<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".09" citation="COMAR 10.34.03.09" title_num="10" subtitle_num="34" chapter_num="03" heading="Medication Packaging — Record Keeping.">
  <paragraph num="A.">
    <text>A licensed pharmacist shall verify the selection of medication to be packaged and verify the completed packaging of medication performed by a registered pharmacy technician for the following:</text>
    <paragraph num="(1)">
      <text>Accuracy;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Completeness:</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Appropriateness; and</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Compliance with the U.S. Food and Drug Administration and current United States Pharmacopeia approved packaging.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Packaging from the Manufacturer’s Original Container. The pharmacy shall use a master log with respect to drugs that are packaged within the pharmacy facility from the original manufacturer’s container which includes the:</text>
    <paragraph num="(1)">
      <text>Lot number assigned by the distributor or manufacturer;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Manufacturer’s expiration date;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Manufacturer;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Lot number assigned by the pharmacy;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Quantity packaged;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Expiration date as defined in §C of this regulations;</text>
    </paragraph>
    <paragraph num="(7)">
      <text>Generic name of the drug;</text>
    </paragraph>
    <paragraph num="(8)">
      <text>Strength;</text>
    </paragraph>
    <paragraph num="(9)">
      <text>Date of packaging;</text>
    </paragraph>
    <paragraph num="(10)">
      <text>Name of person packaging; and</text>
    </paragraph>
    <paragraph num="(11)">
      <text>Initials of verifying licensed pharmacist.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Unless the licensed pharmacist has reason to reduce the time period, the expiration date of the medication is the lesser of:</text>
    <paragraph num="(1)">
      <text>Twelve months from the date of packaging;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The manufacturer’s or distributor’s listed expiration date; or</text>
    </paragraph>
    <paragraph num="(3)">
      <text>The maximum time period allowed for the specific packaging used for the medication.</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>The licensed pharmacist shall ensure that labeling of the medication container includes the:</text>
    <paragraph num="(1)">
      <text>Generic name of the medication;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Brand name of the medication, if appropriate</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Strength of the medication, if appropriate;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Lot number of the distributor or manufacturer;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Expiration date of the medication; and</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Beyond use date of the medication, if appropriate.</text>
    </paragraph>
  </paragraph>
</regulation>