US FDA Gives Wholesalers But Not Manufacturers More Time To Begin Verifying Saleable Returns
Manufacturers Must Still Respond To Verification Requests Within 24 Hours
Wholesalers are given three more years to set up electronic systems to verify saleable returns under another reprieve from the FDA. Yet the reprieve does not extend to manufacturers, who must respond within 24 hours to wholesalers’ requests to manually verify that a returned product is not suspect.
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Roughly half of all pharmaceutical manufacturers have misgivings they will have the necessary systems to electronically verify saleable returns under DSCSA, even though they must respond to these requests within 24 hours.
As the US FDA focuses on COVID-19 pandemic-related activities, the time may be right to ask for an extension in complying with the DSCSA’s saleable returns verification deadline.
As expected, the FDA will not take enforcement action against wholesalers that are unable to comply with DSCSA’s saleable return verification requirements by the 27 November deadline.