,,ii  #aai? ,,congress  #b;d ,session   
,s4 #cghh  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,febru>y #e1 #bjbf ,mr4
 ,scott ( ,florida 7= himself1 ,mrs4    
,gillibr&1 ,mr4 ,tub]ville1 ,mrs4       
,britt1 & ,mr4 ,johnson7 introduc$ !    
foll[+ bill2 :i* 0 read twice & ref]r$  
to ! ,committee on ,heal?1 ,education1  
,labor1 & ,p5sions  ,a ,,bill  ,to am5d 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
to require drug label+ to include       
orig9al manufactur] & supply *a9        
in=mation4  #a4 ,%ort title ,?is ,act   
may be cit$ z ! ,consum] ,label+ =      
,enhanc$ ,,api ,report+ & ,legitimate   
,acc\ntability = ,base ,entity ,li/+s   
,act or ! ,,cle> ,,labels ,act4  #b4    
,require drug label+ to include orig9al 
manufactur] & supply *a9 in=mation      
,section #ejb7;b7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#ceb7;b77 is am5d$--  7#a7 by /rik+     
conta9+ 7#a7 ! "n & place ( bus9ess ( ! 
manufactur]1 pack]1 or di/ributor &     
ins]t+ ! foll[+3 8conta9+--  7,a7 ! "n1 

place ( bus9ess1 & unique facility      
id5tifi] ( ! manufactur]1 pack]1 or     
di/ributor or a l9k1 b>code1 ,,qr code1 
or o!r means to access a se>*able       
electronic portal conta9+ su* in=mation 
2  7#b7 9 clause 7,a7 7z s designat$71  
by /rik+ 7#b7 an accurate & ins]t+ !    
foll[+3  7,b7 an accurate  2  7#c7 9    
clause 7,b7 7z s designat$71 by /rik+   
c\nt3 ,provid$1 ,t "u clause 7#b7 ( ?is 
p>agraph reasonable v>iations & ins]t+  
c\nt1 provid$ t "u ?is clause1          
reasonable v>iations2  7#d7 by /rik+ 7b7
 ,if 9 a package =m & ins]t+ ! foll[+3  
7b7  7#a7 ,if x is a f9i%$ drug product 
9 a package =m  2 &  7#e7 by add+ at !  
end ! foll[+3  7#b7 ,if x is an active  
ph>maceutical +r$i5t1 unless any        
accompany+ label & c]tificate ( analysis
 conta9s ! "n1 place ( bus9ess1 & unique
 facility id5tifi] ( ! orig9al          
manufactur]4  7#c7 7,a7 ,if x is a f9i%$
 drug product1 unless its label+ conta9s
 ! "n1 place ( bus9ess1 & unique        
facility id5tifi] (--  7i7 ! orig9al    

manufactur] ( ea* active ph>maceutical  
+r$i5t2  7ii7 ! orig9al manufactur] ( ! 
f9i%$ drug product2 &  7iii7 ! pack] or 
di/ributor1 if any1  or a l9k1 b>code1  
,,qr code1 or o!r means to access a     
se>*able electronic portal conta9+ su*  
in=mation4  7,b7 ,9 ! case ( a f9i%$    
drug product = :i* !re are multiple     
pot5tial diff]5t manufactur]s ( ! active
 ph>maceutical +r$i5t1 ! requirem5ts (  
?is subp>agraph %all be satisfi$ if all 
su* manufactur]s ( active ph>maceutical 
+r$i5ts = ! drug product are id5tifi$ 9 
! label+ or ! se>*able electronic       
portal4  7#d7 ,a manufactur]1 pack]1 or 
di/ributor requir$ to furni% in=mation  
"u p>agraphs 7#a71 7#b71 & 7#c71 9      
addition to mak+ su* in=mation available
 electronically1 z applicable1 %all make
 su* in=mation available ?r\gh a package
 ins]t1 or 9 pap] copy to any individual
 :o reque/s su* a copy4  7#e7 ,=        
purposes ( ?is subsection1 ! t]m orig9al
 manufactur]1 means ! s+le la/          
e/abli%m5t to conduct sub/antial        

manufactur+ activities prior to         
introduction ( ! active ph>maceutical   
+r$i5t or f9i%$ drug product into       
int]/ate comm]ce4  7#f7 ,! ,secret>y    
%all issue regulations to implem5t      
subp>agraphs 7#b7 & 7#c7 & may provide =
 reasonable v>iations 9 ! implem5tation 
(1 or an alt]native placem5t =1 ! label+
 requirem5ts "u su* subp>agraphs1       
includ+ by electronic means4 ,su*       
regulations %all take effect on a date  
det]m9$ by ! ,secret>y & n e>li] ?an #a 
ye> aft] ! date ( publication ( ! f9al  
regulations1 & %all apply ) respect to  
drugs manufactur$ on or aft] ! effective
 date ( su* regulations4  4  #c4        
,exemption f cu/oms c\ntry ( orig9 m>k+ 
requirem5t ,section #cjd ( ! ,t>iff ,act
 ( #aicj 7#ai ,u4,s4,c4 #acjd7 is am5d$ 
by add+ at ! end ! foll[+3  7m7 ,m>k+ ( 
c]ta9 f9i%$ drug products ,! m>k+       
requirem5ts ( subsections 7a7 & 7b7 %all
 n apply to articles t are f9i%$ drug   
products & are m>k$ 9 accordance ) !    
requirem5ts ( section #ejb7;b77#b77;,a7 

( ! ,f$]al ,food1 ,drug1 & ,cosmetic    
,act 7#ba ,u4,s4,c4 #ceb7;b77#b77;,a774 
4