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.
