Food and Drug Regulations

C.04.404 (1) A fabricator shall not proceed with plasmapheresis or specific immunization unless a physician or physician substitute has determined the donor’s suitability to participate in plasmapheresis more frequently than once every eight weeks based on the donor’s medical history and a medical examination of the donor.

(2) If the donor is determined to be suitable, the fabricator shall document the following information:

• (a) the fact that the donor is suitable to participate in plasmapheresis more frequently than once every eight weeks;

• (b) the donor’s name and personal identifier;

• (c) the name and signature of the physician who makes the determination, or supervises the physician substitute making the determination; and

• (d) the date of the determination.

(3) The fabricator shall not proceed with plasmapheresis or specific immunization if the most recent determination under subsection (1) in respect of the donor was made more than

• (a) 30 days before the date set for the donor’s first participation in plasmapheresis or specific immunization; or

• (b) one year before any other date set for the donor’s participation in plasmapheresis or specific immunization.