Wednesday, June 26, 2013

U.S. Dept. of Justice sues to keep Tinton Falls-based drug compounding business closed

Alexi Friedman/The Star-Ledger

on June 26, 2013 at 5:08 PM, updated June 26, 2013 at 5:40 PM. 
The U.S. Department of Justice has filed a lawsuit to keep a Tinton Falls-based drug compounding business closed three months after mold was discovered in five intravenous bags it had prepared for a hospital.
The complaint against Med Prep Consulting and its owner, Gerald Tighe, cited numerous health violations, drug misbranding and years of repeated failures to comply with warnings as evidence of wrongdoing. The lawsuit, on behalf of the Food and Drug Administration, was filed Friday in federal court in Trenton.
The government is seeking an injunction to keep Med Prep closed permanently unless the company can prove it has complied with health and safety guidelines under the Federal Food, Drug, and Cosmetic Act. According to the lawsuit, FDA violations against Med Prep date to 2009. “Despite these warnings, defendants’ violations have persisted,” the lawsuit said.
Med Prep has remained shut since issuing a nationwide recall of all its drugs following discovery of contaminated bags of magnesium sulfate that were compounded and dispensed to a Connecticut hospital. The recall included dozens of drugs packaged in infusion bags, plastic syringes and glass vials distributed to 70 hospital and health care facilities throughout New Jersey, Pennsylvania, Connecticut and Delaware.

During a March inspection, FDA officials identified a host of lapses that included “failure to conduct appropriate laboratory testing on each batch of drug product purporting to be sterile” and “failure to clean, maintain equipment and utensils,” the suit said. On a more recent visit, FDA officials reported several drugs in dosages and combinations that “are not generally recognized as safe and effective.”
Compounding involves taking mass-manufactured drugs and mixing them to fit a patient’s needs, including turning pills into liquid form.
The legal action against Med Prep follows an aggressive federal and state probe into the 20-year-old company after the mold discovery, in which no injuries were reported.
In April, state regulators said they would allow Med Prep to reopen with restrictions, but it never did.
And late last month, the state Attorney General’s Office hired pharmaceutical drug-compounding experts from the National Association of Boards of Pharmacy to help with the investigation. Officials said the contract was in part a response to last year’s deadly nationwide fungal meningitis outbreak linked to products compounded and distributed by a Massachusetts-based pharmacy.
Med Prep’s attorney, Angelo Cifaldi, could not be reached for comment.

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