<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".35" citation="COMAR 26.13.10.35" title_num="26" subtitle_num="13" chapter_num="10" heading="Residues of Hazardous Waste Pharmaceuticals in Empty Containers.">
  <paragraph num="A.">
    <text>This regulation establishes criteria under which a container that held a pharmaceutical is considered to be empty.</text>
  </paragraph>
  <paragraph num="B.">
    <text>A container that is empty according to the criteria in this regulation is not regulated as hazardous waste unless the materials of construction of the container itself cause the container to meet the definition of hazardous waste.</text>
  </paragraph>
  <paragraph num="C.">
    <text>Stock, Dispensing and Unit-dose Containers.</text>
    <paragraph num="(1)">
      <text>Except as provided in §C(2) of this regulation, the following containers are considered empty, and any residues remaining in the containers are not regulated as hazardous waste if the pharmaceuticals have been removed from the container using the practices commonly employed to remove materials from that type of container:</text>
      <paragraph num="(a)">
        <text>A stock bottle, dispensing bottle, vial, or ampule; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>A unit-dose container, such as a unit-dose packet, cup, wrapper, blister pack, or delivery device.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>The criterion of §C(1) of this regulation does not apply to a stock bottle, dispensing bottle, vial, or ampule that exceeds 1 liter or has a capacity of more than 10,000 pills.</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>Syringes.</text>
    <paragraph num="(1)">
      <text>A syringe is considered empty and the residues are not regulated as hazardous waste if the contents of the syringe have been removed by fully depressing the plunger of the syringe.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>At a healthcare facility that is operating under Regulations .32—.47 of this chapter, if a syringe is not empty, the generator of the waste shall place the syringe with its remaining hazardous waste pharmaceuticals into a container that is managed and disposed of:</text>
      <paragraph num="(a)">
        <text>As a noncreditable hazardous waste pharmaceutical under Regulations .33—.47 of this chapter; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Any applicable federal, state, and local requirements for sharps containers and medical waste.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>Intravenous (IV) Bags.</text>
    <paragraph num="(1)">
      <text>An IV bag is considered empty and the residues are not regulated as hazardous waste if:</text>
      <paragraph num="(a)">
        <text>The pharmaceuticals in the IV bag have been fully administered to a patient; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The IV bag:</text>
        <paragraph num="(i)">
          <text>Held non-acute hazardous waste pharmaceuticals; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Is empty as defined in COMAR 26.13.02.07B(1).</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>At a healthcare facility that is operating under Regulations .32—.47 of this chapter, if an IV bag that is going to be discarded is not empty as specified in §E(1) of this regulation, the generator shall place the IV bag with its remaining hazardous waste pharmaceuticals into a container that is managed and disposed of as a noncreditable hazardous waste pharmaceutical under Regulations .33 — .47 of this chapter.</text>
    </paragraph>
  </paragraph>
  <paragraph num="F.">
    <text>Other Containers, Including Delivery Devices.</text>
    <paragraph num="(1)">
      <text>This section applies to any type of container, including a delivery device, that:</text>
      <paragraph num="(a)">
        <text>Is not identified in §§C—E of this regulation;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Held or contains a pharmaceutical that would be regulated as hazardous waste if discarded; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Is unused, partially administered or fully administered.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Examples of containers subject to this section include inhalers, aerosol cans, nebulizers, and tubes of ointments, gels, or creams.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Except as specified in §F(4) of this regulation, at a healthcare facility that is operating under Regulations .32—.47 of this chapter, the generator of a container identified in §F(1) of this regulation that is going to be discarded shall manage the container as a non-creditable hazardous waste pharmaceutical under Regulations .33—.47 of this chapter.</text>
    </paragraph>
    <paragraph num="(4)">
      <text>§F(3) of this regulation does not apply if the container that is going to be discarded:</text>
      <paragraph num="(a)">
        <text>Held non-acute hazardous waste pharmaceuticals; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Is empty as defined in COMAR 26.13.02.07B(1) or B(2).</text>
      </paragraph>
    </paragraph>
  </paragraph>
</regulation>