2023-07772: Exemption of Certain Categories of Biological Products From Certain Reporting Requirements Under the Federal Food, Drug, and Cosmetic Act
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The Food and Drug Administration (FDA, Agency, or we) is issuing a final order to exempt certain categories of biological products from certain reporting requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). Specifically, each person who registers with FDA with regard to a drug is required to report annually to FDA on the amount of each listed drug that was manufactured, prepared, propagated, compounded, or processed by such person for commercial distribution; however, certain biological products or categories of biological products may be exempted by order from these reporting requirements if FDA determines that applying such reporting requirements is not necessary to protect the public health. This final order exempts two categories of biological products from these reporting requirements because the Agency has determined that applying such requirements is not necessary to protect the public health.
The agency’s own summary, as published.
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