Confusion has arisen regarding the interpretation of 21 CFR 640.63(b)(2). The purpose of this regulation is to prevent plasmapheresis centers from immunizing donors without first giving them a physical examination.
An active plasmapheresis donor who is to be immunized and who has already received a physical examination pursuant to 21 CFR 640.63(b)(1), need not be re-examined for immunization provided that the donor:
is certified by the examining physician as suitable to be an immunized donor,
receives the physician's explanation of the hazards of immunization,
signs an informed consent form for immunization.
A donor who is to be immunized and who is not already in a plasmapheresis program, must be given an initial medical examination no more than one week before the first immunization injection, in addition to 1 thru 3 above. The medical examination for plasmapheresis need not be repeated if the first donation occurs within 21 days after the first injection.