Yesterday, the FDA published a “reminder” clarifying the status of compounded Tirzepatide now that the shortage for this GLP-1 product has been resolved. After confirming with the approved manufacturer of Tirzepatide that they now have sufficient supplies to meet current market demand, FDA is “reminding” both 503A and 503B compounders that, since the product is no longer in shortage, the Agency’s position is that compounding copies of an approved drug (and legal exceptions for making copies of the approved product) are no longer acceptable to them. The Agency announcement (here) makes clear that the “FD&C Act includes restrictions on compounding drugs that are essentially copies of a commercially available drug”.
FDA lists the status of “current shortage status of GLP-1 products (as of October 02, 2024):
- Tirzepatide injection: Shortage resolved.
- Dulaglutide injection: In shortage.
- Semaglutide injection: In shortage. Manufacturer has reported all but one of the presentations are available.
- Liraglutide injection: In shortage. Manufacturer has reported 2 presentations are available, and three have limited availability.
It is clear from the announcement that FDA expectations are that Tirzepatide will no longer be eligible for compounding under the permissible compounding provisions that permit such activities while that drug is under shortage conditions. Since the other GLP-1 products listed above are still in shortage status, the “reminder’ does not apply to those products at this time. It will be interesting to see how aggressive the Agency may be in regard to this “reminder” for Tirzepatide compounding.
