FDA Drug Reporting - Amount of Listed Drugs

As per the NEW FDA Communication on February 14, 2022, the draft guidance document on Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act is not a binding document, and the recommended February 15, 2022 reporting date for 2020 data is not a requirement.

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 drug released for the respective calendar year (January 1 – December 31). 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. Reports for subsequent calendar years should be submitted no later than February 15 of the following calendar year.

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