Product identifiers under the Drug Supply Chain Security Act: questions and answers
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services, issuing body. United States. Food and Drug Administration, 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, June 2021
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Drug Industry Drug Labeling Government Regulation Security Measures United States United States. Department of Health and Human Services United States. Food and Drug Administration
- Genre(s):
- Technical Report
- Abstract:
- This guidance is intended to address anticipated questions regarding product identifiers that are required 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), for packages and homogenous cases of certain drug products. Section 582(b)(2) and (e)(2) require manufacturers and repackagers, respectively, to affix or imprint a product identifier to each package and homogenous case of a product intended to be introduced in a transaction in(to) commerce beginning November 27, 2017, and November 27, 2018, respectively.8 This guidance is intended to clarify FDA’s interpretation of both these requirements, including as they relate to the linear barcode requirements under 21 CFR 201.25.
- 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:
- 9918350982106676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918350982106676