SPL Mapping FHIR R5 Implementation Guide
0.2.1 - Build CI United States of America flag

SPL Mapping FHIR R5 Implementation Guide, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.2.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-spl/ and changes regularly. See the Directory of published versions

: SPL Marketing Categories - TTL Representation

Page standards status: Trial-use Maturity Level: 1

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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

# - resource -------------------------------------------------------------------

 a fhir:ValueSet ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "valueset-splMarketingCategories"] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: ValueSet valueset-splMarketingCategories</b></p><a name=\"valueset-splMarketingCategories\"> </a><a name=\"hcvalueset-splMarketingCategories\"> </a><a name=\"valueset-splMarketingCategories-en-US\"> </a><ul><li>Include these codes as defined in <a href=\"http://terminology.hl7.org/6.1.0/CodeSystem-v3-nciThesaurus.html\"><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></a><table class=\"none\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td></tr><tr><td>C101533</td><td>UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE</td></tr><tr><td>C117717</td><td>Master File</td></tr><tr><td>C132333</td><td>Approved Drug Product Manufactured Under Contract</td></tr><tr><td>C132334</td><td>OTC Monograph Drug Product Manufactured Under Contract</td></tr><tr><td>C132335</td><td>Unapproved Drug Product Manufactured Under Contract</td></tr><tr><td>C175238</td><td>Multi-Market Approved Product</td></tr><tr><td>C175462</td><td>SIP Approved Drug</td></tr><tr><td>C181659</td><td>Outsourcing Facility Compounded Human Drug Product (Exempt From Approval Requirements)</td></tr><tr><td>C190698</td><td>Outsourcing Facility Compounded Human Drug Product (Not Marketed - Not Distributed)</td></tr><tr><td>C200263</td><td>OTC Monograph Drug</td></tr><tr><td>C73583</td><td>ANADA</td></tr><tr><td>C73584</td><td>ANDA</td></tr><tr><td>C73585</td><td>BLA</td></tr><tr><td>C73586</td><td>BULK ACTIVE INGREDIENT</td></tr><tr><td>C73587</td><td>BULK INACTIVE INGREDIENT</td></tr><tr><td>C73588</td><td>CONDITIONAL NADA</td></tr><tr><td>C73590</td><td>EXPORT ONLY</td></tr><tr><td>C73593</td><td>NADA</td></tr><tr><td>C73594</td><td>NDA</td></tr><tr><td>C73605</td><td>NDA AUTHORIZED GENERIC</td></tr><tr><td>C73613</td><td>UNAPPROVED MEDICAL GAS</td></tr><tr><td>C73614</td><td>UNAPPROVED HOMEOPATHIC</td></tr><tr><td>C73615</td><td>UNAPPROVED VITAMIN DRUG</td></tr><tr><td>C73626</td><td>BULK INGREDIENT</td></tr><tr><td>C73627</td><td>UNAPPROVED DRUG OTHER MARKETING CATEGORY</td></tr><tr><td>C75302</td><td>IND</td></tr><tr><td>C80438</td><td>EXEMPT DEVICE</td></tr><tr><td>C80440</td><td>HUMANITARIAN DEVICE EXEMPTION</td></tr><tr><td>C80441</td><td>PREMARKET APPLICATION</td></tr><tr><td>C80442</td><td>PREMARKET NOTIFICATION</td></tr><tr><td>C86952</td><td>DIETARY SUPPLEMENT</td></tr><tr><td>C86964</td><td>MEDICAL FOOD</td></tr><tr><td>C86965</td><td>COSMETIC</td></tr><tr><td>C92556</td><td>LEGALLY MARKETED UNAPPROVED NEW ANIMAL DRUGS FOR MINOR SPECIES</td></tr><tr><td>C94795</td><td>DRUG FOR FURTHER PROCESSING</td></tr><tr><td>C95600</td><td>APPROVED DRUG PRODUCT MANUFACTURED EXCLUSIVELY FOR PRIVATE LABEL DISTRIBUTOR</td></tr><tr><td>C95601</td><td>OTC MONOGRAPH DRUG PRODUCT MANUFACTURED EXCLUSIVELY FOR PRIVATE LABEL DISTRIBUTOR</td></tr><tr><td>C95602</td><td>UNAPPROVED DRUG PRODUCT MANUFACTURED EXCLUSIVELY FOR PRIVATE LABEL DISTRIBUTOR</td></tr><tr><td>C96793</td><td>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</td></tr><tr><td>C96794</td><td>BULK INGREDIENT FOR ANIMAL PRESCRIPTION COMPOUNDING</td></tr><tr><td>C96966</td><td>Emergency Use Authorization</td></tr><tr><td>C98252</td><td>BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING</td></tr></table></li></ul></div>"
  ] ; # 
  fhir:extension ( [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"^^xsd:anyURI ] ;
fhir:value [ fhir:v "brr" ]
  ] [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm"^^xsd:anyURI ] ;
fhir:value [
fhir:v "1"^^xsd:integer ;
      ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom"^^xsd:anyURI ] ;
fhir:value [
fhir:v "http://hl7.org/fhir/us/spl/ImplementationGuide/hl7.fhir.us.spl"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/us/spl/ImplementationGuide/hl7.fhir.us.spl>         ]       ] )     ]
  ] [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"^^xsd:anyURI ] ;
fhir:value [
fhir:v "trial-use" ;
      ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom"^^xsd:anyURI ] ;
fhir:value [
fhir:v "http://hl7.org/fhir/us/spl/ImplementationGuide/hl7.fhir.us.spl"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/us/spl/ImplementationGuide/hl7.fhir.us.spl>         ]       ] )     ]
  ] ) ; # 
  fhir:url [ fhir:v "http://hl7.org/fhir/us/spl/ValueSet/valueset-splMarketingCategories"^^xsd:anyURI] ; # 
  fhir:version [ fhir:v "0.2.1"] ; # 
  fhir:name [ fhir:v "SPLMarketingCategories"] ; # 
  fhir:title [ fhir:v "SPL Marketing Categories"] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:experimental [ fhir:v "false"^^xsd:boolean] ; # 
  fhir:date [ fhir:v "2024-12-10T07:56:13+00:00"^^xsd:dateTime] ; # 
  fhir:publisher [ fhir:v "HL7 International / Biomedical Research and Regulation"] ; # 
  fhir:contact ( [
fhir:name [ fhir:v "HL7 International / Biomedical Research and Regulation" ] ;
    ( fhir:telecom [
fhir:system [ fhir:v "url" ] ;
fhir:value [ fhir:v "http://www.hl7.org/Special/committees/rcrim" ]     ] )
  ] ) ; # 
  fhir:description [ fhir:v "Codes from NCI Thesaurus for SPL Marketing Categories (C43164 Subset)"] ; # 
  fhir:jurisdiction ( [
    ( fhir:coding [
fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ] ;
fhir:code [ fhir:v "US" ] ;
fhir:display [ fhir:v "United States of America" ]     ] )
  ] ) ; # 
  fhir:compose [
    ( fhir:include [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
      ( fhir:concept [
fhir:code [ fhir:v "C101533" ] ;
fhir:display [ fhir:v "UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE" ]       ] [
fhir:code [ fhir:v "C117717" ] ;
fhir:display [ fhir:v "Master File" ]       ] [
fhir:code [ fhir:v "C132333" ] ;
fhir:display [ fhir:v "Approved Drug Product Manufactured Under Contract" ]       ] [
fhir:code [ fhir:v "C132334" ] ;
fhir:display [ fhir:v "OTC Monograph Drug Product Manufactured Under Contract" ]       ] [
fhir:code [ fhir:v "C132335" ] ;
fhir:display [ fhir:v "Unapproved Drug Product Manufactured Under Contract" ]       ] [
fhir:code [ fhir:v "C175238" ] ;
fhir:display [ fhir:v "Multi-Market Approved Product" ]       ] [
fhir:code [ fhir:v "C175462" ] ;
fhir:display [ fhir:v "SIP Approved Drug" ]       ] [
fhir:code [ fhir:v "C181659" ] ;
fhir:display [ fhir:v "Outsourcing Facility Compounded Human Drug Product (Exempt From Approval Requirements)" ]       ] [
fhir:code [ fhir:v "C190698" ] ;
fhir:display [ fhir:v "Outsourcing Facility Compounded Human Drug Product (Not Marketed - Not Distributed)" ]       ] [
fhir:code [ fhir:v "C200263" ] ;
fhir:display [ fhir:v "OTC Monograph Drug" ]       ] [
fhir:code [ fhir:v "C73583" ] ;
fhir:display [ fhir:v "ANADA" ]       ] [
fhir:code [ fhir:v "C73584" ] ;
fhir:display [ fhir:v "ANDA" ]       ] [
fhir:code [ fhir:v "C73585" ] ;
fhir:display [ fhir:v "BLA" ]       ] [
fhir:code [ fhir:v "C73586" ] ;
fhir:display [ fhir:v "BULK ACTIVE INGREDIENT" ]       ] [
fhir:code [ fhir:v "C73587" ] ;
fhir:display [ fhir:v "BULK INACTIVE INGREDIENT" ]       ] [
fhir:code [ fhir:v "C73588" ] ;
fhir:display [ fhir:v "CONDITIONAL NADA" ]       ] [
fhir:code [ fhir:v "C73590" ] ;
fhir:display [ fhir:v "EXPORT ONLY" ]       ] [
fhir:code [ fhir:v "C73593" ] ;
fhir:display [ fhir:v "NADA" ]       ] [
fhir:code [ fhir:v "C73594" ] ;
fhir:display [ fhir:v "NDA" ]       ] [
fhir:code [ fhir:v "C73605" ] ;
fhir:display [ fhir:v "NDA AUTHORIZED GENERIC" ]       ] [
fhir:code [ fhir:v "C73613" ] ;
fhir:display [ fhir:v "UNAPPROVED MEDICAL GAS" ]       ] [
fhir:code [ fhir:v "C73614" ] ;
fhir:display [ fhir:v "UNAPPROVED HOMEOPATHIC" ]       ] [
fhir:code [ fhir:v "C73615" ] ;
fhir:display [ fhir:v "UNAPPROVED VITAMIN DRUG" ]       ] [
fhir:code [ fhir:v "C73626" ] ;
fhir:display [ fhir:v "BULK INGREDIENT" ]       ] [
fhir:code [ fhir:v "C73627" ] ;
fhir:display [ fhir:v "UNAPPROVED DRUG OTHER MARKETING CATEGORY" ]       ] [
fhir:code [ fhir:v "C75302" ] ;
fhir:display [ fhir:v "IND" ]       ] [
fhir:code [ fhir:v "C80438" ] ;
fhir:display [ fhir:v "EXEMPT DEVICE" ]       ] [
fhir:code [ fhir:v "C80440" ] ;
fhir:display [ fhir:v "HUMANITARIAN DEVICE EXEMPTION" ]       ] [
fhir:code [ fhir:v "C80441" ] ;
fhir:display [ fhir:v "PREMARKET APPLICATION" ]       ] [
fhir:code [ fhir:v "C80442" ] ;
fhir:display [ fhir:v "PREMARKET NOTIFICATION" ]       ] [
fhir:code [ fhir:v "C86952" ] ;
fhir:display [ fhir:v "DIETARY SUPPLEMENT" ]       ] [
fhir:code [ fhir:v "C86964" ] ;
fhir:display [ fhir:v "MEDICAL FOOD" ]       ] [
fhir:code [ fhir:v "C86965" ] ;
fhir:display [ fhir:v "COSMETIC" ]       ] [
fhir:code [ fhir:v "C92556" ] ;
fhir:display [ fhir:v "LEGALLY MARKETED UNAPPROVED NEW ANIMAL DRUGS FOR MINOR SPECIES" ]       ] [
fhir:code [ fhir:v "C94795" ] ;
fhir:display [ fhir:v "DRUG FOR FURTHER PROCESSING" ]       ] [
fhir:code [ fhir:v "C95600" ] ;
fhir:display [ fhir:v "APPROVED DRUG PRODUCT MANUFACTURED EXCLUSIVELY FOR PRIVATE LABEL DISTRIBUTOR" ]       ] [
fhir:code [ fhir:v "C95601" ] ;
fhir:display [ fhir:v "OTC MONOGRAPH DRUG PRODUCT MANUFACTURED EXCLUSIVELY FOR PRIVATE LABEL DISTRIBUTOR" ]       ] [
fhir:code [ fhir:v "C95602" ] ;
fhir:display [ fhir:v "UNAPPROVED DRUG PRODUCT MANUFACTURED EXCLUSIVELY FOR PRIVATE LABEL DISTRIBUTOR" ]       ] [
fhir:code [ fhir:v "C96793" ] ;
fhir:display [ fhir:v "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING" ]       ] [
fhir:code [ fhir:v "C96794" ] ;
fhir:display [ fhir:v "BULK INGREDIENT FOR ANIMAL PRESCRIPTION COMPOUNDING" ]       ] [
fhir:code [ fhir:v "C96966" ] ;
fhir:display [ fhir:v "Emergency Use Authorization" ]       ] [
fhir:code [ fhir:v "C98252" ] ;
fhir:display [ fhir:v "BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING" ]       ] )     ] )
  ] . #