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Confusion Persists Surrounding Suspect and Illegitimate Product

Under DSCSA, some manufacturers and distributors are struggling to understand which situations require a 3911 notification.

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At HDA’s Distribution Management Conference in Indianapolis (Mar. 13-15, 2023), a number of attendees asked for further clarification regarding what constitutes suspect and illegitimate product during an FDA DSCSA tele-presentation from Connie Jung, RPh, PhD., senior advisor for policy.

3911s and recalls: One audience member asked about products unfit for distribution, and if there is an expectation that they submit a 3911 notification for product recalls and for lot recalls. Speaking off-the-cuff, Jung noted that the DSCSA requirements are not intended to change or modify current recall processes. Those processes are still in effect and there will likely be some additional clarification during the finalization of that guidance. She said that certain product quality issues that may effectuate a recall would not necessarily fully meet the definition of an illegitimate product.

Reporting party: Another question came up regarding who is responsible for reporting the 3911. Is it the distributor or dispenser that has product in their possession that they suspect to be counterfeit/diverted/stolen, or is it a distributor that has material that's been diverted or stolen?

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