Friday, December 5, 2014

TN Drug Compounding Firm Pleads Guilty

 By Walter F. Roche Jr.

A Tennessee pharmacist and his compounding firm have pleaded guilty to violations of federal law in the shipping of a spinal steroid across state lines.
The guilty pleas were entered by David A. Newbaker and the Main Street Family Pharmacy in Newbern to charges of shipping an adulterated drug across state lines.
The pharmacy shipped the steroid, methylprednisolone acetate, which was contaminated with bacteria. The pharmacy recalled all of its sterile products last year but not before some 26 patients reported adverse events such as abscesses at the injection sites.
Under a plea agreement Newbaker will be on probation for a year and a total of $50,000 in fines will be assessed against him and the pharmacy.
The court also imposed a civil consent decree barring Newbaker and his wife from shipping drugs until they come into compliance with federal drug requirements. The decree and the criminal charges were filed in U.S. District Court in Memphis.
The New Bern pharmacy was producing the same steroid which has been blamed for a 2012 outbreak of fungal meningitis that took the lives of 64 patients and sickened 751. Those drugs came from the New England Compounding Center, which has shut down.
State records show the pharmacy is closed and Christy Newbaker is serving a two-year probation on her pharmacist license. She was fined $12,800 in 2013, David Newbaker's license is active.
A state Health Department spokeswoman said that the pharmacy voluntarily ceased operation in August.

1 comment:

  1. I think that being a compounding pharmacist is a great career choice. There are several people that I know that have chosen this kind of career and are loving it. It's unfortunate that that lawsuit had to happen to this company, but at the end of the day it really will help to ensure that they're able to do it right next time. Thank you for sharing.