August 23, 2023

VSQG Hazardous Waste Pharmaceuticals Guidance

EPA has been made aware of the challenges healthcare facilities are experiencing when shipping hazardous waste pharmaceuticals offsite, due to the backlog of containerized hazardous waste at commercial incinerators. In August 2021, the agency published guidance for hazardous waste generators to navigate the incinerator backlog issue. However, the suggested solutions are not applicable to healthcare facilities. [RO 14939] In more recent guidance, EPA details the options for Part 266, Subpart P healthcare facilities to dispose of hazardous waste pharmaceuticals. [RO 14959]

One healthcare facility asked EPA if they could use the disposal options available in §266.506(b)(3), which are part of a conditional exemption for Drug Enforcement Administration (DEA) controlled substances that are also RCRA hazardous wastes. However, the disposal options in §266.506(b)(3) are only an option for hazardous waste pharmaceuticals that are also DEA-controlled substances and under DEA control. Thus, §266.506(b)(3) is not applicable to most hazardous waste pharmaceuticals and healthcare facilities.

Very small quantity generator (VSQG) healthcare facilities not operating under Subpart P can use the optional provisions in §266.504. They may ship their hazardous waste pharmaceuticals to another healthcare facility per §266.504(b). To be able to use this option, the receiving healthcare facility must be operating under Subpart P and must be:

Under control of the same person, or
Under contract or otherwise documented business relationship, where the receiving healthcare facility supplies the pharmaceuticals to the VSQG healthcare facility.

Additionally, VSQGs that have not opted into Part 266, Subpart P do not have any accumulation time limits and may also send their hazardous waste pharmaceuticals to other facilities mentioned in the VSQG regulations in §262.14(a)(5).

VSQG healthcare facilities that have opted into Part 266, Subpart P cannot use the optional provisions in §266.504. The accumulation time limit for hazardous waste pharmaceuticals is one year under Subpart P, and no regulatory option exists to request an extension. Accordingly, these facilities must send their hazardous waste pharmaceuticals to either a TSDF or reverse distributor and have one year to do so. EPA suggests contacting the implementing agency, usually an authorized state, for additional questions.

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This document addresses issues of a general nature related to the federal environmental regulations. Persons evaluating specific circumstances dealing with the environmental regulations should review state and local laws and regulations, which may be more stringent than federal requirements. In addition, the assistance of a qualified professional should be enlisted to address any site-specific circumstances.