October 21, 2022

FDA agrees to meeting on DTE

FDA representatives have agreed to meet on November 9 with APC and other pharmacy organization leaders about FDA’s recent apparent reclassification of desiccated thyroid extract (DTE) as a biologic, thus prohibiting its use in compounding.

APC requested the meeting with representatives of FDA’s Center for Drug Development & Evaluation and Center for Center for Biologics Evaluation and Research in the wake of a September 16 FDA letter to NABP announcing the reclassification of DTE. APC has invited leaders of APhA, NCPA, and the Outsourcing Facilities Association to join the meeting as well.

“We’ve been clear with FDA that we’re concerned both about the substance of this reclassification and the back-door path they’ve taken in implementing it,” said APC President Dave Miller. “This can only be portrayed as an abandonment by FDA of the more than 60,000 patients who benefit from compounded thyroid therapy, so we look forward to hearing what FDA has to say.”