U.S. Attorney's Office for the Middle District of Pennsylvania issued the following announcement on June 8.
The United States Attorney’s Office for the Middle District of Pennsylvania announced that Savage Family Pharmacy, located in Waynesboro, Pennsylvania, has agreed to pay the United States $180,480 in civil penalties for allegedly failing to comply with recordkeeping and other requirements of the Controlled Substances Act. These alleged violations enabled the diversion of opioids from the pharmacy over an extended period of time.
The Controlled Substances Act, 21 U.S.C. sections 801 et seq. (CSA), was passed to combat illegal distribution and abuse of controlled substances, including prescription medications. The CSA’s recordkeeping and prescribing requirements are 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. 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. Violations of the record-keeping requirements subject DEA registrants to civil monetary penalties.
According to the allegations, between 2015 and 2019, Savage Family Pharmacy did not adequately monitor the conduct of its employees, and failed to keep complete and accurate inventories and records regarding the receipt and dispensing of Schedule II controlled substances, including but not limited to oxycodone and hydrocodone. These alleged violations enabled the altering of incoming inventory counts, as well as the altering of dispensed counts of the controlled substances over an extended period of time. Inventories, when conducted, were not reconciled with the perpetual log. Additionally, pages of the perpetual log were removed, allegedly, by an employee diverting the controlled substances.
As a result of Savage Family Pharmacy’s alleged actions, tens of thousands of doses of controlled substances went unaccounted for and were potentially diverted for illicit purposes.
An act of employee theft of Controlled Substances at the pharmacy in May of 2019 led to the present civil investigation. Savage Family Pharmacy has since enhanced its recordkeeping and compliance program, including instituting a process of reconciling the inventories to the perpetual log, in response to concerns raised by the DEA in the course of this investigation. This settlement addresses the independent obligation of Savage Family Pharmacy to ensure it has systems in place adequate to prevent theft and fraudulent inventory and dispensing, as required by 21 U.S.C. §§ 827, 842, and associated regulations.
“There is no doubt that diversion and subsequent misuse and abuse of high powered opioids has been devastating to many communities throughout the United States, and the Middle District of Pennsylvania is no exception,” said U.S. Attorney Freed. “The ability to dispense powerful controlled substances carries with it the grave responsibility to appropriately monitor the receipt and distribution of those drugs. In the midst of a crisis, lax controls and shoddy record keeping is not only irresponsible, it is dangerous. I commend the owners of Savage Pharmacy for taking responsibility to correct these problems and ensure that they do not reoccur.”
“Pharmacists are entrusted with securing and properly documenting the dispensing of powerful prescription painkillers such as oxycodone so as to prevent illicit diversion,” said Jonathan A. Wilson, Special Agent in Charge of the Drug Enforcement Administration’s (DEA) Philadelphia Field Division. “If Savage Family Pharmacy had maintained adequate records and controls they could have prevented or deterred the diversion of tens of thousands of opioids.”
Original source can be found here.