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<regulation prefix="Regulation" num=".04" citation="COMAR 14.17.11.04" title_num="14" subtitle_num="17" chapter_num="11" heading="Cannabis Product Processing.">
  <paragraph num="A.">
    <text>Controls for Processing of Cannabis Concentrates and Cannabis-Infused Products.</text>
    <paragraph num="(1)">
      <text>A licensed processor of cannabis concentrates and cannabis-infused products shall:</text>
      <paragraph num="(a)">
        <text>Develop standard operating procedures in accordance with COMAR 14.17.11.19, good manufacturing practices, and a training plan before producing cannabis concentrates and cannabis-infused products;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Require that any person involved in processing cannabis concentrates and cannabis-infused products:</text>
        <paragraph num="(i)">
          <text>Is appropriately trained in accordance with their job description to safely operate and maintain the system used for processing;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Has direct access to applicable material safety sheets and labels; and</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Follows OSHA protocols for handling and storage of all chemicals;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(c)">
        <text>Assign a unique lot number to each lot of cannabis concentrate or cannabis-infused product;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>If using a solvent-based extraction method, ensure solvents are at least 99 percent pure;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Require:</text>
        <paragraph num="(i)">
          <text>The use of solvents in a professional grade, closed-loop extraction system designed to recover the solvents;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Work in a spark-free environment with proper ventilation; and</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Following all applicable OSHA regulations, and local fire, safety, and building codes in the processing and storage of the solvents; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(f)">
        <text>If using carbon dioxide gas extraction, ensure:</text>
        <paragraph num="(i)">
          <text>Every vessel is rated to a minimum of 900 pounds per square inch;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>The use of a professional grade, closed-loop system; and</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>The use of carbon dioxide that is at least 99 percent pure.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>A licensed processor may use heat, screens, presses, steam distillation, ice water, and other methods to produce cannabis concentrates.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Upon successful completion of a validation process, the licensed processor shall use an Administration-registered independent testing laboratory to test each unique lot of cannabis concentrate or cannabis-infused product and obtain a certificate of analysis.</text>
  </paragraph>
  <paragraph num="C.">
    <text>Batch Release Controls.</text>
    <paragraph num="(1)">
      <text>If a licensed processor, upon review of the certificate of analysis, determines that a lot meets the specification for the product, the licensed processor may:</text>
      <paragraph num="(a)">
        <text>Assign an expiration date to the lot;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Release the lot for distribution; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Revise the status of the lot in the seed-to-sale tracking system.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>If a licensed processor receives test results that the lot falls outside action limits, the licensed processor:</text>
      <paragraph num="(a)">
        <text>May rework or reprocess the lot according to their standard operating procedure; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>If applicable, shall ensure the reworked or reprocessed lot is resampled and retested by the independent testing laboratory to meet all required specifications.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>A licensed processor shall retain every certificate of analysis.</text>
    </paragraph>
    <paragraph num="(4)">
      <text>All cannabis products shall have a certificate of analysis, as specified in COMAR 14.17.08.05A(5), prior to transfer to a licensed dispensary.</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>Stability Testing and Retention Sampling.</text>
    <paragraph num="(1)">
      <text>A processor shall provide a sample from each unique lot to an independent testing laboratory sufficient to perform stability testing at 6-month intervals to:</text>
      <paragraph num="(a)">
        <text>Ensure product potency and purity; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Provide support for expiration dating.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Retention samples retained from each released lot shall be:</text>
      <paragraph num="(a)">
        <text>Tested by the State Cannabis Testing Laboratory following an adverse event reported to the Administration;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Properly stored by the licensed processor; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Properly discarded 6 months after the expiration date of the lot.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>Correction and Prevention Action.</text>
    <paragraph num="(1)">
      <text>If a processor’s test results indicate the confirmed presence of a pathogen more than once in a 60-day period, the processor shall:</text>
      <paragraph num="(a)">
        <text>Conduct environmental swab testing as required by the Administration’s Technical Authority;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Conduct an investigation to determine the root cause of contamination;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Decontaminate all areas, including rooms, equipment, and surfaces used for cannabis product processing;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Provide, in the manner designated by the Administration:</text>
        <paragraph num="(i)">
          <text>A report of the investigation; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>The licensee’s corrective action plan; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(e)">
        <text>If applicable, update and implement standard operating procedures needed to ensure passing samples in the future.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>The Administration may require a processor to:</text>
      <paragraph num="(a)">
        <text>Conduct further investigation; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Implement additional procedures to prevent future contamination.</text>
      </paragraph>
    </paragraph>
  </paragraph>
</regulation>