The registrants of drug establishments or their authorized agents can now report through the updated application in the NextGen Portal. The FDA has issued a final guidance to assist the registrants of drug establishments in submitting reports to FDA on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution.

This guidance explains how to report information to the FDA if you register under section 510 of the FD&C Act with regard to a listed drug. Listed drugs subject to reporting includes human drug products (including non-exempt biological products) marketed under an approved application, animal drug products marketed under an approved application, medical gases, homeopathic products, OTC drugs, animal drugs not approved, conditionally approved, or indexed under sections 512, 571, and 572 of the FD&C Act.

If reports for calendar year 2023 were already submitted using the previous version, no resubmission is required. For those who haven’t submitted their 2023 report, the deadline is July 31, 2024.

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