It is unclear on what scale the pharmacy's medications were distributed. Fullerton Wellness could not be reached for comment.
Bigger fights
This is just the latest warning about weight-loss drugs from the FDA, which has repeatedly warned of quality and safety problems associated with compounded versions of the drugs. The compounded drugs are essentially intended to be copycat versions of the blockbuster brand name drugs. Compounding pharmacies can only make copycat versions while the drugs are in short supply, acting as a stopgap for patient access. But due to the popularity of the drugs and the high prices of the branded versions, compound formulations are seen as affordable alternatives for many patients.
The situation has become a legal quagmire, with unscrupulous compounding facilities drawing the ire of the FDA, and the big pharmaceutical companies battling their compounding competition. Eli Lilly, maker of Zepbound and Mounjaro (tirzepatide), and Novo Nordisk, maker of Wegovy and Ozempic (semaglutide), have both sued multiple compounding pharmacies over copycat versions of their lucrative drugs, which they claim are unsafe and fraudulent.
Meanwhile, a trade association for large-scale compounding pharmacies sued the FDA in October after the regulator removed tirzepatide from its drug shortage list, a move that prevents compounding companies from making copycat versions of the drug. But the FDA quickly backed down in court, saying it would reconsider the removal and that compounders could continue producing versions of other brands in the meantime.
Also in October, Novo Nordisk asked the FDA to stop authorizing compounded versions of semaglutide, arguing that the drug is too complex for compounding and poses too many safety risks for patients. In response, the compounding trade group, the Outsourcing Facilities Association, submitted a letter to the FDA requesting that Novo Nordisk be required to provide an economic impact statement to assess the costs and price increases that could occur if semaglutide would no longer be available via preparations. pharmacies.
