WASHINGTON - The U.S. District Court for the Eastern District of Arkansas entered a consent decree of permanent injunction against defendants Cantrell Drug Company (Cantrell), and James L. McCarley Jr., Cantrell’s co-owner and Chief Executive Officer. The injunction permanently enjoins the defendants from distributing adulterated drugs in violation of the federal Food, Drug, and Cosmetic Act.
The entered permanent injunction stems from a complaint the Department filed in the U.S. District Court for the Eastern District of Arkansas on Feb. 28, at the request of the U.S. Food and Drug Administration (FDA). That complaint alleged, among other things, that the defendants distributed adulterated drugs in interstate commerce.
As part of the permanent injunction, defendants cannot resume manufacturing, processing, or distributing drugs until they comply with specific remedial measures. Those measures include submitting a remedial plan to FDA, which will provide for an independent expert to conduct inspection(s) of defendants’ facility, ensure defendants implement all recommended corrective actions, and ensure that defendants’ manufacturing and distributing of drugs will be in conformity with current good manufacturing practice. The permanent injunction provides that defendants cannot resume manufacturing, processing, or distributing drugs until FDA notifies them in writing that defendants appear to be in compliance with the ordered remedial measures.
“Compounding pharmacies have a responsibility to ensure that they process drugs in a manner that meets the legal standards necessary to ensure the safety and quality of such drugs,” said Acting Assistant Attorney General Chad A. Readler of the Justice Department’s Civil Division. “The Department of Justice will continue to work with FDA to ensure that doctors and patients can rely on the protections in the Food, Drug, and Cosmetic Act.”
According to the complaint filed by the Department on Feb. 28, defendants’ drugs were adulterated because they were prepared, packed, or held under insanitary conditions whereby they may have been contaminated or may have been rendered injurious to health. The complaint also alleged that defendants’ drugs were adulterated because defendants failed to comply with current good manufacturing practice regulations.
Cantrell initiated voluntary recalls of drug products in 2016 and 2017. The 2016 recall, initiated due to lack of sterility assurance, involved 29 lots of unexpired sterile drug products. The 2017 recall, also due to a lack of sterility assurance, encompassed all lots of unexpired sterile drug products that Cantrell had compounded and distributed between Feb. 16, 2017, and July 19, 2017.
“The Food, Drug, and Cosmetic Act is designed to protect the public health,” said U.S. Attorney Cody Hiland for the Eastern District of Arkansas. “This enforcement action demonstrated our commitment to ensuring that when deficiencies are identified, they are properly addressed.”
“As a public health agency, the FDA is committed to fully implementing the regulatory framework set forth by Congress that helps ensure compounded drugs are made under appropriate production standards,” said FDA Commissioner Scott Gottlieb, M.D. “FDA is committed to taking action against compounders who do not comply with the requirements set forth in federal law.”
The government is represented by Trial Attorney Raquel Toledo of the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney Shannon S. Smith of the U.S. Attorney’s Office for the Eastern District of Arkansas, with the assistance of Associate Chief Counsel, Litigation, Jennifer Kang of the Department of Health and Human Services’ Office of General Counsel’s Food and Drug Division.
Additional information about the Consumer Protection Branch and its enforcement efforts may be found at http://www.justice.gov/civil/consumer-protection-branch. For more information about the U.S. Attorney’s Office for the Eastern District of Arkansas, visit its website at https://www.justice.gov/usao-edar.