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FDA is announcing the availability of the revised draft guidance “Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs” as part of the Drug Supply Chain Security Act. The guidance clarifies the minimum recommended components of robust verification systems for the determination, quarantine, and investigation of suspect products, as well as the quarantine, notification, and disposition of illegitimate products. The guidance also outlines the revisions that were made in response to comments received from stakeholders.
Interested stakeholders are encouraged to submit comments on this revised draft guidance.