In recent years, the popularity of GLP-1 medications like Semaglutide (Ozempic, Wegovy) and Tirzepatide (Mounjaro, Zepbound) has soared, especially due to their effectiveness in managing type-2 diabetes and obesity. However, this surge in demand has led to severe shortages, leaving patients and healthcare providers struggling to access these medications.
While Semaglutide and Tirzepatide remain on the FDA shortage list, compound pharmacies are permitted to produce compounded versions of these medications to help meet patient demand. This allowance provides a vital option for patients who otherwise face limited access to brand-name versions. However, if the FDA removes Semaglutide and Tirzepatide from the shortage list, compound pharmacies will no longer be permitted to produce compounded versions, potentially leaving many patients without affordable or accessible alternatives to the brand-name medications.
That being said, some speculate that providers and pharmacies may continue prescribing compounded medications with custom dosages or off-label uses which is permitted by the FDA.
This post breaks down the timeline, the FDA’s involvement, the role of compounding pharmacies, and how shortages are impacting GLP-1 users who rely on compounded alternatives.
Timeline of the GLP-1 Shortage
The GLP-1 shortage started in early 2022, when demand for Ozempic and Wegovy surged, largely driven by the medication’s effectiveness for weight loss and blood sugar control. Despite manufacturers’ efforts to ramp up production, demand has continued to outpace supply, leaving both diabetes and weight loss patients struggling to secure their prescriptions.
The FDA officially added Semaglutide to the drug shortage list in March 2022. Tirzepatide followed in December 2022.
On October 2, 2024, the FDA declared an end to the shortage of Tirzepatide (Mounjaro/Zepbound), citing Eli Lilly’s increased production capacity. However, following significant feedback from patients and providers indicating continued difficulty accessing the medication, the FDA reversed its decision just days later, allowing compounding pharmacies to continue making Tirzepatide while they reassess the supply chain and market availability.
This rapid change has created an unstable supply environment for patients and compounding pharmacies, many of whom were unprepared for the FDA’s sudden announcement. The FDA has set November 21, 2024, as the next milestone to revisit the status of Tirzepatide shortages and decide on compounding permissions moving forward. Update: The 11/21 update has delayed the decision. The next milestone is set for December 19, 2024 at the latest but a decision from the FDA could come at any time. Update: The FDA has made the decision that Tirzepatide is no longer in a shortage which means compounding of Tirzepatide will end in 2025. 503b Pharmacies are required to stop compounding Tirzepatide on March 19. 503a Pharmacies are required to stop compounding Tirzepatide on February 18. Some telehealth providers have already stopped prescribing Tirzepatide while others will continue until the stop dates approach. The Outsourcing Facilities Association (OFA) has made a statement that they will continue to fight the FDA’s decision. Further legal matters may delay the stop dates.
The Role of Compounding Pharmacies
With limited availability of FDA-approved Semaglutide and Tirzepatide, telehealth companies and compounding pharmacies have become a vital source for patients needing these medications. These pharmacies prepare custom formulations to meet specific patient needs, often at lower prices, and provide alternatives in vial and syringe form rather than auto-injector pens. When the FDA briefly halted compounding after declaring the Tirzepatide shortage over, pharmacies faced increased pressure to fulfill orders, with some patients rushing to stock up on compounded versions before another potential restriction.
While compounding pharmacies are helping to bridge the gap, the current uncertainty around FDA permissions has complicated their ability to maintain consistent stock. The back-and-forth in regulations means that compounded GLP-1 medications may remain at risk of future restrictions depending on the FDA’s assessment of the market supply.
Impact on Patients Using Compounded GLP-1 Medications
For many GLP-1 users, compounded versions have provided an accessible solution when brand-name medications were unavailable or unaffordable. However, patients are now facing longer wait times and possible price increases due to the fluctuation in FDA guidelines. For some, compounded versions are essential, especially if insurance does not cover branded options or if they cannot find them locally. These patients face additional challenges as pharmacies continue to juggle demand and uncertain regulatory status.
Moving Forward
The ongoing GLP-1 drug shortage and the fluctuating FDA guidance highlight the need for transparent communication, stable supply chains, and accessibility for essential medications. Staying informed about FDA updates, checking in with providers, and sourcing reputable telehealth companies and compounding pharmacies are crucial steps for those navigating this shortage. In the meantime, the November reassessment will be an important date for patients and pharmacies alike, as it could provide a clearer direction for the availability of compounded GLP-1 options moving forward.
By staying proactive, patients can manage the impacts of this shortage and continue their GLP-1 treatment journey with the support of their healthcare providers and trusted pharmacy sources.
Sources:
https://www.healthline.com/health-news/mounjaro-zepbound-shortage-ended-fda
https://www.medpagetoday.com/special-reports/exclusives/111577
https://www.pharmavoice.com/news/fdas-glp-1-tirzepatide-shortage-ozempic-mounjaro/730342/
https://www.mwe.com/insights/weight-loss-drug-shortages-will-end-soon/
https://www.cbsnews.com/news/tirzepatide-shortage-zepbound-mounjaro-eli-lilly-patient-concerns/
