21 CFR 640.30 - Plasma.
(a)Proper name and definition. The proper name of this component is Plasma. The component is defined as:
(1) The fluid portion of one unit of human blood intended for intravenous use which is collected in a closed system, stabilized against clotting, and separated from the red cells; or
(2) The fluid portion of human blood intended for intravenous use which is prepared by apheresis methods as specified in the directions for use for the blood collecting, processing, and storage system including closed and open systems.
(1) Plasma shall be obtained by separating plasma from blood collected from blood donors or by plasmapheresis.
(2) Plasma may be obtained from a unit of Whole Blood collected by another licensed establishment.