Food and Drug Regulations

C.04.407 (1) Before beginning plasmapheresis with a donor, a fabricator shall take a blood sample from the donor to determine the plasma protein composition of the donor’s blood by means of a serum protein electrophoresis test or an equivalent test.

(2) A blood sample shall be taken within seven days before the donor’s first plasmapheresis session at which the fabricator proceeds with plasmapheresis.

(3) If 21 days have elapsed from the taking of the sample without a physician examining the test result, the fabricator may not proceed with plasmapheresis until a physician examines the test result.

(4) If a physician concludes that the plasma protein composition of the donor’s blood is not within normal limits, the fabricator may not proceed with plasmapheresis until a physician determines that the plasma protein composition of the donor’s blood is within normal limits.

(5) If the fabricator has not taken a blood sample from the donor as required under subsection (1) for more than four months, the fabricator may not proceed with plasmapheresis until the blood sample is taken from the donor.