,,ii  #aai? ,,congress  #a/ ,session    
,s4 #aghd  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,may #ae1 #bjbe ,mr4   
,pet]s 7= himself1 ,mr4 ,lank=d1 ,ms4   
,ern/1 ,mr4 ,cotton1 ,mr4 ,ka9e1 ,mr4   
,k+1 & ,mr4 ,scott ( ,florida7 introduc$
 ! foll[+ bill2 :i* 0 read twice &      
ref]r$ to ! ,committee on ,heal?1       
,education1 ,labor1 & ,p5sions  ,a      
,,bill  ,to improve coord9ation ( ,f$]al
 ef=ts to id5tify & mitigate heal? &    
national security risks ?r\gh ma9ta9+ a 
li/ ( ess5tial m$ic9es1 conduct+ a risk 
assessm5t ( ess5tial m$ic9e supply *a9s1
 & creat+ a monitor+ sy/em to map       
ess5tial m$ic9e supply *a9s us+ data    
analytics4  #a4  ,%ort title  ,?is ,act 
may be cit$ z ! ,mapp+ ,am]ica's        
,ph>maceutical ,supply ,act or ! ,,maps 
,act4  #b4  ,ess5tial ,m$ic9es ,li/  7a7
  ,9 g5]al  ,! ,secret>y1 9 coord9ation 
) ! heads ( o!r relevant ,f$]al         
dep>tm5ts & ag5cies & 9 consultation )1 
z appropriate1 /akehold]s :o h relevant 
exp]tise1 %all update & ma9ta9 a li/ (  

ess5tial m$ic9es 7ref]r$ to 9 ?is ,act z
 ! ,ess5tial ,m$ic9es ,li/71 initially  
develop$ 9 response to ,executive ,ord] 
#acidd 7#he ,f$4 ,reg4 #diibi71 to      
include active ph>maceutical +r$i5ts &  
drugs--  7#a7 t are directly relat$ to  
respond+ to *emical1 biological1        
radiological1 or nucle> ?reats &        
incid5ts cov]$ by ! ,national ,response 
,framework2  7#b7 ( greate/ priority =  
provid+ heal? c>e & id5tifi$ z be+ at   
high risk ( %ortage2  7#c7 ! %ortage (  
:i* w\ld h an adv]se heal? outcome on   
pati5ts ) *ronic conditions2 or  7#d7 t 
! ,secret>y ( ,def5se det]m9es to be    
critical = milit>y prep>$ness4  7b7     
,updates to li/  ,! ,secret>y %all      
update ! ,ess5tial ,m$ic9es ,li/        
regul>ly1 on a timeframe t ! ,secret>y  
det]m9es necess>y & appropriate1 & n    
less frequ5tly ?an e #b ye>s4  7c7      
,compilation ( initial li/  ,! ,secret>y
 %all complete ! fir/ updates to !      
,ess5tial ,m$ic9es ,li/ requir$ pursuant
 to subsection 7a7 n lat] ?an #ahj days 

aft] ! date ( enactm5t ( ?is ,act4  7d7 
,publication ( li/  ,! ,secret>y %all   
publi% ! ,ess5tial ,m$ic9es ,li/        
promptly aft] ea* update pursuant to    
subsection 7b7 or 7c74  #c4  ,ess5tial  
m$ic9es risk assessm5t  7a7  ,9 g5]al   
,! ,secret>y1 9 coord9ation ) !         
,secret>y ( ,def5se & 9 consultation ) !
 heads ( o!r relevant dep>tm5ts &       
ag5cies1 %all conduct a compreh5sive    
risk assessm5t ( ! supply *a9s = active 
ph>maceutical +r$i5ts & drugs includ$ on
 ! ,ess5tial ,m$ic9es ,li/ describ$ 9   
section #b4  7b7  ,cont5ts ( ess5tial   
m$ic9es risk assessm5t  ,at a m9imum1 ! 
risk assessm5t "u subsection 7a7 %all   
id5tify1 to ! ext5t available--  7#a7   
key />t+ mat]ials & excipi5ts us$ 9     
manufactur+ ! active ph>maceutical      
+r$i5ts & drugs on ! ,ess5tial ,m$ic9es 
,li/2  7#b7 ! active ph>maceutical      
+r$i5ts & drugs on ! ,ess5tial ,m$ic9es 
,li/ t rely on a high-risk =eign suppli]
 or =eign entity ( conc]n 7z def9$ 9    
section #iija7h7 ( ! ,william ,m4 7,mac7

 ,?ornb]ry ,national ,au?orization ,act 
= ,fiscal ,ye> #bjba 7#ae ,u4,s4,c4     
#dfea7h777 = m ?an #ej p]c5t (          
production2  7#c7 ! active ph>maceutical
 +r$i5ts & drugs on ! ,ess5tial ,m$ic9es
 ,li/ t are s\rc$ exclusively or        
prim>ily f =eign e/abli%m5ts1 includ+   
drugs manufactur$ dome/ically f active  
ph>maceutical +r$i5ts s\rc$ exclusively 
or prim>ily f =eign e/abli%m5ts2  7#d7  
curr5t dome/ic manufactur+ capabilities 
= active ph>maceutical +r$i5ts & drugs  
on ! ,ess5tial ,m$ic9es ,li/1 includ+ ! 
key />t+ mat]ials & excipi5ts ( su*     
+r$i5ts & drugs1 & any co/-effective    
manufactur+ te*nologies1 includ+ advanc$
 manufactur+2  7#e7 public heal? &      
national security risks1 includ+        
cyb]security ?reats & critical          
infra/ructure designations specific to !
 supply *a9s ( active ph>maceutical     
+r$i5ts & drugs includ$ on ! ,ess5tial  
,m$ic9es ,li/2  7#f7 any defici5cies1   
lack ( au?orities1 or limitations 9     
policy or process t r$uce ! ability ( ! 

,f$]al ,gov]nm5t to address any id5tifi$
 public heal? or national security risks
 relat$ to supply *a9s = active         
ph>maceutical +r$i5ts & drugs includ$ on
 ! ,ess5tial ,m$ic9es ,li/2 &  7#g7 h[ !
 ,f$]al ,gov]nm5t w mitigate su*        
national security risks1 includ+ ?r\gh !
 use ( au?orities "u ! ,def5se          
,production ,act ( #aiej 7#ej ,u4,s4,c4 
#deja et seq474  7c7  ,report on        
assessm5t  7#a7  ,submission ( report   
,n lat] ?an #ahj days aft] ! date (     
enactm5t ( ?is ,act1 & annually !reaft]1
 ! ,secret>y1 9 consultation ) ! heads (
 relevant ,f$]al dep>tm5ts & ag5cies    
consult$ "u subsection 7a71 %all submit 
a report ) ! f9d+s "u subsection 7b7    
to--  7,a7 ! ,committee on ,arm$        
,s]vices1 ! ,committee on ,heal?1       
,education1 ,labor1 & ,p5sions1 & !     
,committee on ,homel& ,security &       
,gov]nm5tal ,affairs ( ! ,s5ate2  7,b7 !
 ,committee on ,arm$ ,s]vices1 !        
,committee on ,en]gy & ,comm]ce1 & !    
,committee on ,homel& ,security ( !     

,h\se ( ,repres5tatives2 &  7,c7 !      
,(fice ( ! ,director ( ,national        
,intellig5ce4  7#b7 ,publication (      
report ,n lat] ?an #a ye> aft] ! date ( 
enactm5t ( ?is ,act1 ! ,secret>y1 9     
consultation ) ! heads ( relevant ,f$]al
 dep>tm5ts & ag5cies consult$ "u        
subsection 7a71 %all release a public   
v]sion ( ! report submitt$ "u p>agraph  
7#a74  #d4  ,u4,s4 ph>maceutical supply 
*a9s mapp+  7a7  ,ph>maceutical supply  
*a9 mapp+  ,! ,secret>y ( ,heal? &      
,human ,s]vices 7ref]r$ to 9 ?is section
 z ! ,secret>y71 9 coord9ation ) ! heads
 ( o!r relevant ,f$]al dep>tm5ts &      
ag5cies1 %all ensure coord9ation ( ef=ts
 ( ! ,dep>tm5t ( ,heal? & ,human        
,s]vices1 includ+ ?r\gh public-private  
p>tn]%ips1 to--  7#a7 map1 or o!rwise   
visualize1 ! supply *a9s1 f manufactur+ 
( key />t+ mat]ials ?r\gh manufactur+ ( 
f9i%$ dosage =ms & di/ribution1 ( drugs 
7z def9$ 9 section #bja ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cba77 includ$ on ! ,ess5tial 

,m$ic9es ,li/ "u section #b2 &  7#b7 use
 data analytics to id5tify supply *a9   
vuln]abilities t pose a ?reat to        
national security1 z det]m9$ by !       
,secret>y or ! heads ( o!r relevant     
,f$]al dep>tm5ts & ag5cies4  7b7        
,requirem5ts  ,9 c>ry+ out subsection   
7a71 ! ,secret>y %all-- 7#a7 describe ! 
roles & responsibilities ( ag5cies &    
(fices )9 ! ,dep>tm5t ( ,heal? & ,human 
,s]vices relat$ to monitor+ su* supply  
*a9s & assess+ any relat$               
vuln]abilities2 &  7#b7 facilitate !    
ex*ange ( in=mation betwe5 ,f$]al       
dep>tm5ts1 ag5cies1 & (fices1 z         
appropriate & necess>y to enable su*    
ag5cies & (fices to c>ry out roles &    
responsibilities describ$ 9 p>agraph    
7#a7 relat$ to drugs describ$ 9         
subsection 7a77#a71 :i* may include--   
7,a7 ! location ( e/abli%m5ts regi/]$ "u
 subsection 7b71 7c71 or 7i7 ( section  
#eaj ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7     
involv$ 9 ! production ( active         

ph>maceutical +r$i5ts & f9i%$ dosage =ms
 ( drugs describ$ 9 subsection 7a77#a71 
& ! am\nt ( su* +r$i5ts & f9i%$ dosage  
=ms produc$ at ea* su* e/abli%m5t2  7,b7
 to ! ext5t available & z appropriate1 !
 location ( e/abli%m5ts s regi/]$       
involv$ 9 ! production ( ! key />t+     
mat]ials & excipi5ts ne$$ to produce !  
active ph>maceutical +r$i5ts & f9i%$    
dosage =ms1 & ! am\nt ( su* mat]ials &  
excipi5ts produc$ at ea* su* e/abli%m5t2
 &  7,c7 any regulatory actions )       
respect to su* drugs or ! e/abli%m5ts   
manufactur+ su* drugs1 includ+ ) respect
 to inspections & relat$ regulatory     
activities conduct$ "u section #gjd (   
su* ,act 7#ba ,u4,s4,c4 #cgd71 ! seizure
 ( su* a drug pursuant to section #cjd (
 su* ,act 7#ba ,u4,s4,c4 #ccd71 any     
recalls ( su* a drug2 inclusion ( su* a 
drug on ! drug %ortage li/ "u section   
#ejf;,e ( su* ,act 7#ba ,u4,s4,c4       
#cef;e71 or prior drug %ortages reports 
( a discont9uance or int]ruption 9 !    
production ( su* a drug "u #ejf;,c ( su*

 ,act 7#ba ,u4,s4,c4 #cee;d74  7c7      
,report  ,n lat] ?an #ah mon?s aft] !   
date ( enactm5t ( ?is ,act1 & annually  
!reaft]1 ! ,secret>y1 9 consultation ) !
 heads ( ag5cies ) :i* ! ,secret>y      
coord9ates "u subsection 7a71 %all      
submit a report to ! relevant committees
 ( ,congress on--  7#a7 ! curr5t /atus (
 ef=ts to map & analyze ph>maceutical   
supply *a9s1 z describ$ 9 subsection    
7a72  7#b7 activities ( ! ,secret>y     
c>ri$ out "u ?is section to coord9ate   
ef=ts z describ$ 9 subsection 7a71      
includ+ in=mation %>+ betwe5 relevant   
,f$]al dep>tm5ts1 ag5cies1 & (fices2    
7#c7 ! roles & responsibilities describ$
 9 subsection 7b77#a71 includ+ !        
id5tification ( any gaps1 data          
limitations1 or areas ( unnecess>y      
duplication betwe5 su* roles &          
responsibilities2  7#d7 ! ext5t to :i*  
,f$]al ag5cies use data analytics to    
conduct pr$ictive model+ ( anticipat$   
drug %ortages or risks associat$ )      
supply *a9 vuln]abilities t pose a ?reat

 to national security2 &  7#e7 ! ext5t  
to :i* ! ,secret>y has engag$ relevant  
indu/ry 9 su* mapp+4  #e4  ,dep>tm5t (  
,def5se biannual reports  ,n lat] ?an   
#ahj days aft] ! date ( enactm5t ( ?is  
,act1 & e #ahj days !reaft]1 ! ,secret>y
 ( ,def5se %all submit to !             
congressional committees describ$ 9     
subp>agraphs 7,a7 & 7,b7 ( section      
#c7;c77#a7 a report t li/s all drugs    
pur*as$ by ! ,dep>tm5t ( ,def5se dur+ ! 
#ahj-;day p]iod prec$+ ! date ( !       
report--  7#a7 t conta9 key />t+        
mat]ials1 excipi5ts1 or active          
ph>maceutical +r$i5ts s\rc$ f ! ,p's    
,republic ( ,*9a2 or  7#b7 = :i* ! f9i%$
 drug product 0 manufactur$ 9 ! ,p's    
,republic ( ,*9a4  #f4  ,def9itions  ,9 
?is ,act3 7#a7 ,advanc$ manufactur+ ,!  
t]m advanc$ manufactur+ has ! mean+ giv5
 ! t]m advanc$ & cont9u\s ph>maceutical 
manufactur+ 9 section #cjaf7;h7 ( ! #ba/
 ,c5tury ,cures ,act 7#ba ,u4,s4,c4     
#cii;h7h774  7#b7  ,cyb]security ?reat  
,! t]m cyb]security ?reat has ! mean+   

giv5 su* t]m 9 section #bbjj ( ! ,homel&
 ,security ,act ( #bjjb 7#f ,u4,s4,c4   
#fej74  7#c7  ,drug  ,! t]m drug has !  
mean+ giv5 su* t]m 9 section #bja7;g7 ( 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
7#ba ,u4,s4,c4 #cba7;g774  7#d7         
,secret>y  ,! t]m ,secret>y1 except z   
o!rwise specifi$1 means ! ,secret>y (   
,heal? & ,human ,s]vices4  #g4          
,additional provisions  7a7             
,cl>ification  ,! p>ticipation ( !      
,secret>y 9 develop+ & updat+ ! li/ (   
ess5tial m$ic9es "u section #b %all be  
deem$ to be full satisfaction ( !       
requirem5ts applicable to su* secret>y  
"u section #c ( ,executive ,ord] #acidd 
7#he ,f$4 ,reg4 #diibi74  7b7           
,confid5tial comm]cial in=mation  ,!    
ex*ange ( in=mation among ! ,secret>y & 
! heads ( o!r relevant ,f$]al dep>tm5ts 
& ag5cies = purposes ( c>ry+ out        
sections #c & #d %all n be a violation (
 section #aije ( title #ah1 ,unit$      
,/ates ,code4 ,?is section %all n be    
con/ru$ to affect ! /atus1 if any1 ( su*

 in=mation z trade secret or confid5tial
 comm]cial in=mation = purposes (       
section #cja7;j7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cca7;j771 section #eeb ( title #e1     
,unit$ ,/ates ,code1 or section #aije ( 
title #ah1 ,unit$ ,/ates ,code4  7c7    
,cyb]security measures  ,! ,secret>y    
%all ensure t robu/ cyb]security        
measures are 9 place to prev5t          
inappropriate access to1 or unau?oriz$  
disclosure (1 ! in=mation id5tifi$1     
ex*ang$1 or disclos$ "u sections #c &   
#d4