A compounding pharmacy in Newbern, Tennessee, and its co-owner have pleaded guilty to 1 misdemeanor criminal violation of the Federal Food, Drug, and Cosmetic Act.
A compounding pharmacy in Newbern, Tennessee, and its co-owner have pleaded guilty to 1 misdemeanor criminal violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act), according to an FDA press release.
Main Street Family Pharmacy, LLC, produced and shipped methylprednisolone acetate (MPA) that contained microbial contamination, according to the FDA. The pharmacy recalled its products compounded for sterile use in May 2013, after it received 26 reports of adverse events, such as skin abscesses, from patients who received MPA injections compounded by Main Street, according to the FDA.
The pharmacy’s co-owner, David A. Newbaker, has been sentenced to 12 months of probation, and he and Main Street will each have to pay a $25,000 fine. Both Newbaker and the pharmacy’s other co-owner, Christy R. Newbaker, will not be able to manufacture, hold, or distribute drug products until the company complies with all FDA&C Act regulations.
In May and June 2013, the FDA found that the pharmacy was unsanitary and displayed many deviations from the current good manufacturing practice requirements for drug products. For example, equipment and rooms were not adequately cleaned and the employees were not conducting the necessary laboratory testing to ensure the products embodied the strength and purity they were supposed to possess, the FDA stated.
After testing product samples, the FDA also found microbial contamination in certain injectable drug products.
“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, in a press release. “The FDA’s enforcement actions against Main Street and its owners reflect our commitment to using all appropriate authorities to protect the public health.”