<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".04" citation="COMAR 10.34.16.04" title_num="10" subtitle_num="34" chapter_num="16" heading="Requirements of the Portable Drug Kit.">
  <paragraph num="A.">
    <text>The pharmacist shall ensure that the portable drug kit:</text>
    <paragraph num="(1)">
      <text>Is sealed with a tamper evident tag or other means for detecting entry to the kit;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Displays on the outside of the kit:</text>
      <paragraph num="(a)">
        <text>A serial number unique to the kit;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>An expiration date which reflects the earliest expiration date of any item contained in the kit;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>The contents of the kit;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>That the contents are or are not sterile;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>The legend “To be returned to the pharmacy within 5 days of breaking seal, with a completed administration record or prescription enclosed”; and</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Storage requirements for the contents;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>Contains:</text>
      <paragraph num="(a)">
        <text>Only prescription drugs and nonprescription items approved for the kit by a committee as defined in Regulation .01B(1) of this chapter;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>A temperature monitor to indicate maintenance of proper storage conditions; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>A written administration record to be completed by the licensed health care provider using the kit, which includes the administration record indicating:</text>
        <paragraph num="(i)">
          <text>The name of the patient,</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>The name of the prescriber,</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Drug name, form, and dosage,</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Date the drug was used or wasted,</text>
        </paragraph>
        <paragraph num="(v)">
          <text>The reason for administration or wastage of the drug, and</text>
        </paragraph>
        <paragraph num="(vi)">
          <text>The name of the licensed health care provider utilizing the kit;</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>Displays or includes written information inside the kit listing contraindications to use of the kit; and</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Does not contain a controlled dangerous substance.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>A pharmacist shall only distribute a portable drug kit which complies with the requirements of this chapter.</text>
  </paragraph>
</regulation>