SPL Mapping FHIR R5 Implementation Guide
0.2.1 - Build CI
SPL Mapping FHIR R5 Implementation Guide
0.2.1 - Build CI
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
| Page standards status: Trial-use | Maturity Level: 1 |
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<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>
</text>
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<url
value="http://hl7.org/fhir/us/spl/ValueSet/valueset-splMarketingCategories"/>
<version value="0.2.1"/>
<name value="SPLMarketingCategories"/>
<title value="SPL Marketing Categories"/>
<status value="active"/>
<experimental value="false"/>
<date value="2024-12-10T07:56:13+00:00"/>
<publisher value="HL7 International / Biomedical Research and Regulation"/>
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<description
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<display value="United States of America"/>
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<compose>
<include>
<system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<concept>
<code value="C101533"/>
<display value="UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE"/>
</concept>
<concept>
<code value="C117717"/>
<display value="Master File"/>
</concept>
<concept>
<code value="C132333"/>
<display value="Approved Drug Product Manufactured Under Contract"/>
</concept>
<concept>
<code value="C132334"/>
<display
value="OTC Monograph Drug Product Manufactured Under Contract"/>
</concept>
<concept>
<code value="C132335"/>
<display value="Unapproved Drug Product Manufactured Under Contract"/>
</concept>
<concept>
<code value="C175238"/>
<display value="Multi-Market Approved Product"/>
</concept>
<concept>
<code value="C175462"/>
<display value="SIP Approved Drug"/>
</concept>
<concept>
<code value="C181659"/>
<display
value="Outsourcing Facility Compounded Human Drug Product (Exempt From Approval Requirements)"/>
</concept>
<concept>
<code value="C190698"/>
<display
value="Outsourcing Facility Compounded Human Drug Product (Not Marketed - Not Distributed)"/>
</concept>
<concept>
<code value="C200263"/>
<display value="OTC Monograph Drug"/>
</concept>
<concept>
<code value="C73583"/>
<display value="ANADA"/>
</concept>
<concept>
<code value="C73584"/>
<display value="ANDA"/>
</concept>
<concept>
<code value="C73585"/>
<display value="BLA"/>
</concept>
<concept>
<code value="C73586"/>
<display value="BULK ACTIVE INGREDIENT"/>
</concept>
<concept>
<code value="C73587"/>
<display value="BULK INACTIVE INGREDIENT"/>
</concept>
<concept>
<code value="C73588"/>
<display value="CONDITIONAL NADA"/>
</concept>
<concept>
<code value="C73590"/>
<display value="EXPORT ONLY"/>
</concept>
<concept>
<code value="C73593"/>
<display value="NADA"/>
</concept>
<concept>
<code value="C73594"/>
<display value="NDA"/>
</concept>
<concept>
<code value="C73605"/>
<display value="NDA AUTHORIZED GENERIC"/>
</concept>
<concept>
<code value="C73613"/>
<display value="UNAPPROVED MEDICAL GAS"/>
</concept>
<concept>
<code value="C73614"/>
<display value="UNAPPROVED HOMEOPATHIC"/>
</concept>
<concept>
<code value="C73615"/>
<display value="UNAPPROVED VITAMIN DRUG"/>
</concept>
<concept>
<code value="C73626"/>
<display value="BULK INGREDIENT"/>
</concept>
<concept>
<code value="C73627"/>
<display value="UNAPPROVED DRUG OTHER MARKETING CATEGORY"/>
</concept>
<concept>
<code value="C75302"/>
<display value="IND"/>
</concept>
<concept>
<code value="C80438"/>
<display value="EXEMPT DEVICE"/>
</concept>
<concept>
<code value="C80440"/>
<display value="HUMANITARIAN DEVICE EXEMPTION"/>
</concept>
<concept>
<code value="C80441"/>
<display value="PREMARKET APPLICATION"/>
</concept>
<concept>
<code value="C80442"/>
<display value="PREMARKET NOTIFICATION"/>
</concept>
<concept>
<code value="C86952"/>
<display value="DIETARY SUPPLEMENT"/>
</concept>
<concept>
<code value="C86964"/>
<display value="MEDICAL FOOD"/>
</concept>
<concept>
<code value="C86965"/>
<display value="COSMETIC"/>
</concept>
<concept>
<code value="C92556"/>
<display
value="LEGALLY MARKETED UNAPPROVED NEW ANIMAL DRUGS FOR MINOR SPECIES"/>
</concept>
<concept>
<code value="C94795"/>
<display value="DRUG FOR FURTHER PROCESSING"/>
</concept>
<concept>
<code value="C95600"/>
<display
value="APPROVED DRUG PRODUCT MANUFACTURED EXCLUSIVELY FOR PRIVATE LABEL DISTRIBUTOR"/>
</concept>
<concept>
<code value="C95601"/>
<display
value="OTC MONOGRAPH DRUG PRODUCT MANUFACTURED EXCLUSIVELY FOR PRIVATE LABEL DISTRIBUTOR"/>
</concept>
<concept>
<code value="C95602"/>
<display
value="UNAPPROVED DRUG PRODUCT MANUFACTURED EXCLUSIVELY FOR PRIVATE LABEL DISTRIBUTOR"/>
</concept>
<concept>
<code value="C96793"/>
<display value="BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING"/>
</concept>
<concept>
<code value="C96794"/>
<display value="BULK INGREDIENT FOR ANIMAL PRESCRIPTION COMPOUNDING"/>
</concept>
<concept>
<code value="C96966"/>
<display value="Emergency Use Authorization"/>
</concept>
<concept>
<code value="C98252"/>
<display value="BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING"/>
</concept>
</include>
</compose>
</ValueSet>
IG © 2020+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.spl#0.2.1 based on FHIR 5.0.0. Generated 2024-12-10
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