<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".02" citation="COMAR 10.34.05.02" title_num="10" subtitle_num="34" chapter_num="05" heading="Prescription Area.">
  <paragraph num="A.">
    <text>The pharmacy permit holder shall:</text>
    <paragraph num="(1)">
      <text>Ensure that the prescription area:</text>
      <paragraph num="(a)">
        <text>Maintains temperature and ventilation at levels that do not affect the prescription drugs or devices stored in the area; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Permits reasonable communication between the pharmacist and the public when the pharmacy is open;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Provide a means of securing the prescription area;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Prevent an individual from being in the prescription area unless a pharmacist is immediately available on the premises to provide pharmacy services;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Monitor unauthorized or emergency entry after the prescription area has been secured by the pharmacist; and</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Prevent unauthorized entry when the prescription area is closed during a period that the rest of the establishment is open.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>The pharmacist shall:</text>
    <paragraph num="(1)">
      <text>Secure the prescription area and its contents in order that the pharmacy permit holder or the pharmacy permit holder's agent may:</text>
      <paragraph num="(a)">
        <text>Monitor unauthorized or emergency entry after the prescription area has been secured by the pharmacist; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Prevent unauthorized entry when the prescription area is closed during a period that the rest of the establishment is open;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Have sole possession of a means of access to the pharmacy, except in emergencies; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Establish a means of access for use in an emergency when the pharmacist is not available to access the prescription area.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Security.</text>
    <paragraph num="(1)">
      <text>A pharmacy shall be secure from unauthorized entry as follows:</text>
      <paragraph num="(a)">
        <text>Access from outside the premises shall be:</text>
        <paragraph num="(i)">
          <text>Kept to a minimum; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Well controlled;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>The outside perimeter of the premises shall be well lit; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Entry into areas where prescription drugs or devices and patient records are stored shall be limited to authorized personnel.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>A pharmacy shall be equipped with:</text>
      <paragraph num="(a)">
        <text>An alarm system to detect entry after hours;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>A security system that provides protection against theft and diversion;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Appropriate software to facilitate the identification of evidence of tampering with computers or electronic records;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>An inventory management and control system that protects against, detects, and documents any instances of theft, diversion, or counterfeiting;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>A security system to protect the integrity and confidentiality of data and documents limited to authorized personnel; and</text>
      </paragraph>
      <paragraph num="(f)">
        <text>A means to make the data and documentation required under this section readily available to the Board, an agent of the Board, the Division of Drug Control, or federal and other State law enforcement officials.</text>
      </paragraph>
    </paragraph>
  </paragraph>
</regulation>