Enhanced drug distribution security at the package level under the Drug Supply Chain Security Act: guidance for industry

Enhanced drug distribution security at the package level under the Drug Supply Chain Security Act: guidance for industry

Collection:
Health Policy and Services Research
Contributor(s):
United States. Food and Drug Administration. Office of Regulatory Affairs, issuing body.
Center for Drug Evaluation and Research (U.S.), issuing body.
Center for Biologics Evaluation and Research (U.S.), issuing body.
Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, August 2023
Language(s):
English
Format:
Text
Subject(s):
Drug Industry
Drug and Narcotic Control
Drug Packaging
Government Regulation
Security Measures
United States
United States.
United States.
Genre(s):
Guideline
Technical Report
Abstract:
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 go into effect on November 27, 2023. This guidance clarifies the enhanced drug distribution security requirements listed in section 582(g)(1) of the FD&C Act (“enhanced security requirements"). In addition, as specified in section 582(h)(3) of the FD&C Act, this guidance "outlines and makes recommendations with respect to the system attributes necessary to enable secure tracing" of product at the package level, including allowing for the use of verification, inference, and aggregation, as necessary. FDA considers these recommendations to be important to assist in implementing the robust supply chain security envisioned under the DSCSA. Throughout this guidance, the terms, “FDA,” “the Agency,” “we,” and “us” refer to the Food and Drug Administration and the terms “your” and “yours” refer to regulated industry. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (17 pages))
NLM Unique ID:
9918716788806676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918716788806676