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GUIDANCE DOCUMENT

Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act Draft Guidance for Industry June 2021

Draft

Not for implementation. Contains non-binding recommendations.

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.


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-2020-D-2024.

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