FDA proposes restrictions on compounded weight‑loss and peptide drugs

The U.S. Food and Drug Administration announced a proposal to remove semaglutide, tirzepatide and liraglutide from the 503B bulk‑list, ending the last large‑scale legal pathway for compounding weight‑loss injections. The comment period was extended to July 30, and FDA Commissioner Marty Makary said the action reflects the agency’s responsibility to protect patients while preserving a transparent input process. At the height of shortages in 2024, about one‑third of Americans using GLP‑1 drugs obtained them from compounding pharmacies.

At the same time, an FDA advisory panel endorsed the compounding of six additional peptide drugs. The endorsement drew sharp criticism from Penn bioethicist Ezekiel Emanuel, who warned that the move could jeopardise health and reflected a conflict of interest after HHS Secretary Robert F. Kennedy Jr. added panel members with peptide‑selling ties. The six peptides had been barred in 2023 due to safety concerns, and critics note that they have not been rigorously tested for human use, with production often shifting to overseas labs.