U.S. EPA Proposes Standards for Management of Pharmaceutical Wastes

January 23, 2009

In response to growing public concern over the presence of pharmaceutical chemicals and metabolic by-products in surface water and ground water, the regulation of pharmaceutical waste is fast becoming a priority for U.S. EPA and state EPAs.

Currently, pharmaceutical wastes deemed “hazardous” are regulated under Subtitle C of the Resource Conservation and Recovery Act, or “RCRA.” A pharmaceutical waste is “hazardous” if it is among the substances specifically listed as such under RCRA or if it exhibits a hazardous characteristic such as ignitability, corrosivity, reactivity and/or toxicity. Some examples include certain chemotherapeutic drugs, like Mitomycin C, Cytotoxan, as well as other drugs like Epinephrine, Nicotine and Warfarin. According to U.S. EPA, there are at least 31 chemicals with pharmaceutical uses on one or more of its hazardous waste lists. Determining whether a waste is “hazardous” is often difficult, particularly for generators of pharmaceutical wastes. Materials that are deemed “hazardous wastes” are subject to stringent management and disposal requirements.

A hazardous pharmaceutical waste is regulated under RCRA the same way that a hazardous waste generated by industrial processes is regulated. This presents many unique challenges to pharmacies, hospitals, physicians’ offices, dentists’ offices, outpatient care centers, ambulatory health care services, residential care facilities, veterinary clinics, and other facilities that generate varying amounts of hazardous pharmaceutical waste. Unlike hazardous waste generated by industrial facilities, where there are typically a limited number of recurring and predictable waste streams, pharmaceutical waste is often generated at a large number of points in relatively small quantities across the facility. These points of generation could include nursing stations, pharmacies, emergency rooms, operating rooms, and outpatient care centers, to name but a few. Many generators of hazardous pharmaceutical waste may not be aware of the requirements and attendant liability that comes with management of such materials.

In response to these challenges, U.S. EPA is proposing to regulate hazardous pharmaceutical waste under the Universal Waste Rule. The Universal Waste Rule was originally promulgated in 1995 to streamline requirements for certain categories of larger volume hazardous waste generated by a wide variety of generators and facilities, such as batteries, pesticides, mercury-containing equipment, and fluorescent lamps. Hazardous waste managed under the Universal Waste Rule is subject to more streamlined and less stringent requirements. U.S. EPA has proposed to lessen the regulatory burden on hospitals and other medical facilities by adding hazardous pharmaceutical wastes as a new category of universal waste.

The proposed definition of “hazardous pharmaceutical wastes” includes any chemical product, vaccine or allergenic used in the diagnosis, cure, mitigation, treatment, or prevention of disease or injury or intended to affect the structure or function of the body in man or other animals. The proposed definition encompasses containers such as bottles, vials, IV bags, tubes of ointment/gels/creams, and ampules that have held any regulated pharmaceutical waste. It also covers delivery devices such as transdermal patches, gums, and lozenges. The proposed definition does not include sharps or other infectious or biohazardous waste, dental amalgams, medical devices not used for delivery or dispensing purposes, equipment, or contaminated personal protective equipment or cleaning materials.

If the rule becomes final, a facility, such as a hospital or doctor’s office, will have the option of managing hazardous pharmaceutical wastes under the more streamlined universal waste standards. If it so chooses, it will be considered a “handler” of pharmaceutical universal waste rather than a “generator” of hazardous waste. Regulation as a “handler” allows for several benefits including a higher accumulation threshold, a higher on-site accumulation limit, increased storage time, no manifest requirements, and more limited training obligations. U.S. EPA anticipates that generators may choose to manage their hazardous and non-hazardous pharmaceutical waste as universal waste to avoid the difficult and often expensive effort to properly characterize their waste.

Before a facility may choose to manage its hazardous pharmaceutical waste under the Universal Waste Rule, U.S. EPA must finalize the rule and it must be adopted by the state in which the facility is located. The Agency is accepting comment on the proposed rule until February 2, 2009. Depending on the comments received, U.S. EPA expects to issue a final rule sometime in 2010. Additional information may be obtained on U.S. EPA’s website

Please contact Kevin McMurray, Paul Casper, or Jeffery Culver with any questions concerning how hazardous pharmaceutical wastes are currently regulated or how regulation under the Universal Waste Rule may affect your facility.