FHIR Extensions Pack
5.1.0 - 5.1.0 (April 2024) International flag

This page is part of the FHIR Core Extensions Registry (v5.1.0: Release 5.1) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

Extension: Medication Manufacturing Batch

Official URL: http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch Version: 5.1.0
Standards status: Trial-use Maturity Level: 2 Responsible: HL7 International / Pharmacy Computable Name: MedManufacturingBatch
Other Identifiers: OID:2.16.840.1.113883.4.642.5.1415

The date at which the drug substance or drug product was manufactured. The specific operation/step in the process used to determine the date is specified by the manufacturingDateClassification element.

Context of Use

This extension may be used on the following element(s):

  • Element ID Medication.batch
  • Element ID Substance

Usage info

Usage:

  • This Extension is not used by any profiles in this Implementation Guide

Changes since version 1.0.0:

  • The resource metadata has changed (publisher)

    • Formal Views of Extension Content

    Description of Profiles, Differentials, Snapshots, and how the XML and JSON presentations work.

    This structure is derived from Extension

    Summary

    Complex Extension: The date at which the drug substance or drug product was manufactured. The specific operation/step in the process used to determine the date is specified by the manufacturingDateClassification element.

    • manufacturingDate: dateTime: The date at which the drug substance or drug product was manufactured. The specific operation/step in the process used to determine the date is specified by the manufacturingDateClassification element.
    • manufacturingDateClassification: CodeableConcept: A code that provides a rationale for the selection of the manufacturing date.
    • assignedManufacturer: Reference: Describes the details of the actual manufacturer who produced this product on behalf of the sponsor or who wholly or partially produced the medication product. This is intended to identify the exact manufacturing location.
    • expirationDateClassification: CodeableConcept: A code that provides a rationale for the selection of the expiration date.
    • batchUtilization: CodeableConcept: A categorization of the batch that identifies its usage. Examples: commercial, development, etc.
    • batchQuantity: Quantity: The amount of drug product produced in this batch.
    • additionalInformation: string: A placeholder for providing any comments that are relevant to the batch. Examples: first batch manufactured at a new facility; first batch manufactured using a new Active Pharmaceutical Ingredient (API) source, new process, new container closure, etc.
    • lotNumber: string: A combination of letters, numbers, or symbols, or any combination of them to uniquely identify the container's manufacturing lot.
    • type: CodeableConcept: The kind of container that drug substances and finished dosage forms are contained in, which could include both the immediate (or primary) and secondary containers.
    • quantity: Ratio: Amount or volume of the drug product in the container. Expressed as a ratio of the amount of drug per volume of container.
    • closureSystemDescription: string: A description of the sum of container closure system (CCS) components that together contain and protect the dosage form or drug substance.
    • closureType: CodeableConcept: The kind of closures used for the container in which the drug substances and finished dosage forms are stored.

    Maturity: 2

    This structure is derived from Extension

    NameFlagsCard.TypeDescription & Constraintsdoco
    .. Extension 0..1 Extension Extension
    ... Slices for extension Content/Rules for all slices
    .... extension:manufacturingDate 0..1 Extension Extension
    ..... extension 0..0
    ..... url 1..1 uri "manufacturingDate"
    ..... value[x] 1..1 dateTime Value of extension
    .... extension:manufacturingDateClassification 0..1 Extension Extension
    ..... extension 0..0
    ..... url 1..1 uri "manufacturingDateClassification"
    ..... value[x] 1..1 CodeableConcept Value of extension
    .... extension:assignedManufacturer 0..1 Extension Extension
    ..... extension 0..0
    ..... url 1..1 uri "assignedManufacturer"
    ..... value[x] 1..1 Reference(Organization) Value of extension
    .... extension:expirationDateClassification 0..1 Extension Extension
    ..... extension 0..0
    ..... url 1..1 uri "expirationDateClassification"
    ..... value[x] 1..1 CodeableConcept Value of extension
    .... extension:batchUtilization 0..1 Extension Extension
    ..... extension 0..0
    ..... url 1..1 uri "batchUtilization"
    ..... value[x] 1..1 CodeableConcept Value of extension
    .... extension:batchQuantity 0..1 Extension Extension
    ..... extension 0..0
    ..... url 1..1 uri "batchQuantity"
    ..... value[x] 1..1 Quantity Value of extension
    .... extension:additionalInformation 0..1 Extension Extension
    ..... extension 0..0
    ..... url 1..1 uri "additionalInformation"
    ..... value[x] 1..1 string Value of extension
    .... extension:container 0..* Extension Extension
    ..... Slices for extension Content/Rules for all slices
    ...... extension:lotNumber 0..1 Extension Extension
    ....... extension 0..0
    ....... url 1..1 uri "lotNumber"
    ....... value[x] 1..1 string Value of extension
    ...... extension:type 0..1 Extension Extension
    ....... extension 0..0
    ....... url 1..1 uri "type"
    ....... value[x] 1..1 CodeableConcept Value of extension
    ...... extension:quantity 0..1 Extension Extension
    ....... extension 0..0
    ....... url 1..1 uri "quantity"
    ....... value[x] 1..1 Ratio Value of extension
    ...... extension:closureSystemDescription 0..1 Extension Extension
    ....... extension 0..0
    ....... url 1..1 uri "closureSystemDescription"
    ....... value[x] 1..1 string Value of extension
    ...... extension:closureType 0..1 Extension Extension
    ....... extension 0..0
    ....... url 1..1 uri "closureType"
    ....... value[x] 1..1 CodeableConcept Value of extension
    ..... url 1..1 uri "container"
    ..... value[x] 0..0
    ... url 1..1 uri "http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch"
    ... value[x] 0..0

    doco Documentation for this format
    NameFlagsCard.TypeDescription & Constraintsdoco
    .. Extension 0..1 Extension Extension
    ... id 0..1 id Unique id for inter-element referencing
    ... Slices for extension 0..* Extension Additional content defined by implementations
    Slice: Unordered, Open by value:url
    .... extension:manufacturingDate 0..1 Extension Extension
    ..... id 0..1 id Unique id for inter-element referencing
    ..... extension 0..0
    ..... url 1..1 uri "manufacturingDate"
    ..... value[x] 1..1 dateTime Value of extension
    .... extension:manufacturingDateClassification 0..1 Extension Extension
    ..... id 0..1 id Unique id for inter-element referencing
    ..... extension 0..0
    ..... url 1..1 uri "manufacturingDateClassification"
    ..... value[x] 1..1 CodeableConcept Value of extension
    .... extension:assignedManufacturer 0..1 Extension Extension
    ..... id 0..1 id Unique id for inter-element referencing
    ..... extension 0..0
    ..... url 1..1 uri "assignedManufacturer"
    ..... value[x] 1..1 Reference(Organization) Value of extension
    .... extension:expirationDateClassification 0..1 Extension Extension
    ..... id 0..1 id Unique id for inter-element referencing
    ..... extension 0..0
    ..... url 1..1 uri "expirationDateClassification"
    ..... value[x] 1..1 CodeableConcept Value of extension
    .... extension:batchUtilization 0..1 Extension Extension
    ..... id 0..1 id Unique id for inter-element referencing
    ..... extension 0..0
    ..... url 1..1 uri "batchUtilization"
    ..... value[x] 1..1 CodeableConcept Value of extension
    .... extension:batchQuantity 0..1 Extension Extension
    ..... id 0..1 id Unique id for inter-element referencing
    ..... extension 0..0
    ..... url 1..1 uri "batchQuantity"
    ..... value[x] 1..1 Quantity Value of extension
    .... extension:additionalInformation 0..1 Extension Extension
    ..... id 0..1 id Unique id for inter-element referencing
    ..... extension 0..0
    ..... url 1..1 uri "additionalInformation"
    ..... value[x] 1..1 string Value of extension
    .... extension:container 0..* Extension Extension
    ..... id 0..1 id Unique id for inter-element referencing
    ..... Slices for extension 0..* Extension Additional content defined by implementations
    Slice: Unordered, Open by value:url
    ...... extension:lotNumber 0..1 Extension Extension
    ....... id 0..1 id Unique id for inter-element referencing
    ....... extension 0..0
    ....... url 1..1 uri "lotNumber"
    ....... value[x] 1..1 string Value of extension
    ...... extension:type 0..1 Extension Extension
    ....... id 0..1 id Unique id for inter-element referencing
    ....... extension 0..0
    ....... url 1..1 uri "type"
    ....... value[x] 1..1 CodeableConcept Value of extension
    ...... extension:quantity 0..1 Extension Extension
    ....... id 0..1 id Unique id for inter-element referencing
    ....... extension 0..0
    ....... url 1..1 uri "quantity"
    ....... value[x] 1..1 Ratio Value of extension
    ...... extension:closureSystemDescription 0..1 Extension Extension
    ....... id 0..1 id Unique id for inter-element referencing
    ....... extension 0..0
    ....... url 1..1 uri "closureSystemDescription"
    ....... value[x] 1..1 string Value of extension
    ...... extension:closureType 0..1 Extension Extension
    ....... id 0..1 id Unique id for inter-element referencing
    ....... extension 0..0
    ....... url 1..1 uri "closureType"
    ....... value[x] 1..1 CodeableConcept Value of extension
    ..... url 1..1 uri "container"
    ... url 1..1 uri "http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch"

    doco Documentation for this format

    This structure is derived from Extension

    Summary

    Complex Extension: The date at which the drug substance or drug product was manufactured. The specific operation/step in the process used to determine the date is specified by the manufacturingDateClassification element.

    • manufacturingDate: dateTime: The date at which the drug substance or drug product was manufactured. The specific operation/step in the process used to determine the date is specified by the manufacturingDateClassification element.
    • manufacturingDateClassification: CodeableConcept: A code that provides a rationale for the selection of the manufacturing date.
    • assignedManufacturer: Reference: Describes the details of the actual manufacturer who produced this product on behalf of the sponsor or who wholly or partially produced the medication product. This is intended to identify the exact manufacturing location.
    • expirationDateClassification: CodeableConcept: A code that provides a rationale for the selection of the expiration date.
    • batchUtilization: CodeableConcept: A categorization of the batch that identifies its usage. Examples: commercial, development, etc.
    • batchQuantity: Quantity: The amount of drug product produced in this batch.
    • additionalInformation: string: A placeholder for providing any comments that are relevant to the batch. Examples: first batch manufactured at a new facility; first batch manufactured using a new Active Pharmaceutical Ingredient (API) source, new process, new container closure, etc.
    • lotNumber: string: A combination of letters, numbers, or symbols, or any combination of them to uniquely identify the container's manufacturing lot.
    • type: CodeableConcept: The kind of container that drug substances and finished dosage forms are contained in, which could include both the immediate (or primary) and secondary containers.
    • quantity: Ratio: Amount or volume of the drug product in the container. Expressed as a ratio of the amount of drug per volume of container.
    • closureSystemDescription: string: A description of the sum of container closure system (CCS) components that together contain and protect the dosage form or drug substance.
    • closureType: CodeableConcept: The kind of closures used for the container in which the drug substances and finished dosage forms are stored.

    Maturity: 2

    Differential View

    This structure is derived from Extension

    NameFlagsCard.TypeDescription & Constraintsdoco
    .. Extension 0..1 Extension Extension
    ... Slices for extension Content/Rules for all slices
    .... extension:manufacturingDate 0..1 Extension Extension
    ..... extension 0..0
    ..... url 1..1 uri "manufacturingDate"
    ..... value[x] 1..1 dateTime Value of extension
    .... extension:manufacturingDateClassification 0..1 Extension Extension
    ..... extension 0..0
    ..... url 1..1 uri "manufacturingDateClassification"
    ..... value[x] 1..1 CodeableConcept Value of extension
    .... extension:assignedManufacturer 0..1 Extension Extension
    ..... extension 0..0
    ..... url 1..1 uri "assignedManufacturer"
    ..... value[x] 1..1 Reference(Organization) Value of extension
    .... extension:expirationDateClassification 0..1 Extension Extension
    ..... extension 0..0
    ..... url 1..1 uri "expirationDateClassification"
    ..... value[x] 1..1 CodeableConcept Value of extension
    .... extension:batchUtilization 0..1 Extension Extension
    ..... extension 0..0
    ..... url 1..1 uri "batchUtilization"
    ..... value[x] 1..1 CodeableConcept Value of extension
    .... extension:batchQuantity 0..1 Extension Extension
    ..... extension 0..0
    ..... url 1..1 uri "batchQuantity"
    ..... value[x] 1..1 Quantity Value of extension
    .... extension:additionalInformation 0..1 Extension Extension
    ..... extension 0..0
    ..... url 1..1 uri "additionalInformation"
    ..... value[x] 1..1 string Value of extension
    .... extension:container 0..* Extension Extension
    ..... Slices for extension Content/Rules for all slices
    ...... extension:lotNumber 0..1 Extension Extension
    ....... extension 0..0
    ....... url 1..1 uri "lotNumber"
    ....... value[x] 1..1 string Value of extension
    ...... extension:type 0..1 Extension Extension
    ....... extension 0..0
    ....... url 1..1 uri "type"
    ....... value[x] 1..1 CodeableConcept Value of extension
    ...... extension:quantity 0..1 Extension Extension
    ....... extension 0..0
    ....... url 1..1 uri "quantity"
    ....... value[x] 1..1 Ratio Value of extension
    ...... extension:closureSystemDescription 0..1 Extension Extension
    ....... extension 0..0
    ....... url 1..1 uri "closureSystemDescription"
    ....... value[x] 1..1 string Value of extension
    ...... extension:closureType 0..1 Extension Extension
    ....... extension 0..0
    ....... url 1..1 uri "closureType"
    ....... value[x] 1..1 CodeableConcept Value of extension
    ..... url 1..1 uri "container"
    ..... value[x] 0..0
    ... url 1..1 uri "http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch"
    ... value[x] 0..0

    doco Documentation for this format

    Snapshot View

    NameFlagsCard.TypeDescription & Constraintsdoco
    .. Extension 0..1 Extension Extension
    ... id 0..1 id Unique id for inter-element referencing
    ... Slices for extension 0..* Extension Additional content defined by implementations
    Slice: Unordered, Open by value:url
    .... extension:manufacturingDate 0..1 Extension Extension
    ..... id 0..1 id Unique id for inter-element referencing
    ..... extension 0..0
    ..... url 1..1 uri "manufacturingDate"
    ..... value[x] 1..1 dateTime Value of extension
    .... extension:manufacturingDateClassification 0..1 Extension Extension
    ..... id 0..1 id Unique id for inter-element referencing
    ..... extension 0..0
    ..... url 1..1 uri "manufacturingDateClassification"
    ..... value[x] 1..1 CodeableConcept Value of extension
    .... extension:assignedManufacturer 0..1 Extension Extension
    ..... id 0..1 id Unique id for inter-element referencing
    ..... extension 0..0
    ..... url 1..1 uri "assignedManufacturer"
    ..... value[x] 1..1 Reference(Organization) Value of extension
    .... extension:expirationDateClassification 0..1 Extension Extension
    ..... id 0..1 id Unique id for inter-element referencing
    ..... extension 0..0
    ..... url 1..1 uri "expirationDateClassification"
    ..... value[x] 1..1 CodeableConcept Value of extension
    .... extension:batchUtilization 0..1 Extension Extension
    ..... id 0..1 id Unique id for inter-element referencing
    ..... extension 0..0
    ..... url 1..1 uri "batchUtilization"
    ..... value[x] 1..1 CodeableConcept Value of extension
    .... extension:batchQuantity 0..1 Extension Extension
    ..... id 0..1 id Unique id for inter-element referencing
    ..... extension 0..0
    ..... url 1..1 uri "batchQuantity"
    ..... value[x] 1..1 Quantity Value of extension
    .... extension:additionalInformation 0..1 Extension Extension
    ..... id 0..1 id Unique id for inter-element referencing
    ..... extension 0..0
    ..... url 1..1 uri "additionalInformation"
    ..... value[x] 1..1 string Value of extension
    .... extension:container 0..* Extension Extension
    ..... id 0..1 id Unique id for inter-element referencing
    ..... Slices for extension 0..* Extension Additional content defined by implementations
    Slice: Unordered, Open by value:url
    ...... extension:lotNumber 0..1 Extension Extension
    ....... id 0..1 id Unique id for inter-element referencing
    ....... extension 0..0
    ....... url 1..1 uri "lotNumber"
    ....... value[x] 1..1 string Value of extension
    ...... extension:type 0..1 Extension Extension
    ....... id 0..1 id Unique id for inter-element referencing
    ....... extension 0..0
    ....... url 1..1 uri "type"
    ....... value[x] 1..1 CodeableConcept Value of extension
    ...... extension:quantity 0..1 Extension Extension
    ....... id 0..1 id Unique id for inter-element referencing
    ....... extension 0..0
    ....... url 1..1 uri "quantity"
    ....... value[x] 1..1 Ratio Value of extension
    ...... extension:closureSystemDescription 0..1 Extension Extension
    ....... id 0..1 id Unique id for inter-element referencing
    ....... extension 0..0
    ....... url 1..1 uri "closureSystemDescription"
    ....... value[x] 1..1 string Value of extension
    ...... extension:closureType 0..1 Extension Extension
    ....... id 0..1 id Unique id for inter-element referencing
    ....... extension 0..0
    ....... url 1..1 uri "closureType"
    ....... value[x] 1..1 CodeableConcept Value of extension
    ..... url 1..1 uri "container"
    ... url 1..1 uri "http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch"

    doco Documentation for this format

     

    Other representations of profile: CSV, Excel, Schematron

    Constraints

    IdGradePath(s)DetailsRequirements
    ele-1error**ALL** elementsAll FHIR elements must have a @value or children
    : hasValue() or (children().count() > id.count())
    ext-1error**ALL** extensionsMust have either extensions or value[x], not both
    : extension.exists() != value.exists()

    Search Parameters for this Extension

    (none found)