Food and Drug Regulations

C.04.408 (1) A physician shall determine if a donor is suitable to continue to participate in plasmapheresis more frequently than once every eight weeks, based on the test results and collection records for the donor that have been made or received by the fabricator within the preceding four months.

(2) The determination shall be made at least every four months after the date of the initial determination that the donor is suitable under section C.04.404.

(3) If the donor is determined to be temporarily not suitable to participate in plasmapheresis the fabricator shall inform the donor of the reason why they are temporarily not suitable and indicate the date when the donor may continue to participate in plasmapheresis.

(4) If the donor is determined to be not suitable for an indefinite period, the fabricator may not proceed with plasmapheresis and shall inform the donor of the reason why they are not suitable.

(5) If the requirement of subsection (2) is not met, the fabricator may not proceed with plasmapheresis until the determination is made.