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# Two Biological Products Reporting Exemption
- URL: https://www.fdaweb.com/two-biological-products-reporting-exemption/
- Published: 2021-10-26T12:00:00.000Z
- Updated: 2026-09-14T17:20:16.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150447

*Federal Register* proposed order: FDA is proposing to exempt certain categories of biological products from certain reporting requirements under the Federal Food, Drug, and Cosmetic Act as amended by the Coronavirus Aid, Relief, and Economic Security Act. Under the proposal, the following two categories of biological products would be exempt from annual reporting: blood and blood components for transfusion, and cell and gene therapy products, where one lot treats a single patient. The agency has determined that requiring registrants to report annually under section 510(j)(3)(A) of the FD&C Act on the amount of such products manufactured, prepared, propagated, compounded, or processed for commercial distribution is not needed to enhance its ability to identify, prevent, and mitigate possible shortages. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-23396.pdf?ref=fdaweb.com).