NABP Educates Pharmaceutical Industry on New VAWD Program

November 10, 2004

Topics: Uncategorized

The National Association of Boards of Pharmacy® (NABP®), in partnership with BuzzeoPDMA, introduced the Association’s Verified-Accredited Wholesale Distributors™ (VAWD™) program to pharmaceutical manufacturers during a seminar held November 4, 2004, in Iselin, NJ. Representatives from security, compliance, quality assurance, customer service, trade relations, government affairs, and legal counsel departments of pharmaceutical manufacturers were present as was Food and Drug Administration (FDA) and the manufacturers’ trade association, Pharmaceutical Research and Manufacturers of America.

After the seminar, many of the participants indicated that they would recommend that their company require VAWD accreditation for its wholesale distributors. The representatives in attendance learned about the NABP Model Rules for the Licensure of Wholesale Distributors; the VAWD accreditation program including a review of the facility inspection process; state regulations pertaining to wholesale distributors; and a review of US v Rx Bazaar, a recent federal case involving wholesale distributors that were convicted of violations of the Prescription Drug Marketing Act. An interactive question-and-answer session provided for a welcome exchange of information between participants.

NABP began developing VAWD after FDA requested that NABP update its Model Rules for the Licensure of Wholesale Distributors, which are part of the Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy. Members of NABP’s resulting Task Force on Counterfeit Drugs and Wholesale Distributors, which met in October 2003, revised the Model Rules and proposed the creation of an accreditation program and clearinghouse for wholesale distributors — a plan that was immediately supported by FDA — to further combat counterfeit drugs.

To help protect the public from the threat of counterfeit drugs infiltrating the United States’ drug supply, the VAWD program will accredit wholesale distributors whose policies and operations meet the VAWD criteria and comply with state and federal laws. VAWD inspections will be conducted by trained BuzzeoPDMA inspectors. NABP is finalizing the VAWD criteria and will conduct several pilot inspections in November 2004. The target launch date for the VAWD program is December 2004. After its launch, NABP plans to hold additional educational programs for other interested stakeholders.

Founded more than a decade ago, BuzzeoPDMA, Inc, is a recognized industry leader in assisting companies to comply with the policies and regulations of the Food and Drug Administration (FDA), Prescription Drug Marketing Act (PDMA), Drug Enforcement Administration (DEA), Controlled Substance Act (CSA), as well as state health care regulations and licensing.

The National Association of Boards of Pharmacy (NABP) was founded in 1904 and represents all of the pharmacy regulatory and licensing jurisdictions in the United States, the District of Columbia, Puerto Rico, Guam, the Virgin Islands, eight provinces of Canada, two Australian States, New Zealand, and South Africa. Its purpose is to serve as the independent, international, and impartial Association that assists its member boards and jurisdictions in developing, implementing, and enforcing uniform standards for the purpose of protecting the public health.