,,ii  #aag? ,,congress  #a/ ,session    
,s4 #beie  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,augu/ #d1 #bjba,mr4   
,c>d9 7= himself & ,ms4 ,smi?7 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$ %elf life dates =   
ess5tial drugs  7a7 ,9 g5]al ,a         
manufactur] ( a drug subject to         
notification requirem5ts "u section     
#ejf;,c7a7 7ref]r$ to 9 ?is section z an
 ess5tial drug7 %all-- 7#a7 submit to ! 
,secret>y data & in=mation z requir$ by 

subsection 7b77#a72  7#b7 conduct &     
submit ! results ( 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 ess5tial drug to      
submit1 9 su* mann] z ! ,secret>y may   
prescribe1 data & in=mation f any /age (
 developm5t ( ! drug t are adequate to  
assess ! %elf life /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] ( an ess5tial drug
 to1 by a specifi$ date1 make any label+
 *ange reg>d+ ! expiration p]iod t !    
,secret>y det]m9es to be appropriate    
bas$ on ! data & in=mation requir$ to be
 submitt$ "u ?is section or any o!r data
 & in=mation available to ! ,secret>y 9 
accordance ) label+ requirem5ts "u      
subp>t ,g ( "p #baa ( title #ba1 ,code (
 ,f$]al ,regulations 7or any successor  
regulations74  7d7 ,confid5tiality ,no?+
 9 ?is section %all be con/ru$ 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  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 ,if a drug

 manufactur] fails to submit data &     
in=mation z requir$ "u section          
#ejf;,c-#b7;b77#a71 fails to conduct or 
submit ! results ( /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  4  7c7 ,,gao ,/udy (
 %elf life data ,n lat] ?an #b ye>s aft]
 ! date ( enactm5t ( ?is ,act1 !        
,comptroll] ,g5]al ( ! ,unit$ ,/ates    
%all conduct a /udy exam9+ ! process by 
:i* prescription drug manufactur]s      
submit data on %elf life to ! ,food &   
,drug ,adm9i/ration4 ,9 c>ry+ out ?is   
/udy1 ! ,comptroll] ,g5]al %all consid] 
:e!r manufactur]s adequately te/ ! %elf 
life /ability ( _! drug products subject
 to section #baa4aff ( title #ba1 ,code 
( ,f$]al ,regulations 7or any successor 
regulations74  7d7 ,%elf life /ability  
guidance ,n lat] ?an #f mon?s aft] !    
date ( enactm5t ( ?is ,act1 ! ,secret>y 

%all publi% = notice & comm5t 9 ! ,f$]al
 ,regi/] updates to /ability te/+ "u    
section #baa4aff ( title #ba1 ,code (   
,f$]al ,regulations 7or any successor   
regulations74  #c4 ,quality ,managem5t  
,maturity ,/]ile ,injectable ,drug      
,pilot ,program  7a7 ,quality ,managem5t
 ,maturity ,/]ile ,injectable ,drug     
,pilot ,program  7#a7 ,9 g5]al ,n lat]  
?an #f mon?s aft] ! date ( enactm5t (   
?is ,act1 ! ,secret>y ( ,heal? & ,human 
,s]vices 7ref]r$ to 9 ?is section z !   
,secret>y71 act+ ?r\gh ! ,commission] ( 
,food & ,drugs1 %all comm5ce ! ,quality 
,managem5t ,maturity 7,,qmm7 ,/]ile     
,injectable ,drug ,pilot ,program       
7ref]r$ to 9 ?is section z ! pilot      
program7 "u ?is section4 ,"u su*        
program1 ! ,secret>y %all-- 7,a7 select 
eligible drug manufactur]s to p>ticipate
 9 ! program 9 accordance ) p>agraph    
7#b72 &  7,b7 contract ) a ?ird-p>ty    
contractor to develop a ,,qmm assessm5t 
tool & conduct assessm5ts1 9 coop]ation 
) /aff ( ! ,food & ,drug ,adm9i/ration1 

( ea* p>ticipant's quality managem5t    
sy/em4  7#b7 ,eligibility ,to be        
eligible to p>ticipate 9 ! pilot program
 "u ?is section1 a manufactur] %all--   
7,a7 be a =-pr(it or nonpr(it entity2   
7,b7 manufacture a prescription drug t  
is a /]ile injectable drug2  7,c7       
manufacture a drug t is deem$ an        
ess5tial m$ic9e "u ,executive ,ord]     
#acidd 7#he ,f$4 ,reg4 #diibi72  7,d7 h 
receiv$ a f9al classification ( ,no     
,action ,indicat$ or ,volunt>y ,action  
,indicat$ ) respect to all inspections (
 all manufactur+ facilities ( ! entity  
conduct$ by ! ,food & ,drug             
,adm9i/ration )9 ! #e-ye> p]iod         
imm$iately prec$+ ! date ( enactm5t (   
?is ,act2  7,e7 be a p]son :o has       
regi/]$ "o or m e/abli%m5ts "u          
subsection 7b77#a7 or 7i77#a7 ( section 
#eaj ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act 7#ba ,u4,s4,c4 #cfj71 )  
respect to ! manufacture ( a            
prescription drug describ$ 9 subp>agraph
 7,b72 &  7,f7 agree to-- 7i7 p]mit a   

?ird-p>ty contractor to conduct regul>  
assessm5ts "u ! ,,qmm pilot program1 z  
describ$ 9 p>agraph 7#c71 ei!r on-site  
or remotely2  7ii7 collect & submit     
metrics data to ! ,food & ,drug         
,adm9i/ration & ! contractor by an agre$
 ^u date1 prior to ea* assessm5t        
describ$ 9 clause 7i72 &  7iii7 be      
available = consultations ) ! ?ird-p>ty 
contractor & ! ,food & ,drug            
,adm9i/ration prior to & aft] ea*       
assessm5t describ$ 9 clause 7i71 includ+
 discussions reg>d+ ! p>ticipant's      
e/abli%$ ,,qmm-relat$ activities & !    
contractor's po/-assessm5t              
recomm5dations reg>d+ ^! activities4    
7#c7 ,assessm5ts ,assessm5ts t are      
conduct$ jo9tly by a ?ird-p>ty          
contractor1 9 coop]ation ) /aff ( !     
,food & ,drug ,adm9i/ration1 w regul>ly 
conduct manufactur] facility assessm5ts 
to det]m9e ! manufactur]'s quality      
managem5t maturity progress or /atus4   
,pilot program assessm5ts w cov]        
multiple topics & %all include-- 7,a7   

supply *a9 managem5t2  7,b7 manufactur+ 
/rategy & op]ations2  7,c7 safety1      
environm5tal1 & regulatory compliance2  
7,d7 inv5tory managem5t2  7,e7 p]=mance 
managem5t & cont9ual improvem5t2  7,f7  
risk managem5t2  7,g7 managem5t review &
 responsibility2  7,h7 plann+2  7,i7    
work=ce managem5t2  7,j7 quality        
culture2 &  7,k7 cu/om] exp]i5ce4  7#d7 
,program duration ,n lat] ?an #f mon?s  
aft] ! date ( enactm5t ( ?is ,act1 !    
,secret>y %all publi% in/ructions =     
applicants 9 ! ,f$]al ,regi/]4 ,su*     
in/ructions %all include a timel9e = !  
application p]iod = su* program1 & a    
#a-ye> timel9e = ! pilot program foll[+ 
su* application p]iod4  7b7 ,report to  
,congress ,n lat] ?an #f mon?s aft] !   
completion ( ! pilot program1 !         
,secret>y %all submit a report to       
,congress on su* pilot program4 ,su*    
report %all include-- 7#a7 a summ>y (   
?ird-p>ty assessm5ts ( ea* p>ticipat+   
manufactur]'s quality managem5t sy/em2  
7#b7 recomm5dations on next /eps t[>ds  

develop+ a publicly available ,food &   
,drug ,adm9i/ration rat+ sy/em = quality
 managem5t maturity sy/ems ( /]ile      
injectable drug manufactur+ facilities1 
includ+ specific drugs manufactur$ at   
ea* facility2  7#c7 consid]ations !     
,food & ,drug ,adm9i/ration may take 9  
updat+ guidance ( curr5t good           
manufactur+ practice ( /]ile injectable 
drug products2 &  7#d7 recomm5dations on
 incorporat+ pilot programs 7or relat$  
"w7 describ$ 9 ! guidances entitl$1     
,quality ,managem5t ,maturity = ,f9i%$  
,dosage ,=ms ,pilot ,program = ,dome/ic 
,drug ,product ,manufactur]s2 ,program  
,ann\ncem5t1 issu$ by ! ,food & ,drug   
,adm9i/ration on ,octob] #af1 #bjbj 7#he
 ,f$4 ,reg4 #fehbd71 & ,quality         
,managem5t ,maturity = ,active          
,ph>maceutical ,+r$i5ts ,pilot ,program 
= ,=eign ,facilities2 ,program          
,ann\ncem5t1 issu$ by ! ,food & ,drug   
,adm9i/ration on ,octob] #af1 #bjbj 7#he
 ,f$4 ,reg4 #fehbh71 into publicly      
available ,food & ,drug ,adm9i/ration   

rat+ sy/ems = ov]all quality managem5t  
maturity sy/ems4  7c7 ,def9ition ,9 ?is 
section1 ! 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$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cec7;g77 ^: prim>y mode 
( action is t ( a drug or biological    
product1 ^: manufactur+1 di/ribution1 & 
adm9i/ration processes require /]ile    
conditions4  #d4 ,improv$ data %>+3     
ensur+ timely & in=mative notification  
7a7 ,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  7fff7 ,failure ,to       
provide timely & in=mative notification 
,any manufactur] :o violates a          
requirem5t ( ?is ,act t relates to      
critical drugs by fail+ to provide      

timely1 adequate in=mation relat$ to    
drug %ortages pursuant to section       
#ejf;,c7a7 %all be subject to a civil   
p5alty 9 an am\nt n to exce$ #ej1jjj p] 
violation4  4  7b7 ,regulations ,n lat] 
?an #a ye> aft] ! date ( ! enactm5t (   
?is ,act1 ! ,secret>y %all promulgate   
f9al regulations to c>ry out section    
#cja7;fff7 ( ! ,f$]al ,food1 ,drug1 &   
,cosmetic ,act1 z add$ by subsection    
7a74  #e4 ,support+ cont9u\s manufactur+
 to prev5t %ortages = susceptible drugs 
,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]vices1 act+ ?r\gh !  
,commission] ( ,food & ,drugs1 %all     
solicit &1 beg9n+ n lat] ?an "o ye> aft]
 ! date ( enactm5t ( ! ,drug ,%ortages  
,prev5tion & ,quality ,improvem5t ,act1 
receive1 reque/s f in/itutions ( high]  
education & 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$ic9e "u ,executive ,ord] #acidd2  7#b7
 is a /]ile injectable drug2 &  7#c7 is 
vuln]able to %ortage4  7c7 ,grant       
selection ,z a condition = accept+ a    
grant "u ?is section1 an in/itution (   
high] education & nonpr(it entity %all  
agree to p>ticipate 9 ! ,quality        
,managem5t ,maturity ,/]ile ,injectable 
,drug ,pilot ,program e/abli%$ "u       
section #c ( ! ,drug ,%ortages          
,prev5tion & ,quality ,improvem5t ,act4 
7d7 ,au?orization ( appropriations ,to  
c>ry out ?is section1 !re is au?oriz$ to
 be appropriat$ #a1jjj1jjj1jjj = ! p]iod
 ( fiscal ye>s #bjbb ?r\gh #bjbg4  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 way 
7su* z cont9u\s manufactur+ :]e ! input 
mat]ials are cont9u\sly trans=m$ )9 !   
process by #b or m unit op]ations7 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 ^: manufactur+1 di/ribution1 & 
adm9i/ration processes require /]ile    
conditions4  4