Animal health company agrees to $1.1 million settlement for delays in opioid oversight and recordkeeping

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Covetrus North America LLC (Covetrus) reached a $1,125,000 settlement with the U.S. Attorney’s Office to remediate allegations that the company violated the Controlled Substances Act and other applicable regulations.

According to the statement made by the United States Drug Enforcement Administration (DEA),¹ As part of the agreement, Covetrus admitted that from March 29, 2016, to June 18, 2018, a veterinarian’s 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 flagged orders and sent them to the veterinarian’s office, but upon a request from the DEA, the company failed to provide sufficient documentation to justify the decision to release the orders.

U.S. District Court in Boston charged, convicted and sentenced Melissa Paradise, an employee of the veterinary office, after she admitted diverting medications from orders marked for personal use.

“The fight to control the scourge of the opioid epidemic requires a multi-pronged approach. In addition to traditional law enforcement efforts, preventing the diversion of legally produced opioids is also critical. Pharmaceutical distributors must ensure that they maintain complete and accurate records, including meticulously investigating suspicious orders of controlled substances.” has an obligation to handle controlled substances responsibly,” said Acting United States Attorney Joshua S. Levy, JD.¹ “As this decision demonstrates, we will not only prosecute individuals who divert controlled substances, but we will also hold opioid distributors accountable for their failure to comply with important regulations.”

Covetrus also admitted that an order of hydrocodone-homatropine went missing on the way to the veterinarian’s office in March 2018, but that he failed to report the lost controlled substance to the DEA. The statement also said that from January 2015 through July 2023, Covetrus failed to properly review the latest information available in an automated, comprehensive drug reporting system.¹ The system tracks controlled substances from the point of production to distribution and is a requirement of the Controlled Substances Act.

Covetrus and DEA signed a 1-year Memorandum of Agreement (MOU) as part of the agreement. The Memorandum of Understanding requires Covetrus to continue improving its SOM system, and DEA may freely audit and monitor its SOM system, employee training, and overall compliance with federal, state, and local controlled substance laws and regulations.¹

Reference

Covetrus Agrees to Pay $1,125,000 for Failure to Adequately Handle Suspicious Opioid Orders and Inadequate Record Keeping Practices. Newsletter. United States Drug Enforcement Administration. 30 October 2024. Access date: 31 October 2024.