The Ozempic shortage is over. What now?

After nearly three years of backorders and pharmacy scrambles, the high-demand weight-loss drugs Ozempic, Wegovy, and Mounjaro are finally back in full supply. 

The FDA recently declared an end to the nationwide shortage of their active ingredients, semaglutide and tirzepatide. During the shortage, pharmacies were temporarily allowed to sell “compounded” versions—custom-mixed alternatives made from raw ingredients. But now that the FDA-approved brands are widely available, patients are facing new questions about access, safety, and ongoing care. 

Martin Binks, chair of the Department of Nutrition and Food Studies at George Mason University and a researcher and clinician with expertise in obesity, explains what this moment means for patients, providers, and public health. 

Can people still get compounded versions of these drugs? 

In most cases, no. The FDA rule is very clear. Now that the shortage is resolved, prescribers are only allowed to prescribe the safe and effective FDA-approved versions of these medicines—meaning pharmacies are prohibited from creating off-label compounded versions, even so-called “exact copies.”  

There will be rare exceptions when compounded versions are allowed. For example, if a patient has a specific medical need, such as an allergy, which can be resolved through minor changes in the drug’s formulation.  

If the FDA were to declare another shortage of these drugs, pharmacies would be allowed to sell compounded versions again. But this is very unlikely to happen given the huge investments companies like Eli Lilly and Novo Nordisk are making in these medications. 

Why are the compounded versions no longer allowed? What are the risks for patients? 

Compounded versions are not approved by the FDA, meaning they are not subject to testing for safety and efficacy. This creates a lot of risks when the products are used by large populations. Also, the FDA versions are subject to post-approval monitoring for any new safety issues, compounded versions are not.    

While many compounding pharmacies did act ethically during the shortage, and within the scope of the FDA’s temporary rules, the public can’t always identify the difference between those and “bad actors” selling dangerous counterfeits. 

Will “bad actors” continue to sell the non-FDA approved versions? 

Given the nature of demand for these weight loss medications, it’s very likely dangerous entities will continue to sell unapproved compounded versions of these drugs, creating a risk to public health until or unless we can improve access to the FDA-approved medicines. A recent JAMA Network Open study showed that nearly half of all online pharmacies selling semaglutide were illegal operations, with some products containing dangerous impurities or excessive doses. Beyond the adverse effects a patient could directly suffer from this, it may also deter people from using the well-tested, well-controlled FDA versions of these drugs that could actually improve their health, essentially creating a double-edged threat to public health. 

What’s the right way to use weight loss medications like semaglutide and tirzepatide?  

These medications are intended to be used alongside overall healthy habits. Used appropriately, they can help manage appetite and metabolism for people with obesity, but they’re most effective when combined with lifestyle changes like healthy eating, physical activity, sleep, and stress management. It’s also essential that patients meet medical criteria for use. 

How can patients protect themselves now? 

Be cautious about where you get your medication. Don’t rely on online sources that promise cheap or no prescription access. Talk to a licensed health-care provider about safe, approved options. And keep in mind that bad actors may continue trying to sell counterfeit products even as legitimate compounding operations shut down. 

Martin Binks, Ph.D., MBA, is professor and chair of the Department of Nutrition and Food Studies at George Mason University’s College of Public Health. A metabolic disease scientist and clinician who is recognized as an international expert on obesity science and practice. Binks has spent more than 25 years treating patients with obesity through behavioral, pharmacologic, and surgical approaches. His research spans brain health and cognition, 3-D food printing, and nutrition’s role in chronic disease. Binks previously held academic and leadership positions at Texas Tech University, Duke University Medical Center, and he is a fellow of The Obesity Society, the European Society of Preventive Medicine, World Obesity and the New York Academy of Medicine. 

Media inquiries: To schedule an interview with Martin Binks, contact Associate Director of Marketing and Communications Mary Cunningham at mcunni7@gmu.edu. 

Disclosures: 

Martin Binks has interacted with a wide range of pharmaceutical companies in his fundraising role as Secretary Treasurer at The Obesity Society 

Martin Binks has also received research funding from Novo Nordisk related to earlier versions of the GLP-1 medicines (liraglutide) and served on the speaker’s bureau at Novo Nordisk during the launch of Saxenda®  

Martin Binks holds common stock in Eli Lily, Novo Nordisk and Aardvark Therapeutics.