<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".47" citation="COMAR 26.13.10.47" title_num="26" subtitle_num="13" chapter_num="10" heading="Shipping Requirements — Non-creditable Hazardous Waste Pharmaceuticals and Evaluated Hazardous Waste Pharmaceuticals.">
  <paragraph num="A.">
    <text>This regulation establishes requirements that apply to:</text>
    <paragraph num="(1)">
      <text>A healthcare facility shipping non-creditable hazardous waste pharmaceuticals off site; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>A reverse distributor shipping evaluated hazardous wastes pharmaceuticals off site.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>A person identified in §A of this regulation shall:</text>
    <paragraph num="(1)">
      <text>Ship the waste identified in §A of this regulation to a designated facility that is authorized to accept the specified hazardous waste by a hazardous waste facility permit, interim status authority, or other legal mechanism consistent with state and federal hazardous waste regulations; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Ensure that the waste is transported by a transporter that has been issued a CHS Hauler Certificate in accordance with COMAR 26.13.04.01C.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Pre-transport Requirements — Healthcare Facilities.  A healthcare facility shall comply with the following requirements before transporting off site or offering for transport off site a non-creditable hazardous waste pharmaceutical:</text>
    <paragraph num="(1)">
      <text>Package the waste in accordance with the applicable U.S. Department of Transportation regulations on hazardous materials under 49 CFR Parts 173, 178, and 180;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Label each package in accordance with the applicable U.S. Department of Transportation regulations on hazardous materials under 49 CFR Part 172 Subpart E;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Mark each package of hazardous waste pharmaceuticals in accordance with the applicable U.S. Department of Transportation regulations on hazardous materials under 49 CFR Part 172 Subpart D;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Mark each container of 119 gallons or less being used in the off-site shipment with the  following words and information in accordance with the requirements of 49 CFR § 172.304:</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Mark each lab pack container that will be incinerated in compliance with 40 CFR § 268.42(c) as follows:</text>
      <paragraph num="(a)">
        <text>Mark the container with EPA Hazardous Waste Numbers D004, D005, D006, D007, D008, D010, and D011, when applicable, by either:</text>
        <paragraph num="(i)">
          <text>Directly marking the applicable EPA Hazardous Waste Numbers on the container; or</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Using an electronic system for data capture, storage, and retrieval, such as bar coding or a radio frequency identification tag, if the electronic system allows the destination facility to be informed of the container's contents for the purposes of compliance with applicable hazardous waste management regulations; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>It is not necessary to mark the container with EPA Hazardous Waste Numbers other than those identified in §C(5)(a) of this regulation;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(6)">
      <text>Placard the shipment or offer the initial transporter the appropriate placards according to U.S. Department of Transportation regulations for hazardous materials under 49 CFR Part 172, Subpart F.</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>Pre-transport Requirements — Reverse Distributors.  A reverse distributor shipping evaluated hazardous waste pharmaceuticals off site shall:</text>
    <paragraph num="(1)">
      <text>Comply with the requirements of §C of this regulation; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Mark each container of 119 gallons or less that is being used in the off-site shipment with the EPA hazardous waste numbers of the wastes in the container by either:</text>
      <paragraph num="(a)">
        <text>Directly marking the applicable EPA Hazardous Waste Numbers on the container; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Using a method described in §C(5)(a)(ii) of this regulation.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>Manifesting.</text>
    <paragraph num="(1)">
      <text>Except as specified in §E(2) of this regulation, a person identified in §A of this regulation shall comply with the manifest requirements of COMAR 26.13.03.04.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>A healthcare facility shipping non-creditable hazardous waste pharmaceuticals:</text>
      <paragraph num="(a)">
        <text>Is not required to list all applicable hazardous waste numbers, also known as hazardous waste codes, in the “Waste Codes” section of the manifest form, item 13 of EPA Form 8700-22; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Shall write either the code “PHRM” or the code “PHARMS” in the “Waste Codes” section of the manifest form, item 13 of EPA Form 8700-22.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="F.">
    <text>Export and Import Requirements.</text>
    <paragraph num="(1)">
      <text>A healthcare facility or reverse distributor that exports non-creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals is subject to COMAR 26.13.02.07.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Import Requirements.</text>
      <paragraph num="(a)">
        <text>A person that imports a non-creditable hazardous waste pharmaceutical or an evaluated hazardous waste pharmaceutical is subject to COMAR 26.13.02.07.</text>
      </paragraph>
      <paragraph num="(b)">
        <text>A healthcare facility or a reverse distributor may not accept an imported non-creditable hazardous waste pharmaceutical or an imported evaluated hazardous waste pharmaceutical unless the healthcare facility or reverse distributor has a permit or interim status that allows hazardous waste to be accepted from off site.</text>
      </paragraph>
    </paragraph>
  </paragraph>
</regulation>