This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions

• Narrative Content
• XML
• JSON

: Example SubstanceDefinition for Carrageenan - JSON Representation

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{
  "resourceType" : "SubstanceDefinition",
  "id" : "0efb1188-04f0-44ba-bfe7-ca6169ca8703",
  "meta" : {
    "profile" : [
      🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"
    ]
  },
  "text" : {
    "status" : "generated",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"0efb1188-04f0-44ba-bfe7-ca6169ca8703\"> </a><a name=\"hc0efb1188-04f0-44ba-bfe7-ca6169ca8703\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource SubstanceDefinition &quot;0efb1188-04f0-44ba-bfe7-ca6169ca8703&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-excipient.html\">Excipient Drug Substance</a></p></div><p><b>identifier</b>: carrageenan</p><p><b>classification</b>: Structurally Diverse Substance <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C3641132)</span></p><p><b>grade</b>: Company Standard <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134009)</span></p><p><b>manufacturer</b>: <a href=\"Bundle-7ce2088d-d281-4e2f-9a25-120a1f9805d1.html#urn-uuid-4b565cf3-5353-48af-8cd6-5ccf4e9fd579\">urn:uuid:4b565cf3-5353-48af-8cd6-5ccf4e9fd579</a></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td>5C69YCD2YJ <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-UNII.html\">Unique Ingredient Identifier (UNII)</a>#5C69YCD2YJ)</span></td></tr></table><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td><td><b>Type</b></td><td><b>Preferred</b></td></tr><tr><td style=\"display: none\">*</td><td>Carrageenan</td><td>GSRS Preferred Term <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C203355)</span></td><td>true</td></tr></table><h3>SourceMaterials</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Genus</b></td><td><b>Species</b></td><td><b>CountryOfOrigin</b></td></tr><tr><td style=\"display: none\">*</td><td>Plant <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C14258)</span></td><td>palmaria <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td>palmata <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td>United States of America <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-ISO3166Part1.html\">ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code</a>#USA)</span></td></tr></table></div>"
  },
  "identifier" : [
    {
      "value" : "carrageenan"
    }
  ],
  "classification" : [
    {
      "coding" : [
        {
          "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
          "code" : "C3641132",
          "display" : "Structurally Diverse Substance"
        }
      ]
    }
  ],
  "grade" : [
    {
      "coding" : [
        {
          "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
          "code" : "C134009",
          "display" : "Company Standard"
        }
      ]
    }
  ],
  "manufacturer" : [
    {
      "reference" : "urn:uuid:4b565cf3-5353-48af-8cd6-5ccf4e9fd579"
    }
  ],
  "code" : [
    {
      "code" : {
        "coding" : [
          {
            "system" : "http://fdasis.nlm.nih.gov",
            "code" : "5C69YCD2YJ"
          }
        ]
      }
    }
  ],
  "name" : [
    {
      "name" : "Carrageenan",
      "type" : {
        "coding" : [
          {
            "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
            "code" : "C203355",
            "display" : "GSRS Preferred Term"
          }
        ]
      },
      "preferred" : true
    }
  ],
  "sourceMaterial" : {
    "type" : {
      "coding" : [
        {
          "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
          "code" : "C14258",
          "display" : "Plant"
        }
      ]
    },
    "genus" : {
      "text" : "palmaria"
    },
    "species" : {
      "text" : "palmata"
    },
    "countryOfOrigin" : [
      {
        "coding" : [
          {
            "system" : "urn:iso:std:iso:3166",
            "code" : "USA",
            "display" : "United States of America"
          }
        ]
      }
    ]
  }
}