Covetrus Agrees to Pay $1,125,000 for Failing to Adequately Address Suspicious Opioid Orders and for Inadequate Recordkeeping Practices

BOSTON - The U.S. Attorney's Office has reached a $1,125,000 settlement with Covetrus North America, LLC (Covetrus NA) to resolve allegations that it violated the Controlled Substances Act and related regulations. Covetrus NA, headquartered in Portland, Maine, is a company that distributes veterinary medicine to customers worldwide.

Under the settlement, Covetrus NA admitted that, from March 29, 2016 through June 18, 2019, its internal suspicious order monitoring system (SOM) flagged 35 opioid orders from a veterinary office in West Barnstable, Mass. (Veterinary Office) as suspicious. Covetrus NA released each of the suspicious orders and sent them to the Veterinary Office. Following a request from the Drug Enforcement Administration (DEA), Covetrus NA provided inadequate documentation to justify its decision to release the orders.

Melissa Paradise, an employee of the Veterinary Office, was charged and convicted in U.S. District Court in Boston and was sentenced in June 2022 after admitting that she diverted drugs from the orders for her own personal use. Covetrus NA also admitted that, in March 2018, an order of hydrocodone-homatropine was lost in-transit to the Veterinary Office and that Covetrus NA failed to notify the DEA of the lost controlled substances. From January 2015 through July 2023 Covetrus NA also failed to properly review the most recent information made available in ARCOS (an automated, comprehensive drug reporting system which monitors controlled substances from their point of manufacture through distribution) as required by the Controlled Substances Act (the Act).

The Act regulates the manufacturing, purchasing, distribution and maintenance of certain controlled substances. The Act and related regulations required Covetrus NA to keep records and follow security protocols for its controlled substances, including reporting suspicious orders or theft and significant loss of controlled substances. Failure to maintain effective controls against diversion of controlled substances, including opioids, violates the Act. Additionally, registered distributors of opioids, like Covetrus NA, are required to review quarterly information provided by ARCOS, and to keep an accurate record of each controlled substance and how it was used or where it went. Federal and state law enforcement rely on ARCOS data to help prevent diversion of controlled substances.

"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 Acting United States Attorney Joshua S. Levy. "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."

"DEA registrants are responsible for handling-controlled substances responsibly and ensuring that complete and accurate records are being properly kept and accounted for in compliance with the Controlled Substance Act," said Stephen Belleau, Acting Special Agent in Charge of the Drug Enforcement Administration, New England Field Division. "Failure to do so increases the potential for diversion and jeopardizes public health and public safety. We are committed to working with our law enforcement and regulatory partners to ensure that these rules and regulations are followed."

As part of the settlement, Covetrus NA will enter into a one-year Memorandum of Agreement ("MOA") with the DEA. The MOA requires Covetrus NA to continue improving its SOM system and allows the DEA to freely inspect and monitor Covetrus NA's SOM system, employee training and overall compliance with all federal, state and local controlled substance statutes and regulations.

Acting U.S. Attorney Joshua S. Levy and Stephen P. Belleau, Acting Special Agent in Charge of the Drug Enforcement Administration, New England Field Division made the announcement today. Assistant U.S. Attorney Julien M. Mundele of the Affirmative Civil Enforcement Unit handled the case.