,i  #aag? ,,congress  #b;d ,session  ,h4
 ,r4 #gffi  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,may #f1 #bjbb,ms4    
,matsui introduc$ ! foll[+ bill2 :i* 0  
ref]r$ to ! ,committee on ,en]gy &      
,comm]ce  ,a ,,bill  ,to require        
guidance on ext5d+ expiration dates =   
c]ta9 drugs1 & = o!r purposes4  #a4     
,%ort title ,?is ,act may be cit$ z !   
,drug ,%ortages ,%elf ,life ,ext5sion   
,act4  #b4 ,ext5d+ expiration dates =   
c]ta9 drugs  7a7 ,9 g5]al ,n lat] ?an #a
 ye> aft] ! date ( enactm5t ( ?is ,act1 
! ,secret>y ( ,heal? & ,human ,s]vices  
7ref]r$ to 9 ?is section z ! ,secret>y7 
%all issue draft guidance1 or revise    
exi/+ guidance1 to address              
recomm5dations = sponsors ( applications
 submitt$ "u section #eje ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7 or section #cea ( !     
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb7 reg>d+--  7#a7 !        
submission ( /ability te/+ data 9 su*   
applications1 includ+ consid]ations =   

data requirem5ts t c\ld be /reaml9$ or  
r$uc$ to facilitate fa/] review ( long] 
propos$ expiration dates2  7#b7 e/abli%+
 9 ! label+ ( drugs ! longe/ feasible   
expiration date sci5tifically support$  
by su* data1 tak+ into consid]ation h[  
ext5d$ expiration dates may--  7,a7 help
 prev5t or mitigate drug %ortages2 &    
7,b7 affect product quality2 &  7#c7 !  
use ( innovative approa*es = drug &     
comb9ation product /ability model+ to   
support initial product expiration dates
 & expiration date ext5sions4  7b7      
,report ,n lat] ?an #b ye>s aft] ! date 
( enactm5t ( ?is ,act1 & aga9 #b ye>s   
!reaft]1 ! ,secret>y %all submit to !   
,committee on ,heal?1 ,education1       
,labor1 & ,p5sions ( ! ,s5ate & !       
,committee on ,en]gy & ,comm]ce ( !     
,h\se ( ,repres5tatives a report t      
includes--  7#a7 ! numb] ( drugs = :i* !
 ,secret>y has reque/$ ! manufactur]    
make a label+ *ange reg>d+ ! expiration 
date2 &  7#b7 = ea* drug = :i* !        
,secret>y has reque/$ a label+ *ange )  

respect to ! expiration date1 in=mation 
reg>d+ ! circum/ances ( su* reque/1     
includ+--  7,a7 ! "n & dose ( su* drug2 
7,b7 ! rationale = ! reque/2  7,c7 :e!r 
! drug1 at ! "t ( ! reque/1 0 li/$ on ! 
drug %ortage li/ "u section #ejf;,e ( ! 
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cef;e71 or 0 at risk (  
%ortage2  7,d7 :e!r ! reque/ 0 made dur+
 a public heal? em]g5cy decl>$ "u       
section #cai ( ! ,public ,heal? ,s]vice 
,act 7#db ,u4,s4,c4 #bdg;d72 &  7,e7    
:e!r ! manufactur] made ! reque/$ *ange 
by ! reque/$ date1 & = in/ances :]e !   
manufactur] does n make ! reque/$ *ange1
 ! manufactur]'s ju/ification = n mak+ !
 *ange1 if ! manufactur] agrees to      
provide su* ju/ification = inclusion 9 !
 report4