21 C.F.R. § 640.30 Plasma.
Title 21 - Food and Drugs
(a) Proper name and definition. The proper name of this product shall be Plasma. The product is defined as the fluid portion of one unit of human blood intended for intravenous use which in a closed system, has been collected, stabilized against clotting, and separated from the red blood cells. (b) Source. (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. [42 FR 59878, Nov. 22, 1977; 48 FR 13026, Mar. 29, 1983, as amended at 50 FR 4139, Jan. 29, 1985]
Title 21: Food and Drugs
PART 640—ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
Subpart D—Plasma
§ 640.30 Plasma.
