Press Release
“The Prescription Center” To Pay $57,073 In Civil Penalties For Recordkeeping Violations Of The Controlled Substances Act
For Immediate Release
U.S. Attorney's Office, Middle District of Pennsylvania
HARRISBURG —The United States Attorney’s Office for the Middle District of Pennsylvania announced that “The Prescription Center,” located in Scranton, Pennsylvania, has agreed to pay the United States $57,073 in civil penalties for allegedly failing to comply with recordkeeping requirements of the Controlled Substances Act.
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 designed 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, and are subject to compliance audits.
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 Acting United States Attorney Bruce D. Brandler, between March 2020 and March 2021, “The Prescription Center” failed to keep complete, timely, and accurate inventories and records regarding the receipt and dispensing of Schedule II, III, and IV controlled substances, including but not limited to hydrocodone, buprenorphine-naloxone, and alprazolam. As a result of the Center’s alleged actions and inactions, thousands of doses of controlled substances went unaccounted for.
The present civil investigation was prompted by a scheduled DEA audit in March 2021. “The Prescription Center” cooperated with the investigators and has since enhanced its recordkeeping and internal compliance program in response to concerns raised by the DEA in the course of this investigation. Although there are no allegations that any of the alleged unaccounted for controlled substances were diverted, this settlement addresses the independent obligation of “The Prescription Center” to ensure it has systems in place adequate to prevent improper dispensing, as required by 21 U.S.C. §§ 827, 842, and associated regulations.
“While no known actual diversion took place in this instance, pharmacies have a crucial responsibility to protect controlled substances from being diverted and potentially abused. Our nation remains in the midst of an opioid crisis, and the importance of keeping complete and accurate records of incoming and outgoing controlled substances at the pharmacy level cannot be overstated,” said Acting U.S. Attorney Brandler. “I commend the owners of “The Prescription Center” for taking this responsibility seriously and being proactive in this investigation to strengthen their systems and processes to protect their legitimate dispensing from diversion.”
This Settlement Agreement is neither an admission of liability by the pharmacy nor a concession by the United States that its claims are not well founded.
This case was investigated by Drug Enforcement Administration’s Diversion Control Division. The investigation was handled by Assistant United States Attorney, Harlan W. Glasser and the Affirmative Civil Enforcement (ACE) Unit within the U.S. Attorney’s Office.
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Updated October 1, 2021
Topic
Prescription Drugs
Component