Drug Enforcement Administration (DEA) inspections can have significant financial repercussions if the logs and records of controlled substances are not properly maintained. A recent case illustrates how this happens and is a reminder for practices and pharmacies to be sure their business is compliant in this regard.
In January 2014, the DEA inspected the controlled substance ordering and dispensing records relating to Pain Medicine Consultants, Inc., a medical practice which had offices in multiple Bay Area locations (Novato, Pleasant Hill, and Pleasanton).
The government alleged that the DEA inspection uncovered multiple violations of the Controlled Substances Act, 21 U.S.C. § 801 by the practice and the physicians in the group who have the DEA registrations. The government specifically alleged that between January 10, 2012, through January 17, 2014, the medical practice and the physicians failed to:
(1) keep and maintain adequate records pertaining to controlled substances, as required by 21 C.F.R. § 1304, et seq.;
(2) failed to include the address of the patient on controlled substance prescriptions that they each issued as required by 21 C.F.R. § 1306.05(a); and
(3) exceeded the authority of their registrations by filling a prescription for a controlled substance, in violation of 21 C.F.R. § 1306.06.
Now, five years' later, the physicians in the group decided to settle the matter with the U.S. Department of Justice. Thus, on May 18, 2019, physicians Drs.
William Longton, Ruben Kalra, and Richard Shinaman agreed to collectively
pay $260,000 to settle allegations that they
failed to keep and maintain adequate records and other allegations pertaining to
controlled substances at their practice Pain Medicine Consultants, Inc.
This is a civil case and not criminal and the settlement will help resolve all civil claims related to the
violations identified in the investigation. DEA violations can subject a practice to fines and they can add up quickly over the course of years. For this reason, it is a wise idea for the records to be maintained properly and that compliance be revisited on a regular basis. A settlement such as this one also helps avoid an administrative case that could result in a loss of DEA certificate privileges.
Posted by Tracy Green, Esq.
Green and Associates
