,i  #aagth ,,congress  #b;d ,session    
,h4 ,r4 #fdhc  ,,in ,,the ,,house ,,of  
,,representatives  ,january #be1 #bjbb  
,ms4 ,eshoo introduced the following    
bill2 which was referred to the         
,committee on ,energy and ,commerce  ,a 
,,bill  ,to amend the ,federal ,food1   
,drug1 and ,cosmetic ,act to clarify    
reporting requirements for              
establishments within a foreign country 
engaged in the manufacture1 preparation1
 propagation1 compounding1 or processing
 of an active pharmaceutical ingredient1
 and for other purposes4  #a4 ,short    
title ,this ,act may be cited as the    
,improved ,transparency of ,foreign     
,drug ,manufacturing ,act of #bjbb4  #b4
 ,reporting requirement for drug        
manufacturers  7a7 ,establishments in a 
foreign country ,section #eaj7;i7 of the
 ,federal ,food1 ,drug1 and ,cosmetic   
,act 7#ba ,u4,s4,c4 #cfj7;i77 is amended
 by inserting at the end the following3 
7#e7 ,the requirements of paragraphs    
7#a7 and 7#b7 shall apply to            

establishments within a foreign country 
engaged in the manufacture1 preparation1
 propagation1 compounding1 or processing
 of any drug1 including the active      
pharmaceutical ingredient1 that is      
required to be listed pursuant to       
subsection 7j74 ,such requirements shall
 apply regardless of whether the drug or
 active pharmaceutical ingredient       
undergoes further manufacture1          
preparation1 propagation1 compounding1  
or processing at a separate             
establishment or establishments outside 
the ,united ,states prior to being      
imported or offered for import into the 
,united ,states4  4  7b7 ,listing of    
drugs ,section #eaj7;j77#a7 of the      
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cfj7;j77#a77 is    
amended--  7#a7 in subparagraph 7,d71 by
 striking and at the end2  7#b7 in      
subparagraph 7,e71 by striking the      
period at the end and inserting 2 and2  
and  7#c7 by adding at the end the      
following3  7,f7 in the case of a drug  

contained in the applicable list1 a     
certification that the registrant has-- 
7i7 identified every other known        
establishment where manufacturing is    
performed for the drug2 and  7ii7       
notified each known foreign             
establishment engaged in the            
manufacture1 preparation1 propagation1  
compounding1 or processing of the drug1 
including the active pharmaceutical     
ingredient1 of the inclusion of the drug
 in the list and the obligation to      
register4  4  7c7 ,quarterly reporting  
on amount of drugs manufactured ,section
 #eaj7;j77#c77;,a7 of the ,federal      
,food1 ,drug1 and ,cosmetic ,act 7as    
added by section #caab of the ,,cares   
,act 7,public ,law #aaf-acf77 is amended
 by striking annually and inserting once
 during the month of ,march of each     
year1 once during the month of ,june of 
each year1 once during the month of     
,september of each year1 and once during
 the month of ,december of each year4