Final Rule – EPA Management Standards for Hazardous Waste Pharmaceuticals

Mary Madison, RN, RAC-CT, CDP
Clinical Consultant – Briggs Healthcare®

The Final Rule for hazardous waste disposal was signed by Environmental Protection Agency Acting Administrator Andrew Wheeler on December 11, 2018 however it cannot be published in the Federal Register yet due to the ongoing partial government shutdown.

The pre-publication of the unofficial Final Rule with docket number EPA-HQ-RCRA-2007-0932 is 491 pages in length.  (I’ll watch for the official posting in the Federal Register once the partial government shutdown is over and will let you know when that’s available.  This final rule is effective 6 months after that publication in the Federal Register.)  This EPA Final Rule also includes an amendment to the P075 listing for nicotine.  The P075 listing excludes certain U.S. Food and Drug Administration (FDA) approved over-the-counter (OTC) nicotine replacement therapies (NRTs) from being listed as acute hazardous waste.  Most of this information is found on pages 25 through 53.

“This final 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) and reverse distributors will manage their hazardous waste pharmaceuticals under this new set of sector-specific standards in lieu of the generator regulations in part 262. Among other things, this new subpart prohibits the disposal of hazardous waste pharmaceuticals down the drain and eliminates the dual regulation of RCRA hazardous waste pharmaceuticals that are also Drug Enforcement Administration (DEA) controlled substances by finalizing a conditional exemption. The new subpart also maintains the household hazardous waste exemption for pharmaceuticals collected during pharmaceutical take-back programs and events, while ensuring their proper disposal. The new subpart also codifies EPA’s prior policy on the regulatory status of nonprescription pharmaceuticals going through reverse logistics.”  This final rule also establishes the “EPA policy on the regulatory status of unsold retail items that are not pharmaceuticals and are managed via reverse logistics…(it) does not add pharmaceuticals to the hazardous waste listings or expand the hazardous waste characteristics to include additional pharmaceuticals.”

A major difference between the September 2015 proposed rule and this final rule is that Assisted Living communities are not included in the types of long-term care/post-acute care facilities that must comply with these standards when the rule does become effective.  Also not included in these standards are group homes, independent living communities and independent living and assisted living portions of CCRCs.

While these communities are not required to comply with the new standards, the EPA “recommends that assisted living facilities, group homes, independent living communities, and the independent and assisted living portions of continuing care retirement communities develop voluntary pharmaceutical collection programs for both hazardous and non-hazardous waste pharmaceuticals as a best management practice, as allowed by DEA regulations, to ensure proper management, avoid flushing, and minimize the potential for accidental poisonings, misuse or abuse.”  The EPA recommends that “residents of assisted living facilities follow the guidelines developed by the U.S. Office of National Drug Control Policy, the Food and Drug Administration and the EPA for the disposal of unwanted household pharmaceuticals.”  

Hospice facilities, nursing facilities, skilled nursing facilities as well as the nursing and skilled nursing portions of CCRCs still must comply with the EPA’s final rule regarding the disposal of hazardous waste pharmaceuticals.

EPA goals for this final rule include:

  • facilitate compliance among healthcare facilities
  • reduce the amount of pharmaceuticals that are disposed of down the drain
  • address the overlap between EPA’s RCRA hazardous waste regulations and the DEA regulations for controlled substances
  • clarify the regulatory status of a major practice used by healthcare facilities, including retailers in particular, for the management of unused and/or expired pharmaceuticals, known as reverse distribution

I encourage entities affected by this final rule to start reviewing/digesting the information now, in preparation for Federal Register publication and implementation 6 months from the date of publication.  Hopefully the partial shutdown ends soon – 6 months from that date goes by quickly.

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