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Code of Federal Regulations Title 21. Food and Drugs § 21.640.6 Modifications of Whole Blood

Current as of January 02, 2025 | Updated by Findlaw Staff

Upon approval by the Director, Center for Biologics Evaluation and Research, of a supplement to the biologics license application for Whole Blood a manufacturer may prepare Whole Blood from which the antihemophilic factor has been removed, provided the Whole Blood meets the applicable requirements of this subchapter and the following conditions are met:

(a) The antihemophilic factor shall be removed in accordance with paragraphs (a), (b), and (c) of § 640.52.

(b) Although the closed system between the red blood cells and plasma shall be maintained, the red blood cells shall be maintained between 1 and 6 °C at all times, including that time when the plasma is being frozen for removal of the antihemophilic factor.

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Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.640.6 Modifications of Whole Blood - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-640-6/

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