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# Draft Guide on Drug Reporting to FDA
- URL: https://www.fdaweb.com/draft-guide-on-drug-reporting-to-fda/
- Published: 2021-11-01T12:00:00.000Z
- Updated: 2026-09-14T17:21:00.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150483

*Federal Register* notice: FDA has made available a draft guidance entitled *Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act*. The document addresses the process through which registrants of drug establishments should submit to FDA reports on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-11-01/pdf/2021-23722.pdf?ref=fdaweb.com).