Thursday, May 23, 2013

N.J. hires pharmaceutical experts to help investigate drug compounding industry

By Alexi Friedman/The Star-Ledger
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on May 23, 2013 at 6:00 PM, updated May 23, 2013 at 6:09 PM


New Jersey Attorney General Jeffrey Chiesa, a photo last year, said the state would hire drug compounding experts to help with an ongoing investigation on industry practices.Star-Ledger file photo

The state Attorney General’s Office has hired pharmaceutical drug compounding experts to help with its ongoing investigation of the industry, after a recent discovery of mold in intravenous bags prepared by a Tinton Falls compounding business.

The contract with the National Association of Boards ofPharmacy will employ member pharmacists and investigators to help state inspectors in their review, Attorney General Jeffrey Chiesa said today.

Drug compounding takes mass-manufactured drugs and mixes them to fit a patient’s needs, including turning pill into liquid form.

The announcement coincided with a separate report from a consumer advocacy group detailing 10 years of safety violations by drug compounding pharmacies. That report by the U.S. Public Interest Research Group, titled “Prescription for Danger,” found more than 40 compounding pharmacies across the nation — including four in New Jersey — ignored warning letters federal authorities had sent accusing them of safety violations. The report analyzed the years 2002 to 2012.

Chiesa called the report’s findings “alarming,” and in a statement said his office was “drawing upon new resources to supplement its already robust inspections of this industry.”

New Jersey officials, Chiesa said, “will act immediately on any violations” by drug compounding pharmacies and hospitals “that appear to threaten the public’s health and safety.” There are 41 retail pharmacies in the state that compound medicine and 109 hospital pharmacies that may compound sterile products to meet patient needs.

Tinton Falls-based Med Prep Consultingceased operations in mid-March, after several contaminated bags of magnesium sulfate it had compounded and dispensed to a Connecticut hospital were found.

The company issued a nationwide recall of all its drugs but no injuries were ever reported. Last month, state regulators said they would allow Med Prep to reopen with restrictions, but the company remains closed, said its attorney, Angelo Cifaldi.

Chiesa added that the contract with the National Association of Boards of Pharmacy was also a response to last year’s nationwide fungal meningitis outbreak linked to products compounded and distributed by a Massachusetts-based pharmacy. The outbreak caused 55 deaths and sickened more than 740 people — including 51 in New Jersey — according to the Centers for Disease Control and Prevention.

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