,,ii  #aagth ,,congress  #b;d ,session  
,s4 #cdic  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,january #ab   
7legislative day1 ,january #aj71        
#bjbb,mr4 ,cardin 7for himself and ,ms4 
,collins7 introduced the following bill2
 which was read twice and referred to   
the ,committee on ,health1 ,education1  
,labor1 and ,pensions  ,a ,,bill  ,to   
require guidance on extending expiration
 dates for certain drugs1 and for other 
purposes4  #a4 ,short title ,this ,act  
may be cited as the ,drug ,shortages    
,shelf ,life ,extension ,act4  #b4      
,extending expiration dates for certain 
drugs  7a7 ,in general ,not later than  
#ahj days after the date of enactment of
 this ,act1 the ,secretary of ,health   
and ,human ,services 7referred to in    
this section as the ,secretary7 shall   
issue draft guidance1 or revise existing
 guidance1 to address recommendations   
for sponsors of applications under      
section #eje of the ,federal ,food1     
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4

 #cee7 or section #cea of the ,public   
,health ,service ,act 7#db ,u4,s4,c4    
#bfb7 regarding-- 7#a7 the submission of
 stability testing data in such         
applications2 and  7#b7 establishing in 
the labeling of drugs the longest       
feasible expiration date supported by   
such data1 taking into consideration how
 extended expiration dates may help     
prevent or mitigate drug shortages4  7b7
 ,report ,not later than #b years after 
the date of enactment of this ,act1 and 
again #b years thereafter1 the          
,secretary shall submit to the          
,committee on ,health1 ,education1      
,labor1 and ,pensions of the ,senate and
 the ,committee on ,energy and ,commerce
 of the ,house of ,representatives a    
report that includes-- 7#a7 the number  
of drugs for which the ,secretary has   
requested the manufacturer make a       
labeling change regarding the expiration
 date2 and  7#b7 for each drug for which
 the ,secretary has requested a labeling
 change with respect to the expiration  

date1 information regarding the         
circumstances of such request1          
including-- 7,a7 the name and dose of   
such drug2  7,b7 the rationale for the  
request2  7,c7 whether the drug1 at the 
time of the request1 was listed on the  
drug shortage list under section #ejf;,e
 of the ,federal ,food1 ,drug1 and      
,cosmetic ,act 7#ba ,u4,s4,c4 #cef;e71  
or was at risk of shortage2  7,d7       
whether the request was made during a   
public health emergency declared under  
section #cai of the ,public ,health     
,service ,act 7#db ,u4,s4,c4 #bdg;d72   
and  7,e7 whether the manufacturer made 
the requested change by the requested   
date1 and for instances where the       
manufacturer does not make the requested
 change1 the manufacturer's             
justification for not making the change1
 if the manufacturer agrees to provide  
such justification for inclusion in the 
report4