<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".06" citation="COMAR 10.13.02.06" title_num="10" subtitle_num="13" chapter_num="02" heading="Record Keeping.">
  <text>A designated Department representative shall:</text>
  <paragraph num="A.">
    <text>Establish and maintain inventories and records of transactions regarding the receipt and distribution or other disposition of prescription drugs and devices;</text>
  </paragraph>
  <paragraph num="B.">
    <text>Include the following information in the records required under §A of this regulation:</text>
    <paragraph num="(1)">
      <text>The source of a prescription drug or device, including the:</text>
      <paragraph num="(a)">
        <text>Name and principal address of the seller or transferor; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Address of the location from which a prescription drug or device was shipped;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>The identity and quantity of the prescription drugs and devices received and distributed or disposed of;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>The dates of receipt and distribution or other disposition of the prescription drugs and devices; and</text>
    </paragraph>
    <paragraph num="(4)">
      <text>If required by Health Occupations Article, §12-6C-10, Annotated Code of Maryland, the pedigrees for prescription drugs that are wholesale distributed outside the normal distribution channel;</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Establish, maintain, and adhere to written policies and procedures addressing the:</text>
    <paragraph num="(1)">
      <text>Receipt, security, storage, inventory, and distribution of prescription drugs and devices;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Identifying, recording, and reporting of losses or thefts; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Correcting of errors and inaccuracies in inventories;</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>Include in the written policies and procedures established according to §C of this regulation the following:</text>
    <paragraph num="(1)">
      <text>A procedure by which the oldest approved and unexpired stock of a prescription drug or device is distributed first;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Procedures to be followed for handling a recall and withdrawal of a prescription drug or device due to:</text>
      <paragraph num="(a)">
        <text>An action initiated at the request of the United States Food and Drug Administration (FDA) or other federal, State, or local law enforcement or other government agency, including the Maryland Division of Drug Control;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>A voluntary action by the manufacturer to remove a defective or potentially defective prescription drug or device from the market; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>An action undertaken to promote public health and safety by replacing existing merchandise with an improved product or new package design;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>A procedure to ensure that the Department is prepared for, protected against, and able to handle a crisis that affects security or operation of a facility if any of the following situations occur:</text>
      <paragraph num="(a)">
        <text>Strike;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Fire;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Flood;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Catastrophic health emergency as defined in Public Safety Article, §14-3A-01, Annotated Code of Maryland;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Terrorist activities;</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Natural disaster; or</text>
      </paragraph>
      <paragraph num="(g)">
        <text>Other situations of local, State, or national emergency;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>A procedure to ensure that outdated prescription drugs and devices are segregated from other prescription drugs and devices and either returned to the manufacturer or destroyed;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>A procedure for:</text>
      <paragraph num="(a)">
        <text>The disposing and destruction of containers, labels, and packaging to ensure that the containers, labels, and packaging cannot be used in counterfeiting activities; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Appropriate witnessing of the destruction of any labels, packaging, immediate containers, or containers in accordance with applicable federal and State requirements; and</text>
      </paragraph>
    </paragraph>
    <paragraph num="(6)">
      <text>A procedure for:</text>
      <paragraph num="(a)">
        <text>Identifying, investigating, and reporting prescription drug inventory discrepancies involving counterfeiting, suspicion of counterfeiting, contraband, or suspicion of contraband; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Upon discovery, the reporting of a discrepancy within 5 business days to the Board;</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>Make available inventories and records for inspection and copying by authorized federal or State law enforcement agency officials for a period of 3 years after the date of creation of the inventories and records;</text>
  </paragraph>
  <paragraph num="F.">
    <text>Keep the records described in this regulation readily available for inspection by authorized federal, State, or local law enforcement agency officials during the retention period, either:</text>
    <paragraph num="(1)">
      <text>At the inspection site; or</text>
    </paragraph>
    <paragraph num="(2)">
      <text>So as to be immediately retrievable by computer or other electronic means;</text>
    </paragraph>
  </paragraph>
  <paragraph num="G.">
    <text>Within 5 working days of a request by an authorized official of a federal, State, or local law enforcement agency, make available for inspection records kept at a central location apart from the inspection site and not electronically retrievable;</text>
  </paragraph>
  <paragraph num="H.">
    <text>Establish and maintain procedures for reporting counterfeit and contraband or suspected counterfeit and contraband drugs or devices or counterfeiting and contraband or suspected counterfeiting and contraband activities to the Board and the FDA;</text>
  </paragraph>
  <paragraph num="I.">
    <text>Maintain a system for the mandatory reporting of significant inventory losses of prescription drugs and devices where it is known or suspected that diversion is occurring to:</text>
    <paragraph num="(1)">
      <text>The Board;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The FDA; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Where applicable, the U.S. Drug Enforcement Administration; and</text>
    </paragraph>
  </paragraph>
  <paragraph num="J.">
    <text>Consider the following factors when determining if there has been a significant inventory loss:</text>
    <paragraph num="(1)">
      <text>The schedule of the missing items;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The abuse or misuse potential of the missing items;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>The abuse or misuse potential in the Department’s area of the missing substance;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>The quantity missing in relation to the total quantity purchased, for example, one tablet per</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Whether this is the first time a potentially significant inventory loss has occurred;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Whether this loss was reported to local law enforcement authorities; and</text>
    </paragraph>
    <paragraph num="(7)">
      <text>Whether there is a significant resale value of the missing items.</text>
    </paragraph>
  </paragraph>
</regulation>