,i  #aac? ,,congress  #b;d ,session  ,h4
 ,r4 #efac  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,septemb] #ah1 #bjad  
,mr4 ,israel introduc$ ! foll[+ bill2   
:i* 0 ref]r$ to ! ,committee on ,en]gy &
 ,comm]ce  ,a ,,bill  ,to am5d ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act to ensure
 t liquid ov]-!-c\nt] m$ications are    
packag$ ) appropriate dosage deliv]y    
devices &1 9 ! case ( su* m$ications    
label$ = p$iatric use1 appropriate fl[  
re/rictors1 & = o!r purposes4  #a4 ,%ort
 title ,?is ,act may be cit$ z !        
,protect+ ,our ,kids' ,m$ic9e ,act (    
#bjad4  #b4 ,dosage deliv]y devices =   
liquid ,,otc drugs & fl[ re/rictors =   
su* drugs label$ = p$iatric use  7a7 ,9 
g5]al ,section #ejb ( ! ,f$]al ,food1   
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#ceb7 is am5d$ by add+ at ! end !       
foll[+3  7dd7  7#a7 ,if x is a liquid   
=mulation ( a drug t is n subject to    
section #ejc7;b7 &--  7,a7 x is n       
packag$ ) a dosage deliv]y device 9     
accordance ) specifications to be       

det]m9$ by ! ,secret>y by regulation2   
7,b7 9 ! case ( su* a liquid =mulation t
 is label$ = p$iatric use1 x is n       
packag$ ) a dosage deliv]y device1 z    
describ$ 9 subp>agraph 7,a71 &--  7i7 a 
fl[ re/rictor2 or  7ii7 ano!r me*anism  
to r$uce ! frequ5cy & volume ( accid5tal
 +e/ion t provides a level ( safety t is
 equival5t to or great] ?an ! level (   
safety t w\ld be provid$ by a fl[       
re/rictor1 z det]m9$ by ! ,secret>y by  
regulation2 or  7,c7 its label+ is 9    
violation ( subp>agraph 7#b74  7#b7 ,!  
,secret>y %all require t any measurem5t 
9 ! label+ ( a liquid =mulation ( a drug
 t is n subject to section #ejc7;b71    
includ+ any measurem5t 9 ! label+ ( a   
dosage deliv]y device packag$ ) ! liquid
 =mulation1 be express$ exclusively 9   
metric units4 ,! ,secret>y may waive !  
requirem5t 9 ! prec$+ s5t5ce ) respect  
to "o or m liquid =mulations if !       
,secret>y det]m9es t1 ) respect to su*  
=mulations1 implem5tation ( su*         
requirem5t w\ld n b5efit ! public heal?4

  7#c7 ,9 ?is p>agraph3  7,a7 ,! t]m    
dosage deliv]y device--  7i7 means an   
object t is design$ to measure ! dosage 
( a drug 9 liquid =m & deliv] t drug to 
an individual2 &  7ii7 includes         
calibrat$ cups1 dropp]s1 syr+es1 &      
spoons4  7,b7 ,! t]m fl[ re/rictor has  
su* mean+ z ! ,secret>y may prescribe by
 regulation4  4  7b7 ,regulations ,n    
lat] ?an #a ye> aft] ! date ( enactm5t (
 ?is ,act1 ! ,secret>y ( ,heal? & ,human
 ,s]vices1 act+ ?r\gh ! ,commission] (  
,food & ,drugs1 %all--  7#a7 promulgate 
a f9al rule implem5t+ ! am5dm5t made by 
subsection 7a72 &  7#b7 include 9 su*   
rule a def9ition ( ! t]m fl[ re/rictor4 
7c7 ,applicability ,! am5dm5t made by   
subsection 7a7 applies beg9n+ on ! date 
t is #a ye> aft] ! date ( enactm5t ( ?is
 ,act4