On August 31, 2015, the Environmental Protection Agency (“EPA”) Administrator signed the proposed Management Standards for Hazardous Waste Pharmaceuticals rule outlining management and disposal standards for hazardous waste pharmaceuticals that are generated specifically by healthcare facilities. Additionally, this rule “clarif[ies] the regulation of the reverse distribution mechanism used by healthcare facilities for the management of unused and/or expired pharmaceuticals” and aims to “strengthen environmental protection” by prohibiting the flushing of hazardous wastes down the toilet or drain. According to an EPA press release, this regulation will “prevent the flushing of more than 6,400 tons of hazardous waste pharmaceuticals annually.”

This proposed rule is the EPA’s response to commenters’ concerns regarding its 2014 Notice of Data Availability for the retail sector and its 2008 proposed Universal Waste rule, which was never finalized, and addresses stakeholders’ concerns regarding difficulties implementing the Resource Conservation and Recovery Act (“RCRA”) Subtitle C hazardous waste regulations for hazardous waste pharmaceuticals generated at healthcare facilities.

Under the proposed rule, “healthcare facilities” is defined broadly and includes:

any person that (1) provides preventative, diagnostic, therapeutic, rehabilitative, maintenance or palliative care, and counseling, service, assessment or procedure with respect to the physical or mental condition, or functional status, of a human or animal or that affects the structure or function of the human or animal body; or (2) sells or dispenses over-the-counter or prescription pharmaceuticals. 

This definition includes, but is not limited to, hospitals, psychiatric hospitals, ambulatory surgical centers, health clinics, physicians’ offices, optical and dental providers, chiropractors, long-term care facilities, ambulance services, coroners and medical examiners, pharmacies, long-term care pharmacies, mail-order pharmacies, retailers of over-the-counter medications; and veterinary clinics and hospitals.

It is important to note that under this proposal, hazardous wastes from long-term care facilities will no longer be exempt from regulation as household hazardous waste under the RCRA unless (1) the hazardous waste pharmaceuticals are controlled substances and two combustion and disposal conditions are satisfied or (2) the hazardous waste generated by the facility is a small enough quantity to qualify for reduced regulatory requirements. Therefore, unless either exception is applicable, hazardous waste generated at a long-term care facility will be subject to both the RCRA Subtitle C management standards as well as the proposed standards.

This proposed rule has not yet been published in the Federal Register, but in the interim, a pre-publication version of the rule can be found here. Comments will be accepted for 60 days following its publication in the Federal Register.