21 C.F.R. § 640.13

Collection of the blood

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(a) The source blood shall be collected as prescribed in § 640.4.

(b) Source blood may also be derived from Whole Blood manufactured in accordance with applicable provisions of this subchapter.

[38 FR 32089, Nov. 20, 1973, as amended at 50 FR 4139, Jan. 29, 1985; 64 FR 45372, Aug. 19, 1999]