Section 335.757 - Standards for Healthcare Facilities Managing Potentially Creditable Hazardous Waste Pharmaceuticals(a) Hazardous waste determination for potentially creditable pharmaceuticals. A healthcare facility that generates a solid waste that is a potentially creditable pharmaceutical must determine whether the potentially creditable pharmaceutical is a potentially creditable hazardous waste pharmaceutical by determining if it is listed in 40 Code of Federal Regulations (CFR) Part 261, Subpart D or exhibits a characteristic identified in 40 CFR Part 261 , Subpart C as adopted under § 335.504 of this title (relating to Hazardous Waste Determination). A healthcare facility may choose to manage its potentially creditable nonhazardous waste pharmaceuticals as potentially creditable hazardous waste pharmaceuticals under this subchapter.(b) Accepting potentially creditable hazardous waste pharmaceuticals from an off-site healthcare facility that is a very small quantity generator. A healthcare facility may accept potentially creditable hazardous waste pharmaceuticals from an off-site healthcare facility that is a very small quantity generator under 40 CFR § 262.14 as adopted under § 335.53 of this title (relating to General Standards Applicable to Generators of Hazardous Waste) without a permit or without having interim status, provided the receiving healthcare facility: (1) is under the control of the same person as the very small quantity generator healthcare facility that is sending the potentially creditable hazardous waste pharmaceuticals off-site, or has a contractual or other documented business relationship whereby the receiving healthcare facility supplies pharmaceuticals to the very small quantity generator healthcare facility;(2) is operating under this subchapter for the management of its potentially creditable hazardous waste pharmaceuticals;(3) manages the potentially creditable hazardous waste pharmaceuticals that it receives from off-site in compliance with this subchapter; and(4) keeps records of the potentially creditable hazardous waste pharmaceuticals shipments it receives from off-site for three years from the date that the shipment is received.(c) Prohibition. Healthcare facilities are prohibited from sending hazardous wastes other than potentially creditable hazardous waste pharmaceuticals to a reverse distributor.(d) Biennial and Annual Waste Summary reporting by healthcare facilities. A healthcare facility is not subject to the Annual Waste Summary reporting requirements under § 335.9 of this title (relating to Recordkeeping and Annual Reporting Procedures Applicable to Generators) or the biennial reporting requirements in 40 CFR § 262.41 as adopted under § 335.56 of this title (relating to Recordkeeping and Reporting Applicable to Small and Large Quantity Generators) for potentially creditable hazardous waste pharmaceuticals managed under this subchapter.(e) Recordkeeping by healthcare facilities. Healthcare facilities are subject to the following recordkeeping requirements for managing potentially creditable hazardous waste pharmaceuticals.(1) A healthcare facility that initiates a shipment of potentially creditable hazardous waste pharmaceuticals to a reverse distributor must keep the following records (paper or electronic) for each shipment of potentially creditable hazardous waste pharmaceuticals for three years from the date of shipment: (A) the confirmation of delivery; and(B) the shipping papers prepared in accordance with 49 CFR Part 172 , Subpart C, if applicable.(2) The periods of retention referred to in this section are extended automatically during the course of any unresolved enforcement action regarding the regulated activity, or as requested by the executive director.(3) All records must be readily available upon request by an inspector.(f) Response to spills of potentially creditable hazardous waste pharmaceuticals at healthcare facilities. A healthcare facility must immediately contain all spills of potentially creditable hazardous waste pharmaceuticals and manage the spill clean-up materials as non-creditable hazardous waste pharmaceuticals in accordance with this subchapter.30 Tex. Admin. Code § 335.757
Adopted by Texas Register, Volume 47, Number 04, January 28, 2022, TexReg 0346, eff. 2/3/2022