CVS To Pay $11 Million To Settle Civil Penalty Claims Involving Violations Of Controlled Substances Act
One of the largest settlements ever paid for record-keeping violations by retail pharmacy chain related to controlled pharmaceuticals
WASHINGTON - CVS Pharmacy, Inc., and Oklahoma CVS Pharmacy, L.L.C., (collectively “CVS”), have agreed to pay $11,000,000 to the United States to settle civil penalty claims for record-keeping violations under the Controlled Substances Act and related regulations, announced Administrator Michele M. Leonhart of the Drug Enforcement (DEA) and Sanford C. Coats, United States Attorney for the Western District of Oklahoma.
“Abuse of prescription drugs is one of the most critical issues we face today. The scope of this problem is alarming,” said DEA Administrator Leonhart. “This settlement reinforces the responsibilities of all pharmacies to prevent the diversion of dangerous drugs. This case highlights DEA’s steadfast resolve to combat the growing prescription drug abuse problem in this country by ensuring that all DEA registrants, including nationwide pharmacy chains, are in compliance with the law. This is vital to protect public health and keep our communities safe.”
“The abuse of prescription drugs is a well-documented epidemic inflicting devastating, long-term, effects on individuals, families, and entire communities,” said U.S. Attorney Sanford C. Coats. “To combat this problem, it is essential that those who dispense controlled substances comply with DEA’s record-keeping requirements. This ensures that dispensers of prescription drugs remain accountable for the controlled substances within their control and makes the illegal diversion of those drugs more difficult. I commend the DEA Office of Diversion Control who diligently pursued this investigation.”
The Controlled Substances Act, 21 U.S.C. Sections 801 et seq. (“CSA”), was passed by Congress to combat the illegal distribution and abuse of controlled substances, including prescription medications. The CSA is enforced by the DEA’s Office of Diversion Control, whose mission is to prevent, detect, and investigate the diversion of controlled pharmaceuticals and listed chemicals from legitimate sources while ensuring an adequate and uninterrupted supply for legitimate medical, commercial, and scientific needs. Under the CSA, entities registered with the DEA who purchase, distribute, dispense, transfer, or sell controlled substances must comply with inventory and documentation requirements. Regulations promulgated under the CSA require that each DEA registrant, including pharmacies, maintain complete and accurate records of each substance manufactured, received, sold, delivered, dispensed or otherwise disposed of by the registrant for two years. These requirements play a vital role in ensuring the appropriate handling, accounting, and distribution of controlled substances. Violations of the record-keeping requirements subject DEA registrants to civil monetary penalties.
CVS is a Rhode Island corporation with its corporate headquarters in Woonsocket, Rhode Island. CVS currently operates approximately 7,400 retail pharmacies in the United States that dispense branded and generic prescription drugs, including controlled substance medications, to retail consumers. CVS operates 46 pharmacy retail stores in Oklahoma. Each CVS pharmacy retail store is separately registered with DEA and is assigned a unique DEA registration number to dispense controlled substances as required by the CSA.
The United States has alleged that from October 6, 2005 to October 5, 2011, CVS pharmacy retail stores in Oklahoma and elsewhere violated the CSA and the record-keeping regulations by:
- Creating, entering and maintaining invalid “dummy” DEA registration numbers or numbers other than the valid DEA registration number of the prescribing practitioner on dispensing records, which were at times provided to state prescription drug monitoring programs;
- Filling prescriptions for certain prescribers whose DEA registration numbers were not current or valid; and
- Entering and maintaining CVS dispensing records, including prescription vial labels, in which the DEA registration numbers of non-prescribing practitioners were substituted for the DEA registration numbers of the prescribing practitioners.
In order to resolve the claims by the United States, CVS has agreed to pay $11,000,000 to the government to settle civil penalty claims and acknowledged that each of its DEA-registered retail stores is required to comply with the record keeping requirements as provided under the CSA and the regulations promulgated thereunder. In reaching this settlement, CVS did not admit liability, and the government did not make any concession regarding the legitimacy of the claims. The agreement allows the parties to avoid the delay, expense, inconvenience, and uncertainty involved in litigating the case.
This case was investigated by the Drug Enforcement Administration's Office of Diversion Control, Oklahoma City District Office Diversion Group, and was prosecuted by Assistant United States Attorney Ronald R. Gallegos. Settlement was concluded with the assistance of the Department of Justice Criminal Division’s Narcotic and Dangerous Drug Section.