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Cantrell Drug Agrees to Stop Making and Selling Drugs

2 min read

Cantrell Drug Co. of Little Rock agreed to stop making and selling drugs until it complies with federal regulators’ requests for changes, ending a civil lawsuit filed by federal regulators who were seeking an injunction against the Little Rock company. 

Cantrell Drug, which is in bankruptcy court for reorganization, didn’t admit or deny the allegations in the Feb. 28 complaint filed by U.S. Department of Justice on behalf of U.S. Food & Drug Administration. 

The lawsuit filed in U.S. District Court in Little Rock alleged that the compounding pharmacy distributed products to customers that were “prepared, packed, or held under insanitary conditions.” The FDA also alleged that Cantrell’s products were adulterated because the 66-year-old company failed to comply with “current good manufacturing practice regulations,” according to a news release from the Justice Department. 

More: Read the full order.

As part of the consent decree of permanent injunction, which was entered Thursday, Cantrell Drug and its CEO, James McCarley Jr., can’t resume manufacturing, processing or selling drugs until they make some required changes, including submitting a remedial plan to FDA, the news release said. An independent expert also has to inspect Cantrell’s plant to make sure Cantrell’s manufacture and distribution of drugs is “in conformity with current good manufacturing practice,” the news release said. 

The injunction prevents Cantrell and McCarley from making or selling drugs until FDA notifies them in writing that they appear to be in compliance. 

McCarley said in a statement to Arkansas Business Friday that it remains “very optimistic that the FDA will keep their end of the bargain to expedite the process we agreed upon for our reopening. Consent Decrees are a common contract with the FDA, and ours was negotiated by both parties to avoid more draining legal battles.”

He also said that other companies that have been under consent decrees with the FDA include the American Red Cross, Abbott Labs and Eli Lilly. 

After the lawsuit was filed, the FDA issued a news release on March 1, warning hospitals and customers not to use Cantrell’s products. McCarley said in court proceedings last month that sales came to a halt after the announcement. 

Cantrell Drug wanted a bankruptcy judge to stay the FDA’s lawsuit for 45 days. And if it wasn’t stayed, McCarley feared the company would be forced to liquidate because it didn’t have sufficient cash reserves.

Earlier this month, Bankruptcy Judge Phyllis Jones denied the Cantrell’s request to stay the case, which allowed the FDA’s lawsuit to go forward in federal court. 

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