Docket Number:
FDA-2020-D-2024
Issued by:
Guidance Issuing Office
Office of Regulatory Affairs
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research

Read Federal Register Notice Update

This guidance is intended to assist supply chain stakeholders, particularly trading partners, with requirements for enhanced drug distribution security at the package level under section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1), as added by the Drug Supply Chain Security Act (DSCSA) (Title II of Public Law 113-54). Requirements for enhanced drug distribution security, commonly referred to as the “enhanced system” go into effect on November 27, 2023.

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All written comments should be identified with this document's docket number: FDA-2020-D-2024.