The U.S. EPA has finalized the long-awaited rule — Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine. The Final Rule was signed on December 11, 2018, and is expected to be published in the Federal Register in the coming weeks. The Final Rule is intended to streamline requirements for healthcare facilities and reverse distributors when they manage and discard hazardous waste pharmaceuticals. It also exempts certain nicotine replacement therapies (“NRT”) from hazardous waste regulation.
The Final Rule will affect many businesses, including hospitals, doctors’ offices, pharmacies, veterinary clinics, and reverse distributors that handle unused pharmaceuticals that are no longer needed. While the Final Rule provides flexibility from certain hazardous waste requirements, it still requires those covered by the Final Rule to provide certain training, complete reporting, and maintain recordkeeping, among other things. Failure to comply with these requirements can mean enforcement and potential penalties, so it will be particularly important for affected entities to quickly get familiar with the Final Rule and develop a compliance plan.
In 2008, EPA had initially proposed to regulate the disposal of pharmaceuticals as a universal waste, rather than under the more rigid hazardous waste program. Confronted with numerous concerns, EPA decided not to finalize the proposal and instead developed a new pharmaceuticals rule, which was issued for public comment on September 25, 2015.
Facilities Subject to the Final Rule
While “pharmaceuticals” may include a variety of products, the Final Rule addresses only those pharmaceuticals that are deemed hazardous waste by the Resource Conservation and Recovery Act (“RCRA”) — the federal law regulating treatment, storage, and disposal of hazardous wastes.
Although the Final Rule is limited to those pharmaceuticals deemed hazardous wastes, it applies to an expansive list of “healthcare facilities,” which are defined as pharmacies, veterinary clinics, physicians’ offices, optical and dental providers, outpatient care centers, chiropractors, hospitals, surgical centers, nursing care facilities, medical examiners, and coroners’ offices. It also applies to “reverse distributors,” which are entities such as forward distributors and third-party logistics providers that help healthcare facilities calculate and receive credit from pharmaceutical manufacturers when healthcare facilities have unused pharmaceuticals that are no longer needed.
Facilities that are not subject to the Final Rule include pharmaceutical manufacturers, production facilities, or other types of generators of hazardous waste pharmaceuticals, including households, farmers, ranchers, and fisheries.
Additionally, anyone who generates or manages certain discarded NRT will be affected by the amendment to the RCRA listing for nicotine in the Final Rule, as discussed below.
Key Changes for Healthcare Facilities and Reverse Distributors
Historically, hazardous waste management at healthcare facilities has been very complex, because the waste is typically generated at many points (e.g., patient rooms, nursing stations, emergency rooms) in relatively small quantities and in a wide variety of forms. These circumstances make it very difficult to make waste determinations and uniform decisions related to disposal. Moreover, these decisions are often made by healthcare facility employees who are likely, and understandably, unfamiliar with complicated RCRA hazardous waste rules.