21 CFR 640.73 - Reporting of fatal donor reactions.

Regulations last checked for updates: Jun 01, 2024

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

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

§ 640.73 - Reporting of fatal donor reactions.

If a donor has a fatal reaction which, in any way, may be associated with plasmapheresis the Director of the Center for Biologics Evaluation and Research shall be notified by telephone as soon as possible. If the facility is located outside of the continental United States, notification by cable or telegram shall be acceptable.

[41 FR 10770, Mar. 12, 1976, as amended at 49 FR 23834, June 8, 1984; 55 FR 11013, Mar. 26, 1990]

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 640.73