McKesson Agrees to Pay $1 Million to Resolve Recordkeeping Violations under the Controlled Substances Act
McKesson Corporation (McKesson) agreed to pay a $1 million civil penalty to resolve alleged Controlled Substances Act (CSA) recordkeeping violations, the Department of Justice announced today.
The resolution stems from allegations that McKesson’s packaging subsidiary, RxPak, located in Memphis, Tennessee, engaged in a continuing pattern of recordkeeping deficiencies. The alleged recordkeeping deficiencies include failing to take an initial inventory of controlled substances received; failing to maintain complete and accurate records of controlled substances received, manufactured, sold, delivered or disposed of; and failing to maintain complete and accurate DEA-222 forms. Resolved allegations also include that McKesson-RxPak transferred tens of thousands of containers of Schedule II-V controlled substances without maintaining DEA-222 forms or invoices.
The investigation by the DEA Memphis Field Division identified more than 700 separate alleged recordkeeping violations and alleged overages, or excess quantities of drugs on hand, for eight controlled substances. The investigation also identified alleged discrepancies between McKesson RxPak’s records compared with reports it made to the DEA of its sales of Schedule II controlled substances.
“Entities that engage in transactions regulated under the CSA have a duty to maintain records and report required information accurately,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “When companies violate the CSA by failing to make accurate reports or to maintain required records, the department will work with our law enforcement partners to hold them accountable.”
“Enforcing recordkeeping requirements under the CSA is crucial, particularly during the current opioid epidemic, to ensure that often-misused controlled substances are transferred only through legitimate transactions, and not diverted to illegal channels,” said U.S. Attorney Joseph C. Murphy Jr. for the Western District of Tennessee.
“Prescription drug misuse and abuse continue to significantly contribute to the unprecedented opioid epidemic our country is currently facing,” said DEA Administrator Anne Milgram. “In order to protect the safety and health of Americans, all DEA registered entities have a basic obligation to maintain full and complete records, which is essential to preventing potentially addictive medications from being diverted from the legitimate drug supply. DEA will continue working with our partners to hold our registrants accountable when any CSA violation is detected.”
Assistant U.S. Attorney Eileen Kuo of the U.S. Attorney’s Office for the Western District of Tennessee handled the matter, working with Trial Attorney Scott Dahlquist of the Civil Division’s Consumer Protection Branch. Trial Attorneys Harry Matz and Anita J. Gay of the Criminal Division’s Narcotic and Dangerous Drug Section also offered valuable assistance.