Food and Drug Regulations

C.04.419 Notwithstanding section C.04.406(j), (k) and (l) and section C.04.418, plasmapheresis may be conducted on a donor whose plasma is reactive to hepatitis B surface antigen or anti-hepatitis B surface antigen to obtain plasma for production of hepatitis B vaccine, hepatitis B immune globulin or for in vitro diagnostic reagents if specific written authorization for such activity has been provided by the Minister.