Eye on FDA
A series focused on important FDA and related regulatory developments critical to the life sciences industry.
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Eye on FDA
On October 9, the FDA announced that the agency is providing exemptions from the enhanced drug distribution security requirements of section 582 of the Federal Food, Drug and Cosmetic Act (FD&C Act) for eligible trading partners, which were scheduled to take effect on November 27. This exemption applies to drug products transacted by trading partners that have successfully completed (or made documented efforts to complete) data connections with their immediate trading partners, but still face challenges exchanging data.