Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.1.6 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-fda/ and changes regularly. See the Directory of published versions

• Narrative Content
• XML
• JSON

: Example Container Closure - JSON Representation

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{
  "resourceType" : "PackagedProductDefinition",
  "id" : "77ad6922-9c59-43d1-93cb-29d063cc2e8c",
  "meta" : {
    "profile" : [
      🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ContainerClosure"
    ]
  },
  "text" : {
    "status" : "generated",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: PackagedProductDefinition 77ad6922-9c59-43d1-93cb-29d063cc2e8c</b></p><a name=\"77ad6922-9c59-43d1-93cb-29d063cc2e8c\"> </a><a name=\"hc77ad6922-9c59-43d1-93cb-29d063cc2e8c\"> </a><a name=\"77ad6922-9c59-43d1-93cb-29d063cc2e8c-en-US\"> </a><p><b>packageFor</b>: <a href=\"Bundle-bd0f0a7a-27ea-4884-801d-bd0546e80888.html#urn-uuid-5772a6f2-cde1-4903-bfcf-1639340205cc\">Bundle: identifier = UUID:8a5a9684-f8fb-4f21-a397-a1a0996b2b7f; type = document; timestamp = 2023-12-09 07:12:23+0000</a></p><p><b>description</b>: </p><div><p>Plastic Bottle made of high-density polyethylene (HDPE). The plastic is chosen for its resistance to moisture and its ability to maintain the integrity of the drug.</p>\n<p>Child-Resistant Cap: The cap features a Push-and-Turn Cap that he user to push down on the cap while turning it, which is difficult for children but manageable for adults.</p>\n</div><p><b>attachedDocument</b>: <a href=\"Bundle-bd0f0a7a-27ea-4884-801d-bd0546e80888.html#urn-uuid-928a3bb5-7be3-4d6e-830f-1a2fc6dcee9b\">Bundle: identifier = UUID:8a5a9684-f8fb-4f21-a397-a1a0996b2b7f; type = document; timestamp = 2023-12-09 07:12:23+0000</a></p><h3>Packagings</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C43169}, {http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C96114}\">BOTTLE</span></td></tr></table></div>"
  },
  "packageFor" : [
    {
      "reference" : "urn:uuid:5772a6f2-cde1-4903-bfcf-1639340205cc"
    }
  ],
  "description" : "Plastic Bottle made of high-density polyethylene (HDPE). The plastic is chosen for its resistance to moisture and its ability to maintain the integrity of the drug.\n\nChild-Resistant Cap: The cap features a Push-and-Turn Cap that he user to push down on the cap while turning it, which is difficult for children but manageable for adults.",
  "attachedDocument" : [
    {
      "reference" : "urn:uuid:928a3bb5-7be3-4d6e-830f-1a2fc6dcee9b"
    }
  ],
  "packaging" : {
    "type" : {
      "coding" : [
        {
          "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
          "code" : "C43169",
          "display" : "BOTTLE"
        },
        {
          "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
          "code" : "C96114",
          "display" : "Child-resistant, Plastic"
        }
      ]
    }
  }
}