The supply of GLP-1 receptor agonists, such as semaglutide and tirzepatide, has been a pressing concern for patients and healthcare providers alike. These medications, widely used for weight management and type 2 diabetes, have faced ongoing shortages due to increasing demand. However, recent updates from the U.S. Food and Drug Administration (FDA) indicate that supply issues are beginning to ease. At SterlingMedicalCenter.org, our medical team is committed to helping patients navigate these changes while prioritizing safety and evidence-based treatment. Here’s what you need to know about how the FDA is working to ensure the quality and availability of GLP-1 drugs.
GLP-1 Drug Shortages: An Evolving Situation
Since 2022, GLP-1 medications have experienced high demand, leading to national shortages. These shortages affected FDA-approved medications such as:
- Semaglutide (Ozempic®, Wegovy®)
- Tirzepatide (Mounjaro®, Zepbound®)
- Dulaglutide (Trulicity®)
- Liraglutide (Victoza®, Saxenda®)
The FDA has been closely monitoring the supply chain, working with manufacturers to increase production and ensure that approved medications are meeting demand.
FDA Updates on GLP-1 Drug Availability
Semaglutide Shortage Resolution (February 21, 2025)
On February 21, 2025, the FDA announced that the shortage of semaglutide injection products had been resolved. The drug’s manufacturer confirmed that its production levels are now sufficient to meet both current and projected demand. However, the FDA warns that localized supply issues may still occur as pharmacies restock.
To ensure a smooth transition back to FDA-approved products, the agency has temporarily allowed compounded semaglutide under specific conditions:
- State-licensed pharmacies and physicians can continue compounding semaglutide under Section 503A of the Federal Food, Drug, and Cosmetic (FD&C) Act until April 22, 2025.
- Outsourcing facilities under Section 503B may continue compounding until May 22, 2025.
After these dates, FDA enforcement against unauthorized compounded semaglutide will increase.
Tirzepatide Shortage Resolution (December 19, 2024)
The FDA had previously determined that the shortage of tirzepatide was resolved as of December 19, 2024. However, due to ongoing litigation, temporary enforcement discretion was extended:
- State-licensed pharmacies (503A) could compound tirzepatide until February 18, 2025.
- Outsourcing facilities (503B) were granted an extension until March 19, 2025.
Now that both semaglutide and tirzepatide are no longer classified as being in shortage, the FDA is shifting its focus to ensuring quality and safety while reducing reliance on compounded alternatives.
Ensuring Quality: FDA’s Role in Preventing Unsafe Compounded GLP-1 Drugs
Compounded medications are sometimes necessary in cases of drug shortages, but they are not FDA-approved and do not undergo the same rigorous quality control measures. The FDA has identified multiple risks associated with compounded GLP-1 products, including:
- Dosing inconsistencies, which can lead to underdosing or overdosing.
- Potential contamination, as compounded medications do not always meet the same sterility standards as FDA-approved drugs.
- Use of unauthorized salt forms, such as semaglutide sodium and semaglutide acetate, which have not been proven safe or effective.
The FDA has received over 455 reports of adverse events related to compounded semaglutide and more than 320 reports involving compounded tirzepatide, with some cases resulting in hospitalization.
What This Means for Patients and Healthcare Providers
For Patients:
- Only use FDA-approved semaglutide and tirzepatide whenever possible.
- If a compounded version is necessary, ensure it is obtained from a licensed, reputable pharmacy.
- Be aware of potential side effects, including nausea, vomiting, diarrhea, and cardiovascular risks.
- Report any adverse effects to the FDA MedWatch Program.
For Healthcare Providers:
- Transition patients back to FDA-approved formulations as availability improves.
- Educate patients about the risks of compounded versions and counterfeit medications.
- Monitor patients closely for dosing errors or unexpected side effects from compounded GLP-1 drugs.
The Risk of Counterfeit and Illegally Marketed GLP-1 Drugs
The FDA has issued warnings about counterfeit versions of Ozempic® circulating in the U.S. Counterfeit medications may:
- Contain incorrect or harmful ingredients.
- Have too much, too little, or no active ingredient.
- Be sold illegally by unregulated online sources.
Additionally, some online sellers have been marketing GLP-1 drugs under misleading labels such as “for research purposes only” or “not for human consumption.” These products pose significant health risks and should be avoided.
FDA’s Commitment to Safe and Effective GLP-1 Medications
As GLP-1 supply stabilizes, the FDA will continue to:
- Monitor the supply chain to prevent future shortages.
- Investigate reports of counterfeit and unsafe medications.
- Enforce regulations on compounding to ensure patient safety.
Final Thoughts: Navigating the Transition Back to FDA-Approved GLP-1 Drugs
The easing of GLP-1 drug shortages marks an important step toward ensuring that patients have safe and effective access to these essential medications. While compounded alternatives provided temporary relief, FDA-approved medications remain the gold standard for treatment.
At SterlingMedicalCenter.org, we advocate for informed decision-making and patient safety. If you are currently using a compounded GLP-1 drug, consult with your healthcare provider to transition back to an FDA-approved alternative as soon as possible. Staying informed and making evidence-based choices is key to achieving the best health outcomes.
Also Read: FDA Cracks Down on Unapproved GLP-1 Drugs