GLP-1s have been on the FDA’s drug shortage list for years. But semaglutide and tirzepatide are no longer in shortage. Here’s what this means to patients and providers.
Semaglutide and Tirzepatide No Longer in Shortage: All You Need to Know
In recent years, the increased demand for tirzepatide and semaglutide has caused widespread shortages, leaving many patients struggling to access their prescribed medications. Initially developed to treat diabetes, these medications have become more popular for their ability to help people lose weight, further straining supply chains.
This made many patients turn to compounding pharmacies, which legally produced customized versions of these medications while they remained on the FDA’s drug shortage list.
In October 2024, the FDA removed tirzepatide from the shortage list, signaling that the national supply had stabilized. Then, in February 2025, the FDA announced that the semaglutide shortage was resolved, further reducing the need for compounded versions of these medications.
If you’ve had problems filling your prescription for tirzepatide or semaglutide, this is good news. But if you’ve been using compounded versions of these medications, you may be concerned if this update could affect you. Here is what you should know.
Are Semaglutide and Tirzepatide in Shortage?
No, not anymore. Tirzepatide, which is sold as Mounjaro and Zepbound, and semaglutide injection, sold under Ozempic and Wegovy, are no longer listed as being in shortage on the FDA website. Semaglutide and tirzepatide have been on the FDA’s medication shortage list since 2022 due to extremely high patient demand.
The FDA removed tirzepatide from the shortage list in October 2024 after Eli Lilly concluded that its manufacturing capacity could meet “present and projected” demand for the GLP-1 medication.
The FDA first reexamined its decision to remove tirzepatide from its shortages list following a lawsuit from the Outsourcing Facilities Association (OFA). Nevertheless, the agency later confirmed that the GLP-1 medication was no longer in shortage.
Later, in February 2025, the FDA announced that the Novo Nordisk’s GLP-1 semaglutide shortage had been resolved.
However, the FDA cautioned that “patients and prescribers may still see intermittent and limited localized supply disruptions as the products move through the supply chain from the manufacturer and distributors to local pharmacies.”
Why Were Semaglutide and Tirzepatide in Shortage?
The shortages of semaglutide and tirzepatide were primarily caused by unexpected demand and limited manufacturing capacity. Initially designed for diabetes management, these GLP-1 receptor agonists became popular for their effectiveness in weight loss, increasing prescription rates.
According to one study, semaglutide fills rose by 442% between January 2021 and December 2023. Manufacturers struggled to keep up with this surge, leading to supply shortages.
Another reason for the shortage of these GLP-1s is off-label use. While the FDA has approved Wegovy and Zepbound for weight loss, their diabetes equivalents, Ozempic and Mounjaro, are frequently prescribed off-label for the same purpose.
The demand was further fueled by social media buzz and celebrity endorsements, which resulted in a flood of prescriptions that overwhelmed manufacturers.
What’s Next for Compounded Tirzepatide and Compounded Semaglutide Now that the Shortage Has Resolved?
With the FDA removing tirzepatide and semaglutide from the shortage list, the ability of compounding pharmacies to produce these medications has become more restricted. Under federal law, pharmacies can only make copies of FDA-approved drugs if there is a shortage. Now that the shortages have ended, compounded versions of tirzepatide and semaglutide may no longer be legally available.
However, the FDA has allowed these companies a facility-dependent grace period of 60 to 90 days to stop producing and selling compounded GLP-1 medications before the agency begins enforcement action.
State-licensed pharmacies and physicians compounding under section 503A of the FD&C (Federal Food, Drug, and Cosmetic Act) had until February 18, 2025, to compound and distribute tirzepatide and until April 22 to compound semaglutide.
Outsourcing facilities under section 503B of the law are allowed to distribute compounded tirzepatide until March 19, 2025, and semaglutide until until May 22, respectively; however, 503B pharmacies may continue compounding under the FD&C by changing formulations based on patient-specific needs or if the provider changes specific dosing protocols. As litigation is still ongoing, NP2Go will continue to offer these medications as long as compound pharmacies are able to manufacture them.
In response to the FDA’s decision, the OFA filed a lawsuit against the FDA for taking tirzepatide and semaglutide off the federal drug shortage list. The OFA said the decision is “reckless and arbitrary” and will “deprive patients of a vital treatment for type 2 diabetes, obesity, cardiovascular disease, and other serious medical conditions.” Additionally, the group claimed that FDA officials “acted to benefit special interests” and that there are still serious problems with the supply of these medications.
The group also asserts that the agency wrongly estimated manufacturers’ claims that they could supply demand without considering data showing patients lacked access to the prescriptions. The Outsourcing Facilities Association has sued the FDA twice thus far, and both cases are still pending.
Other parties also questioned the high demand for compounded GLP-1 medications and the number of patients requiring a switch from a compounded to an FDA-approved version.
While the FDA doesn’t consider cost an excuse to make compounding medications, telehealth companies have raised this issue, saying that there are costs associated with branded GLP-1 medications, which can be over $1,000 per month compared to less than $200 per month for compounded versions.
The outcome of all these will depend on court rulings and future regulatory decisions.
If you’re worried about losing access to your prescribed compounded semaglutide or tirzepatide, speak to your healthcare provider about whether the approved version of the medications will work for you.
You may also consider other GLP-1 drugs like dulaglutide or liraglutide, which remain on the FDA’s drug shortage list. This means that compounding pharmacies can still compound these medications until they’re removed from the list.
Conclusion
The removal of tirzepatide and semaglutide from the FDA’s drug shortage list marks a turning point in the availability of these medications. While supply has stabilized, the future of compounded versions remains uncertain because of regulatory restrictions and ongoing legal disputes. Pharmaceutical companies and compounding pharmacies continue to battle over the legality and safety of these alternatives, leaving patients uncertain.
However, for NP2GO patients, nothing is changing right now. While the FDA has declared the shortage is over, compounded semaglutide is still allowed under existing regulations, which won’t change immediately.
503B compounding pharmacies can continue producing compounded semaglutide for at least 90 days, and maybe longer, until legal matters are resolved. They can also dispense any previously produced medication until it expires, ensuring availability for at least another year.
If shortages return, which has happened before, compounding may be reinstated, further extending access. NP2GO closely monitors these developments, and we remain committed to helping our patients maintain uninterrupted treatment options. Contact us if you have more questions or concerns about your treatment, and we’ll guide you through your options.