Published in the February 22, 2019 Federal Register, EPA's long-awaited final rule to manage hazardous waste pharmaceuticals generated by healthcare facilities (including hospitals, clinics, and retail stores with pharmacies) and reverse distributors will go into effect August 21, 2019 in EPA territories and in states that do not have an authorized Resource Conservation and Recovery Act (RCRA) program.

The final rule, entitled “Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine,” provides flexibility from certain hazardous waste requirements, but does require regulated entities to provide certain training, complete reporting, and maintain recordkeeping, among other obligations. Failure to comply can result in enforcement and potential penalties, so it's important for affected entities to quickly get familiar with the Final Rule and develop a compliance plan.

RCRA-authorized states are required to adopt the final rule; however, the rule's ban on flushing hazardous waste pharmaceuticals will automatically become effective in all states on August 21, 2019. In addition, because the rule's exemption from the P075 listing is less stringent than current federal regulations, authorized states may, but are not required to, adopt this change to the P075 listing and can still choose to regulate nicotine replacement therapies (NRTs) as listed waste.

The published rule can be found here.