<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".08" citation="COMAR 10.34.36.08" title_num="10" subtitle_num="34" chapter_num="36" heading="Labeling of Resident Medications.">
  <paragraph num="A.">
    <text>A licensed pharmacist shall ensure that medications dispensed by the pharmacy and intended for use within an assisted living program or group home 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 resident, patient, or consumer, as appropriate;</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;</text>
    </paragraph>
    <paragraph num="(9)">
      <text>Directions for use as set forth in the:</text>
      <paragraph num="(a)">
        <text>Medication administration record; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Prescriber’s orders; and</text>
      </paragraph>
    </paragraph>
    <paragraph num="(10)">
      <text>Further cautionary information as may be required or necessary for proper use of the medication.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>A licensed pharmacist 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, are 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 resident, patient or consumer, as appropriate;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Lot number, unless prepared extemporaneously;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Directions for use as set forth in the:</text>
      <paragraph num="(a)">
        <text>Medication administration record; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Prescriber’s orders; and</text>
      </paragraph>
    </paragraph>
    <paragraph num="(7)">
      <text>Expiration date.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <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>