Regulation Text
The proper name of the product shall be Source Plasma. The product is defined as the fluid portion of human blood collected by plasmapheresis and intended as source material for further manufacturing use. The definition excludes single donor plasma products intended for intravenous use.
Authority
21 U.S.C. 321,351,352,353,355,360,371;42 U.S.C. 216,262,263,263a,264.