Drug maker forced to close after black dirt was found in injectable weight-loss drug

It is unclear how widely the pharmacy's drugs were distributed. Fullerton Wellness could not be reached for comment.

Bigger battles

This is just the latest warning about weight loss drugs from the FDA, which has repeatedly warned of quality and safety issues associated with compounded versions of the drugs. The compounded drugs are said to be essentially copycat versions of the blockbuster brand-name drugs. Compounding pharmacies can only produce copycat versions while the drugs are in short supply and serve as a stopgap measure for patient access. But with the popularity of the medications and the high prices of brand-name versions, compounded formulations are seen as an affordable alternative for many patients.

The situation has become a legal quagmire as unscrupulous compounding plants draw the ire of the FDA and major pharmaceutical companies battle their compounding competition. Eli Lilly, maker of Zepbound and Mounjaro (tirzepatide), and Novo Nordisk, maker of Wegovy and Ozempic (semaglutide), have both sued several pharmacies over copycat versions of their lucrative drugs that they say are unsafe and fraudulent.

Meanwhile, a trade group for major compounding pharmacies sued the FDA in October after the regulator removed tirzepatide from the drug shortage list, a move that prevents compounders from making copycat versions of the drug. But the FDA quickly backed down in court, saying it would reconsider the removal and allow manufacturers to continue making off-brand versions in the meantime.

Also in October, Novo Nordisk asked the FDA to stop allowing compounders to make copycat versions of semaglutide, saying the drug was too complex for compounders to produce and posed too many safety risks for patients. In response, the Outsourcing Facilities Association, the trade group for compounders, submitted a letter to the FDA requiring Novo Nordisk to provide an economic impact statement to assess the cost and price increases that could occur if Semaglutide would no longer be available due to compounding in pharmacies.