21 CFR 640.60 - Source Plasma.

Regulations last checked for updates: Feb 08, 2026

Title 21 - Food and Drugs last revised: Dec 18, 2026

View all text of Subpart G [§ 640.60 - § 640.76]

§ 640.60 - Source Plasma.

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.

[41 FR 10768, Mar. 12, 1976, as amended at 50 FR 4140, Jan. 29, 1985]

authority: 21 U.S.C. 321,351,352,353,355,360,371; 42 U.S.C. 216,262,263,263a,264

source: 38 FR 32089, Nov. 20, 1973, unless otherwise noted.

cite as: 21 CFR 640.60