pq-overage-extension
type: StructureDefinition
node role: treeRoot
id:
  v: pq-overage-extension
text:
  status:
    v: extensions
  div: Generated Narrative: StructureDefinition pq-overage-extension Name Flags Card. Type Description & Constraints<img src="[binary]" alt="doco" style="background-color: inherit"/> Extension <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-overage-percent-limit )">C 0..* Extension Overage Extension Constraints: cmc-overage-percent-limit #xD; extension 2..* Extension Extension #xD; Slices for extension Content/Rules for all slices #xD; extension:proportionDecimal S 1..1 Extension Extension #xD; extension 0..0 #xD; url 1..1 uri "proportionDecimal" #xD; <a href="StructureDefinition-pq-overage-extension-definitions.html#Extension.extension:proportionDecimal.value[x]" title="Overage is the proportion of a drug substance in excess of the label claim to compensate for the loss, such as manufacturing or other.#xA;Note: This is not for stability loss, and generally not permitted.#xA;Example: 3% overage of drug that has a label claim of 10mg of active (API) - the formulation would have 10.3 mg. A batch formula for 100 kg would contain 103 kg of API.#xA;The value is entered as a decimal value less then one.">value[x] 0..1 decimal Overage Percent #xD; extension:justification S 1..1 Extension Extension #xD; extension 0..0 #xD; url 1..1 uri "justification" #xD; value[x] 0..1 markdown Overage Justification #xD; url 1..1 uri "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-overage-extension" #xD; value[x] 0..0 #xD; <img src="[binary]" alt="doco" style="background-color: inherit"/> Documentation for this format
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-type-characteristics
  value: code
    v: can-bind
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/pq-overage-extension
identifier:
  system:
    v: urn:ietf:rfc:3986
  value:
    v: urn:oid:2.16.840.1.113883.4.642.40.36.42.66
version:
  v: 2.0.0
name:
  v: OverageExtension
title:
  v: Overage Extension
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: Extension for measurements related to excess for ingredients in the batch formula.
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: rim
  uri:
    v: http://hl7.org/v3
  name:
    v: RIM Mapping
kind:
  v: complex-type
abstract:
  v: false
context:
  type:
    v: element
  expression:
    v: ManufacturedItemDefinition.component.constituent
type:
  v: Extension
base definition:
  v: http://hl7.org/fhir/StructureDefinition/Extension
  link: http://hl7.org/fhir/StructureDefinition/Extension
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: Extension
    path:
      v: Extension
    short:
      v: Overage Extension
    definition:
      v: Extension for measurements related to excess for ingredients in the batch formula.
    min:
      v: 0
    max:
      v: *
    base:
      path:
        v: Extension
      min:
        v: 0
      max:
        v: *
    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
    constraint:
      key:
        v: cmc-overage-percent-limit
      severity:
        v: error
      human:
        v: Overage percent must be less than 1.0
      expression:
        v: extension.where(url='proportionDecimal').single().value < 1
      source:
        v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-overage-extension
        link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-overage-extension
    is modifier:
      v: false
  element:
    id:
      v: Extension.id
    path:
      v: Extension.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:
        value: url
      code:
        v: http://hl7.org/fhirpath/System.String
    condition:
      v: ele-1
    is modifier:
      v: false
    is summary:
      v: false

url
v: id

identity:
  v: rim
map:
  v: n/a

id:
  v: Extension.extension
path:
  v: Extension.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Extension
definition:
  v: An Extension
min:
  v: 2
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: Extension.extension:proportionDecimal
path:
  v: Extension.extension
slice name:
  v: proportionDecimal
short:
  v: Extension
definition:
  v: An Extension
min:
  v: 1
max:
  v: 1
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
must support:
  v: true
is modifier:
  v: false
is summary:
  v: false

id:
  v: Extension.extension:proportionDecimal.id
path:
  v: Extension.extension.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: Extension.extension:proportionDecimal.extension
path:
  v: Extension.extension.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Extension
definition:
  v: An Extension
min:
  v: 0
max:
  v: 0
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: Extension.extension:proportionDecimal.url
path:
  v: Extension.extension.url
representation:
  v: xmlAttr
short:
  v: identifies the meaning of the extension
definition:
  v: Source of the definition for the extension code - a logical name or a URL.
comment:
  v: The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Extension.url
  min:
    v: 1
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: uri
  code:
    v: http://hl7.org/fhirpath/System.String
fixed: uri
  v: proportionDecimal
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: Extension.extension:proportionDecimal.value[x]
path:
  v: Extension.extension.value[x]
short:
  v: Overage Percent
definition:
  v: Overage is the proportion of a drug substance in excess of the label claim to compensate for the loss, such as manufacturing or other. Note: This is not for stability loss, and generally not permitted. Example: 3% overage of drug that has a label claim of 10mg of active (API) - the formulation would have 10.3 mg. A batch formula for 100 kg would contain 103 kg of API. The value is entered as a decimal value less then one.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Extension.value[x]
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: decimal
condition:
  v: ext-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
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: Extension.extension:justification
path:
  v: Extension.extension
slice name:
  v: justification
short:
  v: Extension
definition:
  v: An Extension
min:
  v: 1
max:
  v: 1
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
must support:
  v: true
is modifier:
  v: false
is summary:
  v: false

id:
  v: Extension.extension:justification.id
path:
  v: Extension.extension.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: Extension.extension:justification.extension
path:
  v: Extension.extension.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Extension
definition:
  v: An Extension
min:
  v: 0
max:
  v: 0
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: Extension.extension:justification.url
path:
  v: Extension.extension.url
representation:
  v: xmlAttr
short:
  v: identifies the meaning of the extension
definition:
  v: Source of the definition for the extension code - a logical name or a URL.
comment:
  v: The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Extension.url
  min:
    v: 1
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: uri
  code:
    v: http://hl7.org/fhirpath/System.String
fixed: uri
  v: justification
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: Extension.extension:justification.value[x]
path:
  v: Extension.extension.value[x]
short:
  v: Overage Justification
definition:
  v: The rationale for use of excess drug substance during manufacturing of the drug product [Source: SME Defined]
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Extension.value[x]
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: markdown
condition:
  v: ext-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
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: Extension.url
path:
  v: Extension.url
representation:
  v: xmlAttr
short:
  v: identifies the meaning of the extension
definition:
  v: Source of the definition for the extension code - a logical name or a URL.
comment:
  v: The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Extension.url
  min:
    v: 1
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: uri
  code:
    v: http://hl7.org/fhirpath/System.String
fixed: uri
  v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-overage-extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: Extension.value[x]
path:
  v: Extension.value[x]
short:
  v: Value of extension
definition:
  v: Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://hl7.org/fhir/R5/extensibility.html) for a list).
min:
  v: 0
max:
  v: 0
base:
  path:
    v: Extension.value[x]
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: base64Binary
type:
  code:
    v: boolean
type:
  code:
    v: canonical
type:
  code:
    v: code
type:
  code:
    v: date
type:
  code:
    v: dateTime
type:
  code:
    v: decimal
type:
  code:
    v: id
type:
  code:
    v: instant
type:
  code:
    v: integer
type:
  code:
    v: integer64
type:
  code:
    v: markdown
type:
  code:
    v: oid
type:
  code:
    v: positiveInt
type:
  code:
    v: string
type:
  code:
    v: time
type:
  code:
    v: unsignedInt
type:
  code:
    v: uri
type:
  code:
    v: url
type:
  code:
    v: uuid
type:
  code:
    v: Address
type:
  code:
    v: Age
type:
  code:
    v: Annotation
type:
  code:
    v: Attachment
type:
  code:
    v: CodeableConcept
type:
  code:
    v: CodeableReference
type:
  code:
    v: Coding
type:
  code:
    v: ContactPoint
type:
  code:
    v: Count
type:
  code:
    v: Distance
type:
  code:
    v: Duration
type:
  code:
    v: HumanName
type:
  code:
    v: Identifier
type:
  code:
    v: Money
type:
  code:
    v: Period
type:
  code:
    v: Quantity
type:
  code:
    v: Range
type:
  code:
    v: Ratio
type:
  code:
    v: RatioRange
type:
  code:
    v: Reference
type:
  code:
    v: SampledData
type:
  code:
    v: Signature
type:
  code:
    v: Timing
type:
  code:
    v: ContactDetail
type:
  code:
    v: DataRequirement
type:
  code:
    v: Expression
type:
  code:
    v: ParameterDefinition
type:
  code:
    v: RelatedArtifact
type:
  code:
    v: TriggerDefinition
type:
  code:
    v: UsageContext
type:
  code:
    v: Availability
type:
  code:
    v: ExtendedContactDetail
type:
  code:
    v: Dosage
type:
  code:
    v: Meta
condition:
  v: ext-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
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim

v: N/A

element:
  id:
    v: Extension
  path:
    v: Extension
  short:
    v: Overage Extension
  definition:
    v: Extension for measurements related to excess for ingredients in the batch formula.
  constraint:
    key:
      v: cmc-overage-percent-limit
    severity:
      v: error
    human:
      v: Overage percent must be less than 1.0
    expression:
      v: extension.where(url='proportionDecimal').single().value < 1
    source:
      v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-overage-extension
      link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-overage-extension
element:
  id:
    v: Extension.extension
  path:
    v: Extension.extension
  min:
    v: 2
element:
  id:
    v: Extension.extension:proportionDecimal
  path:
    v: Extension.extension
  slice name:
    v: proportionDecimal
  min:
    v: 1
  max:
    v: 1
  must support:
    v: true
element:
  id:
    v: Extension.extension:proportionDecimal.extension
  path:
    v: Extension.extension.extension
  max:
    v: 0
element:
  id:
    v: Extension.extension:proportionDecimal.url
  path:
    v: Extension.extension.url
  fixed: uri
    v: proportionDecimal
element:
  id:
    v: Extension.extension:proportionDecimal.value[x]
  path:
    v: Extension.extension.value[x]
  short:
    v: Overage Percent
  definition:
    v: Overage is the proportion of a drug substance in excess of the label claim to compensate for the loss, such as manufacturing or other. Note: This is not for stability loss, and generally not permitted. Example: 3% overage of drug that has a label claim of 10mg of active (API) - the formulation would have 10.3 mg. A batch formula for 100 kg would contain 103 kg of API. The value is entered as a decimal value less then one.
  type:
    code:
      v: decimal
element:
  id:
    v: Extension.extension:justification
  path:
    v: Extension.extension
  slice name:
    v: justification
  min:
    v: 1
  max:
    v: 1
  must support:
    v: true
element:
  id:
    v: Extension.extension:justification.extension
  path:
    v: Extension.extension.extension
  max:
    v: 0
element:
  id:
    v: Extension.extension:justification.url
  path:
    v: Extension.extension.url
  fixed: uri
    v: justification
element:
  id:
    v: Extension.extension:justification.value[x]
  path:
    v: Extension.extension.value[x]
  short:
    v: Overage Justification
  definition:
    v: The rationale for use of excess drug substance during manufacturing of the drug product [Source: SME Defined]
  type:
    code:
      v: markdown
element:
  id:
    v: Extension.url
  path:
    v: Extension.url
  fixed: uri
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-overage-extension
element:
  id:
    v: Extension.value[x]
  path:
    v: Extension.value[x]
  max:
    v: 0