It is unclear how widely distributed this pharmacy’s medicines were. Fullerton Wellness could not be reached for comment.
bigger battle
This is just the latest warning from the FDA regarding weight loss drugs, which has repeatedly warned of quality and safety issues associated with combination versions of the drugs. The compounded drugs are essentially meant to be copycat versions of blockbuster brand-name drugs. Compounding pharmacies can only manufacture counterfeit drugs when medicines are in short supply, acting as a stopgap for patients to access. However, due to the popularity of the drug and the high price of the brand name version, combination formulations are considered an affordable alternative for many patients.
The situation is a legal quagmire, with unscrupulous compounding facilities drawing the ire of the FDA and major pharmaceutical companies competing to formulate drugs. Eli Lillymakers of Zepbound and Mounjaro (tirzepatide), and novo nordiskthe makers of Wegoby and Ozempic (semaglutide) are both suing multiple pharmacies over lucrative counterfeit versions of their drugs, claiming they are unsafe and fraudulent.
Meanwhile, in October, a trade group for large compounding pharmacies sued the FDA after the regulator removed tirzepatide from the drug shortage list, which prevents compounders from making counterfeit drugs. It is a measure. But the FDA quickly reversed itself in court, saying it would reconsider the removal and allow formulators to continue producing unbranded versions in the meantime.
Novo Nordisk also in October Urged FDA to stop compounders from making copycat versions of semaglutideargued that the drug was too complex for formulators to make and posed too many safety risks to patients. In response, the Outsourcing Facilities Association, an industry group for formulators, Letter to FDA It seeks to require Novo Nordisk to submit an economic impact report to assess the potential costs and price increases if semaglutide is no longer available in compounding pharmacies.
