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FDA Announced Removal of Tirzepatide from the Drug Shortage List

Doctors and pharmacists are allowed to compound drugs for individual patients when the compounded drug is not commercially available. Licensed outsourcing facilities (LOF) can compound at a higher volume but can only do so in limited circumstances, one such circumstance is when the FDA states a drug is in shortage. Tirzepatide is a glucagon-like peptide-1 (GLP-1) receptor agonist approved to treat type 2 diabetes (Mounjaro by Eli Lilly) and obesity (Zepbound by Eli Lilly). In 2022, the FDA added 10 versions of Mounjaro and Zepbound to their shortage list, which resulted in LOFs, including members of the Outsourcing Facilities Association (OFA), to begin compounding tirzepatide products. However, on October 2, 2024, the FDA announced that tirzepatide was no longer in shortage. In response the OFA filed a lawsuit requesting to “set aside” the FDA’s decision of removing Mounjaro and Zepbound from the FDA shortage list. Prior to the court hearing, the FDA announced that it would reevaluate their decision to remove tirzepatide and agreed not to take action against the compounders until their review was complete. As a result, the court paused further proceedings pending the FDA’s review. However, on December 19, 2024, the FDA and OFA jointly filed an update on the FDA’s decision to reevaluate the shortage status of tirzepatide. In this report, the FDA stated that it had confirmed its original decision that tirzepatide is no longer in shortage. Therefore, the FDA stated that it would not put Mounjaro and Zepbound back on the shortage list. The FDA also stated it would not enforce its decision until February 18, 2025, for pharmacists and physicians, and March 19, 2025, for LOFs. It is expected that the OFA will now file a new request for a court order to maintain the status quo and if that occurs the FDA will not enforce its decision to remove tirzepatide from the shortage list until the court resolves their request.

https://hubs.li/Q030ZksB0

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