REGULATORY
FDA proposal: Semaglutide, Tirzepatide and Liraglutide 503B update
The FDA proposed excluding three substances from the 503B bulks list. This is a proposed regulatory action with public comment, not a final decision.
On April 30, 2026, the FDA announced a proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list. The list concerns bulk substances that outsourcing facilities may use for compounded products, subject to the conditions of U.S. law.
According to the FDA, after reviewing the nominations, it did not identify sufficient clinical need to include the three substances on the list. The proposal was opened for public comment through June 29, 2026, so it is important to distinguish a proposal from a final decision or a binding change already in force.
The update highlights the value of precise language, separating research information from approved products, and reviewing primary sources when assessing regulatory information. This report summarizes the announcement only and is not medical, legal, or regulatory advice.