21 CFR 640.6
§ 640.6 Modifications of Whole Blood.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 640.6, § 640.6 Modifications of Whole Blood, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88466
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Full text
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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.