Coming Soon: Revised and (Mostly) Relaxed Hazardous Waste Pharmaceutical Regs!
Stites & Harbison Client Alert, July 2, 2019
The regulation of hazardous waste in our nation is one of the most important and complicated programs. In no other sector is it more complex than in the healthcare arena where a facility has many unique, highly-regulated categories of waste including a general medical "red-bag" waste, biomedical/infectious waste, radioactive medical waste and hazardous wastes including the unique subset of "pharmaceutical hazardous wastes." Recognizing the complexity to healthcare facilities and the burden on medical professionals, the U.S. Environmental Protection Agency recently amended its regulations to provide more clarity and practicality in how one category, pharmaceutical hazardous wastes, are managed and reported. Under the "Management Standards for Hazardous Waste Pharmaceutical and Amendment to the P075 Listing for Nicotine," to become effective on August 21, 2019,1 the new regulations affect hospitals, pharmacies, grocery stores, outpatient care centers, nursing care, and similar facilities. With one exception in order to protect water quality, the new rules are expected to lighten the regulatory burden on facility staff.
The EPA recognized that hospital-floor medical staff often must make spur-of-the-moment hazardous waste decisions, even though they generally lack the expertise to do so and frankly, are preoccupied with patient medical-care tasks.
The major federal regulatory changes that become effective in August are:
- There will be a total ban on "flushing" hazardous-waste pharmaceuticals. It has become clear that pharmaceuticals sent down the drain or flushed cannot be treated by wastewater treatment plants, and traces of many drugs are found in our waterways notwithstanding dilution at the source, therefore, a complete ban on flushing;
- Eliminating the dual regulatory programs for the hazardous waste pharmaceuticals that are also regulated by the Drug Enforcement Agency controlled substance regulations;
- Allow healthcare facilities to accumulate pharmaceuticals (that are not sent to reverse distributors) for up to one year;
- Reverse Distributors that handle unused or expired pharmaceuticals are no longer determined to be "hazardous waste generators" under 40 CFR 260, rather, they will be a new category with their own regulatory program more consistent with industry practices;
- Revise the classification of nicotine and associated nicotine-related product wastes, e.g. patches, chewing gum, lozenges, and packaging from an "acute hazardous waste" (listing: P075 when discarded) to allow simple disposal in the garbage can.
In a sector where dealing with waste streams from almost every clinical activity warrants constant attention, the new framework for dealing with hazardous waste pharmaceuticals should take some regulatory pressure off of the medical caregivers and also give the EHS staff some slack.
1 84 Fed. Reg. No. 36, February 22, 2019.