21 CFR 640.20 - Platelets.

Regulations last checked for updates: May 01, 2025

Title 21 - Food and Drugs last revised: Apr 28, 2025

View all text of Subpart C [§ 640.20 - § 640.25]

§ 640.20 - Platelets.

(a) Proper name and definition. The proper name of this product shall be Platelets. The product is defined as platelets collected from one unit of blood and resuspended in an appropriate volume of original plasma, as prescribed in § 640.24(d).

(b) Source. The source material for Platelets is plasma which may be obtained by whole blood collection or by plateletpheresis.

[40 FR 4304, Jan. 29, 1975, as amended at 47 FR 49021, Oct. 29, 1982; 50 FR 4139, Jan. 29, 1985; 72 FR 45887, Aug. 16, 2007]

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 640.20