NABP Launches VAWD Program

2/28/2005

The National Association of Boards of Pharmacy^® (NABP^®) is pleased to announce that it is now accepting applications for accreditation through the Verified-Accredited Wholesale Distributors™ (VAWD™) program. VAWD accredits wholesale distributors of prescription drugs and devices and serves as a vehicle to help protect the public from the threat of counterfeit drugs affecting the United States’ drug supply.

NABP began developing VAWD after Food and Drug Administration (FDA) requested that NABP update its 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. Members of NABP’s resulting Task Force on Counterfeit Drugs and Wholesale Distributors, held 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.

"As wholesale distributors apply for and receive VAWD accreditation, the ability for unscrupulous wholesalers to engage in prescription drug counterfeiting and diversion will be impeded," says Donna M. Horn, NABP president. "Not only is the VAWD program a due diligence tool for wholesale distributors and drug manufacturers, but it provides assurance to states assessing for licensure eligibility that facilities are adhering to practices set forth in NABP’s Model Rules that promote patient safety and protect public health."

VAWD accreditation assures stakeholders that wholesaler distributors are legitimate, qualified for state licensure, and employing security and best practices for safely distributing prescription drugs and medical devices from the manufacturer to the pharmacy to the patient. Working with trained and qualified inspectors to perform on-site inspections of wholesale distributor facilities, NABP will carry out extensive examinations of wholesale distributors’ licensure status, policies and procedures, and disciplinary history.

Applicants for VAWD accreditation will be assessed in three basic categories:

• Verification of Licensure

  • Collect documentation demonstrating that the wholesale distributor is licensed and in good standing with the applicable board(s) of pharmacy or state regulatory agency.
  • Verify licensure of primary personnel (ie, designated representatives), if applicable.
  • Screen thoroughly through NABP’s Clearinghouse as well as perform criminal and financial background checks for key personnel.

• Confirmation of Satisfactory Policies and Procedures

  • Assess policies and procedures against VAWD criteria that NABP developed based upon its Model Rules.
  • Address requirements for personnel, the facility, record keeping, pedigrees, and handling of drugs including suspect products.

• On-site Facility Inspections

  • Evaluate operations and review facilities, interview staff, and verify documents.
  • Compare written policies and procedures with actual practices at wholesale distributors’ facilities.

   

The Model Rules for Wholesale Distributors are just now being adopted by the states and NABP will take this into consideration as we evaluate applicants’ documents and operations for purposes of VAWD accreditation. Bearing this in mind, provisional VAWD accreditation may be awarded to qualifying wholesale distributors.

For more information about the VAWD program or to download an application, visit NABP’s Web site at www.nabp.net.