,,ii  #aadth ,,congress  #ast ,session  
,s4 #agij  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,july #af1     
#bjae,mr4 ,vitter 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 prescription drugs from      
approved pharmacies4  #a4 ,short title  
,this ,act may be cited as the ,safe and
 ,affordable ,prescription ,drugs ,act  
of #bjae4  #b4 ,safe and affordable     
prescription drugs ,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  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 pharmacy2    
7,b7 is dispensed by a pharmacist       
licensed to practice pharmacy and       
dispense prescription drugs in the      
country in which the pharmacy is        
located2  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 pharmacy  7#a7 ,in general
 ,in this section1 an approved pharmacy 

is a pharmacy that--  7,a7 is located in
 a country listed or described in       
section #hjb7;b77#a77;,a72 and  7,b7 the
 ,secretary certifies--  7i7 is licensed
 to operate and dispense prescription   
drugs to individuals in the country in  
which such pharmacy is located2 and     
7ii7 meets the criteria under paragraph 
7#c74  7#b7 ,publication of approved    
pharmacies ,the ,secretary shall publish
 on the ,internet ,web site of the ,food
 and ,drug ,administration a list of    
approved pharmacies1 including the      
,internet ,web site address of each such
 approved pharmacy1 from which          
individuals may purchase prescription   
drugs in accordance with subsection 7a74
  7#c7 ,additional criteria ,to be an   
approved 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 pharmacy     
rules and regulations enacted in the    
country in which it is located2  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 the country in which the        
pharmacy is located to customers in the 
,united ,states2 and  7,h7 meets any    
other criteria established by the       
,secretary4  4