Drug Supply Chain Security Act implementation: identification of suspect product and notification
- 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. 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, June 2021
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Drug Industry Drug and Narcotic Control 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 aid trading partners3,4 (manufacturers, repackagers, wholesale distributors, and dispensers) in identifying a suspect product as defined at section 581(21) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee(21)) and terminating notifications. As of January 1, 2015, a trading partner that determines a product in its possession or control is an illegitimate product as defined at section 581(8) of FD&C Act, must notify the Food and Drug Administration (FDA or Agency) and certain immediate trading partners under section 582 of the FD&C Act (21 U.S.C. 360eee-1), as added by the Drug Supply Chain Security Act (DSCSA). Manufacturers are additionally required under section 582 to notify FDA and certain immediate trading partners, as applicable, after the manufacturer determines or is notified by FDA or a trading partner that there is a high risk that a suspect product is illegitimate. This guidance identifies specific scenarios that could significantly increase the risk of a suspect product entering the pharmaceutical distribution supply chain; provides recommendations on how trading partners can identify a product and determine whether a product is a suspect product as soon as practicable; and sets forth the process by which trading partners should notify FDA of illegitimate product or products with a high risk of illegitimacy, and how they must terminate the notifications, in consultation with FDA, pursuant to section 582(h)(2)(A). This guidance does not address all provisions of the DSCSA related to suspect and illegitimate products. As FDA works to implement other provisions of the DSCSA, the Agency intends to issue additional information to support efforts to develop standards, issue guidance and regulations, establish pilot programs, and conduct public meetings.
- 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:
- 9918350982206676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918350982206676