NCPA provides statements on compounding at FDA annual listening session

NCPA June 22, 2022

NCPA members Cheri Garvin and Steven Hoffart made statements at the FDA’s annual drug compounding listening session on June 17. This listening session was an opportunity for stakeholders to voice their views on compounding to the FDA. Cheri’s statement focused on the onerous timeline in preparation for the Pharmacy Compounding Advisory Committee meeting earlier this month, insanitary conditions overreach, any future MOU, drug shortages, and adverse event reporting, while Steven’s statement focused on concerns with GFI 256 and patient access to compounded hormone therapies. NCPA coordinated its statements with the Alliance for Pharmacy Compounding, the American Pharmacists Association, and PCCA, who also provided statements. NCPA also submitted Cheri’s and Steven’s statements for the record, in addition to a larger statement for the record on behalf of NCPA. In related news, Pharmacy Times published an op-ed by Scott Brunner, CEO of Alliance for Pharmacy Compounding, stating his opposition to FDA’s MOU on compounding. We have expressed similar concerns, most recently in FDA’s listening session.