VAWD, DSCSA, and Inspections: What Wholesale Distributors Need to Know
As a wholesale distributor, you may have some familiarity with the Verified-Accredited Wholesale Distributors (VAWD) program. What you may not know, though, is how DSCSA impacts VAWD. Learn what VAWD-accredited wholesale distributors or pharmaceutical companies with wholesale operations must do and how they can prepare for inspections.
What is VAWD?
The VAWD program was created by the National Association of Boards of Pharmacy (NABP) in 2004 as a seal of approval, indicating that a VAWD member has put processes and systems in place to protect the integrity and quality of drug product in their possession. VAWD is recognized by 21 states in the US, and VAWD accreditation is actually required in Indiana, North Dakota, and Wyoming as part of licensure. Other states require VAWD as a condition of license renewal for disciplinary cases. To become VAWD accredited, wholesale distributors must meet dozens of criteria in a number of different categories such as Policies and Procedures, Record Keeping, Personnel, and more.
Because VAWD members may demonstrate a higher level of visibility and control over their distribution and operations, there is a growing trend among hospitals, insurance organizations and other health care entities and buying groups to require their wholesale suppliers to be accredited by VAWD.
How does VAWD interact with DSCSA?
While some people may wonder if DSCSA implementation lessens the significance of VAWD, the NABP believes that the VAWD program is strengthened with the adoption of DSCSA. The NABP has modified certain provisions of VAWD to create closer alignment with DSCSA requirements.
In mid-June, the VAWD program sent out a notification to all member participants about requirements related to DSCSA, setting the expectation that “all VAWD participants should be in compliance with the provisions of Licensing and Reporting, Authorized Trading Partners, Verification and Product Tracing” requirements. The notice outlines the DSCSA-related update for each VAWD criteria.
VAWD participants have now started receiving notices from the National Association of Boards of Pharmacy indicating that they will begin inspecting program members to assure DSCSA compliance.
Failure to pass these inspections can result in VAWD accreditation being pulled from a wholesale distributor. And because some state boards of pharmacy use VAWD accreditation as a requirement to maintain a wholesale distribution license in that state, wholesale distributors who fail to pass an inspection also risk losing their license.
How should wholesale distributors prepare?
For VAWD-accredited wholesale distributors and pharmaceutical companies with wholesale operations, the stakes for DSCSA compliance are even higher. These businesses face potential inspection from the FDA, state officials, and the National Association of Boards of Pharmacy. VAWD-accredited businesses will want to have a robust compliance solution in place, and feel confident that in the event of an inspection by any party, they can quickly produce the Transaction History, Information, and Statement documentation associated with any product that has flowed through their possession.
Learn more about VAWD, and check back next week to learn how to gauge your businesses’ DSCSA inspection-readiness.