»Rabies Vaccine conforms to the regulations of the FDAconcerning biologics (see Biologics á1041ñ).It is a sterile preparation,in dried or liquid form,of inactivated rabies virus harvested from inoculated diploid cell cultures.The cell cultures are shown to consist of diploid cells by tests of karyology,to be non-tumorigenic by tests in hamsters treated with anti-lymphocytic serum (ALS)and to be free from extraneous agents by tests in animals or cell-culture systems.The harvested virus meets the requirements for identity by serological tests,for absence of infectivity by tests in mice or cell-culture systems,and for absence of extraneous agents by tests in animals or cell-culture systems.The Vaccine meets the requirements for absence of live virus by tests using a suitable virus amplification system involving inoculation and incubation of sensitive cell cultures for not less than 14days followed by inoculation of the cell-culture fluid thereafter into not less than 20adult mice.It has a potency of rabies antigen equivalent to not less than 2.5International Units for Rabies Vaccine,per dose,determined with the specific mouse protection test using the U.S.Standard Rabies Vaccine.It meets the requirements for general safety (see Safety Tests—Biologicalsunder Biological Reactivity Tests,in Vivo á88ñ).