,,ii ,cal5d> ,no4 #cfh #aad? ,,congress 
#b;d ,session  ,s4 #dhc  ,,9 ,,! ,,s5ate
 ,,( ,,! ,,unit$ ,,/ates  ,febru>y #ab1 
#bjae,mr4 ,hat* 7= himself1 ,mr4        
,:iteh\se1 ,mr4 ,rubio1 ,mr4 ,vitt]1 &  
,mr4 ,cassidy7 introduc$ ! foll[+ bill2 
:i* 0 read twice & ref]r$ to !          
,committee on ! ,judici>y  ,febru>y #aa1
 #bjaf,report$ by ,mr4 ,grassley1 ) an  
amendment,strike out all aft] ! enact+  
clause & ins]t ! "p pr9t$ 9 italic  ,a  
,,bill  ,to improve en=cem5t ef=ts      
relat$ to prescription drug div]sion &  
abuse1 & = o!r purposes4  #a4 ,%ort     
title ,?is ,act may be cit$ z ! ,ensur+ 
,pati5t ,access & ,effective ,drug      
,en=cem5t ,act ( #bjae4  #b4            
,regi/ration process "u ,controll$      
,sub/ances ,act  7a7 ,def9itions  7#a7  
,factors z may be relevant to & consi/5t
 ) ! public heal? & safety ,section #cjc
 ( ! ,controll$ ,sub/ances ,act 7#ba    
,u4,s4,c4 #hbc7 is am5d$ by add+ at !   
end ! foll[+3  7i7 ,9 ?is section1 !    
phrase factors z may be relevant to &   

consi/5t ) ! public heal? & safety means
 factors t are relevant to & consi/5t ) 
! f9d+s conta9$ 9 section #aja4  4  7#b7
 ,imm95t dang] to ! public heal? or     
safety ,section #cjd7;d7 ( ! ,controll$ 
,sub/ances ,act 7#ba ,u4,s4,c4 #hbd7;d77
 is am5d$--  7,a7 by /rik+ 7d7 ,!       
,attorney ,g5]al & ins]t+ 7d77#a7 ,!    
,attorney ,g5]al2 &  7,b7 by add+ at !  
end ! foll[+3  7#b7 ,9 ?is subsection1 !
 phrase imm95t dang] to ! public heal?  
or safety means t1 9 ! abs5ce ( an      
imm$iate susp5sion ord]1 controll$      
sub/ances w cont9ue to be di/ribut$ or  
disp5s$ by a regi/rant :o kn[s or %\ld  
"k ?r\gh fulfill+ ! obligations ( !     
regi/rant "u ?is ,act--  7,a7 ! disp5s+ 
is outside ! usual c\rse ( pr(essional  
practice2  7,b7 ! di/ribution or disp5s+
 poses a pres5t or =eseeable risk (     
adv]se heal? consequ5ces or dea? due to 
! abuse or misuse ( ! controll$         
sub/ances2 or  7,c7 ! controll$         
sub/ances w cont9ue to be div]t$ outside
 ( legitimate di/ribution *annels4  4   

7b7 ,opportunity ,to submit corrective  
action plan prior to revocation or      
susp5sion ,subsection 7c7 ( section #cjd
 ( ! ,controll$ ,sub/ances ,act 7#ba    
,u4,s4,c4 #hbd7 is am5d$--  7#a7 by     
/rik+ ! la/ two s5t5ces2  7#b7 by /rik+ 
7c7 ,be=e & ins]t+ 7c77#a7 ,be=e2 &     
7#c7 by add+ at ! end ! foll[+3  7#b7   
,an ord] to %[ cause "u p>agraph 7#a7   
%all--  7,a7 conta9 a /atem5t ( ! basis 
= ! d5ial1 revocation1 or susp5sion1    
includ+ specific citations to any laws  
or regulations alleg$ to be violat$ by !
 applicant or regi/rant2  7,b7 direct ! 
applicant or regi/rant to appe> be=e !  
,attorney ,g5]al at a "t & place /at$ 9 
! ord]1 b n less ?an #cj days aft] !    
date ( receipt ( ! ord]2 &  7,c7 notify 
! applicant or regi/rant ( ! opportunity
 to submit a corrective action plan on  
or be=e ! date ( appe>ance4  7#c7 ,^u   
review ( any corrective action plan     
submitt$ by an applicant or regi/rant   
pursuant to p>agraph 7#b71 ! ,attorney  
,g5]al %all det]m9e :e!r d5ial1         

revocation or susp5sion proce$+s %\ld be
 discont9u$1 or def]r$ = ! purposes (   
modification1 am5dm5t1 or cl>ification  
to su* plan4  7#d7 ,proce$+s to d5y1    
revoke1 or susp5d %all be conduct$      
pursuant to ?is section 9 accordance )  
sub*apt] ,,ii ( *apt] #e ( title #e1    
,unit$ ,/ates ,code4 ,su* proce$+s %all 
be indep5d5t (1 & n 9 lieu (1 crim9al   
prosecutions or o!r proce$+s "u ?is     
title or any o!r law ( ! ,unit$ ,/ates4 
7#e7 ,! requirem5ts ( ?is subsection    
%all n apply to ! issuance ( an imm$iate
 susp5sion ord] "u subsection 7d74  4   
#c4 ,report to ,congress on effects (   
law en=cem5t activities on pati5t access
 to m$ications  7a7 ,9 g5]al ,n lat] ?an
 #a ye> aft] ! date ( enactm5t ( ?is    
,act1 ! ,secret>y ( ,heal? & ,human     
,s]vices1 act+ ?r\gh ! ,commission] (   
,food & ,drugs & ! ,director ( ! ,c5t]s 
= ,disease ,control & ,prev5tion1 9     
coord9ation ) ! ,adm9i/rator ( ! ,drug  
,en=cem5t ,adm9i/ration & 9 consultation
 ) ! ,secret>y ( ,def5se & ! ,secret>y (

 ,vet]ans ,affairs1 %all submit a report
 to ! ,committee on ! ,judici>y ( !     
,h\se ( ,repres5tatives1 ! ,committee on
 ,en]gy & ,comm]ce ( ! ,h\se (          
,repres5tatives1 ! ,committee on !      
,judici>y ( ! ,s5ate1 & ! ,committee on 
,heal?1 ,education1 ,labor1 & ,p5sions (
 ! ,s5ate id5tify+--  7#a7 ob/acles to  
legitimate pati5t access to controll$   
sub/ances2  7#b7 issues ) div]sion (    
controll$ sub/ances2 &  7#c7 h[         
collaboration betwe5 ,f$]al1 ,/ate1     
local1 & tribal law en=cem5t ag5cies & !
 ph>maceutical indu/ry c b5efit pati5ts 
& prev5t div]sion & abuse ( controll$   
sub/ances4  7b7 ,consultation ,! report 
"u subsection 7a7 %all incorporate      
fe$back & recomm5dations f ! foll[+3    
7#a7 ,pati5t gr\ps4  7#b7 ,ph>macies4   
7#c7 ,drug manufactur]s4  7#d7 ,common  
or contract c>ri]s & w>eh\sem54  7#e7   
,hospitals1 physicians1 & o!r heal? c>e 
provid]s4  7#f7 ,/ate attorneys g5]al4  
7#g7 ,f$]al1 ,/ate1 local1 & tribal law 
en=cem5t ag5cies4  7#h7 ,heal? insurance

 provid]s & entities t provide ph>macy  
b5efit managem5t s]vices on behalf ( a  
heal? insurance provid]4  7#i7 ,:olesale
 drug di/ributors4  7#aj7 ,vet]9>ians4  
#a4 ,%ort title ,?is ,act may be cit$ z 
! ,ensur+ ,pati5t ,access & ,effective  
,drug ,en=cem5t ,act ( #bjaf4  #b4      
,regi/ration process "u ,controll$      
,sub/ances ,act  7a7 ,def9itions  7#a7  
,factors z may be relevant to & consi/5t
 ) ! public heal? & safety ,section #cjc
 ( ! ,controll$ ,sub/ances ,act 7#ba    
,u4,s4,c4 #hbc7 is am5d$ by add+ at !   
end ! foll[+3  7j7 ,9 ?is section1 !    
phrase factors z may be relevant to &   
consi/5t ) ! public heal? & safety means
 factors t are relevant to & consi/5t ) 
! f9d+s conta9$ 9 section #aja4  4  7#b7
 ,imm95t dang] to ! public heal? or     
safety ,section #cjd7;d7 ( ! ,controll$ 
,sub/ances ,act 7#ba ,u4,s4,c4 #hbd7;d77
 is am5d$--  7,a7 by /rik+ 7d7 ,!       
,attorney ,g5]al & ins]t+ 7d77#a7 ,!    
,attorney ,g5]al2 &  7,b7 by add+ at !  
end ! foll[+3  7#b7 ,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 title  
or title ,,iii1 !re is a sub/antial     
likelihood ( an imm$iate ?reat t dea?1  
s]i\s bodily h>m1 or abuse ( a controll$
 sub/ance w occur 9 ! abs5ce ( an       
imm$iate susp5sion ( ! regi/ration4  4  
7b7 ,opportunity ,to submit corrective  
action plan prior to revocation or      
susp5sion ,subsection 7c7 ( section #cjd
 ( ! ,controll$ ,sub/ances ,act 7#ba    
,u4,s4,c4 #hbd7 is am5d$-- 7#a7 by /rik+
 ! la/ ?ree s5t5ces2  7#b7 by /rik+ 7c7 
,be=e & ins]t+ 7c77#a7 ,be=e2 &  7#c7 by
 add+ at ! end ! foll[+3  7#b7 ,an ord] 
to %[ cause "u p>agraph 7#a7 %all-- 7,a7
 conta9 a /atem5t ( ! basis = ! d5ial1  
revocation1 or susp5sion1 includ+       
specific citations to any laws or       
regulations alleg$ to be violat$ by !   
applicant or regi/rant2  7,b7 direct !  
applicant or regi/rant to appe> be=e !  

,attorney ,g5]al at a "t & place /at$ 9 
! ord]1 b n less ?an #cj days aft] !    
date ( receipt ( ! ord]2 &  7,c7 notify 
! applicant or regi/rant ( ! opportunity
 to submit a corrective action plan on  
or be=e ! date ( appe>ance4  7#c7 ,^u   
review ( any corrective action plan     
submitt$ by an applicant or regi/rant   
pursuant to p>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 ,proce$+s to d5y1    
revoke1 or susp5d %all be conduct$      
pursuant to ?is section 9 accordance )  
sub*apt] ,,ii ( *apt] #e ( title #e1    
,unit$ ,/ates ,code4 ,su* proce$+s %all 
be indep5d5t (1 & n 9 lieu (1 crim9al   
prosecutions or o!r proce$+s "u ?is     
title or any o!r law ( ! ,unit$ ,/ates4 
7#e7 ,! requirem5ts ( ?is subsection    
%all n apply to ! issuance ( an imm$iate
 susp5sion ord] "u subsection 7d74  4   
#c4 ,report to ,congress  7a7 ,9 g5]al  

,n lat] ?an #a ye> aft] ! date (        
enactm5t ( ?is ,act1 ! ,secret>y (      
,heal? & ,human ,s]vices1 act+ ?r\gh !  
,commission] ( ,food & ,drugs1 !        
,adm9i/rator ( ! ,sub/ance ,abuse &     
,m5tal ,heal? ,s]vices ,adm9i/ration1 ! 
,director ( ! ,ag5cy = ,heal?c>e ,rese>*
 & ,quality1 & ! ,director ( ! ,c5t]s = 
,disease ,control & ,prev5tion1 9       
coord9ation ) ! ,adm9i/rator ( ! ,drug  
,en=cem5t ,adm9i/ration & 9 consultation
 ) ! ,secret>y ( ,def5se & ! ,secret>y (
 ,vet]ans ,affairs1 %all submit a report
 to ! ,committee on ! ,judici>y ( !     
,h\se ( ,repres5tatives1 ! ,committee on
 ,en]gy & ,comm]ce ( ! ,h\se (          
,repres5tatives1 ! ,committee on !      
,judici>y ( ! ,s5ate1 & ! ,committee on 
,heal?1 ,education1 ,labor1 & ,p5sions (
 ! ,s5ate id5tify+--  7#a7 ob/acles to  
legitimate pati5t access to controll$   
sub/ances2  7#b7 issues ) div]sion (    
controll$ sub/ances2  7#c7 h[           
collaboration betwe5 ,f$]al1 ,/ate1     
local1 & tribal law en=cem5t ag5cies & !

 ph>maceutical indu/ry c b5efit pati5ts 
& prev5t div]sion & abuse ( controll$   
sub/ances2  7#d7 ! availability ( m$ical
 education1 tra9+ opportunities1 &      
compreh5sive cl9ical guidance = pa9     
managem5t & opioid prescrib+1 & any gaps
 t %\ld be address$2  7#e7 b5eficial    
enhancem5ts to ,/ate prescription drug  
monitor+ programs1 includ+ enhancem5ts  
to require compreh5sive prescrib] input 
& to exp& access to ! programs =        
appropriate au?oriz$ us]s2 &  7#f7 /eps 
to improve report+ requirem5ts s t !    
public & ,congress h m in=mation reg>d+ 
prescription opioids1 su* z ! volume &  
=mulation ( prescription opioids        
prescrib$ annually1 ! disp5s+ ( su*     
prescription opioids1 & outli]s & tr5ds 
)9 l>ge data sets4  7b7 ,consultation ,!
 report "u subsection 7a7 %all          
incorporate fe$back & recomm5dations f !
 foll[+3 7#a7 ,pati5t gr\ps4  7#b7      
,ph>macies4  7#c7 ,drug manufactur]s4   
7#d7 ,common or contract c>ri]s &       
w>eh\sem54  7#e7 ,hospitals1 physicians1

 & o!r heal? c>e provid]s4  7#f7 ,/ate  
attorneys g5]al4  7#g7 ,f$]al1 ,/ate1   
local1 & tribal law en=cem5t ag5cies4   
7#h7 ,heal? insurance provid]s &        
entities t provide ph>macy b5efit       
managem5t s]vices on behalf ( a heal?   
insurance provid]4  7#i7 ,:olesale drug 
di/ributors4  7#aj7 ,vet]9>ians4  7#aa7 
,pr(essional m$ical societies & bo>ds4  
7#ab7 ,/ate & local public heal?        
au?orities4  7#ac7 ,heal? s]vices rese>*
 organizations4  ,febru>y #aa1          
#bjaf,report$ ) an am5dm5t