21 CFR 640.50 - Cryoprecipitated AHF.

Regulations last checked for updates: Oct 16, 2024

Title 21 - Food and Drugs last revised: Sep 30, 2024

View all text of Subpart F [§ 640.50 - § 640.56]

§ 640.50 - Cryoprecipitated AHF.

(a) Proper name and definition. The proper name of this product shall be Cryoprecipitated AHF. The product is defined as a preparation of antihemophilic factor, which is obtained from a single unit of plasma collected and processed in a closed system.

(b) Source. The source material for Cryoprecipitated AHF shall be plasma which may be obtained by whole blood collection or by plasmapheresis.

[42 FR 21774, Apr. 29, 1977; 48 FR 13026, Mar. 29, 1983, as amended at 50 FR 4139, 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 640.50