444 ANNUAL REPORT SMITHSONIAN INSTITUTION, 1937 



be many advantages to each nation to have unifonnity in the strength 

 of the more potent remedies, and the plan met with wide favor — 

 retaining as it did the inherent integrity of each national standard. 



By this agreement, all preparations containing arsenic were made 

 of uniform strength. Many other preparations which would be 

 poisonous if taken in excessive dose were brought to a uniform degree 

 of strength. For Instance, a very important class of preparations — 

 the tinctures — were made of 10 percent strength for all of those which 

 were highly potent, including preparations of such drugs as digitalis, 

 capsicum, opium, aconite, etc. Prior to this agreement, the strengths 

 of potent tinctures varied from 5 to 50 percent, and the new uni- 

 formity thus eliminated the danger of abnormal dosage or inferior 

 therapeutic effects which might have resulted from the filling of a 

 foreign prescription in a local apothecary shop. Tinctures of less 

 active drugs were made 20 percent. 



tup: federal foods and drugs act 



During the first 80 years of the existence of the Pharmacopoeia of 

 the United States, conformity to its standards was voluntary. It 

 speaks well for the codes of ethics influencing the medical and phar- 

 maceutical professions that this national standard was widely fol- 

 lowed and the purpose of the pharmacopoeia thus carried out. How- 

 ever, for the maximum of efficiency, it was believed important to 

 enact laws which would enforce uniformity in standards. Several 

 States had undertaken the passage and the enforcement of such laws, 

 and the question became a national issue. Under the aggressive 

 leadership of Dr. Ilarvey W. AViley, Chief of the Bureau of Chemistry 

 of the Department of Agriculture, and with the enthusiastic support 

 of many physicians and pharmacists, there was introduced into Con- 

 gress and successfully passed what has become known as tlie Federal 

 Food and Drugs Act. This law was actually passed in 1906. Under 

 this legislation it is required that ofllcial medicinal substances shall 

 maintain the strength and conform to the purity standards of the 

 Pharmacopoeia when sold or dispensed as medicines under the official 

 names. There is a provision in the law which permits a modification 

 of the oflicial standards if this act is clearly indicated upon the label. 

 This is known as the "variation clause" and is intended to provide 

 for justifiable modifications in official standards such as half-strength 

 tincture of iodine. The basic principle underlying this law is repre- 

 sented by the principle that, "The product must always be true to 

 its label statement." 



Following the establishment of this national-drug law, which is 

 operative only in interstate commerce and in the District of Columbia 

 and the Territories, most States passed similar laws to enforce the 



