,,ii  #aahth ,,congress  #ast ,session  
,s4 #cadc  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,october #bf1  
#bjbc,mr4 ,rubio 7for himself1 ,mr4     
,rounds1 and ,mr4 ,cramer7 introduced   
the following bill2 which was read twice
 and referred to the ,committee on      
,health1 ,education1 ,labor1 and        
,pensions  ,a ,,bill  ,to establish     
postmarket reporting requirements for   
pharmaceuticals1 and for other purposes4
  #a4 ,short title ,this ,act may be    
cited as the ,further ,strengthening    
,america's ,supply ,chain and ,national 
,security ,act4  #b4 ,modification of   
rules of origin for pharmaceutical      
products  7a7 ,trade agreements ,section
 #cjh7d77;,b7 of the ,trade ,agreements 
,act of #aigi 7#ai ,u4,s4,c4            
#beah7d77;,b77 is amended-- 7#a7 in     
clause 7i71 by striking instrumentality1
 or and inserting instrumentality12     
7#b7 in clause 7ii71 by inserting 1     
other than an active pharmaceutical     
ingredient1 after part of materials2 and

  7#c7 by striking the period at the end
 and inserting 1 or 7iii7 in the case of
 an article which consists of an active 
pharmaceutical ingredient1 the          
pharmaceutical ingredient is wholly the 
growth1 product1 or manufacture of that 
country or instrumentality44  7b7       
,federal ,acquisition ,regulation ,not  
later than #ahj days after the date of  
the enactment of this ,act1 the         
,president shall prescribe regulations  
to update sections #eb4bbe-e and #be4jjc
 of title #dh1 ,code of ,federal        
,regulations 7or successor regulations7 
to be consistent with rules of origin   
determinations for active pharmaceutical
 ingredients made under section         
#cjh7d77;,b7 of the ,trade ,agreements  
,act of #aigi 7#ai ,u4,s4,c4            
#beah7d77;,b771 as amended by subsection
 7a74  #c4 ,postmarket reporting        
requirements for pharmaceuticals  7a7   
,in general ,the ,secretary of ,health  
and ,human ,services1 acting through the
 ,commissioner of ,food and ,drugs1     

shall ensure that each holder of an     
approved application under section #eje 
of the ,federal ,food1 ,drug1 and       
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or  
under section #cea of the ,public       
,health ,service ,act 7#db ,u4,s4,c4    
#bfb7 annually submit1 as part of the   
postmarket annual report required by the
 ,secretary under section               
#cad4ha7;b77#b7 of title #ba1 ,code of  
,federal ,regulations 7or any successor 
regulation71 the following information3 
7#a7 ,the names and addresses of the    
sources of active and inactive          
ingredients of the drug4  7#b7 ,for each
 active and inactive ingredient of the  
drug1 the percentage of the aggregate   
amount of such ingredient used in the   
manufacture of the drug during the      
reporting period that is from each of   
the sources identified under paragraph  
7#a74  7b7 ,disclosure of ,information  
,the ,secretary of ,health and ,human   
,services shall-- 7#a7 annually provide 
the information reported in paragraphs  

7#a7 and 7#b7 of subsection 7a7 to the  
,secretary of ,defense for purposes of  
understanding the dependency on foreign 
manufacturers of drugs used by members  
of the ,armed ,forces2 and  7#b7 publish
 the information reported under such    
paragraphs on a publicly available      
internet website of the ,federal        
,government in a single1 aggregate form1
 without disclosing proprietary         
information4  #d4 ,additional risk      
factors for consideration during        
inspections of drug and device          
establishments ,section #eaj7;h77#d7 of 
the ,federal ,food1 ,drug1 and ,cosmetic
 ,act 7#ba ,u4,s4,c4 #cfj7;h77#d77 is   
amended-- 7#a7 by redesignating         
subparagraph 7,g7 as subparagraph 7,j72 
and  7#b7 by inserting after            
subparagraph 7,f7 the following3  7,g7  
,whether the establishment has been     
inspected by an entity that carries out 
inspections on behalf of a foreign      
government determined to be a foreign   
adversary under section #g4d of title   

#ae1 ,code of ,federal ,regulations 7or 
successor regulations74  7,h7 ,the      
particular drugs or devices 7with a     
focus on drugs and devices included on  
the list of essential medicines pursuant
 to section #c7;c7 of ,executive ,order 
#acidd 7#he ,fed4 ,reg4 #diibi77        
manufactured1 prepared1 propagated1     
compounded1 or processed in the         
establishment1 with particular attention
 to the number of other establishments  
globally that also manufacture1 prepare1
 propagate1 compound1 or process the    
same drug or device from which the      
,united ,states sources such drug or    
device4  7,i7 ,whether the establishment
 is located in a country with a history 
or #a or more previous instances of     
exporting illicit drugs or precursor    
chemicals to the ,united ,states1 as    
determined by the ,secretary by         
reference to the most recent report     
submitted to ,congress pursuant to      
section #dhi of the ,foreign ,assistance
 ,act of #aifa4  4