21 CFR Part 640 · Additional Standards for Human Blood and Blood Products
(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.
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Form FDA 483 observations citing this section, fiscal years 2011–2011 (Biologics).
Federal Register documents that created or amended this section.