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 - XML Representation

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<SubstanceDefinition xmlns="http://hl7.org/fhir">
  <id value="0efb1188-04f0-44ba-bfe7-ca6169ca8703"/>
  <meta>
    <profile
             value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"/>
  </meta>
  <text>
    <status value="generated"/>
    <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>
  </text>
  <identifier>
    <value value="carrageenan"/>
  </identifier>
  <classification>
    <coding>
      <system
              value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
      <code value="C3641132"/>
      <display value="Structurally Diverse Substance"/>
    </coding>
  </classification>
  <grade>
    <coding>
      <system
              value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
      <code value="C134009"/>
      <display value="Company Standard"/>
    </coding>
  </grade>
  <manufacturer>
    <reference value="urn:uuid:4b565cf3-5353-48af-8cd6-5ccf4e9fd579"/>
  </manufacturer>
  <code>
    <code>
      <coding>
        <system value="http://fdasis.nlm.nih.gov"/>
        <code value="5C69YCD2YJ"/>
      </coding>
    </code>
  </code>
  <name>
    <name value="Carrageenan"/>
    <type>
      <coding>
        <system
                value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
        <code value="C203355"/>
        <display value="GSRS Preferred Term"/>
      </coding>
    </type>
    <preferred value="true"/>
  </name>
  <sourceMaterial>
    <type>
      <coding>
        <system
                value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
        <code value="C14258"/>
        <display value="Plant"/>
      </coding>
    </type>
    <genus>
      <text value="palmaria"/>
    </genus>
    <species>
      <text value="palmata"/>
    </species>
    <countryOfOrigin>
      <coding>
        <system value="urn:iso:std:iso:3166"/>
        <code value="USA"/>
        <display value="United States of America"/>
      </coding>
    </countryOfOrigin>
  </sourceMaterial>
</SubstanceDefinition>