Four Michigan pharmacies, including two in Livingston County, have entered into a civil settlement agreement with the federal government to resolve allegations that they violated certain provisions of the Controlled Substances Act (CSA).
United States Attorney Dawn N. Ison announced the charges Friday, saying that in 2020, the Drug Enforcement Administration (DEA) began investigating HealthPlus Pharmacy of Ann Arbor, HealthPlus Pharmacy of Brighton, HealthPlus Pharmacy of Howell, and All Care Pharmacy in Allen Park (collectively, Health Plus Pharmacies) for potential violations of the CSA.
“The DEA’s investigation revealed that Health Plus Pharmacies committed several significant recordkeeping violations, including failing to maintain a complete and accurate record of all Schedule II controlled substances dispensed by the pharmacies,” stated a press release. “The DEA also determined that Health Plus Pharmacies failed to maintain effective controls to guard against the diversion of controlled substances.”
As a result, DEA concluded that Health Plus Pharmacies could not properly account for more than 30,000 hydrocodone and oxycodone pills over an approximate 18-month period.
As part of the settlement agreement, Health Plus Pharmacies will collectively pay civil penalties of $180,000. Health Plus Pharmacies has also entered into a Memorandum of Agreement with the DEA requiring, among other things, that the pharmacies hire an external auditor to conduct unannounced audits of highly abused controlled substances over the next two years and to institute a broad-based educational program for its employees that focuses on prevention of drug diversion in the workplace.
“Our Office is committed to combatting the opioid crisis and will seek to hold accountable participants at every level of the distribution chain who fail to comply with their obligations under the Controlled Substances Act,” said lIson. “Pharmacies play a critical role in preventing drug abuse and diversion, and this settlement helps ensure these four pharmacies comply with the law.”
Congress passed the CSA to combat the illegal distribution and abuse of controlled substances. 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 pharmacies, 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 ensuring the appropriate handling, accounting, and distribution of controlled substances.
Officials say that claims resolved by the settlement are allegations only, and there has been no determination of liability.