How has the FDA shut down GLP-1 compounding?
The FDA declared the semaglutide shortage resolved on February 21, 2025, then set wind-down deadlines — withstanding compounders' court challenges — and in September 2026 proposed to permanently bar semaglutide, tirzepatide and liraglutide from large-scale outsourcing facilities.
The FDA declared the semaglutide shortage resolved on February 21, 2025, having earlier done the same for tirzepatide, and set wind-down deadlines. The compounding industry sued, arguing the decision was flawed; a court denied preliminary injunctions and the FDA ended enforcement discretion for both drugs. In March 2026, a Fifth Circuit panel spent over an hour questioning whether the FDA followed the right procedure and looked at the facts fairly. In September 2026 the FDA proposed to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list, which would permanently bar large-scale outsourcing facilities from compounding them. Supporters say this protects patient safety; critics say it protects manufacturers' pricing.