Food and Drug Administration (FDA) is considering excluding liraglutide, semaglutide, and tirzepatide from its 503B bulks list. Substances identified on the 503B bulks list may be used by outsourcing facilities for compounding (following the conditions in Section 503B of the Federal Food, Drug, and Cosmetic Act). The agency determined that there is no evidence supporting the need for outsourcing facilities to compound these glucagon-like peptide-1 (GLP-1) receptor agonists. The public comment period ended on June 29, 2026, and FDA is reviewing comments.
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07-01-26