DSCSA: Identification of Suspect Product and Notification Guidance

On 3rd June 2021 the FDA issued final Drug Supply Chain Security Act (DSCSA)guidance on “Identification of Suspect Product and Notification”. This guidance identifies some specific scenarios that could significantly increase the risk of suspect products entering the pharmaceutical distribution supply chain and makes recommendations to assist trading partners in identifying suspect product.

The scenarios that could increase the risk of suspect product entering the supply chain includes:

?            Receiving an unsolicited sales offer from an unknown source.

?            Purchasing on the Internet from an unknown source.

?            Purchasing from a source that has engaged in questionable business practices.

?            A product is generally in high demand.

?            Product offered at a price that is “too good to be true.”

?            Product in packaging that is in some way incorrect.

The guidance states that trading partners should exercise due diligence and shall only conduct business with authorized trading partners. A trading partner should consult with the manufacturer when conducting any investigation of suspect product and should also contact regulatory authorities, law enforcement, or other available resources to aid in the determination of the authenticity of product.

The guide goes on to say that FDA interprets this provision of Section 582(b)(4)(B)(ii)(II) of the FD&C Act to require manufacturers to notify (1) FDA and (2) the manufacturer’s immediate trading partners within 24 hours if they identify suspect product. The new document gives guidance on how to notify the FDA.

This new guidance can be found in the Legislation & Guidance section of the NSF Pharma app in the FDA Guidance for Industry: Quality/GMP folder.