Food and Drug Regulations

Version of section C.04.404 from 2006-12-14 to 2014-10-22:

  •  (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.

  • SOR/78-545, s. 1;
  • SOR/85-1022, s. 3;
  • SOR/2006-353, s. 1.
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