Food and Drug Regulations

C.04.403 (1) Every practitioner shall, before commencing the specific immunization of a donor for the purposes of plasmapheresis,

• (a) select the antigen to be injected;

• (b) schedule injections of the antigen; and

• (c) inform the donor of

  • (i) the nature of the material to be injected,

  • (ii) the maximum number of injections to be made,

  • (iii) the approximate duration of the immunization program, and

  • (iv) the possible hazards involved.

(2) During the course of every specific immunization program, the practitioner shall

• (a) evaluate the donor’s clinical response to the program; and

• (b) inject the antigen himself or supervise the injection of the antigen by qualified personnel.