FDA NEWS RELEASE

Federal judge enters consent decree with Med Prep Consulting

Sterile injectable drug compounder distributed contaminated drugs across state lines

A federal judge from the U.S. District Court for New Jersey has entered a consent decree of permanent injunction against Med Prep Consulting, Inc., a pharmacy licensed by the state of New Jersey, and Gerald R. Tighe, the company’s president and owner. The U.S. Department of Justice sought the consent decree on behalf of the U.S. Food and Drug Administration.

Med Prep manufactured sterile drug products for hospitals and health care facilities, including products intended to be injected into the vascular system of patients.  In addition to other requirements, the consent decree enjoins Med Prep from manufacturing, holding, and distributing drug products until it complies with certain requirements of the Federal Food, Drug, and Cosmetic Act and all applicable regulations. 

“Those who violate the Federal Food, Drug, and Cosmetic Act risk serious consequences,” said Melinda K. Plaisier, the FDA's acting associate commissioner for regulatory affairs. “This consent decree shows that the FDA will take aggressive enforcement actions to ensure the safety of drugs.”

“Med Prep put patients’ health at risk by producing contaminated drugs under unacceptable conditions,” said Janet Woodcock, MD, director, FDA’s Center for Drug Evaluation and Research. “While not all the right laws are in place to provide the FDA with appropriate and efficient oversight of these facilities, the FDA will continue using its existing authorities to protect public health.

Following last fall’s tragic fungal meningitis outbreak, the FDA has focused its surveillance efforts on state-licensed facilities that produce sterile drugs.  Since September 2012, the FDA has completed nearly 60 inspections of state-licensed facilities that produce high-risk sterile drug products, including nearly 30 for-cause inspections following reports of adverse events or when states have requested the FDA’s assistance. In addition, the agency has overseen 14 voluntary recalls, mostly due to the lack of sterility assurance in the facilities. 

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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