The U.S. Food and Drug Administration has made significant strides regarding the availability of compounded weight-loss drugs. This week, the FDA removed Eli Lilly’s GLP-1 weight-loss and diabetes medications, Mounjaro and Zepbound, from its shortage list. The decision cuts off U.S. production of cheaper, compounded versions of these drugs.
Mounjaro landed on the FDA shortage list in late 2022 and Zepbound in April 2024. The shortage led to a rise in compounded versions, or custom-made treatments created by altering drug ingredients. Compounded versions were allowed under federal regulations to meet demand. Now that the FDA has removed these drugs from the shortage list, compounded versions can no longer be sold “regularly or in inordinate amounts,” as federal regulations stipulate.
Is this the end of compounded tirzepatide?
This ruling is expected to put pressure on consumers and companies. Many seeking affordable compounded versions from telehealth providers like Hers, Ro and Mochi may need to turn to Eli Lilly’s GLP-1 weight-loss products. A few months ago, the company lowered the price of the costly drug to $399 per month. It has also started selling the lowest dose of Zepbound vials through its direct-to-consumer website.
Experts say this move also grants Eli Lilly greater legal leverage against companies continuing to sell compounded versions of tirzepatide. BMO Capital Markets analyst Evan Seigerman told Reuters, “This essentially precludes compounded tirzepatide from being produced commercially.” According to the FDA’s website, the agency may take action if a pharmacy continues to fill new orders after the drug is removed from its drug shortage list, or if it continues to fill existing orders more than 60 days after it has been removed.
Meanwhile, Novo Nordisk’s Ozempic and Wegovy remain on the FDA’s shortage list, allowing compounded versions to continue being sold for now.
