,i  #aah? ,,congress  #a/ ,session  ,h4 
,r4 #acic  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,m>* #g1 #bjbc,ms4    
,dean ( ,p5nsylvania 7= h]self & ,ms4   
,mace7 introduc$ ! foll[+ bill2 :i* 0   
ref]r$ to ! ,committee on ,en]gy &      
,comm]ce1 & 9 addition to ! ,committee  
on ! ,judici>y1 = a p]iod to be         
subsequ5tly det]m9$ by ! ,speak]1 9 ea* 
case = consid]ation ( su* provisions z  
fall )9 ! jurisdiction ( ! committee    
conc]n$  ,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$-- 7#a7 by     
r$esignat+ p>agraph 7#eh7 7def9+ a s]i\s
 viol5t felony7 z p>agraph 7#ei72  7#b7 
by r$esignat+ ! second p>agraph 7#eg7   
7def9+ a s]i\s drug felony7 z p>agraph  
7#eh72 &  7#c7 by add+ at ! end !       
foll[+3  7#fj7 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$]al
 ,food1 ,drug1 & ,cosmetic ,act 7#ba    
,u4,s4,c4 #cee7;i77 or section          
#cea7;a77#c7 ( ! ,public ,heal? ,s]vice 
,act 7#db ,u4,s4,c4 #bfb7;a77#c77 & t ! 
,secret>y-- 7i7 designates z a          
break?r\gh !rapy "u section #ejf7;a7 ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #cef7;a772 or  7ii7      
au?orizes = exp&$ access "u subsection  
7b7 or 7c7 ( section #efa ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfj;bbb71 ei!r alone or z "p 
( a !rapeutic protocol1 to treat pati5ts
 ) s]i\s or life-?reat5+ diseases = :i* 
no comp>able or satisfactory !rapies are
 available4  7,b7 ,a drug or o!r        
sub/ance %all n be treat$ z 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$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #cfj;bbb71 aft]          
subsection 7f712  7#b7 9 p>agraph 7#b7--
 7,a7 9 subp>agraph 7,a71 by /rik+ 2 or 
& ins]t+ a semicolon2  7,b7 9           
subp>agraph 7,b71 by /rik+ ! p]iod at ! 
end & ins]t+ a semicolon2 &  7,c7 by    
add+ at ! end ! foll[+3  7,c7 ! date on 
:i* ! ,attorney ,g5]al receives         
notification f ! ,secret>y ( ,heal? &   
,human ,s]vices t ! ,secret>y has       
designat$ ! drug z a break?r\gh !rapy "u
 section #ejf7;a7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cef7;a77 or au?oriz$ ! 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$ ! 
drug z a break?r\gh !rapy "u section    
#ejf7;a7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;a77 
or au?oriz$ ! 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