<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".04" citation="COMAR 10.13.02.04" title_num="10" subtitle_num="13" chapter_num="02" heading="Storage and Handling.">
  <paragraph num="A.">
    <text>Storage Facility. A designated Department representative shall store, hold, or handle prescription drugs and devices in a facility that:</text>
    <paragraph num="(1)">
      <text>Is constructed to facilitate:</text>
      <paragraph num="(a)">
        <text>Cleaning; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Maintenance;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Has storage areas designed to provide adequate:</text>
      <paragraph num="(a)">
        <text>Equipment;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Humidity control;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Lighting;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Sanitation;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Security conditions;</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Space;</text>
      </paragraph>
      <paragraph num="(g)">
        <text>Temperature; and</text>
      </paragraph>
      <paragraph num="(h)">
        <text>Ventilation;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>Has a secured separate quarantine area for storage of prescription drugs or devices that are:</text>
      <paragraph num="(a)">
        <text>Adulterated;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Damaged;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Deteriorated;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>In immediate or sealed secondary containers that have been opened;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Misbranded; or</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Outdated;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>Is maintained in a clean and orderly condition; and</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Is free from insects, rodents, birds, or vermin.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Storage.</text>
    <paragraph num="(1)">
      <text>A designated Department representative shall store a prescription drug or device at appropriate temperatures and under appropriate conditions in accordance with requirements:</text>
      <paragraph num="(a)">
        <text>If any, on the labeling of the prescription drug or device; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Set forth in the current edition of an official compendium, such as the United States Pharmacopeia/National Formulary (USP/NF).</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>If no storage requirements are established for a prescription drug or device, a designated Department representative shall hold the prescription drug or device at a controlled room temperature, as defined in an official compendium as set forth in §B(1)(b) of this regulation to help assure that its identity, strength, quality, and purity are not adversely affected.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>A designated Department representative shall document proper storage of prescription drugs and devices in accordance with the:</text>
      <paragraph num="(a)">
        <text>Use of manual, electromechanical, or electronic temperature and humidity recording equipment, devices, and logs; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Record-keeping requirements in Regulation .06 of this chapter for stored prescription drugs and devices.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Examination of Materials.</text>
    <paragraph num="(1)">
      <text>Upon receipt of a prescription drug or device, a designated Department representative shall visually examine each outside shipping container to prevent the acceptance of:</text>
      <paragraph num="(a)">
        <text>An adulterated prescription drug or device; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>A prescription drug or device that is otherwise unfit for distribution.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>A designated Department representative shall examine each prescription drug or device container, as required under §C(1) of this regulation, to ascertain whether there is any damage to the container that would suggest possible contamination or other damage to the contents.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>A designated Department representative shall carefully inspect each outgoing shipment:</text>
      <paragraph num="(a)">
        <text>For identity of the prescription drug or device being shipped; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>To ensure that there is no delivery of a prescription drug or device that has been damaged in storage or held under improper conditions.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>Each unit of the Department, such as a local health department, that receives delivery of the prescription drug or device shall meet the requirements of this regulation for storage, security, and record keeping.</text>
    </paragraph>
    <paragraph num="(5)">
      <text>A designated Department representative shall follow the record-keeping requirements in Regulation .06 of this chapter for an incoming and an outgoing prescription drug or device.</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>Security of the Storage Area. A designated Department representative shall ensure that the area where prescription drugs and devices are stored is secure from unauthorized entry as follows:</text>
    <paragraph num="(1)">
      <text>Access from outside the premises is:</text>
      <paragraph num="(a)">
        <text>Kept to a minimum; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Limited to authorized personnel as determined by the designated Department representative; and</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>The storage area is equipped with:</text>
      <paragraph num="(a)">
        <text>A security system that provides protection against theft and diversion;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>An inventory management and control system that protects against, detects, and documents any instances of theft, diversion, or counterfeiting; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>A security system that protects the integrity and confidentiality of data and documents.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>Authorized Access of Storage Area. A designated Department representative shall ensure that the area where prescription drugs and devices are stored:</text>
    <paragraph num="(1)">
      <text>Has a means in place to make the data and documentation required under this chapter readily available to the Board, an agent of the Board, or federal or State law enforcement officials; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Allows for inspection by a Board representative.</text>
    </paragraph>
  </paragraph>
</regulation>