Maligned N.J. Compounder Med Prep Facing Criminal Charges

A New Jersey-based drug compounder and two of its top corporate officials have been indicted on fraud charges for repackaging and distributing unsterile drugs to several states.

The 37-count indictment, unsealed in U.S. district court in Brooklyn, charges Med Prep Consulting with processing oncology, dialysis, anesthesia, and operating room drugs, along with pain medications, under unclean conditions.

“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,” said Loretta Lynch, U.S. attorney for the eastern district of New York in announcing the charges.

The FDA first discovered problems at Med Prep when it inspected the company’s Tinton Falls, N.J., plant following complaints of mold in injectable magnesium sulfate being shipped from the plant to a Connecticut hospital in March of 2013.

History of Problems

In addition to the mold, investigators found that Med Prep shipped drugs labeled with incorrect strengths or labeled as the wrong drug altogether. Med Prep subsequently recalled all of its drug products and entered into a consent decree to fix quality issues.

The new indictment charges that Med Prep President and owner Gerald Tighe and pharmacist-in-charge Stephen Kalinoski told FDA investigators that the company complied with U.S. Pharmacopeia quality standards when it did not.

The indictment lists a long history of quality lapses that include failure to conduct sterility testing, repackaging IV drugs in unsterile conditions, ignoring instructions not to open and reseal vials of drugs, failing to maintain adequate air filtration and extending expiration dates on products beyond their allowable limits.

In addition, customers have complained about receiving drugs from the company that were prepared at twice the concentration indicated on labeling and receiving vials of drugs that were visibly cloudy.

If convicted, Tighe and Kalinoski could face up to 20 years in prison each for wire fraud for selling drugs that they represented as sterile, as well as additional prison sentences for violations of the FD&C Act.

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