The FDA removed tirzepatide from its Drug Shortages list on October 2, 2024, citing resolved manufacturing capacity per manufacturer (Eli Lilly) reporting. The delisting predated semaglutide's by approximately four months.
The action closed the 503A shortage exception for compounded tirzepatide, with similar implications to the semaglutide delisting that followed in February 2025: compounded tirzepatide remains permissible under narrower documented-medical-necessity grounds, but the broad shortage-driven compounding window closed.
A coalition of compounding pharmacies filed a legal challenge to the tirzepatide delisting in late 2024; the case proceeded through 2025 with mixed rulings but no reinstatement of shortage status.