Compounder prohibited from manufacturing and distributing sterile drug products in violation of law
U.S. District Judge Kristine G. Baker for the Eastern District of Arkansas entered a consent decree of permanent injunction today between the U.S. and Cantrell Drug Company of Little Rock, Arkansas, and the company’s Chief Executive Officer and co-owner, James L. McCarley, Jr.
The consent decree prohibits Cantrell and McCarley from manufacturing, processing, packing, holding, or distributing drugs until they comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA regulations, in addition to other requirements.
“As a public health agency, the FDA is committed to fully implementing the Drug Quality and Security Act for compounded drugs set forth by Congress that helps ensure compounded drugs are made under appropriate production standards,” said FDA Commissioner Scott Gottlieb, M.D. “We’ll continue to take action against compounders who produce drugs under substandard conditions and put the health of patients at risk.”
The complaint filed with the consent decree alleges that Cantrell manufactured and distributed purportedly sterile drug products, such as injectable opioids and antibiotics, that were adulterated under the FD&C Act because the drugs were made under insanitary conditions and in violation of current good manufacturing practice (CGMP) requirements. Drugs that are prepared, packed or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health are adulterated under the FD&C Act.
The consent decree requires Cantrell to cease operations until it completes corrective actions, including hiring a qualified independent expert to inspect its facility to ensure the company is complying with the FD&C Act and CGMP requirements. Under the consent decree, Cantrell cannot resume operations until it receives authorization from the FDA.
Cantrell is registered as an outsourcing facility under section 503B of the FD&C Act. The Drug Quality and Security Act, signed into law on Nov. 27, 2013, added a new section — 503B – to the FD&C Act. Under section 503B, a compounder can elect to register as an outsourcing facility. Outsourcing facilities must comply with CGMP requirements, are inspected by the FDA according to a risk-based schedule and
must meet certain other conditions, such as reporting adverse events and providing the FDA with certain information about the products they compound.
The complaint was filed by the U.S. Department of Justice on behalf of the FDA.