FDA moves to exclude weight loss drugs from compounding chemicals list

April 30 (UPI) -- The U.S. Food and Drug Administration moved on Thursday to exclude semaglutide, tirzepatide and liraglutide -- which are in several popular GLP-1 weight loss drugs -- from its 503B bulks list.

The three chemicals are the active ingredients in drugs made by Novo Nordisk and Eli Lilly for weight loss and diabetes, including Wegovy, Ozempic, Zepbound and Mounjaro, but because there is no shortage of them the agency is leaving them off the list, the FDA said in a press release.

The FDA permits pharmacies to compound personalized drug products under its 503A regulations, but it specifically regulates the bulk compounding of drugs by listing them on its 503B list.

Compounded drugs generally are less expensive than the FDA-approved drugs they mimic, and the availability of cheaper alternatives to the expensive name-brand weight loss drugs has driven some people to them, CNBC reported.

"When FDA-approved drugs are available, outsourcing facilities cannot lawfully compound using bulk drug substances unless there is a clear clinical need," FDA Commissioner Marty Makary said in the release.

"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," Makary said.

The FDA had been permitting compounding facilities to produce the weight loss drugs because of a shortage but earlier this month clarified that the drugs are no longer on its drug shortage list.

The FDA will be accepting comments from the public on excluding the drugs from the 503B list though June 29 before making a final determination on the change, the agency said.

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This story was originally published April 30, 2026 at 1:55 PM.