FDA proposes excluding semaglutide, tirzepatide, and liraglutide from the 503B compounding bulks list
The FDA published a proposed determination that semaglutide, tirzepatide, and liraglutide no longer meet the statutory criteria for large-scale 503B outsourcing-facility compounding, concluding there is no clinical need given that both drug shortages were declared resolved in late 2024 and early 2025. The move would close the legal pathway for industrial-scale compounded versions of these GLP-1 medications; patient-specific 503A compounding with documented medical necessity remains a separate, lawful pathway.
This is a summary. The reporting is U.S. Food & Drug Administration's, and the link below goes to the original article.