NASHVILLE – Bradley Home Health Care Center, Inc. and Bradley Extended Care, Inc. have agreed to pay $250,000 in civil monetary penalties to resolve allegations that they violated the recordkeeping requirements of the Controlled Substances Act (CSA), announced U.S. Attorney Mark H. Wildasin for the Middle District of Tennessee. Bradley Home Health Care Center does business as Bradley Drug Company, and both companies operate pharmacies in Nashville
The United States alleged that Bradley Drug and Bradley Extended Care failed to maintain complete and accurate records of the movement of controlled substances, and omitted material information on multiple forms required by the Drug Enforcement Administration (DEA) that are used to order and track controlled substances. The United States also alleged that Bradley Extended Care transferred more than 5% of its controlled substance stock to Bradley Drug without registering as a distributor.
“Complete and accurate records are vital to ensure the safe distribution of controlled substances and to protect against improper diversion,” said U.S. Attorney Wildasin. “Our Office is committed to and expects total compliance with the closed system of drugs created by the Controlled Substances Act.”
“Proper recordkeeping is an essential step in preventing the diversion of controlled substances,” said Special Agent in Charge Todd Scott, head of the DEA’s Louisville Division. “All DEA registrants are expected to fully comply with the Controlled Substances Act; those who don’t can expect to be penalized accordingly.”
Congress passed the CSA to combat the illegal distribution and abuse of controlled substances, including prescription medications. Under the CSA, entities registered with the DEA who purchase, distribute, dispense, transfer, or sell controlled substances must comply with strict inventory and documentation requirements. Regulations promulgated under the CSA require that each DEA registrant, including narcotic treatment programs, maintain complete and accurate inventories and 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.
The claims resolved by the settlement are allegations only, and there has been no determination of liability.
This case was investigated by the DEA’s Louisville Division – Nashville District Office, Diversion Group. The United States was represented by Assistant U.S. Attorney Ellen Bowden McIntyre.