The Effect of Uniform National Policy on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Standards: Questions and Answers; Draft Guidance for Industry; Availability

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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "The Effect of Section 585 of the FD&C Act on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements: Questions and Answers." FDA is issuing these questions and answers to assist industry and State governments in understanding the effects of section 585 (Uniform National Policy) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) added by Title II of the Drug Quality and Security Act (DQSA), which was enacted on November 27, 2013, on State product tracing requirements and on standards, requirements, and regulations with respect to wholesale distributor and third-party logistics provider (3PL) licensing. Title II is also referred to as the Drug Supply Chain Security Act (DSCSA).