Indiana Wholesale Distributor Licensing Bill Passes Senate, Recognizes VAWD

May 2, 2005 12:00 AM

Indiana Wholesale Distributor Licensing Bill Passes Senate, Recognizes VAWD

The National Association of Boards of Pharmacy® (NABP®) is pleased to announce that its new Verified-Accredited Wholesale Distributors™ (VAWD™) program has been recognized in Indiana House Bill (HB) 1098, which passed the Senate and is now awaiting the signature of Governor Mitch Daniels. HB 1098, which expands requirements for wholesale drug distributor licensing, passed with a 48-to-1 vote on April 28, 2005.

HB 1098 establishes the authority for the Indiana Board of Pharmacy to recognize VAWD accreditation, and also requires pedigrees. HB 1098 also lays the groundwork for the Indiana Board to establish an electronic pedigree program. HB 1098, in principle, is based on NABP's Model Rules for the Licensure of Wholesale Distributors, which is part of the Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy. The Bill can be found at www.in.gov/legislative/bills/2005/HE/HE1098.1.html.

Indiana Board of Pharmacy Director Joshua M. Bolin and the Indiana Board worked tirelessly to promote the bill and win the confidence of stakeholders. The Board's efforts to pass this bill through Indiana's legislature can be seen during NABP's 101st Annual Meeting at the Sheraton New Orleans Hotel, in New Orleans, LA, at the Third Annual Poster Session, located in the Educational Presentation Area, on Saturday, May 21, from 1 to 5 PM and Sunday, May 22, from 8 AM to noon.

NABP's VAWD program provides the stringent safety guidelines for wholesale distributors that will help protect patients from counterfeit drugs affecting the United States' drug supply. The program accredits wholesale distributors and assures stakeholders that the company is legitimate, qualified for state licensure, and employing security and best practices for safely distributing prescription drugs from manufacturer to pharmacy practitioner or health care facility. Applicants for VAWD accreditation undergo a criteria compliance review, licensure verification, an inspection, and screening through NABP's National Clearinghouse of Licensure, Certification, and Accreditation. "No other program offers the assurances concerning the practices and legitimacy of wholesale distributors that the VAWD accreditation program offers," says NABP President Donna M. Horn. "No other program covers as many areas as VAWD, or does so as thoroughly. We are addressing wholesale distributor practice criteria as defined by state and federal regulators, pharmacists, manufacturers, and wholesale distributors themselves. Because we certify wholesale distributors based upon licensure verification, continuous compliance, and on-site inspections, manufacturers, wholesale distributors, pharmacies, and practitioners need only look for VAWD accreditation to be assured of legitimate wholesale distributors and professional practices in the distribution of prescription drugs." In other news, Food and Drug Administration (FDA) and the United States attorney for the District of Utah have announced a series of indictments against multiple prescription drug distributors whose illegal distribution of diverted drugs could affect the safety and efficacy of more than 40 medications purchased by consumers in over 80 pharmacies nationwide. FDA has posted a list of the pharmacies and locations that may have received suspect drugs from these distributors on its Web site: www.fda.gov/bbs/topics/answers/2005/ANS01353lists.html. The Web site also provides a list of the specific types of drugs that were diverted, and the unauthorized distributors.

The importance of tightening wholesale distributor regulation is supported by a recent survey by Ernst & Young, which found that drug industry executives consider the secondary wholesale distributor market the largest source of counterfeit drugs. According to the April 28, 2005 edition of the Wall Street Journal, the Ernst & Young report states that 41% of executives polled currently consider the secondary market as the biggest entry point.

For more information on the VAWD program, visit NABP's Web site at www.nabp.net/vawd/intro.asp or contact Eleni Anagnostiadis, NABP's professional affairs director, via e-mail at eanagnostiadis@nabp.net.

Renee Renganathan