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# Technical Guide on Reporting Drug Amounts
- URL: https://www.fdaweb.com/technical-guide-on-reporting-drug-amounts/
- Published: 2024-02-27T12:00:00.000Z
- Updated: 2026-09-14T14:23:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156435

FDA has released a [final guidance](https://www.fda.gov/media/153612/download?ref=fdaweb.com) entitled “Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide.” The document is intended to assist registrants of drug establishments in submitting reports 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. It describes (**1**) how first-time users can access FDA’s NextGen Portal to submit reports, (**2**) the different methods for submitting reports through the portal, and (**3**) the data elements to be included in such reports. Additionally, the guidance outlines the data elements that should be submitted.