PSM submits comment supporting the exclusion of GLP-1s from the 503B Bulks List
Since May 1, the FDA has been accepting public comment on its proposal to continue excluding semaglutide, tirzepatide, and liraglutide from the list of bulk substances that can be compounded by federally-regulated 503B outsourcing facilities.
On July 28, 2026, the Partnership for Safe Medicines submitted a comment supporting FDA's proposal, which will help protect patient safety and the integrity of the drug approval process. Separate from the considerations specific to this docket we also highlighted significant the patient safety risks associated with the current compounding environment and the need for strong FDA enforcement in this space.
