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EPA publishes final rule on pharmaceutical waste

February 28th, 2019 by Dakota Software Staff

EPA publishes final rule on pharmaceutical waste

The Environmental Protection Agency's long-awaited final rule for managing hazardous waste pharmaceuticals generated by healthcare facilities and reverse distributors was finally published in the Feb. 22, 2019 Federal Register, more than three years after the publication of the proposed rule.

The new regulations will go into effect on August 21 in EPA territories and states that do not have an authorized Resource Conservation and Recovery Act program.

Entitled "Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine," the final rule requires facilities such as hospitals, clinics and stores with pharmacies to provide specific training, complete reporting and maintain recordkeeping, but grants them more flexibility on certain hazardous waste requirements. Failure to comply can result in enforcement and possible penalties.

Although only EPA territories and RCRA-authorized states are required to adopt the full final rule, all states must adopt the rule's ban on flushing hazardous waste pharmaceuticals.

Final rule eases distinguishes health care facilities from industrial facilities

The agency's new rule draws a distinction between the pharmaceutical hazardous waste produced by health care facilities and the hazardous waste produced by industrial facilities, including industrial facilities that manufacture pharmaceuticals. The rule creates an entirely new set of RCRA regulations to address the former, and streamlines requirements to accommodate the management capabilities of health care facilities and reverse distributors.

The updated regulation now stipulates that a healthcare facility will not become a large quantity generator when it generates more than 1 kilogram of acute hazardous waste pharmaceuticals in a month. Furthermore, health care facilities do not have to comply with the satellite accumulation area regulations and do not need to specify hazardous waste codes on manifests.

Health care facilities are also now able to accumulate hazardous waste pharmaceuticals on-site without an RCRA permit for 365 days, which is 275 days more than the current generator regulations.

Hospitals and other health care facilities are now regulated differently than industrial plants.

The new rule requires health care facilities to have basic training requirements, as well.

The final standards are also tailored to how "reverse distributors" of pharmaceuticals operate, and are set to replace the standard generator regulations for the accumulation and management of hazardous waste pharmaceuticals.

A new amendment removes FDA-approved over-the-counter nicotine replacement therapies such as patches and lozenges from regulation as an RCRA hazardous waste under the Hazardous Waste Code P075 for nicotine. Therefore, stores may now discard such smoking cessation products as non-hazardous waste.

Another section prohibits all health care facilities and reverse distributors, regardless of size, from disposing of hazardous waste pharmaceuticals down the drain. The EPA notes that current RCRA and Clean Water Act requirements allow for this practice.

Regulatory distinctions aim to simplify rules for medical professionals

The original hazardous waste provisions of the RCRA were written by Congress to deal with the types of hazardous waste generated by industrial facilities, which are well known and relatively few in number. In fact, a typical manufacturing facility only generates a handful of wastestreams.

A health care facility, by contrast, can at any moment have thousands of medications in its pharmacy, which often turn into hazardous wastes. Under RCRA regulations, the generator of said waste is required to determine whether the waste is a listed hazardous waste or a characteristic hazardous waste. These "generators" are, in many cases, doctors and nurses, who typically lack the expertise required to make hazardous waste determinations.

As noted by Law 360, the prohibition on flushing hazardous waste pharmaceuticals is one of the few aspects of the new final rule that actually increases rather than diminishes the compliance burden on health care professionals. Nurses, doctors and others will no longer be allowed to flush unused medications down the toilet, with the exception of ignitable wastes and wastes that result in toxic fumes within the publicly owned treatment works. This change is intended to reduce the water pollution and ecological degradation that is currently caused by this common practice.

"Under this final rule, EPA expects that the management of hazardous waste pharmaceuticals will improve and the regulatory burden for many hazardous waste pharmaceutical generators will decrease," the agency stated. "This final rule provides a solution to many of the issues facing healthcare facilities. By finalizing a convenient and practical system for the management of hazardous waste pharmaceuticals that is easy to comply with, EPA encourages healthcare facilities to manage all of their pharmaceutical waste - non-hazardous and hazardous - under the final rule."

The final rule will go into effect 6 months from the date of its publication in the Federal Register in EPA territories and in states that do not have an authorized RCRA program, and the drain disposal prohibition will go into effect nationwide.

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