FDA proposes to exclude semaglutide, tirzepatide on 503B bulks list

The U.S. Food and Drug Administration announced it is proposing to exclude semaglutide, tirzepatide, and liraglutide on the 503B bulks list, finding no clinical need for outsourcing facilities to compound these drugs from bulk substances. The 503B bulks list identifies bulk drug substances that outsourcing facilities may use in compounding under the conditions of section 503B of the Federal Food, Drug, and Cosmetic Act. After evaluating the nominations for these three substances, the FDA did not identify a clinical need for outsourcing facilities to compound semaglutide, tirzepatide, and liraglutide from bulk drug substances. “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, M.D., M.P.H. “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 FDA carefully reviewed the nominations it received and did not identify sufficient evidence to include semaglutide, tirzepatide and liraglutide on the 503B bulks list.