Taylor Drug Store Agrees to Pay Civil Penalty to Resolve Alleged Recordkeeping Violations of the Controlled Substances Act

LEXINGTON, Ky. – Taylor Drug Store, a pharmacy located in Pineville, Kentucky, agreed to pay $94,432.50 in civil penalties to resolve allegations that it failed to comply with recordkeeping requirements of the Controlled Substances Act (“CSA”).

Under the CSA, pharmacies authorized to possess controlled substances are required to maintain complete and accurate records of its inventory, including records of when the controlled substances are sold, distributed to patients, or disposed.  The U.S. Drug Enforcement Administration (“DEA”) has the authority to inspect the records of these pharmacies and verify that their controlled substance records are complete and accurate in compliance with the CSA.

In this case, the Government alleged that Taylor Drug Store violated the CSA by failing to maintain complete and accurate records of its controlled substance inventories from August 2019 to August 2021.  In an audit performed by the DEA, Taylor Drug Store’s records did not account for the dispensation or disposal of over 4,500 dosage units of highly addictive substances, including hydrocodone, oxycodone, buprenorphine, and alprazolam.

The recordkeeping provisions of the CSA are designed to protect the public from the dangers posed by highly addictive or dangerous controlled substances, such as opioids, being diverted into the illicit market.  The CSA creates a closed system that tracks controlled substances from manufacture through distributor, to the ultimate end-user, allowing the DEA to monitor the flow of controlled substances in the United States at every juncture.  When a pharmacy fails to maintain complete and accurate records, the system is at risk for illegal diversion into the community.

“These procedures are critical to public safety and pharmacies simply must keep track of these controlled substances,” said Carlton S. Shier, IV, United States Attorney for the Eastern District of Kentucky. “Especially in areas like ours, that are acutely affected by severe drug abuse, these recordkeeping requirements play an essential role in ensuring that controlled substances maintained by pharmacies are not ultimately diverted for illegitimate purposes.”

“As DEA registrants dispensing controlled substances, pharmacies have an obligation to maintain accurate recordkeeping in accordance with the Controlled Substances Act, and Taylor Drug Store fell short of their obligation,” said Erek Davodowich, Acting Special Agent in Charge of the Drug Enforcement Administration’s Louisville Division. “A substantial fine, as well as the implementation of corrective measures, should ensure that Taylor Drug Store meets the CSA’s mandatory recordkeeping requirements going forward.”

The DEA and Taylor Drug Store also entered into a Memorandum of Agreement as part of the settlement.  Taylor Drug Store agreed to submit compliance reports to DEA and to provide employee training on the identification and reporting of suspected drug abuse or diversion.

The settlement considered the penalties associated with the alleged violations, as well as Taylor Drug Store’s financial ability-to-pay.

The Federal Government is committed to combating the prescription opioid crisis by enforcing the requirements of the Controlled Substances Act that prevent the illegal diversion of opioids. Anyone with concerns about prescription drug diversion can report them to the DEA, by submitting a tip at https://www.dea.gov/submit-tip.

This case was investigated by the Drug Enforcement Administration’s London Resident Office Diversion Group.  Assistant United States Attorney Katie Sheridan represented the United States. The claims resolved by the settlement are allegations only, and there has been no determination of liability.

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