To further protect the integrity of the United States drug supply chain, the National Association of Boards of Pharmacy® (NABP®) has updated the criteria for the Association’s Verified-Accredited Wholesale Distributors® (VAWD®) accreditation program. Revisions to the criteria will allow virtual manufacturers and virtual wholesale distributors – a growing segment of the pharmaceutical wholesale industry – to qualify for VAWD, as well as implement other changes aimed to help to ensure that the drug supply chain remains secure.
The revised VAWD criteria responds to changing business models and helps safeguard drugs in distribution at a time when there is an increased risk of counterfeit and substandard drugs entering the legitimate US drug supply chain. In particular, the criteria have been revised to provide stronger assurance that drugs diverted from pharmacies and unlawful sources are prevented from entering into the supply chain. In three instances in the past 14 months, counterfeit cancer medications were distributed to US medical practices, with the most recent incident involving a US distributor. In addition, there have been many reports of gray market distributors selling to hospitals drugs that are not always authenticated, placing patients at risk. Further, at the NABP 108th Annual Meeting in May 2012, member boards of pharmacy adopted a resolution (NABP Resolution 108-2-12) stressing concern about the increased risk that counterfeits may enter the secure drug supply chain when virtual distributors and virtual manufacturers distribute pharmaceuticals without taking physical possession of the products.
Recognizing that the Association’s VAWD program, established in 2004, has proven its value in helping to deter the introduction of counterfeit drugs into the supply chain, NABP members adopted Resolution 108-2-12, calling for the establishment of a task force to review and revise the VAWD criteria with the protection of public health at the forefront of its charge. The NABP Task Force on Virtual Manufacturers and Virtual Wholesale Distributors met December 11-12, 2012, and, as part of their charge, also reviewed existing current and state laws and regulations addressing virtual manufacturers and virtual wholesale distributors and relevant Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy language. The revisions to the VAWD criteria were among the recommendations of the task force.
“For almost a decade, pharmacists and other health care providers responsible for purchasing medications have been able to rely on the VAWD Seal as assurance that they are receiving products from a legitimate wholesale distributor,” states NABP President Michael A. Burleson, RPh. “The revised VAWD criteria will provide continued assurance that VAWD-accredited wholesale distributors – including virtuals – are in compliance with state and federal laws, and will also provide greater assurance that accredited entities are following responsible distribution practices.”
The revised VAWD criteria will apply immediately to new VAWD applications. Recognizing that current VAWD-accredited facilities will require sufficient time to review and assess the revisions and the impact, if any, on their business practices, NABP will soon be providing to current applicants and accredited facilities detailed information about the implementation process and timelines for compliance with the updated criteria.
NABP and the state boards of pharmacy developed the VAWD program to help protect the public from counterfeit, adulterated, and substandard drugs, and the initiative received the support of Food and Drug Administration. Since its launch, over 540 facilities across the country have become VAWD accredited. Of the 21 states that recognize VAWD, Indiana, North Dakota, and Wyoming require VAWD accreditation as a component of licensure. The role of VAWD in helping to protect US patients from counterfeit and substandard drugs has been highlighted by the Institute of Medicine, which, in a recent report on counterfeit drugs, recommended that all state boards of pharmacy should require VAWD accreditation as a requisite for licensure.
For more information about the VAWD program and the complete updated VAWD criteria, visit www.nabp.net/programs/accreditation/vawd.
NABP is the independent, international, and impartial Association that assists its state member boards and jurisdictions in developing, implementing, and enforcing uniform standards for the purpose of protecting the public health.