,,ii  #aah? ,,congress  #a/ ,session    
,s4 #fhi  ,,9 ,,! ,,s5ate ,,( ,,!       
,,unit$ ,,/ates  ,m>* #g1 #bjbc,mr4     
,book] 7= himself & ,mr4 ,paul7         
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on !     
,judici>y  ,a ,,bill  ,to am5d !        
,controll$ ,sub/ances ,act to def9e     
curr5tly accept$ m$ical use ) sev]e     
re/rictions1 & = o!r purposes4  #a4     
,curr5tly accept$ m$ical use ) sev]e    
re/rictions  7a7 ,def9itions ,section   
#ajb ( ! ,controll$ ,sub/ances ,act 7#ba
 ,u4,s4,c4 #hjb7 is am5d$ by ins]t+ aft]
 p>agraph 7#g7 ! foll[+3  7#g7 7,a7     
,subject to subp>agraph 7,b71 ! t]m     
curr5tly accept$ m$ical use ) sev]e     
re/rictions1 ) respect to a drug or o!r 
sub/ance1 includes a drug or o!r        
sub/ance t is an active metabolite1     
moiety1 or +r$i5t 7:e!r 9 natural or    
syn!tic =m7 ( an inve/igational new drug
 = :i* a waiv] is 9 effect "u section   
#eje7;i7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;i77 

or section #cea7;a77#c7 ( ! ,public     
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#bfb7;a77#c77 & t ! ,secret>y-- 7i7     
designates z a break?r\gh !rapy "u      
section #ejf7;a7 ( ! ,food ,drug &      
,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;a772
 or  7ii7 au?orizes = exp&$ access "u   
subsection 7b7 or 7c7 ( section #efa ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #cfj;bbb71 ei!r alone or 
z "p ( a !rapeutic protocol1 to treat   
pati5ts ) s]i\s or life-?reat5+ diseases
 = :i* no comp>able or satisfactory     
!rapies are available4  7,b7 ,a drug or 
o!r sub/ance %all n meet ! crit]ia "u   
subp>agraph 7,a7 = hav+ a curr5tly      
accept$ m$ical use ) sev]e re/rictions  
if-- 7i7 9 ! case ( a drug or o!r       
sub/ance describ$ 9 subp>agraph         
7,a77ii7-- 7,i7 ! ,secret>y places !    
exp&$ access or protocol = su* drug on  
cl9ical hold z describ$ 9 section       
#cab4db ( title #ba1 ,code ( ,f$]al     
,regulations 7or any successor          
regulations72  7,,ii7 !re is no o!r     

inve/igational new drug conta9+ ! drug  
or o!r sub/ance = :i* exp&$ access has  
be5 au?oriz$ "u section #efa7;a7 ( !    
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cfj;bbb7a772 &  7,,iii7 
! drug or o!r sub/ance does n meet !    
requirem5ts ( subp>agraph 7,a77i72 or   
7ii7 ! drug or o!r sub/ance is approv$  
"u section #eje ( ! ,f$]al ,food1 ,drug1
 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7  
or section #cea ( ! ,public ,heal?      
,s]vice ,act 7#db ,u4,s4,c4 #bfb74  4   
7b7 ,au?ority & crit]ia = classification
 ( sub/ances ,section #bja7;j7 ( !      
,controll$ ,sub/ances ,act 7#ba         
,u4,s4,c4 #haa7;j77 is am5d$-- 7#a7 9   
p>agraph 7#a71 by ins]t+ a drug         
designat$ z a break?r\gh !rapy "u       
section #ejf7;a7 ( ! ,food ,drug &      
,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;a771
 or a drug au?oriz$ = exp&$ access "u   
subsection 7b7 or 7c7 ( section #efa ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #cfj;bbb7 aft] subsection
 7f712  7#b7 9 p>agraph 7#b7-- 7,a7 9   

subp>agraph 7,a71 by /rik+ 2 or & ins]t+
 a semicolon2  7,b7 9 subp>agraph 7,b71 
by /rik+ ! p]iod at ! end & ins]t+ a    
semicolon2 &  7,c7 by add+ at ! end !   
foll[+3  7,c7 ! date on :i* ! ,attorney 
,g5]al receives notification f !        
,secret>y ( ,heal? & ,human ,s]vices t !
 ,secret>y has designat$ a drug z a     
break?r\gh !rapy "u section #ejf7;a7 ( !
 ,food ,drug & ,cosmetic ,act 7#ba      
,u4,s4,c4 #cef7;a77 or au?oriz$ a drug =
 exp&$ access "u subsection 7b7 or 7c7 (
 section #efa ( ! ,f$]al ,food1 ,drug1 &
 ,cosmetic ,act 7#ba ,u4,s4,c4          
#cfj;bbb72 or  7,d7 ! date on :i* !     
,attorney ,g5]al receives any writt5    
notification demon/rat+ t ! ,secret>y1  
be=e ! date ( enactm5t ( ?is            
subp>agraph1 designat$ a drug z a       
break?r\gh !rapy "u section #ejf7;a7 ( !
 ,food ,drug & ,cosmetic ,act 7#ba      
,u4,s4,c4 #cef7;a77 or au?oriz$ a drug =
 exp&$ access "u subsection 7b7 or 7c7 (
 section #efa ( ! ,f$]al ,food1 ,drug1 &
 ,cosmetic ,act 7#ba ,u4,s4,c4          

#cfj;bbb74  2  7#c7 9 p>agraph 7#c71 by 
ins]t+ or p>agraph 7#d7 aft] p>agraph   
7#a72 &  7#d7 by add+ at ! end ! foll[+3
  7#d7 ,) respect to a drug mov$ f      
s*$ule ,i to s*$ule ,,ii pursuant to    
p>agraph 7#a7 & ! exp$it$ proc$ures     
describ$ "u ?is subsection1 if ! drug no
 long] has a curr5tly accept$ m$ical use
 ) sev]e re/rictions & ! ,secret>y (    
,heal? & ,human ,s]vices recomm5ds t !  
,attorney ,g5]al control ! drug 9 s*$ule
 ,i pursuant to subsections 7a7 & 7b71 !
 ,attorney ,g5]al %all1 n lat] ?an #ij  
days aft] receiv+ writt5 notification f 
! ,secret>y1 issue an int]im f9al rule  
controll+ ! drug 9 accordance ) su*     
subsections & section #bjb7;b7 us+ !    
proc$ures describ$ 9 p>agraph 7#c7 ( ?is
 subsection4  4