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# Annual Reporting Exemption for 2 Biologic Classes
- URL: https://www.fdaweb.com/annual-reporting-exemption-for-2-biologic-classes/
- Published: 2023-04-13T12:00:00.000Z
- Updated: 2026-09-14T18:25:28.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5154210

*Federal Register* notice: FDA has issued a final order to exempt certain categories of biological products from annual reporting requirements under the Federal Food, Drug, and Cosmetic Act as amended by the Coronavirus Aid, Relief, and Economic Security Act. Biologic makers are required to report to FDA the amount of each listed drug that was manufactured, prepared, propagated, compounded, or processed by such person for commercial distribution. Two categories of biological products are now exempted from the reporting requirements because the agency determined that applying such requirements is not necessary to protect the public health. They are (**1**) blood and blood components for transfusion and (**2**) cell and gene therapy products, where one lot treats a single patient. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-04-13/pdf/2023-07772.pdf?ref=fdaweb.com).