,i  #aac? ,,congress  #a/ ,session  ,h4 
,r4 #dhf  ,,9 ,,! ,,h\se ,,(            
,,repres5tatives  ,febru>y #d1 #bjac    
,mr4 ,keat+ 7= himself1 ,mr4 ,rog]s (   
,k5tucky1 ,mr4 ,rahall1 ,mr4 ,lyn*1 ,ms4
 ,hanabusa1 & ,mr4 ,bu*anan7 introduc$ !
 foll[+ bill2 :i* 0 ref]r$ to !         
,committee on ,en]gy & ,comm]ce  ,a     
,,bill  ,to am5d ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act to inc5tivize !        
developm5t ( abuse-det]r5t drugs4  #a4  
,%ort title ,?is ,act may be cit$ z !   
,/op ,tamp]+ ( ,prescription ,pills ,act
 ( #bjac4  #b4 ,abuse-det]r5t te*nology 
7a7 ,def9ition ,section #bja ( ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cba7 is am5d$ by add+ at !   
end ! foll[+3  7ss7 ,! t]m abuse-det]r5t
 drug means a drug t--  7#a7 conta9s z  
an active moiety a controll$ sub/ance t 
has be5 classifi$ z opium1 an opiate1 or
 a d]ivative !re(1 z su* t]ms are def9$ 
or us$ 9 section #ajb ( ! ,controll$    
,sub/ances ,act2  7#b7 has be5 =mulat$ =
 oral adm9i/ration2 &  7#c7 7,a7        

exhibits physico*emical prop]ties       
7demon/rat$ by 9 vitro1 9 vivo1 or o!r  
te/+1 or "s comb9ation !re(1 z det]m9$  
appropriate by ! ,secret>y7 t make      
product manipulation significantly m    
difficult or ineffective 9 alt]+ !      
*>act]i/ics ( ! drug = purposes ( misuse
 or abuse :5 comp>$ to drugs )\t su*    
prop]ties2 or  7,b7 conta9s "o or m     
additional active or inactive +r$i5ts t 
are int5d$ to det] abuse ?r\gh pot5tial 
ph>macological effects1 ! effectiv5ess (
 :i* has be5 demon/rat$ by at lea/ "o   
adequate & well-controll$ inve/igation4 
4  7b7 ,requir$ in=mation 9 application 
= approval ( br& "n drugs ,section      
#eje7;b7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77 
is am5d$ by add+ at ! end ! foll[+3     
7#g7 ,abuse-det]r5t drugs ,if an        
application submitt$ "u ?is subsection  
is pot5tially subject to refusal "u     
subsection 7d77#g71 ! application %all  
include su* in=mation z ! ,secret>y     
det]m9es necess>y to demon/rate t !     

application is n subject to su* refusal4
  4  7c7 ,approval ( new br& "n drugs   
,section #eje7;d7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;d77 is am5d$--  7#a7 by ins]t+    
7#g77;,a7 su* drug has be5 =mulat$ =    
oral adm9i/ration2 7,b7 su* drug conta9s
 z an active moiety a controll$ sub/ance
 t has be5 classifi$ z opium1 an opiate1
 or a d]ivative !re(1 z su* t]ms are    
def9$ or us$ 9 section #ajb ( !         
,controll$ ,sub/ances ,act2 7,c7 su*    
drug is n an abuse-det]r5t drug2 & 7,d7 
! ,secret>y has previ\sly approv$       
pursuant to an application submitt$ "u  
subsection 7b7 or 7j7 a drug t 7i7      
conta9s ! same active moiety2 7ii7 is an
 abuse-det]r5t drug1 & 7iii7 has n be5  
discont9u$ f m>ket+2 or aft] 7#f7 !     
application fail$ to conta9 ! pat5t     
in=mation prescrib$ by subsection 7b72  
or2  7#b7 by /rik+ 7#g7 bas$ on fair &  
ins]t+ 7#h7 bas$ on fair2  7#c7 by /rik+
 clauses 7#a7 ?r\gh 7#f7 & ins]t+       
p>agraphs 7#a7 ?r\gh 7#g72 &  7#d7 by   

ins]t+ ,! ,secret>y may issue an ord]   
approv+ an application1 ev5 if p>agraph 
7#g7 applies1 ^u a f9d+ t p>agraphs 7#a7
 ?r\gh 7#f7 & p>agraph 7#h7 d n apply & 
t su* approval is necess>y ei!r to      
prev5t or alleviate a drug %ortage or to
 o!rwise address a significant unmet    
public heal? ne$4 be=e ,z us$ 9 ?is     
subsection & subsection 7e74  7d7 ,g5]ic
 drugs ,section #eje7;j7 ( ! ,f$]al     
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7;j77 is am5d$--  7#a7 9  
p>agraph 7#b7--  7,a7 subp>agraph 7,a7--
  7i7 9 clause 7vii71 by /rik+ & at !   
end2  7ii7 9 clause 7viii71 by /rik+ !  
p]iod at ! end & ins]t+ 2 &2  7iii7 by  
ins]t+ aft] clause 7viii7 ! foll[+3     
7ix7 if ! li/$ drug is an abuse-det]r5t 
drug due to its physico*emical          
prop]ties1 in=mation f comp>ative 9     
vitro1 9 vivo1 or o!r te/+1 or "s       
comb9ation !re(1 z appropriate bas$ on !
 type ( data submitt$ = ! li/$ drug1 t  
demon/rates ! new drug resi/s           
manipulation or ! effect ( manipulation 

to a degree at lea/ comp>able to ! li/$ 
drug4  2 &  7iv7 9 ! cont9uation text at
 ! end ( ! subp>agraph1 by /rik+ clauses
 7i7 ?r\gh 7viii7 & ins]t+ clauses 7i7  
?r\gh 7ix72  7,b7 9 subp>agraph 7,c7--  
7i7 9 clause 7i71 by /rik+ or at ! end2 
7ii7 9 clause 7ii71 by /rik+ ! p]iod at 
! end & ins]t+ 2 or2 &  7iii7 by add+ at
 ! end ! foll[+3  7iii7 t ! li/$ drug is
 an abuse-det]r5t drug & "o or m ( ! new
 drug's active moieties diff] 9 any     
mat]ial respect 79 am\nt or o!rwise7 f  
^? ( ! li/$ drug4  2  7#b7 9 p>agraph   
7#e71 by add+ at ! end ! foll[+3  7,g7  
,if a drug has be5 approv$ pursuant to  
an application submitt$ "u p>agraph     
7#b71 & !reaft] ! li/$ drug ref]r$ to 9 
! application becomes an abuse-det]r5t  
drug1 ! drug s approv$ %all n be        
consid]$ to be bioequival5t to1 or to h 
! same !rapeutic effect z1 ! li/$ drug  
7z describ$ 9 p>agraph 7#b77;,a77iv77   
unless & until ! drug s approv$ has be5 
f\nd by ! ,secret>y to meet !           
requirem5ts ( p>agraph 7#b77;,a77ix74  2

 &  7#c7 9 p>agraph 7#f7--  7,a7 by     
/rik+ 7#f7 ,if a drug & ins]t+ 7#f77;,a7
 ,if a drug2  7,b7 by /rik+ 7,a7 = ! &  
ins]t+ 7i7 = !2  7,c7 by /rik+ 7,b7 if !
 & ins]t+ 7ii7 if !2 &  7,d7 by add+ at 
! end ! foll[+3  7,b7 ,= purposes ( ?is 
p>agraph & p>agraph 7#g77;,c71 a )drawal
 or susp5sion ( a drug =mulat$ = oral   
adm9i/ration %all be consid]$ to h be5 =
 safety or effectiv5ess reasons if--    
7i7 ! approval ( a li/$ drug1 :i* is n  
an abuse-det]r5t drug1 is )drawn or     
susp5d$1 or a li/$ drug1 :i* is n an    
abuse-det]r5t drug1 is )drawn f sale2 & 
7ii7 ! ,secret>y has previ\sly approv$  
pursuant to an application "u subsection
 7b7 a drug t--  7,i7 is 9 ! same dosage
 =m2  7,,ii7 conta9s ! same controll$   
sub/ance z an active moiety2  7,,iii7 is
 an abuse-det]r5t drug2 &  7,,iv7 has n 
be5 discont9u$ f m>ket+4  4  7e7        
,)drawal ( previ\sly approv$ br& "n &   
g5]ic drugs ,section #eje7;e7 ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act 7#ba    
,u4,s4,c4 #cee7;e77 is am5d$--  7#a7 by 

ins]t+ or 7#f77;,a7 ! drug conta9s z an 
active moiety a controll$ sub/ance t has
 be5 classifi$ z opium1 an opiate1 or a 
d]ivative !re(1 z su* t]ms are def9$ or 
us$ 9 section #ajb ( ! ,controll$       
,sub/ances ,act2 7,b7 ! drug is =mulat$ 
= oral adm9i/ration2 7,c7 ! drug is n an
 abuse-det]r5t drug2 & 7,d7 ! ,secret>y 
has previ\sly approv$ pursuant to an    
application submitt$ "u subsection 7b7  
or 7j7 a drug t conta9s ! same active   
moiety1 is an abuse-det]r5t drug1 & has 
n be5 discont9u$ f m>ket+ be=e 3        
,provid$12 &  7#b7 by add+ at ! end !   
foll[+3 ,! ,secret>y may waive !        
application ( p>agraph 7#f7 ( ! fir/    
s5t5ce ( ?is subsection 9 ! case ( a    
drug int5d$ = use 9 a special ne$s      
population4 ,9 )draw+ 7"u p>agraph 7#f7 
( ! fir/ s5t5ce ( ?is subsection7 !     
approval ( an application ) respect to  
any drug1 ! ,secret>y %all1 on a        
case-by-case basis1 delay ! effective   
date ( su* )drawal = a p]iod deem$      
suffici5t by ! ,secret>y to give !      

sponsor an opportunity to obta9 approval
 "u ?is section = a =mulation ( ! drug  
meet+ ! crit]ia describ$ 9 p>agraph 7#b7
 ( ! def9ition ( a abuse-det]r5t drug 9 
section #bja7ss744  7f7 ,li/$ drugs     
,section #eje7;j77#g7 ( ! ,f$]al ,food1 
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;j77#g77 is am5d$ by add+ at ! end 
! foll[+3  7,d7 ,beg9n+ #fj days aft] ! 
date ( ! enactm5t ( ! ,/op ,tamp]+ (    
,prescription ,pills ,act ( #bjac1 !    
,secret>y %all--  7i7 include 9 ! li/ "u
 subp>agraph 7,a7 a li/ ( ea* drug or   
category ( drugs :i* ! ,secret>y has    
f\nd to be abuse-det]r5t drugs2 &  7ii7 
update ! li/ "u subp>agraph 7,a7--  7,i7
 to remove f ! li/ ( abuse-det]r5t drugs
 any drug ! ,secret>y lat] det]m9es is n
 an abuse-det]r5t drug2 &  7,,ii7 z     
requir$ by subp>agraph 7,c7 to reflect !
 application ( p>agraph 7#f77;,b7 to    
drugs t are )drawn or susp5d$4  4