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March 18, 2023

Recordkeeping Violations Under the Controlled Substances Act Result in Mckesson Paying $1M

The DOJ announced Monday that McKesson Corporation agreed to pay $1M to resolve allegations of recordkeeping violations under the Controlled Substances Act.  Specifically, DOJ alleged that McKesson’s drug packaging business, RxPak, had a continuing pattern of failing to maintain records of controlled substances as required by the Act.  A recordkeeping allegation of this magnitude is unusual for opioid regulatory enforcement. Nevertheless, the DOJ confirmed that “[e]nforcing 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.” The DOJ announcement is a reminder that opioid misuse by providers at every level of the supply chain is taken seriously by enforcement authorities.