,,ii  #aaith ,,congress  #b;d ,session  
,s4 #cghh  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,february #e1  
#bjbf ,mr4 ,scott of ,florida 7for      
himself1 ,mrs4 ,gillibrand1 ,mr4        
,tuberville1 ,mrs4 ,britt1 and ,mr4     
,johnson7 introduced the following bill2
 which was read twice and referred to   
the ,committee on ,health1 ,education1  
,labor1 and ,pensions  ,a ,,bill  ,to   
amend the ,federal ,food1 ,drug1 and    
,cosmetic ,act to require drug labeling 
to include original manufacturer and    
supply chain information4  #a4 ,short   
title ,this ,act may be cited as the    
,consumer ,labeling for ,enhanced ,,api 
,reporting and ,legitimate              
,accountability for ,base ,entity       
,listings ,act or the ,,clear ,,labels  
,act4  #b4 ,require drug labeling to    
include original manufacturer and supply
 chain information ,section #ejb7;b7 of 
the ,federal ,food1 ,drug1 and ,cosmetic
 ,act 7#ba ,u4,s4,c4 #ceb7;b77 is       
amended--  7#a7 by striking containing  

7#a7 the name and place of business of  
the manufacturer1 packer1 or distributor
 and inserting the following3           
8containing--  7,a7 the name1 place of  
business1 and unique facility identifier
 of the manufacturer1 packer1 or        
distributor or a link1 barcode1 ,,qr    
code1 or other means to access a        
searchable electronic portal containing 
such information  2  7#b7 in clause 7,a7
 7as so designated71 by striking 7#b7 an
 accurate and inserting the following3  
7,b7 an accurate  2  7#c7 in clause 7,b7
 7as so designated71 by striking count3 
,provided1 ,that under clause 7#b7 of   
this paragraph reasonable variations and
 inserting count1 provided that under   
this clause1 reasonable variations2     
7#d7 by striking 7b7 ,if in a package   
form and inserting the following3  7b7  
7#a7 ,if it is a finished drug product  
in a package form  2 and  7#e7 by adding
 at the end the following3  7#b7 ,if it 
is an active pharmaceutical ingredient1 
unless any accompanying label and       

certificate of analysis contains the    
name1 place of business1 and unique     
facility identifier of the original     
manufacturer4  7#c7 7,a7 ,if it is a    
finished drug product1 unless its       
labeling contains the name1 place of    
business1 and unique facility identifier
 of--  7i7 the original manufacturer of 
each active pharmaceutical ingredient2  
7ii7 the original manufacturer of the   
finished drug product2 and  7iii7 the   
packer or distributor1 if any1  or a    
link1 barcode1 ,,qr code1 or other means
 to access a searchable electronic      
portal containing such information4     
7,b7 ,in the case of a finished drug    
product for which there are multiple    
potential different manufacturers of the
 active pharmaceutical ingredient1 the  
requirements of this subparagraph shall 
be satisfied if all such manufacturers  
of active pharmaceutical ingredients for
 the drug product are identified in the 
labeling or the searchable electronic   
portal4  7#d7 ,a manufacturer1 packer1  

or distributor required to furnish      
information under paragraphs 7#a71 7#b71
 and 7#c71 in addition to making such   
information available electronically1 as
 applicable1 shall make such information
 available through a package insert1 or 
in paper copy to any individual who     
requests such a copy4  7#e7 ,for        
purposes of this subsection1 the term   
original manufacturer1 means the single 
last establishment to conduct           
substantial manufacturing activities    
prior to introduction of the active     
pharmaceutical ingredient or finished   
drug product into interstate commerce4  
7#f7 ,the ,secretary shall issue        
regulations to implement subparagraphs  
7#b7 and 7#c7 and may provide for       
reasonable variations in the            
implementation of1 or an alternative    
placement for1 the labeling requirements
 under such subparagraphs1 including by 
electronic means4 ,such regulations     
shall take effect on a date determined  
by the ,secretary and not earlier than  

#a year after the date of publication of
 the final regulations1 and shall apply 
with respect to drugs manufactured on or
 after the effective date of such       
regulations4  4  #c4 ,exemption from    
customs country of origin marking       
requirement ,section #cjd of the ,tariff
 ,act of #aicj 7#ai ,u4,s4,c4 #acjd7 is 
amended by adding at the end the        
following3  7m7 ,marking of certain     
finished drug products ,the marking     
requirements of subsections 7a7 and 7b7 
shall not apply to articles that are    
finished drug products and are marked in
 accordance with the requirements of    
section #ejb7;b77#b77;,a7 of the        
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #ceb7;b77#b77;,a774 
4