Food and Drug Regulations

C.04.413 (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.