EPA's final rule for pharmaceutical wastes

• The rule prohibits dumping all hazardous waste pharmaceuticals down the drain and requires them to be sent for incineration or other responsible disposal options.

The Environmental Protection Agency (EPA) published its final rule, Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine, on February 22, 2019, with an effective date of August 21, 2019. The rule is intended to streamline standards for managing hazardous waste pharmaceuticals in the healthcare and retail sectors.

Under the rule, hospitals, pharmacies, and medical offices have more flexibility to safely manage drug waste. In addition, Food and Drug Administration (FDA)-approved over-the-counter nicotine replacement therapies such as gums, patches, and lozenges will no longer be considered hazardous wastes when disposed of. Until this rule, these wastes were treated as acute hazardous wastes, meaning accumulating as little as one kilogram of a nicotine-containing waste could push a generator into the large quantity generator (LQG) category.

The final rule creates Part 266 Subpart P for the management of hazardous waste pharmaceuticals by healthcare facilities and reverse distributors. Healthcare facilities and reverse distributors will manage hazardous waste pharmaceuticals under this set of sector-specific standards instead of the generator regulations in Part 262.

The rule prohibits dumping all hazardous waste pharmaceuticals down the drain and requires them to be sent for incineration or other responsible disposal options. This is expected to reduce the amount of toxic chemicals entering U.S. surface waters by up to 2,300 tons per year. Further, the rule eliminates the dual regulation of hazardous waste pharmaceuticals that are also Drug Enforcement Administration (DEA) controlled substances by exempting them from Resource Conservation and Recovery Act (RCRA) regulation.

The final rule does not add pharmaceuticals to the hazardous waste listings at 40 CFR 261 Subpart D or expand the hazardous waste characteristics to include additional pharmaceuticals in 40 CFR 261 Subpart C.

A note on household hazardous waste: Drugs collected during pharmaceutical take-back programs and events are considered to be exempt household hazardous waste. EPA encourages these collections to ensure proper disposal.