What the end of the shortage changed
Event ·
FDA chronology updated ·
What happened
On 21 February 2025, FDA declared the national shortage of semaglutide injections over. Manufacturing could meet U.S. demand, the agency said. That didn’t mean every local shelf would stay stocked.
Tirzepatide had its own timeline: an initial decision on 2 October 2024, then a new decision on 19 December after another review. The two medicines didn’t leave the shortage list together.
What it means
The shortages had allowed certain compounded copies: medicines prepared by a pharmacy or another authorized facility, rather than an approved finished product. Once national supplies recovered, those shortage-based exceptions ended after temporary grace periods.
For semaglutide, the original pharmacy deadline was 22 April 2025, or the court’s ruling if later. FDA confirmed that period had ended after the 24 April ruling. Larger outsourcing facilities had until 22 May. The regulatory page puts those dates in order.
Neither semaglutide nor tirzepatide has FDA approval in compounded form. FDA has reported medication errors with compounded semaglutide, including some requiring hospital care. A licensed U.S. clinician can discuss approved treatments and an individual’s needs.