§ 640.6. Modifications of Whole Blood.
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/us/cfr/t21/s§ 640.6·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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. [38 FR 32089, Nov. 20, 1973, as amended at 49 FR 23834, June 8, 1984; 50 FR 4138, Jan. 29, 1985; 55 FR 11013, Mar. 26, 1990; 59 FR 49351, Sept. 28, 1994; 64 FR 45372, Aug. 19, 1999; 64 FR 56453, Oct. 20, 1999]
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§ 640.6
Modifications of Whole Blood.
Fed. Reg.×1
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