The FDA proposed not to include semaglutide, tirzepatide and liraglutide on the 503B bulks list — the roster of substances outsourcing facilities may legally compound from bulk. The agency stated it had reviewed the nominations it received and did not find sufficient evidence of a clinical need for any of the three. If finalised, the change would close the principal remaining legal route for large-scale compounding of these drugs. This is a proposal, not a final rule.
Sources: Federal Register 2026-08552
