U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act--Compliance Policies
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act--Compliance Policies August 2023

Final Level 1 Guidance
Docket Number:
FDA-2023-D-1909
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled “Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act--Compliance Policies.”  This guidance describes FDA’s compliance policies regarding enforcement of requirements for the interoperable, electronic, package level product tracing (referred to as enhanced drug distribution security requirements) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) that will go into effect on November 27, 2023. FDA believes the compliance policies outlined in this guidance will help supply chain stakeholders, particularly trading partners, by accommodating the additional time that may be needed to continue to develop and refine appropriate systems and processes to conduct interoperable, electronic tracing at the package level, to achieve robust supply chain security under the Drug Supply Chain Security Act (DSCSA) while helping ensure continued patient access to prescription drugs.


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-2023-D-1909.

Back to Top