FDA Drug Reporting - Amount of Listed Drugs

FDA had announced a new requirement of reporting the amount of each listed drug that was manufactured, prepared, propagated, compounded, or processed for commercial distribution, in order to identify, prevent, and mitigate possible drug shortages, and improves FDA’s visibility into drug supply chains.

Each person who registers with FDA (including repackers and relabelers) with regard to a listed drug which includes a finished dosage form product, an active pharmaceutical ingredient (API), and other types of listed drugs, medical gases, homeopathic products, OTC monograph drugs and animal drug products are required to report the amount of each listed drug that was manufactured, prepared, propagated, compounded, or processed by such person for commercial distribution except for biological products or categories thereof exempted by an order under section 510(j)(3)(B).

In case of private label distributor, the data should be submitted separately by the NDC associated with the registrant’s labeler code and the NDC associated with the private label distributor’s labeler code.

These reports can be submitted by the registrant’s themselves or by an agent that has knowledge regarding the amount of drug released and who has been authorized by the registrant to submit the registrant’s reporting.

Reports on the amount of each registrant’s listed drugs must be submitted annually. Such reports should include information regarding the amount of drugs released for the respective calendar year (January 1 – December 31). Reports for each calendar year must be submitted before March 31st of the calendar year. The drug reporting for the year 2024 must be submitted no later than July 31, 2024.