United States Drug Enforcement Administration

WASHINGTON – A federal court ordered an Elkin, North Carolina, pharmacy to pay a $500,000 penalty and enjoined the pharmacy and its pharmacists from dispensing controlled substances, including opioids, without taking steps to help ensure the drugs will not be abused or diverted.

The consent decree resolves a complaint filed by the United States on Nov. 27, which alleged that Elk Pharmacy Inc., Larry Irwin, the pharmacy’s owner and pharmacists Susan Baker, S. Jason Couch, Beth Pence and Lori Wyble filled prescriptions in violation of the Controlled Substances Act (CSA). The complaint alleges that the defendants dispensed prescription opioids while disregarding numerous “red flags” — that is, obvious indications of drug abuse, drug diversion and drug-seeking behavior. For example, according to the complaint, the defendants filled dangerous combination prescriptions; filled prescriptions for long-term, high-dose opioids that exceeded known recommendations for treating pain; filled prescriptions for patients who appeared to be “shopping” for doctors or pharmacies; and filled prescriptions written by prescribers known to be suspected of illegal prescribing, including one doctor who the North Carolina Medical Board had barred from prescribing controlled substances.

“The pharmacists at Elk Pharmacy Inc. had a corresponding responsibility, along with the prescribing practitioners, to only dispense prescriptions for a legitimate medical purpose,” said Special Agent in Charge Robert J. Murphy of the DEA Atlanta Division. “The DEA will continue to pursue healthcare providers who are not in compliance with mandatory regulations.”

“Pharmacists have a duty to help protect consumers from the life-threatening dangers of controlled substance abuse,” said Principal Deputy Assistant Attorney General Brian Boynton, head of the Justice Department’s Civil Division. “The department will continue to work with its law enforcement partners to hold medical professionals accountable when they fail to fulfill that duty.”

“Pharmacists are trained professionals who cannot simply rubber-stamp doctors’ prescriptions,” said U.S. Attorney Sandra J. Hairston for the Middle District of North Carolina. “They have an independent responsibility to ensure that the prescriptions they fill are for a legitimate medical purpose.”

The defendants agreed to settle the suit and be bound by a consent decree of permanent injunction. The injunction entered by U.S. District Judge Thomas D. Schroeder for the Middle District of North Carolina prohibits the defendants from filling certain “red flag” prescriptions and requires the defendants to fill other orders only after receiving documentation justifying the prescriptions.

The government was represented by Senior Litigation Counsel Donald R. Lorenzen of the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney Cassie Crawford for the Middle District of North Carolina, with substantial assistance from the DEA Greensboro Resident Office’s Diversion Group.

For more information about the enforcement efforts of the Consumer Protection Branch visit www.justice.gov/civil/consumer-protection-branch.

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