pharmacyThe Environmental Protection Agency (EPA) has issued proposed regulations regarding the disposal of drugs which the Agency calls “pharmaceutical hazardous waste.” The EPA has concluded that the Resource Conservation and Recovery Act (RCRA), which was designed for regulating industrial hazardous waste, has not been a perfect fit for regulating pharmaceutical wastes generated by the healthcare sector.
The new rules will affect all pharmacies, hospitals and clinics, veterinary clinics, dentists’ offices, physicians’ offices, nursing homes and all senior living facilities and rehabilitation centers that dispense drugs. This proposed regulation will also apply to pharmaceutical reverse distributors that collect unused pharmaceuticals and assist health care facilities in managing excess drugs. These regulations will not apply to pharmaceutical manufacturing facilities.
At issue are over-the-counter and prescription drugs. The proposed definition of “pharmaceutical” is broadly defined to include dietary supplements, drug residues, contaminated personal protective equipment, and clean-up materials used in a pharmaceutical spill.
The proposed legislation covers the labeling of these wastes, as well as their disposal. The EPA is also pursuing emergency planning, training and preparedness programs in facilities that have the capacity to dispense medication.
The EPA contends that this rule will protect our drinking water and surface water by preventing “sewering” of prescription and over-the-counter medication. The legislation bans regulated health care facilities from flushing pharmaceutical hazardous waste down the drain. The EPA contends that these proposed regulations will protect waterways from the 6,400 tons of pharmaceutical hazardous waste that is flushed down toilets or sinks yearly.
The proposed regulations also provide healthcare facilities with unique industry specific standards to address pharmaceutical waste, manifest codes, record-keeping, waste accumulation rules, and storage rules. Unlike other RCRA provisions, these rules are generally not waste volume dependent.
The EPA ruling will go into the public comment phase, which will last for 60 days, pending the publication of the ruling in the Federal Register. Comments on the Rule can be submitted to Federal eRulemaking Portal, Docket No-EPA-HQ-RCRA-2007-0932.
By Susan J. Sadler, Member, Dawda, Mann, Mulcahy & Sadler, PLC