<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".02" citation="COMAR 14.17.19.02" title_num="14" subtitle_num="17" chapter_num="19" heading="Research and Development.">
  <paragraph num="A.">
    <text>The Administration may register an entity to grow, process, test, or transfer cannabis for the purposes of research and development.</text>
  </paragraph>
  <paragraph num="B.">
    <text>An entity under §A of this regulation shall conduct research and development only for the purposes under Alcoholic Beverages and Cannabis Article, §36-702, Annotated Code of Maryland.</text>
  </paragraph>
  <paragraph num="C.">
    <text>Registration.</text>
    <paragraph num="(1)">
      <text>An entity shall submit an application to the Administration that includes:</text>
      <paragraph num="(a)">
        <text>The name of the primary researcher or entity;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The address the research will be primarily taking place;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>The research purpose; and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>An application fee as specified in COMAR 14.17.21.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Registrations under this regulation shall be valid for 2 years and may be renewed for additional 2 year terms in a manner determined by the Administration.</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>Research and development entities under this regulation shall otherwise comply with Alcoholic Beverages and Cannabis Article, §36-702, Annotated Code of Maryland, and the following requirements:</text>
    <paragraph num="(1)">
      <text>The study shall be conducted in conformity with study protocols provided and any additional Administration guidance;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The entity shall notify the Administration of any adverse events reported by study participants within 48 hours of the study’s primary researcher being made aware of the adverse event;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Within 30 days, the entity or primary researcher shall update the Administration with any changes to the study protocols, including but not limited to:</text>
      <paragraph num="(a)">
        <text>Scope;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Researcher;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Number of participants;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Study duration; and</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Products used;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>The entity may continue to conduct research under this regulation while awaiting Administration approval of any changes to the study protocols;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>The entity or primary researcher shall provide documentation of Institutional Review Board or Institutional Animal Care and Use Committee, whichever is applicable, approval prior to the beginning of the study;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>An entity shall track the cannabis used for research and development in the seed-to-sale tracking system;</text>
    </paragraph>
    <paragraph num="(7)">
      <text>A batch or lot of cannabis originally used or processed for research and development purposes:</text>
      <paragraph num="(a)">
        <text>May not be used in the processing of cannabis sold to a licensed dispensary; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Shall be destroyed and logged as green waste; and</text>
      </paragraph>
    </paragraph>
    <paragraph num="(8)">
      <text>An entity shall maintain a record of all research and development tests for at least 2 years and provide copies of the test results to the Administration, upon request.</text>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>Edible Cannabis Product Development. An entity that processes edible cannabis products for research and development shall:</text>
    <paragraph num="(1)">
      <text>Quarantine each batch or lot in a quarantine area and label each batch or lot with a distinctive label; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Process the cannabis for research and development during a time that does not overlap with the processing of any cannabis that will be intended for distribution.</text>
    </paragraph>
  </paragraph>
  <paragraph num="F.">
    <text>Limited Testing for Edible Cannabis Product Development.</text>
    <paragraph num="(1)">
      <text>An entity may conduct the research and development testing on the entity’s premises or through an independent testing laboratory.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>If an independent testing laboratory conducts the research and development testing on the edible cannabis product, the laboratory shall clearly mark any certificate of analysis or reporting of test results with “R&amp;D TESTING ONLY” on the header and footer of the report in 20-point white font and a red background.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>The cannabis product shall be categorized as “Work in Process” in the seed-to-sale tracking system.</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Any edible cannabis product transferred from the premises for research and development testing shall:</text>
      <paragraph num="(a)">
        <text>Be packaged in accordance with COMAR 14.17.18.05;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Be labeled with the statements:</text>
        <paragraph num="(i)">
          <text>“CAUTION: THIS PRODUCT IS FOR APPROVED R&amp;D USAGE ONLY.”; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>“This product has not been approved by the Administration and is intended for research and development purposes only.”;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(c)">
        <text>Identify the name and telephone number of the entity who manufactured the product; and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Include a unique identifying number.</text>
      </paragraph>
    </paragraph>
  </paragraph>
</regulation>