                     EPA/HQ Summary  -  Meeting with HDMA

Attendees

HDMA:		 	Anita Ducca, Allison Tuszynski

RegNet:		Bob Fensterheim (consultant)

Olssen, Frank & Weeda:	Tish Pahl (outside counsel)

EPA/HQ: 	Jessica Young, Kristin Fitzgerald, Betsy Devlin, Barnes Johnson, Ricardo Jones, Drew Lausch, Josh Smeraldi, Richard Huggins, Meghan Radtke

Date:			December 16, 2015

Location:  		EPA/HQ  -  Potomac Yard

Summary

EPA HQ met with representatives of HDMA and their outside counsel and consultant to discuss the Hazardous Waste Pharmaceuticals Proposed Rule.  

HDMA gave a presentation about the operations of their members, which include wholesale distributors and reverse distributors, and the expected impacts of the proposed rule on their members. HDMA noted that approximately 90% of returns to wholesale distributors are saleable. HDMA requested that wholesale distributors be included within the definition of healthcare facility under the final rule (although they would prefer a different term). HDMA requested that EPA reiterate our previous policy regarding the point of generation of pharmaceuticals going through reverse distribution. HDMA also requested that we defer to FDA regulations for recalled pharmaceuticals until the recall is complete.

