Justice Department seeks to stop drug production at Cantrell Drug over sanitary conditions | Arkansas Blog

Thursday, March 1, 2018

Justice Department seeks to stop drug production at Cantrell Drug over sanitary conditions

Posted By on Thu, Mar 1, 2018 at 4:47 PM

click to enlarge CANTRELL DRUG NAMED: The company's location and its CEO, James McCarley Jr. - ARKANSAS BUSINESS
  • Arkansas Business
  • CANTRELL DRUG NAMED: The company's location and its CEO, James McCarley Jr.

The federal Justice Department announced today that it had filed a civil action to stop drug production by Cantrell Drug Company because of unsanitary operations.

A release from the U.S. attorney's office said the U.S. had asked for an inunction against Cantrell Drug Company and its CEO, James McCarley Jr.

A complaint filed in federal district court said the company — a compounding pharmacy that produces drugs for others — had distributed adulterated drugs, meaning they were prepared, packed or held under unsanitary conditions and may have been contaminated or rendered "injurious" to health.

The news release said Cantrell had done voluntary recalls of drugs in 2016 and 2017 for lack of sterility assurance. The Justice Department said the Food and Drug Administration had found evidence of unsanitary conditions and deviations from good practice in a 2017 inspection.

Arkansas Business' Mark Friedman  reported problems at the company after it filed for bankruptcy reorganization last year. The company employed about 85 people at that time.

Here's the full complaint.

The FDA today issued a warning to health professionals and consumers about use of drugs made by Cantrell Drug.

McCarley has issued a news release saying the company was attempting through a motion in bankruptcy court to stop the FDA from shutting the company down.  Said the release:

If Cantrell Drug shuts down, thousands of patients may not receive the pain medication they need and hospital pharmacists will be scrambling. All of this is in direct conflict with Congress’ intent to provide a solution for drug shortages through 503B Outsourcing Facilities such as Cantrell.
The Justice Department news release said:

“The Food, Drug, and Cosmetic Act is designed to protect patients from potentially unsafe drugs,” said U.S. Attorney Cody Hiland for the Eastern District of Arkansas. “This action demonstrates our commitment to enforcing these laws. We remain steadfast in our dedication to keeping the citizens of our communities safe by whatever means available under federal law.”

If entered by the Court, the Proposed Order of Preliminary Injunction sought in conjunction with the filed complaint would require defendants temporarily to cease their current operations and to recall and destroy all non-expired drugs manufactured, held, and/or distributed by them. The Proposed Order also provides defendants with a pathway to resume manufacturing and distribution by establishing specific actions defendants must take to remedy their operations.

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