,,ii  #aaf? ,,congress  #a/ ,session    
,s4 #hdd  ,,9 ,,! ,,s5ate ,,( ,,!       
,,unit$ ,,/ates  ,m>* #ad1 #bjai,ms4    
,klobu*> 7= h]self1 ,mr4 ,lee1 ,mr4     
,durb91 & ,mr4 ,grassley7 introduc$ !   
foll[+ bill2 :i* 0 read twice & ref]r$  
to ! ,committee on ,heal?1 ,education1  
,labor1 & ,p5sions  ,a ,,bill  ,to all[ 
= exp$it$ approval ( g5]ic prescription 
drugs & tempor>y importation (          
prescription drugs 9 ! case ( m>g9ally  
competitive drug m>kets & drug %ortages4
  #a4 ,%ort title ,?is ,act may be cit$ 
z ! ,%ort on ,competition ,act4  #b4    
,tempor>y importation ( prescription    
drugs  7a7 ,tempor>y importation        
,section #ejf;,c ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cef;c7 is am5d$-- 7#a7 by r$esignat+   
subsections 7h7 & 7i7 z subsections 7i7 
& 7j71 respectively2 &  7#b7 by ins]t+  
aft] subsection 7g7 ! foll[+3  7h7      
,tempor>y importation au?ority  7#a7 ,9 
g5]al ,if1 bas$ on notifications        
describ$ 9 subsection 7a7 or any o!r    

relevant in=mation1 ! ,secret>y         
concludes t !re is1 or is likely to be1 
a drug %ortage ( a drug describ$ 9      
subsection 7a71 except z provid$ 9      
p>agraph 7#c71 ! ,secret>y %all au?orize
 importation ( su* drug = a p]iod ( up  
to #c ye>s if-- 7,a7 ! drug is a drug   
subject to section #ejc7;b77#a71 includ+
 a comb9ation product ^: prim>y mode (  
action is t ( a drug z det]m9$ "u       
section #ejc7;g77#a77;,d77i71 o!r ?an a 
drug describ$ 9 subp>agraphs 7,a7 ?r\gh 
7,f7 ( section #hjd7;a77#c72  7,b7 !    
drug is au?oriz$ to be lawfully m>ket$ 9
 "o or m ( ! c\ntries includ$ 9 ! li/ "u
 section #hjb7;b77#a72  7,c7 ! import$  
drug has ! same active +r$i5t z ! drug =
 :i* !re is a %ortage ) respect to      
manufactur]s 9 ! ,unit$ ,/ates2  7,d7 ! 
manufactur] c]tifies to ! ,secret>y t x 
int5ds to seek approval ( ! drug "u     
section #eje7;j72 &  7,e7 an import] 7z 
def9$ 9 section #hjd7;a77 files ) !     
,secret>y in=mation-- 7i7 atte/+ t !    
requirem5ts "u subp>agraphs 7,a7 ?r\gh  

7,d7 are satisfi$2  7ii7 id5tify+ ! drug
 ! import] proposes to import & !       
manufactur] f :om ! import] proposes to 
import su* drug2 &  7iii7 reque/+       
au?ority to import ! drug4  7#b7 ,beg9n+
 date ( importation ,except z provid$ 9 
p>agraph 7#c71 if all ( ! conditions "u 
p>agraph 7#a7 are met1 ! ,secret>y %all 
au?orize importation ( a drug 9         
accordance ) su* p>agraph beg9n+ n lat] 
?an #fj days aft] receipt ( ! in=mation 
"u p>agraph 7#a77;,e74  7#c7            
,discretion>y d5ial ( importation ,!    
,secret>y may d5y importation ( a drug  
o!rwise qualifi$ = importation "u       
p>agraph 7#a7 if ! ,secret>y det]m9es   
t-- 7,a7 ! drug is n safe & effective2  
7,b7 ! drug is us$ 9 conjunction ) a    
device = :i* !re is no reasonable       
assurance ( safety & effectiv5ess2 or   
7,c7 ! au?orization to m>ket ! drug 9 "o
 or m ( ! c\ntries includ$ 9 ! li/ "u   
section #hjb7;b77#a7 has be5 resc9d$ or 
)drawn because ( any conc]n relat+ to ! 
safety or effectiv5ess ( ! drug4  7#d7  

,t]m9ation ( au?ority ,! au?ority to    
import a drug pursuant to p>agraph 7#a7 
%all t]m9ate aft] #c ye>s1 or :5 ! drug 
%ortage no long] applies1 :i*ev] occurs 
fir/4  4  7b7 ,m>g9ally competitive drug
 m>kets ,*apt] ,v ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cea et seq47 is am5d$ by ins]t+ aft]   
section #ejf;,c-#a ! foll[+3            
#ejf;,c-#b4 ,m>g9ally competitive drug  
m>kets  7a7 ,9 g5]al ,if ! ,secret>y    
det]m9es "u subsection 7b7 t a m>g9ally 
competitive m>ket exi/s ) respect to an 
applicable drug1 ! ,secret>y-- 7#a7 %all
 treat su* m>g9ally competitive m>ket z 
creat+ a drug %ortage only = purposes ( 
subsections 7g7 & 7h7 ( section #ejf;,c2
 &  7#b7 7,a7 may exp$ite ! review (    
applications & inspections ) respect to 
! drug 9 accordance ) section           
#ejf;,c7g72 &  7,b7 %all au?orize       
importation ( ! drug 9 accordance )     
section #ejf;,c7h74  7b7 ,det]m9ation ( 
m>g9ally competitive m>ket  7#a7 ,9     
g5]al ,! ,secret>y %all det]m9e t a     

m>g9ally competitive m>ket exi/s )      
respect to an applicable drug if-- 7,a7 
= at lea/ #b consecutive mon?s prior to 
! det]m9ation1 few] ?an #e drugs approv$
 "u section #eje7;c7 7ref]r$ to 9 ?is   
p>agraph z ! #8applicable li/$ drug'7 or
 "u section #eje7;j7 t ref]5ce !        
applicable li/$ drug 7 comm]cially      
available 9 ! ,unit$ ,/ates2  7,b7 !    
applicable li/$ drug 0 approv$ at lea/  
#aj ye>s be=e su* det]m9ation2 &  7,c7  
ea* pat5t :i* claims an active +r$i5t ( 
! applicable li/$ drug has expir$4  7#b7
 ,comm]cially available  7,a7 ,9 g5]al  
,= purposes ( p>agraph 7#a77;,a71 a drug
 is n comm]cially available 9 ! ,unit$  
,/ates if-- 7i7 ! hold] ( an application
 approv$ "u subsection 7c7 or 7j7 (     
section #eje has publicly ann\nc$ t x   
has discont9u$ ! manufactur+ ( ! drug2  
7ii7 a drug approv$ "u subsection 7c7 or
 7j7 ( section #eje has be5 )drawn or   
discont9u$2 or  7iii7 ! ,secret>y has   
any o!r reasonable basis to conclude t a
 drug approv$ "u subsection 7c7 or 7j7 (

 section #eje is n competitively        
relevant4  7,b7 ,hold] ( approv$        
application ,9 det]m9+ :e!r #e drugs are
 comm]cially available "u p>agraph      
7#a77;,a71 9 ! case ( a s+le p]son :o is
 ! hold] ( m ?an "o application approv$ 
z describ$ 9 p>agraph 7#a77;,a7 )       
respect to an applicable drug1 only "o  
su* drug %all be consid]$ to be         
comm]cially available4  7c7 ,applicable 
drug ,9 ?is section1 ! t]m applicable   
drug means a drug t is n a radio        
ph>maceutical drug product or any o!r   
product z designat$ by ! ,secret>y4  4  
7c7 ,annual report+ on drug %ortages    
,section #ejf;,c-#a7;a77#c77;,b7 ( !    
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cef;c-#a7;a77#c77;,b77  
is am5d$-- 7#a7 9 clause 7i71 by /rik+ 2
 & & ins]t+ 22  7#b7 9 clause 7ii71 by  
add+ & aft] ! semicolon2 &  7#c7 by     
ins]t+ aft] clause 7ii7 ! foll[+3  7iii7
 ! numb] ( drugs au?oriz$ = tempor>y    
importation "u section #ejf;,c7h72  4