Recent developments regarding weight loss drugs and the FDA’s policies on compounding pharmacies have sparked significant changes in the healthcare and wellness sectors. With the FDA announcing that Eli Lilly’s popular weight loss drug, Tirzepatide, is no longer in shortage and clarifying its policies on compounding GLP-1 receptor agonists, these changes could influence MedSpa operations, patient care, and the broader healthcare landscape.
Eli Lilly’s Weight Loss Drug Shortage Ends
The U.S. Food and Drug Administration (FDA) recently confirmed that Eli Lilly’s weight loss drug, Mounjaro (tripeptide), is no longer in shortage. This medication is known for its dual benefits in controlling blood sugar for Type 2 diabetics and aiding in weight loss, making it particularly popular in the MedSpa and wellness communities.
The shortage of Mounjaro, along with other drugs in its class, like Novo Nordisk’s Ozempic and Wegovy, led many patients to seek alternatives, including compounded versions of these medications.
Now that the supply of Mounjaro has stabilized, MedSpas which offer weight loss programs are making changes.
FDA’s Clarification on GLP-1 Compounding Policies
The FDA also issued new clarifications on compounding practices in response to the growing demand for GLP-1 receptor agonists. Compounding pharmacies have been increasingly stepping in to meet patient needs during the shortage, but the FDA has expressed concerns about the quality and safety of compounded drugs, especially when commercially available alternatives are on the market.
In its latest update, the FDA emphasized that the compounded versions of GLP-1 receptor agonists should only be used when the FDA-approved, commercially available options are not available or if a patient has a legitimate medical need for a compounded version, such as an allergy to an ingredient in the commercially available product. This policy clarification is part of the FDA’s broader mission to ensure patient safety while balancing access to necessary medications.
Implications for MedSpa Providers
These developments directly impact MedSpa owners and practitioners who offer weight loss treatments involving GLP-1 receptor agonists. With Mounjaro no longer in shortage, MedSpas that use FDA-approved drugs may see an increase in patient trust and satisfaction. Patients may prefer treatments involving branded medications over compounded versions due to their established safety profiles and FDA oversight. That being said, the out-of-pocket costs of branded medications are unaffordable for many patients.
Providers must carefully weigh the benefits and risks of compounded medications and ensure compliance with FDA regulations to avoid potential legal and safety issues. Section 503B of the Federal Food, Drug, and Cosmetic Act restricts outsourcing facilities like compounding pharmacies from making compounded drugs that are essentially copies of one or more FDA-approved drugs. This means the compounded drug may not be identical or nearly identical to an FDA-approved drug unless the approved drug is on the FDA’s drug shortage list. Since Tirzepatide is no longer on the FDA’s drug shortage list, compounding pharmacies must essentially stop making it.
Conclusion
The FDA’s recent updates on Eli Lilly’s Mounjaro and the clarified policies on compounding GLP-1 receptor agonists are essential for healthcare providers, including MedSpas and compounding pharmacies, to follow closely. As weight loss drugs continue gaining popularity in medical aesthetics and wellness programs, understanding regulatory changes will help providers make informed decisions prioritizing patient safety and treatment efficacy.
Please contact the Lengea legal team for specific advice for your practice on this important issue.