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RESOLUTION NO: 118-4-22
TITLE: National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers
ACTION: PASS

WHEREAS, the Drug Quality and Security Act (DQSA) was enacted by Congress on November 27, 2013; and

WHEREAS, Title II of DQSA, the Drug Supply Chain Security Act, outlines that United States Food and Drug Administration (FDA) shall establish, by regulation, standards for the licensing of wholesale distributors and third-party logistics providers and that all state and federal licensing should be consistent with the national standards;1 and

WHEREAS, FDA published proposed regulations on February 4, 2022, titled National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers;2 and

WHEREAS, the proposed regulations outline the federal licensing process, which suggests that states implement similar procedures to ensure that all licenses issued are consistent with the proposed regulations; and

WHEREAS, FDA, the boards of pharmacy, and other state regulatory bodies share a common goal of protecting the nation’s patients and share in responsibility for the regulation of the prescription drug supply chain;

THEREFORE BE IT RESOLVED that NABP formally request that FDA provide timely guidance to states regarding how the agency intends to assess whether a state’s licensing statutes, regulations, and processes are consistent with the national standards for licensure; and

BE IT FURTHER RESOLVED that NABP formally request that FDA focus its assessment of consistency on issues that truly impact patient safety; and

BE IT FURTHER RESOLVED that NABP encourage the boards of pharmacy to provide public comment on the proposed rule.

(Resolution passed at the 118th Annual Meeting in Phoenix, AZ.)

1https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/title-ii-drug-quality-and-security-act

2https://www.govinfo.gov/content/pkg/FR-2022-02-04/pdf/2022-01929.pdf