<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".34" citation="COMAR 26.13.10.34" title_num="26" subtitle_num="13" chapter_num="10" heading="Conditional Exemption — Controlled Substances and Household Waste Pharmaceuticals.">
  <paragraph num="A.">
    <text>If the conditions of §B of this regulation are met, the following are exempt from the requirements of COMAR 26.13.03—26.13.10:</text>
    <paragraph num="(1)">
      <text>A hazardous waste pharmaceutical that is also listed on a schedule of controlled substances by the Drug Enforcement Administration in 21 CFR Part 1308; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>A household waste pharmaceutical that is collected in a take-back event or program, including, but not limited to, a household waste pharmaceutical that is:</text>
      <paragraph num="(a)">
        <text>Collected by an authorized collector, as defined by the Drug Enforcement Administration, who is registered with the Drug Enforcement Administration; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Commingled by the authorized collector with controlled substances from an ultimate user as defined by the Drug Enforcement Administration.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Conditions for Exemption. The exemption of §A of this regulation applies if a waste pharmaceutical identified in §A of this regulation is:</text>
    <paragraph num="(1)">
      <text>Managed in compliance with the sewer prohibition of Regulation .33 of this chapter;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Collected, stored, transported, and disposed of in compliance with all applicable Drug Enforcement Administration regulations for controlled substances; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Either:</text>
      <paragraph num="(a)">
        <text>Destroyed by a method that the Drug Enforcement Administration has publicly deemed in writing to meet the Drug Enforcement Administration’s non-retrievable standard of destruction; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Combusted at one of the facilities identified in 40 CFR §266.506(b)(3)(i)—(v).</text>
      </paragraph>
    </paragraph>
  </paragraph>
</regulation>