Source: Office of United States Attorneys
HARRISBURG, PA —The United States Attorney’s Office for the Middle District of Pennsylvania announced that Dr. Donald J. Dinello, D.M.D., with practice locations in Harrisburg and Hershey, has agreed to pay the United States $120,000 in civil penalties for allegedly failing to comply with recordkeeping and other 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 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 prescription, inventory, and other documentation requirements. Regulations promulgated under the CSA require that each DEA registrant, including registered practitioners, 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 and prescription requirements subject DEA registrants to civil monetary penalties.
According to the allegations, between January of 2023 and August of 2024, Dr. Dinello failed to use the required DEA form 222 for each distribution of a Schedule II Controlled Substance, failed to maintain complete and accurate records of controlled substances dispensed by him at both his registered locations, failed to maintain biennial inventory at both his registered locations, and in one instance, failed to issue a prescription for a Schedule IV controlled substance in the usual course of his professional practice. Dr. Dinello acknowledges he is required to operate in accordance with the statutory and regulatory provisions of the CSA and its implementing regulations.
“Practitioners who register with DEA in order to prescribe and dispense medications that fall under the Controlled Substances Act have an obligation to prescribe appropriately and keep careful records and inventories,” said U.S. Attorney Gerard M. Karam. “Not fulfilling those obligations makes it difficult or even impossible to be sure those potentially dangerous medications are being dispensed and handled appropriately and are not being diverted. The pursuit of this matter illustrates the continued dedication of our office to protecting the public in MDPA.”
“The goal of DEA’s closed system of distribution is to ensure accountability for controlled substances and physicians who fail to maintain proper records of controlled substances create conditions ripe for diversion” said Thomas Hodnett, Special Agent in Charge of the DEA’s Philadelphia Field Division. “The government’s pursuit of this matter illustrates its emphasis on combating diversion of controlled substances. The record keeping and other regulations applicable to DEA registrants, including physicians, are the tools by which the DEA deters drug diversion.”
The Settlement Agreement is neither an admission of liability by Dr. Dinello nor a concession by the United States that its claims are not well founded.
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 (ACE) Unit within the U.S. Attorney’s Office for the Middle District of Pennsylvania.
# # #