,i  #aah? ,,congress  #a/ ,session  ,h4 
,r4 #eege  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,septemb] #ai1        
#bjbc,mr4 ,posey introduc$ ! foll[+     
bill2 :i* 0 ref]r$ to ! ,committee on   
,en]gy & ,comm]ce1 & 9 addition to !    
,committees on ,arm$ ,s]vices1 ,vet]ans'
 ,affairs1 & ,ways & ,means1 = a p]iod  
to be subsequ5tly det]m9$ by ! ,speak]1 
9 ea* case = consid]ation ( su*         
provisions z fall )9 ! jurisdiction ( ! 
committee conc]n$  ,a ,,bill  ,to direct
 ! ,secret>ies ( ,heal? & ,human        
,s]vices1 ,def5se1 & ,vet]ans ,affairs  
to end ,am]ican ov]-dep5d5ce on ,*9ese  
ph>maceuticals by enc\rag+ ! gr[? ( a   
robu/ dome/ic m$ic9e supply *a9 = g5]ic 
drugs1 to emp[] ! ,food & ,drug         
,adm9i/ration to issue box$ w>n+s 9 !   
case ( critical contam9ation1 & = o!r   
purposes4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,safe ,m$ic9e ,act4  #b4   
,f9d+s ,congress f9ds ! foll[+3 7#a7    
,foll[+ ! enactm5t ( ! ,drug ,price     
,competition & ,pat5t ,t]m ,re/oration  

,act ( #aihd 7,public ,law #ih-dag71 !  
,p's ,republic ( ,*9a 0 able to corn] ! 
m>ket on g5]ic drugs1 ph>maceutical     
+r$i5ts1 & relat$ mat]ials ?r\gh its    
/eady supply ( readily exploitable labor
 & ?readb>e safety regulations4 ,n9ety  
p]c5t ( ! m$ications tak5 by individuals
 9 ! ,unit$ ,/ates are g5]ic1 r5d]+ !m  
especially dep5d5t on supplies orig9at+ 
9 ! ,p's ,republic ( ,*9a4  7#b7 ,!     
numb] ( drugs produc$ outside ( ! ,unit$
 ,/ates d\bl$ betwe5 #bjja & #bjjh4 ,at 
pres5t1 #hj p]c5t ( ! active            
ph>maceutical +r$i5ts us$ 9 drugs tak5  
by individuals 9 ! ,unit$ ,/ates come f 
ov]seas1 ma9ly ! ,p's ,republic ( ,*9a &
 ! ,republic ( ,india4 ,! ,unit$ ,/ates 
no long] produces p5icill91 ) ! la/     
f]m5tation plant phas+ out ( production 
9 #bjjd4  7#c7 ,9 #bjjh1 ! c\nt]feit+ ( 
,hep>9 precursor *emicals by a          
,*9ese-bas$ ph>maceutical plant l$ to ! 
dea?s ( #ha individuals 9 ! ,unit$      
,/ates1 ) #ghe m be+ sev]ely injur$4 ,! 
c\nt]feit product co/ "o-hundr$? ( !    

price ( ! real product1 indicat+ a cle> 
economic motive = di/ribut+ contam9at$  
mat]ials4  7#d7 ,9 #bjah1 ! ,secret>y ( 
,heal? & ,human ,s]vices1 act+ ?r\gh !  
,commission] ( ,food & ,drugs1 issu$    
recalls ( ,vals>tan1 ,los>tan1 &        
,irbes>tan1 common blood pressure drugs4
 ,! ,secret>y ( ,heal? & ,human         
,s]vices1 act+ ?r\gh ! ,commission] (   
,food & ,drugs1 det]m9$ t v]sions ( su* 
drugs h be5 contam9at$ z a result (     
,*9ese & ,indian manufactur+ practices &
 t "o ,*9ese company1 ,zhejaiang ,huahai
 ,ph>maceuticals1 _h sy/emic problems ( 
sup]vision1 ) ! pot5t c>c9og5s          
,n-,nitroso-,n-me?yl-#d-;am9obutyric    
acid 7,,nmba71 ,n-,nitrosodime?ylam9e   
7,,ndma71 & ,n-,nitrosodie?ylam9e       
7,,ndea71 = a p]iod ( #d ye>s be=e be+  
detect$4  7#e7 ,dur+ an ,octob] #cj1    
#bjbj1 he>+ be=e ! ,heal? ,subcommittee 
( ! ,en]gy & ,comm]ce ,committee ( !    
,h\se ( ,repres5tatives1 x 0 discov]$ t 
! ,food & ,drug ,adm9i/ration 7,,fda7   
has data on active ph>maceutical +r$i5t 

facilities & locations because !y       
regulate & inspect !m4 ,b ! ,,fda does n
 "k h[ mu* volume is produc$ at ^!      
facilities4 ,a s+le plant c\ld make #ij 
p]c5t ( global supply or #aj p]c5t1 b ! 
,,fda does n "k4  7#f7 ,! ,,fda _c      
det]m9e ! ,unit$ ,/ates dep5d5ce because
 x does n ?or\ghly regulate or inspect !
 facilities :]e ! key *emicals & raw    
mat]ials to make active ph>maceutical   
+r$i5ts are made4  7#g7 ,dome/ic        
ph>maceutical facilities und]go f> m    
rigor\s inspections ?an manufactur+     
facilities 9 ! ,p's ,republic ( ,*9a4   
,s9ce e>ly #bjbj1 ! ,,fda recall$ its   
inspectors f ,*9a & else:]e to protect  
!m f ! ,coronavirus4 ,z a result1 ,,fda 
inspections h plummet$ to ne> z]o = !   
pa/ ye>4  7#h7 ,9 #bjaj1 ! ,p's         
,republic ( ,*9a emb>go$ ! %ipm5t ( r>e 
e>? metals to ,japan z political lev]age
 9 its negotiations ov] a boat+ incid5t 
t took place betwe5 ! #b c\ntries 9 !   
,ea/ ,*9a ,sea4 ,national security      
exp]ts w>n t if su* an incid5t 7 to take

 place betwe5 ! ,unit$ ,/ates & ,*9a1 & 
,*9a 7 to emb>go m$ic9e & ph>maceutical 
+r$i5ts1 ! ,unit$ ,/ates w\ld be        
helpless4 ,sun ,yu & ,demetri           
,seva/opulo1 ,*9a ,t>gets ,r>e ,e>?     
,export ,curbs ,to ,hobble ,,u ,def5se  
,indu/ry4 ,ars ,te*nica1 ,febru>y #af1  
#bjba1                                  
ar/e*nica4com_/te*-policy_/#bjba_/jb_/;*
9a-t>gets-r>e-e>?-export-curbs-to-hobble
-u-def5se-indu/ry_/4 ,unit$ ,/ates      
dep5d5ce on ,*9ese m$ic9e &             
ph>maceutical +r$i5ts poses a national  
security risk4  7#i7 ,! ,unit$ ,/ates is
 dep5d5t on o!r nations1 p>ticul>ly     
,*9a1 = our g5]ic m$ic9e & key +r$i5ts t
 are us$ to make ^! drugs4 ,inspections 
at ,*9ese facilities are inadequate     
comp>$ to inspections at facilities     
locat$ 9 ! ,unit$ ,/ates4  7#aj7 ,!     
,unit$ ,/ates _c rely on que/ionable    
inspections at facilities locat$ 9 ,*9a4
  7#aa7 ,to protect ,am]icans1 we mu/   
enc\rage ! developm5t ( ess5tial g5]ic  
drug manufactur+ "h 9 ! ,unit$ ,/ates & 

c\ntries alli$ ) ! ,unit$ ,/ates 9 a    
curr5t def5se ef=t = ! #bbg ess5tial    
m$ic9es & m$ical c\nt]measures id5tifi$ 
by ! ,,fda 9 accordance ) ,executive    
,ord] #acidd1 issu$ on ,augu/ #f1 #bjbj4
  #c4 ,dome/ic manufactur+ to end       
ov]-dep5d5ce ( ! ,unit$ ,/ates on ,*9ese
 drugs  7a7 ,9 g5]al ,! ,secret>ies (   
,heal? & ,human ,s]vices1 ,def5se1 &    
,vet]ans ,affairs1 act+ jo9tly & 9      
consultation ) ! ,commission] ( ,food & 
,drugs1 %all-- 7#a7 n lat] ?an #ahj days
 aft] ! date ( enactm5t ( ?is ,act1     
develop a procurem5t /rategy1 includ+ = 
long-t]m contracts1 to /r5g!n & mobilize
 ! ,public ,heal? ,indu/rial ,base to   
increase ! manufacture 9 ! ,unit$ ,/ates
 ( ess5tial m$ic9es1 m$ical             
c\nt]measures1 & critical inputs1       
includ+ ! #bbg ess5tial m$ic9es1 m$ical 
c\nt]measures1 & critical inputs publi%$
 on ,octob] #cj1 #bjbj1 by ! ,food &    
,drug ,adm9i/ration 9 accordance )      
,executive ,ord] #acidd2 &  7#b7 beg9n+ 
z soon z feasible aft] ! developm5t (   

su* /rategy1 & n lat] ?an #e ye>s aft] !
 developm5t ( su* /rategy1 implem5t su* 
/rategy4  7b7 ,cont5ts ,! /rategy "u    
subsection 7a7 %all-- 7#a7 be consi/5t )
 all applicable ,f$]al law2  7#b7       
id5tify ess5tial compon5ts1 includ+ key 
/>t+ mat]ials1 active +r$i5ts1 &        
critical inputs1 necess>y = manufactur+ 
! ess5tial m$ic9es & m$ical             
c\nt]measures publi%$ on ,octob] #cj1   
#bjbj1 by ! ,food & ,drug ,adm9i/ration 
9 accordance ) ,executive ,ord] #acidd2 
&  7#c7 address ! capacity ( ! supply   
*a9 & indu/rial base to /r5g!n &        
mobilize ! ,public ,heal? ,indu/rial    
,base to increase ! manufacture 9 !     
,unit$ ,/ates ( ess5tial m$ic9es1 m$ical
 c\nt]measures1 & critical inputs4  7c7 
,def9itions ,9 ?is section3 7#a7 ,! t]m 
critical inputs means active            
ph>maceutical +r$i5ts1 active           
ph>maceutical +r$i5t />t+ mat]ial1 & o!r
 +r$i5ts ( drugs & compon5ts ( m$ical   
devices t ! ,commission] ( ,food &      
,drugs det]m9es to be critical 9 assess+

 ! safety & effectiv5ess ( ess5tial     
m$ic9es & m$ical c\nt]measures4  7#b7 ,!
 t]m ess5tial m$ic9e means m$ic9e-- 7,a7
 t is ne$$ to protect ! ,am]ican public 
at all times1 includ+ f outbreaks (     
em]g+ infecti\s diseases1 su* z         
,,covid-#ai1 z well z *emical1          
biological1 radiological1 & nucle>      
?reats2 &  7,b7 ( :i* suffici5t &       
reliable1 long-t]m dome/ic production ( 
^! products1 mo/ly g5]ic drugs1 _!      
active ph>maceutical +r$i5ts1 & key />t+
 mat]ials1 is ne$$ to m9imize pot5tial  
%ortages by r$uc+ ! ,nation's dep5d5ce  
on =eign manufactur]s ( ^! products4    
7#c7 ,! t]m m$ical c\nt]measure means-- 
7,a7 a qualifi$ c\nt]measure 7z def9$ 9 
section #cai;,f-#a ( ! ,public ,heal?   
,s]vice ,act 7#db ,u4,s4,c4             
#bdg;d-#f;a772  7,b7 a qualifi$ p&emic  
or epidemic product 7z def9$ 9 section  
#cai;,f-#c ( su* ,act 7#db ,u4,s4,c4    
#bdg;d-#f;d772  7,c7 a security         
c\nt]measure 7z def9$ 9 section         
#cai;,f-#b ( su* ,act 7#db ,u4,s4,c4    

#bdg;d-#f;b772 or  7,d7 p]sonal         
protective equipm5t 7su* z gloves1      
respirators 7face masks71 & v5tilators74
  7#d7 ,! t]m ,public ,heal? ,indu/rial 
,base means ! facilities & associat$    
work=ces )9 ! ,unit$ ,/ates1 includ+    
rese>* & developm5t facilities1 t help  
produce ess5tial m$ic9es1 m$ical        
c\nt]measures1 & critical inputs = !    
heal? c>e & public heal? sector4  #d4   
,requir+ box$ w>n+s on pot5tially       
contam9at$ drugs  7a7 ,9 g5]al ,!       
,secret>y ( ,heal? & ,human ,s]vices1   
act+ ?r\gh ! ,commission] ( ,food &     
,drugs1 %all-- 7#a7 issue an ord] deem+ 
a drug or active ph>maceutical +r$i5t   
7or a category !re(7 to be misbr&$ )9 ! 
mean+ ( section #ejb ( ! ,f$]al ,food1  
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#ceb7 if su* drug or active             
ph>maceutical +r$i5t 7or category       
!re(7-- 7,a7 is manufactur$ 9 a c\ntry t
 ! ,secret>y det]m9es may be produc+    
contam9at$ drugs or active ph>maceutical
 +r$i5ts because ( sy/emic problems (   

sup]vision 9 ! manufacture ( drugs or   
active ph>maceutical +r$i5ts2 &  7,b7 ! 
label+ ( su* drug or active             
ph>maceutical +r$i5t 7or category !re(7 
does n be> a box$ w>n+ ( ! pot5tial =   
contam9ation2  7#b7 make ea* su* ord]   
effective = a p]iod ( n m ?an #ahj days2
 &  7#c7 r5ew ea* su* ord] ea* "t !     
prec$+ ord] ends & ! crit]ia li/$ 9     
p>agraph 7#a7 cont9ue to apply4  7b7    
,waiv]s ,! ,secret>y ( ,heal? & ,human  
,s]vices1 act+ ?r\gh ! ,commission] (   
,food & ,drugs-- 7#a7 may waive !       
requirem5t to issue or r5ew an ord] "u  
subsection 7a7 s long z ! label+ ( !    
drug or active ph>maceutical +r$i5t 7or 
category !re(7 be>s a box$ w>n+ ( !     
pot5tial = contam9ation2  7#b7 %all make
 any su* waiv] effective = a p]iod n to 
exce$ #ahj days2 &  7#c7 may r5ew any   
su* waiv] "o or m times4  #e4           
,limitation on waiv] au?ority "u !      
,trade ,agreem5ts ,act ( #aigi ,section 
#cja ( ! ,trade ,agreem5ts ,act ( #aigi 
7#ai ,u4,s4,c4 #beaa7 is am5d$ by add+  

at ! end ! foll[+3  7g7 ,limitation on  
waiv] au?ority relat+ to ess5tial       
m$ic9es1 m$ical c\nt]measures1 &        
critical inputs  7#a7 ,9 g5]al ,!       
au?ority ( ! ,presid5t "u subsection 7a7
 to waive ! application ( any law1      
regulation1 proc$ure1 or practice reg>d+
 ,gov]nm5t procurem5t does n au?orize ! 
waiv] ( any pref]5ces = goods t are     
ess5tial m$ic9es1 m$ical c\nt]measures1 
or critical inputs4  7#b7 ,def9itions ,9
 ?is subsection1 ! t]ms ess5tial        
m$ic9es1 m$ical c\nt]measures1 &        
critical inputs-- 7,a7 h ! mean+s giv5  
su* t]ms 9 section #c7;c7 ( ! ,safe     
,m$ic9e ,act2 &  7,b7 include ! #bbg    
ess5tial m$ic9es1 m$ical c\nt]measures1 
& critical inputs publi%$ on ,octob]    
#cj1 #bjbj1 by ! ,food & ,drug          
,adm9i/ration 9 accordance ) ,executive 
,ord] #acidd4  4