PharmE^® News Alert

EPA Signs New Management Standards for Hazardous Waste Pharmaceuticals

(Brookfield, WI – December 12, 2018) PharmEcology Services, WM Sustainability Services

EPA has issued the pre-publication version of its Final Rule on the management of hazardous waste pharmaceuticals with the following summary:

SUMMARY: Some pharmaceuticals are regulated as hazardous waste under the Resource Conservation and Recovery Act (RCRA) when discarded. This final rule creates a new part 266 subpart P for the management of hazardous waste pharmaceuticals by healthcare facilities and reverse distributors. Healthcare facilities (for both humans and animals) and reverse distributors will manage their hazardous waste pharmaceuticals under this new set of sector-specific standards in lieu of the generator regulations in part 262. Among other things, this new subpart prohibits the disposal of hazardous waste pharmaceuticals down the drain and eliminates the dual regulation of RCRA hazardous waste pharmaceuticals that are also Drug Enforcement Administration (DEA) controlled substances by finalizing a conditional exemption. The new subpart also maintains the household hazardous waste exemption for pharmaceuticals collected during pharmaceutical take-back programs and events, while ensuring their proper disposal. The new subpart also codifies EPA’s prior policy on the regulatory status of nonprescription pharmaceuticals going through reverse logistics. EPA is also taking two actions aside from adding part 266 subpart P. First, EPA is finalizing an amendment to the P075 acute hazardous waste listing of nicotine and salts to exclude certain U.S. Food and Drug Administration (FDA) approved over-the-counter (OTC) nicotine replacement therapies (NRTs). Second, in the preamble to this final rule, EPA establishes a policy on the regulatory status of unsold retail items that are not pharmaceuticals and are managed via reverse logistics, fulfilling the commitment we made in the Retail Strategy of September 2016. This final rule does not add pharmaceuticals to the hazardous waste listings or expand the hazardous waste characteristics to include additional pharmaceuticals.

The rule becomes effective federally six months from the date of publication in the Federal Register.

https://www.epa.gov/hwgenerators/pre-publication-management-standards-hazardous-waste-pharmaceuticals-and-amendment-p075

• Posted: December 12, 2018