FDA Intensifies Crackdown on GLP-1 Compounding

The FDA is proposing the removal of three GLP-1 drugs from the 503B bulks list of active ingredients that outsourcing facilities can use to make compounded medicines, the agency announced on Thursday.

Following a review, the FDA found no clinical need for outsourcing facilities to compound semaglutide (Ozempic, Wegovy), tirzepatide (Mounjaro, Zepbound), and liraglutide (Victoza, Saxenda) from bulk substances.

Typically, outsourcing facilities can only compound drugs using bulk ingredients if the drug is on the FDA’s drug shortage list or the 503B bulks list.

“When FDA-approved drugs are available, outsourcing facilities cannot lawfully compound using bulk drug substances unless there is a clear clinical need,” said FDA Commissioner Marty Makary, MD, MPH, in a statement. “This action reflects our responsibility to protect patients and preserve the integrity of the drug approval process while continuing to provide a transparent, science-based pathway for public input.”

The move comes just 2 months after the FDA announced a crackdown on GLP-1 copycats, citing concerns that compounded drugs cannot be verified for quality, safety, and efficacy. Other organizations, including the American Medical Association, American Diabetes Association, and the Endocrine Society, have also been vocal about the risks of knock-off GLP-1 products.

The surge in GLP-1 compounding began a few years ago when high demand triggered widespread shortages. Shortages of tirzepatide (resolved in December 2024) and semaglutide (resolved in February 2025) have since ended, though liraglutide remains on the shortage list with limited availability.

Under the Federal Food, Drug, and Cosmetic Act, 503B outsourcing facilities may produce large batches of medicines to be sold to healthcare facilities. State-licensed physicians and pharmacies, meanwhile, can compound medicines under the 503A bulk list, according to prescriptions specific to particular patients. It’s estimated that 503A pharmacies handle about three-fourths of the market for compounded drugs.

The public comment period for FDA’s new proposal will remain open through June 29.

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