,,ii  #aad? ,,congress  #a/ ,session    
,s4 #bbad  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,octob] #bh1 #bjae     
,mrs4 ,gillibr& 7= h]self1 ,ms4 ,w>r51  
,ms4 ,/ab5[1 ,mr4 ,br[n1 & ,mr4         
,blum5?al7 introduc$ ! foll[+ bill2 :i* 
0 read twice & ref]r$ to ! ,committee on
 ,heal?1 ,education1 ,labor1 & ,p5sions 
,a ,,bill  ,to am5d ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act to require      
pati5t m$ication in=mation to be provid$
 ) c]ta9 prescription drugs4  #a4 ,%ort 
title  ,?is ,act may be cit$ z ! ,cody  
,mill] ,pati5t ,m$ication ,in=mation    
,act4  #b4 ,pati5t m$ication in=mation =
 prescription drugs ,*apt] ,v ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act 7#ba    
,u4,s4,c4 #cea et seq47 is am5d$ by     
ins]t+ aft] section #eje;,e ! foll[+3   
#eje;,f4 ,pati5t m$ication in=mation =  
prescription drugs  7a7 ,9 g5]al ,n lat]
 ?an #b ye>s aft] ! date ( enactm5t (   
?is section1 ! ,secret>y %all issue f9al
 regulations reg>d+ ! au?or%ip1 cont5t1 
=mat1 & dissem9ation requirem5ts =      

pati5t m$ication in=mation = drugs      
subject to section #ejc7;b77#a74  7b7   
,cont5t ,! regulations promulgat$ "u    
subsection 7a7 %all require t ! pati5t  
m$ication in=mation ) respect to a      
drug--  7#a7 be sci5tifically accurate1 
include relevant pati5t safety          
in=mation1 & be bas$ on ! pr(essional   
label+ approv$ by ! ,secret>y2 &  7#b7  
include /&>d1 nonte*nical1 und]/&able1  
pla9 language t is n promotional 9 tone 
or cont5t1 & conta9 at lea/--  7,a7 !   
e/abli%$ "n ( ! drug or ! prop] "n ( !  
biological product1 z applicable2  7,b7 
drug uses2  7,c7 g5]al directions =     
prop] use2  7,d7 contra9dications1 ! mo/
 frequ5tly occurr+ adv]se reactions1 &  
adv]se reactions t are important = o!r  
reasons 7su* z because !y are s]i\s71   
especially ) respect to c]ta9 gr\ps su* 
z *ildr51 pregnant wom51 & ! eld]ly2    
7,e7 measures pati5ts may be able to    
take1 if any1 to r$uce ! side effects & 
risks ( ! drug2  7,f7 :5 a pati5t %\ld  
contact 8 or h] heal? c>e pr(essional2  

7,g7 in/ructions n to %>e m$ications1 &1
 if any exi/1 key /orage requirem5ts1 & 
recomm5dations relat+ to prop] disposal 
( any unus$ portion ( ! drug2  7,h7 kn[n
 cl9ically important int]actions ) o!r  
drugs & sub/ances2 &  7,i7 a /atem5t (  
:e!r suffici5t data are available       
conc]n+ ! use ( ! drug 9 specifi$       
subpopulations1 su* z wom51 pregnant    
wom51 lactat+ wom51 wom5 & m5 (         
reproductive age1 p$iatric1 g]iatric1   
racial & e?nic m9ority gr\ps1 & o!r     
subpopulations4  7c7 ,timel9ess1        
consi/5cy1 & accuracy ,! regulations    
promulgat$ "u subsection 7a7 %all       
include /&>ds relat+ to h[ ! ,secret>y--
  7#a7 %all p]=m timely reviews &       
updates ( pati5t m$ication in=mation z  
new drugs & new in=mation become        
available2  7#b7 may p]=m1 :5           
appropriate1 updates to help communicate
 in=mation t is %>$ by simil> drug      
products or drugs )9 classes (          
m$ications 9 ord] to avoid pati5t       
confusion & h>m2 &  7#c7 %all develop a 

process1 includ+ consum] te/+1 to assess
 ! quality & effectiv5ess ( pati5t      
m$ication in=mation 9 ensur+ t pati5t   
m$ication in=mation develop$ 9          
accordance ) ?is section promotes pati5t
 und]/&+ & safe & effective m$ication   
use4  7d7 ,electronic repository ,!     
regulations promulgat$ "u subsection 7a7
 %all provide = ! developm5t ( a        
publicly accessible electronic          
repository = all pati5t m$ication       
in=mation docum5ts & cont5t to          
facilitate ! availability ( pati5t      
m$ication in=mation4  4  #c4 ,en=cem5t &
 dissem9ation  7a7 ,en=cem5t ,section   
#ejb ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7 is  
am5d$ by add+ at ! end ! foll[+3  7dd7  
,if x is a drug subject to section      
#ejc7;b77#a7 & pati5t m$ical in=mation  
describ$ 9 section #eje;,f is n provid$1
 z requir$ "u section #ejc7;b77#a74  4  
7b7 ,dissem9ation ,section #ejc7;b7 ( ! 
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cec7 is am5d$ by ins]t+ 

,"u ! circum/ances det]m9$ by !         
,secret>y ?r\gh regulation or guidance1 
a drug disp5s$ 9 accordance ) ?is       
p>agraph %all be accompani$ by ! pati5t 
m$ication in=mation = su* drug develop$ 
9 accordance ) section #eje;,f aft] by !
 ph>maci/44