Tirzepatide Compounding Exemption Ending Soon

Posted By Madilyn Moeller, Wednesday, August 14, 2024

Scale and measuring tape

Injectable medical weight loss medications (semaglutide: sold under the brand names Ozempic and Wegovy; tirzepatide: sold under the brand names Mounjaro, Zepbound) have long been in shortage, forcing aesthetic and wellness practices to turn to compounding pharmacies to meet the demand of their patients.

On August 2, the FDA Drug Shortages list was updated to list the tirzepatide drugs Mounjaro and Zepbound, from manufacturer Eli Lilly and Co., as Available.

As of August 6, only one dosage of Wegovy, from Novo Nordisk, Inc. is listed as Limited Availability, while the other Wegovy and Ozempic injections (also from Novo Nordisk) are listed as Available.

However, both Tirzepatide and Semaglutide are still listed as "currently in shortage" despite the update. As AmSpa previously reported, when drugs are placed on the FDA Drug Shortages List, certain exemptions in the FDA approval process are allowed, making it possible for the drugs to be compounded to meet the public’s need for the medication. Once the manufacturer catches up with demand and the drugs are removed from the list, the exemptions for compounding the medications are removed as well.

The first reports have emerged of the manufacturer informing clinics and pharmacies that tirzepatide is no longer in shortage. However, the FDA has not determined the shortage to be "resolved" as of yet. 

Medical spas offering compounded tirzepatide products should be aware of this impending change in designation and review their practices for compliance and make adjustments as needed.

Learn more about starting a medical weight loss program in your aesthetic practice.