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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Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act Draft Guidance for Industry June 2021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Not for implementation.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.

This guidance is being distributed for comment purposes only.

Submit Comments by

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

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


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

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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