Union of http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part and http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part

This is the set of resources that conform to either of the profiles Manufactured Drug Product (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part) and Manufactured Drug Product (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part). E.g. what you have to deal with if you get resources conforming to one of them

Structure

Name	Flags	Card.	Type	Description & Constraints
ManufacturedItemDefinition	C	0..*		The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product 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-capsule-count-required: Capsule constituent count is required when the dosage form is 'Capsule' cmc-arbitrary-unit-text-required: BR – Product Total Weight Textual - If the UOM is UCUM Arbitrary Unit [arb'U], units must be described in Weight Textual cmc-coating-indication-required: Coating indication is required when the dosage form is a tablet, lozenge or capsule cmc-tablet-layer-count-required: Tablet layer count is required when the dosage form is a tablet cmc-tablet-bead-count-required: Tablet bead count is required when the dosage form is a tablet cmc-capsule-classification-required: when the the dosage form is 'capsule' and a 'capsule shell' part exists, a capsule shell part classification is mandatory
meta	Σ	0..1	Meta	Metadata about the resource ele-1: All FHIR elements must have a @value or children
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
versionId	Σ	0..1	id	Version specific identifier ele-1: All FHIR elements must have a @value or children
lastUpdated	Σ	0..1	instant	When the resource version last changed ele-1: All FHIR elements must have a @value or children
source	Σ	0..1	uri	Identifies where the resource comes from ele-1: All FHIR elements must have a @value or children
profile	SΣ	1..1	canonical(StructureDefinition)	Profiles this resource claims to conform to ele-1: All FHIR elements must have a @value or children
security	Σ	0..*	Coding	Security Labels applied to this resource Binding: ?? (extensible): Security Labels from the Healthcare Privacy and Security Classification System. ele-1: All FHIR elements must have a @value or children
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". 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	SΣ	0..1	Identifier	Unique identifier ele-1: All FHIR elements must have a @value or children
status	?!SΣ	1..1	code	draft | active | retired | unknown Binding: ?? (required): The lifecycle status of an artifact. ele-1: All FHIR elements must have a @value or children
name	SΣ	0..1	string	Product Proprietary Name | Product Non-proprietary Name ele-1: All FHIR elements must have a @value or children
manufacturedDoseForm	Σ	1..1	CodeableConcept	Dose form as manufactured (before any necessary transformation) Binding: ?? (required): Dose form for a medication, in the form suitable for administering to the patient, after mixing, where necessary. ele-1: All FHIR elements must have a @value or children
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: ?? (required) ele-1: All FHIR elements must have a @value or children
text	Σ	0..1	string	Plain text representation of the concept ele-1: All FHIR elements must have a @value or children
unitOfPresentation	Σ	0..1	CodeableConcept	The “real-world” units in which the quantity of the item is described Binding: ?? (example): The presentation type in which an administrable medicinal product is given to a patient. ele-1: All FHIR elements must have a @value or children
manufacturer	Σ	0..*	Reference(Organization)	Manufacturer of the item, one of several possible ele-1: All FHIR elements must have a @value or children
marketingStatus	Σ	0..*	MarketingStatus	Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated ele-1: All FHIR elements must have a @value or children
ingredient	Σ	0..*	CodeableConcept	The ingredients of this manufactured item. Only needed if these are not specified by incoming references from the Ingredient resource Binding: ?? (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. ele-1: All FHIR elements must have a @value or children
property	SΣ	5..*	BackboneElement	General characteristics of this item 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	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. ele-1: All FHIR elements must have a @value or children
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
coding	Σ	0..*	Coding	Code defined by a terminology system ele-1: All FHIR elements must have a @value or children
text	SΣ	1..1	string	Plain text representation of the concept ele-1: All FHIR elements must have a @value or children
value[x]	Σ	0..1		A value for the characteristic ele-1: All FHIR elements must have a @value or children
valueCodeableConcept			CodeableConcept
valueQuantity			Quantity
valueDate			date
valueBoolean			boolean
valueMarkdown			markdown
valueAttachment			Attachment
valueReference			Reference(Binary)
component	SΣC	1..*	BackboneElement	Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup ele-1: All FHIR elements must have a @value or children cmc-ppidref-required: A PPiDref is required when the PPiD is designated a child.
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	left: Extensions that cannot be ignored even if unrecognized; right: Extension 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	Product Part Type 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
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: ?? (required) ele-1: All FHIR elements must have a @value or children
text	Σ	0..1	string	Plain text representation of the concept ele-1: All FHIR elements must have a @value or children
function	SΣ	0..*	CodeableConcept	left: The function of this component within the item e.g. delivers active ingredient, masks taste; right: Product Part Function Description ele-1: All FHIR elements must have a @value or children
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
coding	Σ	0..*	Coding	Code defined by a terminology system ele-1: All FHIR elements must have a @value or children
text	SΣ	0..1	string	Product Part Function Description ele-1: All FHIR elements must have a @value or children
amount	SΣ	0..*	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume) ele-1: All FHIR elements must have a @value or children
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
value	SΣ	1..1	decimal	Product Part Total Weight Numeric Numerator ele-1: All FHIR elements must have a @value or children
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: ?? (required): How the Quantity should be understood and represented. ele-1: All FHIR elements must have a @value or children
unit	SΣ	1..1	string	Product Part Total Weight Numeric Numerator UOM ele-1: All FHIR elements must have a @value or children
system	ΣC	0..1	uri	System that defines coded unit form ele-1: All FHIR elements must have a @value or children
code	SΣC	1..1	code	Coded form of the unit Binding: ?? (required) ele-1: All FHIR elements must have a @value or children
constituent	SΣC	1..*	BackboneElement	left: A reference to a constituent of the manufactured item as a whole, linked here so that its component location within the item can be indicated. This not where the item's ingredient are primarily stated (for which see Ingredient.for or ManufacturedItemDefinition.ingredient); right: Product Part Ingredient Component Function Category ele-1: All FHIR elements must have a @value or children cmc-ingredient-functions: If Drug Product Component constituent Function Category is Active Ingredient or Adjuvant THEN Drug Product Component constituent Function is not applicable. If Drug Product Component Function Category constituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list.
extension		0..*	Extension	Extension 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	left: Extensions that cannot be ignored even if unrecognized; right: Extension ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
amount	SΣ	1..2	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) ele-1: All FHIR elements must have a @value or children
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
value	SΣ	1..1	decimal	Product Part Ingredient Amount Numeric Numerator ele-1: All FHIR elements must have a @value or children
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: ?? (required): How the Quantity should be understood and represented. ele-1: All FHIR elements must have a @value or children
unit	SΣ	1..1	string	Product Part Ingredient Amount Numeric Numerator UOM ele-1: All FHIR elements must have a @value or children
system	ΣC	0..1	uri	System that defines coded unit form ele-1: All FHIR elements must have a @value or children
code	SΣC	1..1	code	Coded form of the unit Binding: ?? (required) ele-1: All FHIR elements must have a @value or children
location	SΣ	0..*	CodeableConcept	Product Part Ingredient Physical Location 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
coding	SΣ	1..1	Coding	Code defined by a terminology system Binding: ?? (required) ele-1: All FHIR elements must have a @value or children
text	SΣ	0..1	string	Plain text representation of the concept ele-1: All FHIR elements must have a @value or children
function	SΣ	1..2	CodeableConcept	The function of this constituent within the component e.g. binder ele-1: All FHIR elements must have a @value or children
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
coding	SΣ	1..1	Coding	Code defined by a terminology system ele-1: All FHIR elements must have a @value or children
text	Σ	0..1	string	Plain text representation of the concept ele-1: All FHIR elements must have a @value or children
hasIngredient	SΣ	1..1	CodeableReference(Drug Product Component | #sd-pqcmc-component-pqcmc-component) {b}	left: The ingredient that is the constituent of the given component; right: Reference to a resource or a concept ele-1: All FHIR elements must have a @value or children
property	SΣ	2..*	BackboneElement	General characteristics of this component 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	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. ele-1: All FHIR elements must have a @value or children
value[x]	Σ	0..1		A value for the characteristic ele-1: All FHIR elements must have a @value or children
valueCodeableConcept			CodeableConcept
valueQuantity			Quantity
valueDate			date
valueBoolean			boolean
valueMarkdown			markdown
valueAttachment			Attachment
valueReference			Reference(Binary)
component	SΣ	0..*		A component that this component contains or is made from ele-1: All FHIR elements must have a @value or children
Documentation for this format