FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide From 503B Bulks List, Citing 'No Clinical Need'
The FDA announced a proposal on April 30 to exclude semaglutide, tirzepatide, and liraglutide from the 503B outsourcing-facility bulks list, finding no clinical need for large-scale compounding now that branded supply has stabilized. Commissioner Marty Makary said outsourcing facilities cannot lawfully compound from bulk substances when FDA-approved drugs are available unless a clear clinical need exists. Public comments are open through June 29, 2026. The proposal targets 503B outsourcing facilities only and does not directly affect 503A patient-specific compounding, but it forecloses the largest legal pathway for branded-active GLP-1 compounding.