FDA, DOJ Take Enforcement Action Against Defiant 503B Compounder

March 1, 2018 at 6:08 PM
FDA announced Thursday (March 1) that it is working with the Department of Justice to block a registered 503B compounder from “manufacturing, processing, packing, labeling, holding and/or distributing” its product after the company disobeyed FDA's wishes and continued compounding after it had to recall all of its sterile products in July 2017. “Despite the FDA’s concerns about egregious conditions observed at Cantrell’s facility, during several inspections, with the most recent in 2017, the company continued to compound and distribute drugs...


Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.