,,ii  #aag? ,,congress  #b;d ,session   
,s4 #cdic  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,janu>y #ab            
7legislative day1 ,janu>y #aj71         
#bjbb,mr4 ,c>d9 7= himself & ,ms4       
,coll9s7 introduc$ ! foll[+ bill2 :i* 0 
read twice & ref]r$ to ! ,committee on  
,heal?1 ,education1 ,labor1 & ,p5sions  
,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 #ahj days 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 "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*   
applications2 &  7#b7 e/abli%+ 9 !      
label+ ( drugs ! longe/ feasible        
expiration date support$ by su* data1   
tak+ into consid]ation h[ ext5d$        
expiration dates may help prev5t or     
mitigate drug %ortages4  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