,,ii  #aaith ,,congress  #ast ,session  
,s4 #aghd  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,may #ae1 #bjbe
 ,mr4 ,peters 7for himself1 ,mr4        
,lankford1 ,ms4 ,ernst1 ,mr4 ,cotton1   
,mr4 ,kaine1 ,mr4 ,king1 and ,mr4 ,scott
 of ,florida7 introduced the following  
bill2 which was read twice and referred 
to the ,committee on ,health1           
,education1 ,labor1 and ,pensions  ,a   
,,bill  ,to improve coordination of     
,federal efforts to identify and        
mitigate health and national security   
risks through maintaining a list of     
essential medicines1 conducting a risk  
assessment of essential medicine supply 
chains1 and creating a monitoring system
 to map essential medicine supply chains
 using data analytics4  #a4  ,short     
title  ,this ,act may be cited as the   
,mapping ,america's ,pharmaceutical     
,supply ,act or the ,,maps ,act4  #b4   
,essential ,medicines ,list  7a7  ,in   
general  ,the ,secretary1 in            
coordination with the heads of other    

relevant ,federal departments and       
agencies and in consultation with1 as   
appropriate1 stakeholders who have      
relevant expertise1 shall update and    
maintain a list of essential medicines  
7referred to in this ,act as the        
,essential ,medicines ,list71 initially 
developed in response to ,executive     
,order #acidd 7#he ,fed4 ,reg4 #diibi71 
to include active pharmaceutical        
ingredients and drugs--  7#a7 that are  
directly related to responding to       
chemical1 biological1 radiological1 or  
nuclear threats and incidents covered by
 the ,national ,response ,framework2    
7#b7 of greatest priority for providing 
health care and identified as being at  
high risk of shortage2  7#c7 the        
shortage of which would have an adverse 
health outcome on patients with chronic 
conditions2 or  7#d7 that the ,secretary
 of ,defense determines to be critical  
for military preparedness4  7b7         
,updates to list  ,the ,secretary shall 
update the ,essential ,medicines ,list  

regularly1 on a timeframe that the      
,secretary determines necessary and     
appropriate1 and not less frequently    
than every #b years4  7c7  ,compilation 
of initial list  ,the ,secretary shall  
complete the first updates to the       
,essential ,medicines ,list required    
pursuant to subsection 7a7 not later    
than #ahj days after the date of        
enactment of this ,act4  7d7            
,publication of list  ,the ,secretary   
shall publish the ,essential ,medicines 
,list promptly after each update        
pursuant to subsection 7b7 or 7c74  #c4 
,essential medicines risk assessment    
7a7  ,in general  ,the ,secretary1 in   
coordination with the ,secretary of     
,defense and in consultation with the   
heads of other relevant departments and 
agencies1 shall conduct a comprehensive 
risk assessment of the supply chains for
 active pharmaceutical ingredients and  
drugs included on the ,essential        
,medicines ,list described in section   
#b4  7b7  ,contents of essential        

medicines risk assessment  ,at a        
minimum1 the risk assessment under      
subsection 7a7 shall identify1 to the   
extent available--  7#a7 key starting   
materials and excipients used in        
manufacturing the active pharmaceutical 
ingredients and drugs on the ,essential 
,medicines ,list2  7#b7 the active      
pharmaceutical ingredients and drugs on 
the ,essential ,medicines ,list that    
rely on a high-risk foreign supplier or 
foreign entity of concern 7as defined in
 section #iija7h7 of the ,william ,m4   
7,mac7 ,thornberry ,national            
,authorization ,act for ,fiscal ,year   
#bjba 7#ae ,u4,s4,c4 #dfea7h777 for more
 than #ej percent of production2  7#c7  
the active pharmaceutical ingredients   
and drugs on the ,essential ,medicines  
,list that are sourced exclusively or   
primarily from foreign establishments1  
including drugs manufactured            
domestically from active pharmaceutical 
ingredients sourced exclusively or      
primarily from foreign establishments2  

7#d7 current domestic manufacturing     
capabilities for active pharmaceutical  
ingredients and drugs on the ,essential 
,medicines ,list1 including the key     
starting materials and excipients of    
such ingredients and drugs1 and any     
cost-effective manufacturing            
technologies1 including advanced        
manufacturing2  7#e7 public health and  
national security risks1 including      
cybersecurity threats and critical      
infrastructure designations specific to 
the supply chains of active             
pharmaceutical ingredients and drugs    
included on the ,essential ,medicines   
,list2  7#f7 any deficiencies1 lack of  
authorities1 or limitations in policy or
 process that reduce the ability of the 
,federal ,government to address any     
identified public health or national    
security risks related to supply chains 
for active pharmaceutical ingredients   
and drugs included on the ,essential    
,medicines ,list2 and  7#g7 how the     
,federal ,government will mitigate such 

national security risks1 including      
through the use of authorities under the
 ,defense ,production ,act of #aiej 7#ej
 ,u4,s4,c4 #deja et seq474  7c7  ,report
 on assessment  7#a7  ,submission of    
report  ,not later than #ahj days after 
the date of enactment of this ,act1 and 
annually thereafter1 the ,secretary1 in 
consultation with the heads of relevant 
,federal departments and agencies       
consulted under subsection 7a71 shall   
submit a report with the findings under 
subsection 7b7 to--  7,a7 the ,committee
 on ,armed ,services1 the ,committee on 
,health1 ,education1 ,labor1 and        
,pensions1 and the ,committee on        
,homeland ,security and ,governmental   
,affairs of the ,senate2  7,b7 the      
,committee on ,armed ,services1 the     
,committee on ,energy and ,commerce1 and
 the ,committee on ,homeland ,security  
of the ,house of ,representatives2 and  
7,c7 the ,office of the ,director of    
,national ,intelligence4  7#b7          
,publication of report ,not later than  

#a year after the date of enactment of  
this ,act1 the ,secretary1 in           
consultation with the heads of relevant 
,federal departments and agencies       
consulted under subsection 7a71 shall   
release a public version of the report  
submitted under paragraph 7#a74  #d4    
,u4,s4 pharmaceutical supply chains     
mapping  7a7  ,pharmaceutical supply    
chain mapping  ,the ,secretary of       
,health and ,human ,services 7referred  
to in this section as the ,secretary71  
in coordination with the heads of other 
relevant ,federal departments and       
agencies1 shall ensure coordination of  
efforts of the ,department of ,health   
and ,human ,services1 including through 
public-private partnerships1 to--  7#a7 
map1 or otherwise visualize1 the supply 
chains1 from manufacturing of key       
starting materials through manufacturing
 of finished dosage forms and           
distribution1 of drugs 7as defined in   
section #bja of the ,federal ,food1     
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4

 #cba77 included on the ,essential      
,medicines ,list under section #b2 and  
7#b7 use data analytics to identify     
supply chain vulnerabilities that pose a
 threat to national security1 as        
determined by the ,secretary or the     
heads of other relevant ,federal        
departments and agencies4  7b7          
,requirements  ,in carrying out         
subsection 7a71 the ,secretary shall--  
7#a7 describe the roles and             
responsibilities of agencies and offices
 within the ,department of ,health and  
,human ,services related to monitoring  
such supply chains and assessing any    
related vulnerabilities2 and  7#b7      
facilitate the exchange of information  
between ,federal departments1 agencies1 
and offices1 as appropriate and         
necessary to enable such agencies and   
offices to carry out roles and          
responsibilities described in paragraph 
7#a7 related to drugs described in      
subsection 7a77#a71 which may include-- 
7,a7 the location of establishments     

registered under subsection 7b71 7c71 or
 7i7 of section #eaj of the ,federal    
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cfj7 involved in the         
production of active pharmaceutical     
ingredients and finished dosage forms of
 drugs described in subsection 7a77#a71 
and the amount of such ingredients and  
finished dosage forms produced at each  
such establishment2  7,b7 to the extent 
available and as appropriate1 the       
location of establishments so registered
 involved in the production of the key  
starting materials and excipients needed
 to produce the active pharmaceutical   
ingredients and finished dosage forms1  
and the amount of such materials and    
excipients produced at each such        
establishment2 and  7,c7 any regulatory 
actions with respect to such drugs or   
the establishments manufacturing such   
drugs1 including with respect to        
inspections and related regulatory      
activities conducted under section #gjd 
of such ,act 7#ba ,u4,s4,c4 #cgd71 the  

seizure of such a drug pursuant to      
section #cjd of such ,act 7#ba ,u4,s4,c4
 #ccd71 any recalls of such a drug2     
inclusion of such a drug on the drug    
shortage list under section #ejf;,e of  
such ,act 7#ba ,u4,s4,c4 #cef;e71 or    
prior drug shortages reports of a       
discontinuance or interruption in the   
production of such a drug under #ejf;,c 
of such ,act 7#ba ,u4,s4,c4 #cee;d74    
7c7  ,report  ,not later than #ah months
 after the date of enactment of this    
,act1 and annually thereafter1 the      
,secretary1 in consultation with the    
heads of agencies with which the        
,secretary coordinates under subsection 
7a71 shall submit a report to the       
relevant committees of ,congress on--   
7#a7 the current status of efforts to   
map and analyze pharmaceutical supply   
chains1 as described in subsection 7a72 
7#b7 activities of the ,secretary       
carried out under this section to       
coordinate efforts as described in      
subsection 7a71 including information   

sharing between relevant ,federal       
departments1 agencies1 and offices2     
7#c7 the roles and responsibilities     
described in subsection 7b77#a71        
including the identification of any     
gaps1 data limitations1 or areas of     
unnecessary duplication between such    
roles and responsibilities2  7#d7 the   
extent to which ,federal agencies use   
data analytics to conduct predictive    
modeling of anticipated drug shortages  
or risks associated with supply chain   
vulnerabilities that pose a threat to   
national security2 and  7#e7 the extent 
to which the ,secretary has engaged     
relevant industry in such mapping4  #e4 
,department of ,defense biannual reports
  ,not later than #ahj days after the   
date of enactment of this ,act1 and     
every #ahj days thereafter1 the         
,secretary of ,defense shall submit to  
the congressional committees described  
in subparagraphs 7,a7 and 7,b7 of       
section #c7;c77#a7 a report that lists  
all drugs purchased by the ,department  

of ,defense during the #ahj-;day period 
preceding the date of the report--  7#a7
 that contain key starting materials1   
excipients1 or active pharmaceutical    
ingredients sourced from the ,people's  
,republic of ,china2 or  7#b7 for which 
the finished drug product was           
manufactured in the ,people's ,republic 
of ,china4  #f4  ,definitions  ,in this 
,act3 7#a7 ,advanced manufacturing ,the 
term advanced manufacturing has the     
meaning given the term advanced and     
continuous pharmaceutical manufacturing 
in section #cjaf7;h7 of the #bast       
,century ,cures ,act 7#ba ,u4,s4,c4     
#cii;h7h774  7#b7  ,cybersecurity threat
  ,the term cybersecurity threat has the
 meaning given such term in section     
#bbjj of the ,homeland ,security ,act of
 #bjjb 7#f ,u4,s4,c4 #fej74  7#c7  ,drug
  ,the term drug has the meaning given  
such term in section #bja7;g7 of the    
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cba7;g774  7#d7    
,secretary  ,the term ,secretary1 except

 as otherwise specified1 means the      
,secretary of ,health and ,human        
,services4  #g4  ,additional provisions 
7a7  ,clarification  ,the participation 
of the ,secretary in developing and     
updating the list of essential medicines
 under section #b shall be deemed to be 
full satisfaction of the requirements   
applicable to such secretary under      
section #c of ,executive ,order #acidd  
7#he ,fed4 ,reg4 #diibi74  7b7          
,confidential commercial information    
,the exchange of information among the  
,secretary and the heads of other       
relevant ,federal departments and       
agencies for purposes of carrying out   
sections #c and #d shall not be a       
violation of section #aije of title #ah1
 ,united ,states ,code4 ,this section   
shall not be construed to affect the    
status1 if any1 of such information as  
trade secret or confidential commercial 
information for purposes of section     
#cja7;j7 of the ,federal ,food1 ,drug1  
and ,cosmetic ,act 7#ba ,u4,s4,c4       

#cca7;j771 section #eeb of title #e1    
,united ,states ,code1 or section #aije 
of title #ah1 ,united ,states ,code4    
7c7  ,cybersecurity measures  ,the      
,secretary shall ensure that robust     
cybersecurity measures are in place to  
prevent inappropriate access to1 or     
unauthorized disclosure of1 the         
information identified1 exchanged1 or   
disclosed under sections #c and #d4