On August 31, 2015, EPA released a pre-publication copy of proposed regulations that would impose new requirements on hospitals, long-term care facilities, clinics, pharmacies, and other medical service providers that handle pharmaceuticals regulated as hazardous waste.

The new regulations apply to all healthcare facilities that label, manage, or dispose of hazardous waste pharmaceuticals without regard to the volume of wastes—meaning the existing distinctions between small quantity generators and large quantity generators under RCRA Subtitle C would no longer apply. However, "Conditionally Exempt Small Quantity Generators" (CESQGs) would be exempt from most of the provisions of the regulations. The regulation presumes that those exemptions apply to long-term care facilities with fewer than 10 beds.

The regulations would apply to "hazardous waste pharmaceuticals," including approximately 30 commercial chemical products listed as hazardous waste under RCRA that have pharmaceutical uses and any pharmaceutical product that exhibits one or more of the four characteristics of a hazardous waste (ignitability, corrosivity, reactivity, and toxicity). For example, solutions containing more than 24% alcohol are considered hazardous based on their ignitability characteristic.

Among other things, the proposed regulations would ban healthcare facilities from flushing hazardous waste pharmaceuticals down the sink or toilet. The regulations would also impose new training requirements on healthcare facilities. 

At the same time, the regulations would relax certain requirements that apply to generators of non-pharmaceutical hazardous waste, including satellite accumulation area regulations and hazardous waste manifesting requirements. EPA has characterized these generally applicable regulations, which were developed for traditional hazardous waste generators in the manufacturing sector, as "a poor fit for healthcare facilities" and believes that the proposed regulations are designed to be "workable in a health care setting while ensuring safe management and disposal of hazardous waste pharmaceuticals."

The proposed rule, "Management Standards for Hazardous Waste Pharmaceuticals," is available here. EPA will accept public comments on the proposal for 60 days following its publication in the Federal Register.