,i  #aai? ,,congress  #a/ ,session  ,h4 
,r4 #aajj  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,febru>y #f1 #bjbe,ms4
 ,/ansbury 7= h]self1 ,mr4 ,grijalva1   
,ms4 ,pett]s51 ,ms4 ,sal9as1 & ,mr4     
,hors=d7 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 provide = 
! regulation ( critical p>ts ( tablet+  
ma*9es & encapsulat+ ma*9es1 & = o!r    
purposes4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,/op ! ,opioid ,pill       
,press] & ,f5tanyl ,act or ! ,,/opp     
,act4  #b4 ,def9itions ,section #ajb ( !
 ,controll$ ,sub/ances ,act 7#ba        
,u4,s4,c4 #hjb7 is am5d$-- 7#a7 9       
p>agraph 7#ch71 by /rik+ or an          
encapsulat+ ma*9e & ins]t+ an           
encapsulat+ ma*9e1 a critical "p ( a    

tablet+ ma*9e1 or a critical "p ( an    
encapsulat+ ma*9e2  7#b7 9 p>agraph     
7#ci77;,b7-- 7,a7 by /rik+ di/ribution1 
importation1 or exportation ( & ins]t+  
di/ribution1 receipt1 sale1 importation1
 or exportation (1 or an int]national   
transaction involv+ %ipm5t (2 &  7,b7 by
 /rik+ or encapsulat+ ma*9e & ins]t+ 1  
encapsulat+ ma*9e1 critical "p ( a      
tablet+ ma*9e1 or critical "p ( an      
encapsulat+ ma*9e2  7#c7 9 p>agraph     
7#db71 by /rik+ a li/$ *emical & ins]t+ 
a li/$ *emical1 a tablet+ ma*9e1 an     
encapsulat+ ma*9e1 a critical "p ( a    
tablet+ ma*9e1 or a critical "p ( an    
encapsulat+ ma*9e2  7#d7 9 p>agraph     
7#dc71 by /rik+ a li/$ *emical & ins]t+ 
a li/$ *emical1 a tablet+ ma*9e1 an     
encapsulat+ ma*9e1 a critical "p ( a    
tablet+ ma*9e1 or a critical "p ( an    
encapsulat+ ma*9e2 &  7#e7 by add+ at ! 
end ! foll[+3  7#fj7 ,! t]m critical "p1
 :5 us$ 9 ref]5ce to a tablet+ ma*9e or 
encapsulat+ ma*9e1 means any ( ! foll[+ 
integral p>ts :5 design$ prim>ily = use 

9 a tablet+ or encapsulat+ ma*9e3 7,a7  
,press pun*4  7,b7 ,die sy/em4  7,c7    
,press turret4  7,d7 ,hopp]4  7,e7      
,compression roll]4  7,f7 ,dis*>ge *ute4
  7,g7 ,vacuum sy/em4  7,h7 ,capsule    
fe$+ unit4  7,i7 ,automatic fe$+ unit4  
7,j7 ,any o!r item id5tifi$ 9 a         
regulation publi%$ by ! ,attorney ,g5]al
 us$ 9 ! op]at+ ( tablet+ or encapsulat+
 ma*9es4  4  #c4 ,regulat$ transactions 
( critical p>ts  7a7 ,record ( regulat$ 
transactions ,section #caj ( !          
,controll$ ,sub/ances ,act 7#ba         
,u4,s4,c4 #hcj7 is am5d$-- 7#a7 9       
subsection 7a77#a7-- 7,a7 by /rik+ or an
 encapsulat+ ma*9e & ins]t+ an          
encapsulat+ ma*9e1 a critical "p ( a    
tablet+ ma*9e1 or a critical "p ( an    
encapsulat+ ma*9e2 &  7,b7 by ins]t+ 1 9
 su* =m & mann] z ! ,attorney ,g5]al    
%all prescribe by regulation1 aft]      
record ( ! transaction2 &  7#b7 9       
p>agraph 7a77#b71 by /rik+ or           
encapsulat+ ma*9e & ins]t+ 1 encapsulat+
 ma*9e1 critical "p ( a tablet+ ma*9e1  

or critical "p ( an encapsulat+ ma*9e4  
7b7 ,reports to attorney g5]al &        
recordkeep+ ,section #caj7;b77#a7 ( !   
,controll$ ,sub/ances ,act 7#ba         
,u4,s4,c4 #hcj7 is am5d$-- 7#a7 9       
subp>agraph 7,a7-- 7,a7 by /rik+ paym5t 
or deliv]y & ins]t+ paym5t or deliv]y ( 
a li/$ *emical1 tablet+ ma*9e1          
encapsulat+ ma*9e1 a critical "p ( a    
tablet+ ma*9e1 or a critical "p ( an    
encapsulat+ ma*9e2 &  7,b7 by /rik+ any 
o!r circum/ance t ! regulat$ p]son      
believes may indicate t ! li/$ *emical &
 ins]t+ any o!r circum/ance t ! regulat$
 p]son believes may indicate t ! li/$   
*emical1 tablet+ ma*9e1 encapsulat+     
ma*9e1 critical "p ( a tablet+ ma*9e1 or
 critical "p ( an encapsulat+ ma*9e2    
7#b7 9 subp>agraph 7,c71 by /rik+ li/$  
*emical & ins]t+ li/$ *emical1 tablet+  
ma*9e1 encapsulat+ ma*9e1 critical "p ( 
a tablet+ ma*9e1 or critical "p ( an    
encapsulat+ ma*9e2 &  7#c7 9 subp>agraph
 7,d71 by /rik+ or an encapsulat+ ma*9e 
& ins]t+ 1 an encapsulat+ ma*9e1        

critical "p ( a tablet+ ma*9e1 or       
critical "p ( an encapsulat+ ma*9e4  7c7
 ,effective date ,! am5dm5ts made by ?is
 section %all apply beg9n+ on ! date t  
is #abj days aft] ! date ( enactm5t (   
?is ,act1 except t ! ,attorney ,g5]al   
may1 by ord] publi%$ 9 ! ,f$]al ,regi/]1
 po/pone su* date ( application = su*   
p]iod z ! ,attorney ,g5]al may det]m9e  
to be necess>y = ! effici5t adm9i/ration
 ( ! ,controll$ ,sub/ances ,act 7#ba    
,u4,s4,c4 #hja et seq474  #d4           
,s]ialization ( c]ta9 ma*9es & p>ts ,!  
,controll$ ,sub/ances ,act 7#ba         
,u4,s4,c4 #hja et seq47 is am5d$ by     
ins]t+ aft] section #caj 7#ba ,u4,s4,c4 
#hcj7 ! foll[+3  #caj;,a ,s]ialization (
 c]ta9 ma*9es & p>ts  7a7 ,s]ial numb]  
,ea* manufactur]1 di/ributor1 import]1  
or export] ( a tablet+ ma*9e1           
encapsulat+ ma*9e1 a critical "p ( a    
tablet+ ma*9e1 or a critical "p ( an    
encapsulat+ ma*9e %all1 :5 & z requir$  
by regulation ( ! ,attorney ,g5]al1     
id5tify ! tablet+ ma*9e1 encapsulat+    

ma*9e1 critical "p ( a tablet+ ma*9e1 or
 critical "p ( an encapsulat+ ma*9e by a
 s]ial numb] :i* %all be engrav$1 ca/1  
or o!rwise p]man5tly affix$ to a        
non-removable "p ( ! tablet+ ma*9e1     
encapsulat+ ma*9e1 critical "p ( a      
tablet+ ma*9e1 or critical "p ( an      
encapsulat+ ma*9e 9 accordance ) su*    
regulations4  7b7 ,report+ ,any regulat$
 p]son :o manufactures1 di/ributes1     
receives1 sells1 imports1 or exports a  
tablet+ ma*9e1 encapsulat+ ma*9e1       
critical "p ( a tablet+ ma*9e1 or       
critical "p ( an encapsulat+ ma*9e t is 
subject to ! s]ialization requirem5t set
 =? 9 subsection 7a71 %all report !     
transaction to ! ,attorney ,g5]al &     
ma9ta9 records ( su* transaction1 9 su* 
=m & mann] z ! ,attorney ,g5]al %all    
prescribe by regulation4  4  #e4        
,regi/ration ( c]ta9 ma*9es & p>ts ,!   
,controll$ ,sub/ances ,act 7#ba         
,u4,s4,c4 #hja et seq471 z am5d$ by     
section #d1 is fur!r am5d$ by ins]t+    
aft] section #caj;,a ! foll[+3  #caj;,b4

 ,regi/ration ( c]ta9 ma*9es & p>ts  7a7
 ,regi/ration ( c]ta9 ma*9es & p>ts ,ea*
 manufactur]1 di/ributor1 import]1 or   
export] ( a tablet+ ma*9e1 encapsulat+  
ma*9e1 critical "p ( a tablet+ ma*9e1 or
 critical "p ( an encapsulat+ ma*9e     
%all1 :5 & z requir$ by regulation ( !  
,attorney ,g5]al1 regi/] ! tablet+      
ma*9e1 encapsulat+ ma*9e1 critical "p ( 
a tablet+ ma*9e1 or critical "p ( an    
encapsulat+ ma*9e ) ! ,attorney ,g5]al 9
 accordance ) su* regulation4  7b7      
,report+ ,any regulat$ p]son :o         
manufactures1 di/ributes1 receives1     
sells1 imports1 exports1 or de/roys a   
tablet+ ma*9e1 encapsulat+ ma*9e1       
critical "p ( a tablet+ ma*9e1 or       
critical "p ( an encapsulat+ ma*9e t is 
requir$ to be regi/]$ pursuant to       
subsection 7a71 %all report t act to !  
,attorney ,g5]al & ma9ta9 records ( su* 
act z requir$ 9 section #caj1 9 su* =m &
 mann] z ! ,attorney ,g5]al %all        
prescribe by regulation4  7c7           
,regulations ,! ,attorney ,g5]al is     

au?oriz$ to promulgate rules &          
regulations relat+ to tablet+ ma*9es &  
encapsulat+ ma*9es4 ,! ,attorney ,g5]al 
%all by regulation e/abli% :i* tablet+  
ma*9es1 encapsulat+ ma*9es1 critical    
p>ts ( tablet+ ma*9es1 & critical p>ts (
 encapsulat+ ma*9es are subject to !    
regi/ration & report+ requirem5ts (     
subsections 7a7 & 7b7 & ! in=mation to  
be provid$ pursuant to subsections 7a7 &
 7b71 :i* %all include ! location ( !   
tablet+ ma*9e1 encapsulat+ ma*9e1       
critical "p ( a tablet+ ma*9e1 or       
critical "p ( an encapsulat+ ma*9e4  7d7
 ,national pill press regi/ry ,!        
,attorney ,g5]al %all ma9ta9 a c5tral   
regi/ry ( all tablet+ ma*9es1           
encapsulat+ ma*9es1 critical p>ts ( a   
tablet+ ma*9e1 or critical p>ts ( an    
encapsulat+ ma*9e t are subject to !    
regi/ration requirem5t set =? 9         
subsection 7a71 :i* %all be kn[n &      
ref]r$ to z ! ,national ,pill ,press    
,regi/ry4  7e7 ,def9itions ,= ! purposes
 ( ?is section3 7#a7 ,manufacture ,! t]m

 manufacture means ! production or      
assembly ( a tablet+ ma*9e1 encapsulat+ 
ma*9e1 critical "p ( a tablet+ ma*9e1 or
 critical "p ( an encapsulat+ ma*9e4    
7#b7 ,di/ribute ,! t]m di/ribute means  
to deliv] a tablet+ ma*9e1 encapsulat+  
ma*9e1 critical "p ( a tablet+ ma*9e1 or
 critical "p ( an encapsulat+ ma*9e4    
7#c7 ,deliv] ,! t]m deliv] means !      
actual1 con/ructive1 or attempt$ transf]
 ( a tablet+ ma*9e1 encapsulat+ ma*9e1  
critical "p ( a tablet+ ma*9e1 or       
critical "p ( an encapsulat+ ma*9e1 :e!r
 or n !re exi/s an ag5cy relation%ip4   
7#d7 ,de/roy ,! t]m de/roy means to     
cause su* s]i\s damage to a tablet+     
ma*9e1 encapsulat+ ma*9e1 critical "p ( 
a tablet+ ma*9e1 or critical "p ( an    
encapsulat+ ma*9e s t x c no long] be   
us$ = its int5d$ purpose4  4  #f4       
,regi/ration ( manufactur]s1 import]s1  
export]s1 & deal]s ( tablet+ ma*9es1    
encapsulat+ ma*9es1 & critical p>ts ,!  
,controll$ ,sub/ances ,act 7#ba         
,u4,s4,c4 #hja et seq471 z am5d$ by     

sections #d & #e1 is fur!r am5d$ by     
ins]t+ aft] section #caj;,b ! foll[+3   
#caj;,c4 ,regi/ration ( manufactur]s1   
import]s1 export]s1 & deal]s ( tablet+  
ma*9es1 encapsulat+ ma*9es1 & critical  
p>ts  7a7 ,regi/ration  7#a7 ,9 g5]al ,e
 p]son :o manufactures1 imports1        
exports1 or deals1 or proposes to engage
 9 ! manufacture1 importation1          
exportation1 or deal+ ( any tablet+     
ma*9e1 encapsulat+ ma*9e1 critical "p ( 
a tablet+ ma*9e1 or critical "p ( an    
encapsulat+ ma*9e1 %all obta91 on an    
annual basis1 a regi/ration issu$ by !  
,attorney ,g5]al4  7#b7 ,waiv] ,!       
,attorney ,g5]al may1 by regulation1    
waive ! requirem5t = regi/ration ( c]ta9
 manufactur]s1 import]s1 export]s1 &    
di/ributors ( any tablet+ ma*9e1        
encapsulat+ ma*9e1 critical "p ( a      
tablet+ ma*9e1 or critical "p ( an      
encapsulat+ ma*9e if ! ,attorney ,g5]al 
f9ds t issu+ su* a waiv] w\ld be        
consi/5t ) public heal? & safety4  7#c7 
,sep>ate regi/rations requir$ ,a sep>ate

 regi/ration %all be requir$ = ea*      
pr9cipal place ( bus9ess :]e ! applicant
 manufactures1 imports1 exports1 or     
deals a tablet+ ma*9e1 encapsulat+      
ma*9e1 critical "p ( a tablet+ ma*9e1 or
 critical "p ( an encapsulat+ ma*9e4    
7#d7 ,t]m9ation  7,a7 ,9 g5]al ,a       
regi/ration to manufacture1 import1     
export1 or deal a tablet+ ma*9e1        
encapsulat+ ma*9e1 critical "p ( a      
tablet+ ma*9e1 or critical "p ( an      
encapsulat+ ma*9e t]m9ates if & :5 su*  
regi/rant-- 7i7 ceases legal exi/5ce2   
7ii7 ceases to engage 9 ! manufacture1  
importation1 exportation1 or deal+ ( su*
 a ma*9e or critical "p !re(2 or  7iii7 
surr5d]s su* regi/ration4  7,b7         
,notification ,9 ! case ( su* a         
regi/rant :o ceases legal exi/5ce or    
ceases to engage 9 ! manufacture1       
importation1 exportation1 or deal+1 su* 
regi/rant1 or ag5t or successor 9 int]e/
 ( su* regi/rant1 %all promptly notify !
 ,attorney ,g5]al 9 writ+ ( su* fact4   
7#e7 ,re-assignm5t ,a regi/ration to    

manufacture1 import1 export1 or deal a  
tablet+ ma*9e1 encapsulat+ ma*9e1       
critical "p ( a tablet+ ma*9e1 or       
critical "p ( an encapsulat+ ma*9e may  
only be assign$ to ano!r entity ) !     
writt5 cons5t (1 & ^u su* conditions z1 
! ,attorney ,g5]al may specify4  7b7    
,regi/ration consid]ations ,! ,attorney 
,g5]al %all regi/] an applicant to      
manufacture1 import1 export1 or deal a  
tablet+ ma*9e1 encapsulat+ ma*9e1       
critical "p ( a tablet+ ma*9e1 or       
critical "p ( an encapsulat+ ma*9e1     
unless ! ,attorney ,g5]al det]m9es t    
regi/ration ( ! applicant is inconsi/5t 
) ! public int]e/4  7c7 ,consid]ations  
,9 det]m9+ ! public int]e/ = ! purposes 
( subsection 7b71 ! ,attorney ,g5]al    
%all consid]-- 7#a7 developm5t &        
ma9t5ance ( effective controls aga9/    
div]sion ( tablet+ ma*9es1 encapsulat+  
ma*9es1 & critical p>ts !re( into o!r   
?an legitimate *annels2  7#b7 compliance
 ) applicable ,f$]al1 ,/ate1 & local    
law2  7#c7 prior conviction record ( !  

applicant2  7#d7 pa/ exp]i5ce 9 !       
manufacture1 import1 export1 & deal+ (  
tablet+ ma*9es1 encapsulat+ ma*9es1 or  
critical p>ts !re(2 &  7#e7 su* o!r     
factors z may be relevant to & consi/5t 
) ! public heal? & safety4  7d7         
,au?oriz$ activities ,no p]son may      
manufacture1 import1 export1 or deal any
 tablet+ ma*9e1 encapsulat+ ma*9e1      
critical "p ( a tablet+ ma*9e1 or       
critical "p ( an encapsulat+ ma*9e      
unless su* p]son has an active          
regi/ration to d s issu$ by ! ,attorney 
,g5]al1 unless-- 7#a7 su* p]son is an   
ag5t or employee ( any regi/rant act+ 9 
! usual c\rse ( 8 bus9ess or employm5t2 
or  7#b7 a common or contract c>ri] or  
w>eh\seman1 or an employee !re(1 ^:     
possession ( ! tablet+ ma*9e1           
encapsulat+ ma*9e1 or critical "p !re(  
is 9 ! lawful & usual c\rse ( 8 bus9ess 
or employm5t4  7e7 ,inspection ,!       
,attorney ,g5]al is au?oriz$ to inspect 
! e/abli%m5t ( a regi/rant or applicant 
= regi/ration 9 accordance ) ! rules &  

regulations promulgat$ by ! ,attorney   
,g5]al4  7f7 ,d5ial1 revocation1 or     
susp5sion ( regi/ration  7#a7 ,susp5sion
 or revocation ,a regi/ration pursuant  
to subsection 7b7 ( ?is section to      
manufacture1 import1 export1 or deal a  
tablet+ ma*9e1 encapsulat+ ma*9e1       
critical "p ( a tablet+ ma*9e1 or       
critical "p ( an encapsulat+ ma*9e may  
be susp5d$ or revok$ by ! ,attorney     
,g5]al ^u a f9d+ t ! regi/rant-- 7,a7   
has mat]ially falsifi$ any application  
fil$ pursuant to or requir$ by ?is      
sub*apt] or sub*apt] ,,ii2  7,b7 has be5
 convict$ 9 any c\rt ( an (f5se involv+ 
a tablet+ ma*9e1 encapsulat+ ma*9e1 a   
critical "p ( a tablet+ ma*9e1 or a     
critical "p ( an encapsulat+ ma*9e2 or  
7,c7 has committ$ su* acts z w\ld r5d] 8
 regi/ration inconsi/5t ) ! public      
int]e/4  7#b7 ,ord]  7,a7 ,9 g5]al ,be=e
 susp5d+ or revok+ a regi/ration to     
manufacture1 import1 export1 or deal    
tablet+ ma*9es1 encapsulat+ ma*9es1     
critical p>ts ( tablet+ ma*9es1 or      

critical p>ts ( encapsulat+ ma*9es1 or  
pursuant to a d5ial ( regi/ration1 !    
,attorney ,g5]al %all s]ve ^u !         
applicant or regi/rant an ord] to %[    
cause :y regi/ration %\ld n be d5i$1    
revok$1 or susp5d$4  7,b7 ,cont5ts ,an  
ord] to %[ cause %all conta9 a /atem5t (
 ! basis = ! d5ial1 revocation1 or      
susp5sion1 includ+ specific citations to
 any laws or regulations alleg$ to be   
violat$ by ! applicant or regi/rant1    
direct ! applicant or regi/rant to appe>
 be=e ! ,attorney ,g5]al at a "t & place
 /at$ 9 ! ord]1 & notify ! applicant or 
regi/rant ( ! opportunity to submit a   
corrective action plan on or be=e ! date
 ( appe>ance4  7,c7 ,corrective action  
plan review ,^u review ( any corrective 
action plan submitt$ by an applicant or 
regi/rant pursuant to subp>agraph 7,b71 
! ,attorney ,g5]al %all det]m9e :e!r    
d5ial1 revocation1 or susp5sion proce$+s
 %\ld be discont9u$1 or def]r$ = !      
purposes ( modification1 am5dm5t1 or    
cl>ification to su* plan4  7,d7         

,applicable law ,proce$+s to d5y1       
revoke1 or susp5d %all be conduct$ 9    
accordance ) sub*apt] ,,ii ( *apt] #e ( 
title #e4 ,su* proce$+s %all be         
indep5d5t (1 & n 9 lieu (1 crim9al      
prosecutions or o!r proce$+s "u ?is     
sub*apt] or any o!r law ( ! ,unit$      
,/ates4  7,e7 ,relation%ip to imm$iate  
susp5sion ord] ,! requirem5ts ( ?is     
subsection %all n apply to ! issuance ( 
an imm$iate susp5sion ord] "u p>agraph  
7#c74  7#c7 ,susp5sion ( regi/ration 9  
cases ( imm95t dang]  7,a7 ,9 g5]al ,!  
,attorney ,g5]al may1 9 ! discretion ( !
 ,attorney ,g5]al1 susp5d any           
regi/ration simultane\sly ) ! in/itution
 ( proce$+s "u ?is section1 9 cases :]e 
he f9ds t !re is an imm95t dang] to !   
public heal? or safety4 ,a susp5sion "u 
?is subsection %all cont9ue 9 effect    
until ! conclusion ( su* proce$+s1      
includ+ judicial review !re(1 unless    
soon] )drawn by ! ,attorney ,g5]al or   
dissolv$ by a c\rt ( compet5t           
jurisdiction4  7,b7 ,imm95t dang] to !  

public safety def9$ ,9 ?is subsection1 !
 phrase imm95t dang] to ! public heal?  
or safety means t1 due to ! failure ( ! 
regi/rant to ma9ta9 effective controls  
aga9/ div]sion or o!rwise comply ) !    
obligations ( a regi/rant "u ?is ,act1  
!re is a sub/antial likelihood t a      
tablet+ ma*9e1 encapsulat+ ma*9e1       
critical "p ( a tablet+ ma*9e1 or       
critical "p ( an encapsulat+ ma*9e w be 
us$ 9 ! illicit manufacture ( controll$ 
sub/ances & cause dea?1 s]i\s bodily    
h>m1 or abuse ( a controll$ sub/ance 9 !
 abs5ce ( an imm$iate susp5sion ( !     
regi/ration4  7g7 ,disposition ( tablet+
 ma*9es1 encapsulat+ ma*9es1 & critical 
"p  7#a7 ,9 g5]al ,^u t]m9ation1        
susp5sion1 or revocation ( regi/ration (
 a regi/rant1 ! =m] regi/rant may1 )9   
#cj days or su* additional p]iod        
designat$ by ! ,attorney ,g5]al = good  
cause1 liquidate any rema9+ tablet+     
ma*9es1 encapsulat+ ma*9es1 critical    
p>ts ( tablet+ ma*9es1 or critical p>ts 
( encapsulat+ ma*9es by lawfully sell+1 

transf]r+1 or o!rwise dispos+ ( !       
tablet+ ma*9es1 encapsulat+ ma*9es1     
critical p>ts ( a tablet+ ma*9es1 or    
critical p>ts ( encapsulat+ ma*9es to a 
regi/]$ manufactur]1 import]1 export]1  
or deal] ( tablet+ ma*9es1 encapsulat+  
ma*9es1 critical p>ts ( tablet+ ma*9es1 
or critical p>ts ( encapsulat+ ma*9es4  
7#b7 ,exception ,except = ! liquidation 
( rema9+ inv5tory to a regi/rant )9 #cj 
days 7or approv$ p]iod7 9 accordance )  
p>agraph 7#a71 a =m] regi/rant may no   
long] deal tablet+ ma*9es1 encapsulat+  
ma*9es1 critical p>ts ( tablet+ ma*9es1 
or critical p>ts ( encapsulat+ ma*9es4  
7h7 ,records & reports  7#a7 ,e         
regi/rant %all ma9ta91 on a curr5t      
basis1 a complete & accurate record (   
ea* tablet+ ma*9e1 encapsulat+ ma*9e1   
critical "p ( a tablet+ ma*9e1 or       
critical "p ( an encapsulat+ ma*9e      
possess$1 manufactur$1 receiv$1 import$1
 export$1 sold1 di/ribut$1 deliv]$1 or  
de/roy$1 ) su* in=mation1 & 9 su* =m &  
mann] z ! ,attorney ,g5]al may by       

regulations require4  7#b7 ,e regi/rant 
%all1 at su* "t or times1 ) su*         
in=mation1 & 9 su* =m & mann] z !       
,attorney ,g5]al may by regulations     
require1 make p]iodic reports to !      
,attorney ,g5]al4  7#c7 ,e record       
requir$ "u ?is section %all be kept & be
 readily retrievable1 = at lea/ #aj     
ye>s1 = inspection & copy+ by (fic]s or 
employees ( ! ,unit$ ,/ates au?oriz$ by 
! ,attorney ,g5]al4  7i7 ,regulations & 
fees ,! ,attorney ,g5]al is au?oriz$ to 
promulgate rules & regulations & *>ge   
reasonable fees relat+ to ! regi/ration 
& control ( ! manufacture1 importation1 
exportation1 & deal+ ( tablet+ ma*9es1  
encapsulat+ ma*9es1 critical p>ts (     
tablet+ ma*9es1 & critical p>ts (       
encapsulat+ ma*9es4 ,! ,attorney ,g5]al 
%all by regulation e/abli% :i* tablet+  
ma*9es1 encapsulat+ ma*9es1 critical    
p>ts ( tablet+ ma*9es1 & critical p>ts (
 encapsulat+ ma*9es are subject to !    
regi/ration1 recordkeep+1 & report+     
requirem5ts "u ?is section1 & ! =m1     

mann]1 & in=mation to be ma9ta9$ &      
furni%$ "u su* requirem5ts4  7j7        
,def9itions ,= ! purposes ( ?is section3
 7#a7 ,deal ,! t]m deal means to engage 
9 ! bus9ess ( sell+ or di/ribut+ tablet+
 ma*9es1 encapsulat+ ma*9es1 critical   
p>ts ( tablet+ ma*9es1 or critical p>ts 
( encapsulat+ ma*9es at :olesale or     
retail4  7#b7 ,deliv]y1 di/ribute1      
de/roy1 manufacture ,! t]ms deliv]1     
di/ribute1 de/roy1 & manufacture h !    
mean+s giv5 su* t]ms 9 section #caj;,b4 
7#c7 ,engag$ 9 ! bus9ess ,! t]m engag$ 9
 ! bus9ess means devot+ "t1 att5tion1 & 
labor to deal+ tablet+ ma*9es1          
encapsulat+ ma*9es1 critical p>ts (     
tablet+ ma*9es1 or critical p>ts ( an   
encapsulat+ ma*9e z a regul> trade or   
bus9ess to pr$om9antly e>n a pr(it ?r\gh
 ! repetitive pur*ase & resale4  7k7    
,effective date ,?is section %all apply 
beg9n+ #abj days aft] ! date ( enactm5t 
( ?is section1 except t ! ,attorney     
,g5]al may by ord] publi%$ 9 ! ,f$]al   
,regi/] po/pone ! effective date ( ?is  

section = su* p]iod z ! ,attorney ,g5]al
 may det]m9e to be necess>y = ! effici5t
 adm9i/ration ( ?is ,act4  4  #g4       
,(f5ses2 p5alties  7a7 ,s]ial numb]s    
7#a7 ,prohibit$ ,acts ,b--,p5alties     
,section #djb7;a7 ( ! ,controll$        
,sub/ances ,act 7#ba ,u4,s4,c4 #hdb7;a77
 is am5d$-- 7,a7 9 p>agraph 7#af71 by   
/rik+ or at ! end2  7,b7 9 p>agraph     
7#ag71 by /rik+ ! p]iod at ! end &      
ins]t+ a semicolon2 &  7,c7 by ins]t+   
aft] p>agraph 7#ag7 ! foll[+3  7#ah7 to 
violate subsection 7a7 ( section        
#caj;,a2  7#ai7 to refuse or neglig5tly 
fail to make a report "u subsection 7b7 
( section #caj;,a2  4  7#b7 ,prohibit$  
,acts ,c--,p5alties ,section #djc ( !   
,controll$ ,sub/ances ,act 7#ba         
,u4,s4,c4 #hdc7 is am5d$-- 7,a7 9       
subsection 7a71 9 ea* ( p>agraphs 7#f7 &
 7#g71 by ins]t+ critical "p ( a tablet+
 ma*9e1 critical "p ( an encapsulat+    
ma*9e1 aft] encapsulat+ ma*9e12 &  7,b7 
by add+ at ! end ! foll[+3  7g7 ,x %all 
be unlawful to-- 7#a7 int5tionally      

remove1 alt]1 or oblit]ate any s]ial    
numb] affix$ to any tablet+ ma*9e1      
encapsulat+ ma*9e1 critical "p ( a      
tablet+ ma*9e1 or critical "p ( an      
encapsulat+ ma*9e t is requir$ to h a   
s]ial numb] pursuant to subsection 7a7 (
 section #caj;,a1 if ! p]son remov+1    
alt]+1 or oblit]at+ su* s]ial numb] kn[s
 or has reasonable cause to believe !   
s]ial numb] is s requir$2  7#b7         
transport1 %ip1 receive1 or possess any 
tablet+ ma*9e1 encapsulat+ ma*9e1       
critical "p ( a tablet+ ma*9e1 or       
critical "p ( an encapsulat+ ma*9e t is 
requir$ to h a s]ial numb] pursuant to  
subsection 7a7 ( section #caj;,a1 if !  
p]son transport+1 %ipp+1 receiv+1 or    
possess+ su* a ma*9e or critical "p !re(
 kn[s t ! s]ial numb] has be5 remov$1   
oblit]at$1 or alt]$1 & has reasonable   
cause to believe ! s]ial numb] is       
requir$ pursuant to subsection 7a7 (    
section #caj;,a2 or  7#c7 possess a     
tablet+ ma*9e or an encapsulat+ ma*9e t 
is requir$ to h a s]ial numb] pursuant  

to subsection 7a7 ( section #caj;,a1 if 
! p]son 9 possession ( su* ma*9e kn[s t 
! ma*9e does n h a s]ial numb]1 & has   
reasonable cause to believe ! s]ial     
numb] is requir$ pursuant to subsection 
7a7 ( section #caj;,a4  7h7 ,9 a        
prosecution = an (f5se "u subsection    
7g77#c71 x is an affirmative def5se1 z  
to :i* ! def5dant has ! burd5 ( pro( by 
a prepond]ance ( ! evid5ce1 t ! p]son   
possess$ ! tablet+ ma*9e or encapsulat+ 
ma*9e on ! day be=e ! effective date (  
?is subsection &1 n lat] ?an #ahj days  
aft] t date1 or = su* additional p]iod  
designat$ by ! ,attorney ,g5]al = good  
cause1 ! p]son-- 7#a7 sold or o!rwise   
transf]r$ ! tablet+ ma*9e or encapsulat+
 ma*9e to a manufactur]1 import]1       
export]1 or deal] ( tablet+ ma*9es or   
encapsulat+ ma*9es t is regi/]$ "u      
section #caj;,c7a72  7#b7 _h a s]ial    
numb] engrav$1 ca/1 or o!rwise affix$ to
 a non-removable "p ( ! tablet+ ma*9e or
 encapsulat+ ma*9e by a manufactur]1    
import]1 export]1 or deal] ( tablet+    

ma*9es or encapsulat+ ma*9es t is       
regi/]$ "u section #caj;,c7a72 or  7#c7 
de/roy$ ! tablet+ ma*9e or encapsulat+  
ma*9e4  7i7 ,= purposes ( ?is           
subsection1 ! t]m de/roy has ! mean+    
giv5 su* t]m 9 section #caj;,b4  7j7    
,subsection 7g7 does n apply to a       
manufactur]1 import]1 export]1 or deal] 
( tablet+ ma*9es or encapsulat+ ma*9es t
 is regi/]$ "u section #caj;,c7a77#a7 or
 exempt f regi/ration pursuant to       
section #caj;,c7a77#b74 ,subsection 7g7 
%all become effective #b ye>s aft] !    
date ( enactm5t1 except t ! ,attorney   
,g5]al may by ord] publi%$ 9 ! ,f$]al   
,regi/] po/pone ! effective date (      
subsection 7g7 = su* p]iod z he may     
det]m9e to be necess>y = ! effici5t     
adm9i/ration ( ?is ,act4  4  7b7        
,regi/ration ( c]ta9 ma*9es & p>ts      
,section #djb7;a7 ( ! ,controll$        
,sub/ances ,act 7#ba ,u4,s4,c4          
#hdb7;a771 z am5d$ by subsection 7a71 is
 fur!r am5d$ by ins]t+ aft] p>agraph    
7#ai7 ! foll[+3  7#bj7 to violate       

subsection 7a7 or 7b7 ( section #caj;,b2
 or  4  7c7 ,regi/ration ( manufactur]s1
 import]s1 export]s1 & deal]s ,section  
#djb7;a7 ( ! ,controll$ ,sub/ances ,act 
7#ba ,u4,s4,c4 #hdb7;a771 z am5d$ by    
subsections 7a7 & 7b71 is fur!r am5d$ by
 ins]t+ aft] p>agraph 7#bj7 ! foll[+3   
7#ba7 to manufacture1 import1 export1 or
 deal a tablet+ ma*9e1 encapsulat+      
ma*9e1 critical "p ( a tablet+ ma*9e1 or
 critical "p ( an encapsulat+ ma*9e )\t 
a regi/ration requir$ by section        
#caj;,c1 except z specifi$ 9 subsection 
7g77#a7 ( su* section4  4