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# FDA Portal for Annual Drug Manufacturing Reporting
- URL: https://www.fdaweb.com/fda-portal-for-annual-drug-manufacturing-reporting/
- Published: 2021-10-29T12:00:00.000Z
- Updated: 2026-09-14T17:20:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150479

FDA has announced the availability of a “NextGen Portal” for reporting the annual amount of listed human and animal drugs and human biological products that an establishment manufactured, prepared, propagated, compounded, or processed (including repacking and relabeling) for commercial distribution. All registrants of drug establishments or their authorized agents should use the portal to submit annual reports as required under section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act, FDA says.

The agency has released two related guidances to assist registrants. The [draft guidance](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reporting-amount-listed-drugs-and-biological-products-under-section-510j3-federal-food-drug-and?ref=fdaweb.com) *Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act Guidance for Industry* describes the process that should be used for reporting by each person who registers with FDA. The [guidance](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reporting-amount-listed-drugs-and-biological-products-technical-conformance-guide?ref=fdaweb.com) *Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide* describes **1)** how first-time users can access FDA’s CDER NextGen Portal to submit these reports, **2)** the different methods for submitting the reports through the portal, and **3)** the data elements to be included in the reports.