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Pharmacy agrees to pay $50k in civil penalties for alleged violations of Controlled Substances Act



national prescription drug take-back day
MorgueFile : see [1], CC BY-SA 3.0, via Wikimedia Commons

United States Attorney Darren LaMarca announced on Friday that Fayette Discount Drugs, located in Fayette, Mississippi, has agreed to pay the United States $50,000 in civil penalties to resolve allegations that it violated the Controlled Substances Act by failing to maintain complete and accurate records of controlled substances.

The Controlled Substances Act (“CSA”) was passed to combat illegal distribution and abuse of controlled substances, including prescription medications. The CSA’s recordkeeping and prescribing requirements are designed to prevent the diversion of controlled substances for illegal purposes. The CSA is enforced by the Drug Enforcement Administration’s Diversion Control Division, whose mission is to prevent, detect, and investigate the diversion of controlled pharmaceuticals and listed chemicals from legitimate sources while ensuring 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, and are subject to compliance audits.

Regulations promulgated under the CSA require that each DEA registrant, including pharmacies, both maintain complete and accurate records of each substance manufactured, received, sold, delivered, dispensed, or otherwise disposed of by the registrant and promptly report any thefts or significant losses. 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.

The present civil investigation stemmed from a report alleging diversion of controlled substances. Fayette Discount Drugs cooperated with the DEA’s investigation, and a DEA inspection revealed that, between June 2020 and July 2022, Fayette Discount Drugs failed to keep complete, timely, and accurate inventories and records regarding the receipt and dispensing of Schedule II, III, IV, and V controlled substances, including hydrocodone, oxycodone, codeine, alprazolam, and testosterone. As a result of Fayette Discount Drugs’ alleged actions and inactions, thousands of doses of controlled substances could not be accounted for. This settlement addresses the independent obligation of Fayette Discount Drugs to ensure it has systems in place to prevent improper dispensing, as required by 21 U.S.C. §§ 827, 842, and associated regulations.

“This settlement illustrates the United States Attorney’s Office’s continued commitment to combating the opioid epidemic,” said U.S. Attorney Darren LaMarca. “Part of our strategy is making sure that registered opioid handlers keep accurate records of these highly addictive and extremely dangerous drugs. Our office is committed to working collaboratively with our agency counterparts to ensure that pharmacies in this district are doing their part to address the national opioid crisis. I am glad that Fayette Discount Drugs acknowledges the seriousness of the CSA’s requirements, recognizes the gaps in its past practices, and intends to put measures in place to prevent the loss and diversion of controlled substances.”

DEA Assistant Special Agent in Charge Kevin Gaddy said, “All DEA Registrants, including Pharmacies, have an obligation to ensure that they are complying with regulations set forth in the Controlled Substances Act, which include record keeping and prescribing laws. Any registrant who violates or ignores their obligations will be held accountable. DEA will continue to partner with the U.S. Attorney’s Office to ensure that all Registrants are following requires protocols, keeping our communities safe in the midst of this drug poisoning epidemic.”

U.S. Attorney LaMarca commended the work of the U.S. Drug Enforcement Administration in its investigation of this case.

The claims resolved by this settlement are allegations only, and there has been no determination of civil or criminal liability.

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