On Dec. 11, 2018, the U.S. Environmental Protection Agency (EPA) finalized standards for managing hazardous waste pharmaceuticals in the healthcare sector.
The rule creates a new Part 266 Subpart P for the management of hazardous waste pharmaceuticals by healthcare facilities and reverse distributors. Healthcare facilities for both humans and animals, as well as reverse distributors, will manage their hazardous waste pharmaceuticals under the new set of sector-specific standards, in lieu of the generator regulations in Part 262.
The most significant change from the proposed rule is that the final rule adds provisions so that FDA-approved, over-the-counter nicotine replacement therapies will no longer be considered hazardous waste when discarded.
A second significant change from the proposed rule is an establishment of the EPA’s policy on the regulatory status of unsold retail items, including nonprescription pharmaceuticals and other unsold retail items that have a reasonable expectation of being legitimately used/reused or reclaimed.
Specifically, the final rule:
- Prohibits the disposal of hazardous waste pharmaceuticals down the drain.
- Eliminates the dual regulation of Resource Conservation and Recovery Act (RCRA) hazardous waste pharmaceuticals that are also Drug Enforcement Administration (DEA) controlled substances by finalizing a conditional exemption.
- Maintains the household hazardous waste exemption for pharmaceuticals collected during pharmaceutical takeback programs and events, while providing for their proper disposal.
- Clarifies that FDA-approved, over-the-counter nicotine replacement therapies (i.e., nicotine patches, gums and lozenges) will no longer be considered hazardous waste when discarded.
- Reaffirms the EPA’s long-standing policy that nonprescription pharmaceuticals and other unsold retail items with a reasonable expectation of being legitimately used/reused or reclaimed are not solid waste.
The final rule fundamentally changes the EPA’s long-held position on the point at which a pharmaceutical product is considered a solid waste under RCRA. That change will create significant regulatory uncertainty — and potential liability — for entities in the pharmaceutical distribution chain that suddenly find themselves evaluating compliance with the new rule.
While Acting EPA Administrator Andrew Wheeler signed the rule on Dec. 11, 2018, the rule will not become effective until 6 months after it is published in the Federal Register. The rule also could be subject to petitions for reconsideration, or to challenge in the Court of Appeals for the D.C. Circuit. The final rule will likely become effective in Alaska, Iowa, Kentucky, New Jersey, Pennsylvania and Puerto Rico; all other states will have to incorporate the new rules into their existing regulations.
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