,,ii  #aai? ,,congress  #b;d ,session   
,s4 #ejdc  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,july #ba1 #bjbf,mr4   
,budd introduc$ ! foll[+ bill2 :i* 0    
read twice & ref]r$ to ! ,committee on  
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to direct ! ,food & ,drug   
,adm9i/ration to prev5t ! importation ( 
c\nt]feit1 unapprov$1 misbr&$1 or       
adult]at$ drugs f ! ,p's ,republic (    
,*9a or o!r =eign c\ntries1 to e/abli%  
enhanc$ safegu>ds = import$ drug        
products1 & = o!r purposes4  #a4 ,%ort  
title ,?is ,act may be cit$ z ! ,secure 
,drug ,supply ,*a9 ,act ( #bjbf4  #b4   
,purpose ,! purposes ( ?is ,act are--   
7#a7 to prev5t ! unlawful importation ( 
c\nt]feit1 unapprov$1 misbr&$1 or       
adult]at$ drugs f ! ,p's ,republic (    
,*9a & o!r c\ntries t are kn[n to engage
 9 intellectual prop]ty !ft1 =c$ labor1 
or ! di/ribution ( c\nt]feit & illicit  
ph>maceutical products t und]m9e !      
public heal? & economic int]e/s ( !     
,unit$ ,/ates2  7#b7 to increase        

visibility into ! ,unit$ ,/ates         
ph>maceutical supply *a92 &  7#c7 to    
r$uce ! direct & indirect dep5d5ce ( !  
,unit$ ,/ates on active ph>maceutical   
+r$i5ts & key />t+ mat]ials s\rc$ f !   
,p's ,republic ( ,*9a or t are ( ,*9ese 
orig9 & s\rc$ ?r\gh ?ird c\ntries1 9    
ord] to /r5g!n ! resili5ce ( ! ,unit$   
,/ates drug supply & protect public     
heal? & national security4  #c4         
,prev5tion ( importation ( unlawful     
c\nt]feit prescription & ov]-!-c\nt]    
drugs  7a7 ,9 g5]al ,! ,secret>y (      
,heal? & ,human ,s]vices 7ref]r$ to 9   
?is ,act z ! ,secret>y7 %all utilize    
au?orities "u ! ,f$]al ,food1 ,drug1 &  
,cosmetic ,act 7#ba ,u4,s4,c4 #cja et   
seq47 to prev5t ! importation ( drugs1  
includ+ active ph>maceutical +r$i5ts &  
key />t+ mat]ials1 t are c\nt]feit1     
unapprov$1 misbr&$1 or adult]at$ &      
manufactur$1 prep>$1 propagat$1         
comp\nd$1 & process$ 9 a =eign          
e/abli%m5t1 ) p>ticul> emphasis on      
prev5t+ importation ( su* drugs1 includ+

 active ph>maceutical +r$i5ts & key />t+
 mat]ials1 f ! ,p's ,republic ( ,*9a &  
o!r c\ntries t are designat$ z adv]s>ial
 by ! ,secret>y ( ,/ate4  7b7 ,en=cem5t 
actions ,9 c>ry+ out subsection 7a71 !  
,secret>y %all-- 7#a7 conduct compliance
 & en=cem5t actions direct$ at entities 
involv$ 9 ! manufacture1 prep>ation1    
propagation1 comp\nd+1 process+1 or     
di/ribution ( unapprov$1 adult]at$1 or  
misbr&$ drugs1 includ+ active           
ph>maceutical +r$i5ts & key />t+        
mat]ials1 t are (f]$ = import2  7#b7 9  
coop]ation ) ! ,attorney ,g5]al1        
initiate civil & crim9al en=cem5t       
actions1 includ+ injunctions & seizures1
 "u sections #cja1 #cjb1 #cjc1 #cjd1 &  
#hja ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act 7#ba ,u4,s4,c4 #cca1     
#ccb1 #ccc1 #ccd1 #cha72  7#c7 refuse   
entry into ! ,unit$ ,/ates ( su* drugs1 
includ+ active ph>maceutical +r$i5ts or 
key />t+ mat]ials2 &  7#d7 conduct      
inspections (1 or use alt]native tools )
 respect to1 z appropriate1 facilities  

engag$ 9 comp\nd+ to monitor =          
unau?oriz$ receipt1 use1 or h&l+ ( drugs
 f ! ,p's ,republic ( ,*9a & o!r        
c\ntries designat$ z adv]s>ial by !     
,secret>y ( ,/ate t 7 import$ into !    
,unit$ ,/ates 9 violation ( applicable  
laws & regulations4  7c7 ,annual report+
 ,beg9n+ ) fiscal ye> #bjbg1 n lat] ?an 
#ahj days aft] ! end ( ea* fiscal ye>1 !
 ,secret>y %all submit a report to !    
,committee on ,heal?1 ,education1       
,labor1 & ,p5sions ( ! ,s5ate & !       
,committee on ,en]gy & ,comm]ce ( !     
,h\se ( ,repres5tatives1 detail+        
en=cem5t actions describ$ 9 subsection  
7b7 t 7 tak5 9 ! previ\s fiscal ye>1    
includ+ in=mation on ! numb] & type (   
drugs1 active ph>maceutical +r$i5ts1 &  
key />t+ mat]ials t 7 ! subjects ( su*  
actions dur+ ! previ\s fiscal ye>4  7d7 
,guidance2 recomm5dations ,n lat] ?an   
#ahj days aft] ! submission ( ea* report
 "u subsection 7c71 bas$ on ! in=mation 
compil$ 9 ! report1 ! ,secret>y %all--  
7#a7 issue or update guidance = import]s

 ( drugs to comply ) ! requirem5ts ( ?is
 ,act1 includ+ ! am5dm5ts made by ?is   
,act2 &  7#b7 submit to ,congress       
legislative proposals relat+ to res\rces
 & policies t w\ld facilitate c>ry+ out 
?is ,act1 includ+ ! am5dm5ts made by ?is
 ,act4  #d4 ,supply *a9 transp>5cy &    
resili5ce  7a7 ,report+ requirem5ts =   
active ph>maceutical +r$i5ts & key />t+ 
mat]ials  7#a7 ,9 g5]al ,section        
#eaj7;j77#c7 ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4           
#cfj7;j77#c77 is am5d$-- 7,a7 9 ! fir/  
s5t5ce ( subp>agraph 7,a7-- 7i7 by /rik+
 annually & ins]t+ qu>t]ly2 &  7ii7 by  
ins]t+ & ! in=mation describ$ 9         
subp>agraph 7,c7 be=e ! p]iod at ! end2 
&  7,b7 by add+ at ! end ! foll[+3  7,c7
 7i7 ,! annual report requir$ "u        
subp>agraph 7,a7 %all include !         
in=mation describ$ 9 clause 7ii7 )      
respect to drugs1 9 accordance ) !      
foll[+3 7,i7 ,9 ! #a-ye> p]iod beg9n+ on
 ! effective date ( ! f9al regulations  
describ$ 9 section #d7;c7 ( ! ,secure   

,drug ,supply ,*a9 ,act ( #bjbf1 !      
in=mation describ$ 9 clause 7ii7 %all be
 includ$ 9 ! report "u subp>agraph 7,a7 
) respect to any drug t-- 7aa7 is       
includ$ on ! ,ess5tial ,m$ic9es ,li/    
ma9ta9$ by ! ,food & ,drug ,adm9i/ration
 pursuant to ,executive ,ord] #acidd    
7#he ,f$4 ,reg4 #diibi72 &  7bb7 is a   
drug = :i* any active ph>maceutical     
+r$i5t1 key />t+ mat]ial1 or acquir$    
int]m$iate is s\rc$ f ! ,p's ,republic (
 ,*9a or ano!r =eign c\ntry ( conc]n4   
7,,ii7 ,beg9n+ on ! day aft] ! la/ day (
 ! #a-ye> p]iod describ$ 9 subclause    
7,i71 ! in=mation describ$ 9 clause 7ii7
 %all be includ$ 9 ! report "u          
subp>agraph 7,a7 if x is a drug = :i*   
any active ph>maceutical +r$i5t1 key    
/>t+ mat]ial1 or acquir$ int]m$iate is  
s\rc$ f ! ,p's ,republic ( ,*9a or ano!r
 =eign c\ntry ( conc]n4  7ii7 ,!        
in=mation describ$ 9 ?is clause is !    
foll[+1 z applicable3 7,i7 ,! id5tity ( 
ea* active ph>maceutical +r$i5t1 key    
/>t+ mat]ial1 & acquir$ int]m$iate us$  

by ! regi/rant to manufacture ! li/$    
drug4  7,,ii7 ,! total am\nt ( ea* su*  
active ph>maceutical +r$i5t1 key />t+   
mat]ial1 & acquir$ int]m$iate us$ by !  
regi/rant to manufacture ! li/$ drug    
dur+ ! report+ p]iod1 express$ 9 su*    
units z ! ,secret>y %all specify4       
7,,iii7 ,! c\ntry ( orig9 ( ea* su*     
active ph>maceutical +r$i5t1 key />t+   
mat]ial1 & acquir$ int]m$iate1 includ+ !
 "n1 address1 & unique facility id5tifi]
 7z applicable7 ( ea* e/abli%m5t at :i* 
su* active ph>maceutical +r$i5t1 key    
/>t+ mat]ial1 or acquir$ int]m$iate 0   
manufactur$4  7iii7 ,in=mation report$  
"u ?is subp>agraph %all include ! c\ntry
 ( orig9 )\t reg>d to any di/ribution or
 %ipm5t ?r\gh a c\ntry o!r ?an ! c\ntry 
( orig94  7iv7 ,a p]son requir$ to      
report in=mation "u ?is subp>agraph %all
 ma9ta9 su* records & support+          
docum5tation z ! ,secret>y %all require 
to v]ify ! accuracy & complet5ess (     
in=mation submitt$ "u ?is p>agraph1 = a 
p]iod ( n less ?an #e ye>s1 & %all make 

su* records available to ! ,secret>y ^u 
reque/4  7,d7 ,n lat] ?an #ah mon?s aft]
 ! #a-ye> p]iod describ$ 9 subp>agraph  
7,c77i77,i7 ends1 & annually !reaft]1 ! 
,secret>y %all1 bas$ on ! reports       
submitt$ "u subp>agraph 7,a71 issue a   
confid5tial report to ,congress t-- 7i7 
analyzes ,unit$ ,/ates vuln]abilities   
aris+ f dep5d5ce on active ph>maceutical
 +r$i5ts & key />t+ mat]ials s\rc$ f !  
,p's ,republic ( ,*9a or o!r =eign      
c\ntries ( conc]n1 includ+ any su*      
+r$i5ts or mat]ials ) orig9s 9 ! ,p's   
,republic ( ,*9a or ano!r =eign c\ntry (
 conc]n t are s\rc$ ?r\gh ?ird c\ntries2
  7ii7 id5tifies ! proportion ( drugs   
manufactur$1 prep>$1 propagat$1         
comp\nd$1 or process$ = comm]cial       
di/ribution 9 ! ,unit$ ,/ates t dep5d on
 active ph>maceutical +r$i5ts & key />t+
 mat]ials s\rc$ f ! ,p's ,republic (    
,*9a or o!r =eign c\ntries ( conc]n1    
disaggregat$ by c\ntry ( orig9 to !     
ext5t practicable2  7iii7 det]m9es      
specific supply *a9 vuln]abilities1     

includ+ drug classes or !rapeutic       
categories = :i* dep5d5ce on active     
ph>maceutical +r$i5ts & key />t+        
mat]ials s\rc$ f ! ,p's ,republic ( ,*9a
 or ano!r =eign c\ntry ( conc]n1 poses a
 risk to public heal? or national       
security2 &  7iv7 tracks tr5ds ov] "t 9 
dep5d5ce on active ph>maceutical +r$i5ts
 & key />t+ mat]ials s\rc$ f ! ,p's     
,republic ( ,*9a or ano!r =eign c\ntry (
 conc]n1 includ+ anonymiz$ aggregate    
data reflect+ increases or decreases 9  
su* dep5d5ce4  7,e7 ,9 ?is p>agraph3 7i7
 ,! t]m acquir$ int]m$iate means a      
mat]ial produc$ dur+ /eps 9 !           
manufacture ( an active ph>maceutical   
+r$i5t t und]goes fur!r molecul> *ange  
or purification be=e x becomes an active
 ph>maceutical +r$i5t & is manufactur$  
at an e/abli%m5t o!r ?an ! e/abli%m5t at
 :i* ! active ph>maceutical +r$i5t is   
manufactur$4  7ii7 ,! t]m c\ntry ( orig9
 means1 ) respect to an active          
ph>maceutical +r$i5t1 key />t+ mat]ial1 
or acquir$ int]m$iate1 ea* c\ntry 9 :i* 

su* +r$i5t1 int]m$iate1 or mat]ial 0    
manufactur$ into its *emical id5tity    
?r\gh *emical syn!sis1 f]m5tation1      
extraction1 purification1 or o!r        
manufactur+ process includ+ ea* c\ntry  
at :i* su* active ph>maceutical +r$i5t1 
key />t+ mat]ial1 or acquir$ int]m$iate 
0 repackag$1 relabel$1 f9i%$1 bl5d$1 or 
te/$4  7iii7 ,! t]m =eign c\ntry (      
conc]n has ! mean+ giv5 su* t]m 9       
section #ajfab7;a7 ( ! ,rese>* &        
,developm5t1 ,competition1 & ,innovation
 ,act4  4  7#b7 ,confid5tiality ,no?+ 9 
! am5dm5t made by p>agraph 7#a7 %all be 
con/ru$ z au?oriz+ ! ,secret>y to       
disclose any in=mation t is a trade     
secret or confid5tial in=mation subject 
to section #eeb7;b77#d7 ( title #e1     
,unit$ ,/ates ,code1 or section #aije ( 
title #ah1 ,unit$ ,/ates ,code4  7b7    
,regulatory gap analysis ,n lat] ?an    
#ahj days aft] ! date ( enactm5t ( ?is  
,act1 ! ,secret>y %all id5tify & submit 
to ,congress a report describ+-- 7#a7   
exi/+ regulatory au?orities available to

 ! ,secret>y to support or inc5tivize ! 
s\rc+ ( active ph>maceutical +r$i5ts &  
key />t+ mat]ials f c\ntries o!r ?an !  
,p's ,republic ( ,*9a1 or f s\rces ) no 
,p's ,republic ( ,*9a orig9 cont5t2 &   
7#b7 any defici5cies 9 exi/+ regulatory 
au?orities t limit ! ability ( !        
,secret>y to support or inc5tivize su*  
s\rc+1 toge!r ) recomm5dations =        
legislative or adm9i/rative action to   
address su* defici5cies4  7c7           
,regulations ,! ,secret>y ( ,heal? &    
,human ,s]vices %all-- 7#a7 n lat] ?an  
#ij days aft] ! date ( enactm5t ( ?is   
,act1 issue propos$ regulations         
implem5t+ ! am5dm5ts made by subsection 
7a72 &  7#b7 n lat] ?an #ahj days aft]  
issuance ( ! propos$ regulations        
describ$ 9 p>agraph 7#a71 f9alize su*   
regulations4  #e4 ,am5dm5ts to ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act  7a7 ,ban
 on imports ( drugs f e/abli%m5ts us+   
=c$ labor or violat+ sanctions ,section 
#hja7;a7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;a77 

is am5d$1 9 ! ?ird s5t5ce-- 7#a7 by     
ins]t+ or 7#f7 su* article is a drug & !
 safety ( su* drug is bas$ solely on    
in=mation or c]tifications provid$ by a 
=eign gov]nm5t1 includ+ any inspection  
describ$ 9 section #gjd7;i71 )\t r\t9e  
inspections conduct$ by ,unit$ ,/ates   
inspectors to v]ify compliance ) ?is    
,act1 or 7#g7 su* article is a drug & 0 
manufactur$1 prep>$1 propagat$1         
comp\nd$1 process$ 9 an e/abli%m5t kn[n 
to h us$ =c$ labor 7z def9$ 9 section   
#cjg ( ! ,t>iff ,act ( #aicj7 or to h   
be5 9 violation ( sanctions impos$ by ! 
,f$]al ,gov]nm5t "u ! ,int]national     
,em]g5cy ,economic ,p[]s ,act or o!r    
applicable law1 z det]m9$ by ! ,secret>y
 9 consultation ) ! ,secret>y ( ,homel& 
,security1 aft] #cja7;cc712 &  7#b7 by  
/rik+ clauses 7#a7 ?r\gh 7#e7 & ins]t+  
clauses 7#a7 ?r\gh 7#g74  7b7           
,de/ruction ( ,refus$ ,articles ,pres5t+
 ,significant ,public ,heal? ,conc]ns   
,section #hja ( ! ,f$]al ,food1 ,drug1 &
 ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7 is 

am5d$ by add+ at ! end ! foll[+3  7v7   
,de/ruction ( refus$ articles pres5t+   
significant public heal? conc]ns  7#a7  
,9 g5]al ,if ! ,secret>y det]m9es t an  
article t has be5 refus$ admission "u   
subsection 7a7 pres5ts a significant    
public heal? conc]n1 ! ,secret>y may    
issue to ! own] or consignee ( ! article
 an ord] to de/roy ! article1 )\t !     
opportunity = export4  7#b7 ,deadl9e2   
co/s ,n lat] ?an #ij days aft] !        
issuance ( an ord] "u p>agraph 7#a71 !  
own] or consignee %all de/roy ! article4
 ,! own] or consignee %all be           
responsible = ! co/s ( su* de/ruction4  
7#c7 ,due process ,! ,secret>y %all     
provide to ! own] or consignee ( an     
article subject to an ord] "u p>agraph  
7#a7 appropriate due process prior to ! 
de/ruction ( ! article4 ,su* due process
 %all include notice & an opportunity to
 appe> be=e ! ,secret>y & introduce     
te/imony on ! de/ruction1 9 comb9ation )
 ! notice & opportunity to appe> &      
introduce te/imony on ! refusal (       

admission ( ! article "u subsection 7a7 
or sep>ately4  4  7c7 ,prohibition on   
regi/ration ( c]ta9 =eign e/abli%m5ts   
,section #eaj7;i7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cfj7;i77 is am5d$ by add+ at ! end !   
foll[+3  7#f7 ,not)/&+ any o!r provision
 ( ?is section1 any e/abli%m5t t kn[+ly 
us$1 or p>tn]$ )1 contract$ )1 or       
pur*as$ f an entity t has us$1 =c$ labor
 7z def9$ 9 section #cjg ( ! ,t>iff ,act
 ( #aicj7 or t kn[+ly violat$ sanctions 
impos$ by ! ,f$]al ,gov]nm5t "u !       
,int]national ,em]g5cy ,economic ,p[]s  
,act or o!r applicable law1 z det]m9$ by
 ! ,secret>y 9 consultation ) !         
,secret>y ( ,homel& ,security1 %all n be
 eligible = regi/ration "u ?is section1 
& ! ,secret>y %all revoke any           
regi/ration ( su* an e/abli%m5t t 0     
accept$ prior to ! date ( enactm5t ( !  
,secure ,drug ,supply ,*a9 ,act ( #bjbf4
  4  7d7 ,prohibit$ acts ,section #cja (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act
 7#ba ,u4,s4,c4 #cca7 is am5d$ by add+  

at ! end ! foll[+3  7jjj7 ,! unau?oriz$ 
movem5t1 or introduction or deliv]y =   
introduction into int]/ate comm]ce1     
includ+ export1 ( an article t is       
subject to an ord] = de/ruction "u      
section #hja7v74  7kkk7 ,! kn[+         
provision ( a mat]ially false1          
fictiti\s1 or fraudul5t /atem5t or      
repres5tation to ! ,secret>y t          
accompanies or relates to a drug import$
 or (f]$ = import into ! ,unit$ ,/ates4 
7lll7 ,! import or (f]+ = import into ! 
,unit$ ,/ates ( a drug t previ\sly has  
be5 refus$ admission "u section #hja7;a7
 or export$ dur+ ! p5d5cy ( a det5tion1 
unless ! p]son reimport+ or re(f]+ !    
drug affirmatively makes ref]5ce to !   
orig9al refusal or det5tion & e/abli%es 
t ! drug complies ) ! applicable        
requirem5ts ( ?is ,act1 z det]m9$ by !  
,secret>y4  4  7e7 ,misbr&$ drugs       
,section #ejb ( ! ,f$]al ,food1 ,drug1 &
 ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7 is 
am5d$ by add+ at ! end ! foll[+3  7hh7  
,if x is a drug1 includ+ an active      

ph>maceutical +r$i5t & key />t+ mat]ial1
 import$ or (f]$ = import & ! drug is   
accompani$ by a mat]ially false1        
fictiti\s1 or fraudul5t /atem5t or      
repres5tation kn[+ly made by ! p]son    
import+ ! drug or (f]+ ! drug = import4 
4  7f7 ,adult]at$ drugs ,section #eja ( 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
7#ba ,u4,s4,c4 #cea7 is am5d$ by add+ at
 ! end ! foll[+3  7k7 ,if x is an active
 ph>maceutical +r$i5t t has n be5       
approv$ z "p ( an application "u section
 #eje ( ?is ,act or #cea ( ! ,public    
,heal? ,s]vice ,act1 or o!rwise approv$ 
or au?oriz$ = use 9 a drug or device1 & 
x 0 manufactur$1 prep>$1 propagat$1     
comp\nd$1 or process$ 9-- 7#a7 an       
e/abli%m5t t 0 n inspect$ )9 !          
imm$iately prec$+ #c-ye> p]iod2 or  7#b7
 9 ! case ( an e/abli%m5t locat$ 9 a    
=eign c\ntry ) :i* ! ,secret>y has an   
arrangem5t or agreem5t "u section #hji  
to recognize ! inspection ( e/abli%m5ts 
by ! gov]nm5t or an ag5cy ( ! gov]nm5t (
 su* c\ntry1 )9 ! imm$iately prec$+     

#e-ye> p]iod4  7l7 ,if x is a drug t 0  
manufactur$1 prep>$1 propagat$1         
comp\nd$1 or process$ 9 an e/abli%m5t t 
! ,secret>y1 9 consultation ) !         
,secret>y ( ,homel& ,security1          
det]m9es-- 7#a7 kn[+ly utilizes =c$     
labor 7z def9$ 9 section #cjg ( ! ,t>iff
 ,act ( #aicj72 or  7#b7 is 9 violation 
( sanctions impos$ by ! ,f$]al ,gov]nm5t
 "u ! ,int]national ,em]g5cy ,economic  
,p[]s ,act or o!r applicable law1       
includ+ an e/abli%m5t t is designat$ to 
! li/ ( specially designat$ nationals & 
block$ p]sons ma9ta9$ by ! ,(fice (     
,=eign ,assets ,control ( ! ,dep>tm5t ( 
! ,treasury or own$ #ej p]c5t m or m1   
directly or indirectly1 by "o or m su*  
designat$ p]sons4  4  7g7 ,regulations  
,! ,secret>y ( ,heal? & ,human ,s]vices 
%all-- 7#a7 n lat] ?an #ij days aft] !  
date ( enactm5t ( ?is ,act1 issue       
propos$ regulations implem5t+ ! am5dm5ts
 made by ?is section2 &  7#b7 n lat] ?an
 #ahj days aft] issuance ( ! draft      
guidance describ$ 9 p>agraph 7#a71      

f9alize su* guidance4  7h7              
,applicability ,! am5dm5ts made by ?is  
section %all apply beg9n+ on ! date t is
 #ahj days aft] ! f9al guidance "u      
section #f7b7 is issu$4  #f4 ,def9+ key 
/>t+ mat]ial ,! ,secret>y ( ,heal? &    
,human ,s]vices %all-- 7#a7 n lat] ?an  
#ij days aft] ! date ( enactm5t ( ?is   
,act1 issue draft guidance def9+ ! t]m  
key />t+ mat]ial = purposes ( ?is ,act &
 ! am5dm5ts made by ?is ,act2 &  7#b7 n 
lat] ?an #ahj days aft] ! date (        
enactm5t ( ?is ,act1 issue f9al guidance
 def9+ su* t]m = su* purposes4