FDA Affirms Decision on Tirzepatide Shortage Resolved, Sets Transition Period for Compounding

The FDA issued a declaratory order affirming that the shortage of tirzepatide (Munjaro, Zepbound; Eli Lilly and Company) injection products is resolved. As a result, compounders will have a limited grace period during which the FDA will not take legal action against them for producing the drug. This transitional period allows 60 days for state-licensed pharmacists and physicians and 90 days for outsourcing facilities to wrap up production and distribution.^1,2

Mounjaro tirzepatide GLP-1 receptor agonist vial | Image Credit: © Cynthia - stock.adobe.com

Approved in 2022 for type 2 diabetes and in 2023 for chronic weight management alongside diet and exercise, tirzepatide is the first and only dual GIP/GLP-1 receptor agonist (RAs) available. It has gained recognition as one of the most effective weight-loss injectables on the market. On December 15, 2022, the FDA added tirzepatide injection to the drug shortage list. This decision was challenged when compounders sued the FDA 5 days later. A subsequent court order required the agency to reevaluate its determination.^3-5

The FDA reexamined its decision and revoked the previous determination, providing detailed reasoning for the current resolution of the shortage. Although some reports indicate difficulties in obtaining tirzepatide, the FDA attributes these challenges to supply chain logistics rather than a national shortage.^1,2

To ensure a smooth transition, the FDA extended enforcement discretion for compounders temporarily. State-licensed pharmacists and physicians may continue compounding tirzepatide under section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for 60 days, until February 18, 2025. Outsourcing facilities operating under section 503B have a 90-day window, ending March 19, 2025.^1,2

According to the letter to the manufacturer, the FDA will not take legal action against compounders "to avoid unnecessary disruption to patient treatment and to help facilitate an orderly transition.”²

The grace period allows compounders to continue producing tirzepatide for a limited time while transitioning patients to FDA-approved products. The agency noted that this policy aims to facilitate an "orderly transition" and prevent any unnecessary disruption to patient care. However, the FDA acknowledged that patients and prescribers might experience localized supply disruptions due the process of moving products through the supply chain from manufacturers to wholesalers and retail pharmacies.^1,2

Although the tirzepatide’s shortage has been resolved, other GLP-1 RAs such as semaglutide (Ozempic, Wegovy; Novo Nordisk), dulaglutide (Trulicity; Eli Lilly and Company), and liraglutide (Victoza, Saxenda; Novo Nordisk) remain on the FDA's shortage list. Despite being reported as "available" by their manufacturers, the FDA has not yet declared their shortages resolved. The agency has stated that it will continue to monitor the supply and demand for these products, including tirzepatide.^1,2

REFERENCES

1. FDA says compounded tirzepatide must exit the market. MedPage Today. December 19, 2024. Accessed December 20, 2024. https://www.medpagetoday.com/endocrinology/obesity/113478?xid=nl_mpt_DHE_2024-12-19&mh=6d2b5f4f91352444bdf817a9c17750bc&utm_source=Sailthru&utm_medium=email&utm_campaign=Daily%20Headlines%20Evening%20-%20Randomized%202024-12-19&utm_term=NL_Daily_DHE_dual-gmail-definition

2. Donnelly, P. (2024, December 19). Declaratory Order: Resolution of Shortages of Tirzepatide Injection Products (Mounjaro and Zepbound). Sent by e-mail to Patty Donnelly, Ph.D., Senior Vice President, Global Quality, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana 46285. Accessed December 20, 2024. https://dps.fda.gov/drugshortages/resolved/tirzepatide-injection

3. FDA approves new medication for chronic weight management. News release. FDA. November 8, 2023. Accessed December 20, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-new-medication-chronic-weight-management

4. FDA approves Lilly's Mounjaro™ (tirzepatide) injection, the first and only GIP and GLP-1 receptor agonist for the treatment of adults with type 2 diabetes. News release. Lilly. May 13, 2022. Accessed December 20, 2024. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-mounjarotm-tirzepatide-injection-first-and

5. Gallagher A. Outsourcing facilities association sues FDA over sudden removal of tirzepatide from drug shortage list. Pharmacy Times. October 14, 2024. Accessed December 20, 2024. https://www.pharmacytimes.com/view/outsourcing-facilities-association-sues-fda-over-sudden-removal-of-tirzepatide-from-drug-shortage-list