CVS Pharmacy Inc. Pays $5M to Settle Alleged Violations of the Controlled Substance Act
SACRAMENTO, Calif. — CVS Pharmacy Inc. has paid $5 million to resolve federal Controlled Substances Act (CSA) allegations that its pharmacies in the Eastern District of California failed to keep and maintain accurate records of Schedule II, III, IV, and V controlled substances, U.S. Attorney Phillip A. Talbert and Drug Enforcement Administration Special Agent in Charge John J. Martin announced today.
Drugs, substances, and certain chemicals used to make drugs are classified into five distinct categories or schedules depending upon the drug’s acceptable medical use and the drug’s abuse or dependency potential.
In addition to the settlement payment, CVS has agreed to an administrative compliance plan with the DEA. The payment and plan resolve the United States’ allegations that during the period from April 30, 2011, through April 30, 2013, CVS pharmacies failed to provide effective controls and procedures to guard against diversion when CVS failed to: record the amount received and the date received of Schedule II drugs on DEA-222 Forms; maintain DEA-222 Forms and keep them separate from other records; record the date of acquisition of controlled substances in Schedules II through V; maintain invoices for drugs in Schedules III through V and keep the records separate from non-controlled substance records; and conduct a biennial inventory on one specific day.
“The Department of Justice is committed to fighting prescription drug abuse, including the alarming rise of prescription opioid abuse that is plaguing the country,” U.S. Attorney Talbert stated. “National retailers that distribute massive amounts of controlled substances have a responsibility to comply with recordkeeping regulations because these regulations are specifically designed to prevent dangerous drugs from being diverted into the community and abused.”
“The nation is in the midst of an opioid crisis and all entities that distribute controlled substances must hold the frontline. Regulatory compliance and accurate recordkeeping are key in a pharmacy’s ability to prevent prescription drug diversion,” stated DEA Special Agent in Charge Martin.
Under the settlement reached July 5, 2017, CVS acknowledges that its DEA-registered pharmacies were and are required to comply with the CSA, and that nine CVS pharmacies in the Eastern District of California failed to fulfill these recordkeeping obligations in a manner fully consistent with CVS’s responsibilities under the CSA. The settlement and compliance plan cover the 168 CVS pharmacies that operated in the Eastern District of California from April 30, 2011, through April 30, 2013.
The allegations resolved by this settlement were uncovered during a DEA investigation that began in 2012 after CVS self-reported thefts and losses of hydrocodone, a Schedule III drug at the time, at five of its Sacramento-area pharmacies. Under the CSA, DEA-registered pharmacies are obligated to report any thefts or significant losses of controlled substances to DEA.
To address the issues uncovered by this investigation, CVS made improvements to its pharmacies in the Eastern District of California by, among other things, instituting annual CSA compliance training of its pharmacy staff, increasing loss prevention oversight, and excluding controlled substances prescriptions from the volume metric that can impact pharmacy staff compensation.
Assistant U.S. Attorneys M. Anderson Berry and Kurt Didier handled the case with assistance from diversion investigators at DEA’s Sacramento field office.