<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".09" citation="COMAR 10.34.36.09" title_num="10" subtitle_num="34" chapter_num="36" heading="Drug Control and Accountability.">
  <paragraph num="A.">
    <text>Medications may be accepted for return if:</text>
    <paragraph num="(1)">
      <text>The returned medication is properly labeled and properly sealed in the manufacturer’s package or an individually labeled unit dose of a drug or a device;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>A licensed pharmacist determines that procedures are in place that the returned medication has been handled in a manner which preserves the strength, quality, purity, and identity of the drug or device during an interim period between the sale of the drug or device and its return to the pharmacy; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>The permit holder otherwise complies with COMAR 10.34.10.07.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Discontinued Medications — Controlled Dangerous Substances.</text>
    <paragraph num="(1)">
      <text>Except as provided in §§B(2) and C(2) of this regulations, drugs classified as Schedule II, Schedule III, Schedule IV, and Schedule V may not be returned to the inventory of the pharmacy.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Schedule III, Schedule IV, and Schedule V medications may be returned to inventory of a pharmacy when the pharmacy uses a distribution system that classifies medications as pharmacy inventory until the utilization of the medication by the resident.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>A compounded sterile preparation may not be returned to the inventory of a pharmacy.</text>
  </paragraph>
  <paragraph num="D.">
    <text>Drugs requiring refrigeration may not be returned to the inventory of a pharmacy.</text>
  </paragraph>
  <paragraph num="E.">
    <text>Interim Box. An interim box may be provided to an assisted living program by a permit holder if:</text>
    <paragraph num="(1)">
      <text>A licensed nurse is present on site 24 hours a day, 7 days a week;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The assisted living program is compliant with the pharmacy’s policies and procedures regarding usage of the interim box under Regulation .03 of this chapter; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>The contents of the interim box are part of the pharmacy inventory until administered.</text>
    </paragraph>
  </paragraph>
  <paragraph num="F.">
    <text>Prescriber Orders.</text>
    <paragraph num="(1)">
      <text>A licensed pharmacist shall dispense medications from the pharmacy only upon receipt of a valid written prescription, chart order, or verbal order from an authorized prescriber.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>A chart order shall be considered a prescription drug order provided that the prescription drug order contains:</text>
      <paragraph num="(a)">
        <text>The full name of the resident, patient, or consumer, as appropriate;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The date of issuance;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>The name, strength, and dosage form of the drug prescribed;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>The name, type, and specifications of any device;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>The directions for use;</text>
      </paragraph>
      <paragraph num="(f)">
        <text>If written, the authorized prescriber’s signature or the signature of the authorized prescriber’s agent (including the name of the authorized prescriber);</text>
      </paragraph>
      <paragraph num="(g)">
        <text>If electronically transmitted, prescription requirements as described in COMAR 10.34.20; and</text>
      </paragraph>
      <paragraph num="(h)">
        <text>If verbal, the name of the prescriber and the prescriber’s agent, if applicable.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>A written order may be received by the pharmacy by facsimile, electronic transmission, or as the original physician order.</text>
    </paragraph>
    <paragraph num="(4)">
      <text>The licensed pharmacist shall document immediately a verbal order in writing.</text>
    </paragraph>
    <paragraph num="(5)">
      <text>A licensed pharmacist may receive a verbal order:</text>
      <paragraph num="(a)">
        <text>By telephone with the licensed pharmacist reading back the prescription to the prescriber or the prescriber’s agent; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>By a voice messaging system.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="G.">
    <text>Controlled Dangerous Substances.</text>
    <paragraph num="(1)">
      <text>Drug Accountability. The permit holder shall ensure that personnel employed by the pharmacy abide by the laws and regulations as defined in:</text>
      <paragraph num="(a)">
        <text>Health-General Article, Title 27, Annotated Code of Maryland; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>COMAR 10.19.03.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Storage and Security. The permit holder shall establish effective procedures for storage and security of Schedule II controlled dangerous substances including limitation of access to these drugs in the pharmacy to licensed pharmacists and registered pharmacy technicians.</text>
    </paragraph>
  </paragraph>
  <paragraph num="H.">
    <text>Drug Recalls. The licensed pharmacist shall develop and implement a recall procedure that can be readily activated to ensure that drugs which have been recalled are:</text>
    <paragraph num="(a)">
      <text>Returned to the pharmacy;</text>
    </paragraph>
    <paragraph num="(b)">
      <text>Sequestered; and</text>
    </paragraph>
    <paragraph num="(c)">
      <text>Handled as appropriate to the level of the recall.</text>
    </paragraph>
  </paragraph>
  <paragraph num="I.">
    <text>Adverse Drug Reactions.</text>
    <paragraph num="(1)">
      <text>The licensed pharmacist shall participate on the appropriate committee, if applicable of the assisted living program or group home, to establish procedures to report and record adverse drug reactions.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The licensed pharmacist shall ensure the procedures established include, at a minimum:</text>
      <paragraph num="(a)">
        <text>The reporting of significant adverse drug reactions to the attending prescriber or designee and other parties as specified by the appropriate committee of the assisted living program or group home; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The recording in writing of an adverse reaction on the resident’s chart at the time it is reported.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="J.">
    <text>Records and Reports. The licensed pharmacist shall maintain records and reports as may be required by law, this chapter, and the policies of the assisted living program or group home.</text>
  </paragraph>
</regulation>