Inspections, Compliance, Enforcement, and Criminal Investigations
CPG Sec. 251.100- Schedule of Physical Examination for Donors Receiving Immunization Injections
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:
1. is certified by the examining physician as suitable to be an immunized donor,
2. receives the physician's explanation of the hazards of immunization,
3. 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.