,,ii  #aag? ,,congress  #a/ ,session    
,s4 #bgdj  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,septemb] #ad1         
#bjba,mr4 ,br[n 7= himself & ,mr4       
,cassidy7 introduc$ ! foll[+ bill2 :i* 0
 read twice & ref]r$ to ! ,committee on 
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to e/abli% a /rategic active
 ph>maceutical +r$i5t res]ve to ma9ta9 a
 dome/ic supply ( active ph>maceutical  
+r$i5ts & key />t+ mat]ials ne$$ = !    
manufactur+ ( ess5tial g5]ic m$ic9es1 & 
to build a pipel9e = dome/ic active     
ph>maceutical +r$i5t production4  #a4   
,%ort title ,?is ,act may be cit$ z !   
,promot+ ,read9ess & ,ensur+ ,prop]     
,active ph>maceutical +r$i5t ,res]ves ( 
,ess5tial m$ic9es ,act ( #bjba or !     
,,prep>e ,act4  #b4 ,li/+ ( ess5tial    
g5]ic m$ic9es ,"p ,b ( title ,,iii ( !  
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bdc et seq47 is am5d$ by     
ins]t+ aft] section #cai,m ! foll[+3    
#cai,n4 ,li/+ ( ess5tial g5]ic m$ic9es  
7a7 ,9 g5]al ,! ,secret>y1 9            

consultation ) ! ,commission] ( ,food & 
,drugs1 ! ,assi/ant ,secret>y =         
,prep>$ness & ,response1 ! ,secret>y (  
,def5se1 ,secret>y ( ,homel& ,security1 
& o!r heads ( ag5cies1 z appropriate1   
%all e/abli% & make public a li/ (      
ess5tial g5]ic m$ic9es det]m9$1 9       
accordance ) subsection 7b71 to be      
m$ically necess>y to h available at all 
times4  7b7 ,requirem5ts  7#a7 ,initial 
li/ ,! initial li/ ( ess5tial g5]ic     
m$ic9es "u subsection 7a7 %all be !     
g5]ic m$ic9es includ$ on ! li/ (        
ess5tial m$ic9es1 m$ical c\nt]measures1 
& critical inputs id5tifi$ by !         
,commission] ( ,food & ,drugs z publi%$ 
on ,octob] #cj1 #bjbj1 9 accordance )   
section #c7;c7 ( ,executive ,ord]       
#acidd4  7c7 ,updates  7#a7 ,annual     
review ,n less ?an once ea* ye>1 !      
,secret>y1 aft] consultation ) !        
,commission] ( ,food & ,drugs1 !        
,assi/ant ,secret>y = ,prep>$ness &     
,response1 ! ,secret>y ( ,def5se1       
,secret>y ( ,homel& ,security1 & o!r    

heads ( ag5cies1 z appropriate1 %all    
review & update ! li/ ( ess5tial g5]ic  
m$ic9es requir$ "u subsection 7a74  7#b7
 ,rationale ,9 c>ry+ out ! annual review
 & update "u p>agraph 7#a71 ! ,secret>y 
%all provide a rationale = ea* ess5tial 
g5]ic m$ic9e add$ to1 or remov$ f1 ! li/
 "u subsection 7a74  7#c7 ,specific     
populations ,! ,secret>y %all consid]   
includ+ on ! li/ "u subsection 7a71 &1  
:]e appropriate1 include on su* li/1    
ess5tial g5]ic m$ic9es t are ess5tial to
 specific subpopulations1 includ+       
p$iatric populations1 9 develop+ ! li/  
"u su* subsection4  7#d7 ,?reat         
assessm5ts  7,a7 ,9 g5]al ,! ,secret>y1 
aft] consultation ) ! ,public ,heal?    
,em]g5cy ,m$ical ,c\nt]measures         
,ent]prise e/abli%$ "u section #bhaa-a1 
%all conduct regul> ?reat assessm5ts1 & 
take su* assessm5ts into consid]ation 9 
updat+ ! li/ 9 accordance ) p>agraph    
7#a74  7,b7 ,?reat assessm5ts           
consid]ations ,ea* ?reat assessm5t "u   
?is p>agraph %all include consid]ation  

(-- 7i7 ! lack ( exi/+ dome/ic capacity 
( ess5tial g5]ic m$ic9es2  7ii7 !       
conc5tration ( curr5t supply ( !        
ess5tial g5]ic m$ic9e or active         
ph>maceutical +r$i5ts ( ! ess5tial g5]ic
 m$ic9e 9 "o geographical region2  7iii7
 :e!r !re are less ?an #b manufactur]s (
 ! ess5tial g5]ic m$ic9e or active      
ph>maceutical +r$i5ts ( ! ess5tial g5]ic
 m$ic9e2 &  7iv7 ! pot5tial = increas$  
dem& 9 a public heal? em]g5cy4  7#e7    
,director ( ! /rategic active           
ph>maceutical +r$i5ts res]ve ,!         
,secret>y %all appo9t a ,director ( !   
,/rategic ,active ,ph>maceutical        
,+r$i5ts ,res]ve :o has exp]i5ce 9 "o or
 m ( ! foll[+ areas3 supply *a9         
managem5t1 disa/] response1             
ph>maceutical or active ph>maceutical   
+r$i5t developm5t1 or logi/ics4 ,su*    
,director %all ensure a suffici5t supply
 ( ! active ph>maceutical +r$i5ts &     
critical compon5ts necess>y to          
manufacture ! ess5tial g5]ic m$ic9es    
includ$ on ! li/ "u subsection 7a7 9 an 

am\nt adequate to s]ve ! ne$s ( pati5ts 
liv+ 9 ! ,unit$ ,/ates & 9 ! appropriate
 dosage =ms4  7d7 ,appeal process ,!    
,secret>y %all e/abli% a process by :i* 
/akehold]s may appeal a det]m9ation by !
 ,secret>y n to include an ess5tial     
g5]ic m$ic9e on ! li/ "u subsection 7a74
  7e7 ,def9itions ,9 ?is section3 7#a7  
,drug ,! t]m drug has ! mean+ giv5 su*  
t]m 9 section #bja7;g7 ( ! ,f$]al ,food1
 ,drug1 & ,cosmetic ,act1 & includes a  
biological product 7z def9$ 9 section   
#cea7;i7 ( ?is ,act74 ,su* t]m includes 
prescription & nonprescription drugs1 or
 active ph>maceutical +r$i5ts ( drugs4  
7#b7 ,ess5tial g5]ic m$ic9e ,! t]m      
ess5tial g5]ic m$ic9e means a drug = :i*
 a g5]ic is approv$1 t is m$ically      
necess>y to h available at all times    
because ! drug is-- 7,a7 commonly us$ to
 prev5t1 mitigate1 or treat a common    
disease or condition1 or us$ 9 a common 
proc$ure2  7,b7 an antibiotic or        
antifungal us$ to treat an infecti\s    
diseases2  7,c7 necess>y to prev5t or   

mitigate a public heal? em]g5cy2 or     
7,d7 life-support+1 life-su/a9+1 or     
int5d$ = use 9 ! prev5tion or treatm5t (
 a debilitat+ disease or condition4  4  
#c4 ,e/abli%m5t ( ! /rategic active     
ph>maceutical +r$i5t res]ve ,"p ,b (    
title ,,iii ( ! ,public ,heal? ,s]vice  
,act 7#db ,u4,s4,c4 #bdc et seq471 z    
am5d$ by section #b1 is fur!r am5d$ by  
ins]t+ aft] section #cai,n ! foll[+3    
#cai,n-#a4 ,/rategic active             
ph>maceutical +r$i5t res]ve  7a7        
,/rategic ,active ,ph>maceutical ,+r$i5t
 ,res]ve ,plan  7#a7 ,9 g5]al ,n lat]   
?an #ij days aft] ! date ( enactm5t ( ! 
,promot+ ,read9ess & ,ensur+ ,prop]     
,active ph>maceutical +r$i5t ,res]ves ( 
,ess5tial m$ic9es ,act ( #bjba1 !       
,secret>y1 9 consultation ) ! ,assi/ant 
,secret>y = ,prep>$ness & ,response1 !  
,director ( ! ,c5t]s = ,disease ,control
 & ,prev5tion1 ! ,commission] ( ,food & 
,drugs1 & ! ,director ( ! ,biom$ical    
,advanc$ ,rese>* & ,developm5t          
,au?ority1 %all prep>e & submit to      

,congress a ,/rategic ,active           
,ph>maceutical ,+r$i5t ,res]ve ,plan    
7ref]r$ to 9 ?is section z ! ,plan7 9   
accordance ) subsection 7b71 :i* %all be
 us$ by ! ,secret>y 9 e/abli%+ & ma9ta9+
 ! ,/rategic ,active ,ph>maceutical     
,+r$i5t ,res]ve describ$ 9 subsection   
7c74  7#b7 ,annual updates ,! ,secret>y 
%all update ! plan annually &1 by n lat]
 ?an ,june #a ( ea* ye>1 submit ! updat$
 plan to ! applicable committees (      
,congress4  7#c7 ,national security     
consid]ations  7,a7 ,submissions ,!     
,secret>y %all ensure t any submission (
 ! plan 7includ+ any update to ! plan7  
to ! applicable committees ( ,congress  
is 9 a mann] t does n compromise        
national security4  7,b7 ,exemption f   
disclosure ,in=mation 9 ! plan t1 9 !   
judgm5t ( ! ,secret>y1 w\ld reveal      
public heal? vuln]abilities %all be     
exempt f disclosure "u section          
#eeb7;b77#c7 ( title #e1 ,unit$ ,/ates  
,code4  7b7 ,plan requirem5ts  7#a7 ,9  
g5]al ,! ,plan requir$ "u subsection 7a7

 %all-- 7,a7 detail ! design1           
con/ruction1 & fill+ ( ! /orage & relat$
 facilities compris+ ! ,/rategic ,active
 ,ph>maceutical ,+r$i5t ,res]ve describ$
 9 subsection 7c7 7ref]r$ to 9 ?is      
section z ! ,res]ve72  7,b7 detail !    
requirem5ts = ma9ta9+ ! ,res]ve describ$
 9 subsection 7c71 includ+-- 7i7 /orage 
& te/+ requirem5ts1 consi/5t ) p>ts #baj
 & #baa ( title #ba1 ,code ( ,f$]al     
,regulations1 or any successor          
regulation2 &  7ii7 any specific crit]ia
 agre$ to by ! ,secret>y & ! manufactur]
 ( ! ess5tial g5]ic m$ic9e us+ ! active 
ph>maceutical +r$i5t or key />t+        
mat]ial2  7,c7 be design$ to m9imize !  
impact ( any int]ruption or r$uction 9  
imports (-- 7i7 active ph>maceutical    
+r$i5ts & o!r key />t+ mat]ials t !     
,secret>y det]m9es are1 or are likely to
 become1 dep5d5t ^u su* imports = a     
sub/antial portion ( f9i%$ ess5tial     
g5]ic m$ic9es2 &  7ii7 f9i%$ dosage =ms 
( ess5tial g5]ic m$ic9es = :i* active   
ph>maceutical +r$i5ts & o!r key />t+    

mat]ials are n import$2  7,d7 include   
provisions to /r5g!n dome/ic capacity = 
active ph>maceutical +r$i5t production1 
/orage1 & conv]sion2 &  7,e7 outl9e     
plans & processes = coord9at+ &         
consult+1 z appropriate1 ) ! ,assi/ant  
,secret>y = ,prep>$ness & ,response     
reg>d+ relevant issues ( int]e/ p]ta9+  
to ! ma9t5ance & /ock+ ( ! /rategic     
national /ockpile4  7#b7 ,requir$       
compon5ts  7,a7 ,9 g5]al ,! ,plan %all  
include ! foll[+3 7i7 ,id5tification &  
prioritization ( ! ess5tial g5]ic       
m$ic9es includ$ on ! mo/ rec5t li/ "u   
section #cai,n7a7-- 7,i7 t ! ,secret>y  
det]m9es are ess5tial = heal? c>e ne$s 9
 ! ,unit$ ,/ates2 &  7,,ii7 = :i* !     
,secret>y det]m9es t !re is ! greate/   
ne$ to ma9ta9 a res]ve ( ! active       
ph>maceutical +r$i5ts & key />t+        
mat]ials = ! ess5tial g5]ic m$ic9es--   
7aa7 tak+ into acc\nt factors includ+ ! 
ext5t to :i* ! ,unit$ ,/ates is1 or is  
at risk ( becom+1 dep5d5t on =eign      
s\rces = a sub/antial portion ( !       

dome/ic ne$2 &  7bb7 giv+ special       
consid]ation to ! ess5tial g5]ic m$ic9es
 at risk ( supply int]ruption z a result
 ( ! factors describ$ 9 section         
#cai,n7c77#d77;,b74  7ii7 ,an evaluation
 ( ! utilization levels ( ! ess5tial    
g5]ic m$ic9es id5tifi$ "u clause 7i7 to 
in=m h[ mu* ( ! active ph>maceutical    
+r$i5ts ( su* m$ic9es is requir$ to cov]
 ! project$ heal? c>e ne$s = "o ye> ( ! 
,unit$ ,/ates population4  7iii7 ,a     
compreh5sive assessm5t ( ! ess5tial     
g5]ic m$ic9es id5tifi$ "u clause 7i71   
includ+ ! exi/+ manufactur+ bases = ea* 
su* m$ic9e 7includ+ id5tification &     
location ( own]%ip ( su* facilities7 &  
:e!r ! active ph>maceutical +r$i5ts (   
su* +r$i5ts are manufactur$ dome/ically 
or abroad1 & :e!r f9i%$ dosage conv]sion
 /eps = su* ess5tial g5]ic m$ic9es are  
p]=m$ dome/ically or abroad4  7iv7 ,!   
types ( facilities1 equipm5t1 &         
te*nology requir$ to appropriately /ore1
 track1 te/1 & conv]t all =ms ( active  
ph>maceutical +r$i5ts t are critical    

inputs ( drugs t are ess5tial g5]ic     
m$ic9es1 prelim9>y propos$ locations =  
su* public & privately own$ facilities 9
 multiple locations 9 ! ,unit$ ,/ates1 !
 capacity requir$ ( ! facilities us$1 & 
! e/imat$ co/ ( acquisition & /orage ( !
 active ph>maceutical +r$i5ts &         
managem5t & op]ation ( ! facilities4    
7v7 ,an evaluation ( ! impact t !       
e/abli%m5t & ongo+ ma9t5ance ( ! ,res]ve
 may h1 includ+ on availability & pric+ 
( active ph>maceutical +r$i5ts & f9i%$  
drug dosages4  7vi7 ,a di/ribution plan 
= ! active ph>maceutical +r$i5ts held 9 
! ,res]ve1 :i* %all include-- 7,i7      
protocols = ! me?od ( conv]sion ( active
 ph>maceutical +r$i5ts into f9i%$ drugs1
 includ+ conv]sion ( key />t+ mat]ials  
into active ph>maceutical +r$i5ts &     
di/ribution f ! ,res]ve into ! /rategic 
national /ockpile & o!r gov]nm5t &      
comm]cial ph>maceutical di/ribution     
networks2 &  7,,ii7 b5*m>ks = !         
,secret>y to initiate conv]sion ( drug  
products t are ess5tial g5]ic m$ic9es   

us+ ! active ph>maceutical +r$i5ts /or$ 
9 ! ,res]ve = transf] to ! /rategic     
national /ockpile or o!r gov]nm5t or    
comm]cial ph>maceutical di/ribution     
networks1 bas$ on *anges 9 ! supply *a9 
= ! top ess5tial g5]ic m$ic9es or a     
det]m9ation by ! ,secret>y reg>d+ a     
?reat to public heal?4  7vii7 ,a        
me*anism ?r\gh :i* private sector       
manufactur]s ( active ph>maceutical     
+r$i5ts or f9i%$ dosage =ms may1 ?r\gh  
contracts ) exi/+ ,res]ve facilities1   
/ore & )draw su* +r$i5ts 9 ! ,res]ve to 
enhance resili5ce & r$uce %ortages &    
disruptions 9 ! supply *a94  7viii7 ,a  
me*anism ?r\gh :i* ! ,f$]al ,gov]nm5t   
may pur*ase1 via manufactur+ p>tn]s1    
res]ve capacity = f9i%$ drug manufactur+
 to conv]t active ph>maceutical +r$i5ts 
into f9i%$ drugs = ess5tial g5]ic       
m$ic9es4  7,b7 ,numb] ( drugs  7i7 ,9   
g5]al ,pursuant to subp>agraph 7,a77i71 
! ,secret>y %all ensure t = ! fir/ ye>  
aft] ! date ( enactm5t ( ! ,promot+     
,read9ess & ,ensur+ ,prop] ,active      

ph>maceutical +r$i5t ,res]ves (         
,ess5tial m$ic9es ,act ( #bjba1 ! ,plan 
includes n less ?an #be ess5tial g5]ic  
m$ic9es1 & t #be additional ess5tial    
g5]ic m$ic9es are includ$ 9 su* ,plan = 
ea* ye> !reaft] until ! active          
ph>maceutical +r$i5ts necess>y to       
support ! full li/ ( ess5tial g5]ic     
m$ic9es id5tifi$ "u section #cai,n7a7   
are cov]$4  7ii7 ,prioritization ,!     
,secret>y %all prioritize ess5tial g5]ic
 m$ic9es ne$$ imm$iately 9 ! ev5t ( an  
em]g5cy4  7#c7 ,quantities ( ,a,p,is &  
key />t+ mat]ials  7,a7 ,9 g5]al ,to !  
maximum ext5t practicable1 ! ,plan %\ld 
include a plan to ensure t1 = ea*       
ess5tial g5]ic m$ic9e includ$ 9 ! ,plan1
 ! active ph>maceutical +r$i5ts us$ 9 ! 
production ( su* m$ic9e t are /or$ 9 !  
,res]ve are available 9 ! m9imum        
quantities z foll[s3 7i7 ,by ! date t is
 #ah mon?s aft] ! date ( enactm5t ( !   
,promot+ ,read9ess & ,ensur+ ,prop]     
,active ph>maceutical +r$i5t ,res]ves ( 
,ess5tial m$ic9es ,act ( #bjba1 n less  

?an #aj p]c5t ( ! total am\nt ( su*     
+r$i5ts ne$$ to produce suffici5t       
quantities ( ! ess5tial g5]ic m$ic9es = 
! treatm5t ( individuals liv+ 9 ! ,unit$
 ,/ates4  7ii7 ,by ! date t is #c ye>s  
aft] su* date ( enactm5t1 n less ?an #be
 p]c5t ( ! total am\nt ( su* +r$i5ts    
ne$$ to produce suffici5t quantities ( !
 ess5tial g5]ic m$ic9es = ! treatm5t (  
individuals liv+ 9 ! ,unit$ ,/ates4     
7iii7 ,by ! date t is #e ye>s aft] su*  
date ( enactm5t1 n less ?an #ej p]c5t ( 
! total am\nt ( su* +r$i5ts ne$$ to     
produce suffici5t quantities ( !        
ess5tial g5]ic m$ic9es = ! treatm5t (   
individuals liv+ 9 ! ,unit$ ,/ates4     
7iv7 ,by ! date t is #aj ye>s aft] su*  
date ( enactm5t1 n less ?an #ij p]c5t ( 
! total am\nt ( su* +r$i5ts ne$$ to     
produce suffici5t quantities ( !        
ess5tial g5]ic m$ic9es = ! treatm5t (   
individuals liv+ 9 ! ,unit$ ,/ates4     
7,b7 ,calculation ( quantity ( ,,api ,9 
calculat+ ! quantities ( active         
ph>maceutical +r$i5ts ne$$ = purposes ( 

subp>agraph 7,a71 ! ,secret>y %all      
det]m9e ! quantity ( ea* ess5tial g5]ic 
m$ic9e requir$ to cov] ! project$ heal? 
c>e ne$s1 ov] a #a-ye> p]iod1 ( p liv+ 9
 ! ,unit$ ,/ates1 bas$ on av]age annual 
dem& dur+ ! #c-ye> p]iod prec$+ ! date (
 enactm5t ( ! ,promot+ ,read9ess &      
,ensur+ ,prop] ,active ph>maceutical    
+r$i5t ,res]ves ( ,ess5tial m$ic9es ,act
 ( #bjba4  7c7 ,adm9i/]+ ! /rategic     
active ph>maceutical +r$i5t res]ve  7#a7
 ,9 g5]al ,) respect to ea* active      
ph>maceutical +r$i5t & key />t+ mat]ial 
t is includ$ 9 ! ,plan1 ! ,secret>y %all
 place 9 /orage1 transport1 track1 &    
ex*ange quantities ( ! sub/ance t are-- 
7,a7 produc$ 9 con=mance ) all quality  
requirem5ts "u ?is ,act & ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act1 includ+ 
! associat$ regulations ( su* ,acts2    
7,b7 /or$ 9 compliance )-- 7i7 !        
requirem5ts ( p>ts #baj & #baa ( title  
#ba1 ,code ( ,f$]al ,regulations1 or any
 successor regulation2 &  7,c7 any      
specific crit]ia agre$ to by ! ,secret>y

 & ! manufactur] ( ! ess5tial g5]ic     
m$ic9e us+ ! active ph>maceutical +r$i5t
 or key />t+ mat]ial4  7#b7 ,requirem5ts
 ,to ! greate/ ext5t practicable1 9     
c>ry+ out p>agraph 7#a71 ! ,secret>y    
%all acquire active ph>maceutical       
+r$i5ts & key />t+ mat]ials 9 a mann] t 
m9imizes co/1 m9imizes vuln]ability ( ! 
,unit$ ,/ates to sev]e %ortages or      
disruptions = ess5tial g5]ic m$ic9es1   
m9imizes ! impact ( acquisition ( su*   
+r$i5ts & mat]ials to ! m>ketplace1     
gives pref]5ce to dome/ic manufactur]s1 
& enc\rages competition 9 ! m>ketplace4 
7#c7 ,drawd[n ( ! ,res]ve  7,a7 ,9 g5]al
 ,! ,secret>y may di/ribute active      
ph>maceutical +r$i5ts & key />t+        
mat]ials 9 ! ,res]ve 9 ord] to initiate 
conv]sion ( active ph>maceutical +r$i5ts
 & f9i%$ dosage =m1 9 accordance ) !    
,plan develop$ "u subsection 7b74  7,b7 
,deviations f plan ,9 di/ribut+ active  
ph>maceutical +r$i5ts & key />t+        
mat]ials "u subp>agraph 7,a71 !         
,secret>y1 9 consultation ) !           

,commission] ( ,food & ,drugs & !       
,assi/ant ,secret>y = ,prep>$ness &     
,response1 may deviate f ! ,plan        
develop$ "u subsection 7b7 only aft]    
c]tify+ t ! di/ribution f ! ,res]ve is  
requir$ 9 response to a significant drug
 supply int]ruption4  7d7 ,consultation 
7#a7 ,9 g5]al ,9 c>ry+ out ?is section1 
! ,secret>y %all consult )-- 7,a7 !     
,commission] ( ,food & ,drugs1 ) respect
 to id5tify+ ess5tial g5]ic m$ic9es2    
7,b7 ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e
  ,m$icaid ,s]vices1 ) respect to       
det]m9+ ! volume ( ess5tial g5]ic       
m$ic9es ne$$ dome/ically2 &  7,c7 !     
,assi/ant ,secret>y = ,prep>$ness &     
,response1 &1 z appropriate1 ! ,director
 ( ! ,c5t]s = ,disease ,control &       
,prev5tion1 reg>d+ coord9ation ) !      
/rategic national /ockpile4  7#b7       
,report+ by ,,fda ,! ,commission] (     
,food & ,drugs %all provide to !        
,secret>y ! in=mation collect$ "u       
section #eaj7;j77#c7 ( ! ,f$]al ,food1  
,drug1 & ,cosmetic ,act1 = purposes (   

c>ry+ out ?is section4  7e7 ,contract+  
7#a7 ,9 g5]al ,9 c>ry+ out ?is section1 
! ,secret>y %all-- 7,a7 prioritize !    
pur*ase ( active ph>maceutical +r$i5ts &
 o!r key />t+ mat]ials manufactur$ 9 !  
,unit$ ,/ates by dome/ic manufactur]s to
 ! maximum ext5t possible2  7,b7        
contract ) dome/ic entities = !-- 7i7   
di/ribution ( active ph>maceutical      
+r$i5ts & f9i%$ drug products2  7ii7    
/orage1 )drawal1 te/+1 & conv]sion (    
active ph>maceutical +r$i5ts & o!r key  
/>t+ mat]ials2  7iii7 track+ & coord9at+
 ! /orage1 te/+1 & sale ( active        
ph>maceutical +r$i5ts & o!r key />t+    
mat]ials2  7iv7 sale ( active           
ph>maceutical +r$i5ts 9 advance ( _!    
expiration dates2 &  7v7 manufactur+1   
includ+ cont9u\s manufactur+ z          
appropriate1 ( an active ph>maceutical  
+r$i5t or o!r key />t+ mat]ial ( an     
ess5tial g5]ic m$ic9e t is anticipat$ to
 be 9 %ortage1 z def9$ by ! ,secret>y = 
purposes ( ?is section2  7,c7 give      
pref]5ce to dome/ic nonpr(it &          

public-private p>tn]%ips1 z appropriate2
  7,d7 ensure geographic div]sity ( !   
physical /orage ( active ph>maceutical  
+r$i5ts & o!r key />t+ mat]ials2  7,e7  
support dome/ic manufactur]s ( active   
ph>maceuticals & o!r key />t+ mat]ials &
 facilitate long-t]m dome/ic capacity = 
ess5tial g5]ic m$ic9es 9 ! ,unit$       
,/ates2 &  7,f7 prioritize contracts t  
facilitate ! conv]sation ( active       
ph>maceutical +r$i5ts & o!r key />t+    
mat]ials into f9i%$ dosage =m4  7#b7    
,rule ( con/ruction ,no?+ 9 ?is         
subsection %all be con/ru$ to limit !   
,secret>y's ability to ent] into o!r    
types ( contracts to facilitate !       
implem5tation ( ?is section4  7f7       
,reports to ,congress ,! ,secret>y %all 
report to ! applicable committees (     
,congress on supply *a9 resili5cy )     
respect to active ph>maceutical +r$i5ts 
= ess5tial g5]ic m$ic9es1 ! /atus ( !   
,res]ve1 & o!r relevant in=mation 9 a   
mann] t does n compromise national      
security4  7g7 ,def9itions ,9 ?is       

section3 7#a7 ,applicable committees (  
,congress ,! t]m applicable committees (
 ,congress means-- 7,a7 ! ,committee on 
,heal?1 ,education1 ,labor1 & ,p5sions &
 ! ,committee on ,intellig5ce ( !       
,s5ate2 &  7,b7 ! ,committee on ,en]gy &
 ,comm]ce ( ! ,h\se ( ,repres5tatives4  
7#b7 ,ess5tial g5]ic m$ic9e ,! t]m      
ess5tial g5]ic m$ic9e means a drug      
includ$ on ! mo/ curr5t li/ "u section  
#cai,n7a74  7#c7 ,key />t+ mat]ial ,!   
t]m key />t+ mat]ial means an active    
ph>maceutical +r$i5t or critical input  
us$ 9 ! manufactur+ ( an ess5tial g5]ic 
m$ic9e1 z well z +r$i5ts or compon5ts t 
possess unique attributes ess5tial 9    
assess+ ! safety & effectiv5ess ( su*   
ess5tial g5]ic m$ic9es1 includ+         
excipi5ts & inactive +r$i5ts4  7h7      
,au?orization ( appropriations ,!re are 
au?oriz$ to be appropriat$ to c>ry out  
?is section su* sums z may be necess>y4 
4  #d4 ,waiv] ( c]ta9 ,,fda ,,&a        
requirem5ts ,section #eje7;j7 ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act 7#ba    

,u4,s4,c4 #cee7;j77 is am5d$ by add+ at 
! end ! foll[+3  7#ad7 ,not)/&+ any o!r 
provision ( ?is section1 ! hold] ( an   
approv$ application "u ?is subsection t 
*anges ! s\rce ( an active ph>maceutical
 +r$i5t ( ! drug t is ! subject ( su*   
application to a s\rce available ?r\gh !
 ,/rategic ,active ,ph>maceutical       
,+r$i5t ,res]ve e/abli%$ "u section     
#cai,n-#a ( ! ,public ,heal? ,s]vice    
,act-- 7,a7 %all n be requir$ to update 
! approv$ application ) respect to su*  
*ange be=e *ang+ ! s\rce2 &  7,b7 %all  
in=m ! ,secret>y ( ! *ange1 ?r\gh an    
update to ! approv$ application or o!r  
mann] det]m9$ appropriate by !          
,secret>y1 prior to comm]cial           
di/ribution ( ! drug4  4  #e4 ,,gao     
report ,by n lat] ?an #ah mon?s aft] !  
date ( enactm5t ( ?is ,act1 !           
,comptroll] ,g5]al ( ! ,unit$ ,/ates    
%all prep>e & submit a report to        
,congress t includes-- 7#a7 an assessm5t
 ( :at is kn[n ab\t active ph>maceutical
 +r$i5t manufactur+1 includ+-- 7,a7 ! "t

 ne$$ to develop & implem5t dome/ic     
manufactur+ capabilities2  7,b7 project$
 co/s ( develop+ new manufactur+        
capabilities = active ph>maceutical     
+r$i5ts n curr5tly available            
dome/ically1 z ( ! date ( ! report2 &   
7,c7 project$ co/s ( exp&+ exi/+ dome/ic
 capabilities & policies1 z ( ! date ( !
 report1 t may help e/abli% or /r5g!n   
dome/ic manufactur+ capacity = active   
ph>maceutical +r$i5ts1 excipi5ts1 key   
/>t+ mat]ials1 compon5ts1 functional    
+r$i5ts1 & f9i%$ dosage manufactur+     
facilities2 &  7#b7 an assessm5t (      
inc5tives already (f]$ or be+ consid]$ =
 ! developm5t or improvem5t ( dome/ic   
capacity to manufacture active          
ph>maceutical +r$i5ts1 _! int]m$iates1 &
 _! excipi5ts1 includ+-- 7,a7           
contractual arrangem5ts = exi/+ dome/ic 
/orage & manufactur+ ( active           
ph>maceutical +r$i5ts2  7,b7 gu>ante$   
contracts = initial pur*ase & repl5i%m5t
 ( ess5tial g5]ic m$ic9es2 &  7,c7 o!r  
policies design$ to help inc5tivize !   

relocation ( manufactur+ facilities to !
 ,unit$ ,/ates or provide economic      
inc5tives = dome/ic production4