FDA: Tirzepatide Shortage is over, again!
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The FDA has declared the shortage for tirzepatide products, including Mounjaro and Zepbound to be over. (see full statement below)
What does this mean if you have a prescription for compounded tirzepatide?
"Essential copy" compounded versions of tirzepatide will come to an end eventually.
Compounding will continue as normal in the short-term:
- 503A compounding pharmacies have 60 days until Feb 18, 2025
- 503B compounding pharmacies have 90 days until March 19, 2025
Compounding will likely continue in some form afterwards:
After the 60 and 90 day grace period we expect many compounding pharmacies will continue to compound tirzepatide for patients who qualify for customized medications. This may mean custom formulations with additional ingredients or customized dosing for those who have a medical need for dosing that is different from what is commercially available. It may also include different delivery methods such as oral versions.
It's important to note that this is new legal territory with minimal precedents and no one can say for sure what will happen. We expect Eli Lilly to sue those continuing to compound and we don't know what the outcome will be.
Didn't the shortage end before? What happened?
Here is a timeline of what has happened with the tirzepatide shortage so far:
October 2, 2024: The FDA removed the shortage on Mounjaro/Zepbound/tirzepatide
October 6, 2024: The OFA (Outsourcing Facilities Association, which represents compounding pharmacies) sued the FDA, saying that the shortage change was inaccurate.
October 11, 2024: FDA decided to pause enforcement while reconsidering the shortage change
November 21, 2024: Update was expected to be filled from both the FDA and the compounding pharmacies. The update delayed the update to Dec 19th.
December 19, 2024: FDA declared the shortage resolved again
OFA lawsuit case against the FDA
The OFA (Outsourcing Facilities Association, which represents compounding pharmacies) has ongoing litigation against the FDA related to them removing the shortage. We expect for the litigation to continue, and that may bring the shortage back.
What this means for other GLP-1 medications
No changes for other medications. Semaglutide remains in shortage.
- Semaglutide injection: In shortage. Manufacturer has reported all presentations are available.
- Dulaglutide injection: In shortage. Manufacturer has reported all presentations are available.
- Liraglutide injection: In shortage. Manufacturer has reported two presentations are available, and three have limited availability.
- Retatutride is not FDA approved for any condition and has not been deemed safe, yet. It is illegal to compound and you should report any providers offering it to the FDA.
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