Today, February 22, 2019, EPA published the final “Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine” rule in the Federal Register. The final rule becomes effective at the federal level on August 21, 2019. As we previously reported, EPA released a prepublication copy of the final rule on December 11, 2018.
The final rule, applicable to “healthcare facilities” and “reverse distributors,” establishes new sector-specific regulations in 40 C.F.R. Part 266 Subpart P for managing hazardous waste pharmaceuticals pursuant to the Resource Conservation and Recovery Act (RCRA). Among other provisions, the regulations include a prohibition on disposing hazardous waste pharmaceuticals in sewer systems (i.e., down the drain), a limited carve-out for hazardous waste pharmaceuticals that are also DEA controlled substances, and new management standards related to reverse distribution of prescription pharmaceuticals. The final rule also clarifies that nonprescription pharmaceuticals that are sent to reverse logistics facilities (distinguished from reverse distributors) are not yet a waste at the healthcare facility where there is a reasonable expectation of being used/reused or reclaimed. The final rule also excludes FDA-approved, over-the-counter nicotine replacement therapy products—which include gums, lozenges, and patches—from regulation as an acute hazardous waste.
For an in-depth analysis of the final rule and discussion about state adoption, please see our January 4, 2019 Law360 article, “A Closer Look at New Pharmaceutical Hazardous Waste Regs.”