In the February 22, 2019 Federal Register EPA issued a final rule that created a new set of regulations for pharmaceuticals that are regulated as hazardous waste under the Resource Conservation and Recovery Act (RCRA) when discarded. This final rule imposes a new set of regulations on healthcare facilities (for humans and animals) and reverse distributors in lieu of the existing hazardous waste generator regulations. Importantly, healthcare facility is defined broadly as any person who is lawfully authorized to provide preventative, diagnostic, therapeutic, rehabilitative, maintenance or palliative care, etc. These new regulations also prohibit 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. The rules also maintain the household waste exemption for pharmaceuticals collected during pharmaceutical take-back programs. The rules codify EPA’s prior policy on the regulatory status of nonprescription pharmaceuticals going through reverse logistics and also exclude over-the-counter (OTC) nicotine replacement therapies (NRTs) from regulation as hazardous waste. The rules become effective on August 21, 2019.
US EPA Issues Final Rule Governing Management for Hazardous Waste Pharmaceuticals, 84 FR 5816 (February 22, 2019).