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Cardinal Health reaches agreement with DEA over alleged controlled substance distribution

Posted On: May. 15, 2012 12:00 AM CST

LAKELAND, Fla.—Cardinal Health Inc. reached an agreement with the U.S. Drug Enforcement Agency over allegations that its Lakeland, Fla., distribution center failed to ensure that controlled substances were not diverted for illegitimate uses.

The agreement with the pharmaceutical and medical products company, announced Tuesday, stems from the DEA's efforts to combat a drug abuse epidemic in Florida and end the state's role as a major source of diverted pharmaceutical drugs to other states, according to DEA information.

In February, the DEA announced that it had issued immediate suspension orders for Cardinal's wholesale distribution center in Lakeland and for two of its customers, both CVS Caremark Corp. pharmacies.

The DEA said then that an ISO is served “when a DEA-registered business or individual (‘registrant') constitutes an imminent danger to the public safety and suspends a registrant's ability to handle or distribute a controlled substance such as oxycodone, hydrocodone” and other drugs.

It was not the DEA's first visit to the Lakeland facility.

In 2007, the DEA issued an ISO at the same location that it said was due to the distribution of hydrocodone to “rogue Internet pharmacies.”

“That action, and similar actions at other Cardinal Health facilities across the United States, resulted in a $34 million fine,” the DEA said in a February press release. Cardinal Health has been operating under an Administrative Memorandum of Agreement with the DEA that requires Cardinal Health to “maintain a compliance program designed to detect and prevent diversion of controlled substances as required under the Controlled Substances Act and applicable DEA regulations.”

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On Tuesday, Dublin, Ohio-based Cardinal Health said it agreed to a two-year suspension of its Lakeland distribution center’s DEA registration to ship controlled medicines. It also agreed to improve its anti-diversion procedures.

But the distribution center will remain open, with all other operations at the facility continuing.

“This agreement allows us to put this matter behind us and, just as important, will clear the way for a more productive dialogue about how we and others in the health care and regulatory community can work together to prevent the abuse and misuse of prescription drugs,” said George Barrett, Cardinal Health chairman and CEO, in a statement.