Compounder prohibited from making drugs intended as sterile
A federal court has ordered a Texas-based company to stop producing compounded drug products intended to be sterile until the company complies with the Federal Food, Drug, and Cosmetic Act and other requirements, the Food and Drug Administration today. The government alleges that Guardian Pharmacy Services distributed purportedly sterile drug products made under unsanitary conditions and in violation of current good manufacturing practice requirements. According to the complaint, the company also made and distributed misbranded drugs because their labels did not include adequate directions for patient use, were false or misleading. In 2017, the FDA received adverse event reports concerning at least 43 patients who received eye injections during cataract surgery of a drug compounded by Guardian.