<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".07" citation="COMAR 10.34.23.07" title_num="10" subtitle_num="34" chapter_num="23" heading="Medication Packaging.">
  <paragraph num="A.">
    <text>A licensed pharmacist shall verify the:</text>
    <paragraph num="(1)">
      <text>Selection of medication to be packaged; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Completed packaging of medication performed by registered pharmacy technicians for the following:</text>
      <paragraph num="(a)">
        <text>Accuracy;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Completeness;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Appropriateness; and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Compliance with the U.S. Food and Drug Administration and current United States Pharmacopeia approved packaging.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>The licensed pharmacist shall ensure that labeling of the medication container includes the:</text>
    <paragraph num="(1)">
      <text>Brand or generic name of the medication;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Strength of the medication, if appropriate;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Name of the pharmacy;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Expiration date of the medication.</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>12 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>Packaged from the Manufacturer’s Original Container. The pharmacy may use a lot number and expiration date assigned by the pharmacy instead of the distributor or manufacturer information in a master log if kept 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>Name of the drug;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Strength;</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>Lot number assigned by the distributor or manufacturer;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Quantity packaged;</text>
    </paragraph>
    <paragraph num="(7)">
      <text>Expiration date as defined in §C of this regulation;</text>
    </paragraph>
    <paragraph num="(8)">
      <text>Manufacturer's expiration date;</text>
    </paragraph>
    <paragraph num="(9)">
      <text>Date of packaging;</text>
    </paragraph>
    <paragraph num="(10)">
      <text>Name of pharmacy technician packaging; and</text>
    </paragraph>
    <paragraph num="(11)">
      <text>Name and initials of verifying licensed pharmacist.</text>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>Packaged from Another Pharmacy. The licensed pharmacist may package patient specific medication received from another pharmacy licensed in Maryland or operated by the government of the United States provided that:</text>
    <paragraph num="(1)">
      <text>The licensed pharmacist determines that the 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 time it was dispensed by the original pharmacy and received by the packaging pharmacy;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The licensed pharmacist packages and dispenses all at one time the entire quantity of the prescription medications received from another pharmacy for packaging;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>The manufacturer’s name is present on the container received from the other pharmacy; and</text>
    </paragraph>
    <paragraph num="(4)">
      <text>The licensed pharmacist maintains a master log that includes the following information:</text>
      <paragraph num="(a)">
        <text>Name of the drug;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Lot number assigned by the packaging pharmacy;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Strength;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Manufacturer;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Name, address, and telephone number of the original dispensing pharmacy;</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Prescription number for the original dispensing pharmacy;</text>
      </paragraph>
      <paragraph num="(g)">
        <text>Quantity packaged;</text>
      </paragraph>
      <paragraph num="(h)">
        <text>Expiration date as assigned by the original dispensing pharmacy;</text>
      </paragraph>
      <paragraph num="(i)">
        <text>Date of packaging;</text>
      </paragraph>
      <paragraph num="(j)">
        <text>Name of pharmacy technician packaging;</text>
      </paragraph>
      <paragraph num="(k)">
        <text>Name and initials of verifying licensed pharmacist; and</text>
      </paragraph>
      <paragraph num="(l)">
        <text>Name of the patient.</text>
      </paragraph>
    </paragraph>
  </paragraph>
</regulation>