FDA guides on handling suspect illegitimate drugs

Question mark tablets in blisterNew legislation in the US mandates that from the start of 2015, any trading partner in the medicines supply chain who suspects a drug is counterfeit or adulterated must by law notify the FDA.

Now, the recommended framework for that notification has been published by the FDA and is open for comment.

The new guidance is the first in a series that will be produced by the FDA to implement the Drug Supply Chain Security Act (DSCSA), which in turn is part (Title II) of the Drug Quality and Security Act (DQSA) that was adopted last year and lays out a schedule for the introduction of a track-and-trace system for pharmaceutical products.

Under the guidance, manufacturers, repackagers, wholesale distributors or dispensers of medicines should have notification systems for suspected counterfeit, diverted, stolen or adulterated medicines in place for both the FDA and immediate trading partners by January 1, 2015.

The document is intended to help trading partners understand how illegitimate products can enter the supply chain, advise how they can be spotted and sets out a recommended procedure for notification, as well as cancelling notification if the suspicions turn out to be unfounded.

For example, it suggests that illegal medicines are more likely to be supplied by a source new to the trading partner and those which send unsolicited sales offers. Other risky transactions could involve drugs purchased over the Internet or from organisations which are reluctant to provide transaction history information in a timely manner. Products associated with an elevated level of risk include high-demand or high sales volume medicines or those currently in short supply, says the guidance.

The primary objective of the DSCSA is to introduce full traceability for medicine packs through the supply chain within 10 years, with a requirement for all drug packages to carry a unique serial number within four years.

Other guidance documents that will be developed by the FDA to facilitate the implementation of the Act include the format of transaction information that will have to change hands as goods flow through the supply chain, a waiver process by which companies could become exempt from the traceability requirements, and grandfathering of products already in inventory when the serialization and tracing requirements come into effect.
A full list of all forthcoming guidance, and a timeline for completion, can be viewed on the FDA's website.

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