A May 1 Federal Register notice formalized the FDAs move to exclude semaglutide, tirzepatide, and liraglutide from bulk compounding, and opened a public comment window that closes in late June.
A May 1, 2026 Federal Register notice formalized the FDAs proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list, the main pathway for large-scale compounding, finding no clinical need now that shortages are resolved. A public comment period opened, with comments due by late June 2026 before a final decision.
The FDAs late-April move against bulk-compounded GLP-1s became official in the Federal Register on May 1.
With it came a closing window for public input.
On May 1, 2026, the FDA published a Federal Register notice formalizing its proposal not to include semaglutide, tirzepatide, and liraglutide on the 503B bulks list, the list of bulk substances outsourcing facilities may use to compound at scale. The agency stated it found no clinical need for bulk compounding of these drugs now that FDA-approved versions are available and shortages have resolved. The notice opened a public comment period, with comments due by late June 2026, after which the FDA will consider input before a final determination.
Because the underlying shortages were already declared resolved, finalizing the exclusion would remove the main remaining route for large-scale compounding of these GLP-1s, leaving only narrow, patient-specific 503A compounding in limited cases. One nuance: liraglutide injection reportedly remained on a shortage list at the time, so its compounding status differed in the near term.
For consumers, the comment window underscores that broadly available compounded GLP-1s are nearing the exit, pending a final rule. Compounded versions are not FDA-approved and have been linked to quality and dosing concerns. As approved products become more accessible, the case for compounded versions weakens. The practical guidance is to prioritize FDA-approved GLP-1s from licensed prescribers and pharmacies, and to be cautious of sources marketing compounded or unbranded versions.
Watch the close of the comment period and whether the FDA finalizes the exclusion, which would substantially reduce compounded supply. Pricing and access for approved products will shape the real-world impact. For individuals using compounded GLP-1s, the prudent step is to discuss FDA-approved alternatives with a prescriber rather than turning to unregulated or online sources as legitimate compounded supply contracts.