VAWD Background Information
The Verified-Accredited Wholesale Distributors® (VAWD®) program, developed and administered by the National Association of Boards of Pharmacy® (NABP®), was created to help protect the public from the threat of counterfeit drugs affecting the United States’ drug supply.
“Incidences of counterfeit drugs reaching the public continues to rise. The Internet makes almost any prescription drug purchase possible, and the growing sophistication of counterfeit drugs is also aiding the risk to public health,” notes Rich Palombo, RPh. “NABP recognizes the need to further protect the drug distribution system by offering a system for wholesale distributors to undergo an objective, third-party audit of the facilities’ practices and procedures. VAWD accreditation provides this system and added level of security.”
Launched in February 2005, 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 on-site survey, and screening through NABP’s Clearinghouse.
“In 2003, Food and Drug Administration [FDA] requested that NABP update the Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy, specifically, its Model Rules for the Licensure of Wholesale Distributors,” says Palombo. “From the onset, there has been support for the VAWD program, and the plan to create an accreditation program and clearinghouse for wholesale distributors that was proposed by members of the NABP October 2003 Task Force on Counterfeit Drugs and Wholesale Distributors.”
To earn VAWD accreditation, the wholesale distributor facility must be legitimate, validly licensed in good standing, and employing security and best practices for safely distributing prescription drugs from manufacturers to pharmacies and other institutions. VAWD applicants will undergo a vigorous compliance review including an on-site examination of the wholesale distributor facility as well as criminal background checks for designated representatives and other responsible persons and screening through NABP’s National Clearinghouse of Licensure, Certification, and Accreditation. Wholesale distributors’ eligibility for VAWD accreditation is judged in seven key areas: licensure; facility; personnel; record keeping; authentication and verification; returned, damaged, and outdated drugs; and policies and procedures.
NABP, through the VAWD program, has developed an accreditation and audit process to maintain the integrity of the US drug distribution system. In addition to the initial on-site survey required for accreditation, trained NABP surveyors will perform resurveys of accredited sites to ensure they qualify for renewal of accreditation.
It is only after successfully completing the application, verification, and site visit process that a wholesale distributor facility is awarded VAWD accreditation. Once a facility becomes accredited, an annual review and reaccreditation process will be conducted. Random site visits are projected for one-third of the VAWD-accredited facilities each year, with all wholesale distributors being visited once every three years to ensure they continue to meet VAWD criteria.
“The VAWD accreditation program is a unique program that validates the operations of wholesale distributors. NABP accredits wholesale distributors based upon licensure verification, compliance with state and federal laws, and on-site surveys,” says Palombo. “No other program provides better coverage of so many areas as VAWD. The criteria used to accredit wholesale distributors is defined by state and federal regulators, pharmacists, manufacturers, and wholesale distributors themselves.”