FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide From the 503B Bulks List

On April 30, 2026, the FDA announced it is proposing to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list. The agency said it found no clinical need for outsourcing facilities to compound these drugs from bulk substances. The Federal Register notice for the proposal is dated May 1, 2026; April 30 is the FDA announcement date.

The 503B bulks list governs which bulk drug substances outsourcing facilities may use in compounding under section 503B. A proposal to exclude a substance from that list, if finalized, would remove that bulk-compounding route for the named substances.

The FDA invited public comments through the docket by June 29, 2026, and said it would consider comments before a final determination. Later reporting indicates the comment period was extended to July 30, 2026.

The status of this action must be stated exactly: it was a proposal only, and as of the end of April 2026 no final determination had been published. Section 503B compounding of these substances was not finally banned on this date, and FDA approval continues to belong only to specific approved drug products and their labeled indications.