FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List - fda.gov
The FDA is proposing to remove semaglutide, tirzepatide, and liraglutide from the list of ingredients that outsourcing pharmacies can use to make bulk drug products. This change would prevent compounding pharmacies from manufacturing cheaper generic versions of these weight-loss and diabetes drugs.
FDA moving to block 503B compounding of semaglutide, tirzepatide and liraglutide protects Lilly and Novo branded franchises while gutting telehealth compounders' core GLP-1 supply.
- FDA proposes excluding semaglutide, tirzepatide, liraglutide from 503B bulks list
- Move would bar outsourcing facilities from compounding bulk versions of these drugs
- Targets cheaper compounded alternatives to branded weight-loss and diabetes drugs

