,,ii #aae? ,,congress #b;d ,session ,s4 #bhch ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,may #ae1 #bjah,mrs4 ,fe9/e9 7= h]self1 ,mr4 ,grassley1 ,mrs4 ,capito1 & ,mr4 ,durb97 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ! ,judici>y ,a ,,bill ,to am5d ! ,controll$ ,sub/ances ,act to require ! ,drug ,en=cem5t ,adm9i/ration to report c]ta9 in=mation on di/ribution ( opioids1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,us+ ,data to ,prev5t ,opioid ,div]sion ,act ( #bjah4 #b4 ,f9d+s ,congress f9ds ! foll[+3 7#a7 ,9 #bjaf1 !re 7 ne>ly #fd1jjj drug ov]dose dea?s 9 ! ,unit$ ,/ates4 ,m ?an #db1jjj ( ^! dea?s 7 opioid-relat$4 7#b7 ,! regulations promulgat$ "u ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hja et seq47 require drug manufactur]s & di/ributors to-- 7,a7 provide effective controls aga9/ ! div]sion ( controll$ sub/ances2 7,b7 detect & disclose suspici\s ord]s to ! ,drug ,en=cem5t ,adm9i/ration2 & 7,c7 keep complete & accurate records relat+ to ! manufacture or di/ribution ( controll$ sub/ances4 7#c7 ,despite ! requirem5ts describ$ 9 p>agraph 7#b71 x has be5 publicly report$ t betwe5 #bjjf & #bjaf1 ne>ly #ba1jjj1jjj opioids 7 di/ribut$ to #b ph>macies 9 ,williamson1 ,we/ ,virg9ia1 :i* has a population ( approximately #c1jjj4 ,x has be5 fur!r report$ t betwe5 #bjjg & #bjjh1 ne>ly #i1jjj1jjj pills 7 di/ribut$ to a s+le ph>macy 9 ,k]mit1 ,we/ ,virg9ia1 :i* has a population ( #cib4 7#d7 ,simil>ly1 x has be5 publicly report$ t #ghj1jjj1jjj oxycodone & hydrocodone pills 7 di/ribut$ to ph>macies ?r\gh\t ,we/ ,virg9ia betwe5 #bjjg & #bjab4 ,9 ! same p]iod1 m ?an #a1gjj p 9 ! ,/ate di$ f ov]doses ( ^! #b sub/ances4 7#e7 ,drug manufactur]s & di/ributors are requir$ to report ! sale1 deliv]y or o!r disposal ( n>cotics to ! ,drug ,en=cem5t ,adm9i/ration ?r\gh ! ,automat$ ,reports & ,consolidat$ ,ord]+ ,sy/em4 7#f7 ,not)/&+ ! report+ requirem5t describ$ 9 p>agraph 7#e71 ! ,drug ,en=cem5t ,adm9i/ration does n disclose ! total quantity & type ( opioids di/ribut$ to a s+le ph>macy or practition] ) ^? manufactur]s & di/ributors :o are requir$ to input in=mation into ! ,automat$ ,reports & ,consolidat$ ,ord]+ ,sy/em4 ,?is creates a b>ri] to id5tify+ & /opp+ pot5tially suspici\s ord]s4 7#g7 ,al?\gh manufactur]s & di/ributors are already requir$ to provide effective controls aga9/ ! div]sion ( controll$ sub/ances1 ?is lack ( data %>+ may create a b>ri] to bett] id5tify+ & /opp+ pot5tially suspici\s ord]s4 7#h7 ,on an annual basis1 ! ,attorney ,g5]al ( ! ,unit$ ,/ates is /atutorily requir$ to %>e ! controll$ sub/ance or sub/ances 9 s*$ule ,,ii t h ! highe/ rates ( abuse & to prep>e & make available reports on ! di/ribution patt]ns ( su* sub/ances1 ) ,/ate regulatory1 lic5s+1 & law en=cem5t ag5cies4 ,! ,attorney ,g5]al ( ! ,unit$ ,/ates has ent]$ into data %>+ agreem5ts ) ! attorneys g5]al ( ! va/ majority ( ,/ates1 ,pu]to ,rico1 & ! ,di/rict ( ,colombia to %>e1 pursuant to ,/ate law & policy1 data obta9$ f ,/ate prescription drug monitor+ programs & o!r s\rces4 7#i7 ,to fur!r r$uce b>ri]s associat$ ) id5tify+ suspici\s patt]ns & /opp+ ! div]sion ( opioids1 ! rema9+ ,/ates & t]ritories ( ! ,unit$ ,/ates %\ld ent] into simil> agreem5ts )1 & to ! greate/ ext5t practical %>e data obta9$ f ,/ate prescription drug monitor+ programs )1 ! ,attorney ,g5]al ( ! ,unit$ ,/ates4 #c4 ,purpose 7a7 ,9 g5]al ,! purpose ( ?is ,act is to provide drug manufactur]s & di/ributors ) access to anonymiz$ in=mation ?r\gh ! ,automat$ ,reports & ,consolidat$ ,ord]+ ,sy/em to help drug manufactur]s & di/ributors id5tify1 report1 & /op suspici\s ord]s ( opioids & r$uce div]sion rates4 7b7 ,rule ( con/ruction ,no?+ 9 ?is ,act %\ld be con/ru$ to absolve a drug manufactur]1 drug di/ributor1 or o!r ,drug ,en=cem5t ,adm9i/ration regi/rant f ! responsibility ( ! manufactur]1 di/ributor1 or o!r regi/rant to-- 7#a7 id5tify1 report1 & /op suspici\s ord]s2 or 7#b7 use all available s\rces ( in=mation to det]m9e-- 7,a7 ! legitimacy ( a cu/om]'s ord]2 & 7,b7 :e!r or n an ord] describ$ 9 subp>agraph 7,a7 is suspici\s4 #d4 ,am5dm5ts 7a7 ,records & reports ( regi/rants ,section #cjg ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hbg7 is am5d$-- 7#a7 by r$esignat+ subsections 7f71 7g71 & 7h7 z subsections 7g71 7h71 & 7i71 respectively2 7#b7 by ins]t+ aft] subsection 7e7 ! foll[+3 7f7 7#a7 ,! ,attorney ,g5]al %all1 n less frequ5tly ?an qu>t]ly1 make ! foll[+ in=mation available to manufactur] & di/ributor regi/rants ?r\gh ! ,automat$ ,reports & ,consolidat$ ,ord]+ ,sy/em1 or any subsequ5t automat$ sy/em develop$ by ! ,drug ,en=cem5t ,adm9i/ration to monitor select$ controll$ sub/ances3 7,a7 ,! total numb] ( di/ributor regi/rants t di/ribute controll$ sub/ances to a ph>macy or practition] regi/rant1 aggregat$ by ! "n & address ( ea* ph>macy & practition] regi/rant4 7,b7 ,! total quantity & type ( opioids di/ribut$1 li/$ by ,adm9i/ration ,controll$ ,sub/ances ,code ,numb]1 to ea* ph>macy & practition] regi/rant describ$ 9 subp>agraph 7,a74 7#b7 ,! in=mation requir$ to be made available "u p>agraph 7#a7 %all be made available n lat] ?an ! #ae? day ( ! fir/ mon? foll[+ ! qu>t] to :i* ! in=mation relates4 7#c7 7,a7 ,all regi/]$ manufactur]s & di/ributors %all be responsible = review+ ! in=mation made available by ! ,attorney ,g5]al "u ?is subsection4 7,b7 ,9 det]m9+ :e!r to initiate proce$+s "u ?is title aga9/ a regi/]$ manufactur] or di/ributor bas$ on ! failure ( ! regi/rant to ma9ta9 effective controls aga9/ div]sion or o!rwise comply ) ! requirem5ts ( ?is title or ! regulations issu$ !reund]1 ! ,attorney ,g5]al may take into acc\nt t ! in=mation made available "u ?is subsection 0 available to ! regi/rant4 2 & 7#c7 by ins]t+ aft] subsection 7i71 z s r$esignat$1 ! foll[+3 7j7 ,all ( ! reports requir$ "u ?is section %all be provid$ 9 an electronic =mat4 4 7b7 ,coop]ative arrangem5ts ,section #ejc ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hgc7 is am5d$-- 7#a7 by /rik+ subsection 7c7 & ins]t+ ! foll[+3 7c7 7#a7 ,! ,attorney ,g5]al %all1 once e #f mon?s1 prep>e & make available to regulatory1 lic5s+1 attorneys g5]al1 & law en=cem5t ag5cies ( ,/ates a /&>diz$ report conta9+ descriptive & analytic in=mation on ! actual di/ribution patt]ns1 z ga!r$ ?r\gh ! ,automat$ ,reports & ,consolidat$ ,ord]+ ,sy/em1 or any subsequ5t automat$ sy/em1 pursuant to section #cjg & :i* include detail$ am\nts1 outli]s1 & tr5ds ( di/ributor & ph>macy regi/rants1 9 su* ,/ates = ! controll$ sub/ances conta9$ 9 s*$ule ,,ii1 :i*1 9 ! discretion ( ! ,attorney ,g5]al1 are det]m9$ to h ! highe/ abuse4 7#b7 ,if ! ,attorney ,g5]al publi%es ! report describ$ 9 p>agraph 7#a7 once e #f mon?s z requir$ "u p>agraph 7#a71 no?+ 9 ?is subsection %all be con/ru$ to br+ an action 9 any c\rt to *all5ge ! suffici5cy ( ! in=mation or to compel ! ,attorney ,g5]al to produce any docum5ts or reports ref]r$ to 9 ?is subsection4 4 7c7 ,civil & crim9al p5alties ,section #djb ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hdb7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 p>agraph 7#ae71 by /rik+ or at ! end2 7,b7 9 p>agraph 7#af71 by /rik+ ! p]iod at ! end & ins]t+ 2 or2 & 7,c7 by ins]t+ aft] p>agraph 7#af7 ! foll[+3 7#ag7 9 ! case ( a regi/]$ manufactur] or di/ributor ( opioids1 to fail to review ! mo/ rec5t in=mation made available by ! ,attorney ,g5]al 9 accordance ) section #cjg7;f7 be=e ea* di/ribution ( a controll$ sub/ance ref]r$ to 9 su* in=mation4 2 & 7#b7 9 subsection 7c7-- 7,a7 9 p>agraph 7#a71 by /rik+ subp>agraph 7,b7 & ins]t+ ! foll[+3 7,b7 7i7 ,except z provid$ 9 clause 7ii71 9 ! case ( a violation ( p>agraph 7#e71 7#aj71 or 7#ag7 ( subsection 7a71 ! p5alty %all n exce$ #aj1jjj4 7ii7 ,9 ! case ( a violation describ$ 9 clause 7i7 committ$ by a regi/]$ manufactur] or di/ributor ( opioids & relat$ to ! report+ ( suspici\s ord]s = opioids1 fail+ to ma9ta9 effective controls aga9/ div]sion ( opioids1 or fail+ to review ! mo/ rec5t in=mation made available by ! ,attorney ,g5]al 9 accordance ) section #cjg7;f71 ! p5alty %all n exce$ #ajj1jjj4 2 & 7,b7 9 p>agraph 7#b7-- 7i7 9 subp>agraph 7,a71 by ins]t+ or 7,d7 aft] subp>agraph 7,b72 & 7ii7 by add+ at ! end ! foll[+3 7,d7 ,9 ! case ( a violation describ$ 9 subp>agraph 7,a7 t 0 a violation ( p>agraph 7#e71 7#aj71 or 7#ag7 ( subsection 7a7 committ$ by a regi/]$ manufactur] or di/ributor ( opioids t relates to ! report+ ( suspici\s ord]s = opioids1 fail+ to ma9ta9 effective controls aga9/ div]sion ( opioids1 or fail+ to review ! mo/ rec5t in=mation made available by ! ,attorney ,g5]al 9 accordance ) section #cjg7;f71 ! crim9al f9e "u title #ah1 ,unit$ ,/ates ,code1 %all n exce$ #ejj1jjj4 4 #e4 ,report ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,attorney ,g5]al %all submit to ,congress a report t provides in=mation ab\t h[ ! ,attorney ,g5]al is us+ data 9 ! ,automation ( ,reports & ,consolidat$ ,ord]s ,sy/em to id5tify & /op suspici\s activity1 includ+ :e!r ! ,attorney ,g5]al is look+ at aggregate ord]s f individual ph>macies to multiple di/ributors t 9 total are suspici\s1 ev5 if no individual ord] rises to ! level ( a suspici\s ord] to a giv5 di/ributor4