Civil settlement resolves allegations of record keeping violations against Savannah area weight loss physician

SAVANNAH, GA: A physician who operates weight-loss clinics in the Savannah area has agreed to pay civil penalties and to accept increased oversight to resolve allegations that he violated the Controlled Substances Act.

Dr. Donald Lyle Gates, who operates three Savannah-area Scale Solutions clinics, reached a settlement with the Southern District of Georgia U.S. Attorney's Office, said Jill E. Steinberg, U.S. Attorney for the Southern District of Georgia, that requires Gates to pay a civil penalty of $100,000. An agreement with the Drug Enforcement Administration also allows Dr. Gates to maintain DEA registrations to dispense controlled substances while abiding by specific conditions that include a two-year term of increased oversight by DEA.

"Those with the authority to dispense potentially addictive drugs are expected to balance that power with the responsibility to provide adequate and trustworthy recordkeeping," said U.S. Attorney Steinberg. "Recordkeeping requirements serve a critical role to ensure that controlled substances are not diverted for illegal purposes."

Dr. Gates operates Georgia weight-loss clinics called Scale Solutions in Savannah, Pooler, and Hinesville, and previously operated a clinic in Bluffton, S.C. The United States, through the U.S. Attorney's Office and the Drug Enforcement Administration, alleged that Gates failed to keep and maintain records for the prescription weight-loss drugs phentermine and phendimetrazine, and dispensed those drugs in violation of the Controlled Substances Act.

DEA Diversion Investigators conducted on-site inspections of Dr. Gates' offices and determined, among other findings, that the offices did not have complete and accurate records of controlled substances for which Dr. Gates was responsible, including inventories, documents memorializing his receipt of controlled substances, their distribution, and their dispensation. Investigators alleged that on more than one occasion, Dr. Gates failed to keep controlled substances at the locations registered with DEA and instead transferred those controlled substances to his home.

The Controlled Substances Act creates a closed system that tracks controlled substances from manufacture through distributor, to the ultimate end-user, allowing the DEA to monitor the flow of controlled substances in the United States at every juncture. When a dispensing practitioner fails to maintain complete and accurate records, the system is at risk for illegal diversion into the community.

The civil settlement and the Memorandum of Agreement are neither an admission of liability by Dr. Gates, nor a concession by the United States that its claims are not well-founded.

"Diverted and misused prescription medications pose a grave threat to public health," said Robert J. Murphy, Special Agent in Charge of the DEA Atlanta Division. "Therefore, it's expected and required that physicians and other trusted medical providers maintain meticulous records of these controlled substances to prevent prescription drug abuse."

The case was investigated by the Drug Enforcement Administration, and the civil settlement was negotiated by Assistant U.S. Attorney Bradford C. Patrick.

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