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 |
|
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Ingredient | Ingredient | |||
meta | ||||
profile | S | ..1 | ||
Slices for extension | Slice: Unordered, Open by value:url | |||
additional-info | S | 0..1 | markdown |
Drug Product Component Additional Information URL: http://hl7.org/fhir/us/pq-cmc/StructureDefinition/pq-additional-info-extension |
for | Reference to MedicinalProductDefinition | |||
role | Binding: Drug Product Component Function Category Terminology ( required ) | |||
substance | 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. |
||
code | S | CodeableReference (Component Substance) | Ingredient Substance | |
strength | S | 1..1 | ||
Slices for extension | 1.. | Slice: Unordered, Open by value:url | ||
strengthFactors | S | 1..1 | (Complex) |
Strength Extension
URL: http://hl7.org/fhir/us/pq-cmc/StructureDefinition/strength-extension |
Slices for presentation[x] | S | 1 .. | Slice: Unordered, Open by type:$this | |
presentationRatio | Ratio | |||
presentationQuantity | Quantity | |||
presentation[x]:presentationRatio | S | 0..1 | Ratio | |
numerator | S | 1.. | ||
value | S | 1.. | Product Ingredient Amount Numeric Numerator | |
unit | S | 1.. | Product Ingredient Amount Numeric Numerator UOM | |
code | S | 1.. | Binding: Units Of Measure Terminology ( required ) | |
denominator | S | 1.. | ||
value | S | 1.. | Product Ingredient Amount Numeric Denominator | |
unit | S | 1.. | ||
code | S | 1.. | Binding: Units Of Measure Terminology ( required ) | |
presentation[x]:presentationQuantity | S | 0..1 | Quantity | |
value | S | 1.. | Product Ingredient Amount Numeric | |
unit | 1.. | |||
code | 1.. | Binding: Units Of Measure Terminology ( required ) | ||
textPresentation | S | 1.. | Strength Textual | |
Documentation for this format |
Produced 08 Sep 2023