FDA has announced the new use of a NextGen Portal for reporting the annual amount of listed human and animal drugs and human biological products that an establishment manufactured, prepared, propagated, compounded, or processed (including repacking and relabeling) for commercial distribution. All registrants of drug establishments or their authorized agents should use the portal to submit annual reports as required under section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act, as added by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).
The reported data will improve FDA’s visibility into the drug supply chain and will help the agency identify, prevent, and mitigate drug shortages.
Reports for calendar year 2020 should be submitted no later than February 15, 2022, and reports for calendar year 2021 should be submitted no later than May 16, 2022.
FDA has also issued two draft guidances to assist registrants of drug establishments in reporting the amount of listed drugs and biological products.
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