Food and Drug Regulations (C.R.C., c. 870)

Regulations are current to 2014-04-02 and last amended on 2014-01-29. Previous Versions

Maximum Volumes and Minimum Intervals

  •  (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.

Anticoagulant Solution

  •  (1) During plasmapheresis, the fabricator shall mix an anticoagulant solution with the blood collected from the donor.

  • (2) The anticoagulant solution shall have a valid drug identification number under these Regulations that indicates the solution is suitable for use in plasmapheresis.

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

Samples for Testing

  •  (1) During a plasmapheresis session, the fabricator shall take a sample of blood or plasma in a manner that does not contaminate the sample or the source plasma.

  • (2) When the sample is taken, the fabricator shall clearly and permanently label the sample container with the unique identifier assigned to the source plasma.

  • (3) The fabricator shall ensure that the person who labels the sample container is the same person who labels the container holding the source plasma under subsection C.04.416(2).

  • SOR/78-545, s. 1;
  • SOR/2006-353, s. 1.
  •  (1) The fabricator shall test a sample taken under section C.04.412 to detect evidence of the following disease agents:

    • (a) HIV types 1 and 2;

    • (b) hepatitis B virus;

    • (c) hepatitis C virus; and

    • (d) syphilis.

  • (2) The fabricator shall retain the source plasma collected at the plasmapheresis session until all the test results are determined to be negative or non-reactive.

  • (3) In the case of a positive or reactive test result for any disease agent referred to in subsection (1), the fabricator shall

    • (a) clearly and permanently label the container holding the source plasma collected at the session with

      • (i) the statement “Caution: Not for Manufacturing Use” or “Précaution : Non destiné à la fabrication”, and

      • (ii) the hazard symbol for Biohazardous Infectious Material set out in Schedule II to the Controlled Products Regulations; and

    • (b) segregate and dispose of the source plasma.

  • (4) In the case of a positive or reactive test result for syphilis, the fabricator may not proceed with plasmapheresis until a subsequent test shows that the donor is not infected with syphilis and a physician determines that the donor can continue to participate in plasmapheresis.

  • (5) In the case of a positive or reactive test result for a disease agent referred to in subsection (1), other than syphilis, the fabricator shall discontinue plasmapheresis and inform the donor of the reason why they are not suitable to participate in plasmapheresis for an indefinite period.

  • SOR/78-545, s. 1;
  • SOR/97-12, s. 48;
  • SOR/2006-353, s. 1.