Partnership for Safe Medicines Applauds FDA Action to Curb Unsafe Compounding of GLP-1 Medications

The Partnership for Safe Medicines strongly supports the Food and Drug Administration's proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list. This action reflects sound science, sound law, and a clear-eyed commitment to patient safety.

Mass compounding of GLP-1 medications has been linked to hundreds of adverse events — including sepsis, liver injury, and hospitalizations — as well as recalls involving thousands of contaminated or improperly dosed vials. With FDA-approved drugs no longer on FDA’s shortage list, there is no legal or clinical justification for outsourcing facilities to continue compounding these substances. The FDA is right to act.

The Partnership for Safe Medicines plans to submit a full comment to the Federal Register docket ahead of the June 29 deadline, and we encourage other patient safety advocates to do the same.