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The U.S. Attorney’s Office for the Middle District of Pennsylvania announced Monday that Savage Family Pharmacy, of Waynesboro, has agreed to pay $180,480 in civil penalties for allegedly failing to comply with record keeping and other requirements of the Controlled Substances Act.
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, according to a news release from the Department of Justice.
Inventories, when conducted, were not reconciled with the perpetual log. In addition, pages of the perpetual log were removed, allegedly, by an employee diverting the controlled substances, the release said.
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, according to the U.S. Attorney’s Office.
An act of employee theft of controlled substances at the pharmacy in May of 2019 led to the present civil investigation.
“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 Dave Freed. “The ability to dispense powerful controlled substances carries with it the grave responsibility to appropriately monitor the receipt and distribution of those drugs.”
Savage has since enhanced its record keeping 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, according to the release.
“In the midst of a crisis, lax controls and shoddy record keeping is not only irresponsible, it is dangerous,” Freed added. “I commend the owners of Savage Pharmacy for taking responsibility to correct these problems and ensure that they do not reoccur.
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.
The Controlled Substances Act, 21 U.S.C. sections 801 et seq., was passed to combat illegal distribution and abuse of controlled substances, including prescription medications.
The CSA’s record keeping and prescribing requirements are to prevent the diversion of controlled substances for illegal purposes and are enforced by the Drug Enforcement Administration’s Diversion Control Division.
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.
Violations of the record-keeping requirements subject DEA registrants to civil monetary penalties.
“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 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.”
This settlement agreement is neither an admission of liability by the pharmacy nor a concession by the U.S. that its claims are not well founded, the release said.
The case was investigated by Drug Enforcement Administration’s Diversion Control Division. The investigation was handled by Assistant United States Attorney, Tamara J. Haken and the Affirmative Civil Enforcement Unit within the U.S. Attorney’s Office.