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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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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.

FDA Warning Letter Hits Distributor McKesson For Allowing Diversion Of Opioids And Other Medications

FDA has issued its first warning letter under DSCSA to San Francisco-based distributor McKesson Corp. for failing to exercise adequate control over products that were tampered with while stored in its facility. The firm was also chastised for its lax response to reports from pharmacies that opioids and other prescription drugs were removed from bottles and replaced with other drugs while the bottles were in its possession.

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