,,ii  #aacth ,,congress  #b;d ,session  
,s4 #bedi  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,june #bf1     
#bjad ,ms4 ,klobuchar 7for herself and  
,mr4 ,mc,cain7 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 allow for  
the personal importation of safe and    
affordable drugs from approved          
pharmacies in ,canada4  #a4 ,short title
  ,this ,act may be cited as the ,safe  
and ,affordable ,drugs from ,canada ,act
 of #bjad4  #b4 ,safe and affordable    
drugs from ,canada ,chapter ,,viii of   
the ,federal ,food1 ,drug1 and ,cosmetic
 ,act 7#ba ,u4,s4,c4 #cha et seq47 is   
amended by adding at the end the        
following3  #haj4 ,importation by       
individuals of prescription drugs from  
,canada  7a7 ,in general                
,notwithstanding any other provision of 
this ,act1 not later than #ahj days     

after the date of enactment of this     
section1 the ,secretary shall promulgate
 regulations permitting individuals to  
safely import into the ,united ,states a
 prescription drug described in         
subsection 7b74  7b7 ,prescription drug 
,a prescription drug described in this  
subsection-- 7#a7 is a prescription drug
 that-- 7,a7 is purchased from an       
approved ,canadian pharmacy2  7,b7 is   
dispensed by a pharmacist licensed to   
practice pharmacy and dispense          
prescription drugs in ,canada2  7,c7 is 
purchased for personal use by the       
individual1 not for resale1 in          
quantities that do not exceed a #ij-;day
 supply2  7,d7 is filled using a valid  
prescription issued by a physician      
licensed to practice in a ,state in the 
,united ,states2 and  7,e7 has the same 
active ingredient or ingredients1 route 
of administration1 dosage form1 and     
strength as a prescription drug approved
 by the ,secretary under chapter ,v2 and
  7#b7 does not include-- 7,a7 a        

controlled substance 7as defined in     
section #ajb of the ,controlled         
,substances ,act 7#ba ,u4,s4,c4 #hjb772 
7,b7 a biological product 7as defined in
 section #cea of the ,public ,health    
,service ,act 7#db ,u4,s4,c4 #bfb772    
7,c7 an infused drug 7including a       
peritoneal dialysis solution72  7,d7 an 
intravenously injected drug2  7,e7 a    
drug that is inhaled during surgery2    
7,f7 a parenteral drug2  7,g7 a drug    
manufactured through #a or more         
biotechnology processes1 including-- 7i7
 a therapeutic ,,dna plasmid product2   
7ii7 a therapeutic synthetic peptide    
product of not more than #dj amino      
acids2  7iii7 a monoclonal antibody     
product for in vivo use2 and  7iv7 a    
therapeutic recombinant ,,dna-derived   
product2  7,h7 a drug required to be    
refrigerated at any time during         
manufacturing1 packing1 processing1 or  
holding2 or  7,i7 a photoreactive drug4 
7c7 ,approved ,canadian pharmacy  7#a7  
,in general ,in this section1 an        

approved ,canadian pharmacy is a        
pharmacy that-- 7,a7 is located in      
,canada2 and  7,b7 that the ,secretary  
certifies-- 7i7 is licensed to operate  
and dispense prescription drugs to      
individuals in ,canada2 and  7ii7 meets 
the criteria under paragraph 7#c74  7#b7
 ,publication of approved canadian      
pharmacies ,the ,secretary shall publish
 on the ,internet ,web site of the ,food
 and ,drug ,administration a list of    
approved ,canadian pharmacies1 including
 the ,internet ,web site address of each
 such approved ,canadian pharmacy1 from 
which individuals may purchase          
prescription drugs in accordance with   
subsection 7a74  7#c7 ,additional       
criteria ,to be an approved ,canadian   
pharmacy1 the ,secretary shall certify  
that the pharmacy-- 7,a7 has been in    
existence for a period of at least #e   
years preceding the date of such        
certification and has a purpose other   
than to participate in the program      
established under this section2  7,b7   

operates in accordance with pharmacy    
standards set forth by the provincial   
pharmacy rules and regulations enacted  
in ,canada2  7,c7 has processes         
established by the pharmacy1 or         
participates in another established     
process1 to certify that the physical   
premises and data reporting procedures  
and licenses are in compliance with all 
applicable laws and regulations1 and has
 implemented policies designed to       
monitor ongoing compliance with such    
laws and regulations2  7,d7 conducts or 
commits to participate in ongoing and   
comprehensive quality assurance programs
 and implements such quality assurance  
measures1 including blind testing1 to   
ensure the veracity and reliability of  
the findings of the quality assurance   
program2  7,e7 agrees that laboratories 
approved by the ,secretary shall be used
 to conduct product testing to determine
 the safety and efficacy of sample      
pharmaceutical products2  7,f7 has      
established1 or will establish or       

participate in1 a process for resolving 
grievances and will be held accountable 
for violations of established guidelines
 and rules2  7,g7 does not resell       
products from online pharmacies located 
outside ,canada to customers in the     
,united ,states2 and  7,h7 meets any    
other criteria established by the       
,secretary4  4