,i  #aacth ,,congress  #b;d ,session    
,h4 ,r4 #efac  ,,in ,,the ,,house ,,of  
,,representatives  ,september #ah1 #bjad
 ,mr4 ,israel introduced the following  
bill2 which was referred to the         
,committee on ,energy and ,commerce  ,a 
,,bill  ,to amend the ,federal ,food1   
,drug1 and ,cosmetic ,act to ensure that
 liquid over-the-counter medications are
 packaged with appropriate dosage       
delivery devices and1 in the case of    
such medications labeled for pediatric  
use1 appropriate flow restrictors1 and  
for other purposes4  #a4 ,short title   
,this ,act may be cited as the          
,protecting ,our ,kids' ,medicine ,act  
of #bjad4  #b4 ,dosage delivery devices 
for liquid ,,otc drugs and flow         
restrictors for such drugs labeled for  
pediatric use  7a7 ,in general ,section 
#ejb of the ,federal ,food1 ,drug1 and  
,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7 is  
amended by adding at the end the        
following3  7dd7  7#a7 ,if it is a      
liquid formulation of a drug that is not

 subject to section #ejc7;b7 and--  7,a7
 it is not packaged with a dosage       
delivery device in accordance with      
specifications to be determined by the  
,secretary by regulation2  7,b7 in the  
case of such a liquid formulation that  
is labeled for pediatric use1 it is not 
packaged with a dosage delivery device1 
as described in subparagraph 7,a71 and--
  7i7 a flow restrictor2 or  7ii7       
another mechanism to reduce the         
frequency and volume of accidental      
ingestion that provides a level of      
safety that is equivalent to or greater 
than the level of safety that would be  
provided by a flow restrictor1 as       
determined by the ,secretary by         
regulation2 or  7,c7 its labeling is in 
violation of subparagraph 7#b74  7#b7   
,the ,secretary shall require that any  
measurement in the labeling of a liquid 
formulation of a drug that is not       
subject to section #ejc7;b71 including  
any measurement in the labeling of a    
dosage delivery device packaged with the

 liquid formulation1 be expressed       
exclusively in metric units4 ,the       
,secretary may waive the requirement in 
the preceding sentence with respect to  
one or more liquid formulations if the  
,secretary determines that1 with respect
 to such formulations1 implementation of
 such requirement would not benefit the 
public health4  7#c7 ,in this paragraph3
  7,a7 ,the term dosage delivery        
device--  7i7 means an object that is   
designed to measure the dosage of a drug
 in liquid form and deliver that drug to
 an individual2 and  7ii7 includes      
calibrated cups1 droppers1 syringes1 and
 spoons4  7,b7 ,the term flow restrictor
 has such meaning as the ,secretary may 
prescribe by regulation4  4  7b7        
,regulations ,not later than #a year    
after the date of enactment of this     
,act1 the ,secretary of ,health and     
,human ,services1 acting through the    
,commissioner of ,food and ,drugs1      
shall--  7#a7 promulgate a final rule   
implementing the amendment made by      

subsection 7a72 and  7#b7 include in    
such rule a definition of the term flow 
restrictor4  7c7 ,applicability ,the    
amendment made by subsection 7a7 applies
 beginning on the date that is #a year  
after the date of enactment of this     
,act4