Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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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

: Example RoutineSubstanceDefinition for Asprin - JSON Representation

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{
  "resourceType" : "SubstanceDefinition",
  "id" : "cd84a8b5-4e96-551c-15c6-c97c943eb38a",
  "meta" : {
    "profile" : [
      🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance"
    ]
  },
  "text" : {
    "status" : "generated",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"cd84a8b5-4e96-551c-15c6-c97c943eb38a\"> </a><a name=\"hccd84a8b5-4e96-551c-15c6-c97c943eb38a\"> </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;cd84a8b5-4e96-551c-15c6-c97c943eb38a&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-routine-drug-substance.html\">Routine Drug Substance</a></p></div><p><b>identifier</b>: salicylate</p><p><b>classification</b>: Chemical <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C48807)</span></p><p><b>grade</b>: USP-NF <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C134006)</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><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>R16CO5Y76E <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>#R16CO5Y76E)</span></td></tr></table><blockquote><p><b>name</b></p><p><b>name</b>: ACETYLSALICYLIC ACID</p><p><b>type</b>: Generic Name <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C97054)</span></p></blockquote><blockquote><p><b>name</b></p><p><b>name</b>: ASPIRIN</p><p><b>type</b>: 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></p><p><b>preferred</b>: true</p></blockquote></div>"
  },
  "identifier" : [
    {
      "value" : "salicylate"
    }
  ],
  "classification" : [
    {
      "coding" : [
        {
          "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
          "code" : "C48807",
          "display" : "Chemical"
        }
      ]
    }
  ],
  "grade" : [
    {
      "coding" : [
        {
          "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
          "code" : "C134006",
          "display" : "USP-NF"
        }
      ]
    }
  ],
  "manufacturer" : [
    {
      "reference" : "urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5"
    }
  ],
  "code" : [
    {
      "code" : {
        "coding" : [
          {
            "system" : "http://fdasis.nlm.nih.gov",
            "code" : "R16CO5Y76E"
          }
        ]
      }
    }
  ],
  "name" : [
    {
      "name" : "ACETYLSALICYLIC ACID",
      "type" : {
        "coding" : [
          {
            "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
            "code" : "C97054",
            "display" : "Generic Name"
          }
        ]
      }
    },
    {
      "name" : "ASPIRIN",
      "type" : {
        "coding" : [
          {
            "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
            "code" : "C203355",
            "display" : "GSRS Preferred Term"
          }
        ]
      },
      "preferred" : true
    }
  ]
}