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YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS

FDA on September 23 issued a Drug Supply Chain Security Act (DSCSA)-related compliance policy stating it will not take enforcement action against wholesalers that do not have systems in place to verify product identifiers of saleable returned product prior to further distribution until November 27, 2020. FDA’s decision was necessary because existing drug distribution systems are not prepared to handle and verify the large volumes of returned product in the supply chain in the United States. The extended compliance period also allows wholesalers to issue transaction statements for returned product without certification statements concerning verification processes.

FDA’s decision to extend the compliance period for verification does not relieve wholesalers from having systems in place to identify suspect and illegitimate product or from conducting appropriate investigations. The extended policy is just to avoid disruption or delay in the supply of drugs that are routinely returned and able to be further distributed. Wholesalers now have another year to acquire, implement, and train on verification systems, and in the interim, they should continue to rely on existing audit systems to identify suspect product before further distributing it.