Animal health company agrees to $1.1M settlement for lapses in opioid oversight and recordkeeping

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Covetrus North America LLC, (Covetrus), reached an $1,125,000 settlement with the US Attorney’s Office to rectify allegations that the company violated the Controlled Substances Act and other related regulation.

According to the release from the United States Drug Enforcement Administration (DEA),¹ as part of the settlement, Covetrus admitted that from March 29, 2016 through June 18, 2018, a veterinary office in West Barnstable, Massachusetts, triggered the company’s suspicious order monitoring (SOM) and flagged 35 opioid orders as suspicious. Covetrus then released each of the orders that were flagged and sent them to the veterinary office, but following a request from the DEA, the company provided insufficient documentation to justify the decision to release the orders.

The US District Court in Boston charged, convicted, and sentenced Melissa Paradise, an employee of the veterinary office, after she admitted to diverting the drugs from the orders that were flagged for personal use.

“The struggle to bring the scourge of the opioid epidemic under control requires a multi prong approach. In addition to traditional law enforcement efforts, preventing the diversion of lawfully manufactured opioids is also critical. Drug distributors have an obligation to handle controlled substances responsibly, including maintaining complete and accurate records, and diligently investigating suspicious orders of controlled substances,” said Joshua S. Levy, JD, Acting United States Attorney.¹ “As this resolution demonstrates we not only prosecute individuals who divert controlled substances, but we will hold opioid distributors accountable for their failure to comply with important regulations.”

Covetrus also admitted that an order of hydrocodone-homatropine was lost in-transit to the veterinary office in March 2018, but failed to make notification to the DEA of the lost controlled substance. The release also noted that from January 2015 through July 2023, Covetrus failed to properly review the most recent information available in an automated, comprehensive drug reporting system.¹ The system monitors controlled substances from the point of manufacturing through distribution and is a requirement of the Controlled Substances Act.

Covetrus and the DEA have entered a 1-year Memorandum of Agreement (MOU) as part of the settlement. The MOU requires Covetrus to keep improving its SOM system and the DEA can freely inspect and monitor its SOM system, employee training, and overall compliance with federal, state, and local controlled substance statues and regulations.¹

Reference

Covetrus Agrees To Pay $1,125,000 for Failing to Adequately Address Suspicious Opioid Orders and for Inadequate Recordkeeping Practices. News release. United States Drug Enforcement Administration. October 30, 2024. Accessed October 31, 2024. https://www.dea.gov/press-releases/2024/10/30/covetrus-agrees-pay-1125000-failing-adequately-address-suspicious-opioid