Tenn. Compounder Pleads Guilty to Criminal Charges From Contaminated Products

A compounding pharmacy pled guilty to manufacturing contaminated products that caused skin infections, the first compounder to be convicted of criminal charges for poor quality since the FDA gained new authority in 2013.

Tennessee-based Main Street Family Pharmacy and its co-owner Christy Newbaker will pay separate $25,000 fines for one federal misdemeanor charge each for violating the FD&C Act by shipping contaminated methylprednisolone acetate (MPA). Main Street also entered into a consent decree that prohibits it from manufacturing, holding and distributing products until the pharmacy comes into FDA compliance. Newbaker received a year of probation from a federal judge in the U.S. District Court for the Western District of Tennessee.

The charges stem from a 2013 recall of all of Main Street’s sterile products. The recall was initiated after the agency received 26 adverse event reports, including skin abscesses, from patients in four states who were injected with MPA compounded by Main Street, the FDA said.

The FDA inspected Main Street’s Newbern, Tenn., facility in May and June last year and uncovered several troubling good manufacturing practice violations.

Investigators discovered the compounder had no written pest control procedures, and observed two spiders in the facility’s clean room. Main Street also didn’t use any type of sporicidal cleaning agent inside or outside of its clean room, says a Form 483 issued to the company.

The agency identified other problems with the company’s equipment and processes. For example, a motor used in the lyophilization unit started to leak oil. Facility personnel placed a paper towel between the motor and lyophilization unit to absorb the oil rather than fix the issue, the FDA said.

Main Street also tests the potency of a finished product on a random basis, with no scientifically justified schedule or plan, said the form with 25 observations.

The compounder is halting all operations related to manufacturing, holding or distributing drug products, according to the consent decree. To resume operations, Main Street must comply with agency quality regulations and hire an expert to inspect its facilities.

Main Street was the first compounder to face criminal charges since the New England Compounding Center and several employees were charged with compounding contaminated drugs that caused a nationwide meningitis outbreak in 2012. That investigation is still ongoing.

The meningitis outbreak sparked Congress to grant the FDA additional powers in 2013 to regulate larger compounding facilities. The agency has warned more than 25 compounders since the Drug Quality and Security Act was signed into law late last year.

Main Street could not be reached for comment.

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