On December 11, 2018, the Acting Administrator of the U.S. Environmental Protection Agency (EPA) signed a final rule establishing special management standards for pharmaceutical wastes that are classified as hazardous wastes under the Resource Conservation and Recovery Act (RCRA). The Final Rule culminates a decade-long effort to tailor the federal hazardous waste program for these wastes, including a 2008 proposal (in the waning days of the Bush Administration) to classify and regulate the wastes as “universal wastes” and a 2015 proposal (in the next-to-last year of the Obama Administration) to establish an entirely new framework for pharmaceutical wastes. See generally "EPA Proposes New Rules for Pharmaceutical Wastes That Qualify as RCRA Hazardous Wastes" (September 10, 2015). The Final Rule tracks the 2015 proposal fairly closely, but with a number of significant modifications.

Key highlights of the Final Rule are presented briefly below. A more in-depth summary and analysis of the Rule is here. The Rule has not yet been officially promulgated through publication in the Federal Register, perhaps in part because of the ongoing partial federal government shutdown. Once the Rule is published, it will take effect six months later at the federal level. However, as discussed in the final section of the attached summary and analysis, it may take months or years for most of the Rule to become effective in the vast majority of states, and portions of the Rules might not ever be adopted by some states (although EPA encourages them to do so). 

Highlights

The Final Rule prohibits sewering of hazardous waste pharmaceuticals by healthcare facilities (defined to include pharmaceutical distributors and retailers) and by reverse distributors of prescription pharmaceuticals.

The Rule reaffirms long-standing EPA guidance that products handled in reverse logistics systems are generally not solid or hazardous wastes, but departs from that guidance for prescription pharmaceuticals sent to reverse distributors to facilitate or verify return credits from a manufacturer – effectively moving the point at which such products are classified and must be handled as wastes back to the originating healthcare facilities.

The Rule establishes new standards for healthcare facilities (as broadly defined) and for reverse distributors of prescription pharmaceuticals, including detailed requirements for storage, labeling, recordkeeping, reporting, and off-site shipment. 

The Rule revises the RCRA definition of “empty” for containers of hazardous waste pharmaceuticals (including delivery devices such as syringes, intravenous (IV) bags, inhalers, and nebulizers) so as to facilitate handling of used pharmaceutical containers in an environmentally protective manner, without always requiring containers that were formerly used for acutely hazardous pharmaceuticals to be triple-rinsed or requiring containers formerly used for other (non-acutely) hazardous pharmaceuticals wastes to be evaluated to determine the amount of residues remaining. 

The Rule exempts over-the-counter (OTC) nicotine gums, lozenges, and patches that have been approved by the Food and Drug Administration (FDA) as nicotine replacement therapies, thereby correcting the historical misclassification of these items as acutely hazardous wastes, which caused large numbers of retailers to be regulated as large quantity generators of hazardous wastes whenever they had to discard just a few boxes of expired or damaged products. However, the exemption does not extend to other low-concentration nicotine products such as prescription nicotine replacement therapies, electronic cigarettes (e-cigarettes), vaping pens, and “e-liquids” (i.e., refills for e-cigarettes and vaping pens). 

The Rule establishes new conditional exemptions for hazardous waste pharmaceuticals that qualify as controlled substances under the rules of the U.S. Drug Enforcement Administration (DEA) and/or are collected in household pharmaceutical waste takeback programs or events.

The Rule establishes new exclusions for pharmaceuticals being managed pursuant to recalls, litigation holds, or FDA-approved new drug investigations, until the materials are released from applicable legal controls and/or a decision is made to discard the materials.

Beveridge & Diamond assists clients in a wide range of industrial sectors with solid and hazardous waste regulatory issues under RCRA, its state counterparts, international treaties, and the laws and regulations of countries around the world. We regularly help clients in understanding and complying with the regulatory requirements for discarded pharmaceuticals and other consumer products, including the threshold issues of when these materials qualify as “wastes,” when wastes qualify as “hazardous,” and when hazardous wastes are eligible for regulatory exemptions or exclusions. We have been lead counsel in many cases challenging key portions of the RCRA regulations, and defend companies in related enforcement actions. For more information about EPA’s Final Rule on pharmaceutical wastes, please contact the author, Aaron Goldberg, or any other member of our RCRA/Hazardous Waste practice group.