September 2022

FDA Proposes National Licensure Standards for Wholesale Drug Distributors and Third-Party Logistics Providers

In the National Association of Boards of Pharmacy’s (NABP) Innovations publication, government and regulatory partner Libby Baney and health care associate Jonathan Keller, PharmD, discuss the United States Food and Drug Administration’s proposed rule to establish national standards for wholesale drug distributors and third-party logistics providers.

Baney and Keller outline key points of the proposed rule, which spans nearly 50 pages in the Federal Register, highlight pertinent changes and provide considerations for state licensing authorities regarding adopting the federal licensing standards.

The authors examine the 1) pre-emption of state requirements, 2) scope of licensed activities, 3) application process, 4) change of entity ownership and 5) reasons for denying license and renewal applications.

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