,i  #aai? ,,congress  #b;d ,session  ,h4
 ,r4 #hbfi  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,april #ad1 #bjbf,mr4 
,mc,cormick 7= himself & ,ms4 ,de,lauro7
 introduc$ ! foll[+ bill2 :i* 0 ref]r$  
to ! ,committee on ,ways & ,means1 & 9  
addition to ! ,committee on ,en]gy &    
,comm]ce1 = 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 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$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#ceb7;b77 is am5d$ to read z foll[s3    
7b7  7#a7 ,if x is a f9i%$ drug product 

9 a package =m1 unless x be>s a label   
conta9+-- 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=mation2 &  7,b7 an       
accurate /atem5t ( ! quantity ( !       
cont5ts 9 t]ms ( weight1 measure1 or    
num]ical c\nt1 provid$ t "u ?is clause  
reasonable v>iations %all be p]mitt$1 & 
exemptions z to small packages %all be  
e/abli%$1 by regulations prescrib$ by ! 
,secret>y4  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 subp>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 p>agraph1 ! 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#c77;,a7 ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act4  4