Cantrell Drug Co. of Little Rock announced Tuesday that it has received final approval from the Food & Drug Administration to resume operations.
Earlier this month, Arkansas Business reported that Cantrell Drug, which is in bankruptcy court for reorganization, finally got the FDA to inspect its operations and had expected to resume operations soon.
“Patient safety is Cantrell Drug’s number one priority,” Chairman and CEO Dr. James McCarley Jr. said in a news release Tuesday. “Cantrell has been through the most robust of federal and independent reviews. The FDA’s approval means our facilities, equipment, and processes meet current Good Manufacturing Practice standards.
“We wholeheartedly share the FDA’s objective to ensure our drugs are safe and effective. We are readier than ever before to supply patients with quality medications.”
The company will begin by producing two drugs that are in critically short supply: morphine sulfate and hydromorphone.
The company had signed a consent decree with the FDA on April 19, promising to stop making and selling drugs until it met federal regulators’ requests for changes. The agreement ended a civil lawsuit filed by the regulators, who said Cantrell Drug distributed products to customers that were “prepared, packed, or held under insanitary conditions.”
“I started my career as a retail pharmacist and I’m keenly aware that behind every batch, every order, every syringe is a patient with a name: someone’s spouse, father, mother, brother, sister, friend or relative,” McCarley said Tuesday’s news release. “The drugs we make help save lives and for that I’m humbled and I’m grateful to have the opportunity to be of service to our customers, and to their patients. To our customers, and to our vendors and suppliers, thank you for your understanding. Thank you for your patience. And most of all, thank you for your continued business.”
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