CHAPTER LXXII 

 CONTROL AND STANDARDIZATION OF BIOLOGICAL PRODUCTS 



G. W. McCOY 

 Hygienic Laboratory, Washington, D.C. 



GENERAL MEASURES OF CONTROL 



In certain countries of the world the control of biological products is assigned to 

 governmental agencies separate from those responsible for the purity and safety of 

 drugs in general. This is true in the United States where control of these preparations, 

 in so far as it properly falls under federal jurisdiction, is carried out by the Public 

 Health Service. This agency exercises its functions in this field chiefly through the 

 Hygienic Laboratory. The responsibilities of the federal government are limited in 

 this connection to preparations offered commercially for import, export, or interstate 

 traffic, and to those sold in the District of Columbia. 



Foreign countries usually have special control over biological preparations. Ger- 

 many requires official testing in addition to the tests made by the manufacturer on 

 each lot or batch of certain preparations, notably the antitoxins of diphtheria and 

 tetanus, anti-meningococcus serum and tuberculin; other preparations are for the most 

 part ignored. France and Italy have licensing requirements somewhat similar to those 

 of the United States. England has been without special restrictions until recently when 

 a Therapeutic Substances Act which includes biological products came into force. 



Certain products of this group are included in the pharmacopoeias of different 

 countries. In the United States the following are to be found in the tenth revision of 

 the Pharmacopoeia which is official at the present time : diphtheria antitoxin, tetanus 

 antitoxin, and smallpox vaccine. 



The field of biological control is one in which there is great activity and in which 

 changes are constantly occurring, chiefly the result of the rapid advances being made 

 by research in infectious diseases. 



In the United States the law is interpreted as requiring a license for each product 

 falling in the group of biological products. This at once brings to the fore the question 

 of issuing licenses for preparations which the licensing authorities consider valueless 

 or of doubtful worth. While no hard-and-fast rule can be followed, the practice in 

 general is that of withholding a license unless either experimental or clinical evidence 

 is available at least strongly suggestive that the preparation has prophylactic or 

 therapeutic value. In some cases the licensing authority insists upon considering tests 

 made under its own control prior to reaching a decision on an application for license. 



Inspection. — Producing laboratories are inspected prior to the issuing of a license 

 in order that the licensing authority may have full information as to the facilities of 

 the plant as regards personnel, methods, and equipment. Inspections are repeated 

 usually annually, in order that there may be no undetected lapses in any respect which 

 might impair the quality of the products. Inspection discloses such defects as failure 



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