HARRISBURG, PA —The United States Attorney’s Office for the Middle District of Pennsylvania announced that GDD Pharmacy Services, Inc., located in Mechanicsburg, Pennsylvania, has agreed to pay the United States $70,000 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 dispensing, distribution, and recordkeeping 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.
Regulations promulgated under the CSA limit the manner in which pharmacies can dispense or distribute controlled substances. The CSA also requires the maintenance of 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 these requirements subject DEA registrants to civil monetary penalties.
According to the allegations, between January 2019 and May 2021, GDD Pharmacy Services, Inc., doing business as Harrisburg Pharmacy and See Right Pharmacy, failed to keep and maintain complete and accurate records and inventories in violation of the CSA.
GDD Pharmacy Services, Inc. cooperated with the investigation, and has since enhanced its internal controls in response to concerns raised by the DEA during this investigation. Although there are no allegations that any controlled substances were diverted, this settlement addresses the independent obligation of GDD Pharmacy Services, Inc. to ensure it has adequate systems in place to prevent improper dispensing or distribution, as required by 21 U.S.C. §§ 829, 842, and associated regulations.
“GDD Pharmacy Services, Inc., through their retail pharmacies, has an obligation to properly document and account for the controlled substances in their inventory,” said Thomas Hodnett, Special Agent in Charge of the Drug Enforcement Administration’s (DEA) Philadelphia Field Division. “Failing to do so jeopardizes the security of the controlled substances they are entrusted with dispensing.”
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 matter was handled by DEA Philadelphia Field Division and Assistant United States Attorney Tamara Haken and the Affirmative Civil Enforcement (ACE) Unit within the U.S. Attorney’s Office for the Middle District of Pennsylvania.
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