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COVID-19 Could Offer Some DSCSA Enforcement Relief For Manufacturers

Executive Summary

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.

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US FDA Gives Wholesalers But Not Manufacturers More Time To Begin Verifying Saleable Returns

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.

FDA Exempts COVID-19 Prescription Drugs From DSCSA Tracing Requirements

Prescription drugs that are deemed necessary for treating patients in public health emergencies such as COVID-19 would not have to comply with DSCSA tracing requirements, says the FDA. Such drugs would not need to have product identifiers and saleable returns would not have to be verified.

FDA Gives Wholesalers One-Year Breather From Saleable Returns Verification

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.

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