According to an FDA press announcement, Main Street Family Pharmacy, LLC plead guilty on December 4, 2014 to shipping drugs that were considered adulterated under the Food, Drug, and Cosmetic (FD&C) Act, which is a misdemeanor criminal violation. Main Street had multiple regulatory compliance issues in the previous year. In May and June 2013, the compounding pharmacy failed U.S. Food and Drug Administration (FDA) inspections due to insanitary conditions, deviations from current good manufacturing practices, and FDA’s findings of microbial contamination in some of the its drug products. Main Street also announced a voluntary recall of its products compounded for sterile use in May 2013 after 26 adverse events were reported regarding its compounded methylprednisolone acetate (MPA) injections.
The United States District Court for the Western District of Tennessee ordered Main Street and its co-owner David A. Newbaker to pay a fine of $25,000 each, and Newbaker was sentenced to 12 months of probation. The court also entered a civil consent decree of permanent injunction against Main Street, David A. Newbaker, and Christie R. Newbaker, the compounding pharmacy’s other co-owner. Under the consent decree, Main Street and its owners are prohibited from manufacturing, holding, and distributing drug products until the company complies with the FD&C Act and other FDA regulations.
Non-compliance with FDA regulations can have detrimental consequences. In order for a drug facility to succeed in the U.S., it must fully understand and comply with FDA’s requirements. Registrar Corp can help navigate drug facilities through FDA regulations, as well as assist with certain requirements. For questions regarding FDA drug regulations, contact Registrar Corp at +1-757-224-0177 or through the 24 hour live help service.