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 companys president and owner. The U.S. Department of Justice sought the consent decree on behalf of the Food and Drug Administration (FDA).

Med Prep manufactured sterile drug products for hospitals and healthcare 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, says 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.

A recent FDA inspection at Med Preps Tinton Falls, N.J., facility found insanitary conditions and numerous violations of current good manufacturing practice requirements for drugs.  In addition, FDA analyses of product samples found mold in certain injectable drug products labeled as sterile, and revealed that some of the products were sub-potent (that is, they did not include enough active ingredients).  Further, the company produced and distributed numerous drug products without receiving patient-specific prescriptions and without having an approved new drug application or approved abbreviated new drug application.

Med Prep put patients health at risk by producing contaminated drugs under unacceptable conditions, says Janet Woodcock, MD, director of the FDAs 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.

On March 18, 2013, Med Prep voluntarily recalled of all of its sterile products. The FDA is not aware of any reports of injury or illness associated with these products.

Following last falls 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 FDAs assistance. In addition, the agency has overseen 14 voluntary recalls, mostly due to the lack of sterility assurance in the facilities. 

Source: FDA