Amid shortages, the FDA has permitted compounding pharmacies to make generic versions of the branded drugs, allowing telehealth companies such as Noom and Hims to offer low-cost alternatives as demand surged.
Semaglutide — the key ingredient in Ozempic and Wegovy — had been in shortage since 2022. Now that supply has stabilized, state-licensed compounding pharmacies and physicians must stop selling compounded semaglutide by April 22, while outsourcing facilities have until May 22 to cease production and distribution.
While exact copies of Ozempic and Wegovy will no longer be allowed, compounders may still create modified versions if they change the dosage, add other ingredients, or alter the method of administration in compliance with FDA regulations, Fortune reported.
“FDA confirmed with the drug’s manufacturer that their stated product availability and manufacturing capacity can meet the present and projected national demand,” the agency said. However, it warned of potential “intermittent and limited localized supply disruptions” as inventory moves through the supply chain.
Compounding pharmacies and brand-name GLP-1 manufacturers have long debated the safety and necessity of compounded versions. Drugmakers argue the medications are too complex to safely replicate, while compounders have defended their quality and expressed skepticism about drugmakers’ ability to keep up with demand.
“Now that the FDA has determined the drug shortage for semaglutide has been resolved, we will continue to offer access to personalized treatments as allowed by law to meet patient needs,” Andrew Dudum, CEO of Hims, said in a Feb. 21 post on X.. “We’re also closely monitoring potential future shortages, as Novo Nordisk stated two weeks ago that it would continue to have ‘capacity limitations’ and ‘expected continued periodic supply constraints and related drug shortage notifications.'”
In a Feb. 21 news release, Novo Nordisk said its production facilities are operating 24/7, with all doses of Wegovy and Ozempic being regularly shipped to wholesalers. The drugmaker has invested $6.5 billion to increase manufacturing capacity in the U.S. this year alone.
