CFR section

21 CFR 640.21(f): Eligibility of donors

PART 640-ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS · Subpart C-Platelets

Key facts

Citation 21 CFR 640.21(f)
Section Eligibility of donors
Part PART 640-ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
Subpart Subpart C-Platelets
Subchapter 21 CFR F Biologics
Product types cited Biologics
Regulation text (excerpt) (f) Deferral of plateletpheresis donors due to red blood cell loss. (1) You must defer a donor from donating platelets by plateletpheresis or a co-collection of platelets and plasma by apheresis for 8 weeks if the donor has donated a unit of Whole Blood, or a single unit of Red Blood Cells by apheresis unless at least 2 calendar days have passed and the extracorporeal volume of the apheresis device is less than 100 milliliters. (2) You must defer a donor from donating platelets for a period of…

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