(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.

Source Note: The provisions of this §335.769 adopted to be effective February 3, 2022, 47 TexReg 318