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.
21 CFR Part 640 · Additional Standards for Human Blood and Blood Products
§ 640.73 Reporting of fatal donor reactions
Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.
What FDA inspectors cite under § 640.73
Form FDA 483 observations citing this section, fiscal years 2018–2018 (Biologics).
- Reporting of fatal donor reactions 1
Amendment history
Federal Register documents that created or amended this section.
- 41 FR 10770 12 Mar 1976
- 49 FR 23834 8 Jun 1984
- 55 FR 11013 26 Mar 1990