<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".48" citation="COMAR 26.13.10.48" title_num="26" subtitle_num="13" chapter_num="10" heading="Shipments of Potentially Creditable Hazardous Waste Pharmaceuticals to a Reverse Distributor.">
  <paragraph num="A.">
    <text>A healthcare facility or a reverse distributor that transports off site or offers for transport off site potentially creditable hazardous waste pharmaceuticals to a reverse distributor shall comply with all applicable U.S. Department of Transportation regulations in 49 CFR Parts 171—180 for any potentially creditable hazardous waste pharmaceutical that meets the definition of hazardous material in 49 CFR § 171.8.</text>
  </paragraph>
  <paragraph num="B.">
    <text>Delivery Confirmation. A reverse distributor that receives a shipment of potentially creditable hazardous waste pharmaceuticals:</text>
    <paragraph num="(1)">
      <text>Shall, upon receipt of the shipment, provide confirmation of receipt to the healthcare facility or reverse distributor that initiated the shipment;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Shall indicate in the confirmation of receipt that the shipment of potentially creditable hazardous waste pharmaceuticals has arrived at its destination and is under the control of the reverse distributor; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>May provide the confirmation of receipt in a paper format or an electronic format.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Required Actions if a Timely Confirmation of Delivery is not Received.  If 35 days have elapsed since a healthcare facility or reverse distributor initiated a shipment of potentially creditable hazardous waste pharmaceuticals to a reverse distributor, and the initiating shipper has not received confirmation of delivery, the initiating shipper shall promptly contact the carrier and the reverse distributor that was the intended recipient of the shipment to:</text>
    <paragraph num="(1)">
      <text>Report that the delivery confirmation has not been received; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Determine the status of the potentially creditable hazardous waste pharmaceuticals that were shipped.</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>Exports.  A healthcare facility or reverse distributor that sends a potentially creditable hazardous waste pharmaceutical to a foreign destination:</text>
    <paragraph num="(1)">
      <text>Is not required to comply with the manifesting requirements of 40 CFR § 262.83(c);</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Shall comply with:</text>
      <paragraph num="(a)">
        <text>The applicable sections of 40 CFR Part 262, Subpart H, as qualified by COMAR 26.13.03.07B(2); and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>§§A—C of this regulation.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>Imports.</text>
    <paragraph num="(1)">
      <text>A person that imports potentially creditable hazardous waste pharmaceuticals into the United States is subject to §§A—C of this regulation instead of 40 CFR Part 262, Subpart H.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Immediately after a potentially creditable hazardous waste pharmaceutical enters the United States, the potentially creditable hazardous waste pharmaceutical is subject to all applicable requirements of Regulations .32—.49 of this chapter.</text>
    </paragraph>
  </paragraph>
  <paragraph num="F.">
    <text>Transporter Requirements. A person that transports potentially creditable hazardous waste pharmaceuticals to a reverse distributor:</text>
    <paragraph num="(1)">
      <text>May do so without meeting the requirements of COMAR 26.13.04 that apply to persons who transport hazardous waste; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Shall comply with all applicable requirements of the U.S. Department of Transportation for the transport of hazardous materials.</text>
    </paragraph>
  </paragraph>
</regulation>