<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".02" citation="COMAR 14.17.14.02" title_num="14" subtitle_num="17" chapter_num="14" heading="Records.">
  <paragraph num="A.">
    <text>A licensee shall maintain:</text>
    <paragraph num="(1)">
      <text>Independent of the seed-to-sale tracking system, a searchable, secure, tamper-evident record of each distribution that contains:</text>
      <paragraph num="(a)">
        <text>If applicable, the name and address of the patient;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The quantity delivered; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>The product name, strength, batch number, and lot number.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>To ensure uniformity, for each batch and lot:</text>
      <paragraph num="(a)">
        <text>Records of production and distribution; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Daily checklists;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>A record of test methods and test results for each batch and lot;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>A log of individuals visiting each premises; and</text>
    </paragraph>
    <paragraph num="(5)">
      <text>A duplicate set of all records at a secure, off-site location.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Unless otherwise specified, a licensee, or a certifying provider shall retain a record for a period of 2 years.</text>
  </paragraph>
</regulation>