The FDA has proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list, the latest move in a monthslong crackdown on the compounded GLP-1 market.
The 503B bulks list identifies bulk drug substances outsourcing facilities can use in compounding under section 503B of the Federal Food, Drug, and Cosmetic Act, according to an April 30 agency news release. In most cases, outsourcing facilities cannot compound drugs using bulk substances unless the substance appears on the list or the drug is on the FDA’s shortage list at the time of compounding, distribution and dispensing.
After reviewing nominations, the FDA said it did not identify a clinical need for outsourcing facilities to compound the three drugs from bulk substances. The agency is accepting public comments through May 29 before making a final determination.
Compounded versions of GLP-1s accounted for up to 30% of U.S. supply of the drugs in 2024, and telehealth companies have continued to sell them despite manufacturer opposition. Both brand-name manufacturers have pushed for restrictions. Novo Nordisk petitioned the FDA in December 2024 to exclude liraglutide from the 503B bulks list, and Eli Lilly joined a lawsuit to block compounding pharmacies from challenging the FDA’s determination that the tirzepatide shortage had ended.
The agency has also stepped up enforcement. On April 1, the FDA issued guidance stating that pharmacies must stop compounding GLP-1 drugs once branded versions leave the shortage list, and sent 30 warning letters to telehealth companies for misleading claims about compounded products. It has also cited a compounding facility for improper production practices and failure to meet sterility requirements for compounded semaglutide and tirzepatide.
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