Tuesday, December 16, 2014

Read What Authors of FDA Law Blog Say About Recent Main Street Family Pharmacy Case

Main Street Family Pharmacy Compounder Pleads Guilty to Misdemeanor Violations of the FDCA, and Accepts Probation, a $25,000 Fine and a Permanent Injunction

By Karla L. Palmer On December 4, 2014, in the United States District Court for the District of Tennessee, Main Street Family Pharmacy, LLC and its co-owner David Newbaker each pled guilty to a misdemeanor criminal violation of the Federal Food, Drug, & Cosmetic Act (FDCA).  Under the terms of the plea deal, David Newbaker was sentenced to 12 months probation, and the pharmacy and Newbaker were ordered to pay a fine of $25,000.  The Court also entered a civil Consent Decree of Permanent Injunction under 21 U.S.C. 332(a) against both Newbaker and the company’s co-owner, Christy Newbaker.  The decree prohibits the co-owners and the pharmacy from “manufacturing, holding, and distributing drug products until the company comes into compliance with the FDCA” and its implementing regulations, among other requirements.  Paragraph 29 of the Consent Decree sets forth additional penalties for any failure to comply with the Decree’s terms.
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