The Drug Supply Chain Security Act (Act), Title II of the Drug Quality and Security Act, was recently signed into law and contains provisions related to the integrity of the drug distribution supply chain. State boards of pharmacy have received correspondence from attorneys indicating that the Act preempts states from recognizing or requiring NABP’s Verified-Accredited Wholesale Distributors® (VAWD®) program. NABP’s initial legal analysis of the Act indicates that this is not the case. In fact, the Act specifically requires NABP to assist the Food and Drug Administration (FDA) in developing the implementing regulations. Furthermore, the Act includes several requirements that the VAWD program already encompasses, including inspection of third party logistics providers. NABP is performing a more detailed legal analysis in discussion with FDA and will be releasing that analysis to the states when completed. NABP urges states to delay making any decisions on the status of VAWD in their state until they have an opportunity to review this analysis, as the Association is confident that in-depth review of the new law will prove the strengthened status of the VAWD program.
One correspondence received by the boards of pharmacy claims: “… under the Act, as of the November effective date, states may not ‘establish or continue any standards, requirements, or regulations with respect to wholesale prescription drug distributor or third-party logistics provider licensure that are inconsistent with, less stringent than, directly related to, or covered by [the Act].’ 21 U.S.C. § 360eee-4(b)(1). . . . The Congressional intent in enacting this bill was for conformity and consistency among the states in the licensure and regulation of wholesale distribution.” While the Act does contain provisions for a uniform national policy, it does not prohibit states from requiring VAWD accreditation as a condition of licensure. Further, it should be noted that NABP’s VAWD program is utilized by the states to validate compliance with state and federal requirements. NABP is the only organization in the United States entering and inspecting drug distributors, large and small, nationwide on a daily basis. Accordingly, the states requiring or recognizing VAWD rely on the program to provide a valid measure of assurance when granting licensure to drug distributors shipping across state lines.
NABP is working with FDA and states to ensure uniformity among the VAWD criteria, provisions in the new federal law, and the subsequent regulations that FDA will develop in consultation with NABP. VAWD has, since its implementation nine years ago, provided for uniformity and consistency among the states. The recognition or requirement of NABP’s VAWD program by the states is in harmony with the federal law and an effective public-private partnership among the states, FDA, and NABP to verify the compliance of wholesale distributors with federal and state requirements and standards for secure medication distribution.
Efforts by special interest groups to derail states’ recognition and requirement of NABP’s VAWD program are viewed by some as a means to remove any state regulation or oversight of wholesale distributors and to return the system to the unscrupulous and dangerous regulatory setting of earlier years. The enactment of the Prescription Drug Marketing Act in 1988, which recognized states’ power to regulate wholesale drug distributors, in conjunction with the establishment of VAWD in 2005, helped to eliminate the proliferation of abuse and diversion cases in the US distribution system. If the new law were interpreted as removing the state oversight that has protected drug distribution security, the Act’s 10-year implementation time frame would be of equal concern. Billions of pharmaceutical products can move through the distribution supply chain in a 10-year time period, and if state oversight were reduced, it could have disastrous and catastrophic results. Based on more than 20 years of experience assisting states with model rules for distribution, as well as the knowledge gained from accrediting more than 500 wholesale distributors, NABP asserts that such changes would be a huge threat to the public health.
Regulations for implementation of the Act have not yet been developed; so, any consideration to not recognize or require NABP’s VAWD program are wholly without merit and may pose serious risk to public safety. Because the Act commissions NABP to collaborate with FDA to develop implementing regulations, NABP’s VAWD program will synchronize with the new Act and will continue to forge the public-private partnership that promotes safety, uniformity, and consistency among the states and with FDA.