$490k Paid for Controlled Substances Act Violations
$490k Paid for Controlled Substances Act Violations
Philadelphia physician agrees to pay nearly $490,000 for Controlled Substances Act violations, like writing prescriptions “for stock.”
United States Attorney Jacqueline C. Romero announced on November 14, 2022, that Kenneth Fox, D.O., has agreed to pay $489,025 to resolve allegations that he violated the Controlled Substances Act (CSA) by failing to maintain complete and accurate records of controlled substances, failing to keep required receipt and dispensing records, failing to perform biennial inventories, and writing prescriptions “for stock.”
The United States’ investigation involved Fox’s practice located at 1310 Frosty Hollow Road, Levittown, PA 19056.
As part of the settlement, Fox 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.
Fox prescribes and administers phentermine, a Schedule IV controlled substance, and suboxone, a Schedule III controlled substance. In February 2013, DEA Investigators discovered that Fox allegedly failed to conduct a biennial inventory, failed to maintain records for receipt and dispensing of controlled substances, and failed to keep controlled substances secure – all in violation of applicable regulations and statutes. In April 2013, the DEA issued a Letter of Admonition to Fox, who agreed to correct his conduct thenceforth.
Nine years later, the DEA performed another scheduled on-site inspection of Fox’s facility. During this inspection, Investigators discovered that Fox continued the same violations as before, and in addition, was prescribing controlled substances “for stock” in violation of the applicable regulations. On the date of inspection, Fox allegedly produced non-compliant and incomplete dispensing records, and no records of biennial inventory, or invoices/receipts for controlled substances. The Investigators obtained records of Fox’s 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.
The claims resolved by this settlement are allegations only and there has been no determination of liability.
Approximate date(s) of the diversion:
04/01/2013
Where the Diversion Occurred:
Kenneth Fox, D.O.
1310 Frosty Hollow Road, Levittown, PA 19056
Type of Healthcare Facility:
Hospital
Person Diverting:
Kenneth Fox, D.O.
Profession of the person diverting:
Physician or Medical Doctor (MD)
Has the incident been reported?
e.g. to local law enforcement, county board of health, state licensure board, and/or federal DEA or FDA authorities?
Yes
To whom has the incident been reported?
Drug Enforcement Administration (DEA)
