,,ii  #aaf? ,,congress  #a/ ,session    
,s4 #ig  ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$
 ,,/ates  ,janu>y #aj1 #bjai,mr4 ,s&]s  
7= himself1 ,mr4 ,book]1 ,mr4 ,casey1   
,ms4 ,baldw91 ,mr4 ,blum5?al1 ,mr4      
,br[n1 ,ms4 ,cantwell1 ,mrs4 ,gillibr&1 
,ms4 ,h>ris1 ,ms4 ,hassan1 ,mr4 ,he9ri*1
 ,mr4 ,k+1 ,mr4 ,leahy1 ,ms4 ,klobu*>1  
,mr4 ,man*91 ,mr4 ,m]kley1 ,mr4 ,re$1   
,mrs4 ,%ahe51 ,ms4 ,smi?1 ,ms4 ,/ab5[1  
,mr4 ,udall1 ,mr4 ,van ,holl51 ,ms4     
,w>r51 & ,mr4 ,:iteh\se7 introduc$ !    
foll[+ bill2 :i* 0 read twice & ref]r$  
to ! ,committee on ,heal?1 ,education1  
,labor1 & ,p5sions  ,a ,,bill  ,to am5d 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
to all[ = ! importation ( af=dable &    
safe drugs by :olesale di/ributors1     
ph>macies1 & individuals4  #a4 ,%ort    
title ,?is ,act may be cit$ z !         
,af=dable & ,safe ,prescription ,drug   
,importation ,act4  #b4 ,import+        
af=dable & safe drugs  7a7 ,9 g5]al     
,section #hjd ( ! ,f$]al ,food1 ,drug1 &
 ,cosmetic ,act 7#ba ,u4,s4,c4 #chd7 is 

am5d$ to read z foll[s3  #hjd4          
,importation ( safe & af=dable drugs by 
:olesale di/ributors1 ph>macies1 &      
individuals  7a7 ,9 g5]al ,n lat] ?an   
#ahj days aft] ! date ( enactm5t ( !    
,af=dable & ,safe ,prescription ,drug   
,importation ,act1 ! ,secret>y %all     
promulgate regulations p]mitt+ !        
importation ( qualify+ prescription     
drugs into ! ,unit$ ,/ates1 9 accordance
 ) ?is section4  7b7 ,def9itions ,=     
purposes ( ?is section3 7#a7 ,c]tifi$   
=eign sell] ,! t]m c]tifi$ =eign sell]  
means a lic5s$ =eign ph>macy or =eign   
:olesale di/ributor t ! ,secret>y       
c]tifies "u subsection 7d77#a77;,b71 t  
pays ! fee requir$ "u subsection        
7d77#a77;,c71 & t is includ$ on ! li/   
describ$ 9 subsection 7c74  7#b7 ,=eign 
:olesale di/ributor ,! t]m =eign        
:olesale di/ributor means a p]son 7o!r  
?an a manufactur]1 a manufactur]'s      
co-lic5s$ p>tn]1 a ?ird-p>ty logi/ics   
provid]1 or a repackag]7 engag$ 9       
:olesale di/ribution4  7#c7 ,import] ,! 

t]m import] means a disp5s] 7z def9$ 9  
section #eha7c77 or :olesale di/ributor 
regi/]$ "u section #ejc7;e7 :o imports  
prescription drugs into ! ,unit$ ,/ates 
9 accordance ) ?is section4  7#d7       
,lic5s$ =eign ph>macy ,! t]m lic5s$     
=eign ph>macy means a ph>macy locat$ 9  
,canada1 or subject to subsection 7e71  
ano!r applicable c\ntry1 t--  7,a7      
op]ates 9 accordance ) applicable       
ph>macy /&>ds set =? by ! prov9cial     
ph>macy rules & regulations enact$ 9    
,canada1 or1 subject to subsection 7e71 
su* applicable rules & regulations ( !  
p]mitt$ c\ntry 9 :i* su* sell] is       
locat$2 &  7,b7 is lic5s$ to op]ate &   
disp5se prescription drugs to           
individuals 9 ,canada1 or1 subject to   
subsection 7e71 ! p]mitt$ c\ntry 9 :i* !
 ph>macy is locat$4  7#e7 ,qualify+     
prescription drug ,! t]m qualify+       
prescription drug-- 7,a7 means a        
prescription drug t--  7i7 is approv$ = 
use 9 pati5ts1 & m>ket$1 9 ,canada1 or  
subject to subsection 7e71 approv$ = use

 9 pati5ts1 & m>ket$1 9 ano!r p]mitt$   
c\ntry2  7ii7 is manufactur$ 9 a        
facility regi/]$ "u subsection 7b77#a7  
or 7i7 ( section #eaj t is 9 compliance 
) good manufactur+ practices regulations
 ( ! ,food & ,drug ,adm9i/ration2  7iii7
 has ! same active +r$i5t or +r$i5ts1   
r\te ( adm9i/ration1 & /r5g? z a        
prescription drug approv$ "u *apt] ,v1  
or1 = purposes ( subp>agraph 7,b77iv71  
is biosimil> to an approv$ biological   
product & has ! same r\te ( adm9i/ration
 & /r5g? z ! approv$ biological product2
 &  7iv7 is label$ 9 accordance )-- 7,i7
 ! laws ( ,canada1 or ano!r c\ntry f :i*
 importation is p]mitt$ pursuant to     
subsection 7e72 &  7,,ii7 ! requirem5ts 
promulgat$ by ! ,secret>y1 :i* %all     
include label+ 9 ,engli%2  7,b7 )       
respect to import]s only1 includes-- 7i7
 p]itoneal dialysis solution2  7ii7     
insul92  7iii7 a drug = :i* a risk      
evaluation & mitigation /rategy is      
requir$ "u section #eje-a2  7iv7        
biological products1 z def9$ 9 section  

#cea ( ! ,public ,heal? ,s]vice ,act t  
are prote9s 7except any *emically       
syn!siz$ polypeptides7 or analog\s      
products2 &  7v7 intrav5\sly infus$     
drugs2 &  7,c7 does n include--  7i7 a  
controll$ sub/ance 7z def9$ 9 section   
#ajb ( ! ,controll$ ,sub/ances ,act72   
7ii7 an ane/hetic drug inhal$ dur+      
surg]y2 or  7iii7 a comp\nd$ drug4  7#f7
 ,valid prescription ,! t]m valid       
prescription means a prescription t is  
issu$ = a legitimate m$ical purpose 9 ! 
usual c\rse ( pr(essional practice by-- 
7,a7 a practition] :o has conduct$ at   
lea/ "o 9-p]son m$ical evaluation ( !   
pati5t2 or  7,b7 a cov]+ practition]4   
7c7 ,publication ( c]tifi$ =eign sell]s 
,! ,secret>y %all publi% on a d$icat$   
int]net website a li/ ( c]tifi$ =eign   
sell]s1 includ+ ! int]net website       
address1 physical address1 & telephone  
numb] ( ea* su* c]tifi$ =eign sell]4    
7d7 ,additional crit]ia  7#a7 ,c]tifi$  
=eign sell]s  7,a7 ,9 g5]al ,to be a    
c]tifi$ =eign sell]1 su* sell] %all--   

7i7 be c]tifi$ by ! ,secret>y 9         
accordance ) subp>agraph 7,b72  7ii7 pay
 ! regi/ration fee e/abli%$ "u          
subp>agraph 7,c72 &  7iii7 sell only    
qualify+ prescription drugs to import]s 
or individuals :o import prescription   
drugs into ! ,unit$ ,/ates 9 accordance 
) ?is section4  7,b7 ,c]tification ,to  
be a c]tifi$ =eign sell]1 ! ,secret>y   
%all c]tify t su* sell]-- 7i7 is a =eign
 :olesale di/ributor or lic5s$ =eign    
ph>macy op]at+ an e/abli%m5t1 :i* may   
include an onl9e =eign ph>macy1 t is    
locat$ 9 ,canada1 or1 subject to        
subsection 7e71 ano!r p]mitt$ c\ntry2   
7ii7 is engag$ 9 ! di/ribution or       
disp5s+ ( a prescription drug t is      
import$ or (f]$ = importation into !    
,unit$ ,/ates2  7iii7 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  7iv7 9 ! case 
( a c]tifi$ =eign sell] t is a lic5s$   
=eign ph>macy1 agrees to disp5se a      

qualify+ prescription drug to an        
individual 9 ! ,unit$ ,/ates only aft]  
receiv+ a valid prescription1 z describ$
 9 p>agraph 7#b77;,c72  7v7 has         
processes e/abli%$ by ! sell]1 or       
p>ticipates 9 ano!r e/abli%$ process1 to
 c]tify t ! physical premises & data    
report+ proc$ures & lic5ses are 9       
compliance ) all applicable laws &      
regulations ( ,canada1 or1 subject to   
subsection 7e71 ! p]mitt$ c\ntry 9 :i* !
 sell] is locat$1 & has implem5t$       
policies design$ to monitor ongo+       
compliance ) su* laws & regulations2    
7vi7 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    
7vii7 agrees t1 pursuant to subsection  
7g71 laboratories approv$ by ! ,secret>y
 may be au?oriz$ to conduct product te/+
 to det]m9e ! *emical au!nticity (      
sample ph>maceutical products2  7viii7  

agrees to notify ! ,secret>y1 import]s1 
& individuals ( product recalls 9       
,canada1 or pursuant to subsection 7e71 
! p]mitt$ c\ntry 9 :i* ! sell] is       
locat$1 & agrees to cease1 or refra9 f1 
export+ su* product2  7ix7 has e/abli%$1
 or w e/abli% or p>ticipate 91 a process
 = resolv+ grievances1 z def9$ by !     
,secret>y1 & w be held acc\ntable =     
violations ( e/abli%$ guidel9es & rules2
  7x7 except z o!rwise p]mitt$ "u ?is   
section1 does n sell products t ! sell] 
c\ld n o!rwise legally sell 9 ,canada1  
or1 subject to subsection 7e71 ! p]mitt$
 c\ntry 9 :i* su* sell] is locat$ to    
cu/om]s 9 ! ,unit$ ,/ates2 &  7xi7 meets
 any o!r crit]ia e/abli%$ by !          
,secret>y4  7,c7 ,c]tification fee ,n   
lat] ?an #cj days be=e ! />t ( ea*      
fiscal ye>1 ! ,secret>y %all e/abli% a  
fee to be collect$ f =eign sell]s = su* 
fiscal ye> t are c]tifi$ "u subp>agraph 
7,b71 9 an am\nt t is suffici5t1 & n m  
?an necess>y1 to pay ! co/s ( adm9i/]+ !
 program "u ?is section1 & en=c+ ?is    

section pursuant to section #cjc7;h71 = 
t fiscal ye>4  7,d7 ,rec]tification ,a  
c]tification "u subp>agraph 7,b7 %all be
 9 effect = a p]iod ( #b ye>s1 or until 
!re is a mat]ial *ange 9 ! circum/ances 
"u :i* ! =eign sell] meets ! requirem5ts
 "u su* subp>agraph1 :i*ev] occurs      
e>li]4 ,a =eign sell] may reapply =     
c]tification "u su* subp>agraph 7,b71 9 
accordance ) a process e/abli%$ by !    
,secret>y4  7#b7 ,individuals ,an       
individual may import a qualify+        
prescription drug describ$ 9 subsection 
7b7 f ,canada or ano!r c\ntry pursuant  
to subsection 7e7 if su* drug--  7,a7 is
 disp5s$1 includ+ ?r\gh an onl9e        
ph>macy1 by a c]tifi$ =eign sell] t is a
 lic5s$ =eign ph>macy2  7,b7 is pur*as$ 
= p]sonal use by ! individual1 n =      
resale1 9 quantities t d n exce$ a      
#ij-;day supply2 &  7,c7 is fill$ only  
aft] provid+ to ! lic5s$ =eign ph>macy a
 valid prescription issu$ by a heal? c>e
 practition] lic5s$ to practice 9 a     
,/ate 9 ! ,unit$ ,/ates4  7e7           

,importation f o!r c\ntries ,beg9n+ on !
 date t is #b ye>s aft] ! date on :i*   
f9al regulations are promulgat$ to c>ry 
out ?is section1 if1 bas$ on a review ( 
! evid5ce obta9$ aft] su* effective     
date1 includ+ ! reports submitt$ "u     
section #b7;d7 ( ! ,af=dable & ,safe    
,prescription ,drug ,importation ,act1 t
 importation ( qualify+ prescription    
drugs f ,canada "u ?is section result$ 9
 co/ sav+s = consum]s 9 ! ,unit$ ,/ates 
& increas$ access to safe m$ication1 !  
,secret>y %all h ! au?ority to p]mit    
importation ( qualify+ prescription     
drugs by import]s & individuals f1 9    
addition to ,canada1 any c\ntry t--     
7#a7 is a memb] ( ! ,organisation =     
,economic ,co-op]ation & ,developm5t2 & 
7#b7 has /atutory or regulatory /&>ds = 
! approval & sale ( prescription drugs t
 are comp>able to ! /&>ds 9 ! ,unit$    
,/ates & t--  7,a7 au?orizes ! approval 
( drugs only if a drug has be5 det]m9$  
to be safe & effective by exp]ts employ$
 by or act+ on behalf ( a gov]nm5tal    

entity & qualifi$ by sci5tific tra9+ &  
exp]i5ce to evaluate ! safety &         
effectiv5ess ( drugs2  7,b7 requires t  
any det]m9ation ( safety & effectiv5ess 
describ$ 9 subp>agraph 7,a7 be made on !
 basis ( adequate & well-controll$      
inve/igations1 includ+ cl9ical          
inve/igations1 z appropriate1 conduct$  
by exp]ts qualifi$ by sci5tific tra9+ & 
exp]i5ce to evaluate ! safety &         
effectiv5ess ( drugs2  7,c7 requires !  
me?ods us$ 91 & ! facilities & controls 
us$ =1 ! manufacture1 process+1 & pack+ 
( drugs 9 ! c\ntry to be adequate to    
pres]ve ! id5tity1 quality1 purity1 &   
/r5g? ( ! drugs2 &  7,d7 requires !     
report+ ( adv]se reactions to drugs &   
e/abli% proc$ures to recall1 & )draw    
approval (1 drugs f\nd n to be safe or  
effective4  7f7 ,label+ ,any qualify+   
prescription drug import$ t meets !     
label+ requirem5ts describ$ 9 subsection
 7b77#e77;,a77iv7 is deem$ n misbr&$ =  
purposes ( section #ejb4  7g7 ,drug te/+
 laboratories ,! ,secret>y may approve  

"o or m laboratories to conduct r&om    
te/+ ( prescription drugs sold by       
c]tifi$ =eign sell]s to assess ! *emical
 au!nticity ( su* drugs4  7h7 ,unfair & 
discrim9atory ,acts & practices ,x is   
unlawful = a manufactur]1 directly or   
indirectly 7includ+ by be+ a p>ty to a  
lic5s+ agreem5t or o!r agreem5t7--  7#a7
 to discrim9ate by *>g+ a high] price = 
a prescription drug sold to a c]tifi$   
=eign sell] t sells su* drug to an      
import] 9 accordance ) ?is section ?an !
 price t is *>g$1 inclusive ( rebates or
 o!r inc5tives to ! c\ntry f :i* ! drug 
is export$1 to ano!r p]son t is 9 ! same
 c\ntry & t does n import su* a drug    
into ! ,unit$ ,/ates 9 accordance ) ?is 
section2  7#b7 except ) respect to a    
prescription drug on ! drug %ortage li/ 
"u section #ejf;,e1 discrim9ate by d5y+1
 re/rict+1 or delay+ supplies ( a       
prescription drug to a c]tifi$ =eign    
sell]1 on acc\nt ( su* sell]'s /atus z a
 c]tifi$ =eign sell]1 t sells su* drug  
to an import] 9 accordance ) ?is        

section1 or by publicly1 privately1 or  
o!rwise refus+ to d bus9ess ) su* a     
c]tifi$ =eign sell] on acc\nt ( su*     
sell]'s /atus z a c]tifi$ =eign sell]2  
7#c7 cause !re to be a diff]5ce 7includ+
 a diff]5ce 9 active +r$i5t1 r\te (     
adm9i/ration1 bioequival5ce1 /r5g?1     
=mulation1 manufactur+ e/abli%m5t1      
manufactur+ process1 or p]son t         
manufactures ! drug7 betwe5 a           
prescription drug = di/ribution 9 !     
,unit$ ,/ates & ! drug = di/ribution 9  
,canada or ano!r p]mitt$ c\ntry1 subject
 to subsection 7e71 = ! purpose ( avoid+
 sales by c]tifi$ =eign sell]s2 or  7#d7
 except ) respect to a prescription drug
 on ! drug %ortage li/ "u section       
#ejf;,e1 engage 9 any o!r action to     
re/rict1 prohibit1 or delay !           
importation ( a prescription drug "u ?is
 section4  7i7 ,in=mation & records     
7#a7 ,biannual reports ,ea* import] %all
 submit biannual reports to ! ,secret>y 
:i* %all conta91 = ea* qualify+         
prescription drug import$ into ! ,unit$ 

,/ates--  7,a7 ! unique facility        
id5tifi] ( ! manufactur] ( ! drug1      
describ$ 9 section #eaj2  7,b7 !        
transaction in=mation describ$ 9 section
 #eha7bf7 7o!r ?an ! in=mation describ$ 
9 subp>agraph 7,c772 &  7,c7 ! price    
paid by ! import] = ! drug4  7#b7       
,ma9t5ance ( records by ,secret>y ,!    
,secret>y %all ma9ta9 in=mation &       
docum5tation submitt$ "u p>agraph 7#a7 =
 su* p]iod ( "t z ! ,secret>y det]m9es  
to be appropriate4  7j7 ,susp5sion (    
importation  7#a7 ,patt]ns (            
noncompliance ,! ,secret>y %all require 
t importation ( a specific qualify+     
prescription drug or importation by a   
specific c]tifi$ =eign sell] or import] 
pursuant to ?is section be imm$iately   
susp5d$ if ! ,secret>y det]m9es t !re is
 a patt]n ( importation ( su* specific  
drug or by su* specific sell] or import]
 t involves c\nt]feit drugs1 drugs t h  
be5 recall$ or )drawn1 or drugs 9       
violation ( any requirem5t ( ?is        
section1 until an inve/igation is       

complet$ & ! ,secret>y det]m9es t       
importation ( su* drug or by su* sell]  
or import] does n endang] ! public      
heal?4  7#b7 ,tempor>y susp5sion ,!     
,secret>y may require t importation ( a 
specific qualify+ prescription drug or  
importation by a specific c]tifi$ =eign 
sell] or import] pursuant to ?is section
 be tempor>ily susp5d$ if1 ) respect to 
su* drug1 sell]1 or import]1 !re is a   
violation ( any requirem5t ( ?is section
 or if ! ,secret>y det]m9es t           
importation ( su* drug or by su* sell]  
or import] might endang] ! public heal?4
 ,su* tempor>y susp5sion %all apply     
until ! ,secret>y completes an          
inve/igation & det]m9es t importation ( 
su* drug or by su* sell] or import] does
 n endang] ! public heal?4  7k7 ,supply 
*a9 security  7#a7 ,pur*ase f regi/]$   
facilities & c]tifi$ =eign sell]s  7,a7 
,9 g5]al ,except z provid$ 9 subp>agraph
 7,b71 c]tifi$ =eign sell]s :o sell     
qualify+ prescription drugs =           
importation into ! ,unit$ ,/ates        

pursuant to ?is section may pur*ase su* 
drugs only f manufactur]s or entities   
regi/]$ "u section #eaj or o!r c]tifi$  
=eign sell]s4  7,b7 ,exception ,c]tifi$ 
=eign sell]s :o sell qualify+           
prescription drugs = importation into ! 
,unit$ ,/ates pursuant to ?is section   
may pur*ase su* drugs f =eign sell]s 9  
,canada or ano!r p]mitt$ c\ntry1 ev5 if 
su* =eign sell] is n a manufactur]      
regi/]$ "u section #eaj or a c]tifi$    
=eign sell]1 if ! ,secret>y ent]s into a
 memor&um ( und]/&+ or coop]ative       
agreem5t ) ,canada1 or su* o!r p]mitt$  
c\ntry1 to ensure compliance1 to ! ext5t
 appropriate & feasible1 ) sub*apt] ,h (
 *apt] ,v4 ,! ,secret>y %all seek to    
ent] into su* a memor&um ( und]/&+ or   
coop]ative agreem5t ) ,canada & ea*     
c\ntry f :i* importation is p]mitt$ "u  
subsection 7e74  7#b7 ,importation trac+
 ,c]tifi$ =eign sell]s %all provide     
import]s ) ! unique facility id5tifi]   
associat$ ) ! manufactur] regi/]$ "u    
section #eaj ( ! qualify+ prescription  

drug & ! in=mation "u p>agraph 7#be71   
p>agraph 7#bf7 7o!r ?an subp>agraph     
7,c771 & subp>agraphs 7,d71 7,f71 & 7,g7
 ( p>agraph 7#bg7 ( section #eha4       
,c]tifi$ =eign sell]s %all provide su*  
in=mation to individuals pur*as+ su*    
drugs1 ^u reque/4  7l7 ,r,e,ms ,9 ! case
 ( an import] t imports a qualify+      
prescription drug1 :]e ! drug ) ! same  
active +r$i5t or +r$i5ts 7or t is       
biosimil> to an approv$ biological      
product71 r\te ( adm9i/ration1 & /r5g? t
 is approv$ "u *apt] ,v or section #cea 
( ! ,public ,heal? ,s]vice ,act is      
subject to elem5ts to assure safe use "u
 section #eje-a1 su* import] %all be    
subject to su* elem5ts to assure safe   
use1 z applicable & appropriate4  7m7   
,con/ruction ,no?+ 9 ?is section limits 
! au?ority ( ! ,secret>y relat+ to !    
importation ( prescription drugs1 o!r   
?an ) respect to section #hja7;d77#a7 z 
provid$ 9 ?is section4  4  7b7 ,p5alties
 ) respect to onl9e ph>macies ,section  
#cjc ( ! ,f$]al ,food1 ,drug1 &         

,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7 is  
am5d$ by add+ at ! end ! foll[+3  7h7 ,9
 ! case ( p]son op]at+ an int]net       
website1 :e!r 9 ! ,unit$ ,/ates or 9    
ano!r c\ntry1 t violates section        
#cja7;aa7 by--  7#a7 sell+1 by means ( !
 int]net1 ) ! int5t to defraud or       
mislead or ) reckless disreg>d = safety 
( ! public1 an adult]at$ or c\nt]feit   
drug to an individual 9 ! ,unit$ ,/ates2
 or  7#b7 disp5ses1 by means ( !        
int]net1 a drug to an individual 9 !    
,unit$ ,/ates :o ! p]son kn[s or has    
reasonable cause to believe1 does n     
possess a valid prescription = t drug1  
su* p]son %all be imprison$ = n m ?an   
#aj ye>s or f9$ n m ?an #bej1jjj4  4    
7c7 ,no preemption ,no?+ 9 ?is ,act1    
includ+ ! am5dm5ts made by ?is ,act1    
%all be con/ru$ to preempt1 alt]1       
displace1 abridge1 or supplant any rem$y
 available "u any ,/ate or ,f$]al law1  
includ+ common law1 t provides a rem$y =
 civil relief4  7d7 ,reports  7#a7 ,,hhs
 ,n lat] ?an #a ye> aft] ! date on :i*  

f9al regulations are promulgat$ to c>ry 
out section #hjd ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#chd71 z am5d$ by ?is ,act1 & e #b ye>s 
!reaft]1 ! ,secret>y ( ,heal? & ,human  
,s]vices1 aft] consultation )           
appropriate ,f$]al ag5cies1 %all submit 
to ,congress & make public a report on !
 importation ( drugs into ! ,unit$      
,/ates4  7#b7 ,,gao report ,n lat] ?an  
#ah mon?s aft] ! date on :i* f9al       
regulations are promulgat$ to c>ry out  
section #hjd ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #chd71 z  
am5d$ by ?is ,act1 ! ,comptroll] ,g5]al 
( ! ,unit$ ,/ates %all submit to        
,congress a report conta9+ an analysis (
 ! implem5tation ( ! am5dm5ts made by   
?is ,act1 includ+ a review ( drug safety
 & co/-sav+s & exp5ses1 includ+         
co/-sav+s to consum]s 9 ! ,unit$ ,/ates 
& trans-%ipm5t & importation trac+      
processes1 result+ f su* implem5tation4