21 CFR 640.66
§ 640.66 Immunization of donors.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 640.66, § 640.66 Immunization of donors, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88502
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Full text
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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.