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# FDA Guide on Identifying Suspect Drug Supply
- URL: https://www.fdaweb.com/fda-guide-on-identifying-suspect-drug-supply/
- Published: 2016-12-09T12:00:00.000Z
- Updated: 2026-09-14T21:53:34.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137530

*Federal Register* Notice: FDA has made available a guidance on “Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.” The document is intended to aid certain trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) in identifying a suspect product and specific scenarios that could significantly increase the risk of a suspect product entering the pharmaceutical distribution supply chain. It also describes how trading partners should notify FDA of illegitimate product and sets forth a process for terminating notifications of illegitimate product in consultation with FDA. Additionally, the guidance includes a new section, for comment purposes only, that describes when manufacturers should notify FDA of a high risk that a product is illegitimate. To view the guidance, click [here](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM400470.pdf?ref=fdaweb.com). To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-12-09/pdf/2016-29588.pdf?ref=fdaweb.com).