1. Regulations
  2. title 21
  3. chapter I-i6
  4. part 640
  5. subpart G
  6. § 640.73

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