,i  #aac? ,,congress  #a/ ,session  ,h4 
,r4 #afjh  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,april #ag1 #bjac ,mr4
 ,ow5s introduc$ ! foll[+ bill2 :i* 0   
ref]r$ to ! ,committee on ,en]gy &      
,comm]ce  ,a ,,bill  ,to require !      
,secret>y ( ,heal? & ,human ,s]vices to 
promulgate regulations reg>d+ !         
au?or%ip1 cont5t1 =mat1 & dissem9ation (
 ,pati5t ,m$ication ,in=mation to ensure
 pati5ts receive consi/5t & high-quality
 in=mation ab\t _! prescription         
m$ications & are aw>e ( ! pot5tial risks
 & b5efits ( prescription m$ications4   
#a4 ,%ort title ,?is ,act may be cit$ z 
! ,cody ,mill] ,initiative = ,saf]      
,prescriptions ,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;,d ! foll[+3  #eje;,e4 ,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 regulations reg>d+ 
! au?or%ip1 cont5t1 =mat1 & dissem9ation
 requirem5ts = pati5t m$ication         
in=mation 7ref]r$ to 9 ?is section z    
,,pmi7 = drugs subject to section       
#ejc7;b77#a74  7b7 ,cont5t ,!           
regulations promulgat$ "u subsection 7a7
 %all require t ! ,,pmi ) respect to a  
drug--  7#a7 be sci5tifically accurate &
 bas$ on ! pr(essional label+ approv$ by
 ! ,secret>y & au?oritative1 pe]-review$
 lit]ature2 &  7#b7 includes            
nonte*nical1 und]/&able1 pla9 language t
 is n promotional 9 tone or cont5t1 &   
conta9s at lea/--  7,a7 ! e/abli%$ "n ( 
drug1 includ+ ! e/abli%$ "n ( su* drug z
 a li/$ drug 7z describ$ 9 section      
#eje7;j77#b77;,a77 & z a drug t is !    
subject ( an approv$ abbreviat$ new drug
 application "u section #eje7;j7 or ( an
 approv$ lic5se = a biological product  
submitt$ "u section #cea7k7 ( ! ,public 
,heal? ,s]vice ,act1 if applicable2     
7,b7 drug uses & cl9ical b5efits2  7,c7 
g5]al directions = prop] use2  7,d7     

contra9dications1 common side effects1 &
 mo/ s]i\s risks ( ! drug1 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/ances4  7c7 ,timel9ess1 
consi/5cy1 & accuracy ,! regulations    
promulgat$ "u subsection 7a7 %all       
include /&>ds relat$ to--  7#a7 p]=m+   
timely updates ( drug in=mation z new   
drugs & new in=mation becomes available2
  7#b7 ensur+ t common in=mation is     
appli$ consi/5tly & simultane\sly across
 simil> drug products & = drugs )9      
classes ( m$ications 9 ord] to avoid    
pati5t confusion & h>m2 &  7#c7 develop+
 a process1 includ+ consum] te/+1 to    

assess ! quality & effectiv5ess ( ,,pmi 
9 ensur+ t ,,pmi 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  
,,pmi docum5ts & cont5t to facilitate ! 
availability ( ,,pmi4  4  #c4           
,publication on int]net ,web site ,!    
,secret>y ( ,heal? & ,human ,s]vices    
%all publi% on ! ,int]net ,web site ( ! 
,food & ,drug ,adm9i/ration a l9k to !  
,daily ,m$ ,web site                    
7http3_/_/dailym$4nlm4nih4gov_/dailym$7 
7or any successor ,web site74