FDA Issues New Draft Guidance on Identification of Suspect Products and Notification

On June 11, 2014, the FDA announced the availability of a draft guidance entitled "Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification." The draft guidance clarifies for trading partners certain new requirements in the Federal Food, Drug, and Cosmetic Act, as amended by the Drug Supply Chain Security Act (DSCSA). The DSCSA mandates that certain trading partners investigate "suspect products" and notify the FDA and immediate trading partners regarding "illegitimate products," both of which are defined in the DSCSA. The draft guidance identifies scenarios that could increase the risk of a "suspect product" entering the drug supply chain, recommends certain precautions that should be taken by supply chain trading partners to identify "suspect products," and sets forth the process by which trading partners should act in notifying the FDA of "illegitimate products" and terminating this notification. Although the draft guidance is informative, it does not address certain ambiguities that may be important to assess the obligations that it discusses. For more information on the draft guidance, please click here.

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