Pharmacy Compliance Director’s Guilty Plea Highlights FDA’s Compounding Focus

A former compliance director for the now-shuttered pharmacy compounder Pharmakon Pharmaceuticals Inc. pleaded guilty to distributing subpotent and overpotent compounded drug products to hospitals around the country, illustrating the FDA’s increasing focus on reining in substandard drug compounding practices.

Caprice R. Bearden, of Carmel, Ind., pleaded guilty in the U.S. District Court for the Southern District of Indiana, including to a charge she knowingly conspired to defraud the FDA by obstructing its lawful functions, the Justice Department said Nov. 22. She also pleaded guilty to introducing adulterated drugs into interstate commerce, including opioids nearly 25 times the strength indicated on the labels of the drugs being administered to three infants.

Bearden’s guilty plea comes as the FDA is stepping up its enforcement efforts in the pharmacy compounding area. So far this year, the agency has sent more than 30 warning letters to pharmacy compounders about their noncompliance with current good manufacturing (cGMP) practice requirements. During 2016, the agency sent more than 40 warning letters to compounders.

In drug compounding, a licensed pharmacist combines, mixes, or alters ingredients of a drug to create a medication for an individual patient. Patients in several states received overpotent drugs compounded by Pharmakon, which led to a national recall and the closure of the facility.

The conspiracy charge to which Bearden pleaded guilty carries a maximum sentence of five years in prison and a fine of $250,000 or twice the gross gain or gross loss from the offense, the Justice Department said. The six misdemeanor charges each carry a statutory maximum punishment of one year in prison and a fine of $100,000 or twice the gross gain or gross loss from the offense.

Chief Judge Jane E. Magnus-Stinson accepted the plea but hasn’t yet scheduled a sentencing date.

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