<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".06" citation="COMAR 10.34.03.06" title_num="10" subtitle_num="34" chapter_num="03" heading="Security.">
  <paragraph num="A.">
    <text>If a pharmacist is not present within the pharmacy, the pharmacist shall lock and secure the pharmacy and any of its decentralized areas that contain pharmaceuticals before leaving the pharmacy or the decentralized area.</text>
  </paragraph>
  <paragraph num="B.">
    <text>The  director of pharmacy shall establish policies and procedures for emergency access to the pharmacy or any of its decentralized areas.</text>
  </paragraph>
  <paragraph num="C.">
    <text>Security Requirements. Entry into an institutional pharmacy area where prescription drugs or devices are held shall be limited to authorized personnel under a pharmacist’s direct supervision.</text>
  </paragraph>
  <paragraph num="D.">
    <text>An institutional pharmacy shall be equipped with:</text>
    <paragraph num="(1)">
      <text>A security system to detect entry after hours, if applicable;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>A security system that provides additional protection against theft and diversion;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Appropriate software to facilitate the identification of evidence of tampering with computers or electronic records;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>An inventory management and control system designed to protect against, detect, and document instances of theft, diversion, or counterfeiting;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>A security system designed to protect the integrity and confidentiality of data and documents;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Video monitoring of entrances and exits, or alternate acceptable security; and</text>
    </paragraph>
    <paragraph num="(7)">
      <text>A means to make the data and documentation required under this chapter readily available to:</text>
      <paragraph num="(a)">
        <text>The Board;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>An agent of the Board; or</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Federal and State regulatory and law enforcement officials.</text>
      </paragraph>
    </paragraph>
  </paragraph>
</regulation>