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Main Street Family Pharmacy, LLC, a compounding pharmacy in Newbern, Tenn., and the company’s co-owner, David A. Newbaker, each pleaded guilty today in the United States District Court for the Western District of Tennessee to one misdemeanor criminal violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The pleas are in connection with Main Street’s interstate shipment of methylprednisolone acetate (MPA) that was adulterated under the FD&C Act because the MPA contained microbial contamination. In May 2013, Main Street announced a recall of all of its products compounded for sterile use. This followed 26 reports of adverse events, including skin abscesses, from patients in four states who received MPA injections compounded by Main Street.
At sentencing, District Court Judge Daniel J. Breen sentenced Newbaker to 12 months of probation and ordered Newbaker and Main Street to each pay a fine of $25,000.
The court today also entered a civil consent decree of permanent injunction against Main Street, David 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. This action further protects the health of the American public by ensuring that Main Street and the Newbakers comply with the law.
“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,” says FDA commissioner Margaret A. Hamburg, MD. “The FDA’s enforcement actions against Main Street and its owners reflect our commitment to using all appropriate authorities to protect the public health.”
In May and June 2013, the FDA inspected Main Street and found insanitary 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 certain 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 investigation, which resulted in the misdemeanor criminal charges.