CHAPTER III* 

 MANUFACTURE OF VACCINES 



INTRODUCTION 



On July i, 1902, by Act of Congress, the Secretary of the Treasury, 

 through the Public Health Service, was placed in control of all manu- 

 facture and sale of viruses, sera, toxins, and analogous products for 

 human use. In order to manufacture and place such products upon 

 the interstate market, any individual or corporation must secure a 

 license from the Secretary of the Treasury through the Surgeon General 

 of the United States Public Health Service. All candidates, before 

 securing federal approval for such licenses, must allow federal inspectors 

 the privilege of examining their laboratories, including the details 

 involved in the processes of manufacture. At frequent intervals the 

 Hygienic Laboratory purchases samples of licensed products upon the 

 open market for the purpose of subjecting these to careful examination, 

 If the samples of any products are found to be misrepresented as to 

 potency or kind and amount of preservative, or if contaminating organ- 

 isms are present, the manufacturer is immediately notified to recall 

 such products from the market. 



July i, 1913, by a similar Congressional Act, the Secretary of Agri- 

 culture, through the Bureau of Animal Industry, was authorized to 

 regulate the preparation and sale of viruses, sera, toxins and 

 analogous products intended for use in the treatment of domestic 

 animals. 



The federal control of the manufacture of vaccines, sera, toxins 

 and other biologic products related to specific infectious diseases, has 

 reduced to a minimum the danger formerly involved in the use of such 

 materials. 



For one who is not a student of microbiology and preventive 

 medicine, or not familiar with the technic involved in preparing biologic 

 materials such as sera, tuberculins and vaccines it is difficult to 



*Prepared by W. E. King. 



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