<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".13" citation="COMAR 10.34.03.13" title_num="10" subtitle_num="34" chapter_num="03" heading="Controlled Dangerous Substances.">
  <paragraph num="A.">
    <text>Drug Accountability.</text>
    <paragraph num="(1)">
      <text>The director of pharmacy is responsible for establishing procedures and maintaining adequate written or electronic records regarding dispensing and accountability of controlled dangerous substances which specify at least the following:</text>
      <paragraph num="(a)">
        <text>Name and strength of the drug;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Dose;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Dosage form;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Prescriber;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Patient name with second identifier;</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Date and time of administration; and</text>
      </paragraph>
      <paragraph num="(g)">
        <text>Individual administering the drug;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>The director of pharmacy shall be responsible for establishing and maintaining adequate procedures for documentation of:</text>
      <paragraph num="(a)">
        <text>Recording of receipt of delivery to the pharmacy;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Entering into pharmacy inventory;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Receiving into Schedule II inventory; and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Dispensing of controlled dangerous substances, Schedule II — Schedule V.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>The director of pharmacy or designee shall be responsible for establishing and maintaining adequate procedures for documenting partially administered controlled dangerous substances:</text>
      <paragraph num="(a)">
        <text>For disposal by hospital policy; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Return of unused drugs to the pharmacy.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>The director of pharmacy or designee shall establish procedures to ensure that controlled dangerous substance records include the handwritten or electronic signature of the individual authorized:</text>
      <paragraph num="(a)">
        <text>By the institution to dispose of drugs or to return them to the pharmacy; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>To witness the disposal, as defined by the institution's policies and procedures.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Storage and Security in the Institutional pharmacy.</text>
    <paragraph num="(1)">
      <text>On at least a monthly basis, a pharmacist or registered pharmacy technician shall perform a physical count of each Schedule II controlled dangerous substance in the pharmacy and shall then compare that count with the perpetual inventory maintained by the pharmacy with reference to each drug;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>On at least a monthly basis, the director of pharmacy or designee shall:</text>
      <paragraph num="(a)">
        <text>Investigate discrepancies within the pharmacy;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Report losses as required by law; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Take appropriate action; and</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>The director of pharmacy or designee shall establish a procedure by which previously dispensed controlled dangerous substances that are no longer necessary for medical reasons are returned to the pharmacy.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Storage and Security in the Institution. The director of pharmacy shall develop policies that only permit the dispensing of controlled dangerous substances when the following security precautions exist in the institution and the pharmacy:</text>
    <paragraph num="(1)">
      <text>Access to controlled dangerous substances outside the pharmacy is restricted to authorized personnel approved by institutional policy;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Controlled dangerous substances stored outside the pharmacy are accounted for at least at the change of each shift by licensed personnel authorized by the institution, unless a controlled access automated dispensing system provides an on-demand report of a perpetual inventory; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>A pharmacist reviews the discrepancies in counts of controlled dangerous substances previously reported by other professional personnel.</text>
    </paragraph>
  </paragraph>
</regulation>