,,ii  #aah? ,,congress  #a/ ,session    
,s4 #cadc  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,octob] #bf1 #bjbc,mr4 
,rubio 7= himself1 ,mr4 ,r\nds1 & ,mr4  
,cram]7 introduc$ ! foll[+ bill2 :i* 0  
read twice & ref]r$ to ! ,committee on  
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to e/abli% po/m>ket report+ 
requirem5ts = ph>maceuticals1 & = o!r   
purposes4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,fur!r ,/r5g!n+ ,am]ica's  
,supply ,*a9 & ,national ,security ,act4
  #b4 ,modification ( rules ( orig9 =   
ph>maceutical products  7a7 ,trade      
agreem5ts ,section #cjh7d77;,b7 ( !     
,trade ,agreem5ts ,act ( #aigi 7#ai     
,u4,s4,c4 #beah7d77;,b77 is am5d$-- 7#a7
 9 clause 7i71 by /rik+ in/rum5tality1  
or & ins]t+ in/rum5tality12  7#b7 9     
clause 7ii71 by ins]t+ 1 o!r ?an an     
active ph>maceutical +r$i5t1 aft] "p (  
mat]ials2 &  7#c7 by /rik+ ! p]iod at ! 
end & ins]t+ 1 or 7iii7 9 ! case ( an   
article :i* consi/s ( an active         
ph>maceutical +r$i5t1 ! ph>maceutical   

+r$i5t is :olly ! gr[?1 product1 or     
manufacture ( t c\ntry or               
in/rum5tality44  7b7 ,f$]al ,acquisition
 ,regulation ,n lat] ?an #ahj days aft] 
! date ( ! enactm5t ( ?is ,act1 !       
,presid5t %all prescribe regulations to 
update sections #eb4bbe-e & #be4jjc (   
title #dh1 ,code ( ,f$]al ,regulations  
7or successor regulations7 to be        
consi/5t ) rules ( orig9 det]m9ations = 
active ph>maceutical +r$i5ts made "u    
section #cjh7d77;,b7 ( ! ,trade         
,agreem5ts ,act ( #aigi 7#ai ,u4,s4,c4  
#beah7d77;,b771 z am5d$ by subsection   
7a74  #c4 ,po/m>ket report+ requirem5ts 
= ph>maceuticals  7a7 ,9 g5]al ,!       
,secret>y ( ,heal? & ,human ,s]vices1   
act+ ?r\gh ! ,commission] ( ,food &     
,drugs1 %all ensure t ea* hold] ( an    
approv$ application "u section #eje ( ! 
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee7 or "u section #cea 
( ! ,public ,heal? ,s]vice ,act 7#db    
,u4,s4,c4 #bfb7 annually submit1 z "p ( 
! po/m>ket annual report requir$ by !   

,secret>y "u section #cad4ha7;b77#b7 (  
title #ba1 ,code ( ,f$]al ,regulations  
7or any successor regulation71 ! foll[+ 
in=mation3 7#a7 ,! names & addresses ( !
 s\rces ( active & inactive +r$i5ts ( ! 
drug4  7#b7 ,= ea* active & inactive    
+r$i5t ( ! drug1 ! p]c5tage ( !         
aggregate am\nt ( su* +r$i5t us$ 9 !    
manufacture ( ! drug dur+ ! report+     
p]iod t is f ea* ( ! s\rces id5tifi$ "u 
p>agraph 7#a74  7b7 ,disclosure (       
,in=mation ,! ,secret>y ( ,heal? &      
,human ,s]vices %all-- 7#a7 annually    
provide ! in=mation report$ 9 p>agraphs 
7#a7 & 7#b7 ( subsection 7a7 to !       
,secret>y ( ,def5se = purposes ( und]/&+
 ! dep5d5cy on =eign manufactur]s (     
drugs us$ by memb]s ( ! ,arm$ ,=ces2 &  
7#b7 publi% ! in=mation report$ "u su*  
p>agraphs on a publicly available       
int]net website ( ! ,f$]al ,gov]nm5t 9 a
 s+le1 aggregate =m1 )\t disclos+       
propriet>y in=mation4  #d4 ,additional  
risk factors = consid]ation dur+        
inspections ( drug & device e/abli%m5ts 

,section #eaj7;h77#d7 ( ! ,f$]al ,food1 
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cfj7;h77#d77 is am5d$-- 7#a7 by        
r$esignat+ subp>agraph 7,g7 z           
subp>agraph 7,j72 &  7#b7 by ins]t+ aft]
 subp>agraph 7,f7 ! foll[+3  7,g7 ,:e!r 
! e/abli%m5t has be5 inspect$ by an     
entity t c>ries out inspections on      
behalf ( a =eign gov]nm5t det]m9$ to be 
a =eign adv]s>y "u section #g4d ( title 
#ae1 ,code ( ,f$]al ,regulations 7or    
successor regulations74  7,h7 ,!        
p>ticul> drugs or devices 7) a focus on 
drugs & devices includ$ on ! li/ (      
ess5tial m$ic9es pursuant to section    
#c7;c7 ( ,executive ,ord] #acidd 7#he   
,f$4 ,reg4 #diibi77 manufactur$1 prep>$1
 propagat$1 comp\nd$1 or process$ 9 !   
e/abli%m5t1 ) p>ticul> att5tion to !    
numb] ( o!r e/abli%m5ts globally t also 
manufacture1 prep>e1 propagate1 comp\nd1
 or process ! same drug or device f :i* 
! ,unit$ ,/ates s\rces su* drug or      
device4  7,i7 ,:e!r ! e/abli%m5t is     
locat$ 9 a c\ntry ) a hi/ory or #a or m 

previ\s in/ances ( export+ illicit drugs
 or precursor *emicals to ! ,unit$      
,/ates1 z det]m9$ by ! ,secret>y by     
ref]5ce to ! mo/ rec5t report submitt$  
to ,congress pursuant to section #dhi ( 
! ,=eign ,assi/ance ,act ( #aifa4  4