,,ii ,cal5d> ,no4 #ebc #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 ,johnson1
 ,mrs4 ,moody1 ,mr4 ,lee1 ,mr4 ,cram]1  
,mr4 ,ris*1 ,mr4 ,grassley1 ,mr4        
,ricketts1 ,ms4 ,ern/1 & ,mr4 ,arm/rong7
 introduc$ ! foll[+ bill2 :i* 0 read    
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,july #bg1 #bjbf,report$ by ,mr4        
,cassidy1 ) an amendment,strike out all 
aft] ! enact+ clause & ins]t ! "p pr9t$ 
9 italic  ,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$]al ,food1 ,drug1 & ,cosmetic    
,act 7#ba ,u4,s4,c4 #ceb7;b77#b77;,a774 
4  #a4 ,%ort title ,?is ,act may be cit$
 z ! ,consum] ,label+ = ,enhanc$ ,,api  
,report+ & ,legitimate ,acc\ntability = 
,base ,entity ,li/+s ,act or ! ,,cle>   
,,labels ,act4  #b4 ,require drug labels
 to include orig9al manufactur] & supply
 *a9 in=mation ,section #ejc ( ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cec7 is am5d$ by add+ at !   
end ! foll[+ --  7i7 ,orig9al           
,manufactur] & ,supply ,*a9 ,in=mation  
7#a7 ,9 g5]al ,no p]son %all introduce  
or deliv] = introduction into int]/ate  
comm]ce any drug-- 7,a7 if x is an      
active ph>maceutical +r$i5t1 unless !   
label & c]tificate ( analysis conta9 !  
"n & place ( bus9ess ( ! orig9al        

manufactur]2 or  7,b7 if x is a f9i%$   
drug product 9 a package =m1 unless !   
label includes1 ei!r pr9t$ directly or  
made available ?r\gh electronic means1 !
 "n & place ( bus9ess (-- 7i7 ! orig9al 
manufactur] ( ea* active ph>maceutical  
+r$i5t2  7ii7 ! orig9al manufactur] ( ! 
f9i%$ drug product2 &  7iii7 ! pack] or 
di/ributor1 if any4  7#b7 ,multiple     
orig9al manufactur]s ,9 ! case ( a f9i%$
 drug product = :i* !re are multiple    
diff]5t orig9al manufactur]s ( an active
 ph>maceutical +r$i5t1 ! requirem5ts (  
p>agraph 7#a77;,b77i7 %all be satisfi$  
if ! label includes1 ei!r pr9t$ directly
 or made available ?r\gh electronic     
means1 ! "n & place ( bus9ess ( ea*     
applicable orig9al manufactur] ( !      
active ph>maceutical +r$i5t = !         
applicable drug product lot4  7#c7      
,effect ( noncompliance ,9 ! case (     
noncompliance ) ! requirem5ts ( p>agraph
 7#a71 ! ,secret>y %all h discretion to 
det]m9e t su* noncompliance con/itutes  
misbr&+ & to assess a civil monet>y     

p5alty1 z describ$ 9 section            
#cjc7;f77#aj71 except t ! ,secret>y may 
n treat a violation ( ?is subsection z a
 crim9al violation4  7#d7 ,def9ition (  
orig9al manufactur] ,= purposes ( ?is   
subsection1 ! t]m orig9al manufactur]   
means ! e/abli%m5t t conducts ! majority
 ( ! significant phases ( manufactur+   
7*emical1 physical1 or biological       
manipulation7 to produce ! active       
ph>maceutical +r$i5t or ! f9i%$ dosage  
=m4  4  #c4 ,p5alties  7a7 ,9 g5]al     
,section #cjc7;f7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#ccc7;f77 is am5d$ by add+ at ! end !   
foll[+3  7#aj7 7,a7 ,any p]son :o fails 
to comply ) ! requirem5ts ( section     
#ejc7;i7 %all be subject to a civil     
monet>y p5alty 9 an am\nt n to exce$ #be
 p]c5t ( ! total value ( ! drug product 
lot or lots involv$4  7,b7 ,9 det]m9+   
:e!r to assess a p5alty "u ?is p>agraph 
aga9/ a p]son1 & ! am\nt ( su* a p5alty1
 ! ,secret>y %all consid]-- 7i7 ! size (
 ! bus9ess ( su* p]son & ! gravity ( !  

violation2  7ii7 :e!r su* p]son receiv$ 
writt5 notice ( ! noncompliance 9       
advance ( su* proce$+ & 0 provid$ an    
opportunity by ! ,secret>y to correct ! 
violation foll[+ su* notice2 &  7iii7   
:e!r su* p]son act$ 9 good fai? to      
correct ! violation foll[+ any su*      
notice4  4  7b7 ,con=m+ am5dm5ts        
,section #cjc7;f77#e77;,a7 ( ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #ccc7;f77#e77;,a77 is am5d$ by
 /rik+ 7#a71 7#b71 7#c71 7#d71 or 7#i7 &
 ins]t+ 7#a71 7#b71 7#c71 7#d71 7#i71 or
 7#aj74  #d4 ,ag5cy coord9ation reg>d+  
,,fda & cu/oms c\ntry ( orig9           
requirem5ts ,9 c>ry+ out ! am5dm5ts made
 by ?is ,act1 ! ,commission] ( ,food &  
,drugs %all coord9ate ) ! ,commission] (
 ,u4,s4 ,cu/oms & ,bord] ,protection on 
ef=ts to address ! pot5tial adm9i/rative
 burd5 on manufactur]s ( active         
ph>maceutical +r$i5ts & f9i%$ drug      
products relat$ to any pot5tial ov]lap  
)1 or duplication or conflict betwe51 ! 
requirem5ts ( su* am5dm5ts & section    

#cjd ( ! ,t>iff ,act ( #aicj 7#ai       
,u4,s4,c4 #acjd74 ,su* coord9ation may  
include ! e/abli%m5t ( me*anisms to     
facilitate ! %>+ ( relevant in=mation   
betwe5 ! ,food & ,drug ,adm9i/ration &  
,u4,s4 ,cu/oms & ,bord] ,protection to  
ensure compliance ) su* am5dm5ts & su*  
section #cjd1 & jo9t rulemak+1 if       
det]m9$ by su* commission]s to be       
appropriate4  #e4 ,confid5tiality ,no?+ 
9 ! am5dm5ts made by ?is ,act %all be   
con/ru$ z au?oriz+ ! ,secret>y ( ,heal? 
& ,human ,s]vices 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  #f4 ,effective    
date ,! am5dm5ts made by ?is ,act %all  
apply to active ph>maceutical +r$i5ts & 
f9i%$ drug products t are manufactur$ & 
packag$ on or aft] ! date t is #e ye>s  
aft] ! date ( enactm5t ( ?is ,act4      
,july #bg1 #bjbf,report$ ) an am5dm5t