According to the Healthcare Environmental Resource Center, “EPA will not be publishing a rule finalizing the Hazardous Waste Pharmaceuticals Rule in October of 2016 along with the Hazardous Waste Generator Improvements final rule and previously projected.”

Pharmacy retailers have anxiously awaited the final Management Standards for Hazardous Waste Pharmaceuticals rule (80 Fed. Reg. 50,014), after the U.S. Environmental Protection Agency (U.S. EPA) published the proposed rule on September 25, 2015 in the Federal Register, but it appears the wait will continue.  Pharmacy retailers have hoped that the final rule would, among other things, provide a means of avoiding Large Quantity Generator (LQG) status and the onerous requirements, which are ill-suited for retailers.  However, based on discussions with U.S. EPA sources, we now understand that the Pharmaceuticals rule is not likely to be finalized before the change in presidential administration.  Given the change in administration, and depending on the election results, we may not see a final Pharmaceuticals rule for years.
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California’s environmental prosecutors have scrutinized hazardous waste management for several years now, particularly at major retailers.  This focus has led to California settlements with Costco, CVS, Home Depot, Lowe’s, Wal-Mart, and Walgreens, among other retailers.  The settlements resolved alleged mismanagement of hazardous waste generated from material such as consumer products, pharmaceuticals, and general home improvement products.
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In 2011, U.S. EPA issued guidance concluding that generators of p-listed pharmaceutical wastes did not need to count the weight of non-RCRA empty containers in determining their generator status. Instead, EPA determined that “it is only the residue in the non-RCRA empty container that is considered a p-listed hazardous waste; the container itself is not a hazardous waste.” Containers that Once Held P Listed Pharmaceuticals, November 4, 2011.  This EPA memo was long-awaited by retail pharmacies and other healthcare facilities, as it provided a mechanism to forego counting containers that previously held warfarin-family pharmaceuticals toward generator status.  This was particularly helpful, given that where a facility accumulates more than 1 kilogram (2.2 pounds) of acute hazardous waste at any one time, the facility is subject to stringent Large Quantity Generator of hazardous waste (LQG) regulations.  While such generators may still be subject to LQG requirements based on generation of other p-listed waste such as nicotine replacement therapy products, EPA’s November 4, 2011 memo significantly reduced the likelihood that retail pharmacies and other healthcare facilities would be subject to LQG regulation.
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Atlanta lawyer Karlie Webb recently authored an article for the winter edition of the State Bar of Georgia Environmental Law Section newsletter, “Perspectives” on the EPA’s sector-specific rules for hazardous waste pharmaceuticals. She discusses the proposed requirements and the impacts on healthcare facilities. To read the article, click here.

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. 
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As reported by Law360, Troutman Sanders LLP and members of its Environmental and Natural Resources Practice Group assisted Safeway Inc. regarding its recent settlement of retail and pharmaceutical waste issues in California.  The Alameda County District Attorney’s office, along with 43 other California jurisdictions, filed a Complaint and Stipulation of Final Judgment resolving the case for payments of penalties, investigative costs and Supplemental Environmental Projects valued at $9.87 M. Prosecutors alleged that Safeway and its approximately 500 grocery stores and pharmacies, as well as two distribution centers, had improperly disposed of hazardous and medical wastes under state laws regulating the disposal of these materials.
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In recent years, there has been a significant increase in the number of on-site inspections and enforcement activity related to retail and pharmaceutical hazardous waste. In the wake of this heightened scrutiny, the regulated community (including, for example, big box retailers, hospitals, medical clinics, and retail pharmacies) is rigorously working to maintain regulatory compliance, but the applicable RCRA regulatory scheme has proven to be the source of much confusion.  Fortunately, it is clear that EPA appreciates the difficulties inherent in the current regulatory scheme, and, according to its website, EPA is set to release a proposed pharmaceutical waste management rule for public comment in March 2014.
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