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21CFR640.52

§ 640.52 Collection of source material.

Regulation Text

(a) Whole blood used as a source of Cryoprecipitated AHF shall be collected as prescribed in § 640.4 . Whole blood from which both Platelets and Cryoprecipitated AHF is derived shall be maintained as required under § 640.24 until the platelets are removed. (b) If plasmapheresis is used, the procedure for collection shall be as prescribed in § 640.64 (except that paragraph (c)(3) of that section shall not apply), and 640.65.

Authority

21 U.S.C. 321,351,352,353,355,360,371;42 U.S.C. 216,262,263,263a,264.

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