November 27, 2021

Volume XI, Number 331

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November 24, 2021

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August 21 Effective Date for New EPA Standards for Management of Hazardous Waste Pharmaceuticals

We recently outlined key provisions of the Environmental Protection Agency’s (EPA’s) Final Rule modifying the standards governing industry management of hazardous waste pharmaceuticals, which become effective August 21, 2019. 

Impacted industries must immediately comply with the nationwide ban on the sewering of hazardous waste pharmaceuticals as of the August 21st effective date.  The ban applies to a wide range of stakeholders, including, but not limited to reverse distributors, pharmacies, hospitals, and wholesalers.

Additional regulatory changes under the Final Rule involving the management of FDA-approved over-the-counter nicotine replacement therapies (“NRT”) and hazardous waste prescription pharmaceuticals destined for reverse distribution also become effective on August 21st in Alaska and Iowa.  All other states will have the option to adopt the NRT changes at the state level before they become effective.  As for the changes to management of hazardous waste prescription pharmaceuticals, all other states must adopt the EPA’s regulatory changes by July 1, 2022 if enacted through legislation, or by July 1, 2021, if enacted through state regulation.  The other 48 states may also adopt more stringent changes to the handling of hazardous waste prescription pharmaceuticals than envisioned by the EPA—in other words, for these states, the EPA regulation serves a regulatory floor, not a ceiling.

August 21, 2019 marks the start of the battle at the state level for regulatory consistency regarding the management of NRT waste and hazardous waste prescription pharmaceuticals.  Many impacted stakeholders will be subject to multiple states’ hazardous waste regulations, either through multi-state stakeholder business locations or through waste that is transported across multiple state lines.  Without some measure of state law consistency, entities who manage NRT waste or hazardous waste prescription pharmaceuticals may see their compliance costs rise as they struggle to comport with variable and possibly conflicting state requirements.

©2021 Epstein Becker & Green, P.C. All rights reserved.National Law Review, Volume IX, Number 228
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About this Author

John S. Linehan, Epstein Becker Green, Health Care Attorney, Life Science
Senior Counsel

JOHN “JACK” S. LINEHAN is an attorney in the Health Care and Life Sciences practice, in the Baltimore and Washington, DC, offices of Epstein Becker Green. His practice focuses on pharmacy law, drug distribution and reimbursement, and related fraud and abuse issues, government investigations, and litigation matters.

Mr. Linehan:

  • Counsels retail and specialty pharmacies, drug manufacturers and distributors, pharmacy benefit managers (PBMs), insurers, and other health care providers and suppliers...

443-663-1355
Christopher H. Smith Health Care Attorney Epstein Becker
Senior Counsel

CHRISTOPHER R. SMITH is a Senior Counsel in the Health Care & Life Sciences and Litigation & Business Disputes practices, in the Washington, DC, office of Epstein Becker Green. His practice focuses on pharmacy law, drug distribution, and reimbursement issues.

Mr. Smith:

  • Advises on pharmaceutical supply chain law and regulations, including the Drug Supply Chain Security Act, EPA pharmaceutical hazardous waste regulations, consumer drug take-back and disposal regulations, and legislative...
202-861-1882
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