Food and Drug Regulations

C.04.110 Smallpox vaccine

• (a) shall be a virus vaccine;

• (b) shall be the living virus of vaccinia or its derivatives obtained from

  • (i) the vesicles produced in the skin of healthy calves by inoculation of vaccinia virus,

  • (ii) specifically infected membranes of chick embryos, or

  • (iii) suitable tissue culture infected with vaccinia virus or its derivatives; and

• (c) shall be in fluid or dried form.