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 - JSON Representation

Page standards status: Trial-use Maturity Level: 1

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{
  "resourceType" : "ValueSet",
  "id" : "valueset-splMarketingCategories",
  "text" : {
    "status" : "generated",
    "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>"
  },
  "extension" : [
    {
      "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
      "valueCode" : "brr"
    },
    {
      "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
      "valueInteger" : 1,
      "_valueInteger" : {
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
            "valueCanonical" : "http://hl7.org/fhir/us/spl/ImplementationGuide/hl7.fhir.us.spl"
          }
        ]
      }
    },
    {
      "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
      "valueCode" : "trial-use",
      "_valueCode" : {
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
            "valueCanonical" : "http://hl7.org/fhir/us/spl/ImplementationGuide/hl7.fhir.us.spl"
          }
        ]
      }
    }
  ],
  "url" : "http://hl7.org/fhir/us/spl/ValueSet/valueset-splMarketingCategories",
  "version" : "0.2.1",
  "name" : "SPLMarketingCategories",
  "title" : "SPL Marketing Categories",
  "status" : "active",
  "experimental" : false,
  "date" : "2024-12-10T07:56:13+00:00",
  "publisher" : "HL7 International / Biomedical Research and Regulation",
  "contact" : [
    {
      "name" : "HL7 International / Biomedical Research and Regulation",
      "telecom" : [
        {
          "system" : "url",
          "value" : "http://www.hl7.org/Special/committees/rcrim"
        }
      ]
    }
  ],
  "description" : "Codes from NCI Thesaurus for SPL Marketing Categories (C43164 Subset)",
  "jurisdiction" : [
    {
      "coding" : [
        {
          "system" : "urn:iso:std:iso:3166",
          "code" : "US",
          "display" : "United States of America"
        }
      ]
    }
  ],
  "compose" : {
    "include" : [
      {
        "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
        "concept" : [
          {
            "code" : "C101533",
            "display" : "UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE"
          },
          {
            "code" : "C117717",
            "display" : "Master File"
          },
          {
            "code" : "C132333",
            "display" : "Approved Drug Product Manufactured Under Contract"
          },
          {
            "code" : "C132334",
            "display" : "OTC Monograph Drug Product Manufactured Under Contract"
          },
          {
            "code" : "C132335",
            "display" : "Unapproved Drug Product Manufactured Under Contract"
          },
          {
            "code" : "C175238",
            "display" : "Multi-Market Approved Product"
          },
          {
            "code" : "C175462",
            "display" : "SIP Approved Drug"
          },
          {
            "code" : "C181659",
            "display" : "Outsourcing Facility Compounded Human Drug Product (Exempt From Approval Requirements)"
          },
          {
            "code" : "C190698",
            "display" : "Outsourcing Facility Compounded Human Drug Product (Not Marketed - Not Distributed)"
          },
          {
            "code" : "C200263",
            "display" : "OTC Monograph Drug"
          },
          {
            "code" : "C73583",
            "display" : "ANADA"
          },
          {
            "code" : "C73584",
            "display" : "ANDA"
          },
          {
            "code" : "C73585",
            "display" : "BLA"
          },
          {
            "code" : "C73586",
            "display" : "BULK ACTIVE INGREDIENT"
          },
          {
            "code" : "C73587",
            "display" : "BULK INACTIVE INGREDIENT"
          },
          {
            "code" : "C73588",
            "display" : "CONDITIONAL NADA"
          },
          {
            "code" : "C73590",
            "display" : "EXPORT ONLY"
          },
          {
            "code" : "C73593",
            "display" : "NADA"
          },
          {
            "code" : "C73594",
            "display" : "NDA"
          },
          {
            "code" : "C73605",
            "display" : "NDA AUTHORIZED GENERIC"
          },
          {
            "code" : "C73613",
            "display" : "UNAPPROVED MEDICAL GAS"
          },
          {
            "code" : "C73614",
            "display" : "UNAPPROVED HOMEOPATHIC"
          },
          {
            "code" : "C73615",
            "display" : "UNAPPROVED VITAMIN DRUG"
          },
          {
            "code" : "C73626",
            "display" : "BULK INGREDIENT"
          },
          {
            "code" : "C73627",
            "display" : "UNAPPROVED DRUG OTHER MARKETING CATEGORY"
          },
          {
            "code" : "C75302",
            "display" : "IND"
          },
          {
            "code" : "C80438",
            "display" : "EXEMPT DEVICE"
          },
          {
            "code" : "C80440",
            "display" : "HUMANITARIAN DEVICE EXEMPTION"
          },
          {
            "code" : "C80441",
            "display" : "PREMARKET APPLICATION"
          },
          {
            "code" : "C80442",
            "display" : "PREMARKET NOTIFICATION"
          },
          {
            "code" : "C86952",
            "display" : "DIETARY SUPPLEMENT"
          },
          {
            "code" : "C86964",
            "display" : "MEDICAL FOOD"
          },
          {
            "code" : "C86965",
            "display" : "COSMETIC"
          },
          {
            "code" : "C92556",
            "display" : "LEGALLY MARKETED UNAPPROVED NEW ANIMAL DRUGS FOR MINOR SPECIES"
          },
          {
            "code" : "C94795",
            "display" : "DRUG FOR FURTHER PROCESSING"
          },
          {
            "code" : "C95600",
            "display" : "APPROVED DRUG PRODUCT MANUFACTURED EXCLUSIVELY FOR PRIVATE LABEL DISTRIBUTOR"
          },
          {
            "code" : "C95601",
            "display" : "OTC MONOGRAPH DRUG PRODUCT MANUFACTURED EXCLUSIVELY FOR PRIVATE LABEL DISTRIBUTOR"
          },
          {
            "code" : "C95602",
            "display" : "UNAPPROVED DRUG PRODUCT MANUFACTURED EXCLUSIVELY FOR PRIVATE LABEL DISTRIBUTOR"
          },
          {
            "code" : "C96793",
            "display" : "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING"
          },
          {
            "code" : "C96794",
            "display" : "BULK INGREDIENT FOR ANIMAL PRESCRIPTION COMPOUNDING"
          },
          {
            "code" : "C96966",
            "display" : "Emergency Use Authorization"
          },
          {
            "code" : "C98252",
            "display" : "BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING"
          }
        ]
      }
    ]
  }
}