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Tennessee Compounding Pharmacy Pleads Guilty to Shipping Tainted Drug
A Tennessee compounding pharmacy and its co-owner pleaded guilty in federal court to charges stemming from the interstate shipment of contaminated methylprednisolone acetate (MPA) that was blamed for 26 adverse events.
Main Street Family Pharmacy, LLC, in Newbern, Tennessee, and co-owner David A. Newbaker pleaded guilty in U.S. District Court in Memphis to one misdemeanor criminal violation of the federal Food, Drug, and Cosmetic (FD&C) Act. District Judge Daniel J. Breen sentenced Newbaker to 12 months of probation and ordered him and his company to each pay fines of $25,000.
Patients in four states who received MPA injections compounded by Main Street reported adverse events, including skin abscesses. The MPA was found to contain microbial contamination. Main Street recalled all of its products compounded for sterile use after the reports surfaced in May 2013.
“Americans expect and deserve safe, high-quality drug products, yet Main Street produced and shipped unapproved drugs that were contaminated, and put patients at risk for serious infection,” said FDA Commissioner Margaret A. Hamburg, MD.
The federal court also entered a civil consent decree of permanent injunction against Main Street, Newbaker, and the company’s other co-owner, Christy R. Newbaker. The consent decree prohibits Main Street and the Newbakers from manufacturing, holding, and distributing drug products until the company comes into compliance with the FD&C Act and its regulations, among other requirements.
In May and June 2013, the FDA inspected Main Street and found unsanitary conditions and numerous deviations from the current good manufacturing practice (CGMP) requirements for drug products. FDA analyses of product samples also found microbial contamination in some injectable drug products. FDA investigators noted, among other observations, that the company did not adequately clean and disinfect rooms and equipment, and failed to conduct laboratory testing to ensure that products have the identity, strength, quality and purity they purport to possess.
In addition to the findings from the 2013 regulatory inspection, the FDA’s Office of Criminal Investigations conducted its own inquiry, which resulted in the misdemeanor criminal charges.
Source: FDA; December 4, 2014.