March 6, 2019

Presented by the Food and Drug Law Institute, cosponsored by the Environmental Law Institute

The EPA recently finalized its rule on “Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine.” The new regulations will require retailers, heath care facilities, pharmacies, and reverse distributors to examine – and likely restructure – their hazardous waste management practices. In addition, under this final rule, FDA-approved, over-the-counter nicotine replacement therapies are no longer considered hazardous waste when discarded, but e-cigarettes are still considered an acute hazardous waste and subject to the new requirements. The rule triggers new, stringent standards for these products and entities, and restricts the movement of product once it is considered waste. Speakers addressed the new standards, compliance strategies and challenges, implications for pharmaceutical and nicotine manufacturers, and potential enforcement pitfalls.

Kristin Fitzgerald
, Environmental Protection Specialist, Office of Resource Conservation and Recovery, EPA
Brian Knieser, Physical Scientist, U.S. EPA Office of Resource Conservation and Recovery
Elise Paeffgen, Senior Associate, Alston & Bird LLP
Laura Stanley, Economist, U.S. EPA Office of Resource Conservation and Recovery
Caitlin F. McCarthy, Director, Associates Program, Environmental Law Institute (Moderator)