,,ii  #aac? ,,congress  #b;d ,session   
,s4 #bedi  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,june #bf1 #bjad ,ms4  
,klobu*> 7= h]self & ,mr4 ,mc,cain7     
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to am5d ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act to all[ = !     
p]sonal importation ( safe & af=dable   
drugs f approv$ ph>macies 9 ,canada4    
#a4 ,%ort title  ,?is ,act may be cit$ z
 ! ,safe & ,af=dable ,drugs f ,canada   
,act ( #bjad4  #b4 ,safe & af=dable     
drugs f ,canada ,*apt] ,,viii ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act 7#ba    
,u4,s4,c4 #cha et seq47 is am5d$ by add+
 at ! end ! foll[+3  #haj4 ,importation 
by individuals ( prescription drugs f   
,canada  7a7 ,9 g5]al ,not)/&+ any o!r  
provision ( ?is ,act1 n lat] ?an #ahj   
days aft] ! date ( enactm5t ( ?is       
section1 ! ,secret>y %all promulgate    
regulations p]mitt+ individuals to      
safely import into ! ,unit$ ,/ates a    

prescription drug describ$ 9 subsection 
7b74  7b7 ,prescription drug ,a         
prescription drug describ$ 9 ?is        
subsection-- 7#a7 is a prescription drug
 t-- 7,a7 is pur*as$ f an approv$       
,canadian ph>macy2  7,b7 is disp5s$ by a
 ph>maci/ lic5s$ to practice ph>macy &  
disp5se prescription drugs 9 ,canada2   
7,c7 is pur*as$ = p]sonal use by !      
individual1 n = resale1 9 quantities t d
 n exce$ a #ij-;day supply2  7,d7 is    
fill$ us+ a valid prescription issu$ by 
a physician lic5s$ to practice 9 a ,/ate
 9 ! ,unit$ ,/ates2 &  7,e7 has ! same  
active +r$i5t or +r$i5ts1 r\te (        
adm9i/ration1 dosage =m1 & /r5g? z a    
prescription drug approv$ by ! ,secret>y
 "u *apt] ,v2 &  7#b7 does n include--  
7,a7 a controll$ sub/ance 7z def9$ 9    
section #ajb ( ! ,controll$ ,sub/ances  
,act 7#ba ,u4,s4,c4 #hjb772  7,b7 a     
biological product 7z def9$ 9 section   
#cea ( ! ,public ,heal? ,s]vice ,act    
7#db ,u4,s4,c4 #bfb772  7,c7 an infus$  
drug 7includ+ a p]itoneal dialysis      

solution72  7,d7 an intrav5\sly inject$ 
drug2  7,e7 a drug t is inhal$ dur+     
surg]y2  7,f7 a p>5t]al drug2  7,g7 a   
drug manufactur$ ?r\gh #a or m          
biote*nology processes1 includ+-- 7i7 a 
!rapeutic ,,dna plasmid product2  7ii7 a
 !rapeutic syn!tic peptide product ( n m
 ?an #dj am9o acids2  7iii7 a monoclonal
 antibody product = 9 vivo use2 &  7iv7 
a !rapeutic recomb9ant ,,dna-d]iv$      
product2  7,h7 a drug requir$ to be     
refrig]at$ at any "t dur+ manufactur+1  
pack+1 process+1 or hold+2 or  7,i7 a   
photoreactive drug4  7c7 ,approv$       
,canadian ph>macy  7#a7 ,9 g5]al ,9 ?is 
section1 an approv$ ,canadian ph>macy is
 a ph>macy t-- 7,a7 is locat$ 9 ,canada2
 &  7,b7 t ! ,secret>y c]tifies-- 7i7 is
 lic5s$ to op]ate & disp5se prescription
 drugs to individuals 9 ,canada2 &  7ii7
 meets ! crit]ia "u p>agraph 7#c74  7#b7
 ,publication ( approv$ canadian        
ph>macies ,! ,secret>y %all publi% on ! 
,int]net ,web site ( ! ,food & ,drug    
,adm9i/ration a li/ ( approv$ ,canadian 

ph>macies1 includ+ ! ,int]net ,web site 
address ( ea* su* approv$ ,canadian     
ph>macy1 f :i* individuals may pur*ase  
prescription drugs 9 accordance )       
subsection 7a74  7#c7 ,additional       
crit]ia ,to be an approv$ ,canadian     
ph>macy1 ! ,secret>y %all c]tify t !    
ph>macy-- 7,a7 has be5 9 exi/5ce = a    
p]iod ( at lea/ #e ye>s prec$+ ! date ( 
su* c]tification & has a purpose o!r ?an
 to p>ticipate 9 ! program e/abli%$ "u  
?is section2  7,b7 op]ates 9 accordance 
) ph>macy /&>ds set =? by ! prov9cial   
ph>macy rules & regulations enact$ 9    
,canada2  7,c7 has processes e/abli%$ by
 ! ph>macy1 or p>ticipates 9 ano!r      
e/abli%$ process1 to c]tify t ! physical
 premises & data report+ proc$ures &    
lic5ses are 9 compliance ) all          
applicable laws & regulations1 & has    
implem5t$ policies design$ to monitor   
ongo+ compliance ) su* laws &           
regulations2  7,d7 conducts or commits  
to p>ticipate 9 ongo+ & compreh5sive    
quality assurance programs & implem5ts  

su* quality assurance measures1 includ+ 
bl9d te/+1 to ensure ! v]acity &        
reliability ( ! f9d+s ( ! quality       
assurance program2  7,e7 agrees t       
laboratories approv$ by ! ,secret>y %all
 be us$ to conduct product te/+ to      
det]m9e ! safety & efficacy ( sample    
ph>maceutical products2  7,f7 has       
e/abli%$1 or w e/abli% or p>ticipate 91 
a process = resolv+ grievances & w be   
held acc\ntable = violations ( e/abli%$ 
guidel9es & rules2  7,g7 does n resell  
products f onl9e ph>macies locat$       
outside ,canada to cu/om]s 9 ! ,unit$   
,/ates2 &  7,h7 meets any o!r crit]ia   
e/abli%$ by ! ,secret>y4  4