FDA notches a win after Tennessee compounder pleads guilty

The FDA closed another chapter in regulating errant compounders when the co-owner of Main Street Family Pharmacy, a Tennessee-based compounding pharmacy, pleaded guilty in federal court to a misdemeanor criminal violation related to a contaminated steroid that caused 26 people to become ill.

David Newbaker entered a guilty plea on behalf of himself and the company last Thursday in U.S. District Court in Tennessee for violating the Federal Food, Drug and Cosmetic Act. He was charged with interstate shipment of methylprednisolone acetate (MPA) that had microbial contamination.

The company recalled all of its products in May 2013, following 26 reports of adverse reactions to the drug, including skin abscesses, from patients in four states who received MPA injections compounded by Main Street.

That recall came on the heels of a 2012 fungal meningitis outbreak linked to the same drug produced by New England Compounding Center (NECC) that killed 64 people, sickened more than 700 people, and led to Congress granting the FDA new powers to regulate large compounding pharmacies.

Newbaker was sentenced to 12 months probation. He and the company were each ordered to pay a fine of $25,000. The court also ordered a permanent injunction against Main Street, Newbaker and the other co-owner, Christy Newbaker, prohibiting them from "manufacturing, holding, and distributing drug products until the company comes into compliance with the FD&C Act and its regulations."

The court action in the Main Street case came the same day the trustee for the now-bankrupt NECC filed a plan in federal court to establish a fund of at least $135 million in compensation for victims and families affected by a fungal meningitis outbreak caused by the company's drug.

- see the FDA release