Judge orders injunction against New Jersey compounding pharmacy

Reuters News
Posted: Jun 28, 2013 5:48 PM

By Jessica Dye

NEW YORK (Reuters) - A federal judge has entered a consent decree and permanent injunction against a New Jersey compounding pharmacy after it was discovered that some of its products might be contaminated, the Food and Drug Administration said Friday.

Med Line Prep Consulting Inc compounded and distributed drugs for hospital and healthcare facilities. It ceased operations in March following a voluntary recall of products compounded at its facility in New Jersey.

The recall was prompted by the discovery of mold contaminating sterile bags of intravenous solution at a hospital in Connecticut.

The regulation of so-called compounding pharmacies, which combine, mix or alter medical ingredients, has been in the spotlight since a deadly meningitis outbreak last year linked to steroid injections made by the New England Compound Center in Massachusetts.

Congress is wants to increase federal oversight for pharmacies that compound drugs and sterile products, and ship them across state lines. Proposed legislation currently pending before the Senate would create a new regulatory classification for compounding pharmacies like NECC that make products used nationally without prescriptions to do so or before they obtain them.

The FDA filed a complaint against Med Prep on June 24, accusing it of failing to prevent the contamination of sterile products. The agency said it found unsanitary conditions and violations of manufacturing standards at Med Prep's New Jersey facility earlier this year.

The consent decree entered by U.S. District Judge Peter Sheridan in New Jersey on Thursday prohibits Med Prep from resuming operations until it corrects violations and implements safeguards. The company must retain an expert to inspect its facility and federal officials must confirm it is complying before it can resume production, according to court documents.

Med Prep and its president, Gerald Tighe, who was also named in the complaint, did not admit to any of the FDA allegations as part of the decree.

A lawyer for Med Prep, Angelo Cifaldi, said the company is negotiating a similar agreement with the New Jersey Board of Pharmacy and is not attempting to resume operations at this time.

Cifaldi said the contamination was only discovered in a small number of products at the Connecticut hospital. The FDA said it was not aware of any reports or injuries associated with Med Prep products.

The Med Prep decree "shows that the FDA will take aggressive enforcement actions to ensure the safety of its drugs," FDA acting associate commissioner for regulatory affairs Melinda Plaisier said in a statement.

(Reporting by Jessica Dye. Editing by Andre Grenon)