U.S. District Court Judge Peter G. Sheridan entered a consent decree of permanent injunction against Med Prep Consulting Inc., a Tinton Falls, N.J., pharmacy licensed by the state of New Jersey, the Justice Department announced today. The permanent injunction was also entered against Gerald R. Tighe, president and owner of Med Prep.
Although operating as a state-licensed pharmacy, until it recently halted production, Med Prep manufactured numerous sterile drug products, including pain medications, anesthesia, operating room drugs and oncology and dialysis drugs and did not receive patient-specific prescriptions. As set forth in the complaint filed by the United States on June 24, the United States Food and Drug Administration (FDA) conducted an inspection of defendants’ facility from March 15, 2013 to April 3, 2013, and documented numerous deviations from current good manufacturing practice requirements for drugs. In addition, Med Prep did not have approved new drug applications or approved abbreviated new drug applications for any of the products it produced.
According to the complaint, the FDA found that the company failed to create and follow appropriate procedures to prevent contamination of drugs which were purported to be sterile. As stated in the complaint, FDA found that the company failed to properly clean and maintain its equipment to ensure the safety and quality of the drugs it manufactured, and that the company failed to conduct adequate investigations of injectable drugs that failed to meet minimum quality specifications. FDA’s recent inspection of the company followed reports that the company had distributed, to a Connecticut hospital, intravenous drug products containing visible contaminants that were confirmed to be mold. Med Prep voluntarily recalled all products in the field and has halted production.
Compliance with current good manufacturing practice requirements helps assure that drugs meet the safety requirements of the law and have the identity and strength and meet the quality and purity characteristics that they purport to or are represented to possess. FDA regulations, which establish minimum current good manufacturing practice requirements for drugs, require manufacturers to control all aspects of the processes and procedures by which drugs are manufactured in order to prevent the production of unsafe and ineffective products.
“Under this resolution, Med Prep cannot manufacture or distribute drugs until it fully complies with the consumer protections set forth in the law,” said Stuart F. Delery, Acting Assistant Attorney General for the Justice Department’s Civil Division. “Patients who take injectable drug products contaminated with mold are at risk of major illness or death. This settlement requires Med Prep to clean up its act before its products are allowed to return to market."
The consent decree entered by the district court resolves the complaint by requiring Med Prep to take a wide range of actions to correct its violations and ensure that they do not happen again. The injunction establishes a series of steps which must occur before Med Prep can resume drug manufacturing operations, including the retention of an expert to inspect the company’s manufacturing facility, the development and implementation of a remediation plan, and an inspection by FDA to confirm that the company’s manufacturing processes are fully compliant with the law.
“MedPrep put patients at risk by producing contaminated drugs under unacceptable conditions,” said Melinda K. Plaisier, Acting Associate Commissioner for Regulatory Affairs for the FDA. “The Department of Justice and FDA will continue to work together to protect the health of Americans by taking aggressive enforcement actions to ensure the safety of drugs.”
Acting Assistant Attorney General Delery thanked the FDA for referring this matter to the Department of Justice and the U.S. Attorney’s office in New Jersey for their contributions to the case. Phil Toomajian, Trial Attorney of the Consumer Protection Branch of the Civil Division of the Justice Department and Scott Kaplan, Associate Chief Counsel of the Food and Drug Division, Office of General Counsel, Department of Health and Human Services, brought this case on behalf of the United States.