<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".08" citation="COMAR 14.01.05.08" title_num="14" subtitle_num="01" chapter_num="05" heading="Establishing and Monitoring a UPL.">
  <paragraph num="A.">
    <text>Adopting a Proposed Regulation Setting a UPL.</text>
    <paragraph num="(1)">
      <text>The proposed regulation shall set a specified UPL amount for specified eligible governmental entities.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The Board and staff shall work with eligible governmental entities to develop the best method for implementing the UPL for the entity and a prospective effective date that provides sufficient time for implementation.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>The per unit final net cost paid by the eligible governmental entity shall not exceed the GovUPL.</text>
    </paragraph>
    <paragraph num="(4)">
      <text>The Board shall provide for the automatic suspension of the UPL for the time that the prescription drug product is on the federal Food and Drug Administration prescription drug shortage list by regulation.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Monitoring a UPL.</text>
    <paragraph num="(1)">
      <text>The Board shall develop a program for monitoring the availability of any prescription drug product for which it sets a UPL.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>If monitoring discloses a shortage of the prescription drug product in the State, the Board may suspend or modify the UPL.</text>
    </paragraph>
  </paragraph>
</regulation>