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BIO Comments on Draft Guidance: Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C

January 3, 2022

On Wednesday, December 29th, BIO submitted comments to the Food and Drug Administration’s recent draft guidance for industry entitled, Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act. Existing regulations require each establishment engaged in activities under section 510 of the FD&C Act, be registered with the FDA and report to the Agency annually on the amount of each drug manufactured, prepared, propagated, compounded, or processed for commercial distribution. Section 3112(e) of the CARES Act added new section 510(j)(3) of the FD&C Act, which requires that each person (including repackers and relabelers) who registers with the FDA under section 510 of the FD&C Act with regard to a drug, must report to FDA annually on the amount of each listed drug that was manufactured, prepared, propagated, compounded, or processed by such person for commercial distribution. This guidance describes the process that should be used for reporting such information by each person registered.

In the comments submitted, BIO posited that the Agency exempt biologics already subject to the similar reporting requirement. BIO also requested that the Agency clarify its proposed actions and the potential impact of these actions. Furthermore, BIO requested that the Agency provide additional information on how it will enforce the reporting requirement and which penalties, if any, would be imposed on establishments that do not report on the quantity of a drug intended for commercial distribution. Additionally, BIO requested further clarity on how to report API/drugs that are manufactured in the US but distributed in a market outside the US. Lastly, BIO strongly urged the Agency to delay the implementation of this reporting requirement from February 2022 until a final guidance has been issued, and industry has a full understanding of the information requested and can determine the operational changes necessary to comply with these requirements.

Download Full Comments Below
BIO Comment Letter 510(j)(3) Guidance FDA 2021 D 1031
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