Federal Judge Enters Consent Decree With Drug Compounder

On April 19, 2018, a US district judge for the Eastern District of Arkansas entered into a consent decree of permanent injunction between the United States and Cantrell Drug Company of Little Rock, Arkansas and James L. McCarley, Jr., the company’s chief executive officer and co-owner. Cantrell and McCarley are prohibited from manufacturing, processing, packing, holding, or distributing drugs until they comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA regulations.

According to FDA, Cantrell, a drug compounder registered as an outsourcing facility under the FD&C Act, manufactured and distributed adulterated injectable opioids and antibiotics that were purportedly sterile. FDA stated in a press release that Cantrell’s products were made under insanitary conditions and may have become contaminated.

Under the consent decree, Cantrell is required to cease operations, complete corrective actions, and hire an independent current good manufacturing practices consultant. The company must receive FDA authorization before it can resume operations.

Source: FDA