Source | hl7.fhir.us.pq-cmc#current:PQ/CMC FHIR Implementation Guide (v5.0.0) |
resourceType | StructureDefinition |
id | pqcmc-component |
canonical | http://hl7.org/fhir/us/pq-cmc/StructureDefinition/pqcmc-component |
version | 0.1.15 |
status | draft |
publisher | HL7 International - Biomedical Research and Regulatory WG |
name | DrugProductComponent |
title | Drug Product Component |
date | 2023-07-17T03:00:13+00:00 |
description | The amount details about the drug product components to define the product composition in a product unit. Use composition. |
jurisdictions | us |
fhirVersion | 5.0.0 |
kind | resource |
abstract | false |
sdTtype | Ingredient |
derivation | constraint |
base | http://hl7.org/fhir/StructureDefinition/Ingredient |
Usages |
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Name | Flags | Card. | Type |
Description & Constraints
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Ingredient | |||
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S | ..1 | ||
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Slice: Unordered, Open by value:url | |||
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S | 0..1 | markdown |
Drug Product Component Additional Information URL: http://hl7.org/fhir/us/pq-cmc/StructureDefinition/pq-additional-info-extension |
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Reference to MedicinalProductDefinition | |||
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Binding: Drug Product Component Function Category Terminology ( required ) | |||
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C |
cmc-strength-type-cases1:
IF Strength Type = Mass THEN Strength Numeric and Strength UOM are Mandatory cmc-strength-type-cases2: 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. |
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S | CodeableReference (Component Substance) | Ingredient Substance | |
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S | 1..1 | ||
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1.. | Slice: Unordered, Open by value:url | ||
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S | 1..1 | (Complex) |
Strength Extension
URL: http://hl7.org/fhir/us/pq-cmc/StructureDefinition/strength-extension |
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S | 1 .. | Slice: Unordered, Open by type:$this | |
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Ratio | |||
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Quantity | |||
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S | 0..1 | Ratio | |
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S | 1.. | ||
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S | 1.. | Product Ingredient Amount Numeric Numerator | |
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S | 1.. | Product Ingredient Amount Numeric Numerator UOM | |
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S | 1.. | Binding: Units Of Measure Terminology ( required ) | |
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S | 1.. | ||
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S | 1.. | Product Ingredient Amount Numeric Denominator | |
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S | 1.. | ||
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S | 1.. | Binding: Units Of Measure Terminology ( required ) | |
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S | 0..1 | Quantity | |
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S | 1.. | Product Ingredient Amount Numeric | |
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1.. | |||
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1.. | Binding: Units Of Measure Terminology ( required ) | ||
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S | 1.. | Strength Textual | |
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Produced 08 Sep 2023