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Drug Product Tracing: The Effect of Section 585 of the FD&C Act February 2022

Docket Number:
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
Office of Regulatory Affairs

The Food and Drug Administration (FDA) is issuing these questions and answers to assist industry and State and local governments in understanding the effects of section 585 (Uniform National Policy) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee- 4), added by Title II of the Drug Quality and Security Act (DQSA), which was enacted on November 27, 2013, on drug product tracing. Title II, which is also referred to as the Drug Supply Chain Security Act (DSCSA), establishes a Federal system for tracing prescription drug products through the pharmaceutical distribution supply chain and requires trading partners to pass, receive, and maintain certain product and distribution information. Section 585 requires there be a uniform national policy, preempting States from establishing or continuing in effect certain standards and requirements. FDA is issuing this guidance to: (1) help industry and States understand the law as it is currently in effect; and (2) clarify the effect of section 585(a) on any regulation of drug product tracing by States.

Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2014-D-1411.

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