Electronic system for illegitimate drug FDA notifications launches

An electronic submission system for notifying the FDA of illegitimate products found in the US supply chain has gone live.

One of the requirements of the Drug Supply Chain Security Act (DSCSA), which was signed into law in 2013, is that manufacturers, repackagers, wholesale distributors, and dispensers of medicines have to notify the FDA promptly if they encounter counterfeit, falsified, diverted or stolen drugs.

They must notify the agency and immediate trading partners not later than 24 hours after making the determination that a product is illegitimate, according to the FDA, which has now published a question & answer document to explain the new process.

Notifications to the FDA are made using Form 3911, with the new electronic portal going live this week after months of development.

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