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FHIR IG Statistics: ValueSet/splSectionCodes

Packagehl7.fhir.us.spl
TypeValueSet
IdsplSectionCodes
FHIR VersionR5
Sourcehttp://hl7.org/fhir/us/spl/https://build.fhir.org/ig/HL7/fhir-spl/ValueSet-splSectionCodes.html
URLhttp://hl7.org/fhir/us/spl/ValueSet/splSectionCodes
Version0.2.8
Statusactive
Date2025-07-07T15:17:39+00:00
NameSPLSectionCodes
TitleSPL Section Codes
Realmus
Authorityhl7
DescriptionSection Codes for SPL Product Submission documents
CopyrightThis material contains content from LOINC (http://loinc.org). LOINC is copyright © 1995-2020, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license at http://loinc.org/license. LOINC® is a registered United States trademark of Regenstrief Institute, Inc.

Resources that use this resource

StructureDefinition
ProductSubmissionDocumentProductSubmissionDocument

Resources that this resource uses

CodeSystem
loinc.orgLOINC Code System
loinc.orgLOINC codes used in this IG
loinc.orgLogical Observation Identifiers, Names and Codes (LOINC)

Narrative

Note: links and images are rebased to the (stated) source

Generated Narrative: ValueSet splSectionCodes


Source

{
  "resourceType": "ValueSet",
  "id": "splSectionCodes",
  "text": {
    "status": "generated",
    "div": "<!-- snip (see above) -->"
  },
  "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/splSectionCodes",
  "version": "0.2.8",
  "name": "SPLSectionCodes",
  "title": "SPL Section Codes",
  "status": "active",
  "experimental": false,
  "date": "2025-07-07T15:17:39+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": "Section Codes for SPL Product Submission documents",
  "jurisdiction": [
    {
      "coding": [
        {
          "system": "urn:iso:std:iso:3166",
          "code": "US",
          "display": "United States of America"
        }
      ]
    }
  ],
  "copyright": "This material contains content from LOINC (http://loinc.org). LOINC is copyright © 1995-2020, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license at http://loinc.org/license. LOINC® is a registered United States trademark of Regenstrief Institute, Inc.",
  "compose": {
    "include": [
      {
        "system": "http://loinc.org",
        "concept": [
          {
            "code": "34086-9",
            "display": "ABUSE SECTION"
          },
          {
            "code": "60555-0",
            "display": "ACCESSORIES"
          },
          {
            "code": "34084-4",
            "display": "ADVERSE REACTIONS SECTION"
          },
          {
            "code": "69761-5",
            "display": "ALARMS"
          },
          {
            "code": "34091-9",
            "display": "ANIMAL PHARMACOLOGY & OR TOXICOLOGY SECTION"
          },
          {
            "code": "60556-8",
            "display": "ASSEMBLY OR INSTALLATION INSTRUCTIONS"
          },
          {
            "code": "34066-1",
            "display": "BOXED WARNING SECTION"
          },
          {
            "code": "60557-6",
            "display": "CALIBRATION INSTRUCTIONS"
          },
          {
            "code": "34083-6",
            "display": "CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION"
          },
          {
            "code": "34090-1",
            "display": "CLINICAL PHARMACOLOGY SECTION"
          },
          {
            "code": "60558-4",
            "display": "CLEANING, DISINFECTING, AND STERILIZATION INSTRUCTIONS"
          },
          {
            "code": "34092-7",
            "display": "CLINICAL STUDIES SECTION"
          },
          {
            "code": "90374-0",
            "display": "CLINICAL TRIALS EXPERIENCE SECTION"
          },
          {
            "code": "69760-7",
            "display": "COMPATIBLE ACCESSORIES"
          },
          {
            "code": "60559-2",
            "display": "COMPONENTS"
          },
          {
            "code": "34070-3",
            "display": "CONTRAINDICATIONS SECTION"
          },
          {
            "code": "34085-1",
            "display": "CONTROLLED SUBSTANCE SECTION"
          },
          {
            "code": "34087-7",
            "display": "DEPENDENCE SECTION"
          },
          {
            "code": "34089-3",
            "display": "DESCRIPTION SECTION"
          },
          {
            "code": "69758-1",
            "display": "DIAGRAM OF DEVICE"
          },
          {
            "code": "69763-1",
            "display": "DISPOSAL AND WASTE HANDLING"
          },
          {
            "code": "34068-7",
            "display": "DOSAGE & ADMINISTRATION SECTION"
          },
          {
            "code": "43678-2",
            "display": "DOSAGE FORMS & STRENGTHS SECTION"
          },
          {
            "code": "34074-5",
            "display": "DRUG & OR LABORATORY TEST INTERACTIONS SECTION"
          },
          {
            "code": "42227-9",
            "display": "DRUG ABUSE AND DEPENDENCE SECTION"
          },
          {
            "code": "34073-7",
            "display": "DRUG INTERACTIONS SECTION"
          },
          {
            "code": "50742-6",
            "display": "ENVIRONMENTAL WARNING SECTION"
          },
          {
            "code": "77291-3",
            "display": "FEMALES & MALES OF REPRODUCTIVE POTENTIAL SECTION"
          },
          {
            "code": "50743-4",
            "display": "FOOD SAFETY WARNING SECTION"
          },
          {
            "code": "34072-9",
            "display": "GENERAL PRECAUTIONS SECTION"
          },
          {
            "code": "34082-8",
            "display": "GERIATRIC USE SECTION"
          },
          {
            "code": "50740-0",
            "display": "GUARANTEED ANALYSIS OF FEED SECTION"
          },
          {
            "code": "71744-7",
            "display": "HEALTH CARE PROVIDER LETTER SECTION"
          },
          {
            "code": "69719-3",
            "display": "HEALTH CLAIM SECTION"
          },
          {
            "code": "88829-7",
            "display": "HEPATIC IMPAIRMENT SUBSECTION"
          },
          {
            "code": "34069-5",
            "display": "HOW SUPPLIED SECTION"
          },
          {
            "code": "88830-5",
            "display": "IMMUNOGENICITY"
          },
          {
            "code": "51727-6",
            "display": "INACTIVE INGREDIENT SECTION"
          },
          {
            "code": "34067-9",
            "display": "INDICATIONS & USAGE SECTION"
          },
          {
            "code": "50744-2",
            "display": "INFORMATION FOR OWNERS/CAREGIVERS SECTION"
          },
          {
            "code": "34076-0",
            "display": "INFORMATION FOR PATIENTS SECTION"
          },
          {
            "code": "59845-8",
            "display": "INSTRUCTIONS FOR USE SECTION"
          },
          {
            "code": "60560-0",
            "display": "INTENDED USE OF THE DEVICE"
          },
          {
            "code": "34079-4",
            "display": "LABOR & DELIVERY SECTION"
          },
          {
            "code": "34075-2",
            "display": "LABORATORY TESTS SECTION"
          },
          {
            "code": "77290-5",
            "display": "LACTATION SECTION"
          },
          {
            "code": "43679-0",
            "display": "MECHANISM OF ACTION SECTION"
          },
          {
            "code": "49489-8",
            "display": "MICROBIOLOGY SECTION"
          },
          {
            "code": "43680-8",
            "display": "NONCLINICAL TOXICOLOGY SECTION"
          },
          {
            "code": "34078-6",
            "display": "NONTERATOGENIC EFFECTS SECTION"
          },
          {
            "code": "34080-2",
            "display": "NURSING MOTHERS SECTION"
          },
          {
            "code": "60561-8",
            "display": "OTHER SAFETY INFORMATION"
          },
          {
            "code": "34088-5",
            "display": "OVERDOSAGE SECTION"
          },
          {
            "code": "55106-9",
            "display": "OTC - ACTIVE INGREDIENT SECTION"
          },
          {
            "code": "50569-3",
            "display": "OTC - ASK DOCTOR SECTION"
          },
          {
            "code": "50568-5",
            "display": "OTC - ASK DOCTOR/PHARMACIST SECTION"
          },
          {
            "code": "50570-1",
            "display": "OTC - DO NOT USE SECTION"
          },
          {
            "code": "50565-1",
            "display": "OTC - KEEP OUT OF REACH OF CHILDREN SECTION"
          },
          {
            "code": "53414-9",
            "display": "OTC - PREGNANCY OR BREAST FEEDING SECTION"
          },
          {
            "code": "55105-1",
            "display": "OTC - PURPOSE SECTION"
          },
          {
            "code": "53413-1",
            "display": "OTC - QUESTIONS SECTION"
          },
          {
            "code": "50566-9",
            "display": "OTC - STOP USE SECTION"
          },
          {
            "code": "50567-7",
            "display": "OTC - WHEN USING SECTION"
          },
          {
            "code": "51945-4",
            "display": "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"
          },
          {
            "code": "88436-1",
            "display": "PATIENT COUNSELING INFORMATION"
          },
          {
            "code": "68498-5",
            "display": "PATIENT MEDICATION INFORMATION SECTION"
          },
          {
            "code": "34081-0",
            "display": "PEDIATRIC USE SECTION"
          },
          {
            "code": "43681-6",
            "display": "PHARMACODYNAMICS SECTION"
          },
          {
            "code": "66106-6",
            "display": "PHARMACOGENOMICS SECTION"
          },
          {
            "code": "43682-4",
            "display": "PHARMACOKINETICS SECTION"
          },
          {
            "code": "90375-7",
            "display": "POSTMARKETING EXPERIENCE SECTION"
          },
          {
            "code": "42232-9",
            "display": "PRECAUTIONS SECTION"
          },
          {
            "code": "42228-7",
            "display": "PREGNANCY SECTION"
          },
          {
            "code": "43683-2",
            "display": "RECENT MAJOR CHANGES SECTION"
          },
          {
            "code": "34093-5",
            "display": "REFERENCES SECTION"
          },
          {
            "code": "53412-3",
            "display": "RESIDUE WARNING SECTION"
          },
          {
            "code": "100382-1",
            "display": "REMS ADDRESSED RISK"
          },
          {
            "code": "87523-7",
            "display": "REMS ADMINISTRATIVE INFORMATION"
          },
          {
            "code": "87526-0",
            "display": "REMS APPLICANT REQUIREMENTS"
          },
          {
            "code": "82344-3",
            "display": "REMS COMMUNICATION"
          },
          {
            "code": "82348-4",
            "display": "REMS ELEMENTS"
          },
          {
            "code": "82345-0",
            "display": "REMS ELEMENTS TO ASSURE SAFE USE"
          },
          {
            "code": "82349-2",
            "display": "REMS GOALS"
          },
          {
            "code": "82350-0",
            "display": "REMS IMPLEMENTATION SYSTEM"
          },
          {
            "code": "82346-8",
            "display": "REMS MATERIAL"
          },
          {
            "code": "82598-4",
            "display": "REMS MEDICATION GUIDE"
          },
          {
            "code": "87525-2",
            "display": "REMS PARTICIPANT REQUIREMENTS"
          },
          {
            "code": "87524-5",
            "display": "REMS REQUIREMENTS"
          },
          {
            "code": "82347-6",
            "display": "REMS SUMMARY"
          },
          {
            "code": "82352-6",
            "display": "REMS TIMETABLE FOR SUBMISSION ASSESSMENTS"
          },
          {
            "code": "88828-9",
            "display": "RENAL IMPAIRMENT SUBSECTION"
          },
          {
            "code": "69759-9",
            "display": "RISKS"
          },
          {
            "code": "60562-6",
            "display": "ROUTE, METHOD AND FREQUENCY OF ADMINISTRATION"
          },
          {
            "code": "50741-8",
            "display": "SAFE HANDLING WARNING SECTION"
          },
          {
            "code": "48779-3",
            "display": "SPL INDEXING DATA ELEMENTS SECTION"
          },
          {
            "code": "48780-1",
            "display": "SPL PRODUCT DATA ELEMENTS SECTION"
          },
          {
            "code": "42231-1",
            "display": "SPL MEDGUIDE SECTION"
          },
          {
            "code": "42230-3",
            "display": "SPL PATIENT PACKAGE INSERT SECTION"
          },
          {
            "code": "42229-5",
            "display": "SPL UNCLASSIFIED SECTION"
          },
          {
            "code": "69718-5",
            "display": "STATEMENT OF IDENTITY SECTION"
          },
          {
            "code": "44425-7",
            "display": "STORAGE AND HANDLING SECTION"
          },
          {
            "code": "60563-4",
            "display": "SUMMARY OF SAFETY AND EFFECTIVENESS"
          },
          {
            "code": "34077-8",
            "display": "TERATOGENIC EFFECTS SECTION"
          },
          {
            "code": "69762-3",
            "display": "TROUBLESHOOTING"
          },
          {
            "code": "43684-0",
            "display": "USE IN SPECIFIC POPULATIONS SECTION"
          },
          {
            "code": "54433-8",
            "display": "USER SAFETY WARNINGS SECTION"
          },
          {
            "code": "50745-9",
            "display": "VETERINARY INDICATIONS SECTION"
          },
          {
            "code": "43685-7",
            "display": "WARNINGS AND PRECAUTIONS SECTION"
          },
          {
            "code": "34071-1",
            "display": "WARNINGS SECTION"
          }
        ]
      }
    ]
  }
}