Food and Drug Regulations

Version of section C.04.410 from 2006-12-14 to 2014-10-22:

  •  (1) A fabricator shall not collect plasma from a donor in a total amount, excluding anticoagulant solution, that exceeds

    • (a) if the donor’s weight is 50 kg or more but less than 68 kg,

      • (i) 625 mL or 640 g in respect of a single plasmapheresis session, and

      • (ii) 11.5 L in respect of all plasmapheresis sessions during the preceding six months;

    • (b) if the donor’s weight is 68 kg or more but less than 80 kg,

      • (i) 750 mL or 770 g in respect of a single plasmapheresis session, and

      • (ii) 15.5 L in respect of all plasmapheresis sessions during the preceding six months; and

    • (c) if the donor’s weight is 80 kg or more,

      • (i) 800 Ml or 820 g in respect of a single plasmapheresis session, and

      • (ii) 18.5 L in respect of all plasmapheresis sessions during the preceding six months.

  • (2) The fabricator shall have written procedures that describe

    • (a) the minimum waiting period for a donor between donations of plasma and between a donation of plasma and a donation of blood or other blood components; and

    • (b) the maximum number of plasma donations a donor may make in a given period.

  • SOR/78-545, s. 1;
  • SOR/85-1022, s. 5;
  • SOR/95-203, s. 1;
  • SOR/2006-353, s. 1.
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