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Human Drug Compounding Policies and Rules
The FDA proposed removing semaglutide, tirzepatide, and liraglutide (weight-loss and diabetes drugs) from the list of bulk ingredients that pharmacies can use to make cheaper compounded copies. The move would force patients to buy the brand-name versions instead of lower-cost pharmacy-made alternatives.
Analysis
FDA moving to bar 503B outsourcing facilities from compounding semaglutide, tirzepatide, and liraglutide closes the cheaper-copy loophole, redirecting demand back to Lilly and Novo brands.
- FDA proposes excluding semaglutide, tirzepatide, liraglutide from 503B bulks list
- Federal Register notice dated 4/30/2026
- Action targets bulk drug substances used by outsourcing facilities for compounding
FDA Drug Approvals & Databases2d
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