The FDA has decided that not only were the operations of New Jersey-based Med Prep Consulting unsterile, they were illegal.
The large compounding pharmacy, its owner, Gerald Tighe, and pharmacist-in-charge Stephen Kalinoski have been named in a 37-count indictment that accuses them of intentionally defrauding the FDA and the hospitals the company sold to by selling drugs it claimed were prepared in safe conditions when in fact, it cut corners to cut costs.
"As detailed in the indictment, Med Prep and its two most senior executives engaged in a disturbing pattern of dangerous practices in order to save money and line their pockets," U.S. Attorney Loretta Lynch said in a statement.
A federal judge in 2013 slapped the Tinton Falls, NJ, compounder with a consent decree after the FDA warned healthcare providers that FDA inspectors had found serious microbiological contamination in the company's plant and that some of its products were discovered to contain mold. FDA inspectors also found that some products did not contain enough of their active ingredients.
The FDA previously warned the operation about its lax operations and discovered that for 5 or 6 months one employee responsible for repacking and processing drugs in Med Prep's "cleanroom" failed to treat an eczema skin condition.
The Med Pro indictment comes about two months after 14 owners and employees of New England Compounding Center (NECC) were named in a 73-count indictment that included 25 counts of second degree murder against two lead pharmacists. NECC was tied to the 2012 nationwide fungal meningitis outbreak that infected 751 people who received injections of an NECC compounded steroid drug. Sixty-four of those died. The outbreak put the FDA on the hot seat and led to Congress passing the Drug Quality and Security Act, which gives the FDA new, but limited, powers to oversee compounding pharmacies.
- here's the FDA release