August 6, 2024
Bormel: Yes, GLP-1s can be compounded
In an interview with Politico last week, Gail Bormel, the director for the FDA’s Office of Compounding Quality and Compliance, once again provided a clear reading of FDA’s ‘essentially a copy’ guidance (link) reiterating that if a drug is listed as “currently in shortage” on the FDA website, it may be compounded — including semaglutide and tirzepatide.
“It’s good validation that what APC has been telling our members, reporters, and others about compounders’ authority to prepare copies of FDA-approved drugs when the drugs are in shortage is perfectly consistent with FDA guidance and agency officials’ public statements,” said APC’s Scott Brunner.
