,,ii  #aac? ,,congress  #b;d ,session   
,s4 #bhfb  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,septemb] #ah1         
#bjad,mr4 ,hat* 7= himself & ,mr4       
,:iteh\se7 introduc$ ! foll[+ bill2 :i* 
0 read twice & ref]r$ to ! ,committee on
 ,heal?1 ,education1 ,labor1 & ,p5sions 
,a ,,bill  ,to am5d ! ,controll$        
,sub/ances ,act ) respect to drug s*$ul+
 recomm5dations by ! ,secret>y ( ,heal? 
& ,human ,s]vices1 & ) respect to       
regi/ration ( manufactur]s & di/ributors
 seek+ to conduct cl9ical te/+1 & = o!r 
purposes4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,regulatory ,transp>5cy1   
,pati5t ,access1 & ,effective ,drug     
,en=cem5t ,act ( #bjad4  #b4 ,s*$ul+ (  
sub/ances includ$ 9 new ,,fda-approv$   
drugs ,section #bja ( ! ,controll$      
,sub/ances ,act 7#ba ,u4,s4,c4 #haa7 is 
am5d$ by ins]t+ aft] subsection 7h7 !   
foll[+3  7i7 ,)9 #de days ( receiv+ a   
recomm5dation f ! ,secret>y to add a    
drug or sub/ance t has nev] be5 m>ket$ 9
 ! ,unit$ ,/ates to a s*$ule "u ?is     

title1 ! ,attorney ,g5]al %all1 )\t     
reg>d to ! f9d+s requir$ by subsection  
7a7 ( ?is section or section #bjb7;b71  
issue an int]im f9al rule1 "u !         
exception = good cause describ$ 9       
subp>agraph 7,b7 ( section #eec7;b7 (   
title #e1 ,unit$ ,/ates ,code1 plac+ !  
drug or sub/ance into ! s*$ule recomm5d$
 by ! ,secret>y4 ,! int]im f9al rule    
%all be made imm$iately effective "u    
section #eec7;d77#c7 ( title #e1 ,unit$ 
,/ates ,code4  4  #c4 ,enhanc+ new drug 
developm5t ,section #cjb ( ! ,controll$ 
,sub/ances ,act 7#ba ,u4,s4,c4 #hbb7 is 
am5d$ by ins]t+ aft] subsection 7g7 !   
foll[+3  7h7 7#a7 ,a p]son :o submits an
 application = regi/ration to           
manufacture or di/ribute a controll$    
sub/ance 9 accordance ) ?is section may 
indicate on ! regi/ration application t 
! sub/ance w be us$ only 9 connection ) 
cl9ical trials ( a drug 9 accordance )  
section #eje7;i7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act4  7#b7 ,:5 an   
application = regi/ration to manufacture

 or di/ribute a controll$ sub/ance      
includes an indication t ! controll$    
sub/ance w be us$ only 9 connection )   
cl9ical trials ( a drug 9 accordance )  
section #eje7;i7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act1 ! ,attorney    
,g5]al %all-- 7,a7 make a f9al decision 
on ! application = regi/ration )9 #ahj  
days2 or  7,b7 provide notice to !      
applicant 9 writ+ (-- 7i7 ! out/&+      
issues t mu/ be resolv$ 9 ord] to rea* a
 f9al decision on ! application2 &  7ii7
 ! e/imat$ date on :i* a f9al decision  
on ! application w be made4  4  #d4     
,regi/ration process "u ,controll$      
,sub/ances ,act  7a7 ,def9itions  7#a7  
,factors z may be relevant to & consi/5t
 ) ! public heal? & safety ,section #cjc
 ( ! ,controll$ ,sub/ances ,act 7#ba    
,u4,s4,c4 #hbc7 is am5d$ by add+ at !   
end ! foll[+3  7i7 ,9 ?is section1 !    
phrase factors z may be relevant to &   
consi/5t ) ! public heal? & safety means
 factors t are relevant to & consi/5t ) 
! f9d+s conta9$ 9 section #aja4  4  7#b7

 ,imm95t dang] to ! public heal? or     
safety ,section #cjd7;d7 ( ! ,controll$ 
,sub/ances ,act 7#ba ,u4,s4,c4 #hbd7;d77
 is am5d$-- 7,a7 by /rik+ 7d7 ,!        
,attorney ,g5]al & ins]t+ 7d77#a7 ,!    
,attorney ,g5]al2 &  7,b7 by add+ at !  
end ! foll[+3  7#b7 ,9 ?is subsection1 !
 phrase imm95t dang] to ! public heal?  
or safety means t1 9 ! abs5ce ( an      
imm$iate susp5sion ord]1 controll$      
sub/ances w cont9ue to be di/ribut$ or  
disp5s$ by a regi/rant :o kn[s or %\ld  
"k ?r\gh fulfill+ ! obligations ( !     
regi/rant "u ?is ,act1 or has reason to 
believe t-- 7,a7 ! disp5s+ is outside ! 
usual c\rse ( pr(essional practice2     
7,b7 ! di/ribution or disp5s+ poses a   
pres5t or =eseeable risk ( adv]se heal? 
consequ5ces or dea? due to ! abuse or   
misuse ( ! controll$ sub/ances2 or  7,c7
 ! controll$ sub/ances w cont9ue to be  
div]t$ outside ( legitimate di/ribution 
*annels4  4  7b7 ,opportunity ,to submit
 corrective action plan prior to        
revocation or susp5sion ,subsection 7c7 

( section #cjd ( ! ,controll$ ,sub/ances
 ,act 7#ba ,u4,s4,c4 #hbd7 is am5d$--   
7#a7 by /rik+ ! la/ two s5t5ces2  7#b7  
by /rik+ 7c7 ,be=e & ins]t+ 7c77#a7     
,be=e2 &  7#c7 by add+ at ! end !       
foll[+3  7#b7 ,an ord] to %[ cause "u   
p>agraph 7#a7 %all-- 7,a7 conta9 a      
/atem5t ( ! basis = ! d5ial1 revocation1
 or susp5sion1 includ+ specific         
citations to any laws or regulations    
alleg$ to be violat$ by ! applicant or  
regi/rant2  7,b7 direct ! applicant or  
regi/rant to appe> be=e ! ,attorney     
,g5]al at a "t & place /at$ 9 ! ord]1 b 
n less ?an #cj days aft] ! date (       
receipt ( ! ord]2 &  7,c7 notify !      
applicant or regi/rant ( ! opportunity  
to submit a corrective action plan on or
 be=e ! date ( appe>ance4  7#c7 ,^u     
review ( any corrective action plan     
submitt$ by an applicant or regi/rant   
pursuant to p>agraph 7#b71 ! ,attorney  
,g5]al %all det]m9e :e!r d5ial1         
revocation or susp5sion proce$+s %\ld be
 discont9u$1 or def]r$ = ! purposes (   

modification1 am5dm5t1 or cl>ification  
to su* plan4  7#d7 ,proce$+s to d5y1    
revoke1 or susp5d %all be conduct$      
pursuant to ?is section 9 accordance )  
sub*apt] ,,ii ( *apt] #e ( title #e1    
,unit$ ,/ates ,code4 ,su* proce$+s %all 
be indep5d5t (1 & n 9 lieu (1 crim9al   
prosecutions or o!r proce$+s "u ?is     
title or any o!r law ( ! ,unit$ ,/ates4 
7#e7 ,! requirem5ts ( ?is subsection    
%all n apply to ! issuance ( an imm$iate
 susp5sion ord] "u subsection 7d74  4   
#e4 ,report to ,congress on effects (   
law en=cem5t activities on pati5t access
 to m$ications  7a7 ,9 g5]al ,n lat] ?an
 #a ye> aft] ! date ( enactm5t ( ?is    
,act1 ! ,secret>y ( ,heal? & ,human     
,s]vices1 act+ ?r\gh ! ,commission] (   
,food & ,drugs & ! ,director ( ! ,c5t]s 
= ,disease ,control & ,prev5tion1 & 9   
consultation ) ! ,adm9i/rator ( ! ,drug 
,en=cem5t ,adm9i/ration & ! ,director ( 
,national ,drug ,control ,policy1 %all  
submit a report to ! ,committees on !   
,judici>y ( ! ,h\se ( ,repres5tatives1 !

 ,committee on ,en]gy & ,comm]ce ( !    
,h\se ( ,repres5tatives1 ! ,committee on
 ! ,judici>y ( ! ,s5ate1 & ! ,committee 
on ,heal?1 ,education1 ,labor & ,p5sions
 ( ! ,s5ate id5tify+-- 7#a7 ob/acles to 
legitimate pati5t access to controll$   
sub/ances2  7#b7 issues ) div]sion (    
controll$ sub/ances2 &  7#c7 h[         
collaboration betwe5 ,f$]al1 ,/ate1     
local1 & tribal law en=cem5t ag5cies & !
 ph>maceutical indu/ry c b5efit pati5ts 
& prev5t div]sion & abuse ( controll$   
sub/ances4  7b7 ,consultation ,! report 
"u subsection 7a7 %all incorporate      
fe$back & recomm5dations f ! foll[+3    
7#a7 ,pati5t gr\ps4  7#b7 ,ph>macies4   
7#c7 ,drug manufactur]s4  7#d7 ,common  
or contract c>ri]s & w>eh\sem54  7#e7   
,hospitals1 physicians1 & o!r heal? c>e 
provid]s4  7#f7 ,/ate attorneys g5]al4  
7#g7 ,f$]al1 ,/ate1 local1 & tribal law 
en=cem5t ag5cies4  7#h7 ,heal? insurance
 provid]s & entities t provide ph>macy  
b5efit managem5t s]vices on behalf ( a  
heal? insurance provid]4  7#i7 ,:olesale

 drug di/ributors4