January 01, 2014

The War on Drugs: Pharmaceutical Waste Management Challenges and Emerging Issues

Lynn Kornfeld and Ann Prouty

The discovery of prescription drugs in water resources throughout the United States has heightened both public and agency scrutiny of pharmaceutical waste management practices. Healthcare facility practices have been reported as a contributor to this water-quality concern. Cornelia Dean, Drugs Are in the Water. Does It Matter? NY Times, Apr. 3, 2007. As a result, many healthcare facilities have been the focus of several large enforcement actions by both the U.S. Environmental Protection Agency (EPA) and state agencies related to the handling, storage, and disposal of pharmaceutical waste. Until recently, hazardous waste management regulatory programs have failed to consider the unique challenges healthcare facilities face in characterizing, handling, and disposing of pharmaceutical wastes. However, more recent agency focus on pharmaceutical waste issues has led to a number of federal and state regulatory and policy initiatives to try to streamline pharmaceutical waste management requirements and facilitate broader compliance.

This article explores recent developments related to pharmaceutical waste management, including enforcement activity under the Resource Conservation and Recovery Act (RCRA) and state implementing programs, in addition to emerging federal and state regulatory initiatives that affect hospitals, pharmacies, clinics, and all other facilities that manage pharmaceutical products and wastes. The article also provides recommendations for healthcare facilities to maintain compliance with this rapidly evolving area of regulation and actions those entities can take to ensure that future regulatory changes and guidance address the unique concerns and challenges faced by the healthcare industry.

Pharmaceutical waste management practices are regulated by a number of federal and state environmental laws and regulations, including RCRA, 42 U.S.C. § 6901 et seq., and the Clean Water Act, 33 U.S.C. § 1251 et seq., and their state implementing regulations. Many states also have specific regulatory programs for the management of infectious or nonhazardous medical waste. These requirements are not only applicable to pharmaceutical manufacturers but to all entities that manage pharmaceuticals, such as hospitals, pharmacies, ambulatory surgery centers, dialysis clinics, nursing homes, veterinarian clinics, as well as supermarkets and big box retailers that contain pharmacies.


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