<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".14" citation="COMAR 10.19.03.14" title_num="10" subtitle_num="19" chapter_num="03" heading="Refilling of Prescriptions.">
  <paragraph num="A.">
    <text>A prescription for a controlled substance listed in Schedule II may not be refilled.</text>
  </paragraph>
  <paragraph num="B.">
    <text>A prescription for a controlled substance listed in Schedule III, IV, or V:</text>
    <paragraph num="(1)">
      <text>May not be refilled more than 6 months after the date on which the prescription was issued;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>May not be refilled more than five times; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Shall require a new and separate prescription to be issued if additional quantities are deemed necessary by the authorized prescribing provider.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>The prescribing provider may authorize additional refills of Schedule III, IV, or V substances on the original prescription through an oral refill authorization transmitted to the pharmacist if the following conditions are met:</text>
    <paragraph num="(1)">
      <text>The total quantity authorized, including the amount of the original prescription, does not exceed five refills or extend beyond 6 months from the date of issue of the original prescription;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The pharmacist obtaining the oral authorization records on the reverse of the original paper prescription or annotates the electronic prescription record with the date, quantity of refill, and number of additional refills authorized, and initials the paper prescription or annotates the electronic prescription record showing who received the authorization from the prescribing practitioner who issued the original prescription;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>The quantity of each additional refill authorized is equal to or less than the quantity authorized for the initial filling of the original prescription; and</text>
    </paragraph>
    <paragraph num="(4)">
      <text>The prescribing practitioner executes a new and separate prescription for any additional quantities beyond the five-refill, 6-month limitation.</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>Required Documentation.</text>
    <paragraph num="(1)">
      <text>Each refilling of a prescription shall be documented on the:</text>
      <paragraph num="(a)">
        <text>Back of the prescription;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>With Department approval, on another appropriate uniformly maintained, readily retrievable record, such as medication records; or</text>
      </paragraph>
      <paragraph num="(c)">
        <text>electronic prescription record.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>The documentation shall indicate the:</text>
      <paragraph num="(a)">
        <text>Number of the prescription;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Name of the controlled substance;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Dosage form of the controlled substance;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Date of each refilling;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Quantity dispensed;</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Identity or initials of the dispensing pharmacist in each refilling;</text>
      </paragraph>
      <paragraph num="(g)">
        <text>Total number of refills for that prescription;</text>
      </paragraph>
      <paragraph num="(h)">
        <text>Pharmacist’s initials; and</text>
      </paragraph>
      <paragraph num="(i)">
        <text>Date by the pharmacist as of the date of dispensing.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>Each refilling of a prescription shall:</text>
      <paragraph num="(a)">
        <text>State the amount dispensed; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>If the amount dispensed is not specifically stated, be deemed to have been dispensed for the full face amount of the prescription.</text>
      </paragraph>
    </paragraph>
  </paragraph>
</regulation>