News

FDA declares semaglutide shortage over, winding down compounded GLP-1 copies

Regulatory 88/100
February 21, 2025↗ source

On February 21, 2025, the FDA determined that the national shortage of injectable semaglutide (Ozempic/Wegovy) was resolved and removed it from the drug-shortage list, triggering a phased wind-down of pharmacy compounding. State-licensed 503A compounding pharmacies generally lost their shortage-list exception by April 22, 2025, and FDA-registered 503B outsourcing facilities had until May 22, 2025 to cease production. The move mirrors the earlier resolution of the tirzepatide shortage and re-establishes that Novo Nordisk's branded products are the only FDA-approved semaglutide injectables. A pending court challenge left narrow enforcement discretion for some 503A operations, but the policy direction is settled: mass compounding of semaglutide is ending as branded supply catches up with demand.

Related peptides

Every claim on this page is sourced. Reliability scores are tier-capped and server-normalized (0–100; green ≥70, amber ≥40, red <40). Drill through to the source page to verify.