In a Sept.16 letter to National Association of Boards of Pharmacy CEO Al Carter, FDA states that desiccated thyroid extract products can put patients at harm and that therapies containing DTE require a biologics license application. The letter encouraged NABP to share the letter with its members, the state boards of pharmacy. Carter relayed the information to boards of pharmacy on Sept. 22. Fearing that this letter may lead to DTE access issues, the Alliance for Pharmacy Compounding has requested that interested NCPA members attend a town hall webinar on the issue on Thursday and that compounders complete a brief survey that will help APC quantify the effects of thyroid USP compounding. APC is also requesting an audience with FDA to further discuss the compounding community’s concerns. See APC’s preliminary briefing document and advocacy webpage for details on the issue.
NCPA