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As of May 2026, FDA has also proposed excluding semaglutide, tirzepatide, and liraglutide from the 503B Bulks List, after stating that it did not identify a clinical need for outsourcing facilities to compound these drugs from bulk substances when FDA-approved versions are available

It also slows down the movement of food through the stomach and curbs appetite, thereby causing weight loss

Brand-name versions of semaglutide and tirzepatide are FDA-approved for weight management under specific indications

The application is based on a 64-week trial of 307 adults with obesity but without diabetes

2023 Sep 21;389(12):106984