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# Guide on Reporting Drug Making Amounts
- URL: https://www.fdaweb.com/guide-on-reporting-drug-making-amounts/
- Published: 2024-02-06T12:00:00.000Z
- Updated: 2026-09-14T14:22:13.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5156305

*Federal Register* notice: FDA is making available a final guidance entitled “Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act.” The document addresses the process that should be used by registrants of drug establishments to submit reports on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution, as required by the Federal Food, Drug, and Cosmetic Act. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-02-06/pdf/2024-02369.pdf?ref=fdaweb.com).