The U.S. Environmental Protection Agency is expected to finalize regulatory changes that would provide new requirements for managing hazardous waste pharmaceuticals later this year. This article provides an overview of the proposed regulations, discusses some of the key issues on which the submitted comments have focused, and analyzes some issues that should be addressed by the final rule.
Facilities that generate waste pharmaceutical products are often subject to the onerous hazardous waste requirements imposed by the Resource Conservation and Recovery Act (RCRA), and facilities with even a single shipment of acutely hazardous pharmaceutical waste (1 kg, or 2.2 lbs. in a single month) become subject to RCRA’s even more stringent large-quantity generator requirements. The EPA has proposed changes to codify requirements for the common practice of returning these products to manufacturers and to clarify other ambiguities with respect to managing hazardous waste pharmaceuticals (HWP). The EPA hopes that these changes will also reduce the amount of HWP that is poured down drains and often passes through sewer treatment processes, thereby improving water quality in drinking water sources.
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