On March 1, 2018, the Department of Justice, in conjunction with the FDA, filed a preliminary injunction asking the U.S. District Court in the Eastern District of Arkansas to order Cantrell Drug Company of Little Rock, Arkansas, to stop manufacturing, processing, packing, labeling, holding, and/or distributing any drugs until the company complies with the Federal Food, Drug, and Cosmetic Act and its implementing regulations. The proposed order would also require Cantrell to recall all non-expired drug products on the market.
The FDA alerted health care professionals and patients not to use drug products produced by Cantrell including opioid products and other drugs intended for sterile injection. The drug products were distributed nationwide. The FDA is concerned about serious deficiencies in Cantrell’s compounding operations, including its processes to ensure quality and sterility assurance that put patient safety at risk. Administration of contaminated or otherwise poor quality drug products can result in serious and life-threatening injury or death.
FDA investigators most recently inspected Cantrell’s facility in June 2017, and observed poor compounding drug operations. Of particular concern, the FDA investigators observed insanitary conditions and violations of Current Good Manufacturing Practice (CGMP) that could cause Cantrell’s drugs to become contaminated or made injurious to health. Because Cantrell produces drugs that are intended for sterile injection, the conditions identified — which can expose such products to contamination and render them unsterile — raise significant public health concerns. In response to the FDA’s recommendation, in July 2017, Cantrell recalled all drug products marketed as sterile and ceased sterile compounding. However, against FDA advice, the company resumed production and distribution without demonstrating that it had adequately addressed the problems identified.
“A key aspect of the FDA’s mission to protect public health is creating a regulatory framework that helps ensure that compounded drugs are made under appropriate quality standards to reduce their risk of patient harm — and to take action when those important standards are forsaken,” said FDA Commissioner Scott Gottlieb, M.D. “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 without adequately addressing their potentially dangerous conditions. This reckless activity threatens patient safety and will not be tolerated.”
Products from the company can be identified by looking at the drug labels — which should include the company name, “Cantrell Drug Co.” Health care professionals should immediately check their medical supplies, quarantine any drug products from Cantrell Drug Company, and not administer them to patients. Examples of some of the drugs that Cantrell has compounded include opioids and common antibiotics. The FDA urged health care professionals who obtained products from Cantrell to make alternative arrangements to obtain medications they administer or dispense to patients from sources that adhere to proper quality standards.
See the FDA Announcement
See the FDA Safety Alert
See also Medical Law Perspectives Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication