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.
- SOR/78-545, s. 1
- SOR/85-1022, s. 5
- SOR/95-203, s. 1
- SOR/2006-353, s. 1
- Date modified: