FDA proposes barring outsourcing facilities from compounding semaglutide and tirzepatide

The FDA proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list, finding no clinical need for outsourcing facilities to compound them from bulk ingredients when FDA-approved versions are available. If finalized, the decision would close the remaining large-scale route for making these GLP-1 peptides from raw ingredients outside a shortage. The notice was published in the Federal Register on May 1, 2026, and the comment period was later extended.