Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act

Issue Date: February 5, 2024
Issued by: Center for Drug Evaluation and Research
Topic(s): Administrative / Procedural
Status: Final

Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act

The Food and Drug Administration (FDA) is issuing this guidance to assist 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, as required by section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360(j)(3)), as added by section 3112(e) of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).

Download the Guidance Document