338 



95 - 



"(A) full reports of investigation which have been made to show 

 whether or not such drug is safe for use and whether such drug 

 is effective in use; (B) a full list of the articles used as 

 components of such drug; (c) a full statement of the composition 

 of such drug; (0) a full description of the methods used in, and 

 the facilities and controls used for, the manufacture, 

 processing, and packing of such drug; (E) such samples of such 

 drug and of the articles used a components thereof as the 

 Secretary may require; and (F) specimens of the labeling 

 proposal to be used for such drug..." 



