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# Supply Chain Act Drug Verification System Guidance
- URL: https://www.fdaweb.com/supply-chain-act-drug-verification-system-guidance/
- Published: 2022-03-09T12:00:00.000Z
- Updated: 2026-09-14T17:35:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151321

FDA has published a draft guidance, *Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs*, to provide clarity about existing requirements to facilitate the tracing and verification of certain prescription drug products through the U.S. pharmaceutical distribution supply chain. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/verification-systems-under-drug-supply-chain-security-act-certain-prescription-drugs?ref=fdaweb.com) describes the agency’s interpretation of the requirements of section 582 of the Federal Food, Drug, and Cosmetic Act regarding verification systems.

The guidance provides recommendations for a robust verification system for the determination, quarantine, and investigation of suspect products, as well as the quarantine, notification, and disposition of illegitimate products, FDA says. It also addresses how the agency recommends that trading partners submit cleared product notifications. And it addresses the statutory requirements for verification, including verification of saleable returns, at the package level for product identifiers on packages and homogenous cases intended to be introduced in a transaction into commerce.

The document revises a 10/2018 draft, including addressing the comments received from stakeholders.