<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".04" citation="COMAR 10.34.03.04" title_num="10" subtitle_num="34" chapter_num="03" heading="Policies and Procedures.">
  <paragraph num="A.">
    <text>The director of pharmacy shall establish and operate under a policies and procedures manual which:</text>
    <paragraph num="(1)">
      <text>Complies with this chapter;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Defines the scope and method of pharmacy services provided to the patients of the institutional facility;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Determines when personnel may have access to the pharmacy area;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Provides for the safe and efficient dispensing and delivery of pharmaceutical products as outlined in this subtitle;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Includes:</text>
      <paragraph num="(a)">
        <text>Labeling requirements that meet the requirements of this chapter;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Distribution methods for medication that assures that a patient receives the correct dose ordered by the prescriber;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Packaging methods that assure the medication is appropriately identified, designed to maintain stability until expiration and traceable throughout the distribution chain to facilitate recall;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Distribution methods that provide for safe handling of medications that may be manual or computerized employing centralized, decentralized, or remote devices that meet the requirements of COMAR 10.34.28.</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Pharmacy security methods that comply with this chapter;</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Conditions in which an emergency drug supply may be replenished or prepared, delivered, and stored by the institutional facility;</text>
      </paragraph>
      <paragraph num="(g)">
        <text>Duties that may be performed by a licensed pharmacist, registered pharmacy technician and unlicensed personnel; and</text>
      </paragraph>
      <paragraph num="(h)">
        <text>Methods for proper disposal of pharmaceuticals as required by State and federal law;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(6)">
      <text>Is provided to:</text>
      <paragraph num="(a)">
        <text>The personnel of the pharmacy;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The institutional facility; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Upon request, an agent of the Board; and</text>
      </paragraph>
    </paragraph>
    <paragraph num="(7)">
      <text>Is in a form that is:</text>
      <paragraph num="(a)">
        <text>Written or electronic; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Readily retrievable;</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>The director of pharmacy shall provide annual training on the policies and procedures manual to the personnel of the pharmacy.</text>
  </paragraph>
</regulation>