FDA says that the GLP-1 shortage is over
March 5, 2025
Summary: Compounders will face new restrictions as the FDA announces that two GLP-1 drugs are no longer in short supply.
Just a few weeks after a Super Bowl commercial for a company that sells compounded GLP-1 anti-obesity medications ignited controversy, the Food and Drug Administration (FDA) has determined that the shortage of semaglutide (Ozempic, Wegovy and Rybelsus) is over. The FDA found that the shortage of tirzepatide (Mounjaro and Zepbound) ended in December.
The FDA allows bulk compounding of prescription medications, which are in shortage, and many Americans are now taking compounded GLP-1 medications. The FDA will allow continued compounding of semaglutide until later this spring and announced that it will not take action against compounding pharmacies or distributors for tirzepatide until later this spring or when an injunction against the FDA is lifted. Compounders have already sued to delay the date when they are prohibited from compounding semaglutide, too.
There are two kinds of compounding pharmacies, 503a pharmacies, which can use active pharmaceutical ingredients to compound medications that are personalized for individuals, and 503b pharmacies, which can do bulk manufacture of compounded medications. The 503b pharmacies are regulated by the FDA, and some of them do contract manufacturing for pharmaceutical companies. The 503a pharmacies will likely be able to continue to manufacture GLP-1 medications in doses different than those available from the manufacturers, or with added vitamins or other drugs even if the FDA prevails in these court cases. One company has already announced that it will stop manufacturing the doses of semaglutide that are available as Wegovy, but will continue to manufacture “personalized” doses.
Implications for employers:
Although almost half of employers stated that they were interested in the potential for compounded GLP-1 medications, according to WTW’s 2025 Best Practices in Healthcare Survey, only 7% said they were “very” interested, and there has been very little employer uptake of compounded medications.
If compounded GLP-1 drugs become unavailable, employers will face increased pressure to provide coverage for GLP-1 medications for their members who are obese overweight with a metabolic complication.
Patients who are on GLP-1 medications and stop them generally regain a substantial amount of the weight that they lost.