madman
Super Moderator
The agency's proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B Bulks List signals that large-scale compounding of these agents has no regulatory future, and carries immediate implications for pharmacy practice.
The FDA has announced that it is proposing to formally exclude semaglutide (Ozempic, Wegovy; Novo Nordisk), tirzepatide (Mounjaro, Zepbound; Eli Lilly and Company), and liraglutide (Victoza, Saxenda; Novo Nordisk) from the 503B outsourcing facility bulk drug substances (bulks) list—the regulatory mechanism that governs which active pharmaceutical ingredients large-scale compounding operations may use. If finalized, the rule would prohibit 503B outsourcing facilities from compounding these agents from bulk substances under any circumstances, regardless of future market conditions.1
The announcement is the latest chapter in a regulatory saga that has unfolded since 2022, when skyrocketing demand for glucagon-like peptide-1 (GLP-1) receptor agonists outpaced brand-name manufacturing capacity and opened the door to a booming compounding market.1
FDA Moves to Permanently Close the Door on Compounded GLP-1s | Pharmacy Times
The agency's proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B Bulks List signals that large-scale compounding of these agents has no regulatory future, and carries immediate implications for pharmacy practice.
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