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Jeffrey S. Chiesa,
Attorney General

Division of Consumer Affairs
Eric T. Kanefsky, Acting Director

 

 

For Immediate Release:
May 1, 2013
For Further Information Contact:
Jeff Lamm, 973-504-6327
Neal Buccino, 973-504-6327

 

New Jersey Division of Consumer Affairs Retains International Pharmacy Association As Expert Consultant, to Assist With Inspections and Evaluations of Compounding Pharmacies

NEWARK – Attorney General Jeffrey S. Chiesa and the New Jersey Division of Consumer Affairs today announced the Division has retained the National Association of Boards of Pharmacy (NABP) as an expert consultant to assist with the Division's ongoing investigations and evaluations of New Jersey's compounding pharmacies.

"There is a significant presence of large-scale compounding pharmacies in New Jersey.  Recent events have made clear that we must remain vigilant in our inspection and analysis of their operations," Attorney General Chiesa said.  "This partnership with NABP enables our inspectors to draw upon a greater body of expertise and experience to address this growing industry.  We are taking a comprehensive look at New Jersey's compounding pharmacies, and will act immediately on any violations that appear to threaten the public's health and safety."

New Jersey licenses approximately 40 retail pharmacies that perform sterile compounding, and 109 hospital pharmacies that may compound sterile products to meet patient needs.  New Jersey Board of Pharmacy regulations hold these pharmacies to stringent compounding standards, mirroring those of the U.S. Pharmacopeial Convention (USP), to protect public health by ensuring the sterility and efficacy of those products. 

The Division of Consumer Affairs' Enforcement Bureau, which includes inspectors who are licensed pharmacists, has routinely inspected New Jersey's pharmacies to ensure compliance with these standards.  Given the growing size of many of these operations, and recent contamination issues at several U.S. facilities, the State will use its new partnership with NABP to supplement its already robust inspections of this industry.

The State's contract with NABP enables the Division to temporarily employ NABP pharmacists and investigators with specific expertise in pharmaceutical compounding on an as-needed basis.  Each NABP consultant has extensive experience in sterile compounding and the operations of compounding pharmacies, including an in-depth knowledge of USP requirements.

The NABP compounding experts will assist the Division in performing field inspections at compounding pharmacies, detailed audits of their records, and in-depth analysis of inspection findings.  They will also assist with investigations into complaints about compounding pharmacies, and in bringing charges against any found to be noncompliant.

Most importantly, they will help the Division of Consumer Affairs, Division of Law, and State Board of Pharmacy determine whether any specific pharmacy's operations pose a potential risk to the public health, safety, and welfare.

"This contract with NABP enables the State to even more effectively inspect, investigate, and analyze the operations of compounding pharmacies, to ensure they are operating consistent with our requirements for public safety," Eric T. Kanefsky, Director of the New Jersey Division of Consumer Affairs, said. 

NABP is an impartial professional organization that supports State boards of pharmacy in creating uniform regulations to protect public health.  NABP aims to ensure the public's health and safety through its pharmacist license transfer and pharmacist assessment programs, as well as through its VIPPS, Vet-VIPPS, VAWD, and DMEPOS accreditation programs.  Its member boards of pharmacy include all 50 United States, the District of Columbia, Guam, Puerto Rico, the Virgin Islands, Australia, eight Canadian provinces, and New Zealand.

The State entered into this short-term contract with NABP pending the selection of a bidder through a formal Request for Proposals to procure a long-term State contract for pharmacy consultant services.

The Division took action partly in response to the discovery this past March of mold contamination in intravenous bags that Med Prep Consulting Inc., a Tinton Falls compounding pharmacy, compounded and sent to a Connecticut hospital.  To date, no injuries or illnesses have been linked to the contamination. The Division's action also is in response to the nationwide fungal meningitis outbreak associated with products compounded and distributed by New England Compounding Center, a Massachusetts-based pharmacy.

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