G. W. McCOY 949 



1902, which covers the control of biological products, the label is required to show the 

 proper name of the product; the name, address, and license number of the manufac- 

 turer; the lot number; a statement as to the potency of the product; and the expira- 

 tion date. The manufacturer is permitted to utilize any trade name he may see fit to 

 employ in addition to the officially authorized name. 



Dating. — The law referred to in the preceding paragraph requires that each pack- 

 age shall be marked with "the date beyond which the contents can not be expected 

 beyond reasonable doubt to yield their specific results." Under this provision of the 

 law somewhat arbitrary requirements have been set up since it is impossible to de- 

 termine always how long a preparation retains its therapeutic or prophylactic activity. 

 Glycerinated smallpox vaccine is permitted a maximum of three months on the market 

 even under favorable conditions of storage. Dried vaccine virus is permitted six 

 months. The antitoxins for which there are official standards are permitted one year 

 if they are sent out with a 20 per cent excess of potency, and as high as four years if 

 sent out with a 50 per cent excess of potency. Antibacterial sera in general are given 

 one year, anti-meningococcus serum being an exception with but six months from 

 date of manufacture. Bacterial vaccines in general and pollen extracts are given 

 eighteen months. 



Standardization and testing. — The descriptions of procedures given here chiefly 

 will follow the practice of the United States, and theoretical considerations will be 

 omitted. In standardization procedures it is the aim to measure if possible the thera- 

 peutically, diagnostically, or prophylactically active elements in the preparation, 

 though there are not at present sufficient data to permit this in every case. This can 

 be done, e.g., in the testing of antitoxins, but in the case of certain other agents — e.g., 

 anti-meningococcus serum — there is no assurance that the immune bodies titrated — 

 e.g., agglutinins, bacteriotropins, or complement-fixing bodies, depending on the meth- 

 od used — have any important part in the therapeutic activity of the material. 



In the United States there are standard units legally established for the antitoxins 

 of diphtheria and tetanus, for those of CI. perfringens (CI. welchii) and the botulinum 

 group and for that of the scarlet fever streptococcus. Control products are distributed 

 by the Hygienic Laboratory for comparison in the testing of anti-dysenteric serum, 

 anti-pneumococcic serum, and anti-meningococcic serum, typhoid and paratyphoid 

 vaccines, scarlet fever streptococcus toxin for the Dick test and for immunization. 

 Standardized methods are prescribed for testing the potency of smallpox vaccine, 

 diphtheria toxin for the Schick test, diphtheria toxin-antitoxin mixture, and diph- 

 theria toxoid. 



In the case of other preparations generally, the potency testing and the standardi- 

 zation are left to the discretion of individual manufacturers. 



VIRUSES 

 SMALLPOX VACCINE (VACCINE VIRUS) 



Tests are required to be carried out to exclude an excessive number of contaminat- 

 ing organisms in smallpox vaccine and to insure freedom from the tetanus organism. 

 These are as follows: 



For the bacterial count poured agar plates are used, the contents of one vaccination out- 



