For the better part of a decade, the regulated community, policymakers, and regulators have grappled with how best to manage hazardous waste pharmaceuticals.  On August 31, 2015, the curtain rose on a new era with the pre-publication of a new proposed standard for stemming the flood of pharmaceuticals entering our water supply and streamlining waste management practices to protect our nation’s drug supply.  On one hand, pharmaceutical waste falls squarely within the scope of the Federal Resource Conservation and Recovery Act (RCRA).[1]  On the other hand, the U.S. Environmental Protection Agency regulations implementing RCRA were clearly designed to apply to industrial facilities, and thus regulating hazardous pharmaceutical waste within RCRA’s framework often seems like fitting a square peg into a round hole.  Complicating the issue is that many states have issued their own policies related to managing hazardous pharmaceutical waste, and thus the regulated community has struggled to implement consistent, national programs under this patchwork of federal and state-specific requirements.  In its pre-publication proposed rule, EPA has tried to strike a balance that is long overdue.

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[1]             42 U.S.C. § 6901 et seq. (1976).