,,ii #aae? ,,congress #b;d ,session ,s4 #cbhb ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,july #bf1 #bjah ,mr4 ,g>dn] 7= himself & ,mr4 ,coons7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ! ,judici>y ,a ,,bill ,to am5d ! ,controll$ ,sub/ances ,act to require t ord]s subject to review be submitt$ ?r\gh a cle>+h\se1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,,dea ,ord] ,cle>+h\se ,act ( #bjah4 #b4 ,requir$ cle>+h\se = regi/rant ord]s 7a7 ,9 g5]al ,! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hja et seq47 is am5d$-- 7#a7 9 section #cjc7;f71 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ ,! ,attorney ,g5]al & ins]t+ ,subject to section #cjc;,a1 ! ,attorney ,g5]al2 & 7#b7 by ins]t+ aft] section #cjc ! foll[+3 #cjc;,a4 ,requir$ cle>+h\se = regi/rant ord]s 7a7 ,9 g5]al ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is section1 ! ,attorney ,g5]al %all-- 7#a7 e/abli% a cle>+h\se t w\ld subject all ord]s ( controll$ sub/ances & li/$ *emicals to ! cle>+h\se = record+ & review1 prior to f9al review by ! regi/rant2 7#b7 am5d ! regulations relative to controll$ sub/ances 9 s*$ule ,,ii ord]+ requirem5ts t w\ld all[ = uni=m electronic ord]+ ( controll$ sub/ances 9 s*$ule ,,ii1 ,,iii1 ,,iv & ,v electronically to ! cle>+h\se2 & 7#c7 may d5y1 susp5d1 or revoke a regi/ration issu$ "u section #cjc7;f71 or ! regi/ration ( a di/ributor "u section #cjc7;b7 or #cjc7;e71 if ! practition] or di/ributor1 z applicable1 is n sub/antially 9 compliance ) ! requirem5ts ( ?is section4 7b7 ,cle>+h\se 7#a7 ,9 g5]al ,an ord] = a controll$ sub/ance may n be fill$ by ! regi/rant unless-- 7,a7 ! ord] is fir/ transmitt$ electronically to ! ,attorney ,g5]al1 act+ ?r\gh ! ,adm9i/rator ( ! ,drug ,en=cem5t ,adm9i/ration 7ref]r$ to 9 ?is section z ! ,adm9i/rator72 7,b7 ! ,adm9i/rator uses ! algori?m describ$ 9 p>agraph 7#b7 to det]m9e if ! ord] is an outli] & is pot5tially suspici\s2 7,c7 ! ,adm9i/rator relays ! ord] to ! regi/rant ) :om ! ord] is plac$1 reg>dless ( :e!r ! algori?m 0 exce$$1 = fur!r analysis ( ! ord] "u section #acja4gd7;b7 ( title #ba1 ,code ( ,f$]al ,regulations2 & 7,d7 ! regi/rant has receiv$ a waiv] f ! ,adm9i/rator exempt+ ! regi/rant f ?is section4 7#b7 ,algori?m 7,a7 ,9 g5]al ,! cle>+h\se e/abli%$ "u ?is section %all use an input-bas$ algori?m1 includ+ te*niques su* z artificial intellig5ce1 ma*9e le>n+1 & o!r me?ods ( analyz+ l>ge data1 t-- 7i7 automatically id5tifies ord]s t exce$ ! metrics ( ! algori?m2 7ii7 notifies ! regi/rant if ! ord] is an outli] & is pot5tially suspici\s2 7iii7 is in=m$ by all data available to ! ,adm9i/rator & uses ph>macy be/ practices2 7iv7 takes into consid]ation exi/+ ,/ate & ,f$]al law2 & 7v7 e/abli%es diff]5t p>amet]s = diff]5t regi/rants us+ relevant in=mation bas$ on ph>macy type1 location1 & size4 7,b7 ,ref9em5t ,! ,adm9i/rator ( ! ,drug ,en=cem5t ,adm9i/ration 7ref]r$ to 9 ?is section z ! ,adm9i/rator7 %all review1 update1 & revise ! algori?m biannually bas$ on fe$back f indu/ry & relevant /akehold]s to ensure functionality4 7#c7 ,consultation ,! ,adm9i/rator %all consult ) ! ,director ( ! ,national ,in/itute ( ,/&>ds & ,te*nology = te*nical assi/ance 9 e/abli%+ ! cle>+h\se4 7c7 ,responsibilities ( di/ributors & manufactur]s reg>d+ suspici\s ord]s ,?is section may n be con/ru$ z reliev+ any di/ributor or manufactur] f ! requirem5ts e/abli%$ 9 section #acja4gd7;b7 ( title #ba1 ,code ( ,f$]al ,regulations1 or any successor regulation1 ) respect to suspici\s ord]s4 7d7 ,contractor reg>d+ data analytics 7#a7 ,9 g5]al ,! ,adm9i/rator %all aw>d a contract to a public or private entity enabl+ ! ,adm9i/rator to c>ry out ! te*nological aspects ( track+1 process+ & evaluat+ ord]s "u ?is section4 7#b7 ,eligible entities ,an entity is eligible = an aw>d "u p>agraph 7#a7 if ! entity has significant exp]i5ce 9 data analytics & 9 process+ ! volume ( electronic data involv$ 9 review+ ord]s "u ?is section )9 ! timeframe requir$ 9 subsection 7c74 7#c7 ,capabilities ,a contract aw>d$ "u p>agraph 7#a7 %all-- 7,a7 provide a data managem5t & configurable visual analytics solution capable ( +e/+ & manag+ data entities1 includ+ manufactur]s1 & di/ributors1 retail disp5s]s across relevant data ma9ta9$ by ! ,adm9i/rator2 7,b7 /&>dize ! data =mat1 ) ! ability to flexibly model data = analyses & l9k data across s\rces2 & 7,c7 provide an environm5t = analysis t is int]op]able4 7#d7 ,comm]cial items ,! ,adm9i/rator %all comply ) section #ccjg ( title #da1 ,unit$ ,/ates ,code1 9 aw>d+ a contract "u p>agraph 7#a74 ,! ,adm9i/rator may n ent] into a contract = any capabilities s\ght "u p>agraph 7#a7 t are n = comm]cial items unless ! ,adm9i/rator fir/ det]m9es 9 writ+ t no comm]cial items are suitable to meet ! ne$s ( ! ,drug ,en=cem5t ,adm9i/ration4 7#e7 ,timel9e ( contract ,any contract aw>d$ "u p>agraph 7#a7 = a data managem5t & visual analytics solution %all require ! public or private entity aw>d$ su* contract to deliv] a function+ solution suffici5t to fulfill ! purposes ( ?is section n lat] ?an #ahj days aft] ! date on :i* ! contract is aw>d$1 unless ! ,adm9i/rator grants an ext5sion = un=ese5 delays4 7#f7 ,f$]al ,acquisition ,regulation ,a contract aw>d$ "u ?is subsection %all be 9 accordance ) ! ,f$]al ,acquisition ,regulation4 7#g7 ,access to data ,an entity t is aw>d$ a contract "u ?is subsection %all h access to ! relevant data to create ! sy/em4 7e7 ,waiv] 7#a7 ,9 g5]al ,beg9n+ on ! date on :i* ! #cf-mon? p]iod describ$ 9 subsection 7b77#a77;,a77ii7 expires1 a ph>macy may submit to ! ,adm9i/rator an application = a waiv] f ! requirem5ts ( subsection 7b77#a77;,a7 if ! ph>macy is unable to transmit ord]s electronically4 7#b7 ,response ,! ,adm9i/rator %all approve or d5y an application submitt$ "u p>agraph 7#a7 n lat] ?an ! #ij-;day p]iod beg9n+ on ! date on :i* ! application is receiv$4 7#c7 ,liability ,no waiv] issu$ "u p>agraph 7#a7 %all mitigate ! liability ( ! ph>macy = any drugs div]t$ t did n pass ?r\gh ! cle>+h\se4 7f7 ,fund+ 7#a7 ,div]sion control fee acc\nt ,! activities p]=m$ "u ?is section %all be consid]$ to be elem5ts ( ! div]sion control program = purposes ( section4 7#b7 ,prohibition ,no regi/rant may pass on ! co/ ( ! cle>+h\se to its cu/om]s4 4 7b7 ,te*nical & con=m+ am5dm5t ,! table ( cont5ts = ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hja et seq47 is am5d$ by ins]t+ aft] ! item relat+ to section #cjc ! foll[+3 ,sec4 #cjc;,a4 ,requir$ cle>+h\se = regi/rant ord]s4 4