New FDA Guidance: When is a Product considered "Suspect"?

In December 2016, the FDA published the Guidance for Industry "Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification".

The document applies to all trading partners such as manufacturers, repackers, wholesalers and dispensers.

Since the 1st of January 2015, all trading partners of the FDA have to inform about any illegitimate product identified as laid down in the Drug Supply Chain Security Act (DSCSA).

Now, the new guideline lists specific scenarios and gives recommendations on how trading partners can identify suspect products and inform the FDA about them. Moreover, the document describes how to terminate a notification in line with the FDA.

If a company identifies a suspect product, the FDA has to be informed within 24 hours.

Section A of the Guidance depicts specific scenarios presenting the risk of suspected products if they would enter the pharmaceutical supply chain. This includes:

1. Trading Partners and Product Sourcing
2. Supply, Demand, History, and Value of the Product
3. Appearance of the Product

Examples for the second point include:


- that are generally in high demand,
,- that have a high sales volume or a high price in the USA,
- that are offered at a price that is "too good to be true"
- that have been previously or are currently being counterfeited or diverted,
- that are currently the subject of a drug shortage
- that are the subject of an illegitimate product notification under the DSCSA,
- that are the subject of an FDA counterfeit or cargo theft alert.

It is of fundamental importance that all the trading partners have the necessary authorisations.

The FDA has a own webpage for the notification of an illegitimate product. This page links to FDA Form 3911 which describes and sets the procedure to be followed.

Please click here to access the complete document: Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.


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