,,ii #aaf? ,,congress #a/ ,session ,s4 #bfhf ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,octob] #bc1 #bjai,mr4 ,g>dn] 7= himself & ,mr4 ,coons7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ! ,judici>y ,a ,,bill ,to improve report+ ( ! di/ribution ( controll$ sub/ances1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,suspici\s ,ord] ,id5tification ,act ( #bjai4 #b4 ,/r5g!n+ ,,arcos ,section #cjg7;d7 ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hbg7;d77 is am5d$ to read z foll[s3 7#a7 7,a7 ,e regi/rant "u section #cjc %all & 9 su* =m z ! ,attorney ,g5]al may require1 make reports 9 electronic =mat to ! ,attorney ,g5]al ( e sale1 deliv]y1 or o!r disposal 7o!r ?an by disp5s+ by a practition]7 by ! regi/rant ( any controll$ sub/ance1 id5tify+ by ! regi/ration numb] assign$ "u ?is title ! p]son or e/abli%m5t 7unless exempt f regi/ration "u section #cjb7;d77 to :om su* sale1 deliv]y1 or o!r disposal 0 made4 7,b7 ,e regi/rant %all make ea* report requir$ "u subp>agraph 7,a7-- 7i7 n lat] ?an #cj days aft] ! sale1 deliv]y1 or o!r disposal2 or 7ii7 aft] ! date on :i* ! real-"t report+ sy/em is e/abli%$ "u section #c7;e77#c7 ( ! ,suspici\s ,ord] ,id5tification ,act ( #bjai is implem5t$1 9 real "t4 4 #c4 ,suspici\s ,ord]s ,task ,=ce 7a7 ,def9itions ,9 ?is section3 7#a7 ,adm9i/rator ,! t]m ,adm9i/rator means ! ,adm9i/rator ( ! ,drug ,en=cem5t ,adm9i/ration4 7#b7 ,controll$ sub/ance2 di/ributor2 manufactur] ,! t]ms controll$ sub/ance1 di/ributor1 & manufactur] h ! mean+s giv5 ^? t]ms 9 section #ajb ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hjb74 7#c7 ,real "t ,! t]m real "t means ) z little delay z te*nically & economically feasible1 z det]m9$ by ! ,attorney ,g5]al foll[+ ! program design$ "u subsection 7e77#a71 b n to exce$ #bd h\rs4 7#d7 ,regi/rant ,! t]m regi/rant-- 7,a7 means a p]son regi/]$ "u section #cjc ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hbc72 & 7,b7 does n include a practition]4 7b7 ,e/abli%m5t ,! ,attorney ,g5]al1 9 consultation ) ! ,director ( ! ,(fice ( ,national ,drug ,control ,policy & ! ,secret>y ( ,heal? & ,human ,s]vices1 %all e/abli% a ,suspici\s ,ord] ,monitor+ ,task ,=ce 7ref]r$ to 9 ?is section z ! ,task ,=ce74 7c7 ,composition 7#a7 ,9 g5]al ,! ,task ,=ce %all be compos$ ( appropriate p]sonnel f-- 7,a7 ! ,dep>tm5t ( ,ju/ice2 7,b7 ! ,drug ,en=cem5t ,adm9i/ration2 7,c7 ! ,(fice ( ,national ,drug ,control ,policy2 7,d7 ! ,national ,in/itute ( ,/&>ds & ,te*nology2 & 7,e7 o!r appropriate ,f$]al1 ,/ate1 & local law en=cem5t & regulatory ag5cies ) exp]i5ce 9 inve/igat+ & prosecut+ illegal transactions ( controll$ sub/ances z det]m9$ by ! ,attorney ,g5]al1 9 consultation ) ! ,secret>y ( ,heal? & ,human ,s]vices4 7#b7 ,consultants ,! ,task ,=ce %all consult )-- 7,a7 indu/ry memb]s1 includ+-- 7i7 data analytic pr(essionals2 7ii7 community ph>macies t disp5se controll$ sub/ances2 7iii7 *a9 ph>macies t disp5se controll$ sub/ances2 7iv7 di/ributors ( controll$ sub/ances2 7v7 manufactur]s ( controll$ sub/ances2 7vi7 ,/ate & local public heal? (ficials2 & 7vii7 o!r relevant indu/ry pr(essionals2 & 7,b7 relevant indu/ry regulators & entities t utilize real-"t report+ ( transactions1 ord]s1 or o!r activities ) ! goal ( id5tify+ suspici\s activity1 su* z appropriate p]sonnel f ! ,f9ancial ,crimes ,en=cem5t ,network & money transf] indu/ry pr(essionals4 7d7 ,meet+s 7#a7 ,9 g5]al ,! ,task ,=ce %all meet n less frequ5tly ?an #d times p] ye> & at su* o!r times z may be det]m9$ necess>y by ! ,task ,=ce4 7#b7 ,initial meet+ ,n lat] ?an #fj days aft] ! date ( enactm5t ( ?is ,act1 ! ,task ,=ce %all hold ! initial meet+ ( ! ,task ,=ce4 7e7 ,prelim9>y ord] evaluation program 7#a7 ,9 g5]al 7,a7 ,design ,n lat] ?an #fj days aft] ! date on :i* ! ,task ,=ce holds ! initial meet+ requir$ "u subsection 7d77#b71 ! ,task ,=ce %all beg9 to design a program 9 accordance ) p>agraph 7#b74 7,b7 ,purpose ,! program describ$ 9 subp>agraph 7,a7 %all be design$ to %>e necess>y data1 9 a limit$ capacity1 ) regi/rants 9 ord] to provide regi/rants ) in=mation to id5tify suspici\s ord]+ 9 real "t4 7,c7 ,deadl9e = completion ,n lat] ?an #h mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,task ,=ce %all complete ! design requir$ "u subp>agraph 7,a74 7#b7 ,requirem5ts 7,a7 ,9 g5]al ,! program requir$ "u p>agraph 7#a7 %all e/abli% a process =-- 7i7 transition+ to a requirem5t to report 9 real "t to ! ,attorney ,g5]al "u section #cjg7;d7 ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hbg7;d77 e sale1 deliv]y1 or o!r disposal by a regi/rant ( any controll$ sub/ance2 7ii7 limit$ %>+ 9 real "t ( ,automation ( ,reports & ,consolidat$ ,ord]s ,sy/em 7commonly kn[n z ,,arcos7 data ) regi/rants to %>e necess>y data1 9 a limit$ capacity1 ) regi/rants 9 ord] to provide regi/rants ) in=mation to id5tify suspici\s ord]+ 9 real "t2 & 7iii7 ensur+ data privacy1 data de-id5tification1 protection ( trade secrets & pur*as+ hi/ory4 7,b7 ,o!r consid]ations ,9 design+ ! program "u p>agraph 7#a71 ! ,task ,=ce %all take into consid]ation-- 7i7 ! inclusion ( a waiv] process = ph>macies & o!r regi/rants unable to transmit ord]s electronically on ! date ( enactm5t ( ?is ,act2 7ii7 a me*anism to ensure t ! co/s ( runn+ ! program are n pass$ ?r\gh to cu/om]s ( regi/rants1 unless ! regi/rants are cu/om] ( o!r regi/rants2 7iii7 te*nical requirem5ts = ensur+ t regi/rants may access all relevant de-id5tifi$ data1 ) output provid$ 9 a /&>d database file =mat2 & 7iv7 a me*anism to ensure t ! program requir$ to be design$ "u subp>agraph 7,a7 is updat$ bas$ on fe$back f indu/ry memb]s & o!r relevant entities4 7#c7 ,implem5tation ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,attorney ,g5]al %all-- 7,a7 implem5t ! program design$ "u p>agraph 7#a7 to collect & %>e 9 real "t data = regi/rants to evaluate ! ord]s ( controll$ sub/ances f di/ributors to manufactur]s & f ph>macies to di/ributors2 or 7,b7 o!rwise implem5t a program to collect & %>e 9 real "t data = drug manufactur]s & di/ributors1 by provid+ access to anonymiz$ in=mation to help drug manufactur]s & di/ributors id5tify1 report1 & /op suspici\s ord]s ( controll$ sub/ances & r$uce div]sion rates4 7#d7 ,recomm5d$ /atutory & regulatory *anges ,9 design+ ! program requir$ "u p>agraph 7#a71 ! ,task ,=ce-- 7,a7 %all submit to ! ,attorney ,g5]al any recomm5dations = necess>y am5dm5ts to regulations ( ! ,dep>tm5t ( ,ju/ice relat+ to ! requirem5ts = ord]+ s*$ule ,,ii controll$ sub/ances1 s z to all[ uni=m electronic ord]+ ( controll$ sub/ances 9 s*$ules ,,ii1 ,,iii1 ,,iv1 & ,v electronically ?r\gh ! program2 & 7,b7 may submit to ,congress any recomm5dations = necess>y legislative *anges s t a real-"t data analytics solution c be us$ across ! ,unit$ ,/ates4 7#e7 ,responsibility ( regi/rants ,all regi/]$ drug manufactur]s & di/ributors %all be responsible = review+ any in=mation made available by ! ,attorney ,g5]al & comply+ ) any regulations reg>d+ ! program design$ "u p>agraph 7#a7 & implem5t$ "u p>agraph 7#c74 7f7 ,fund+ 7#a7 ,9 g5]al ,! ,attorney ,g5]al1 act+ ?r\gh ! ,adm9i/rator1 %all use am\nts collect$ z fees = di/ributors & regi/rants "u section #cjc ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hbc7 & section #ajjg ( ! ,controll$ ,sub/ances ,import & ,export ,act 7#ba ,u4,s4,c4 #ieg7 to c>ry out ?is section4 7#b7 ,(fset 7,a7 ,9 g5]al ,! ,adm9i/rator may1 on an equal basis & 9 accordance ) subp>agraph 7,b71 increase ! fees describ$ 9 p>agraph 7#a7 = di/ributors & regi/rants to ! ext5t necess>y to defray ! co/s ( ?is section4 7,b7 ,ti]$ fee ,! ,adm9i/rator %all e/abli% a ti]$ us] fee = di/ributors & regi/rants 9 proportion to ! volume ( sales & pur*ases4 7g7 ,applicability ( ,,faca 7#a7 ,9 g5]al ,except z provid$ 9 p>agraph 7#b71 ! ,f$]al ,advisory ,committee ,act 7#e ,u4,s4,c4 ,app47 %all apply to ! ,task ,=ce4 7#b7 ,t]m9ation ,! ,task ,=ce %all t]m9ate on ! date on :i* ! program is fully implem5t$ "u subsection 7e77#c74 7h7 ,rules ( con/ruction ,no?+ 9 ?is ,act %all be con/ru$ z reliev+ any manufactur]1 di/ributor1 or o!r regi/rant f ! responsibilities ( ! manufactur]1 di/ributor1 or o!r regi/rant1 z ! case may be1 to-- 7#a7 id5tify1 /op1 & report suspici\s ord]s2 7#b7 ma9ta9 effective controls aga9/ div]sion 9 accordance ) section #cjc ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hbc72 & 7#c7 comply ) ! requirem5ts e/abli%$ 9 section #acja4gd7;b7 ( title #ba1 ,code ( ,f$]al ,regulations1 or any successor regulation !reto1 ) respect to suspici\s ord]s4