Permanent Injunction Issued Against Pharmacy for Improper Manufacturing Practices

A consent decree of permanent injunction was issued against Med Prep Consulting Inc. (Med Prep), a pharmacy licensed by the state of New Jersey, and Med Prep’s president and owner, on behalf of the U.S. Department of Justice and FDA. The FDA’s recent inspection of Med Prep followed reports that the company had distributed to a Connecticut hospital intravenous drug products containing mold.

Background

Med Prep manufactured various sterile drug products, including pain medications, operating room drugs, and oncology and dialysis drugs, although it was operating as a state-licensed pharmacy. Med Prep did not receive patient-specific prescriptions, nor did it have any approved new drug applications or approved abbreviated new drug applications for any of the products it produced.

Compliance

FDA regulations establish minimum current good manufacturing practice requirements for drugs and 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.

The FDA conducted an inspection of Med Prep’s facility in March 2013 and documented violations of current good manufacturing practice requirements for drugs. According to the complaint filed in the district court, the FDA observed Med Prep’s failures to create and follow appropriate procedures to prevent contamination of drugs which were purported to be sterile. Med Prep did not properly clean and maintain its equipment to ensure the safety and quality of the drugs it manufactured and did not conduct adequate testing of injectable drugs that failed to meet minimum quality specifications.

Med Prep is required to take a wide range of actions to correct violations before it can resume drug manufacturing operations, including: (1) retention of an expert to inspect Med Prep’s manufacturing facility; (2) development and implementation of a remediation plan; and (3) inspection by the FDA to confirm full compliance with laws and regulations.