturing itself, re-packaging
effectiveDate	Σ	0..1	Period	Date range of applicability	Σ	0..1	Period	Date range of applicability
organization	Σ	0..*	Reference(Organization)	The organization responsible for the particular process, e.g. the manufacturer or importer	Σ	0..*	Reference(Organization)	The organization responsible for the particular process, e.g. the manufacturer or importer
confidentialityIndicator	Σ	0..1	CodeableConcept	Specifies whether this process is considered proprietary or confidential Binding: ?? (example): Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product.	Σ	0..1	CodeableConcept	Specifies whether this process is considered proprietary or confidential Binding: ?? (example): Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product.
characteristic	Σ	0..*	BackboneElement	Key product features such as "sugar free", "modified release"	Σ	0..*	BackboneElement	Key product features such as "sugar free", "modified release"
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ?? (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ?? (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
value[x]	Σ	0..1	CodeableConcept, markdown, Quantity, integer, date, boolean, Attachment	A value for the characteristic	Σ	0..1	CodeableConcept, markdown, Quantity, integer, date, boolean, Attachment	A value for the characteristic
Documentation for this format