Little Rock, Arkansas-based compounding pharmacy, Cantrell Drug Company, and its Chief Executive Officer and co-owner James L. McCarley Jr., were slapped with a consent decree prohibiting them from manufacturing, processing, packing, holding or distributing pharmaceuticals until they comply with federal regulations. The consent decree was entered by U.S. District Judge Kristine G. Baker for the Eastern District of Arkansas on behalf of the Food and Drug Administration (FDA).
“We will continue to take action against compounders who produce drugs under substandard conditions and put the health of patients at risk,” said FDA Commissioner Scott Gottlieb, M.D.
The complaint alleged that Cantrell made and distributed drug products – including injectable opioids and antibiotics – that were purportedly sterile, but were made under insanitary conditions and in violation of current Good Manufacturing Practice requirements. This called into question whether may have become contaminated with filth or rendered dangerous to health.
Under the consent decree, Cantrell must stop operations until it complies with corrective actions, including hiring a qualified independent expert to inspect its facility to ensure the company is complying with the Federal Food, Drug and Cosmetic Act and current Good Manufacturing Practice requirements. The company cannot resume operations until it receives authorization from the FDA.
The action comes a month after the FDA warned consumers and health care providers not to use drug products made by Cantrell Drug Company because sterility of the products was in question.
Cantrell is an outsourcing facility, a newly added section that compounding pharmacies can elect to register for. But this classification requires these companies to comply with federal requirements, be inspected by the FDA according to a risk-based schedule, and meet certain other conditions, including reporting adverse events and providing the FDA with certain information about the products they compound.
FDA News Release