Definitions of suspect product and illegitimate product for verification obligations under the Drug Supply Chain Security Act: guidance for industry
- Collection:
- Health Policy and Services Research
- Contributor(s):
- 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, March 2023
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Drug Industry Legislation, Drug Drug Packaging Drug and Narcotic Control Government Regulation United States
- Genre(s):
- Guideline Technical Report
- Abstract:
- FDA is issuing this guidance to interpret the terms used in the definition of suspect product set 19 forth in section 581(21) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 20 360eee(21), and the definition of illegitimate product set forth in section 581(8) of the FD&C 21 Act, to assist trading partners in meeting verification obligations (including notification) under 22 section 582(b)(4), (c)(4), (d)(4), and (e)(4) (21 U.S.C. 360eee-1(b)(4), (c)(4), (d)(4), and (e)(4))), respectively. The Drug Supply Chain Security Act (DSCSA) (Title II of Public Law 113-54) amended the FD&C Act to establish requirements for product tracing, verification, and identification for certain drug products that are distributed in the United States. Many of the terms used in these requirements are defined in section 581 of the FD&C Act. 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 (7 pages))
- NLM Unique ID:
- 9918662287306676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918662287306676