Drug compounder seeks FDA restraining order, agency takes legal action
The US Food and Drug Administration (FDA) has issued a release alerting health care professionals and patients not to use drug products produced by Cantrell Drug Company, a 503B registered drug compounding outsourcing facility located in Little Rock, Arkansas.
The FDA inspected the company’s facility in June 2017, at which time it observed “serious deficiencies in Cantrell’s compounding operations,” including unsanitary conditions and violations of current Good Manufacturing Practice (CGMP), the agency said.
Cantrell recalled all drug products and stopped sterile compounding in July 2017; however, it resumed production and distribution “without demonstrating that it had adequately addressed the problems identified,” according to the FDA.
Now, the agency is seeking legal action to prevent Cantrell from further producing and distributing drugs and has filed a complaint injunction in the US District Court in the Eastern District of Arkansas.
The injunction asks the court to order Cantrell “to stop manufacturing, processing, packing, labeling, holding and/or distributing any drugs until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations.”
The FDA does not comment on pending litigation.
Cantrell fires back
Last week, Cantrell published a press release announcing that it has filed a motion with the United States Bankruptcy Court Eastern District of Arkansas Little Rock Division.
“We are currently in the process of getting an emergency hearing to file a restraining order against the FDA this week to prevent further action against us,” Will McCarley, director of communications, Cantrell Drug Company, told us.
“My back is really against the wall,” said Dr. James L. McCarley, Jr., founder and CEO of Cantrell Drug Company in the press release.
McCarley said he would be extending an invitation to FDA Commissioner to visit the facility. “I’ve dedicated the last twelve months and most of my life’s savings trying to satisfy the Agency,” he said.
After being shut down twice the company filed for Chapter 11 Bankruptcy. McCarley said a third shutdown will be the end of the family-owned company.
“We are a family-owned business, and we simply don’t have the resources to continue to fight a bureaucracy that makes broad claims against us, gives little feedback, and ignores independent third-party experts,” he said in the press release.
Cantrell isn’t providing any additional comment at this time.
