FDA Proposes Not to Add Semaglutide, Tirzepatide, or Liraglutide to the 503B Bulks List
In a May 1, 2026 Federal Register notice, FDA evaluated bulk drug substances nominated for the 503B Bulks List — the list of substances outsourcing facilities may compound from when there is a clinical need. FDA proposes not to include semaglutide, tirzepatide, or liraglutide on the list. Comments were due June 30, 2026 under docket FDA-2018-N-3240 (the deadline was later extended).
What this meansIf finalized, this would mean outsourcing facilities have no clinical-need basis to compound these GLP-1s from bulk outside a shortage — a major development for anyone using compounded GLP-1s, and one more reason to ask a provider exactly where its medication comes from and on what legal basis.
Source: FDA original ↗