Drug Product Tracing: The Effect of Section 585 of the Federal Food, Drug, and Cosmetic Act-Questions and Answers; Guidance for Industry; Availability

Issuing agencies

Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Drug Product Tracing: The Effect of Section 585 of the FD&C Act--Questions and Answers." FDA is issuing this guidance to assist industry and State and local governments in understanding the effects of the uniform national policy set forth in the Federal Food, Drug, and Cosmetic Act (FD&C Act) that was added by the Drug Supply Chain Security Act, which was enacted on November 27, 2013. This guidance is intended to help industry and States understand the law as it is currently in effect and clarify its effect on State product tracing. This guidance finalizes the draft guidance entitled "The Effect of Uniform National Policy on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Standards: Questions and Answers" issued on October 8, 2014.