Ad Comm Meeting May Lead To Compounder Lawsuit Against FDA

By Jessica Karins / October 31, 2024 at 11:42 AM
FDA’s Pharmacy Compounding Advisory Committee (PCAC) voted at a meeting Tuesday (Oct. 29) against adding four substances to the 503A bulks list of substances that can be used for bulk drug compounding, some of which are already in use for weight loss and bodybuilding by medspas and wellness clinics. The vote drew a lawsuit threat from an attorney representing compounders, who is also behind the recent lawsuit against the agency over its removal of GLP-1 drug tirezepatide from the shortage...


Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.