VAWD is Changing in 2020: But First, A Look Back on 2019

Posted March 2, 2020

VAWD is Changing in 2020 to the NABP Drug Distributor Accreditation Program

The National Association of Boards of Pharmacy (NABP) has recently rebranded the Verified-Accredited Wholesale Distributors® (VAWD®) program. As of February 2020, VAWD will now be referred to as the NABP Drug Distributor Accreditation program. NABP overhauled several of its accreditation program names so that they are more easily identifiable while replacing the myriad program acronyms that were a potential source of confusion. Currently, 24 states recognize the NABP Drug Distributor Accreditation. Of those 24 states, Indiana, Iowa, North Dakota, and Wyoming require the accreditation as a condition of licensure.

VAWD 2019 Year in Review

State regulators are continuing to leverage the new NABP Drug Distributor Accreditation. In 2019, a handful of states joined the growing list of regulatory boards that recognize or require the NABP Drug Distributor Accreditation as a part of their licensing schemes. Iowa became the 4th state to require NABP Drug Distributor Accreditation as a condition of licensure when it began implementing the requirement during its 2020 renewal cycle for wholesale drug distributors and third-party logistics providers. Two new states, Alaska and Illinois, will now recognize NABP Drug Distributor Accreditation in lieu of a resident state inspection. Michigan also took steps toward recognizing NABP inspections. While many states may not take formal action to incorporate the rebrand for VAWD into their respective laws and regulations, the requirements of VAWD will continue to be in effect.

Iowa Now Requires NABP Drug Distributor Accreditation

Iowa: Effective January 23, 2019, Iowa requires NABP Drug Distributor Accreditation for all new wholesale drug distributors (WDD) and third-party logistics providers (3PL) seeking initial licensure in Iowa. WDDs and 3PLs with existing licenses must provide proof of VAWD/NABP Drug Distributor Accreditation with their 2020 renewal. See Iowa Administrative Code 657.17.3.

The new Iowa regulation provides: “Wholesale distributor license. Every wholesale distributor that engages in wholesale distribution into, out of, or within this state must be licensed by the board before engaging in wholesale distribution. … The following shall also be submitted by the applicant for the application to be considered complete: … c. Evidence of current verified-accredited wholesale distributors (VAWD) [now NABP Drug Distributor] accreditation by the National Association of Boards of Pharmacy. This requirement does not apply to new applicants located in Iowa which must undergo an opening inspection by a board compliance officer or agent of the board prior to issuance of an initial license. Wholesale distributors located in Iowa shall provide evidence of VAWD accreditation on or before license renewal.” IAC 657.17.3.

New States that Recognize VAWD

Alaska: Effective October 31, 2019, Alaska requires licensure of non-resident wholesale drug distributors, outsourcing facilities, and third-party logistics providers. Under the new rules, a wholesale drug distributor must submit a completed self-inspection questionnaire regarding the premises on a form provided by the State or a completed VAWD/NABP Drug Distributor Accreditation inspection report. See 12 Alaska Administrative Code 52.610.

Illinois: Illinois enacted legislation on August 16, 2019 to amend the Pharmacy Practice Act, which requires that every nonresident 3PL be licensed in Illinois. If the resident state responsible for licensing the 3PL does not inspect 3PL providers, a VAWD/NABP Drug Distributor Accreditation or other inspection approved by the Illinois Department of Financial and Professional Regulation will meet the new requirements. See 225 ILCS 120/25.5.

States Considering NABP Drug Distributor Accreditation as a Requirement

Michigan: The State of Michigan published a Proposed Rule on September 1, 2019 that, if adopted, will require that drug and medical device manufacturers applying for licensure obtain an inspection from the manufacturer’s resident state board of pharmacy or VAWD/NABP Drug Distributor Accreditation that has been obtained not more than two years prior to its application. See MI Proposed Rule 338.551(2)(i).

Changes to the VAWD Program in 2020

Along with the rebranding from VAWD to the NABP Drug Distributor Accreditation program, NABP recently announced it will provide new seals/badges for accredited organizations at the end of February 2020. See here.

NABP also introduced a new inspection for drug supply chain companies called the NABP Supply Chain Inspection. Participants of the program will receive an inspection report that may satisfy an inspection requirement from an entity or agency. You will need to check with the licensing body to determine if the inspection will be accepted in lieu of other recognized inspection types. For more information about the inspection program, you can click here.

Conclusion

The Drug Supply Chain Security Act (DSCSA) continues to introduce changes to the drug supply chain space as milestones under the federal law are met (or extended by FDA). There is also the looming question of when the FDA may issue additional guidance on DSCSA’s impact on state licensing regulations. In the interim, states continue to turn to NABP’s Drug Distributor Accreditation (formerly known as VAWD) as a tool to ensure regulatory compliance.


NABP Solutions is here to help you with any facet of NABP Drug Distributor Accreditation, no matter where you are in the process. If you are already accredited and need assistance in preparing for your one year review or your three year re-accreditation process, we can support your efforts. Contact us at info@nabp.solutions for more information.

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