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 |
{
"resourceType" : "ValueSet",
"id" : "splDocumentCodes",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: ValueSet splDocumentCodes</b></p><a name=\"splDocumentCodes\"> </a><a name=\"hcsplDocumentCodes\"> </a><a name=\"splDocumentCodes-en-US\"> </a><ul><li>Include these codes as defined in <a href=\"http://loinc.org\"><code>http://loinc.org</code></a><table class=\"none\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td></tr><tr><td><a href=\"https://loinc.org/98075-5/\">98075-5</a></td><td>ANIMAL CELLS, TISSUES, AND CELL AND TISSUE BASED PRODUCT LABEL</td></tr><tr><td><a href=\"https://loinc.org/77647-6/\">77647-6</a></td><td>ANIMAL COMPOUNDED DRUG LABEL</td></tr><tr><td><a href=\"https://loinc.org/104091-4/\">104091-4</a></td><td>ANIMAL DRUG FOR FURTHER PROCESSING</td></tr><tr><td><a href=\"https://loinc.org/86445-4/\">86445-4</a></td><td>BLANKET NO CHANGES CERTIFICATION OF PRODUCT LISTING</td></tr><tr><td><a href=\"https://loinc.org/53409-9/\">53409-9</a></td><td>BULK INGREDIENT</td></tr><tr><td><a href=\"https://loinc.org/81203-2/\">81203-2</a></td><td>BULK INGREDIENT - ANIMAL DRUG</td></tr><tr><td><a href=\"https://loinc.org/60684-8/\">60684-8</a></td><td>CELLULAR THERAPY</td></tr><tr><td><a href=\"https://loinc.org/58474-8/\">58474-8</a></td><td>COSMETIC</td></tr><tr><td><a href=\"https://loinc.org/103573-2/\">103573-2</a></td><td>COSMETIC FACILITY REGISTRATION</td></tr><tr><td><a href=\"https://loinc.org/104087-2/\">104087-2</a></td><td>COSMETIC FACILITY REGISTRATION-ABBREVIATED RENEWAL</td></tr><tr><td><a href=\"https://loinc.org/104086-4/\">104086-4</a></td><td>COSMETIC FACILITY REGISTRATION-AMENDMENT</td></tr><tr><td><a href=\"https://loinc.org/104089-8/\">104089-8</a></td><td>COSMETIC FACILITY REGISTRATION-BIENNIAL RENEWAL</td></tr><tr><td><a href=\"https://loinc.org/104088-0/\">104088-0</a></td><td>COSMETIC FACILITY REGISTRATION-CANCELLATION</td></tr><tr><td><a href=\"https://loinc.org/103572-4/\">103572-4</a></td><td>COSMETIC PRODUCT LISTING</td></tr><tr><td><a href=\"https://loinc.org/105122-6/\">105122-6</a></td><td>COSMETIC UPDATE</td></tr><tr><td><a href=\"https://loinc.org/104090-6/\">104090-6</a></td><td>COSMETIC-ABBREVIATED RENEWAL</td></tr><tr><td><a href=\"https://loinc.org/58476-3/\">58476-3</a></td><td>DIETARY SUPPLEMENT</td></tr><tr><td><a href=\"https://loinc.org/78744-0/\">78744-0</a></td><td>DRUG FOR FURTHER PROCESSING</td></tr><tr><td><a href=\"https://loinc.org/70097-1/\">70097-1</a></td><td>ESTABLISHMENT DE-REGISTRATION</td></tr><tr><td><a href=\"https://loinc.org/51725-0/\">51725-0</a></td><td>ESTABLISHMENT REGISTRATION</td></tr><tr><td><a href=\"https://loinc.org/89600-1/\">89600-1</a></td><td>FDA-INITIATED COMPLIANCE ACTION DRUG REGISTRATION AND DRUG LISTING INACTIVATION</td></tr><tr><td><a href=\"https://loinc.org/99282-6/\">99282-6</a></td><td>FDA-INITIATED COMPLIANCE ACTION DRUG REGISTRATION AND DRUG LISTING INACTIVATION - ANIMAL DRUG</td></tr><tr><td><a href=\"https://loinc.org/71743-9/\">71743-9</a></td><td>GENERIC DRUG FACILITY IDENTIFICATION SUBMISSION</td></tr><tr><td><a href=\"https://loinc.org/75031-5/\">75031-5</a></td><td>HUMAN COMPOUNDED DRUG LABEL</td></tr><tr><td><a href=\"https://loinc.org/34390-5/\">34390-5</a></td><td>HUMAN OTC DRUG LABEL</td></tr><tr><td><a href=\"https://loinc.org/34391-3/\">34391-3</a></td><td>HUMAN PRESCRIPTION DRUG LABEL</td></tr><tr><td><a href=\"https://loinc.org/72090-4/\">72090-4</a></td><td>IDENTIFICATION OF CBER-REGULATED GENERIC DRUG FACILITY</td></tr><tr><td><a href=\"https://loinc.org/71446-9/\">71446-9</a></td><td>INDEXING - BILLING UNIT</td></tr><tr><td><a href=\"https://loinc.org/77648-4/\">77648-4</a></td><td>INDEXING - BIOLOGICAL DRUG SUBSTANCE</td></tr><tr><td><a href=\"https://loinc.org/93723-5/\">93723-5</a></td><td>INDEXING - DRUG INTERACTIONS</td></tr><tr><td><a href=\"https://loinc.org/63417-0/\">63417-0</a></td><td>INDEXING - INDICATION</td></tr><tr><td><a href=\"https://loinc.org/93372-1/\">93372-1</a></td><td>INDEXING - NATIONAL CLINICAL TRIALS NUMBER</td></tr><tr><td><a href=\"https://loinc.org/60685-5/\">60685-5</a></td><td>INDEXING - PHARMACOLOGIC CLASS</td></tr><tr><td><a href=\"https://loinc.org/73815-3/\">73815-3</a></td><td>INDEXING - PRODUCT CONCEPT</td></tr><tr><td><a href=\"https://loinc.org/82353-4/\">82353-4</a></td><td>INDEXING - RISK EVALUATION & MITIGATION STRATEGIES</td></tr><tr><td><a href=\"https://loinc.org/64124-1/\">64124-1</a></td><td>INDEXING\u00a0- SUBSTANCE</td></tr><tr><td><a href=\"https://loinc.org/77288-9/\">77288-9</a></td><td>INDEXING - WARNING LETTER ALERT</td></tr><tr><td><a href=\"https://loinc.org/101437-2/\">101437-2</a></td><td>INTENTIONAL ANIMAL GENOMIC ALTERATION LABEL</td></tr><tr><td><a href=\"https://loinc.org/53407-3/\">53407-3</a></td><td>LICENSE BLOOD INTERMEDIATES/PASTE LABEL</td></tr><tr><td><a href=\"https://loinc.org/53408-1/\">53408-1</a></td><td>LICENSED MINIMALLY MANIPULATED CELLS LABEL</td></tr><tr><td><a href=\"https://loinc.org/53406-5/\">53406-5</a></td><td>LICENSED VACCINE BULK INTERMEDIATE LABEL</td></tr><tr><td><a href=\"https://loinc.org/66105-8/\">66105-8</a></td><td>LOT DISTRIBUTION DATA</td></tr><tr><td><a href=\"https://loinc.org/55439-4/\">55439-4</a></td><td>MEDICAL DEVICE</td></tr><tr><td><a href=\"https://loinc.org/58475-5/\">58475-5</a></td><td>MEDICAL FOOD</td></tr><tr><td><a href=\"https://loinc.org/53410-7/\">53410-7</a></td><td>NO CHANGE NOTIFICATION</td></tr><tr><td><a href=\"https://loinc.org/53405-7/\">53405-7</a></td><td>NON-STANDARDIZED ALLERGENIC LABEL</td></tr><tr><td><a href=\"https://loinc.org/69968-6/\">69968-6</a></td><td>NDC LABELER CODE INACTIVATION</td></tr><tr><td><a href=\"https://loinc.org/81204-0/\">81204-0</a></td><td>NDC LABELER CODE INACTIVATION - ANIMAL DRUG</td></tr><tr><td><a href=\"https://loinc.org/72871-7/\">72871-7</a></td><td>NDC LABELER CODE REQUEST - ANIMAL DRUG</td></tr><tr><td><a href=\"https://loinc.org/51726-8/\">51726-8</a></td><td>NDC/NHRIC LABELER CODE REQUEST</td></tr><tr><td><a href=\"https://loinc.org/50577-6/\">50577-6</a></td><td>OTC ANIMAL DRUG LABEL</td></tr><tr><td><a href=\"https://loinc.org/69403-4/\">69403-4</a></td><td>OTC MEDICAL DEVICE LABEL</td></tr><tr><td><a href=\"https://loinc.org/50576-8/\">50576-8</a></td><td>OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL</td></tr><tr><td><a href=\"https://loinc.org/50574-3/\">50574-3</a></td><td>OTC TYPE B MEDICATED FEED ANIMAL DRUG LABEL</td></tr><tr><td><a href=\"https://loinc.org/50573-5/\">50573-5</a></td><td>OTC TYPE C MEDICATED FEED ANIMAL DRUG LABEL</td></tr><tr><td><a href=\"https://loinc.org/53411-5/\">53411-5</a></td><td>OUT OF BUSINESS NOTIFICATION</td></tr><tr><td><a href=\"https://loinc.org/60683-0/\">60683-0</a></td><td>PLASMA DERIVATIVE</td></tr><tr><td><a href=\"https://loinc.org/50578-4/\">50578-4</a></td><td>PRESCRIPTION ANIMAL DRUG LABEL</td></tr><tr><td><a href=\"https://loinc.org/69404-2/\">69404-2</a></td><td>PRESCRIPTION MEDICAL DEVICE LABEL</td></tr><tr><td><a href=\"https://loinc.org/78745-7/\">78745-7</a></td><td>RECOMBINANT DEOXYRIBONUCLEIC ACID CONSTRUCT LABEL</td></tr><tr><td><a href=\"https://loinc.org/85274-9/\">85274-9</a></td><td>REMS RELEASE</td></tr><tr><td><a href=\"https://loinc.org/82351-8/\">82351-8</a></td><td>RISK EVALUATION & MITIGATION STRATEGIES</td></tr><tr><td><a href=\"https://loinc.org/60682-2/\">60682-2</a></td><td>STANDARDIZED ALLERGENIC</td></tr><tr><td><a href=\"https://loinc.org/53404-0/\">53404-0</a></td><td>VACCINE LABEL</td></tr><tr><td><a href=\"https://loinc.org/50575-0/\">50575-0</a></td><td>VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL</td></tr><tr><td><a href=\"https://loinc.org/50572-7/\">50572-7</a></td><td>VFD TYPE B MEDICATED FEED ANIMAL DRUG LABEL</td></tr><tr><td><a href=\"https://loinc.org/50571-9/\">50571-9</a></td><td>VFD TYPE C MEDICATED FEED ANIMAL DRUG LABEL</td></tr><tr><td><a href=\"https://loinc.org/75030-7/\">75030-7</a></td><td>WHOLESALE DRUG DISTRIBUTORS AND THIRD-PARTY LOGISTICS FACILITY REPORT</td></tr><tr><td><a href=\"https://loinc.org/77573-4/\">77573-4</a></td><td>WITHDRAWAL OF WHOLESALE DRUG DISTRIBUTORS AND THIRD-PARTY LOGISTICS FACILITY REPORT</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/splDocumentCodes",
"version" : "0.2.1",
"name" : "SPLDocumentCodes",
"title" : "SPL Document Codes",
"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" : "Document 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" : "98075-5",
"display" : "ANIMAL CELLS, TISSUES, AND CELL AND TISSUE BASED PRODUCT LABEL"
},
{
"code" : "77647-6",
"display" : "ANIMAL COMPOUNDED DRUG LABEL"
},
{
"code" : "104091-4",
"display" : "ANIMAL DRUG FOR FURTHER PROCESSING"
},
{
"code" : "86445-4",
"display" : "BLANKET NO CHANGES CERTIFICATION OF PRODUCT LISTING"
},
{
"code" : "53409-9",
"display" : "BULK INGREDIENT"
},
{
"code" : "81203-2",
"display" : "BULK INGREDIENT - ANIMAL DRUG"
},
{
"code" : "60684-8",
"display" : "CELLULAR THERAPY"
},
{
"code" : "58474-8",
"display" : "COSMETIC"
},
{
"code" : "103573-2",
"display" : "COSMETIC FACILITY REGISTRATION"
},
{
"code" : "104087-2",
"display" : "COSMETIC FACILITY REGISTRATION-ABBREVIATED RENEWAL"
},
{
"code" : "104086-4",
"display" : "COSMETIC FACILITY REGISTRATION-AMENDMENT"
},
{
"code" : "104089-8",
"display" : "COSMETIC FACILITY REGISTRATION-BIENNIAL RENEWAL"
},
{
"code" : "104088-0",
"display" : "COSMETIC FACILITY REGISTRATION-CANCELLATION"
},
{
"code" : "103572-4",
"display" : "COSMETIC PRODUCT LISTING"
},
{
"code" : "105122-6",
"display" : "COSMETIC UPDATE"
},
{
"code" : "104090-6",
"display" : "COSMETIC-ABBREVIATED RENEWAL"
},
{
"code" : "58476-3",
"display" : "DIETARY SUPPLEMENT"
},
{
"code" : "78744-0",
"display" : "DRUG FOR FURTHER PROCESSING"
},
{
"code" : "70097-1",
"display" : "ESTABLISHMENT DE-REGISTRATION"
},
{
"code" : "51725-0",
"display" : "ESTABLISHMENT REGISTRATION"
},
{
"code" : "89600-1",
"display" : "FDA-INITIATED COMPLIANCE ACTION DRUG REGISTRATION AND DRUG LISTING INACTIVATION"
},
{
"code" : "99282-6",
"display" : "FDA-INITIATED COMPLIANCE ACTION DRUG REGISTRATION AND DRUG LISTING INACTIVATION - ANIMAL DRUG"
},
{
"code" : "71743-9",
"display" : "GENERIC DRUG FACILITY IDENTIFICATION SUBMISSION"
},
{
"code" : "75031-5",
"display" : "HUMAN COMPOUNDED DRUG LABEL"
},
{
"code" : "34390-5",
"display" : "HUMAN OTC DRUG LABEL"
},
{
"code" : "34391-3",
"display" : "HUMAN PRESCRIPTION DRUG LABEL"
},
{
"code" : "72090-4",
"display" : "IDENTIFICATION OF CBER-REGULATED GENERIC DRUG FACILITY"
},
{
"code" : "71446-9",
"display" : "INDEXING - BILLING UNIT"
},
{
"code" : "77648-4",
"display" : "INDEXING - BIOLOGICAL DRUG SUBSTANCE"
},
{
"code" : "93723-5",
"display" : "INDEXING - DRUG INTERACTIONS"
},
{
"code" : "63417-0",
"display" : "INDEXING - INDICATION"
},
{
"code" : "93372-1",
"display" : "INDEXING - NATIONAL CLINICAL TRIALS NUMBER"
},
{
"code" : "60685-5",
"display" : "INDEXING - PHARMACOLOGIC CLASS"
},
{
"code" : "73815-3",
"display" : "INDEXING - PRODUCT CONCEPT"
},
{
"code" : "82353-4",
"display" : "INDEXING - RISK EVALUATION & MITIGATION STRATEGIES"
},
{
"code" : "64124-1",
"display" : "INDEXING\u00a0- SUBSTANCE"
},
{
"code" : "77288-9",
"display" : "INDEXING - WARNING LETTER ALERT"
},
{
"code" : "101437-2",
"display" : "INTENTIONAL ANIMAL GENOMIC ALTERATION LABEL"
},
{
"code" : "53407-3",
"display" : "LICENSE BLOOD INTERMEDIATES/PASTE LABEL"
},
{
"code" : "53408-1",
"display" : "LICENSED MINIMALLY MANIPULATED CELLS LABEL"
},
{
"code" : "53406-5",
"display" : "LICENSED VACCINE BULK INTERMEDIATE LABEL"
},
{
"code" : "66105-8",
"display" : "LOT DISTRIBUTION DATA"
},
{
"code" : "55439-4",
"display" : "MEDICAL DEVICE"
},
{
"code" : "58475-5",
"display" : "MEDICAL FOOD"
},
{
"code" : "53410-7",
"display" : "NO CHANGE NOTIFICATION"
},
{
"code" : "53405-7",
"display" : "NON-STANDARDIZED ALLERGENIC LABEL"
},
{
"code" : "69968-6",
"display" : "NDC LABELER CODE INACTIVATION"
},
{
"code" : "81204-0",
"display" : "NDC LABELER CODE INACTIVATION - ANIMAL DRUG"
},
{
"code" : "72871-7",
"display" : "NDC LABELER CODE REQUEST - ANIMAL DRUG"
},
{
"code" : "51726-8",
"display" : "NDC/NHRIC LABELER CODE REQUEST"
},
{
"code" : "50577-6",
"display" : "OTC ANIMAL DRUG LABEL"
},
{
"code" : "69403-4",
"display" : "OTC MEDICAL DEVICE LABEL"
},
{
"code" : "50576-8",
"display" : "OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL"
},
{
"code" : "50574-3",
"display" : "OTC TYPE B MEDICATED FEED ANIMAL DRUG LABEL"
},
{
"code" : "50573-5",
"display" : "OTC TYPE C MEDICATED FEED ANIMAL DRUG LABEL"
},
{
"code" : "53411-5",
"display" : "OUT OF BUSINESS NOTIFICATION"
},
{
"code" : "60683-0",
"display" : "PLASMA DERIVATIVE"
},
{
"code" : "50578-4",
"display" : "PRESCRIPTION ANIMAL DRUG LABEL"
},
{
"code" : "69404-2",
"display" : "PRESCRIPTION MEDICAL DEVICE LABEL"
},
{
"code" : "78745-7",
"display" : "RECOMBINANT DEOXYRIBONUCLEIC ACID CONSTRUCT LABEL"
},
{
"code" : "85274-9",
"display" : "REMS RELEASE"
},
{
"code" : "82351-8",
"display" : "RISK EVALUATION & MITIGATION STRATEGIES"
},
{
"code" : "60682-2",
"display" : "STANDARDIZED ALLERGENIC"
},
{
"code" : "53404-0",
"display" : "VACCINE LABEL"
},
{
"code" : "50575-0",
"display" : "VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL"
},
{
"code" : "50572-7",
"display" : "VFD TYPE B MEDICATED FEED ANIMAL DRUG LABEL"
},
{
"code" : "50571-9",
"display" : "VFD TYPE C MEDICATED FEED ANIMAL DRUG LABEL"
},
{
"code" : "75030-7",
"display" : "WHOLESALE DRUG DISTRIBUTORS AND THIRD-PARTY LOGISTICS FACILITY REPORT"
},
{
"code" : "77573-4",
"display" : "WITHDRAWAL OF WHOLESALE DRUG DISTRIBUTORS AND THIRD-PARTY LOGISTICS FACILITY REPORT"
}
]
}
]
}
}
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
Links: Table of Contents |
QA Report
| Version History |
|
Propose a change