Food and Drug Regulations

C.04.410 (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.