September 16, 2019

September 16, 2019

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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.

©2019 Epstein Becker & Green, P.C. All rights reserved.

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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 proposals for foreign drug importation
  • Counsels retail and specialty pharmacies, pharmacy benefit managers (PBMs), insurers, and other health care providers and suppliers on a range of pharmacy law and drug distribution issues, including pharmacy licensure and regulation; drug reimbursement by private insurers and under the federal health care programs; compounding, repackaging, and physician dispensing; contract disputes between PBMs and pharmacies; and the structuring of specialty pharmacy distribution arrangements
  • Works with 340B covered entities, contract pharmacies, and 340B management service providers on 340B compliance, outlook, and strategy, and represents covered entities in connection with the implementation of 340B compliance policies and procedures, contract pharmacy arrangements, self-assessments, and independent audits
  • Advises on the interplay of the Affordable Care Act and pharmacies, including the role of pharmacies and prescription benefit designs within the health insurance exchanges, provider network requirements, and regulations governing nondiscrimination in health care
  • Defends clients in criminal and civil investigative and enforcement matters, including Anti-Kickback Statute and False Claims Act cases (including qui tam litigation)
  • Represents clients in civil rights disputes, including employers in employment discrimination cases
  • Provides litigation counsel in complex civil litigation matters involving health care issues

Before joining Epstein Becker Green, Mr. Smith worked as a Director of Federal Public Policy at a nonprofit trade association that advocates for pro-patient and pro-pharmacy public policy and as a Director of Policy and Regulatory Affairs at a national trade association representing the pharmacist owners, managers, and employees of independent community pharmacies nationwide. He also has a lobbying certificate from the Association of Government Relations Professionals. In addition, he previously served as a Special Assistant Attorney General in the Office of the Attorney General of Maryland and as a litigation attorney at national and regional law firms, where he provided criminal defense and witness counseling in federal terrorism cases, defended alleged funders of the September 11 attacks in multidistrict civil litigation, and defended a state police department against Section 1983 multi-plaintiff racial profiling claims.

202-861-1882