<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".08" citation="COMAR 10.34.23.08" title_num="10" subtitle_num="34" chapter_num="23" heading="Labeling of Patient Medications.">
  <paragraph num="A.">
    <text>The director of pharmacy or designee shall ensure that medications dispensed by the pharmacy and intended for use within the comprehensive care facility are dispensed in appropriate containers and are labeled with the:</text>
    <paragraph num="(1)">
      <text>Name and address of the pharmacy;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Date of dispensing;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Prescription number assigned by the pharmacy;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Name of the patient;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Name, quantity, and strength of the drug;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Name of the prescriber;</text>
    </paragraph>
    <paragraph num="(7)">
      <text>Expiration date of the drug;</text>
    </paragraph>
    <paragraph num="(8)">
      <text>Required precautionary information regarding controlled substances; and</text>
    </paragraph>
    <paragraph num="(9)">
      <text>Further cautionary information as may be required or desirable for proper use of the medication.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>The director of pharmacy or designee shall ensure that medication provided per dosing period in a single container, slot, blister package, any other method of delivering an entire single dosing unit, or as part of a multi-dose dispensing package is labeled with at least the following:</text>
    <paragraph num="(1)">
      <text>Drug name;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Drug strength;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Name of manufacturer;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Name of the patient;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Lot number; and</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Expiration date.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>The director of pharmacy or designee shall be responsible for the safe and efficient dispensing, delivery, control of, and accountability for medications and devices dispensed or distributed by the permit holder.</text>
  </paragraph>
  <paragraph num="D.">
    <text>The director of pharmacy or designee shall work in cooperation with the other professional staff of the comprehensive care facility in meeting the responsibilities set forth in §B of the regulation and in ordering, storing, and accounting for pharmaceutical materials.</text>
  </paragraph>
  <paragraph num="E.">
    <text>Compounded Sterile Preparations. When compounding sterile preparations a licensed pharmacist or a registered pharmacy technician under the licensed pharmacist’s supervision, shall comply with the compounding and labeling requirements of COMAR 10.34.19.</text>
  </paragraph>
</regulation>