Regulation
FDA proposes not to add semaglutide, tirzepatide or liraglutide to the 503B bulks list
The notice names three bulk drug substances the agency has considered and proposes to leave off the list that outsourcing facilities draw on when compounding.
Washington, 1 May 2026 — The Food and Drug Administration published a notice stating that it is evaluating substances nominated for inclusion on the list of bulk drug substances for which there is a clinical need for outsourcing facilities to use in compounding, which the notice calls the 503B Bulks List.
The notice identifies three substances the agency has considered and proposes not to include: semaglutide, tirzepatide and liraglutide. It records that further nominated substances remain under consideration and may be the subject of future notices.