,,ii  #aafth ,,congress  #b;d ,session  
,s4 #ccdc  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,february #bg1 
#bjbj,mr4 ,hawley 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 provide    
enhanced security for the medical supply
 chain4  #a4 ,short title ,this ,act may
 be cited as the ,medical ,supply ,chain
 ,security ,act4  #b4 ,medical supply   
chain security  7a7 ,additional         
manufacturer reporting for essential    
medical devices ,section #ejf;,c of the 
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cef;c7 is amended--
 7#a7 in subsection 7a7-- 7,a7 in the   
matter preceding paragraph 7#a71 by     
inserting or device after a drug2 and   
7,b7 in the flush matter by inserting or
 device after drug each place such term 
appears2  7#b7 in subsection 7c71 by    
inserting and devices after drugs2  7#c7

 in subsection 7g7-- 7,a7 in the matter 
preceding paragraph 7#a71 by striking   
drug shortage of a drug and inserting   
shortage of a drug or device2  7,b7 in  
paragraph 7#a71 by striking 2 or and    
inserting a semicolon2  7,c7 by         
redesignating paragraph 7#b7 as         
paragraph 7#c72  7,d7 by inserting after
 paragraph 7#a7 the following3  7#b7    
expedite the review of a device subject 
to premarket approval under section #eae
 that could help mitigate or prevent    
such shortage2 or  2 and  7,e7 in       
paragraph 7#c71 as so redesignated1 by  
striking drug shortage and inserting    
shortage2  7#d7 in subsection 7h7-- 7,a7
 by amending paragraph 7#b7 to read as  
follows3  7#b7 the term shortage1 with  
respect to a drug or device1 means a    
period of time when the demand or       
projected demand for the drug or device 
within the ,united ,states exceeds the  
supply of the drug or device2 and  2 and
  7,b7 in paragraph 7#c77;,a71 by       
inserting or device after drug2 and     

7#e7 by adding at the end the following3
  7j7 ,additional manufacturer reporting
 for essential drugs and devices ,each  
manufacturer of a drug or device        
described in subsection 7a7 shall       
provide to the ,food and ,drug          
,administration1 on an annual basis1 or 
more frequently at the request of the   
,secretary1 information related to the  
manufacturing capacity of such drug or  
device4 ,such information shall         
include-- 7#a7 details about-- 7,a7 all 
locations of production2  7,b7 the      
sourcing of all component parts2  7,c7  
the sourcing of any active              
pharmaceutical ingredients2 and  7,d7   
the use of any scarce raw materials2 and
  7#b7 any other information determined 
by the ,secretary to be relevant to the 
security of the supply chain of the drug
 or device4  4  7b7 ,provision of       
additional information ,section         
#ejf;,c-#a of the ,federal ,food1 ,drug1
 and ,cosmetic ,act 7#ba ,u4,s4,c4      
#cef;c-#a7 is amended-- 7#a7 in the     

heading1 by striking drug shortages and 
inserting drug or device shortages2     
7#b7 by striking drug shortages each    
place it appears and inserting drug or  
device shortages2  7#c7 in subsection   
7a7-- 7,a7 in paragraph 7#c77;,b7-- 7i7 
in clause 7i71 by striking section      
#ejf;,c7g77#a7 and inserting paragraph  
7#a7 or 7#b7 of section #ejf;,c7g72 and 
7ii7 in clause 7ii71 by striking section
 #ejf;,c7g77#b7 and inserting section   
#ejf;,c7g77#c72 and  7,b7 in paragraph  
7#e71 by striking drug shortage and     
inserting drug or device shortage2 and  
7#d7 in subsection 7c71 by striking drug
 shortage or4