Main Street Pharmacy Co-Owner Pleads Guilty To Criminal Violation Of The Federal Food, Drug, And Cosmetic Act

Jackson, Tenn. – Edward L. Stanton III, United States Attorney for the Western District of Tennessee, and FDA Commissioner Margaret A. Hamburg, M.D, announced today that Main Street Family Pharmacy, LLC, a compounding pharmacy in Newbern, Tennessee, and the company’s co-owner, David A. Newbaker, each pleaded guilty to a misdemeanor criminal violation of the federal Food, Drug, and Cosmetic Act late last week.

In early 2013, the United States Department of Health and Human Services Food and Drug Administration (“FDA”) began an investigation into adulterated Methylprednisolone Acetate (“MPA”), a steroid used to treat pain in human beings. The FDA is authorized by federal law to enforce the Federal Food, Drug, and Cosmetic Act, which, among other things, ensures that drug products are safe and effective for their intended uses and are not adulterated.

According to the information and statements made in open court, on or about May 22, 2013, the FDA collected samples of MPA from Logan Primary care, a clinic in Herrin, Illinois. Invoices obtained from the clinic revealed the source of the MPA obtained was from Main Street Family Pharmacy, LLC, in Newbern, Tennessee. The FDA’s Denver Laboratory tests indicated the MPA sample contained bacterial contaminants.

Newbaker, a state-licensed pharmacist, was responsible for, and actively directed, Main Street Family Pharmacy, LLC’s drug compounding activities. His duties on February 7, 2013 included oversight of employee training and the quality control of sterile drugs compounded by Main Street.

Chief United States District Judge J. Daniel Breen sentenced Newbaker to 12 months of probation, and ordered Newbaker and Main Street to each pay a fine of $25,000.

The 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. This action further protects the health of the American public by ensuring that Main Street and the Newbakers comply with the law.

“This prosecution shows there are high standards for pharmacists to meet to protect the public, and serious consequences for those who fail to meet them,” stated U.S. Attorney Stanton. “No one is above the law, including those that wear white lab jackets.”

“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 Hamburg. “The FDA’s enforcement actions against Main Street and its owners reflect our commitment to using all appropriate authorities to protect the public health.”

The case was investigated by the FDA’s Office of Criminal Investigations. Assistant United States Attorney Matt Wilson represented the United States of America.