| (a) Shipping potentially creditable hazardous waste
pharmaceuticals. A healthcare facility or a reverse distributor who
transports or offers for transport potentially creditable hazardous
waste pharmaceuticals off-site to a reverse distributor must comply
with all applicable United States Department of Transportation regulations
in 49 Code of Federal Regulations (CFR) Parts 171 - 180 for any potentially
creditable hazardous waste pharmaceutical that meets the definition
of hazardous material in 49 CFR §171.8. For purposes of the federal
Department of Transportation regulations, a material is considered
a hazardous waste if it is subject to the Hazardous Waste Manifest
Requirements of the United States Environmental Protection Agency
specified in 40 CFR Part 262 as adopted under Subchapter C of this
title (relating to Standards Applicable to Generators of Hazardous
Waste). Because a potentially creditable hazardous waste pharmaceutical
does not require a manifest, it is not considered hazardous waste
under the Department of Transportation regulations.
(b) Delivery confirmation. Upon receipt of each shipment
of potentially creditable hazardous waste pharmaceuticals, the receiving
reverse distributor must provide confirmation (paper or electronic)
to the healthcare facility or reverse distributor that initiated the
shipment that the shipment of potentially creditable hazardous waste
pharmaceuticals has arrived at its destination and is under the custody
and control of the reverse distributor.
(c) Procedures for when delivery confirmation is not
received within 35 days. If a healthcare facility or reverse distributor
initiates a shipment of potentially creditable hazardous waste pharmaceuticals
to a reverse distributor and does not receive delivery confirmation
within 35 calendar days from the date that the shipment of potentially
creditable hazardous waste pharmaceuticals was sent, the healthcare
facility or reverse distributor that initiated the shipment must contact
the carrier and the intended recipient (i.e., the reverse distributor)
promptly to report that the delivery confirmation was not received
and to determine the status of the potentially creditable hazardous
waste pharmaceuticals.
(d) Exporting potentially creditable hazardous waste
pharmaceuticals. A healthcare facility or reverse distributor that
sends potentially creditable hazardous waste pharmaceuticals to a
foreign destination must comply with the applicable sections of 40
CFR Part 262, Subpart H, as adopted under §335.58 of this title
(relating to Transboundary Movements of Hazardous Waste for Recovery
or Disposal), except the manifesting requirement of 40 CFR §262.83(c),
in addition to subsections (a) - (c) of this section.
(e) Importing potentially creditable hazardous waste
pharmaceuticals. Any person that imports potentially creditable hazardous
waste pharmaceuticals into the United States is subject to subsections
(a) - (c) of this section instead of 40 CFR Part 262, Subpart H. Immediately
after the potentially creditable hazardous waste pharmaceuticals enter
the United States, they are subject to all applicable requirements
of this subchapter.
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