PHILADELPHIA, PA — United States Attorney Jacqueline C. Romero announced that Douglas Daniel Files, D.O., has agreed to pay $100,000 to resolve allegations that he violated the Controlled Substances Act (CSA) by failing to maintain complete and accurate records of a controlled substance (testosterone), failing to keep required receipt and dispensing records, failing to perform biennial inventories, and writing prescriptions “for stock.”
The United States’ investigation involved Files’ practice located at 2346 Trenton Road, Levittown, Pennsylvania 19056.
As part of the settlement, Files has entered into a three-year Memorandum of Agreement (MOA) with the Drug Enforcement Administration (DEA), which includes additional responsibilities regarding the handling of controlled substances. The MOA imposes compliance obligations significantly more stringent than those in the applicable laws and regulations.
Files prescribes and administers testosterone, a Schedule IIIN controlled substance. In April 2022, DEA investigators discovered that Files allegedly failed to conduct a biennial inventory, failed to maintain records for receipt and dispensing of the controlled substance, and was prescribing controlled substances “for stock” – all in violation of applicable regulations and statutes.
The DEA diversion investigators obtained records of Files’ prescriptions “for stock” from a local retail pharmacy. Physicians are prohibited from obtaining controlled substances for the purpose of general dispensing to patients; they must comply with the requirements for a valid prescription, including the date, patient’s name and address, drug name and strength, dosage form, quantity prescribed, directions for use, and the physician/registrant’s name, address, and registration number. The prescription requirement is one of the ways in which controlled substances are tracked to prevent diversion and abuse.
“Physicians who fail to maintain proper records of controlled substances create conditions ripe for diversion, or, at worst, may be engaging in diversion itself,” said U.S. Attorney Romero. “Physicians and pharmacists have a responsibility to ensure that all controlled substances are tracked through the distribution chain. Our Office is committed to ensuring total compliance with the Controlled Substances Act and we will vigorously enforce violations wherever we find them.”
“Dr. Files’ ordering of prescription medicines for stock is not permissible under the regulations of the Controlled Substances Act,” said Thomas Hodnett, Special Agent in Charge of the Drug Enforcement Administration’s Philadelphia Field Division. “Settlements and Memorandum of Agreements such as these help to ensure that physicians properly safeguard, dispense, and account for the controlled substances in their care.”
Congress enacted the CSA to deter the illegal importation, manufacture, distribution, possession, and improper use of controlled substances, including prescription medications, and requires individuals and entities registered with the DEA to maintain complete and accurate records of all controlled substances and security systems so that controlled substances are not lost, stolen, or inappropriately dispensed.
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 investigation was conducted by the Drug Enforcement Administration’s Philadelphia Field Division, Diversion Regulatory Group 2 (D72), and the investigation and settlement were handled by Assistant U.S. Attorney Viveca D. Parker, with DEA Diversion Investigators.
The claims resolved by this settlement are allegations only and there has been no determination of liability.
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