<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".09" citation="COMAR 10.34.23.09" title_num="10" subtitle_num="34" chapter_num="23" heading="Drug Control and Accountability.">
  <paragraph num="A.">
    <text>The director of pharmacy or designee shall develop a process for the pharmacy to be notified of medications which have been discontinued.</text>
  </paragraph>
  <paragraph num="B.">
    <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>The licensed pharmacist determines 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="C.">
    <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 patient.</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>A compounded sterile preparation may not be returned to the inventory of a pharmacy.</text>
  </paragraph>
  <paragraph num="E.">
    <text>Drugs requiring refrigeration may not be returned to the inventory of a pharmacy.</text>
  </paragraph>
  <paragraph num="F.">
    <text>Emergency Drug Kit.</text>
    <paragraph num="(1)">
      <text>The director of pharmacy or designee shall ensure that the emergency drug kit is secured with a tamper-evident seal or electronic security system which will indicate the opening of the kit.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Labeling. The director of pharmacy or designee shall ensure that the emergency drug kit meets the following specifications:</text>
      <paragraph num="(a)">
        <text>The exterior of the emergency drug kit is labeled to indicate clearly and unmistakably that it is an emergency drug kit and that it is for use in emergencies only;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The exterior of the emergency drug kit is labeled to indicate the:</text>
        <paragraph num="(i)">
          <text>Names of the drugs contained in the emergency drug kit;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Strengths of the drugs contained in the emergency drug kit;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>List of contents with expiration dates, with the date of the first item to expire in bold print; and</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>The quantity of each drug contained in the emergency drug kit; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(c)">
        <text>Medications contained in the emergency drug kit are labeled with the:</text>
        <paragraph num="(i)">
          <text>Name of the drug;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Strength of the drug;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Expiration date of the drug;</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Lot number of the drug; and</text>
        </paragraph>
        <paragraph num="(v)">
          <text>Other information required by the medical staff.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>Replacement of Medications.</text>
      <paragraph num="(a)">
        <text>A licensed pharmacist or licensed pharmacist's designee shall replace the emergency drug kit or replenish used or expired drugs contained in the emergency drug kit within 72 hours of notification of use or expiration.</text>
      </paragraph>
      <paragraph num="(b)">
        <text>A licensed pharmacist shall perform the final check on the contents of the emergency drug kit.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="G.">
    <text>Interim Box.</text>
    <paragraph num="(1)">
      <text>An interim box may be provided by the pharmacy and kept at the comprehensive care facility if comprehensive care facility policies and procedures address an interim box and the pharmacy complies with these policies and procedures.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>A licensed pharmacist shall perform the final check on the contents of the interim box.</text>
    </paragraph>
  </paragraph>
  <paragraph num="H.">
    <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 patient;</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="I.">
    <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 Health-General Article, Title 27, Annotated Code of Maryland, and COMAR 10.19.03.</text>
    </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="J.">
    <text>Drug Recalls. The director of pharmacy or designee shall develop and implement a recall procedure that can be readily activated to ensure that drugs which have been recalled are returned to the pharmacy, sequestered, and handled as appropriate to the level of the recall.</text>
  </paragraph>
  <paragraph num="K.">
    <text>Adverse Drug Reactions.</text>
    <paragraph num="(1)">
      <text>The director of pharmacy or designee shall participate on the appropriate committee of the comprehensive care facility to establish procedures to report and record adverse drug reactions.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The director of pharmacy or designee 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 committee of the comprehensive care facility; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The recording in writing of an adverse reaction on the patient’s chart at the time it is reported.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="L.">
    <text>Records and Reports. The director of pharmacy or designee shall maintain records and reports as may be required by law, this chapter, and the policies of the comprehensive care facility.</text>
  </paragraph>
</regulation>