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Hazardous waste pharmaceuticals are a sector-specific, waste-specific category of waste regulated under the Resource Conservation and Recovery Act (RCRA).
EPA published the final rule, Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine, on February 22, 2019. The rule is intended to streamline standards for managing hazardous waste pharmaceuticals in the healthcare and retail sectors.
The final rule is effective on August 21, 2019.
Under the rule, hospitals, pharmacies, and medical offices have more flexibility to safely manage drug waste. In addition, 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 1 kilogram of a nicotine-containing waste could push a generator into the large quantity generator (LQG) category.
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 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.
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