6 CCR 1007-3-267.509 - Shipping potentially creditable hazardous waste pharmaceuticals from a healthcare facility or a reverse distributor to a reverse distributor

(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 U.S. Department of Transportation regulations in 49 CFR part 171 through 180 for any potentially creditable hazardous waste pharmaceutical that meets the definition of hazardous material in 49 CFR 171.8. For purposes of the Department of Transportation regulations, a material is considered a hazardous waste if it is subject to the Hazardous Waste Manifest Requirements of the U.S. Environmental Protection Agency specified in 40 CFR part 262 . 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 calendar 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, except the manifesting requirement of § 262.83(c), in addition to paragraphs (a) through (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 paragraphs (a) through (c) of this section in lieu 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 subpart.

Notes

6 CCR 1007-3-267.509

37 CR 24, December 25, 2014, effective 3/2/2015 38 CR 11, June 10, 2015, effective 6/30/2015 39 CR 05, March 10, 2016, effective 3/30/2016 39 CR 11, June 10, 2016, effective 6/30/2016 40 CR 06, March 25, 2017, effective 4/14/2017 40 CR 11, June 10, 2017, effective 6/30/2017 40 CR 21, November 10, 2017, effective 11/30/2017 41 CR 06, March 25, 2018, effective 4/14/2018 41 CR 11, June 10, 2018, effective 6/30/2018 41 CR 24, December 25, 2018, effective 1/14/2019 42 CR 06, March 25, 2019, effective 4/14/2019 42 CR 06, March 25, 2019, effective 5/30/2019 42 CR 11, June 10, 2019, effective 6/30/2019 43 CR 12, June 25, 2020, effective 7/15/2020 44 CR 06, March 25, 2021, effective 4/14/2021 44 CR 11, June 10, 2021, effective 6/30/2021 44 CR 24, December 25, 2021, effective 1/14/2022 45 CR 11, June 10, 2022, effective 6/30/2022 45 CR 17, September 10, 2022, effective 9/10/2022 45 CR 17, September 10, 2022, effective 9/30/2022 45 CR 23, December 10, 2022, effective 1/30/2023