pqcmc-component
type: StructureDefinition
node role: treeRoot
id:
  v: pqcmc-component
text:
  status:
    v: extensions
  div: Generated Narrative: StructureDefinition pqcmc-component Name Flags Card. Type Description & Constraints<img src="[binary]" alt="doco" style="background-color: inherit"/> Ingredient Ingredient #xD; for 0..* Reference(MedicinalProductDefinition | AdministrableProductDefinition | ManufacturedItemDefinition) Reference to MedicinalProductDefinition #xD; role 1..1 CodeableConcept Purpose of the ingredient within the product, e.g. active, inactive Binding: Drug Product Component Function Category Terminology (required) #xD; comment S 0..1 markdown Drug Product Component Additional Information #xD; substance <a style="padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;; padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;" href="http://hl7.org/fhir/R5/conformance-rules.html#constraints" title="This element has or is affected by constraints ( cmc-strength-type-cases2 )">C 1..1 BackboneElement The substance that comprises this ingredient Constraints: cmc-strength-type-cases2 #xD; code S 1..1 LiteralCodeableReference(Component Substance) {b} Ingredient Substance #xD; Slices for strength S 2..2 BackboneElement The quantity of substance, per presentation, or per volume or mass, and type of quantity Slice: Unordered, Closed by exists:textConcentration #xD; strength:amount S 1..1 BackboneElement The quantity of substance, per presentation, or per volume or mass, and type of quantity #xD; Slices for extension 1..* Extension Extension Slice: Unordered, Open by value:url #xD; extension:strengthFactors S 1..1 CodeableConcept Strength Type URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension Binding: Strength Type Terminology (required) #xD; Slices for concentration[x] S 1..1 The strength per unitary volume (or mass) Slice: Unordered, Open by type:$this #xD; concentrationRatio Ratio #xD; concentrationQuantity Quan…
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-wg
  value: code
    v: brr
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm
  value: integer
    v: 2
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom
      value: canonical
        v: http://hl7.org/fhir/us/pq-cmc-fda/ImplementationGuide/hl7.fhir.us.pq-cmc-fda
        link: http://hl7.org/fhir/us/pq-cmc-fda/ImplementationGuide/hl7.fhir.us.pq-cmc-fda
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status
  value: code
    v: trial-use
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom
      value: canonical
        v: http://hl7.org/fhir/us/pq-cmc-fda/ImplementationGuide/hl7.fhir.us.pq-cmc-fda
        link: http://hl7.org/fhir/us/pq-cmc-fda/ImplementationGuide/hl7.fhir.us.pq-cmc-fda
url:
  v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component
identifier:
  system:
    v: urn:ietf:rfc:3986
  value:
    v: urn:oid:2.16.840.1.113883.4.642.40.36.42.23
version:
  v: 2.0.0
name:
  v: DrugProductComponent
title:
  v: Drug Product Component
status:
  v: active
date:
  v: 2025-07-03T13:07:08+00:00
publisher:
  v: HL7 International / Biomedical Research and Regulation
contact:
  name:
    v: HL7 International / Biomedical Research and Regulation
  telecom:
    system:
      v: url
    value:
      v: http://www.hl7.org/Special/committees/rcrim
  telecom:
    system:
      v: email
description:
  v: The amount details about the drug product components to define the product composition in a product unit. Use composition.
jurisdiction:
  coding:
    system:
      v: urn:iso:std:iso:3166
    code:
      v: US
    display:
      v: United States of America
fhir version:
  v: 5.0.0
mapping:
  identity:
    v: w5
  uri:
    v: http://hl7.org/fhir/fivews
  name:
    v: FiveWs Pattern Mapping
mapping:
  identity:
    v: idmp
  uri:
    v: https://www.iso.org/obp/ui/#iso:std:iso:11615
  name:
    v: IDMP Mapping
mapping:
  identity:
    v: rim
  uri:
    v: http://hl7.org/v3
  name:
    v: RIM Mapping
kind:
  v: resource
abstract:
  v: false
type:
  v: Ingredient
base definition:
  v: http://hl7.org/fhir/StructureDefinition/Ingredient
  link: http://hl7.org/fhir/StructureDefinition/Ingredient
derivation:
  v: constraint
snapshot:
  extension:
    url:
      v: http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version
    value: string
      v: 5.0.0
  element:
    id:
      v: Ingredient
    path:
      v: Ingredient
    short:
      v: An ingredient of a manufactured item or pharmaceutical product
    definition:
      v: An ingredient of a manufactured item or pharmaceutical product.
    min:
      v: 0
    max:
      v: *
    base:
      path:
        v: Ingredient
      min:
        v: 0
      max:
        v: *
    constraint:
      key:
        v: dom-2
      severity:
        v: error
      human:
        v: If the resource is contained in another resource, it SHALL NOT contain nested Resources
      expression:
        v: contained.contained.empty()
      source:
        v: http://hl7.org/fhir/StructureDefinition/DomainResource
        link: http://hl7.org/fhir/StructureDefinition/DomainResource
    constraint:
      key:
        v: dom-3
      severity:
        v: error
      human:
        v: 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
      expression:
        v: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
      source:
        v: http://hl7.org/fhir/StructureDefinition/DomainResource
        link: http://hl7.org/fhir/StructureDefinition/DomainResource
    constraint:
      key:
        v: dom-4
      severity:
        v: error
      human:
        v: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
      expression:
        v: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
      source:
        v: http://hl7.org/fhir/StructureDefinition/DomainResource
        link: http://hl7.org/fhir/StructureDefinition/DomainResource
    constraint:
      key:
        v: dom-5
      severity:
        v: error
      human:
        v: If a resource is contained in another resource, it SHALL NOT have a security label
      expression:
        v: contained.meta.security.empty()
      source:
        v: http://hl7.org/fhir/StructureDefinition/DomainResource
        link: http://hl7.org/fhir/StructureDefinition/DomainResource
    constraint:
      extension:
        value: boolean
      extension:
        value: markdown
      key:
        v: dom-6
      severity:
        v: warning
      human:
        v: A resource should have narrative for robust management
      expression:
        v: text.`div`.exists()
      source:
        v: http://hl7.org/fhir/StructureDefinition/DomainResource
        link: http://hl7.org/fhir/StructureDefinition/DomainResource
    constraint:
      key:
        v: ing-1
      severity:
        v: error

boolean
v: true

markdown
v: When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time.

v: If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource

v: Ingredient.where(allergenicIndicator=true).count() + Ingredient.substance.code.reference.count() < 2

v: false

v: false

v: false

identity:
  v: rim
map:
  v: Entity, Role, or Act

identity:
  v: w5
map:
  v: administrative.medication

identity:
  v: idmp
map:
  v: Ingredient

id:
  v: Ingredient.id
path:
  v: Ingredient.id
short:
  v: Logical id of this artifact
definition:
  v: The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
comment:
  v: Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Resource.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: id
  code:
    v: http://hl7.org/fhirpath/System.String
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true

id:
  v: Ingredient.meta
path:
  v: Ingredient.meta
short:
  v: Metadata about the resource
definition:
  v: The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Resource.meta
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Meta
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true

id:
  v: Ingredient.implicitRules
path:
  v: Ingredient.implicitRules
short:
  v: A set of rules under which this content was created
definition:
  v: A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.
comment:
  v: Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Resource.implicitRules
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: uri
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: true
is modifier reason:
  v: This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
is summary:
  v: true

id:
  v: Ingredient.language
path:
  v: Ingredient.language
short:
  v: Language of the resource content
definition:
  v: The base language in which the resource is written.
comment:
  v: Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Resource.language
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: code
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: Language
  strength:
    v: required
  description:
    v: IETF language tag for a human language
  value set:
    v: http://hl7.org/fhir/ValueSet/all-languages|5.0.0
    link: 5.0
    link: .0
  additional:
    purpose:
      v: starter
    value set:
      v: http://hl7.org/fhir/ValueSet/languages
      link: http://hl7.org/fhir/ValueSet/languages

id:
  v: Ingredient.text
path:
  v: Ingredient.text
short:
  v: Text summary of the resource, for human interpretation
definition:
  v: A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.
comment:
  v: Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.
alias:
  v: narrative
alias:
  v: html
alias:
  v: xhtml
alias:
  v: display
min:
  v: 0
max:
  v: 1
base:
  path:
    v: DomainResource.text
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Narrative
condition:
  v: dom-6
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: Act.text?

id:
  v: Ingredient.contained
path:
  v: Ingredient.contained
short:
  v: Contained, inline Resources
definition:
  v: These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.
comment:
  v: This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.
alias:
  v: inline resources
alias:
  v: anonymous resources
alias:
  v: contained resources
min:
  v: 0
max:
  v: *
base:
  path:
    v: DomainResource.contained
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Resource
condition:
  v: dom-2
condition:
  v: dom-4
condition:
  v: dom-3
condition:
  v: dom-5
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: Ingredient.extension
path:
  v: Ingredient.extension
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: DomainResource.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: Ingredient.modifierExtension
path:
  v: Ingredient.modifierExtension
short:
  v: Extensions that cannot be ignored
definition:
  v: May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: DomainResource.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
must support:
  v: false
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: Ingredient.identifier
path:
  v: Ingredient.identifier
short:
  v: An identifier or code by which the ingredient can be referenced
definition:
  v: The identifier(s) of this Ingredient that are assigned by business processes and/or used to refer to it when a direct URL reference to the resource itself is not appropriate.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Ingredient.identifier
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Identifier
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: w5
  map:
    v: FiveWs.class
mapping:
  identity:
    v: idmp
  map:
    v: n/a

id:
  v: Ingredient.status
path:
  v: Ingredient.status
short:
  v: draft | active | retired | unknown
definition:
  v: The status of this ingredient. Enables tracking the life-cycle of the content.
comment:
  v: Allows filtering of ingredient that are appropriate for use versus not.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Ingredient.status
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: code
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: true
is modifier reason:
  v: This is labeled as "Is Modifier" because applications should not use a retired {{title}} without due consideration
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: PublicationStatus
  strength:
    v: required
  description:
    v: The lifecycle status of an artifact.
  value set:
    v: http://hl7.org/fhir/ValueSet/publication-status|5.0.0
    link: 5.0
    link: .0
mapping:
  identity:
    v: idmp
  map:
    v: n/a

id:
  v: Ingredient.for
path:
  v: Ingredient.for
short:
  v: Reference to MedicinalProductDefinition
definition:
  v: The product which this ingredient is a constituent part of.
min:
  v: 0
max:
  v: *
base:
  path:
    v: Ingredient.for
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition
    link: http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/AdministrableProductDefinition
    link: http://hl7.org/fhir/StructureDefinition/AdministrableProductDefinition
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/ManufacturedItemDefinition
    link: http://hl7.org/fhir/StructureDefinition/ManufacturedItemDefinition
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: n/a

id:
  v: Ingredient.role
path:
  v: Ingredient.role
short:
  v: Purpose of the ingredient within the product, e.g. active, inactive
definition:
  v: A classification of the ingredient identifying its purpose within the product, e.g. active, inactive.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Ingredient.role
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
binding:
  strength:
    v: required
  value set:
    v: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology
    link: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology
mapping:
  identity:
    v: idmp
  map:
    v: Ingredient.Ingredient Role

id:
  v: Ingredient.function
path:
  v: Ingredient.function
short:
  v: Precise action within the drug product, e.g. antioxidant, alkalizing agent
definition:
  v: A classification of the ingredient identifying its precise purpose(s) in the drug product. This extends the Ingredient.role to add more detail. Example: antioxidant, alkalizing agent.
min:
  v: 0
max:
  v: *
base:
  path:
    v: Ingredient.function
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: IngredientFunction
  strength:
    v: example
  description:
    v: A classification of the ingredient identifying its precise purpose(s) in the drug product (beyond e.g. active/inactive).
  value set:
    v: http://hl7.org/fhir/ValueSet/ingredient-function
    link: http://hl7.org/fhir/ValueSet/ingredient-function
mapping:
  identity:
    v: idmp
  map:
    v: n/a

id:
  v: Ingredient.group
path:
  v: Ingredient.group
short:
  v: A classification of the ingredient according to where in the physical item it tends to be used, such the outer shell of a tablet, inner body or ink
definition:
  v: A classification of the ingredient according to where in the physical item it tends to be used, such the outer shell of a tablet, inner body or ink.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Ingredient.group
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: n/a

id:
  v: Ingredient.allergenicIndicator
path:
  v: Ingredient.allergenicIndicator
short:
  v: If the ingredient is a known or suspected allergen
definition:
  v: If the ingredient is a known or suspected allergen. Note that this is a property of the substance, so if a reference to a SubstanceDefinition is used to decribe that (rather than just a code), the allergen information should go there, not here.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Ingredient.allergenicIndicator
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: boolean
meaning when missing:
  v: If this value is not present, there is no statement being made about whether this is an allergen or not. No inference can be made
condition:
  v: ing-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Ingredient.Allergenic Indicator

id:
  v: Ingredient.comment
path:
  v: Ingredient.comment
short:
  v: Drug Product Component Additional Information
definition:
  v: A placeholder for providing any comments that are relevant to the component. [Source: SME Defined] Examples: removed during process, adjusted for loss on drying, etc.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Ingredient.comment
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: markdown
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: idmp
  map:
    v: n/a

id:
  v: Ingredient.manufacturer
path:
  v: Ingredient.manufacturer
short:
  v: An organization that manufactures this ingredient
definition:
  v: The organization(s) that manufacture this ingredient. Can be used to indicate: 1) Organizations we are aware of that manufacture this ingredient 2) Specific Manufacturer(s) currently being used 3) Set of organisations allowed to manufacture this ingredient for this product Users must be clear on the application of context relevant to their use case.
min:
  v: 0
max:
  v: *
base:
  path:
    v: Ingredient.manufacturer
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: BackboneElement
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Ingredient.manufacturer

id:
  v: Ingredient.manufacturer.id
path:
  v: Ingredient.manufacturer.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: string
  code:
    v: http://hl7.org/fhirpath/System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: Ingredient.manufacturer.extension
path:
  v: Ingredient.manufacturer.extension
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: Ingredient.manufacturer.modifierExtension
path:
  v: Ingredient.manufacturer.modifierExtension
short:
  v: Extensions that cannot be ignored even if unrecognized
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
  v: user content
alias:
  v: modifiers
min:
  v: 0
max:
  v: *
base:
  path:
    v: BackboneElement.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: Ingredient.manufacturer.role
path:
  v: Ingredient.manufacturer.role
short:
  v: allowed | possible | actual
definition:
  v: The way in which this manufacturer is associated with the ingredient. For example whether it is a possible one (others allowed), or an exclusive authorized one for this ingredient. Note that this is not the manufacturing process role.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Ingredient.manufacturer.role
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: code
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: IngredientManufacturerRole
  strength:
    v: required
  description:
    v: The way in which this manufacturer is associated with the ingredient.
  value set:
    v: http://hl7.org/fhir/ValueSet/ingredient-manufacturer-role|5.0.0
    link: 5.0
    link: .0
mapping:
  identity:
    v: idmp
  map:
    v: Ingredient.Manufacturer / Establishment (Organisation)

id:
  v: Ingredient.manufacturer.manufacturer
path:
  v: Ingredient.manufacturer.manufacturer
short:
  v: An organization that manufactures this ingredient
definition:
  v: An organization that manufactures this ingredient.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Ingredient.manufacturer.manufacturer
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/Organization
    link: http://hl7.org/fhir/StructureDefinition/Organization
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Ingredient.Manufacturer / Establishment (Organisation)

id:
  v: Ingredient.substance
path:
  v: Ingredient.substance
short:
  v: The substance that comprises this ingredient
definition:
  v: The substance that comprises this ingredient.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Ingredient.substance
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: BackboneElement
condition:
  v: ing-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: cmc-strength-type-cases2
  severity:
    v: error
  human:
    v: IF Strength Type = Activity THEN Strength Textual, Strength UOM ([arb'U]) and Strength Operator are applicable data elements. Strength Textual and Strength UOM will be Mandatory and Operator will be Optional. Codes 75765 [arb'U]; C45420 Activity.
  expression:
    v: defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( strength .extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension') .extension.where( value.coding.where( code = 'C45420' and system = %system ).exists() ).exists() implies ( strength.presentation.ofType(Ratio).exists() and strength.presentation.numerator.where( code = '[arb\'U]' and system = 'http://unitsofmeasure.org' ) ) or ( strength.presentation.ofType(Quantity).exists() and strength.presentation.where( code = '[arb\'U]' and system = 'http://unitsofmeasure.org' ) ))
  source:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Ingredient.Substance

id:
  v: Ingredient.substance.id
path:
  v: Ingredient.substance.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: string
  code:
    v: http://hl7.org/fhirpath/System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: Ingredient.substance.extension
path:
  v: Ingredient.substance.extension
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: Ingredient.substance.modifierExtension
path:
  v: Ingredient.substance.modifierExtension
short:
  v: Extensions that cannot be ignored even if unrecognized
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
  v: user content
alias:
  v: modifiers
min:
  v: 0
max:
  v: *
base:
  path:
    v: BackboneElement.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: Ingredient.substance.code
path:
  v: Ingredient.substance.code
short:
  v: Ingredient Substance
definition:
  v: A code or full resource that represents the ingredient's substance.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Ingredient.substance.code
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: CodeableReference
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-codeable-reference
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-codeable-reference
  target profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component-substance
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component-substance
  aggregation:
    v: bundled
condition:
  v: ing-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: SNOMEDCTSubstanceCodes
  strength:
    v: example
  description:
    v: This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
  value set:
    v: http://hl7.org/fhir/ValueSet/substance-codes
    link: http://hl7.org/fhir/ValueSet/substance-codes
mapping:
  identity:
    v: idmp
  map:
    v: Substance.Substance

id:
  v: Ingredient.substance.strength
path:
  v: Ingredient.substance.strength
slicing:
  discriminator:
    type:
      v: exists
    path:
      v: textConcentration
  ordered:
    v: false
  rules:
    v: closed
short:
  v: The quantity of substance, per presentation, or per volume or mass, and type of quantity
definition:
  v: The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item. The allowed repetitions do not represent different strengths, but are different representations - mathematically equivalent - of a single strength.
min:
  v: 2
max:
  v: 2
base:
  path:
    v: Ingredient.substance.strength
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: BackboneElement
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Specified Substance.Strength

id:
  v: Ingredient.substance.strength.id
path:
  v: Ingredient.substance.strength.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: string
  code:
    v: http://hl7.org/fhirpath/System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: Ingredient.substance.strength.extension
path:
  v: Ingredient.substance.strength.extension
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: Ingredient.substance.strength.modifierExtension
path:
  v: Ingredient.substance.strength.modifierExtension
short:
  v: Extensions that cannot be ignored even if unrecognized
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
  v: user content
alias:
  v: modifiers
min:
  v: 0
max:
  v: *
base:
  path:
    v: BackboneElement.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: Ingredient.substance.strength.presentation[x]
path:
  v: Ingredient.substance.strength.presentation[x]
short:
  v: The quantity of substance in the unit of presentation
definition:
  v: The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item. Unit of presentation refers to the quantity that the item occurs in e.g. a strength per tablet size, perhaps 'per 20mg' (the size of the tablet). It is not generally normalized as a unitary unit, which would be 'per mg').
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Ingredient.substance.strength.presentation[x]
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Ratio
type:
  code:
    v: RatioRange
type:
  code:
    v: CodeableConcept
type:
  code:
    v: Quantity
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Strength.Strength (Presentation)

id:
  v: Ingredient.substance.strength.textPresentation
path:
  v: Ingredient.substance.strength.textPresentation
short:
  v: Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)
definition:
  v: A textual represention of either the whole of the presentation strength or a part of it - with the rest being in Strength.presentation as a ratio.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Ingredient.substance.strength.textPresentation
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: n/a

id:
  v: Ingredient.substance.strength.concentration[x]
path:
  v: Ingredient.substance.strength.concentration[x]
short:
  v: The strength per unitary volume (or mass)
definition:
  v: The strength per unitary volume (or mass).
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Ingredient.substance.strength.concentration[x]
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Ratio
type:
  code:
    v: RatioRange
type:
  code:
    v: CodeableConcept
type:
  code:
    v: Quantity
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Strength.Strength (Concentration)

id:
  v: Ingredient.substance.strength.textConcentration
path:
  v: Ingredient.substance.strength.textConcentration
short:
  v: Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio)
definition:
  v: A textual represention of either the whole of the concentration strength or a part of it - with the rest being in Strength.concentration as a ratio.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Ingredient.substance.strength.textConcentration
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: n/a

id:
  v: Ingredient.substance.strength.basis
path:
  v: Ingredient.substance.strength.basis
short:
  v: A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt)
definition:
  v: A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt).
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Ingredient.substance.strength.basis
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: n/a

id:
  v: Ingredient.substance.strength.measurementPoint
path:
  v: Ingredient.substance.strength.measurementPoint
short:
  v: When strength is measured at a particular point or distance
definition:
  v: For when strength is measured at a particular point or distance. There are products where strength is measured at a particular point. For example, the strength of the ingredient in some inhalers is measured at a particular position relative to the point of aerosolization.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Ingredient.substance.strength.measurementPoint
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Strength.Measurement Point

id:
  v: Ingredient.substance.strength.country
path:
  v: Ingredient.substance.strength.country
short:
  v: Where the strength range applies
definition:
  v: The country or countries for which the strength range applies.
min:
  v: 0
max:
  v: *
base:
  path:
    v: Ingredient.substance.strength.country
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: Country
  strength:
    v: example
  description:
    v: Jurisdiction codes
  value set:
    v: http://hl7.org/fhir/ValueSet/country
    link: http://hl7.org/fhir/ValueSet/country
mapping:
  identity:
    v: idmp
  map:
    v: Strength.Country

id:
  v: Ingredient.substance.strength.referenceStrength
path:
  v: Ingredient.substance.strength.referenceStrength
short:
  v: Strength expressed in terms of a reference substance
definition:
  v: Strength expressed in terms of a reference substance. For when the ingredient strength is additionally expressed as equivalent to the strength of some other closely related substance (e.g. salt vs. base). Reference strength represents the strength (quantitative composition) of the active moiety of the active substance. There are situations when the active substance and active moiety are different, therefore both a strength and a reference strength are needed.
min:
  v: 0
max:
  v: *
base:
  path:
    v: Ingredient.substance.strength.referenceStrength
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: BackboneElement
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Strength.Reference Strength

id:
  v: Ingredient.substance.strength.referenceStrength.id
path:
  v: Ingredient.substance.strength.referenceStrength.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: string
  code:
    v: http://hl7.org/fhirpath/System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: Ingredient.substance.strength.referenceStrength.extension
path:
  v: Ingredient.substance.strength.referenceStrength.extension
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: Ingredient.substance.strength.referenceStrength.modifierExtension
path:
  v: Ingredient.substance.strength.referenceStrength.modifierExtension
short:
  v: Extensions that cannot be ignored even if unrecognized
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
  v: user content
alias:
  v: modifiers
min:
  v: 0
max:
  v: *
base:
  path:
    v: BackboneElement.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: Ingredient.substance.strength.referenceStrength.substance
path:
  v: Ingredient.substance.strength.referenceStrength.substance
short:
  v: Relevant reference substance
definition:
  v: Relevant reference substance.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Ingredient.substance.strength.referenceStrength.substance
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: CodeableReference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/SubstanceDefinition
    link: http://hl7.org/fhir/StructureDefinition/SubstanceDefinition
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: SNOMEDCTSubstanceCodes
  strength:
    v: example
  description:
    v: This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
  value set:
    v: http://hl7.org/fhir/ValueSet/substance-codes
    link: http://hl7.org/fhir/ValueSet/substance-codes
mapping:
  identity:
    v: idmp
  map:
    v: Reference Strength.Reference Substance

id:
  v: Ingredient.substance.strength.referenceStrength.strength[x]
path:
  v: Ingredient.substance.strength.referenceStrength.strength[x]
short:
  v: Strength expressed in terms of a reference substance
definition:
  v: Strength expressed in terms of a reference substance.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Ingredient.substance.strength.referenceStrength.strength[x]
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: Ratio
type:
  code:
    v: RatioRange
type:
  code:
    v: Quantity
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Reference Strength.Reference Strength

id:
  v: Ingredient.substance.strength.referenceStrength.measurementPoint
path:
  v: Ingredient.substance.strength.referenceStrength.measurementPoint
short:
  v: When strength is measured at a particular point or distance
definition:
  v: For when strength is measured at a particular point or distance.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Ingredient.substance.strength.referenceStrength.measurementPoint
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Reference Strength.Measurement Point

id:
  v: Ingredient.substance.strength.referenceStrength.country
path:
  v: Ingredient.substance.strength.referenceStrength.country
short:
  v: Where the strength range applies
definition:
  v: The country or countries for which the strength range applies.
min:
  v: 0
max:
  v: *
base:
  path:
    v: Ingredient.substance.strength.referenceStrength.country
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: Country
  strength:
    v: example
  description:
    v: Jurisdiction codes
  value set:
    v: http://hl7.org/fhir/ValueSet/country
    link: http://hl7.org/fhir/ValueSet/country
mapping:
  identity:
    v: idmp
  map:
    v: Reference Strength.Country

id:
  v: Ingredient.substance.strength:amount
path:
  v: Ingredient.substance.strength
slice name:
  v: amount
short:
  v: The quantity of substance, per presentation, or per volume or mass, and type of quantity
definition:
  v: The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item. The allowed repetitions do not represent different strengths, but are different representations - mathematically equivalent - of a single strength.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Ingredient.substance.strength
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: BackboneElement
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Specified Substance.Strength

id:
  v: Ingredient.substance.strength:amount.id
path:
  v: Ingredient.substance.strength.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: string
  code:
    v: http://hl7.org/fhirpath/System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: Ingredient.substance.strength:amount.extension
path:
  v: Ingredient.substance.strength.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  ordered:
    v: false
  rules:
    v: open
short:
  v: Extension
definition:
  v: An Extension
min:
  v: 1
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false

id:
  v: Ingredient.substance.strength:amount.extension:strengthFactors
path:
  v: Ingredient.substance.strength.extension
slice name:
  v: strengthFactors
short:
  v: Strength Type
definition:
  v: Strength Type (for API)
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
must support:
  v: true
is modifier:
  v: false
is summary:
  v: false

id:
  v: Ingredient.substance.strength:amount.modifierExtension
path:
  v: Ingredient.substance.strength.modifierExtension
short:
  v: Extensions that cannot be ignored even if unrecognized
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
  v: user content
alias:
  v: modifiers
min:
  v: 0
max:
  v: *
base:
  path:
    v: BackboneElement.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: Ingredient.substance.strength:amount.presentation[x]
path:
  v: Ingredient.substance.strength.presentation[x]
short:
  v: The quantity of substance in the unit of presentation
definition:
  v: The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item. Unit of presentation refers to the quantity that the item occurs in e.g. a strength per tablet size, perhaps 'per 20mg' (the size of the tablet). It is not generally normalized as a unitary unit, which would be 'per mg').
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Ingredient.substance.strength.presentation[x]
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Ratio
type:
  code:
    v: RatioRange
type:
  code:
    v: CodeableConcept
type:
  code:
    v: Quantity
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Strength.Strength (Presentation)

id:
  v: Ingredient.substance.strength:amount.textPresentation
path:
  v: Ingredient.substance.strength.textPresentation
short:
  v: Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)
definition:
  v: A textual represention of either the whole of the presentation strength or a part of it - with the rest being in Strength.presentation as a ratio.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Ingredient.substance.strength.textPresentation
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: n/a

id:
  v: Ingredient.substance.strength:amount.concentration[x]
path:
  v: Ingredient.substance.strength.concentration[x]
slicing:
  discriminator:
    type:
      v: type
    path:
      v: $this
  ordered:
    v: false
  rules:
    v: closed
short:
  v: The strength per unitary volume (or mass)
definition:
  v: The strength per unitary volume (or mass).
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Ingredient.substance.strength.concentration[x]
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Ratio
type:
  code:
    v: Quantity
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Strength.Strength (Concentration)

id:
  v: Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity
path:
  v: Ingredient.substance.strength.concentration[x]
slice name:
  v: concentrationQuantity
short:
  v: The strength per unitary volume (or mass)
definition:
  v: The strength per unitary volume (or mass).
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Ingredient.substance.strength.concentration[x]
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Quantity
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
binding:
  strength:
    v: required
  value set:
    v: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units
    link: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units
mapping:
  identity:
    v: idmp
  map:
    v: Strength.Strength (Concentration)

id:
  v: Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.id
path:
  v: Ingredient.substance.strength.concentration[x].id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: id
  code:
    v: http://hl7.org/fhirpath/System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.extension
path:
  v: Ingredient.substance.strength.concentration[x].extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.value
path:
  v: Ingredient.substance.strength.concentration[x].value
short:
  v: Ingredient Total Amount Numeric
definition:
  v: Specifies the quantity of an ingredient in a single dose unit (e.g., one tablet, capsule) of the drug product. [Source: SME Defined] Example: if the tablet contains 325 mg of the ingredient in each unit dose, then Ingredient Total Amount Numeric = 325
comment:
  v: The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).
requirements:
  v: Precision is handled implicitly in almost all cases of measurement.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Quantity.value
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: decimal
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: SN.2 / CQ - N/A
mapping:
  identity:
    v: rim
  map:
    v: PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value

id:
  v: Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.comparator
path:
  v: Ingredient.substance.strength.concentration[x].comparator
short:
  v: Ingredient Total Amount Operator
definition:
  v: A mathematical symbol that denotes equality or inequality between two values. [Source: SME Defined] Examples: LT, EQ, NMT. Note: This is typically applicable to biologics.
requirements:
  v: Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Quantity.comparator
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: code
meaning when missing:
  v: If there is no comparator, then there is no modification of the value
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: true
is modifier reason:
  v: This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: QuantityComparator
  strength:
    v: required
  description:
    v: How the Quantity should be understood and represented.
  value set:
    v: http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
    link: 5.0
    link: .0
mapping:
  identity:
    v: v2
  map:
    v: SN.1 / CQ.1
mapping:
  identity:
    v: rim
  map:
    v: IVL properties

id:
  v: Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.unit
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable
  value: boolean
    v: true
path:
  v: Ingredient.substance.strength.concentration[x].unit
short:
  v: Unit representation
definition:
  v: A human-readable form of the unit.
requirements:
  v: There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Quantity.unit
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: (see OBX.6 etc.) / CQ.2
mapping:
  identity:
    v: rim
  map:
    v: PQ.unit

id:
  v: Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.system
path:
  v: Ingredient.substance.strength.concentration[x].system
short:
  v: System that defines coded unit form
definition:
  v: The identification of the system that provides the coded form of the unit.
requirements:
  v: Need to know the system that defines the coded form of the unit.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Quantity.system
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: uri
condition:
  v: qty-3
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: (see OBX.6 etc.) / CQ.2
mapping:
  identity:
    v: rim
  map:
    v: CO.codeSystem, PQ.translation.codeSystem

id:
  v: Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.code
path:
  v: Ingredient.substance.strength.concentration[x].code
short:
  v: Coded form of the unit
definition:
  v: A computer processable form of the unit in some unit representation system.
comment:
  v: The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.
requirements:
  v: Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Quantity.code
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: code
condition:
  v: qty-3
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: (see OBX.6 etc.) / CQ.2
mapping:
  identity:
    v: rim
  map:
    v: PQ.code, MO.currency, PQ.translation.code

id:
  v: Ingredient.substance.strength:amount.concentration[x]:concentrationRatio
path:
  v: Ingredient.substance.strength.concentration[x]
slice name:
  v: concentrationRatio
short:
  v: The strength per unitary volume (or mass)
definition:
  v: The strength per unitary volume (or mass).
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Ingredient.substance.strength.concentration[x]
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Ratio
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Strength.Strength (Concentration)

id:
  v: Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.id
path:
  v: Ingredient.substance.strength.concentration[x].id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: id
  code:
    v: http://hl7.org/fhirpath/System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.extension
path:
  v: Ingredient.substance.strength.concentration[x].extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator
path:
  v: Ingredient.substance.strength.concentration[x].numerator
short:
  v: Numerator value
definition:
  v: Specifies the quantity of an ingredient in a single dose unit of the drug product. [Source: SME Defined]
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Ratio.numerator
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Quantity
condition:
  v: rat-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
binding:
  strength:
    v: required
  value set:
    v: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units
    link: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units
mapping:
  identity:
    v: rim
  map:
    v: .numerator

id:
  v: Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.id
path:
  v: Ingredient.substance.strength.concentration[x].numerator.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: id
  code:
    v: http://hl7.org/fhirpath/System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.extension
path:
  v: Ingredient.substance.strength.concentration[x].numerator.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.value
path:
  v: Ingredient.substance.strength.concentration[x].numerator.value
short:
  v: Ingredient Total Amount Numeric Numerator
definition:
  v: The value of the measured amount. The value includes an implicit precision in the presentation of the value.
comment:
  v: The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).
requirements:
  v: Precision is handled implicitly in almost all cases of measurement.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Quantity.value
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: decimal
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: SN.2 / CQ - N/A
mapping:
  identity:
    v: rim
  map:
    v: PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value

id:
  v: Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.comparator
path:
  v: Ingredient.substance.strength.concentration[x].numerator.comparator
short:
  v: < | <= | >= | > | ad - how to understand the value
definition:
  v: How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.
requirements:
  v: Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Quantity.comparator
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: code
meaning when missing:
  v: If there is no comparator, then there is no modification of the value
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: true
is modifier reason:
  v: This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: QuantityComparator
  strength:
    v: required
  description:
    v: How the Quantity should be understood and represented.
  value set:
    v: http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
    link: 5.0
    link: .0
mapping:
  identity:
    v: v2
  map:
    v: SN.1 / CQ.1
mapping:
  identity:
    v: rim
  map:
    v: IVL properties

id:
  v: Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.unit
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable
  value: boolean
    v: true
path:
  v: Ingredient.substance.strength.concentration[x].numerator.unit
short:
  v: Ingredient Total Amount Numeric Numerator UOM
definition:
  v: The labeled unit of measure for the content of the drug product, expressed quantitatively per dosage unit. [Source: Adapted for NCI EVS C117055] Example: mg
requirements:
  v: There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Quantity.unit
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: (see OBX.6 etc.) / CQ.2
mapping:
  identity:
    v: rim
  map:
    v: PQ.unit

id:
  v: Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.system
path:
  v: Ingredient.substance.strength.concentration[x].numerator.system
short:
  v: System that defines coded unit form
definition:
  v: The identification of the system that provides the coded form of the unit.
requirements:
  v: Need to know the system that defines the coded form of the unit.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Quantity.system
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: uri
condition:
  v: qty-3
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: (see OBX.6 etc.) / CQ.2
mapping:
  identity:
    v: rim
  map:
    v: CO.codeSystem, PQ.translation.codeSystem

id:
  v: Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.code
path:
  v: Ingredient.substance.strength.concentration[x].numerator.code
short:
  v: Coded form of the unit
definition:
  v: A computer processable form of the unit in some unit representation system.
comment:
  v: The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.
requirements:
  v: Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Quantity.code
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: code
condition:
  v: qty-3
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: (see OBX.6 etc.) / CQ.2
mapping:
  identity:
    v: rim
  map:
    v: PQ.code, MO.currency, PQ.translation.code

id:
  v: Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator
path:
  v: Ingredient.substance.strength.concentration[x].denominator
short:
  v: Denominator value
definition:
  v: The value of the denominator.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Ratio.denominator
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Quantity
  profile:
    v: http://hl7.org/fhir/StructureDefinition/SimpleQuantity
    link: http://hl7.org/fhir/StructureDefinition/SimpleQuantity
condition:
  v: rat-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
binding:
  strength:
    v: required
  value set:
    v: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units
    link: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units
mapping:
  identity:
    v: rim
  map:
    v: .denominator

id:
  v: Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.id
path:
  v: Ingredient.substance.strength.concentration[x].denominator.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: id
  code:
    v: http://hl7.org/fhirpath/System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.extension
path:
  v: Ingredient.substance.strength.concentration[x].denominator.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.value
path:
  v: Ingredient.substance.strength.concentration[x].denominator.value
short:
  v: Ingredient Total Amount Numeric Denominator
definition:
  v: Specifies the quantity of the ingredients within a single dose unit (e.g., vial, syringe) of drug product. [Source: SME Defined] Example: 10mg/syringe, 1mg/ml
comment:
  v: The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).
requirements:
  v: Precision is handled implicitly in almost all cases of measurement.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Quantity.value
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: decimal
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: SN.2 / CQ - N/A
mapping:
  identity:
    v: rim
  map:
    v: PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value

id:
  v: Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.comparator
path:
  v: Ingredient.substance.strength.concentration[x].denominator.comparator
short:
  v: < | <= | >= | > | ad - how to understand the value
definition:
  v: Not allowed to be used in this context
requirements:
  v: Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.
min:
  v: 0
max:
  v: 0
base:
  path:
    v: Quantity.comparator
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: code
meaning when missing:
  v: If there is no comparator, then there is no modification of the value
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: true
is modifier reason:
  v: This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: QuantityComparator
  strength:
    v: required
  description:
    v: How the Quantity should be understood and represented.
  value set:
    v: http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
    link: 5.0
    link: .0
mapping:
  identity:
    v: v2
  map:
    v: SN.1 / CQ.1
mapping:
  identity:
    v: rim
  map:
    v: IVL properties

id:
  v: Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.unit
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable
  value: boolean
    v: true
path:
  v: Ingredient.substance.strength.concentration[x].denominator.unit
short:
  v: Ingredient Total Amount Numeric Denominator UOM
definition:
  v: A human-readable form of the unit.
requirements:
  v: There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Quantity.unit
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: (see OBX.6 etc.) / CQ.2
mapping:
  identity:
    v: rim
  map:
    v: PQ.unit

id:
  v: Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.system
path:
  v: Ingredient.substance.strength.concentration[x].denominator.system
short:
  v: System that defines coded unit form
definition:
  v: The identification of the system that provides the coded form of the unit.
requirements:
  v: Need to know the system that defines the coded form of the unit.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Quantity.system
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: uri
condition:
  v: qty-3
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: (see OBX.6 etc.) / CQ.2
mapping:
  identity:
    v: rim
  map:
    v: CO.codeSystem, PQ.translation.codeSystem

id:
  v: Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.code
path:
  v: Ingredient.substance.strength.concentration[x].denominator.code
short:
  v: Coded form of the unit
definition:
  v: A computer processable form of the unit in some unit representation system.
comment:
  v: The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.
requirements:
  v: Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Quantity.code
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: code
condition:
  v: qty-3
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: (see OBX.6 etc.) / CQ.2
mapping:
  identity:
    v: rim
  map:
    v: PQ.code, MO.currency, PQ.translation.code

id:
  v: Ingredient.substance.strength:amount.textConcentration
path:
  v: Ingredient.substance.strength.textConcentration
short:
  v: Strength Textual
definition:
  v: A written description of the strength of the ingredient. [Source: SME Defined]
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Ingredient.substance.strength.textConcentration
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: n/a

id:
  v: Ingredient.substance.strength:amount.basis
path:
  v: Ingredient.substance.strength.basis
short:
  v: A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt)
definition:
  v: A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt).
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Ingredient.substance.strength.basis
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: n/a

id:
  v: Ingredient.substance.strength:amount.measurementPoint
path:
  v: Ingredient.substance.strength.measurementPoint
short:
  v: When strength is measured at a particular point or distance
definition:
  v: For when strength is measured at a particular point or distance. There are products where strength is measured at a particular point. For example, the strength of the ingredient in some inhalers is measured at a particular position relative to the point of aerosolization.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Ingredient.substance.strength.measurementPoint
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Strength.Measurement Point

id:
  v: Ingredient.substance.strength:amount.country
path:
  v: Ingredient.substance.strength.country
short:
  v: Where the strength range applies
definition:
  v: The country or countries for which the strength range applies.
min:
  v: 0
max:
  v: *
base:
  path:
    v: Ingredient.substance.strength.country
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: Country
  strength:
    v: example
  description:
    v: Jurisdiction codes
  value set:
    v: http://hl7.org/fhir/ValueSet/country
    link: http://hl7.org/fhir/ValueSet/country
mapping:
  identity:
    v: idmp
  map:
    v: Strength.Country

id:
  v: Ingredient.substance.strength:amount.referenceStrength
path:
  v: Ingredient.substance.strength.referenceStrength
short:
  v: Strength expressed in terms of a reference substance
definition:
  v: Strength expressed in terms of a reference substance. For when the ingredient strength is additionally expressed as equivalent to the strength of some other closely related substance (e.g. salt vs. base). Reference strength represents the strength (quantitative composition) of the active moiety of the active substance. There are situations when the active substance and active moiety are different, therefore both a strength and a reference strength are needed.
min:
  v: 0
max:
  v: *
base:
  path:
    v: Ingredient.substance.strength.referenceStrength
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: BackboneElement
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Strength.Reference Strength

id:
  v: Ingredient.substance.strength:amount.referenceStrength.id
path:
  v: Ingredient.substance.strength.referenceStrength.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: string
  code:
    v: http://hl7.org/fhirpath/System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: Ingredient.substance.strength:amount.referenceStrength.extension
path:
  v: Ingredient.substance.strength.referenceStrength.extension
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: Ingredient.substance.strength:amount.referenceStrength.modifierExtension
path:
  v: Ingredient.substance.strength.referenceStrength.modifierExtension
short:
  v: Extensions that cannot be ignored even if unrecognized
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
  v: user content
alias:
  v: modifiers
min:
  v: 0
max:
  v: *
base:
  path:
    v: BackboneElement.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: Ingredient.substance.strength:amount.referenceStrength.substance
path:
  v: Ingredient.substance.strength.referenceStrength.substance
short:
  v: Relevant reference substance
definition:
  v: Relevant reference substance.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Ingredient.substance.strength.referenceStrength.substance
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: CodeableReference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/SubstanceDefinition
    link: http://hl7.org/fhir/StructureDefinition/SubstanceDefinition
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: SNOMEDCTSubstanceCodes
  strength:
    v: example
  description:
    v: This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
  value set:
    v: http://hl7.org/fhir/ValueSet/substance-codes
    link: http://hl7.org/fhir/ValueSet/substance-codes
mapping:
  identity:
    v: idmp
  map:
    v: Reference Strength.Reference Substance

id:
  v: Ingredient.substance.strength:amount.referenceStrength.strength[x]
path:
  v: Ingredient.substance.strength.referenceStrength.strength[x]
short:
  v: Strength expressed in terms of a reference substance
definition:
  v: Strength expressed in terms of a reference substance.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Ingredient.substance.strength.referenceStrength.strength[x]
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: Ratio
type:
  code:
    v: RatioRange
type:
  code:
    v: Quantity
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Reference Strength.Reference Strength

id:
  v: Ingredient.substance.strength:amount.referenceStrength.measurementPoint
path:
  v: Ingredient.substance.strength.referenceStrength.measurementPoint
short:
  v: When strength is measured at a particular point or distance
definition:
  v: For when strength is measured at a particular point or distance.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Ingredient.substance.strength.referenceStrength.measurementPoint
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Reference Strength.Measurement Point

id:
  v: Ingredient.substance.strength:amount.referenceStrength.country
path:
  v: Ingredient.substance.strength.referenceStrength.country
short:
  v: Where the strength range applies
definition:
  v: The country or countries for which the strength range applies.
min:
  v: 0
max:
  v: *
base:
  path:
    v: Ingredient.substance.strength.referenceStrength.country
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: Country
  strength:
    v: example
  description:
    v: Jurisdiction codes
  value set:
    v: http://hl7.org/fhir/ValueSet/country
    link: http://hl7.org/fhir/ValueSet/country
mapping:
  identity:
    v: idmp
  map:
    v: Reference Strength.Country

id:
  v: Ingredient.substance.strength:percent
path:
  v: Ingredient.substance.strength
slice name:
  v: percent
short:
  v: The quantity of substance, per presentation, or per volume or mass, and type of quantity
definition:
  v: The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item. The allowed repetitions do not represent different strengths, but are different representations - mathematically equivalent - of a single strength.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Ingredient.substance.strength
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: BackboneElement
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Specified Substance.Strength

id:
  v: Ingredient.substance.strength:percent.id
path:
  v: Ingredient.substance.strength.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: string
  code:
    v: http://hl7.org/fhirpath/System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: Ingredient.substance.strength:percent.extension
path:
  v: Ingredient.substance.strength.extension
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: Ingredient.substance.strength:percent.modifierExtension
path:
  v: Ingredient.substance.strength.modifierExtension
short:
  v: Extensions that cannot be ignored even if unrecognized
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
  v: user content
alias:
  v: modifiers
min:
  v: 0
max:
  v: *
base:
  path:
    v: BackboneElement.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: Ingredient.substance.strength:percent.presentation[x]
path:
  v: Ingredient.substance.strength.presentation[x]
short:
  v: The quantity of substance in the unit of presentation
definition:
  v: The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item. Unit of presentation refers to the quantity that the item occurs in e.g. a strength per tablet size, perhaps 'per 20mg' (the size of the tablet). It is not generally normalized as a unitary unit, which would be 'per mg').
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Ingredient.substance.strength.presentation[x]
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Ratio
type:
  code:
    v: RatioRange
type:
  code:
    v: CodeableConcept
type:
  code:
    v: Quantity
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Strength.Strength (Presentation)

id:
  v: Ingredient.substance.strength:percent.textPresentation
path:
  v: Ingredient.substance.strength.textPresentation
short:
  v: Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)
definition:
  v: A textual represention of either the whole of the presentation strength or a part of it - with the rest being in Strength.presentation as a ratio.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Ingredient.substance.strength.textPresentation
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: n/a

id:
  v: Ingredient.substance.strength:percent.concentration[x]
path:
  v: Ingredient.substance.strength.concentration[x]
short:
  v: The strength per unitary volume (or mass)
definition:
  v: The strength per unitary volume (or mass).
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Ingredient.substance.strength.concentration[x]
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Quantity
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
binding:
  strength:
    v: required
  value set:
    v: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units
    link: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units
mapping:
  identity:
    v: idmp
  map:
    v: Strength.Strength (Concentration)

id:
  v: Ingredient.substance.strength:percent.concentration[x].id
path:
  v: Ingredient.substance.strength.concentration[x].id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: id
  code:
    v: http://hl7.org/fhirpath/System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: Ingredient.substance.strength:percent.concentration[x].extension
path:
  v: Ingredient.substance.strength.concentration[x].extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: Ingredient.substance.strength:percent.concentration[x].value
path:
  v: Ingredient.substance.strength.concentration[x].value
short:
  v: Ingredient Total Amount Content Percent
definition:
  v: The percentage of the component in the drug product. [Source: SME Defined] Example: Product Total Weight = 1200 mg and Product Ingredient Amount = 325 mg, so Product Ingredient Content Percent = 27.08
comment:
  v: The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).
requirements:
  v: Precision is handled implicitly in almost all cases of measurement.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Quantity.value
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: decimal
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: SN.2 / CQ - N/A
mapping:
  identity:
    v: rim
  map:
    v: PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value

id:
  v: Ingredient.substance.strength:percent.concentration[x].comparator
path:
  v: Ingredient.substance.strength.concentration[x].comparator
short:
  v: < | <= | >= | > | ad - how to understand the value
definition:
  v: How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.
requirements:
  v: Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Quantity.comparator
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: code
meaning when missing:
  v: If there is no comparator, then there is no modification of the value
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: true
is modifier reason:
  v: This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: QuantityComparator
  strength:
    v: required
  description:
    v: How the Quantity should be understood and represented.
  value set:
    v: http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
    link: 5.0
    link: .0
mapping:
  identity:
    v: v2
  map:
    v: SN.1 / CQ.1
mapping:
  identity:
    v: rim
  map:
    v: IVL properties

id:
  v: Ingredient.substance.strength:percent.concentration[x].unit
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable
  value: boolean
    v: true
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable
  value: boolean
    v: true
path:
  v: Ingredient.substance.strength.concentration[x].unit
short:
  v: Unit representation
definition:
  v: A human-readable form of the unit.
requirements:
  v: There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Quantity.unit
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: (see OBX.6 etc.) / CQ.2
mapping:
  identity:
    v: rim
  map:
    v: PQ.unit

id:
  v: Ingredient.substance.strength:percent.concentration[x].system
path:
  v: Ingredient.substance.strength.concentration[x].system
short:
  v: System that defines coded unit form
definition:
  v: The identification of the system that provides the coded form of the unit.
requirements:
  v: Need to know the system that defines the coded form of the unit.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Quantity.system
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: uri
condition:
  v: qty-3
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: (see OBX.6 etc.) / CQ.2
mapping:
  identity:
    v: rim
  map:
    v: CO.codeSystem, PQ.translation.codeSystem

id:
  v: Ingredient.substance.strength:percent.concentration[x].code
path:
  v: Ingredient.substance.strength.concentration[x].code
short:
  v: Ingredient Total Amount Content Percent UOM
definition:
  v: A computer processable form of the unit in some unit representation system.
comment:
  v: The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.
requirements:
  v: Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Quantity.code
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: code
condition:
  v: qty-3
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: (see OBX.6 etc.) / CQ.2
mapping:
  identity:
    v: rim
  map:
    v: PQ.code, MO.currency, PQ.translation.code

id:
  v: Ingredient.substance.strength:percent.textConcentration
path:
  v: Ingredient.substance.strength.textConcentration
short:
  v: Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio)
definition:
  v: A textual represention of either the whole of the concentration strength or a part of it - with the rest being in Strength.concentration as a ratio.
min:
  v: 0
max:
  v: 0
base:
  path:
    v: Ingredient.substance.strength.textConcentration
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: n/a

id:
  v: Ingredient.substance.strength:percent.basis
path:
  v: Ingredient.substance.strength.basis
short:
  v: A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt)
definition:
  v: A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt).
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Ingredient.substance.strength.basis
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: n/a

id:
  v: Ingredient.substance.strength:percent.measurementPoint
path:
  v: Ingredient.substance.strength.measurementPoint
short:
  v: When strength is measured at a particular point or distance
definition:
  v: For when strength is measured at a particular point or distance. There are products where strength is measured at a particular point. For example, the strength of the ingredient in some inhalers is measured at a particular position relative to the point of aerosolization.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Ingredient.substance.strength.measurementPoint
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Strength.Measurement Point

id:
  v: Ingredient.substance.strength:percent.country
path:
  v: Ingredient.substance.strength.country
short:
  v: Where the strength range applies
definition:
  v: The country or countries for which the strength range applies.
min:
  v: 0
max:
  v: *
base:
  path:
    v: Ingredient.substance.strength.country
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: Country
  strength:
    v: example
  description:
    v: Jurisdiction codes
  value set:
    v: http://hl7.org/fhir/ValueSet/country
    link: http://hl7.org/fhir/ValueSet/country
mapping:
  identity:
    v: idmp
  map:
    v: Strength.Country

id:
  v: Ingredient.substance.strength:percent.referenceStrength
path:
  v: Ingredient.substance.strength.referenceStrength
short:
  v: Strength expressed in terms of a reference substance
definition:
  v: Strength expressed in terms of a reference substance. For when the ingredient strength is additionally expressed as equivalent to the strength of some other closely related substance (e.g. salt vs. base). Reference strength represents the strength (quantitative composition) of the active moiety of the active substance. There are situations when the active substance and active moiety are different, therefore both a strength and a reference strength are needed.
min:
  v: 0
max:
  v: *
base:
  path:
    v: Ingredient.substance.strength.referenceStrength
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: BackboneElement
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Strength.Reference Strength

id:
  v: Ingredient.substance.strength:percent.referenceStrength.id
path:
  v: Ingredient.substance.strength.referenceStrength.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: string
  code:
    v: http://hl7.org/fhirpath/System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: Ingredient.substance.strength:percent.referenceStrength.extension
path:
  v: Ingredient.substance.strength.referenceStrength.extension
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: Ingredient.substance.strength:percent.referenceStrength.modifierExtension
path:
  v: Ingredient.substance.strength.referenceStrength.modifierExtension
short:
  v: Extensions that cannot be ignored even if unrecognized
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
  v: user content
alias:
  v: modifiers
min:
  v: 0
max:
  v: *
base:
  path:
    v: BackboneElement.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: Ingredient.substance.strength:percent.referenceStrength.substance
path:
  v: Ingredient.substance.strength.referenceStrength.substance
short:
  v: Relevant reference substance
definition:
  v: Relevant reference substance.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Ingredient.substance.strength.referenceStrength.substance
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: CodeableReference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/SubstanceDefinition
    link: http://hl7.org/fhir/StructureDefinition/SubstanceDefinition
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: SNOMEDCTSubstanceCodes
  strength:
    v: example
  description:
    v: This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
  value set:
    v: http://hl7.org/fhir/ValueSet/substance-codes
    link: http://hl7.org/fhir/ValueSet/substance-codes
mapping:
  identity:
    v: idmp
  map:
    v: Reference Strength.Reference Substance

id:
  v: Ingredient.substance.strength:percent.referenceStrength.strength[x]
path:
  v: Ingredient.substance.strength.referenceStrength.strength[x]
short:
  v: Strength expressed in terms of a reference substance
definition:
  v: Strength expressed in terms of a reference substance.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Ingredient.substance.strength.referenceStrength.strength[x]
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: Ratio
type:
  code:
    v: RatioRange
type:
  code:
    v: Quantity
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Reference Strength.Reference Strength

id:
  v: Ingredient.substance.strength:percent.referenceStrength.measurementPoint
path:
  v: Ingredient.substance.strength.referenceStrength.measurementPoint
short:
  v: When strength is measured at a particular point or distance
definition:
  v: For when strength is measured at a particular point or distance.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Ingredient.substance.strength.referenceStrength.measurementPoint
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Reference Strength.Measurement Point

id:
  v: Ingredient.substance.strength:percent.referenceStrength.country
path:
  v: Ingredient.substance.strength.referenceStrength.country
short:
  v: Where the strength range applies
definition:
  v: The country or countries for which the strength range applies.
min:
  v: 0
max:
  v: *
base:
  path:
    v: Ingredient.substance.strength.referenceStrength.country
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: Country
  strength:
    v: example
  description:
    v: Jurisdiction codes
  value set:
    v: http://hl7.org/fhir/ValueSet/country
    link: http://hl7.org/fhir/ValueSet/country
mapping:
  identity:
    v: idmp
  map:
    v: Reference Strength.Country

element:
  id:
    v: Ingredient.for
  path:
    v: Ingredient.for
  short:
    v: Reference to MedicinalProductDefinition
element:
  id:
    v: Ingredient.role
  path:
    v: Ingredient.role
  binding:
    strength:
      v: required
    value set:
      v: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology
      link: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology
element:
  id:
    v: Ingredient.comment
  path:
    v: Ingredient.comment
  short:
    v: Drug Product Component Additional Information
  definition:
    v: A placeholder for providing any comments that are relevant to the component. [Source: SME Defined] Examples: removed during process, adjusted for loss on drying, etc.
  must support:
    v: true
element:
  id:
    v: Ingredient.substance
  path:
    v: Ingredient.substance
  constraint:
    key:
      v: cmc-strength-type-cases2
    severity:
      v: error
    human:
      v: IF Strength Type = Activity THEN Strength Textual, Strength UOM ([arb'U]) and Strength Operator are applicable data elements. Strength Textual and Strength UOM will be Mandatory and Operator will be Optional. Codes 75765 [arb'U]; C45420 Activity.
    expression:
      v: defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( strength .extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension') .extension.where( value.coding.where( code = 'C45420' and system = %system ).exists() ).exists() implies ( strength.presentation.ofType(Ratio).exists() and strength.presentation.numerator.where( code = '[arb\'U]' and system = 'http://unitsofmeasure.org' ) ) or ( strength.presentation.ofType(Quantity).exists() and strength.presentation.where( code = '[arb\'U]' and system = 'http://unitsofmeasure.org' ) ))
    source:
      v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component
      link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component
element:
  id:
    v: Ingredient.substance.code
  path:
    v: Ingredient.substance.code
  short:
    v: Ingredient Substance
  type:
    code:
      v: CodeableReference
    profile:
      v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-codeable-reference
      link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-codeable-reference
    target profile:
      v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component-substance
      link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component-substance
    aggregation:
      v: bundled
  must support:
    v: true
element:
  id:
    v: Ingredient.substance.strength
  path:
    v: Ingredient.substance.strength
  slicing:
    discriminator:
      type:
        v: exists
      path:
        v: textConcentration
    ordered:
      v: false
    rules:
      v: closed
  min:
    v: 2
  max:
    v: 2
  must support:
    v: true
element:
  id:
    v: Ingredient.substance.strength:amount
  path:
    v: Ingredient.substance.strength
  slice name:
    v: amount
  min:
    v: 1
  max:
    v: 1
  must support:
    v: true
element:
  id:
    v: Ingredient.substance.strength:amount.extension
  path:
    v: Ingredient.substance.strength.extension
  slicing:
    discriminator:
      type:
        v: value
      path:
        v: url
    ordered:
      v: false
    rules:
      v: open
  min:
    v: 1
element:
  id:
    v: Ingredient.substance.strength:amount.extension:strengthFactors
  path:
    v: Ingredient.substance.strength.extension
  slice name:
    v: strengthFactors
  min:
    v: 1
  max:
    v: 1
  type:
    code:
      v: Extension
    profile:
      v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension
      link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension
  must support:
    v: true
element:
  id:
    v: Ingredient.substance.strength:amount.concentration[x]
  path:
    v: Ingredient.substance.strength.concentration[x]
  slicing:
    discriminator:
      type:
        v: type
      path:
        v: $this
    ordered:
      v: false
    rules:
      v: open
  min:
    v: 1
  type:
    code:
      v: Ratio
  type:
    code:
      v: Quantity
  must support:
    v: true
element:
  id:
    v: Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity
  path:
    v: Ingredient.substance.strength.concentration[x]
  slice name:
    v: concentrationQuantity
  min:
    v: 0
  max:
    v: 1
  type:
    code:
      v: Quantity
  must support:
    v: true
  binding:
    strength:
      v: required
    value set:
      v: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units
      link: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units
element:
  id:
    v: Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.value
  path:
    v: Ingredient.substance.strength.concentration[x].value
  short:
    v: Ingredient Total Amount Numeric
  definition:
    v: Specifies the quantity of an ingredient in a single dose unit (e.g., one tablet, capsule) of the drug product. [Source: SME Defined] Example: if the tablet contains 325 mg of the ingredient in each unit dose, then Ingredient Total Amount Numeric = 325
  min:
    v: 1
  must support:
    v: true
element:
  id:
    v: Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.comparator
  path:
    v: Ingredient.substance.strength.concentration[x].comparator

v: Ingredient Total Amount Operator

v: A mathematical symbol that denotes equality or inequality between two values. [Source: SME Defined] Examples: LT, EQ, NMT. Note: This is typically applicable to biologics.

v: true

id:
  v: Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.unit
path:
  v: Ingredient.substance.strength.concentration[x].unit
min:
  v: 1

id:
  v: Ingredient.substance.strength:amount.concentration[x]:concentrationRatio
path:
  v: Ingredient.substance.strength.concentration[x]
slice name:
  v: concentrationRatio
min:
  v: 0
max:
  v: 1
type:
  code:
    v: Ratio
must support:
  v: true

id:
  v: Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator
path:
  v: Ingredient.substance.strength.concentration[x].numerator
definition:
  v: Specifies the quantity of an ingredient in a single dose unit of the drug product. [Source: SME Defined]
min:
  v: 1
must support:
  v: true
binding:
  strength:
    v: required
  value set:
    v: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units
    link: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units

id:
  v: Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.value
path:
  v: Ingredient.substance.strength.concentration[x].numerator.value
short:
  v: Ingredient Total Amount Numeric Numerator
min:
  v: 1
must support:
  v: true

id:
  v: Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.unit
path:
  v: Ingredient.substance.strength.concentration[x].numerator.unit
short:
  v: Ingredient Total Amount Numeric Numerator UOM
definition:
  v: The labeled unit of measure for the content of the drug product, expressed quantitatively per dosage unit. [Source: Adapted for NCI EVS C117055] Example: mg

id:
  v: Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.code
path:
  v: Ingredient.substance.strength.concentration[x].numerator.code
min:
  v: 1
must support:
  v: true

id:
  v: Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator
path:
  v: Ingredient.substance.strength.concentration[x].denominator
min:
  v: 1
must support:
  v: true
binding:
  strength:
    v: required
  value set:
    v: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units
    link: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units

id:
  v: Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.value
path:
  v: Ingredient.substance.strength.concentration[x].denominator.value
short:
  v: Ingredient Total Amount Numeric Denominator
definition:
  v: Specifies the quantity of the ingredients within a single dose unit (e.g., vial, syringe) of drug product. [Source: SME Defined] Example: 10mg/syringe, 1mg/ml
min:
  v: 1
must support:
  v: true

id:
  v: Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.unit
path:
  v: Ingredient.substance.strength.concentration[x].denominator.unit
short:
  v: Ingredient Total Amount Numeric Denominator UOM
min:
  v: 1
must support:
  v: true

id:
  v: Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.code
path:
  v: Ingredient.substance.strength.concentration[x].denominator.code
min:
  v: 1
must support:
  v: true

id:
  v: Ingredient.substance.strength:amount.textConcentration
path:
  v: Ingredient.substance.strength.textConcentration
short:
  v: Strength Textual
definition:
  v: A written description of the strength of the ingredient. [Source: SME Defined]
min:
  v: 1
must support:
  v: true

id:
  v: Ingredient.substance.strength:percent
path:
  v: Ingredient.substance.strength
slice name:
  v: percent
min:
  v: 1
max:
  v: 1
must support:
  v: true

id:
  v: Ingredient.substance.strength:percent.concentration[x]
path:
  v: Ingredient.substance.strength.concentration[x]
min:
  v: 1
type:
  code:
    v: Quantity
must support:
  v: true
binding:
  strength:
    v: required
  value set:
    v: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units
    link: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units

id:
  v: Ingredient.substance.strength:percent.concentration[x].value
path:
  v: Ingredient.substance.strength.concentration[x].value
short:
  v: Ingredient Total Amount Content Percent
definition:
  v: The percentage of the component in the drug product. [Source: SME Defined] Example: Product Total Weight = 1200 mg and Product Ingredient Amount = 325 mg, so Product Ingredient Content Percent = 27.08
min:
  v: 1
must support:
  v: true

id:
  v: Ingredient.substance.strength:percent.concentration[x].code
path:
  v: Ingredient.substance.strength.concentration[x].code
short:
  v: Ingredient Total Amount Content Percent UOM
min:
  v: 1
must support:
  v: true

id:
  v: Ingredient.substance.strength:percent.textConcentration
path:
  v: Ingredient.substance.strength.textConcentration
max:
  v: 0
must support:
  v: true