A Kansas City, Kansas pharmacy has entered into a civil settlement agreement with the federal government to resolve allegations the pharmacy violated the civil provisions of the Controlled Substances Act (CSA).
Daniel Reif, Inc., doing business as The Medicine Shoppe, a retail pharmacy in Kansas City, Kansas, agreed to pay $200,000.
The U.S. Congress enacted the CSA to create “a closed system” of distribution for controlled substances in which the handling of the substances is subject to intense governmental regulation.
Regulations promulgated under the CSA require that DEA registrants maintain complete and accurate records of each substance manufactured, received, sold, delivered, dispensed, or otherwise disposed of by the registrant. These requirements play a vital role in preventing the diversion and abuse of controlled substances.
The CSA is enforced by the Drug Enforcement Administration’s Diversion Control Division. Violations of the record-keeping requirements subject DEA registrants to civil monetary penalties.
The settlement resolves the government’s allegations that between December 31, 2021, through on or about February 23, 2023, the Medicine Shoppe violated the CSA and its implementing
regulations by failing to maintain complete and accurate records and inventories of controlled substances and by failing to maintain certification records for retail sales as required by the Combat Methamphetamine Epidemic Act of 2005.
“The Department of Justice scrutinizes pharmaceutical records for irregularities or suspicious patterns in how controlled substances are prescribed and dispensed.
Without reliable data, we are immensely disadvantaged in our ultimate goal, which is to save lives by preventing the misuse of prescription narcotics,” said U.S. Attorney Ryan A. Kriegshauser. “This settlement demonstrates the Department of Justice’s commitment to enforcing these rules.”
“Failure to comply with laws and regulations set forth to protect the health of Americans comes with a hefty price tag,” Drug Enforcement Administration Special Agent in Charge Michael Davis said. “Daniel Reif, owner and Pharmacist-in-Charge of Medicine Shoppe Pharmacy, learned that lesson.
Registrants are held to high standards and the DEA works to ensure that these individuals are held accountable for their actions.”
The claims resolved by the settlement are allegations only and there has been no determination of liability.