,,ii  #aah? ,,congress  #a/ ,session    
,s4 #behf  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,july #bg1 #bjbc,mr4   
,c>d9 7= himself1 ,ms4 ,smi?1 & ,mr4    
,blum5?al7 introduc$ ! foll[+ bill2 :i* 
0 read twice & ref]r$ to ! ,committee on
 ,heal?1 ,education1 ,labor1 & ,p5sions 
,a ,,bill  ,to address prescription drug
 %ortages & improve ! quality (         
prescription drugs1 & = o!r purposes4   
#a4 ,%ort title ,?is ,act may be cit$ z 
! ,drug ,%ortages ,prev5tion & ,quality 
,improvem5t ,act4  #b4 ,l5g!n expiration
 dates to mitigate critical drug        
%ortages  7a7 ,9 g5]al ,! ,f$]al ,food1 
,drug1 & ,cosmetic ,act is am5d$ by     
ins]t+ aft] section #ejf;,c-#a 7#ba     
,u4,s4,c4 #cef;c-#a7 ! foll[+3          
#ejf;,c-#b4 ,ext5d$ expiration dates =  
life-sav+ drugs  7a7 ,9 g5]al ,a        
manufactur] ( a life-sav+ drug %all--   
7#a7 submit to ! ,secret>y data &       
in=mation z requir$ by subsection       
7b77#a72  7#b7 conduct & submit !       
results1 data1 & in=mation ( any /udies 

requir$ "u subsection 7b77#b72 &  7#c7  
make any label+ *ange describ$ 9        
subsection 7c7 by ! date specifi$ by !  
,secret>y pursuant to su* subsection4   
7b7 ,notification  7#a7 ,9 g5]al ,!     
,secret>y may issue an ord] requir+ !   
manufactur] ( any life-sav+ drug to     
submit1 9 su* mann] z ! ,secret>y may   
prescribe1 data & in=mation f any /age (
 developm5t ( ! drug t are adequate to  
assess ! /ability ( ! drug to det]m9e ! 
longe/ support$ expiration date4  7#b7  
,unavailable or insuffici5t data &      
in=mation ,if ! data & in=mation requir$
 pursuant to an ord] issu$ "u p>agraph  
7#a7 are n available or are insuffici5t1
 ! ,secret>y may require ! manufactur] (
 ! drug to-- 7,a7 conduct /udies        
adequate to provide ! data & in=mation 9
 accordance ) section #baa4aff ( title  
#ba1 ,code ( ,f$]al ,regulations 7or any
 successor regulations72 &  7,b7 submit 
to ! ,secret>y ! results1 data1 &       
in=mation g5]at$ by su* /udies :5       
available4  7c7 ,label+ ,! ,secret>y may

 issue an ord] requir+ ! manufactur] ( a
 life-sav+ drug to1 by a specifi$ date1 
make any label+ *ange reg>d+ !          
expiration date t ! ,secret>y det]m9es  
to be appropriate bas$ on ! data &      
in=mation requir$ to be submitt$ "u ?is 
section 9 accordance ) label+           
requirem5ts "u subp>ts ,f & ,g ( "p #baa
 ( title #ba1 ,code ( ,f$]al            
,regulations 7or any successor          
regulations7 or any o!r data & in=mation
 available to ! ,secret>y4  7d7         
,confid5tiality ,no?+ 9 ?is section %all
 be con/ru$ z au?oriz+ ! ,secret>y to   
disclose any in=mation t is a trade     
secret or confid5tial in=mation subject 
to section #eeb7;b77#d7 ( title #e1     
,unit$ ,/ates ,code1 or section #aije ( 
title #ah1 ,unit$ ,/ates ,code4  7e7    
,def9ition ,9 ?is section1 ! t]m        
life-sav+ drug means a drug describ$ 9  
section #ejf;,c7a74  4  7b7 ,civil      
monet>y p5alty ,section #cjc7;b7 ( !    
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #ccc7;b77 is am5d$ by    

add+ at ! end ! foll[+3  7#i7 7,a7 ,if a
 manufactur] fails to submit data &     
in=mation z requir$ "u section          
#ejf;,c-#b7;b77#a71 fails to conduct or 
submit ! results1 data1 & in=mation     
g5]at$ by /udies z requir$ "u section   
#ejf;,c-#b7;b77#c71 or fails to make a  
label+ *ange z requir$ "u section       
#ejf;,c-#b7;c71 su* manufactur] %all be 
liable to ! ,unit$ ,/ates = a civil     
p5alty 9 an am\nt n to exce$ #aj1jjj =  
ea* su* violation4  7,b7 ,if a violation
 describ$ 9 subp>agraph 7,a7 is n       
correct$ )9 ! #cj-;day p]iod foll[+     
notification by ! ,secret>y ( a         
violation describ$ 9 subp>agraph 7,a71 !
 manufactur] %all1 9 addition to any    
p5alty "u subp>agraph 7,a71 be subject  
to a civil monet>y p5alty ( n m ?an     
#aj1jjj = ea* day ( ! violation aft] su*
 p]iod until ! violation is correct$4  4
  #c4 ,report+ on increases 9 dem& = a  
drug  7a7 ,9 g5]al ,section #ejf;,c ( ! 
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cef;c7 is am5d$-- 7#a7 9

 ! section head+1 by ins]t+ or increase 
9 dem& = aft] production (2  7#b7 9     
subsection 7a71 9 ! matt] foll[+        
p>agraph 7#b71 by /rik+ drug1 & !       
reasons = su* discont9uance or          
int]ruption & ins]t+ drug1 or increase 9
 ! dem& = su* drug t is likely to lead  
to a %ortage ( ! drug1 & ! reasons = su*
 discont9uance1 int]ruption1 or increase
 9 dem&2  7#c7 9 subsection 7b7-- 7,a7 9
 p>agraph 7#a71 by /rik+ 2 or & ins]t+ a
 semicolon2  7,b7 by r$esignat+ p>agraph
 7#b7 z p>agraph 7#c72  7,c7 by ins]t+  
aft] p>agraph 7#a7 ! foll[+3  7#b7 9 !  
case ( an increase 9 ! dem& = a drug1 n 
lat] ?an #cj days aft] ! manufacture has
 k ( su* increase2 or  2 &  7,d7 9      
p>agraph 7#c71 z s r$esignat$1 by /rik+ 
p>agraph 7#a7 & ins]t+ p>agraph 7#a7 or 
7#b72 &  7#d7 9 subsection 7c71 by      
ins]t+ 1 or increase 9 dem& =1 aft] !   
manufacture (4  7b7 ,prohibit$ act  7#a7
 ,9 g5]al ,section #cja ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cca7 is am5d$ by add+ at !   

end ! foll[+3  7jjj7 ,! failure to      
notify ! ,secret>y z requir$ "u section 
#ejf;,c7a74  4  7#b7 ,en=cem5t ,section 
#cjc ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7;c77 
is am5d$-- 7,a7 9 p>agraph 7c71 by add+ 
be=e ! p]iod at ! end ! foll[+3 2 or    
7#g7 = hav+ violat$ section #cja7;jjj7  
if su* p]son act$ 9 good fai? & _h a    
reasonable basis = n notify+ z requir$  
"u section #ejf;,c2 &  7,b7 by add+ at !
 end ! foll[+3  7h7 ,not)/&+ subsection 
7a71 any manufactur] :o violates section
 #cja7;jjj7 %all be subject to a civil  
p5alty 9 an am\nt n to exce$ #ej1jjj p] 
violation4  4  #d4 ,support+ cont9u\s   
manufactur+ to prev5t %ortages =        
susceptible drugs  7a7 ,9 g5]al         
,subtitle ,b ( title ,,iii ( ! #ba/     
,c5tury ,cures ,act is am5d$ by ins]t+  
aft] section #cjaf 7#ba ,u4,s4,c4       
#cii;h7 ! foll[+3  #cjag4 ,grants =     
cont9u\s manufactur+ to prev5t drug     
%ortages  7a7 ,9 g5]al ,! ,secret>y (   
,heal? & ,human ,s]vices %all solicit &1

 beg9n+ n lat] ?an "o ye> aft] ! date ( 
enactm5t ( ! ,drug ,%ortages ,prev5tion 
& ,quality ,improvem5t ,act1 receive1   
reque/s = grants f in/itutions ( high]  
education or nonpr(it entities engag$ 9 
! manufacture ( /]ile injectable drugs =
 ! purpose ( upgrad+ drug e/abli%m5t to 
cont9u\s manufactur+ or o!r advanc$     
manufactur+ capabilities4  7b7 ,grant   
crit]ia ,an in/itution ( high] education
 or a nonpr(it entity %all be eligible =
 a grant "u ?is section if su*          
in/itution or entity manufactures a drug
 t-- 7#a7 is categoriz$ z an ess5tial   
m$ic9e "u ,executive ,ord] #acidd2  7#b7
 is a /]ile injectable drug2 &  7#c7 is 
vuln]able to %ortage1 includ+ z det]m9$ 
?r\gh notifications submitt$ to !       
,secret>y "u section #ejf;,c4  7c7      
,grant selection ,z a condition =       
accept+ a grant "u ?is section1 an      
in/itution ( high] education & nonpr(it 
entity %all agree to develop & c>ry+ out
 a robu/ plan focus$ on su/a9ability ( !
 cont9u\s manufactur+ or o!r advanc$    

manufactur+ capabilities support$ by !  
grant4  7d7 ,au?orization (             
appropriations ,to c>ry out ?is section1
 9 additional to am\nts o!rwise made    
available = su* purposes1 !re is        
au?oriz$ to be appropriat$              
#a1jjj1jjj1jjj = ! p]iod ( fiscal ye>s  
#bjbd ?r\gh #bjbi4  7e7 ,def9itions ,9  
?is section3 7#a7 ,advanc$ manufactur+  
,! t]m advanc$ manufactur+ means an     
approa* = ! manufactur+ ( drugs t       
incorporates novel te*nology1 or uses an
 e/abli%$ te*nique or te*nology 9 a new 
or innovative t enhances drug quality or
 improves ! manufactur+ process4  7#b7  
,cont9u\s manufactur+ ,! t]m cont9u\s   
manufactur+-- 7,a7 means a process :]e !
 input mat]ials are cont9u\sly f$ into &
 trans=m$ )9 ! process1 & ! process$    
output mat]ials are cont9u\sly remov$ f 
! sy/em2 &  7,b7 consi/s ( an integrat$ 
process t consi/s ( a s]ies ( #b or m   
unit op]ations4  7#c7 ,/]ile injectable 
drug ,! t]m /]ile injectable drug means 
a drug approv$ "u section #eje ( !      

,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee71 a biological      
product lic5s$ "u section #cea ( !      
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb71 or a comb9ation product
 7z describ$ 9 section #ejc7;g7 ( !     
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cec7;g77 ^: prim>y mode 
( action is t ( a drug or biological    
product1 t is int5d$ = injection =      
intrav5\s use ( infusion & ^:           
manufactur+1 di/ribution1 & adm9i/ration
 processes require /]ile conditions4  4 
7b7 ,,gao /udy on quality managem5t     
pur*as+ ,! ,comptroll] ,g5]al ( ! ,unit$
 ,/ates %all conduct a /udy on includ+  
quality managem5t maturity z a factor 9 
prescription drug pur*as+ by ,f$]al     
heal? c>e programs 7z def9$ 9 section   
#aabh;,b7f7 ( ! ,social ,security ,act  
7#db ,u4,s4,c4 #acbj;a-#g;b7f7771 & n   
lat] ?an #b ye>s aft] ! date ( enactm5t 
( ?is ,act1 %all submit a report on su* 
/udy to ,congress4  #e4 ,au?ority to use
 alt]native paym5t "u ! ,m$ic>e program 

= drugs & biologicals to prev5t pot5tial
 drug %ortages  7a7 ,paym5t "u "p ,b    
,section #ahdg;,a7e7 ( ! ,social        
,security ,act 7#db ,u4,s4,c4           
#aciew-#c;a7e77 is am5d$-- 7#a7 by /rik+
 ,paym5t 9 ,response to ,public ,heal?  
,em]g5cy4--,9 ! case & ins]t+           
8,paym5ts4--  7#a7 ,9 response to public
 heal? em]g5cy ,9 ! case  2 &  7#b7 by  
add+ at ! end ! foll[+ new p>agraph3    
7#b7 ,prev5t+ pot5tial drug %ortages    
7,a7 ,9 g5]al ,9 ! case ( a drug or     
biological describ$ 9 subp>agraph 7,b71 
! ,secret>y may use ! :olesale          
acquisition co/ 7or o!r reasonable      
measure ( a drug or biological price7   
in/ead ( ! manufactur]'s av]age sales   
price = qu>t]s beg9n+ on or aft] ! date 
on :i* ! ,secret>y det]m9es ! drug or   
biological is describ$ 9 su* subp>agraph
 & = subsequ5t qu>t]s until ! end ( !   
qu>t] 9 :i* su* drug or biological is   
remov$ f ! drug %ortage li/ "u section  
#ejf;,e ( ! ,f$]al ,food1 ,drug1 &      
,cosmetic ,act1 or 9 ! case ( a drug or 

biological describ$ 9 subp>agraph       
7,b77ii77,,ii71 ! date on :i* !         
,secret>y det]m9es ! manufactur+        
capacity or ! numb] ( manufactur]s ( su*
 drug or biological is suffici5t to     
prev5t a pot5tial %ortage ( ! drug or   
biological4  7,b7 ,drug or biological   
describ$ ,= purposes ( subp>agraph 7,a71
 a drug or biological describ$ 9 ?is    
subp>agraph is a drug or biological--   
7i7 t is life-support+1 life-su/a9+1 or 
int5d$ = use 9 ! prev5tion or treatm5t (
 a debilitat+ disease or condition 7z ^?
 t]ms are def9$ = purposes ( section    
#ejf;,c ( ! ,f$]al ,food1 ,drug1 &      
,cosmetic ,act & is subject to ! report+
 requirem5ts "u section #ejf;,c7b7 ( su*
 ,act71 includ+ any su* drug or         
biological t is us$ 9 em]g5cy m$ical c>e
 or dur+ surg]y2 &  7ii7 7,i7 t is li/$ 
on ! drug & biological %ortage li/      
ma9ta9$ by ! ,food & ,drug ,adm9i/ration
 pursuant to section #ejf;,e ( ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act1 & = :i* 
! manufactur] ( su* drug or biological  

notifies ! ,secret>y ( a p]man5t        
discont9uance or an int]ruption t is    
likely to lead to a mean+ful disruption 
9 ! manufactur]'s supply ( t drug or    
biological pursuant to section          
#ejf;,c7b77#a7 ( su* ,act2 or  7,,ii7 t 
0 li/$ on su* drug & biological %ortage 
li/ )9 ! prec$+ #e ye>s & = :i* !       
manufactur+ capacity ( manufactur]s ) an
 approv$ application = su* drug or      
biological1 or ! numb] ( manufactur]s ) 
an approv$ application = su* drug or    
biological1 decl9es dur+ a #f-mon?      
p]iod1 z det]m9$ by ! ,secret>y4  7,c7  
,provision ( additional in=mation ,= ea*
 qu>t] 9 :i* ! am\nt ( paym5t = a drug  
or biological describ$ 9 subp>agraph    
7,b7 pursuant to subp>agraph 7,a7 exce$s
 ! am\nt ( paym5t = ! drug or biological
 o!rwise applicable "u ?is section1 !   
manufactur] ( su* drug or biological    
%all provide to ! ,secret>y in=mation   
relat$ to ! pot5tial cause or causes ( !
 %ortage & ! expect$ l5g? ( ! %ortage ) 
respect to su* drug4  4  7b7 ,additional

 paym5t "u ,,ipps ,section #ahhf7;d77#e7
 ( ! ,social ,security ,act 7#db        
,u4,s4,c4 #acieww7d77#e77 is am5d$ by   
add+ at ! end ! foll[+ new subp>agraph3 
7,n7 ,! ,secret>y %all e/abli% a modifi]
 or o!r me*anism = purposes ( track+    
utilization ( drugs on ! %ortage li/    
pursuant to section #ejf;,e ( ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act1 & update
 ! modifi] to reflect ! drugs on su* li/
 ea* cal5d> ye>4  4  7c7 ,,gao /udy on  
drug %ortages ,n lat] ?an #b ye>s aft] !
 date ( enactm5t ( ?is ,act1 !          
,comptroll] ,g5]al ( ! ,unit$ ,/ates    
%all-- 7#a7 conduct a /udy on-- 7,a7    
drugs & biologicals = :i* paym5t is made
 "u ! inpati5t prospective paym5t sy/em 
7,,ipps7 "u section #ahhf ( ! ,social   
,security ,act 7#db ,u4,s4,c4 #acieww7 &
 ! hospital outpati5t prospective paym5t
 sy/em 7,,opps7 "u section #ahcc7t7 ( ! 
,social ,security ,act 7#db ,u4,s4,c4   
#aciel7t77 t h be5 on ! %ortage li/ "u  
section #ejf;,e ( ! ,f$]al ,food1 ,drug1
 & ,cosmetic ,act 7#ba ,u4,s4,c4        

#cef;e7c77#b77 9 ! la/ #e ye>s2 &  7,b7 
:e!r any *anges to paym5t "u su* paym5t 
sy/ems w\ld decrease-- 7i7 ! numb] (    
drugs & biologicals on su* %ortage li/2 
or  7ii7 ! frequ5cy ) :i* ! drugs &     
biologicals appe> on su* %ortage li/2 & 
7#b7 submit to ,congress recomm5dations 
= legislation & adm9i/rative actions )  
respect to ! matt]s describ$ 9          
subp>agraphs 7,a7 & 7,b7 ( p>agraph     
7#a74