US Judge Upholds FDA Ban on Compounded Ozempic, Wegovy Copies

THE WHAT?  A U.S. federal judge has upheld the FDA’s decision to remove semaglutide, the active ingredient in Ozempic and Wegovy, from the drug shortage list—blocking compounding pharmacies from continuing to produce versions of the medications.

THE DETAILS The ruling, made public on June 18, follows a lawsuit filed by the Outsourcing Facilities Association, which argued that the FDA acted prematurely and ignored ongoing supply issues. The FDA maintained that it had assessed current market availability before delisting the drug. The decision impacts compounding pharmacies that had been allowed to make versions of semaglutide-based drugs during the shortage. Larger facilities were given a May 22 deadline to stop production; smaller pharmacies were required to cease by April. This is the second legal defeat for the group, following a similar challenge over Eli Lilly’s Zepbound and Mounjaro.

THE WHY? The court’s decision ends temporary access to compounded versions of semaglutide-based drugs that had become widespread amid demand for weight-loss treatments. While not classified as cosmetic products, Ozempic and Wegovy have gained popularity for aesthetic weight-loss purposes, leading to cross-industry implications for the personal care sector.

Source: Reuters

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