Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.20 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc/ and changes regularly. See the Directory of published versions

• Narrative Content
• XML
• JSON

: Example SubstanceDefinition for anhydrous citric acid - XML Representation

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<SubstanceDefinition xmlns="http://hl7.org/fhir">
  <id value="fd84a8b5-9e96-451c-a5c6-097c943eb38a"/>
  <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="fd84a8b5-9e96-451c-a5c6-097c943eb38a"> </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;fd84a8b5-9e96-451c-a5c6-097c943eb38a&quot; </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-pqcmc-excipient.html">Excipient Drug Substance</a></p></div><p><b>identifier</b>: Citric acid</p><p><b>classification</b>: Chemical <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ema-dummy.html">Dummy EMA Codesystem</a>#1)</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">Dummy NCIT Codesystem</a>#C134009)</span></p><p><b>manufacturer</b>: <a href="Bundle-6004e36e-7df9-469d-9b29-8e9f9bd7e95f.html#urn-uuid-e99bddfa-c1b5-435b-bbe8-24816b4e23e5">urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5</a></p><p><b>supplier</b>: <a href="Bundle-6004e36e-7df9-469d-9b29-8e9f9bd7e95f.html#urn-uuid-d9e7c2f7-0f59-4645-bb6d-5a8dd2425049">urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049</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>XF417D3PSL <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (gsrs.ncats.nih.gov#XF417D3PSL)</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>ANHYDROUS CITRIC ACID</td><td>GSRS Preferred Term <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</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></tr><tr><td style="display: none">*</td><td>Chemical <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C48807)</span></td></tr></table></div>
  </text>
  <identifier>
    <value value="Citric acid"/>
  </identifier>
  <classification>
    <coding>
      <system
              value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ema-dummy"/>
      <code value="1"/>
      <display value="Chemical"/>
    </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:e99bddfa-c1b5-435b-bbe8-24816b4e23e5"/>
  </manufacturer>
  <supplier>
    <reference value="urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049"/>
  </supplier>
  <code>
    <code>
      <coding>
        <system value="https://gsrs.ncats.nih.gov"/>
        <code value="XF417D3PSL"/>
      </coding>
    </code>
  </code>
  <name>
    <name value="ANHYDROUS CITRIC ACID"/>
    <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="C48807"/>
        <display value="Chemical"/>
      </coding>
    </type>
  </sourceMaterial>
</SubstanceDefinition>