If specific immunization of a donor is to be performed, the selection, scheduling and administration of the antigen, and the evaluation of each donor's clinical response, shall be by the responsible physician. Any material used for immunization shall be either a product licensed under section 351 of the Public Health Service Act for such purpose or one specifically approved by the Director, Center for Biologics Evaluation and Research, Food and Drug Administration. Immunization procedures shall be on file at each plasmapheresis center where immunizations are performed.
21 CFR Part 640 · Additional Standards for Human Blood and Blood Products
§ 640.66 Immunization of donors
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 § 640.66
Form FDA 483 observations citing this section, fiscal years 2014–2016 (Biologics).
- Procedures 1
- Immunization - physician eval, sched., & admin. 1
FDA guidance that cites § 640.66
Amendment history
Federal Register documents that created or amended this section.
- 38 FR 32089 20 Nov 1973
- 49 FR 23834 8 Jun 1984
- 55 FR 11013 26 Mar 1990
- 80 FR 29905 22 May 2015