,i  #aae? ,,congress  #b;d ,session  ,h4
 ,r4 #efhg  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,may #g1 #bjah,mr4    
,hudson 7= himself1 ,mr4 ,butt]field1 & 
,mr4 ,budd7 introduc$ ! foll[+ bill2 :i*
 0 ref]r$ to ! ,committee on ,en]gy &   
,comm]ce  ,a ,,bill  ,to am5d ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act to       
require improv$ packag+ & disposal      
me?ods ) respect to c]ta9 drugs1 & = o!r
 purposes4  #a4 ,%ort title ,?is ,act   
may be cit$ z ! ,secur+ ,opioids &      
,unus$ ,n>cotics ) ,delib]ate ,disposal 
& ,packag+ ,act ( #bjah or ! ,,s\nd     
,disposal & ,packag+ ,act4  #b4 ,improv$
 te*nologies1 controls1 or measures )   
respect to ! packag+ or disposal ( c]ta9
 drugs  7a7 ,9 g5]al ,*apt] ,v ( !      
,f$]al ,food1 ,drug1 & ,cosmetic ,act is
 am5d$ by ins]t+ aft] section #eje-a    
7#ba ,u4,s4,c4 #cee-a7 ! foll[+ new     
section3  #eje-b4 ,safety-enhanc+       
packag+ & disposal features  7a7 ,ord]s 
7#a7 ,9 g5]al ,! ,secret>y may1 aft]    
consultation ) relevant /akehold]s1     

issue an ord] requir+ ! hold] ( a cov]$ 
application to implem5t or modify "o or 
m te*nologies1 controls1 or measures )  
respect to ! packag+ or disposal ( "o or
 m drugs id5tifi$ 9 ! cov]$ application1
 if ! ,secret>y det]m9es su*            
te*nologies1 controls1 or measures to be
 appropriate to help mitigate ! risk (  
abuse or misuse ( su* drug or drugs1    
includ+ by r$uc+ ! availability ( unus$ 
drugs4  7#b7 ,assur+ access & m9imiz+   
burd5 ,te*nologies1 controls1 or        
measures requir$ "u p>agraph 7#a7 %all--
 7,a7 be comm5surate ) ! specific risk (
 abuse or misuse ( ! drug li/$ 9 ! cov]$
 application2  7,b7 consid]+ su* risk1 n
 be unduly burd5some on pati5t access to
 ! drug1 consid]+ 9 p>ticul> ! available
 evid5ce reg>d+ ! expect$ or demon/rat$ 
public heal? impact ( su* te*nologies1  
controls1 or measures2 &  7,c7 r$uce !  
risk ( abuse or misuse ( su* drug4  7#c7
 ,ord] cont5ts ,an ord] issu$ "u        
p>agraph 7#a7 may--  7,a7 provide = a   
range ( options = implem5t+ or modify+ !

 te*nologies1 controls1 or measures     
requir$ to be implem5t$ by su* ord]2 &  
7,b7 incorporate by ref]5ce /&>ds reg>d+
 packag+ or disposal set =? 9 an (ficial
 comp5dium1 e/abli%$ by a nationally or 
int]nationally recogniz$ /&>d developm5t
 organization1 or describ$ on ! public  
,int]net website ( ! ,food & ,drug      
,adm9i/ration1 s long z ! ord] includes 
! rationale = incorporation ( su* /&>d4 
7#d7 ,ord]s applicable to drug class ,:5
 a conc]n ab\t ! risk ( abuse or misuse 
( a drug relates to a ph>macological    
class1 ! ,secret>y may1 aft]            
consultation ) relevant /akehold]s1     
issue an ord] "u p>agraph 7#a7 :i*      
applies to ! ph>macological class4  7b7 
,compliance ,! hold] ( a cov]$          
application %all-- 7#a7 submit a        
supplem5t conta9+ propos$ *anges to !   
cov]$ application to comply ) an ord]   
issu$ "u subsection 7a7 n lat] ?an--    
7,a7 #ahj cal5d> days aft] ! date on :i*
 ! ord] is issu$2 or  7,b7 7i7 su* long]
 "t p]iod z specifi$ by ! ,secret>y 9   

su* ord]2 or  7ii7 if a reque/ = an     
alt]native date is submitt$ by ! hold] (
 su* application n lat] ?an #fj cal5d>  
days aft] ! date on :i* su* ord] is     
issu$--  7,i7 su* reque/$ alt]native    
date if agre$ to by ! ,secret>y2 or     
7,,ii7 ano!r date z specifi$ by !       
,secret>y2 &  7#b7 implem5t ! *anges    
approv$ pursuant to su* supplem5t n lat]
 ?an ! lat] (-- 7,a7 #ij cal5d> days    
aft] ! date on :i* ! supplem5t is       
approv$2 or  7,b7 ! end ( su* long]     
p]iod z is-- 7i7 det]m9$ to be          
appropriate by ! ,secret>y2 or  7ii7    
approv$ by ! ,secret>y pursuant to a    
reque/ by ! hold] ( ! cov]$ application 
t expla9s :y su* long] p]iod is ne$$1   
includ+ to satisfy any o!r applicable   
,f$]al /atutory or regulatory           
requirem5ts4  7c7 ,alt]native measures  
,! hold] ( ! cov]$ application may      
propose1 & ! ,secret>y %all approve1    
te*nologies1 controls1 or measures      
reg>d+ packag+1 /orage1 or disposal o!r 
?an ^? specifi$ 9 ! applicable ord]     

issu$ "u subsection 7a71 if su*         
te*nologies1 controls1 or measures are  
support$ by data & in=mation demon/rat+ 
t su* alt]native te*nologies1 controls1 
or measures c be expect$ to mitigate !  
risk ( abuse or misuse ( ! drug or drugs
 involv$1 includ+ by r$uc+ !            
availability ( unus$ drugs1 to at lea/ !
 same ext5t z ! te*nologies1 controls1  
or measures specifi$ 9 su* ord]4  7d7   
,dispute resolution ,if a dispute arises
 9 connection ) a supplem5t submitt$ "u 
subsection 7b71 ! hold] ( ! cov]$       
application may appeal a det]m9ation    
made ) respect to su* supplem5t us+     
applicable dispute resolution proc$ures 
specifi$ by ! ,secret>y 9 regulations or
 guidance4  7e7 ,def9itions ,9 ?is      
section-- 7#a7 ! t]m cov]$ application  
means an application submitt$ "u        
subsection 7b7 or 7j7 ( section #eje =  
approval "u su* section or an           
application approv$ "u section #cea (   
,public ,heal? ,s]vice ,act1 ) respect  
to a drug t is or conta9s an opioid =   

:i* a li/+ 9 s*$ule ,,ii or ,,iii 7on a 
tempor>y or p]man5t basis7 is 9 effect  
"u section #bjb ( ! ,controll$          
,sub/ances ,act2 &  7#b7 ! t]m relevant 
/akehold]s may include sci5tific exp]ts 
)9 ! drug manufactur+ indu/ry2 br& &    
g5]ic drug manufactur]s2 /&>d developm5t
 organizations2 :olesal]s & di/ributors2
 pay]s2 heal? c>e provid]s2 ph>maci/s2  
manufactur]s2 poison c5t]s2 &           
repres5tatives ( ! ,national ,in/itute  
on ,drug ,abuse1 ! ,national ,in/itutes 
( ,heal?1 ! ,c5t]s = ,disease ,control &
 ,prev5tion1 ! ,c5t]s = ,m$ic>e         
,m$icaid ,s]vices1 ! ,drug ,en=cem5t    
,ag5cy1 ! ,consum] ,product ,safety     
,commission1 individuals :o specialize 9
 treat+ addiction1 & pati5t & c>egiv]   
gr\ps4  4  7b7 ,prohibit$ acts ,section 
#eja ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act 7#ba ,u4,s4,c4 #cea7 is  
am5d$ by ins]t+ aft] p>agraph 7j7 !     
foll[+3  7k7 ,if x is a drug approv$ "u 
a cov]$ application 7z def9$ 9 section  
#eje-b7;e771 ! hold] ( :i* does n meet !

 requirem5ts ( p>agraphs 7#a7 & 7#b7 (  
subsection 7b7 ( su* section4  4  7c7   
,requir$ cont5t ( an abbreviat$ new drug
 application ,section #eje7;j77#b77;,a7 
( ! ,f$]al ,food1 ,drug1 & ,cosmetic    
,act 7#ba ,u4,s4,c4 #cee7;j77#b77;,a77  
is am5d$--  7#a7 9 clause 7vii77,,iv71  
by /rik+ & at ! end2  7#b7 9 clause     
7viii71 by /rik+ ! p]iod at ! end &     
ins]t+ 2 &2 &  7#c7 by add+ at ! end !  
foll[+3  7ix7 if ! drug is or conta9s an
 opioid = :i* a li/+ 9 s*$ule ,,ii or   
,,iii 7on a tempor>y or p]man5t basis7  
is 9 effect "u section #bjb ( !         
,controll$ ,sub/ances ,act1 in=mation to
 %[ t ! applicant has propos$           
te*nologies1 controls1 or measures      
relat$ to ! packag+ or disposal ( ! drug
 t are comp>ably effective to ^? requir$
 = ! applicable li/$ drug "u section    
#eje-b1 if applicable4  4  7d7 ,gr\nds =
 refus+ ,to approve an abbreviat$ new   
drug application ,section #eje7;j77#d7 (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act
 7#ba ,u4,s4,c4 #cee7;j77#d771 is       

am5d$-- 7#a7 9 subp>agraph 7,j71 by     
/rik+ or at ! end2  7#b7 9 subp>agraph  
7,k71 by /rik+ ! p]iod at ! end & ins]t+
 2 or2 &  7#c7 by add+ at ! end !       
foll[+3  7,l7 if ! drug is a drug       
describ$ 9 p>agraph 7#b77;,a77ix7 & !   
applicant has n propos$ te*nologies1    
controls1 or measures relat$ to !       
packag+ or disposal ( su* drug t !      
,secret>y det]m9es are comp>ably        
effective to ^? requir$ = ! applicable  
li/$ drug "u section #eje-b4  4  7e7    
,rules ( con/ruction  7#a7 ,any label+  
describ+ te*nologies1 controls1 or      
measures relat$ to packag+1 /orage1 or  
disposal int5d$ to mitigate ! risk (    
abuse or misuse ( a drug product t is   
subject to an abbreviat$ new drug       
application1 includ+ label+ describ+    
diff]5ces f ! ref]5ce li/$ drug result+ 
f ! application ( section #eje-b ( !    
,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z
 add$ by subsection 7a71 %all n be      
con/ru$--  7,a7 z *anges to label+ n    
p]missible "u clause 7v7 ( section      

#eje7;j77#b77;,a7 ( su* ,act 7#ba       
,u4,s4,c4 #cee7;j77#b77;,a771 or a *ange
 9 ! conditions ( use prescrib$1        
recomm5d$1 or sugge/$ 9 ! label+ propos$
 = ! new drug "u clause 7i7 ( su*       
section2 or  7,b7 to prohibit approval (
 an abbreviat$ new drug application "u  
subp>agraph 7,b7 or 7,g7 ( section      
#eje7;j77#d7 ( su* ,act 7#ba ,u4,s4,c4  
#cee7;j77#d774  7#b7 ,= a cov]$         
application t is an application submitt$
 "u subjection 7j7 ( section #eje ( !   
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee71 subp>agraph       
7j77#b77;,a7 ( su* section #eje %all n  
be con/ru$ to limit ! type ( data or    
in=mation ! ,secret>y ( ,heal? & ,human 
,s]vices may reque/ or consid] 9        
connection ) mak+ any det]m9ation "u    
section #eje-b4  7f7 ,,gao report ,n    
lat] ?an #ab mon?s aft] ! date (        
enactm5t ( ?is ,act1 ! ,comptroll]      
,g5]al ( ! ,unit$ ,/ates %all prep>e &  
submit to ! ,congress a report conta9+--
  7#a7 a description ( available        

evid5ce1 if any1 on ! effectiv5ess (    
site-(-use1 9-home controll$ sub/ance   
disposal products & packag+ te*nologies2
  7#b7 id5tification ( ways 9 :i* su*   
disposal products int5d$ = use by       
pati5ts1 consum]s1 & o!r end us]s t are 
n regi/rants "u ! ,controll$ ,sub/ances 
,act1 are made available to ! public &  
b>ri]s to ! use ( su* disposal products2
  7#c7 id5tification ( ways 9 :i*       
packag+ te*nologies are made available  
to ! public & b>ri]s to ! use ( su*     
te*nologies2  7#d7 a description (      
,f$]al ov]sight1 if any1 ( site-(-use1  
9-home controll$ sub/ance disposal      
products1 includ+--  7,a7 id5tification 
( ! ,f$]al ag5cies t ov]see su*         
products2  7,b7 id5tification ( ! me?ods
 ( disposal ( controll$ sub/ances       
recomm5d$ by ^! ag5cies = site-(-use1   
9-home disposal2 &  7,c7 a description (
 ! effectiv5ess ( su* recomm5dations at 
prev5t+ ! div]sion ( legally prescrib$  
controll$ sub/ances2  7#e7 a description
 ( ,f$]al ov]sight1 if any1 ( controll$ 

sub/ance packag+ te*nologies1 includ+-- 
7,a7 id5tification ( ! ,f$]al ag5cies t 
ov]see su* te*nologies2  7,b7           
id5tification ( ! te*nologies recomm5d$ 
by ^! ag5cies1 includ+ unit dose        
packag+1 packag+ t provides a set       
duration1 or o!r packag+ sy/ems t may   
mitigate abuse or misuse2 &  7,c7 a     
description ( ! effectiv5ess ( su*      
recomm5dations at prev5t+ ! div]sion (  
legally prescrib$ controll$ sub/ances2 &
  7#f7 recomm5dations on-- 7,a7 :e!r    
site-(-use1 9-home controll$ sub/ance   
disposal products & packag+ te*nologies 
require ,f$]al ov]sight &1 if s1 :i*    
ag5cies %\ld be responsible = su*       
ov]sight &1 z applicable1 approval ( su*
 products or te*nologies2 &  7,b7 !     
pot5tial role ( ! ,f$]al ,gov]nm5t 9    
evaluat+ su* products to ensure product 
efficacy4