<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".10" citation="COMAR 10.34.22.10" title_num="10" subtitle_num="34" chapter_num="22" heading="Required Information and Procedures for Ceasing to Operate.">
  <paragraph num="A.">
    <text>If a wholesale distributor is located in another state, a wholesale distributor anticipating ceasing to operate in Maryland shall return the permit to the Board within 10 days of ceasing to operate in Maryland.</text>
  </paragraph>
  <paragraph num="B.">
    <text>Procedures for Wholesale Distributors Located in this State for Ceasing to Operate.</text>
    <paragraph num="(1)">
      <text>Notification.</text>
      <paragraph num="(a)">
        <text>At least 30 days before a wholesale distributor’s anticipated date of ceasing to operate, the wholesale distributor shall notify the Board in writing, by certified mail, return receipt requested, or hand delivered to the Board’s office, of the day on which the wholesale distributor will cease to operate.</text>
      </paragraph>
      <paragraph num="(b)">
        <text>A wholesale distributor shall:</text>
        <paragraph num="(i)">
          <text>Notify drug and device suppliers that supply prescription drugs and devices to the wholesale distributor, at least 30 days in advance of ceasing to operate, of the date that the wholesale distributor will cease to operate;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Notify manufacturers, wholesale distributors, licensed pharmacies and authorized prescribers that receive prescription drugs and devices from the wholesale distributor, at least 30 days in advance of ceasing to operate, of the date that the wholesale distributor will cease to operate; and</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Comply with applicable federal regulations.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>The wholesale distributor shall submit to and pass a closing inspection conducted by the Board.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>With the exception of controlled dangerous substances, the wholesale distributor shall dispose of prescription drugs or devices in stock by one or more of the following means:</text>
      <paragraph num="(a)">
        <text>Returning the prescription drugs or devices to a distributor or manufacturer;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Transferring the prescription drugs or devices to another wholesale distributor, licensed pharmacy, authorized prescriber, or other person or entity approved by the Board; or</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Destroying in accordance with this regulation.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>Disposition of Controlled Dangerous Substances. The wholesale distributor shall comply with the procedures set forth in this regulation in addition to those set forth in COMAR 10.19.03.10 governing the transfer, return or disposal of controlled dangerous substances.</text>
    </paragraph>
    <paragraph num="(5)">
      <text>At the closing inspection, the wholesale distributor shall provide to the Board the following:</text>
      <paragraph num="(a)">
        <text>The exact date on which the wholesale distributor ceased to operate;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>A copy of the inventory of prescription drugs or devices disposed of, transferred, or returned.</text>
      </paragraph>
      <paragraph num="(c)">
        <text>The names, addresses, telephone numbers, and Drug Enforcement Administration registration numbers, if applicable, of the persons or business entities to whom prescription drugs or devices in stock were returned or transferred under this regulation;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>The wholesale distributor permit;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>If prescription drugs or devices are destroyed pursuant to this regulation, a letter, signed under oath by the wholesale distributor, stating the:</text>
        <paragraph num="(i)">
          <text>Date, place and manner in which the prescription drugs or devices were destroyed;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Names, addresses, and telephone numbers of the persons responsible for destroying the prescription drugs or devices; and</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Name, dosage unit, and quantity of each type of prescription drug or device destroyed; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(f)">
        <text>If any pedigrees or other documents are transferred, a letter, signed under oath by the wholesale distributor, stating:</text>
        <paragraph num="(i)">
          <text>The date, time, place to which and manner in which the pedigrees or other documents were transferred; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>The names, addresses, and telephone numbers of the persons responsible for transferring the pedigrees or other documents.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(6)">
      <text>At the closing inspection, the wholesale distributor shall provide to the Division of Drug Control the following pertaining to controlled dangerous substances:</text>
      <paragraph num="(a)">
        <text>The exact date on which the wholesale distributor ceased to operate;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>A copy of the closing inventory of controlled dangerous substances required by the Drug Enforcement Administration.</text>
      </paragraph>
      <paragraph num="(c)">
        <text>The names, addresses, telephone numbers, Drug Enforcement Administration registration numbers, Division of Drug Control registration numbers, and Board permit numbers, if applicable, of the persons or business entities to whom controlled dangerous substances in stock were returned or transferred under this regulation; and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>The Maryland Department of Health Controlled Dangerous Substance Registration for cancellation.</text>
      </paragraph>
    </paragraph>
  </paragraph>
</regulation>