#aae? ,,congress  #b;d ,session  ,h4 ,r4
 #ebbh  ,,an ,,act  ,to /r5g!n !        
au?orities ( ! ,food & ,drug            
,adm9i/ration to address c\nt]feit      
drugs1 illegal & syn!tic opioids1 &     
opioid-l sub/ances1 & = o!r purposes4   
#a4 ,%ort title2 table ( cont5ts  7a7   
,%ort title ,?is ,act may be cit$ z !   
,/op ,c\nt]feit ,drugs by ,regulat+ &   
,enhanc+ ,en=cem5t ,n[ ,act or ! ,,scre5
 ,act4  7b7 ,table ( cont5ts ,! table ( 
cont5ts ( ?is ,act is z foll[s3  ,sec4  
#a4 ,%ort title2 table ( cont5ts4 ,sec4 
#b4 ,det5tion1 refusal1 & de/ruction (  
drugs (f]$ = importation4 ,sec4 #c4     
,notification1 nondi/ribution1 & recall 
( adult]at$ or misbr&$ drug products4   
,sec4 #d4 ,s+le s\rce patt]n ( %ipm5ts (
 adult]at$ or misbr&$ drugs4 ,sec4 #e4  
,fund to /r5g!n ef=ts ( ,,fda to combat 
! opioid & sub/ance use epidemic4 ,sec4 
#f4 ,consid]ation ( pot5tial = misuse & 
abuse requir$ = drug approval4  #b4     
,det5tion1 refusal1 & de/ruction ( drugs
 (f]$ = importation  7a7 ,increas+ !    

maximum doll> am\nt ( drugs subject to  
de/ruction ,! six? s5t5ce 9 section     
#hja7;a7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;a77 
is am5d$ by /rik+ except t ! ,secret>y &
 all t foll[s ?r\gh ! two p]iods at !   
end & ins]t+ except t ! ,secret>y (     
,heal? & ,human ,s]vices may de/roy1 )\t
 ! opportunity = export1 any drug refus$
 admission "u ?is section1 if su* drug  
is decl>$ to be valu$ at an am\nt t is  
#b1ejj or less 7or su* high] am\nt z !  
,secret>y ( ! ,treasury may set by      
regulation pursuant to section          
#dih7;a77#a7 ( ! ,t>iff ,act ( #aicj or 
su* high] am\nt z ! ,commission] ( ,food
 & ,drugs may set bas$ on a f9d+ by !   
,commission] t ! high] am\nt is 9 !     
int]e/ ( public heal?71 or if su* drug  
is ent]+ ! ,unit$ ,/ates by mail1 & 0 n 
br\ght into compliance z describ$ "u    
subsection 7b744  7b7 ,de/ruction (     
articles ( conc]n ,! six? s5t5ce (      
section #hja7;a7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  

#cha7;a771 z am5d$ by subsection 7a71 is
 fur!r am5d$ by ins]t+ be=e ! p]iod at !
 end ! foll[+3 2 & ! ,secret>y ( ,heal? 
& ,human ,s]vices may de/roy1 )\t !     
opportunity = export1 any article refus$
 admission "u clause 7#f7 ( ! ?ird      
s5t5ce ( ?is subsection4  7c7 ,te*nical 
am5dm5ts ,! sev5?1 eigh?1 & n9? s5t5ces 
( section #hja7;a7 ( ! ,f$]al ,food1    
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cha7;a77 are am5d$-- 7#a7 by /rik+ a   
drug ea* place x appe>s & ins]t+ an     
article2 &  7#b7 by /rik+ ! drug ea*    
place x appe>s & ins]t+ ! article4  7d7 
,rule ( con/ruction ,! la/ s5t5ce 9     
section #hja7;a7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cha7;a77 is am5d$ to read z foll[s3    
,clauses 7#b71 7#e71 & 7#f7 ( ! ?ird    
s5t5ce ( ?is subsection %all n be       
con/ru$ to prohibit ! admission (       
n>cotic or nonn>cotic drugs or o!r      
sub/ances1 ! importation ( :i* is       
p]mitt$ "u ! ,controll$ ,sub/ances      
,import & ,export ,act44  #c4           

,notification1 nondi/ribution1 & recall 
( adult]at$ or misbr&$ drug products    
7a7 ,prohibit$ ,acts ,section #cja ( !  
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cca7 is am5d$ by add+ at
 ! end ! foll[+3  7eee7 ,! failure to   
comply ) any ord] issu$ "u section      
#efi;,d4  4  7b7 ,notification1         
nondi/ribution1 & recall ( adult]at$ or 
misbr&$ drugs ,sub*apt] ,e ( *apt] ,v ( 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
7#ba ,u4,s4,c4 #cfj;bbb et seq47 is     
am5d$ by add+ at ! end ! foll[+3        
#efi;,d4 ,notification1 ,nondi/ribution1
 ,& ,recall ,( ,adult]at$ ,or ,misbr&$  
,drugs  7a7 ,ord] ,to cease di/ribution 
& recall  7#a7 ,9 g5]al ,^u a           
det]m9ation t ! use or consumption (1 or
 exposure to1 a drug may pres5t an      
imm95t or sub/antial haz>d to ! public  
heal?1 ! ,secret>y %all issue an ord]   
requir+ any p]son :o di/ributes ! drug  
to imm$iately cease di/ribution ( !     
drug4  7#b7 ,he>+ ,an ord] "u p>agraph  
7#a7 %all provide ! p]son subject to !  

ord] ) an opportunity = an in=mal he>+1 
to be held n lat] ?an #aj days aft] !   
date ( issuance ( ! ord]1 on-- 7,a7 !   
actions requir$ by ! ord]2 &  7,b7 :e!r 
! ord] %\ld be am5d$ to require a recall
 ( ! drug4  7#c7 ,inadequate gr\nds ,if1
 aft] provid+ an opportunity = a he>+ "u
 p>agraph 7#b71 ! ,secret>y det]m9es t  
inadequate gr\nds exi/ to support !     
actions requir$ by ! ord]1 ! ,secret>y  
%all vacate ! ord]4  7#d7 ,am5dm5t to   
ord] to require recall ,if1 aft] provid+
 an opportunity = an in=mal he>+ "u     
p>agraph 7#b71 ! ,secret>y det]m9es t ! 
ord] %\ld be am5d$ to include a recall (
 ! drug ) respect to :i* ! ord] 0 issu$1
 ! ,secret>y %all-- 7,a7 am5d ! ord] to 
require a recall2 &  7,b7 aft]          
consultation ) ! drug sponsor1 specify a
 timetable 9 :i* ! recall w occur4  7#e7
 ,notice to p]sons affect$ ,an ord] "u  
?is subsection %all require any p]son :o
 di/ributes ! drug to provide = notice1 
includ+ to individuals z appropriate1 to
 p]sons :o may be affect$ by ! ord] to  

cease di/ribution ( or recall ! drug1 z 
applicable4  7#f7 ,action foll[+ ord]   
,any p]son :o is subject to an ord] "u  
p>agraph 7#a7 or 7#d7 %all imm$iately   
cease di/ribution ( or recall1 z        
applicable1 ! drug & provide            
notification z requir$ by su* ord]4  7b7
 ,notice to consum]s & heal? (ficials ,!
 ,secret>y %all1 z ! ,secret>y det]m9es 
to be necess>y1 provide notice ( a      
recall ord] "u ?is section to--  7#a7   
consum]s to :om ! drug 01 or may h be51 
di/ribut$2 &  7#b7 appropriate ,/ate &  
local heal? (ficials4  7c7 ,ord] ,to    
recall  7#a7 ,cont5ts ,an ord] to recall
 a drug "u subsection 7a7 %all-- 7,a7   
require p]iodic reports to ! ,secret>y  
describ+ ! progress ( ! recall2 &  7,b7 
provide = notice1 includ+ to individuals
 z appropriate1 to p]sons :o may be     
affect$ by ! recall4  7#b7 ,assi/ance   
all[$ ,9 provid+ = notice "u p>agraph   
7#a77;,b71 ! ,secret>y may all[ = !     
assi/ance ( heal? pr(essionals1 ,/ate or
 local (ficials1 or o!r individuals     

designat$ by ! ,secret>y4  7#c7         
,nondelegation ,an ord] "u ?is section  
%all be ord]$ by ! ,secret>y or an      
(ficial designat$ by ! ,secret>y4 ,an   
(ficial may n be s designat$ "u ?is     
section unless ! (ficial is ! ,director 
( ! ,c5t] = ,drug ,evaluation & ,rese>*1
 is an (ficial s5ior to su* ,director1  
or is s designat$ by su* ,director4  7d7
 ,sav+s clause ,no?+ conta9$ 9 ?is      
section %all be con/ru$ z limit+--  7#a7
 ! au?ority ( ! ,secret>y to issue an   
ord] to cease di/ribution (1 or to      
recall1 an drug "u any o!r provision (  
?is ,act or ! ,public ,heal? ,s]vice    
,act2 or  7#b7 ! ability ( ! ,secret>y  
to reque/ any p]son to p]=m a volunt>y  
activity relat$ to any drug subject to  
?is ,act or ! ,public ,heal? ,s]vice    
,act4  4  7c7 ,drugs subject to refusal 
,! ?ird s5t5ce ( subsection 7a7 (       
section #hja ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cha7 is  
am5d$ by ins]t+ or 7#e7 9 ! case ( a    
drug1 su* drug is subject to an ord] "u 

section #efh to cease di/ribution ( or  
recall ! drug1 be=e !n su* article %all 
be refus$ admission4  7d7 ,application  
,sections #cja7;eee7 & #efi;,d ( !      
,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z
 add$ by subsections 7a7 & 7b71 %all    
apply ) respect to a drug z ( su* date1 
n lat] ?an #a ye> aft] ! date ( !       
enactm5t ( ?is ,act1 z ! ,secret>y (    
,heal? & ,human ,s]vices %all specify4  
#d4 ,s+le s\rce patt]n ( %ipm5ts (      
adult]at$ or misbr&$ drugs ,section #hja
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act is am5d$ by add+ at ! end ! foll[+3
  7t7 ,s+le s\rce patt]n ( %ipm5ts (    
adult]at$ or misbr&$ drugs ,if !        
,secret>y id5tifies a patt]n ( adult]at$
 or misbr&$ drugs be+ (f]$ = import f ! 
same manufactur]1 di/ributor1 or        
import]1 ! ,secret>y may by ord] *oose  
to treat all drugs be+ (f]$ = import f  
su* manufactur]1 di/ributor1 or import] 
z adult]at$ or misbr&$ unless o!rwise   
demon/rat$4  4  #e4 ,fund to /r5g!n     
ef=ts ( ,,fda to combat ! opioid &      

sub/ance use epidemic ,*apt] ,x ( !     
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cia et seq47 is am5d$ by
 add+ at ! end ! foll[+3  #ajae4 ,fund  
to /r5g!n ef=ts ( ,,fda to combat !     
opioid & sub/ance use epidemic  7a7 ,9  
g5]al ,! ,commission] ( ,food & ,drugs  
%all use any funds appropriat$ pursuant 
to ! au?orization ( appropriations "u   
subsection 7c7 to c>ry out ! programs & 
activities describ$ 9 subsection 7d7 to 
/r5g!n & facilitate ! ,food & ,drug     
,adm9i/ration's ef=ts to address !      
opioid & sub/ance use epidemic4 ,su*    
funds %all be 9 addition to any funds   
:i* are o!rwise available to c>ry out   
su* programs & activities4  7b7 ,,fda   
,opioid & ,sub/ance ,use ,epidemic      
,response ,fund  7#a7 ,e/abli%m5t ( fund
 ,!re is e/abli%$ 9 ! ,treasury a fund1 
to be kn[n z ! ,,fda ,opioid & ,sub/ance
 ,use ,epidemic ,response ,fund 7ref]r$ 
to 9 ?is subsection z ! ,fund71 =       
purposes ( fund+ ! programs & activities
 describ$ 9 subsection 7d74  7#b7       

,transf] ,= ! p]iod ( fiscal ye>s #bjai 
?r\gh #bjbc1 #aaj1jjj1jjj %all be       
transf]r$ to ! ,fund f ! g5]al fund ( ! 
,treasury4  7#c7 ,am\nts deposit$ ,any  
am\nts transf]r$ "u p>agraph 7#b7 %all  
rema9 unavailable 9 ! ,fund until su*   
am\nts are appropriat$ pursuant to      
subsection 7c74  7c7 ,appropriations    
7#a7 ,au?orization ( appropriations ,= !
 p]iod ( fiscal ye>s #bjai ?r\gh #bjbc1 
!re is au?oriz$ to be appropriat$ f !   
,fund to ! ,food & ,drug ,adm9i/ration1 
= ! purpose ( c>ry+ out ! programs &    
activities describ$ 9 subsection 7d71 an
 am\nt n to exce$ ! total am\nt         
transf]r$ to ! ,fund "u subsection      
7b77#b74 ,not)/&+ subsection 7g71 su*   
funds %all rema9 available until exp5d$4
  7#b7 ,(fsett+ future appropriations ,=
 any ( fiscal ye>s #bjai ?r\gh #bjbc1 = 
any discretion>y appropriation out ( !  
,fund to ! ,food & ,drug ,adm9i/ration  
pursuant to ! au?orization (            
appropriations "u p>agraph 7#a7 = !     
purpose ( c>ry+ out ! programs &        

activities describ$ 9 subsection 7d71 ! 
total am\nt ( su* appropriations = !    
applicable fiscal ye> 7n to exce$ !     
total am\nt rema9+ 9 ! ,fund7 %all be   
subtract$ f ! e/imate ( discretion>y    
budget au?ority & ! result+ outlays =   
any e/imate "u ! ,congressional ,budget 
& ,imp\ndm5t ,control ,act ( #aigd or ! 
,balanc$ ,budget & ,em]g5cy ,deficit    
,control ,act ( #aihe1 & ! am\nt        
transf]r$ to ! ,fund %all be r$uc$ by ! 
same am\nt4  7d7 ,food & ,drug          
,adm9i/ration ,! entirety ( ! funds made
 available pursuant to subsection       
7c77#a7 %all be = ! ,commission] ( ,food
 & ,drugs1 pursuant to applicable       
au?orities 9 ! ,public ,heal? ,s]vice   
,act 7#db ,u4,s4,c4 #bja et seq47 or ?is
 ,act & o!r applicable ,f$]al law1 to   
support widespread innovation 9         
non-opioid & non-addictive m$ical       
products = pa9 treatm5t1 access to      
opioid addiction treatm5ts1 appropriate 
use ( approv$ opioids1 & ef=ts to r$uce 
illicit importation ( opioids4 ,su*     

support may include ! foll[+ programs & 
activities3  7#a7 ,obligat+ contract    
funds beg9n+ 9 fiscal ye> #bjai = an    
educational campaign t w-- 7,a7 educate 
pati5ts & _! families to diff]5tiate    
opioid m$ications2  7,b7 raise aw>5ess  
ab\t pref]r$ /orage & disposal me?ods2 &
  7,c7 in=m pati5ts1 families1 &        
communities ab\t m$ication-assi/$       
treatm5t options4  7#b7 ,build+ ! ,food 
& ,drug ,adm9i/ration's pres5ce 9       
int]national mail facilities1 includ+   
?r\gh-- 7,a7 improvem5ts 9 equipm5t &   
in=mation te*nology enhancem5ts to      
id5tify unapprov$1 c\nt]feit1 or o!r    
unlawful ph>maceuticals = de/ruction2   
7,b7 increas$ & improv$ surveillance2   
7,c7 r5ovations at int]national mail    
facility locations2 &  7,d7 ! pur*ase ( 
laboratory equipm5t4  7#c7 ,enhanc+ !   
id5tification & t>get+ ( entities (f]+  
products & products be+ (f]$ by su*     
entities = import into ! ,unit$ ,/ates  
?r\gh review & analysis ( ,int]net      
websites1 import data1 & o!r s\rces (   

intellig5ce = purposes ( mak+ ! be/ use 
( ! ,food & ,drug ,adm9i/ration's       
inspection & analytical res\rces4  7#d7 
,increas+ ! numb] ( /aff ( ! ,food &    
,drug ,adm9i/ration to increase ! numb] 
( packages be+ exam9$1 ensur+ ! safety (
 ! /aff und]tak+ su* exam9ations1 &     
ensur+ t packages id5tifi$ z illegal1   
c\nt]feit1 misbr&$1 or adult]at$ are    
remov$ f comm]ce ?r\gh available        
au?orities1 includ+ adm9i/rative        
de/ruction4  7#e7 ,enhanc+ ! ,food &    
,drug ,adm9i/ration's crim9al           
inve/igations res\rces 7includ+ full-"t 
equival5t employees & equipm5t71 imports
 surveillance1 & int]national "w4  7#f7 
,obta9+ = ! ,food & ,drug ,adm9i/ration 
equipm5t & full-"t equival5t employees  
ne$$ to effici5tly scre5 & analyze      
products (f]$ = import1 includ+ by      
build+ data libr>ies ( new sub/ances &  
analogues to facilitate id5tification & 
evaluation ( ph>maceutical-bas$ ag5ts & 
by pur*as+ scre5+ te*nologies = use at  
int]national mail facilities4  7#g7     

,op]at+ ! ,food & ,drug ,adm9i/ration's 
=5sic laboratory facility to ensure     
adequate laboratory space &             
functionality = additional "w & full-"t 
equival5t employees4  7e7 ,acc\ntability
 & ov]sight  7#a7 ,"w plan  7,a7 ,9     
g5]al ,n lat] ?an #ahj days aft] ! date 
( enactm5t ( ?is ,act1 ! ,commission] ( 
,food & ,drugs %all submit to !         
,committee on ,heal?1 ,education1 ,labor
 & ,p5sions ( ! ,s5ate & ! ,committee on
 ,en]gy & ,comm]ce ( ! ,h\se (          
,repres5tatives1 a "w plan includ+ !    
propos$ allocation ( funds appropriat$  
pursuant to ! au?orization (            
appropriations "u subsection 7c7 = ea* (
 fiscal ye>s #bjai ?r\gh #bjbc & !      
cont5ts describ$ 9 subp>agraph 7,b74    
7,b7 ,cont5ts ,! "w plan submitt$ "u    
subp>agraph 7,a7 %all include--  7i7 !  
am\nt ( money to be obligat$ or exp5d$  
out ( ! ,fund 9 ea* fiscal ye> = ea*    
program & activity describ$ 9 subsection
 7d72 &  7ii7 a description &           
ju/ification ( ea* su* program &        

activity4  7#b7 ,reports  7,a7 ,annual  
reports ,n lat] ?an ,octob] #a ( ea* (  
fiscal ye>s #bjbj ?r\gh #bjbd1 !        
,secret>y ( ,heal? & ,human ,s]vices    
%all submit to ! ,committee on ,heal?1  
,education1 ,labor & ,p5sions ( ! ,s5ate
 & ! ,committee on ,en]gy & ,comm]ce ( !
 ,h\se ( ,repres5tatives a report t     
includes-- 7i7 ! am\nt ( money obligat$ 
or exp5d$ out ( ! ,fund 9 ! prior fiscal
 ye> = ea* program & activity describ$ 9
 subsection 7d72  7ii7 a description (  
all programs & activities us+ funds     
provid$ pursuant to ! au?orization (    
appropriations "u subsection 7c72 &     
7iii7 h[ ! programs & activities are    
advanc+ public heal?4  7,b7 ,additional 
reports ,at ! reque/ ( ! ,committee on  
,heal?1 ,education1 ,labor & ,p5sions ( 
! ,s5ate or ! ,committee on ,en]gy &    
,comm]ce ( ! ,h\se ( ,repres5tatives1 ! 
,commission] %all provide an update 9 ! 
=m ( te/imony & any additional reports  
to ! respective congressional committee 
reg>d+ ! allocation ( fund+ "u ?is      

section or ! description ( ! programs & 
activities und]tak5 ) su* fund+4  7f7   
,limitations ,not)/&+ any transf]       
au?ority au?oriz$ by ?is section or any 
appropriations ,act1 any funds made     
available pursuant to ! au?orization (  
appropriations "u subsection 7c7 may n  
be us$ = any purpose o!r ?an ! programs 
& activities describ$ 9 subsection 7d7  
to /r5g!n & facilitate ! ,food & ,drug  
,adm9i/ration's ef=ts to address !      
opioid & sub/ance use epidemic4  7g7    
,sunset ,?is section %all expire on     
,septemb] #cj1 #bjbb1 except t-- 7#a7   
?is subsection does n apply to report+  
"u subsection 7e77#b72 &  7#b7 ?is      
section %all rema9 9 effect until su*   
"t1 & to su* ext5t1 z may be necess>y = 
! funds transf]r$ by subsection 7b77#b7 
to be fully exp5d$4  4  #f4             
,consid]ation ( pot5tial = misuse &     
abuse requir$ = drug approval  7a7 ,9   
g5]al ,section #eje7;d7 ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7;d77 is am5d$--  7#a7 9 !

 fir/ s5t5ce-- 7,a7 by /rik+ or 7#g7 &  
ins]t+ 7#g72 &  7,b7 by ins]t+ or 7#h7  
if ! drug is or conta9s a controll$     
sub/ance = :i* a li/+ 9 any s*$ule is 9 
effect "u ! ,controll$ ,sub/ances ,act  
or t is p]man5tly s*$ul$ pursuant to    
section #bja ( su* ,act1 on ! basis (   
in=mation submitt$ to him z "p ( !      
application1 or ^u ! basis ( any o!r    
in=mation be=e him ) respect to su*     
drug1 ! drug is unsafe = use due to !   
risks ( abuse or misuse or !re is       
insuffici5t in=mation to %[ t ! drug is 
safe = use consid]+ su* risks2 be=e he  
%all issue an ord] refus+ to approve !  
application2 &  7#b7 9 ! second s5t5ce1 
by /rik+ 7#f7 & ins]t+ 7#h74  7b7       
,)drawal au?ority ,section #eje7;e7 ( ! 
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee7;e77 is am5d$ 9 !   
fir/ s5t5ce-- 7#a7 by /rik+ or 7#e7 &   
ins]t+ 7#e72 &  7#b7 by ins]t+ ! foll[+3
 2 or 7#f7 t1 9 ! case ( a drug t is or 
conta9s a controll$ sub/ance = :i* a    
li/+ 9 any s*$ule is 9 effect "u !      

,controll$ ,sub/ances ,act or t is      
p]man5tly s*$ul$ pursuant to section    
#bja ( su* ,act1 on ! basis ( new       
in=mation be=e him ) respect to su*     
drug1 evaluat$ toge!r ) ! in=mation     
available to him :5 ! application 0     
approv$1 t ! drug is unsafe = use due to
 ! risks ( abuse or misuse aft] ( a     
mat]ial fact4  7c7 ,rule ( con/ruction  
,no?+ 9 ! am5dm5ts made by ?is section  
%all be con/ru$ to limit or n>r[1 9 any 
mann]1 ! mean+ or application ( !       
provisions ( p>agraphs 7#a71 7#b71 7#c71
 7#d71 7#e71 & 7#g7 ( section #eje7;d7 (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act
 7#ba ,u4,s4,c4 #cee7;d77 or p>agraphs  
7#a7 & 7#b7 ( section #eje7;e7 ( su*    
,act 7#ba ,u4,s4,c4 #cee7;e774  ,pass$ !
 ,h\se ( ,repres5tatives ,june #ab1     
#bjah4;,cl]k4