FDA Says Shortage of GLP-1 Tirzepatide (Mounjaro, Zepbound) Is Over
By Ernie Mundell HealthDay Reporter
THURSDAY, Dec. 19, 2024 -- The U.S. Food and Drug Administration re-issued a decision first made by the agency in October that a shortage of the diabetes/weight-loss medication tirzepatide is over.
Tirzepatide includes blockbuster injected GLP-1 medications Mounjaro (for diabetes) and Zepbound (for weight loss).
The FDA first announced two months ago that any shortage of the medications observed during the summer was over.
However, it was forced to "re-evaluate" that decision after demands by the Outsourcing Facilities Association (OFA), a trade group for compounding pharmacists, which sued the agency claiming that tirzepatide was still in short supply.
As long as the drug shortage was declared, compounding pharmacies were still eligible to produce their own versions of Zepbound/Mounjaro.
However, Thursday's FDA announcement effectively puts an end to that, and compounding pharmacies must now cease producing the lucrative drugs within a set time period.
For many compounding pharmacies that date is 60 days from today (Feb.18) and for "bulk" compounding pharmacies the date is 90 days away (March 19), the FDA said in a statement.
"FDA may still take action regarding violations of any other statutory or regulatory requirements, such as to address findings that a product may be of substandard quality or otherwise unsafe," the agency noted.
Eli Lilly, the maker of Zepbound and Mounjaro, had pushed back against the OFA's assertion that shortages of tirzepatide were still in place, and has also claimed that versions of the drug made by compounded pharmacies are often "untested, unapproved knockoffs," according to NBC News.
As for other popular GLP-1s, the FDA listed these ongoing shortages:
-
Dulaglutide (Trulicity) injection remains in shortage
-
Liraglutide (Saxenda) injection remains in shortage
Sources
- FDA announcement, Dec. 19, 2024
- NBC News
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
© 2025 HealthDay. All rights reserved.
Posted December 2024
Read this next
Coffee Is Mostly Safe, Study Finds, But Some Contaminants Remain
WEDNESDAY, Aug. 13, 2025 — Your morning coffee is mostly free from harmful levels of toxins and contaminants, but a new investigation shows there’s room for...
Dollar Store Eats Aren't Harming American Diets, Study Says
WEDNESDAY, Aug. 13, 2025 — Dollar General, Dollar Tree, Family Dollar and other dollar stores are chock full of cheap, highly processed foods — just the sort of eats...
A Doctor's Guide to Intermittent Fasting: Is It Right for You?
TUESDAY, Aug. 12, 2025 — As a bariatric surgeon, I talk with patients every day about weight loss and improving their overall health. One topic that comes up more and more...
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.