What changed
FDA proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list, citing no identified clinical need for bulk compounding by outsourcing facilities.
What the evidence does not settle
Proposal, not final determination. Federal Register publication followed May 1. Patient-specific 503A conditions are distinct.
Evidence record
Event date: 2026-04-30. Source review: inherited source synthesis; not re-audited in this expansion. Editorial publication: 2026-10-29. Original source links below retain their publication dates. These dates are not interchangeable. This is targeted source synthesis, not an exhaustive archive or a qualified clinical/legal review.
Revision history
29 October 2026: migrated from the research edition, retaining source links and evidence qualifications; not re-audited in the current expansion. Report a proposed correction through Contact us; do not include patient data.