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Electronic Code of Federal Regulations

e-CFR data is current as of December 10, 2019

Title 21Chapter ISubchapter FPart 640Subpart G → §640.66


Title 21: Food and Drugs
PART 640—ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
Subpart G—Source Plasma


§640.66   Immunization of donors.

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.

[38 FR 32089, Nov. 20, 1973, as amended at 49 FR 23834, June 8, 1984; 55 FR 11013, Mar. 26, 1990; 80 FR 29905, May 22, 2015]

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