592 BIOLOGY OF PNEUMOCOCCUS 



cic serum (Types I and II) is included among those products for 

 which "the official standards of potency . . . shall be those dis- 

 tributed by the National Institute of Health of the United States 

 Public Health Service." 



Minimum standards for Type I serum to be submitted for offi- 

 cial tests were established in 1919, but they need not be discussed 

 here since they were based on methods no longer in use. In Janu- 

 ary, 1934, a regulation 1437 was promulgated to the effect that 

 samples of all antipneumococcic serum intended for sale in inter- 

 state commerce must be submitted to and released by the United 

 States Public Health Service before distribution. A memorandum 

 of December, 1935, 1438 stated that after April 1, 1936, the Na- 

 tional Institute of Health would pass for distribution only serums 

 (Type I) showing at least 1,000 units per cubic centimeter if con- 

 centrated and at least 500 units per cubic centimeter if unconcen- 

 trated. A later memorandum effective March 1, 1937, established 

 the same minimal potency for Type II serum. 



The British Therapeutic Substances Act of 1925, 549 followed by 

 the Statutory Rules and Orders of 1927, is similar to the United 

 States regulations governing biological products. The Statutory 

 Rules and Orders of 1935 551 regulate the preparation of both 

 Type I and Type II serums. 



Governmental control over therapeutic antipneumococcic serum 

 is desirable for uniformity in standardization and in interpreting 

 clinical results. Ideally, however, it would be preferable to secure 

 international agreement for a set of standard regulations without 

 interference with separate governmental requirements. 



Author's Note: The 1936 (11th) edition of the United States Pharma- 

 copoeiaio87 gives official recognition only to Type I antipneumococcic serum. 



The Production of Diagnostic Serum 

 In order that patients with lobar pneumonia may be given ef- 

 fective serum treatment, it is necessary first to determine the in- 

 fecting type of Pneumococcus. Before the serological differentia- 



