,,ii  #aahth ,,congress  #b;d ,session  
,s4 #ecfh  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,november #ba1 
#bjbd,mr4 ,kaine 7for himself and ,mr4  
,cotton7 introduced the following bill2 
which was read twice and referred to the
 ,committee on ,health1 ,education1     
,labor1 and ,pensions  ,a ,,bill  ,to   
amend the ,federal ,food1 ,drug1 and    
,cosmetic ,act to expand drug shortage  
notification practices to include surges
 in demand for a drug1 and for other    
purposes4  #a4 ,short title ,this ,act  
may be cited as the ,end ,drug          
,shortages ,act4  #b4 ,drug shortage    
notification practices ,section #ejf;,c 
of the ,federal ,food1 ,drug1 and       
,cosmetic ,act 7#ba ,u4,s4,c4 #cef;c7 is
 amended-- 7#a7 in the section heading1 
by inserting or surge in demand for     
after production of2  7#b7 in subsection
 7a71 in the matter following paragraph 
7#b7-- 7,a7 by striking or an           
interruption of the manufacture of the  
drug and inserting 1 an interruption of 

the manufacture of the drug1 or a surge 
in demand for the drug2  7,b7 by        
striking such discontinuance or         
interruption and inserting such         
discontinuance1 interruption1 or surge  
in demand2  7,c7 by striking the        
discontinuation or interruption and     
inserting the discontinuation1          
interruption1 or surge in demand2 and   
7,d7 by striking such discontinuation or
 interruption2 the expected duration of 
the interruption2 and inserting such    
discontinuation1 interruption1 or surge 
in demand2 the expected duration of the 
interruption or surge in demand2  7#c7  
in subsection 7b71 by striking          
paragraphs 7#a7 and 7#b7 and inserting  
the following3  7#a7 in the case of a   
notice of a discontinuance or           
interruption in the manufacture of a    
drug-- 7,a7 at least #f months prior to 
the date of the discontinuance or       
interruption2 or  7,b7 if compliance    
with subparagraph 7,a7 is not possible1 
as soon as practicable2 or  7#b7 in the 

case of a notice of a surge in demand   
for a drug1 as soon as practicable4  2  
7#d7 in subsection 7c7-- 7,a7 by        
striking discontinuance or interruption 
and inserting discontinuance1           
interruption1 or surge in demand2 and   
7,b7 by inserting and outsourcing       
facilities 7as defined in section       
#ejc;,b7d77 after patient organizations2
 and  7#e7 in subsection 7h7-- 7,a7 in  
paragraph 7#a71 by striking and that is 
subject to section #ejc7;b77#a7 and     
inserting or the active pharmaceutical  
ingredient of such a drug2  7,b7 by     
amending paragraph 7#b71 to read as     
follows3  7#b7 the term drug shortage or
 shortage1 with respect to a drug1 means
 a period of time with the demand or    
projected demand for the drug within the
 ,united ,states exceeds the supply of  
the drug1 taking into consideration--   
7,a7 how the drug is prepared or        
dispensed1 including the route of       
administration and dosage form2 and     
7,b7 information reported by            

manufacturers1 health care              
professionals1 and patients2  2  7,c7 in
 paragraph 7#c77;,b71 by striking the   
period and inserting 2 and2 and  7,d7 by
 adding at the end the following3  7#d7 
the term surge means an increase in     
demand or projected demand for a drug   
that the manufacturer likely will be    
unable to meet without meaningful       
shortfall or delay4  4  #c4 ,outsourcing
 facility compounding ,section #ejc;,b  
of the ,federal ,food1 ,drug1 and       
,cosmetic ,act 7#ba ,u4,s4,c4 #cec;b7 is
 amended-- 7#a7 by redesignating the #b 
subsections 7d7 7relating to definitions
 and relating to obligation to pay fees7
 as subsections 7e7 and 7f71            
respectively2 and  7#b7 by inserting    
after subsection 7c7 the following3  7d7
 ,list of identified bulk drug          
substances ,the ,secretary shall make   
publicly available annual updates on the
 evaluation of bulk drug substances for 
purposes of the list maintained under   
subsection 7a77#b77;,a77i74  4  #d4     

,hospital and health system compounding 
,not later than #a year after the date  
of enactment of this ,act1 the          
,secretary of ,health and ,human        
,services shall finalize the draft      
guidance entitled ,hospital and ,health 
,system ,compounding ,under ,section    
#ejc;,a of the ,federal ,food1 ,drug1   
and ,cosmetic ,act3 ,guidance for       
,industry issued in ,october #bjba1 and 
ensure that such guidance is consistent 
with the most current research and best 
clinical practices for pharmacy         
compounding relating to implementing    
section #ejc;,a of the ,federal ,food1  
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cec;a74