,,ii #aaf? ,,congress #a/ ,session ,s4 #bgfd ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,octob] #ca1 #bjai,mr4 ,grassley 7= himself1 ,ms4 ,ern/1 & ,mrs4 ,fe9/e97 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ! ,judici>y ,a ,,bill ,to am5d ! ,controll$ ,sub/ances ,act to cl>ify h[ controll$ sub/ance analogues t are import$ or (f]$ = import are to be regulat$1 & = o!r purposes4 #a4 ,%ort title2 table ( cont5ts 7a7 ,%ort title ,?is ,act may be cit$ z ! ,/op ! ,importation & ,manufactur+ ( ,syn!tic ,analogues ,act ( #bjai or ,,simsa4 7b7 ,table ( cont5ts ,! table ( cont5ts ( ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title2 table ( cont5ts4,sec4 #b4 ,e/abli%m5t ( ,s*$ule ,a4,sec4 #c4 ,tempor>y & p]man5t s*$ul+ ( s*$ule ,a sub/ances4,sec4 #d4 ,p5alties4,sec4 #e4 ,false label+ ( s*$ule ,a controll$ sub/ances4,sec4 #f4 ,regi/ration requirem5ts = import]s & export]s ( s*$ule ,a sub/ances4,sec4 #g4 ,additional con=m+ am5dm5ts4,sec4 #h4 ,s5t5c+ review4,sec4 #i4 ,rules ( con/ruction4 #b4 ,e/abli%m5t ( ,s*$ule ,a ,section #bjb ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hab7 is am5d$-- 7#a7 9 subsection 7a71 by /rik+ five s*$ules ( controll$ sub/ances1 to be kn[n z s*$ules ,i1 ,,ii1 ,,iii1 ,,iv1 & ,v & ins]t+ six s*$ules ( controll$ sub/ances1 to be kn[n z s*$ules ,i1 ,,ii1 ,,iii1 ,,iv1 ,v1 & ,a2 7#b7 9 subsection 7b71 by add+ at ! end ! foll[+3 7#f7 ,s*$ule ,a 7,a7 ,9 g5]al ,! drug or sub/ance-- 7i7 is or has be5 import$1 or is (f]$ = import1 into ! ,unit$ ,/ates2 7ii7 has-- 7,i7 a *emical /ructure t is sub/antially simil> to ! *emical /ructure ( a controll$ sub/ance 9 s*$ule ,i1 ,,ii1 ,,iii1 ,,iv1 or ,v2 & 7,,ii7 an actual or pr$ict$ /imulant1 depressant1 or halluc9og5ic effect on ! c5tral n]v\s sy/em t is sub/antially simil> to or great] ?an ! /imulant1 depressant1 or halluc9og5ic effect on ! c5tral n]v\s sy/em ( a controll$ sub/ance 9 s*$ule ,i1 ,,ii1 ,,iii1 ,,iv1 or ,v2 & 7iii7 is n-- 7,i7 li/$ or o!rwise includ$ 9 any o!r s*$ule 9 ?is section or by regulation ( ! ,attorney ,g5]al2 & 7,,ii7 ) respect to a p>ticul> p]son1 subject to an exemption t is 9 effect = inve/igational use1 = t p]son1 "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 to ! ext5t conduct ) respect to su* sub/ance is pursuant to su* exemption4 7,b7 ,pr$ict$ /imulant1 depressant1 or halluc9og5ic effect ,= purpose ( ?is p>agraph1 a pr$ict$ /imulant1 depressant1 or halluc9og5ic effect on ! c5tral n]v\s sy/em may be bas$ on-- 7i7 7,i7 ! *emical /ructure2 & 7,,ii7 7aa7 ! /ructure activity relation%ips2 or 7bb7 b9d+ receptor assays & o!r relevant sci5tific in=mation ab\t ! sub/ance2 7ii7 7,i7 ! curr5t or relative pot5tial = abuse ( ! sub/ance2 & 7,,ii7 ! cl&e/9e importation1 manufacture1 or di/ribution1 or div]sion f legitimate *annels1 ( ! sub/ance2 or 7iii7 ! capacity ( ! sub/ance to cause a /ate ( dep5d5ce1 includ+ physical or psy*ological dep5d5ce t is simil> to or great] ?an t ( a controll$ sub/ance 9 s*$ule ,i1 ,,ii1 ,,iii1 ,,iv1 or ,v4 2 & 7#c7 9 subsection 7c7-- 7,a7 9 ! matt] prec$+ s*$ule ,i1 by /rik+ ,,iv1 & ,v & ins]t+ ,,iv1 ,v1 & ,a2 & 7,b7 by add+ at ! end ! foll[+3 ,s*$ule ,a ,any sub/ance tempor>ily or p]man5tly s*$ul$ by ! ,attorney ,g5]al 9 accordance ) section #bja7k74 4 #c4 ,tempor>y & p]man5t s*$ul+ ( s*$ule ,a sub/ances ,section #bja ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #haa7 is am5d$ by add+ at ! end ! foll[+3 7k7 ,tempor>y & p]man5t s*$ul+ ( s*$ule ,a sub/ances 7#a7 ,9 g5]al ,! ,attorney ,g5]al may issue a tempor>y ord] add+ a drug or sub/ance to s*$ule ,a if ! ,attorney ,g5]al f9ds t-- 7,a7 ! drug or o!r sub/ance satisfies ! crit]ia = be+ consid]$ a s*$ule ,a sub/ance2 & 7,b7 add+ su* drug or sub/ance to s*$ule ,a w assi/ 9 prev5t+ abuse ( ! drug or o!r sub/ance4 7#b7 ,duration ( tempor>y s*$ul+ ord] ,a tempor>y s*$ul+ ord] issu$ "u p>agraph 7#a7 %all-- 7,a7 n take effect until #cj days aft] ! date ( ! publication by ! ,attorney ,g5]al ( a notice 9 ! ,f$]al ,regi/] ( ! int5tion to issue su* ord] & ! gr\nds ^u :i* su* ord] is to be issu$2 & 7,b7 expire n lat] ?an #e ye>s aft] ! date on :i* ! ord] becomes effective1 except t ! ,attorney ,g5]al may1 dur+ ! p5d5cy ( proce$+s "u p>agraph 7#e71 ext5d ! tempor>y s*$ul+ ord] = up to #ahj days4 7#c7 ,effect ( issuance ( p]man5t s*$ul+ ord] ,a tempor>y s*$ul+ ord] issu$ "u p>agraph 7#a7 %all be vacat$ ^u ! issuance ( a p]man5t ord] issu$ "u p>agraph 7#e7 ) reg>d to ! same sub/ance1 or ^u ! subsequ5t issuance ( any s*$ul+ ord] "u ?is section4 7#d7 ,limitation on judicial review ,a tempor>y s*$ul+ ord] issu$ "u p>agraph 7#a7 %all n be subject to judicial review4 7#e7 ,p]man5t s*$ul+ ord] 7,a7 ,9 g5]al ,except z provid$ 9 subp>agraph 7,b71 n e>li] ?an #c ye>s aft] ! date on :i* ! ,attorney ,g5]al issues an ord] tempor>ily s*$ul+ a drug or sub/ance "u ?is subsection1 ! ,attorney ,g5]al may1 by rule1 issue a p]man5t ord] add+ ! drug or o!r sub/ance to s*$ule ,a if su* drug or sub/ance satisfies ! crit]ia = be+ consid]$ a s*$ule ,a sub/ance4 7,b7 ,limitation ,if ! ,secret>y ( ,heal? & ,human ,s]vices has det]m9$1 bas$ on relevant sci5tific /udies & necess>y data reque/$ by ! ,secret>y ( ,heal? & ,human ,s]vices & ga!r$ by ! ,attorney ,g5]al1 t a drug or o!r sub/ance t has be5 tempor>ily plac$ 9 s*$ule ,a does n h suffici5t pot5tial = abuse to w>rant control 9 any s*$ule1 & provides writt5 notice ( su* det]m9ation to ! ,attorney ,g5]al1 ! ,attorney ,g5]al-- 7i7 may n issue a p]man5t s*$ul+ ord] "u subp>agraph 7,a72 & 7ii7 n lat] ?an #cj days aft] ! date on :i* ! ,attorney ,g5]al receives su* notice1 %all issue an ord] imm$iately t]m9at+ ! tempor>y s*$ul+ ord] = ! drug or o!r sub/ance4 7#f7 ,notice to ,,hhs ,be=e initiat+ proce$+s "u p>agraph 7#a71 ! ,attorney ,g5]al %all transmit notice ( a tempor>y ord] propos$ to be issu$ to ! ,secret>y ( ,heal? & ,human ,s]vices4 ,9 issu+ an ord] "u p>agraph 7#a71 ! ,attorney ,g5]al %all take into consid]ation any comm5ts submitt$ by ! ,secret>y ( ,heal? & ,human ,s]vices 9 response to a notice transmitt$ pursuant to ?is p>agraph4 4 #d4 ,p5alties ,section #ajaj ( ! ,controll$ ,sub/ances ,import & ,export ,act 7#ba ,u4,s4,c4 #ifj7 is am5d$-- 7#a7 9 subsection 7a71 by ins]t+ or a drug or sub/ance 9 s*$ule ,a aft] controll$ sub/ance ea* place x appe>s2 & 7#b7 9 subsection 7b71 by add+ at ! end ! foll[+3 7#h7 ,9 ! case ( a violation "u subsection 7a7 involv+ a controll$ sub/ance 9 s*$ule ,a1 ! p]son committ+ su* violation %all be s5t5c$ to a t]m ( imprisonm5t ( n m ?an #bj ye>s & if dea? or s]i\s bodily injury results f ! use ( su* sub/ance %all be s5t5c$ to a t]m ( imprisonm5t = any t]m ( ye>s or = life1 a f9e n to exce$ ! great] ( t au?oriz$ 9 accordance ) ! provisions ( title #ah1 ,unit$ ,/ates ,code1 or #a1jjj1jjj if ! def5dant is an individual or #e1jjj1jjj if ! def5dant is o!r ?an an individual1 or bo?4 ,if any p]son commits su* a violation aft] a prior conviction = a felony drug (f5se has become f9al1 su* p]son %all be s5t5c$ to a t]m ( imprisonm5t ( n m ?an #cj ye>s & if dea? or s]i\s bodily injury results f ! use ( su* sub/ance %all be s5t5c$ to a t]m ( imprisonm5t = any t]m ( ye>s or = life1 a f9e n to exce$ ! great] ( twice t au?oriz$ 9 accordance ) ! provisions ( title #ah1 ,unit$ ,/ates ,code1 or #b1jjj1jjj if ! def5dant is an individual or #aj1jjj1jjj if ! def5dant is o!r ?an an individual1 or bo?4 ,not)/&+ section #cehc ( title #ah1 ,unit$ ,/ates ,code1 any s5t5ce impos+ a t]m ( imprisonm5t "u ?is p>agraph %all1 9 ! abs5ce ( su* a prior conviction1 impose a t]m ( sup]vis$ release ( n less ?an #c ye>s 9 addition to su* t]m ( imprisonm5t & %all1 if !re 0 su* a prior conviction1 impose a t]m ( sup]vis$ release ( n less ?an #f ye>s 9 addition to su* t]m ( imprisonm5t4 ,not)/&+ ! prior s5t5ce1 & not)/&+ any o!r provision ( law1 ! c\rt %all n place on probation or susp5d ! s5t5ce ( any p]son s5t5c$ "u ! provisions ( ?is p>agraph :i* provide = a m&atory t]m ( imprisonm5t if dea? or s]i\s bodily injury results4 4 #e4 ,false label+ ( s*$ule ,a controll$ sub/ances 7a7 ,9 g5]al ,section #cje ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hbe7 is am5d$ by add+ at ! end ! foll[+3 7f7 ,false label+ ( s*$ule ,a controll$ sub/ances 7#a7 ,x %all be unlawful to import or export1 ) int5t to manufacture1 di/ribute1 or disp5se1 a s*$ule ,a sub/ance or product conta9+ a s*$ule ,a sub/ance1 unless ! sub/ance or product be>s a label cle>ly id5tify+ a s*$ule ,a sub/ance or product conta9+ a s*$ule ,a sub/ance by ! nom5clature us$ by ! ,int]national ,union ( ,pure & ,appli$ ,*emi/ry 7,,iupac74 7#b7 7,a7 ,a product describ$ 9 subp>agraph 7,b7 is exempt f ! ,int]national ,union ( ,pure & ,appli$ ,*emi/ry nom5clature requirem5t ( ?is subsection if su* product is label$ 9 ! mann] requir$ "u ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act4 7,b7 ,a product is describ$ 9 ?is subp>agraph if ! product-- 7i7 is ! subject ( an approv$ application z describ$ 9 section #eje7;b7 or 7j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act2 or 7ii7 is exempt f ! provisions ( section #eje ( su* ,act relat+ to new drugs because-- 7,i7 x is int5d$ solely = inve/igational use z describ$ 9 section #eje7;i7 ( su* ,act2 & 7,,ii7 su* product is be+ us$ exclusively = purposes ( a cl9ical trial t is ! subject ( an effective inve/igational new drug application4 4 7b7 ,p5alties ,section #djb ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hdb7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 p>agraph 7#af71 by /rik+ or at ! end2 7,b7 by r$esignat+ p>agraph 7#ag7 z p>agraph 7#ah72 & 7,c7 by ins]t+ aft] p>agraph 7#af7 ! foll[+3 7#ag7 to violate section #cje7;f72 or 2 & 7#b7 9 subsection 7c7-- 7,a7 9 p>agraph 7#a7-- 7i7 9 subp>agraph 7,b77i71 by /rik+ 7#ag7 & ins]t+ 7#ah72 & 7ii7 9 subp>agraph 7,c71 by ins]t+ or 7#ag7 aft] p>agraph 7#af7 ea* place x appe>s2 & 7,b7 9 p>agraph 7#b77;,d71 by /rik+ 7#ag7 & ins]t+ 7#ah74 #f4 ,regi/ration requirem5ts = import]s & export]s ( s*$ule ,a sub/ances ,section #ajjh ( ! ,controll$ ,sub/ances ,import & ,export ,act 7#ba ,u4,s4,c4 #ieh7 is am5d$ by add+ at ! end ! foll[+3 7j7 7#a7 ,! ,attorney ,g5]al %all regi/] an applicant to import or export a s*$ule ,a sub/ance if-- 7,a7 ! applicant demon/rates t ! s*$ule ,a sub/ance w be us$ = rese>*1 analytical1 or indu/rial purposes approv$ by ! ,attorney ,g5]al2 & 7,b7 ! ,attorney ,g5]al det]m9es t su* regi/ration is consi/5t ) ! public int]e/ & ) ! ,unit$ ,/ates obligations "u int]national treaties1 conv5tions1 or protocols 9 effect on ! date ( enactm5t ( ?is subsection4 7#b7 ,9 det]m9+ ! public int]e/ "u p>agraph 7#a77;,b71 ! ,attorney ,g5]al %all consid]-- 7,a7 ma9t5ance ( effective controls aga9/ div]sion ( p>ticul> controll$ sub/ances & any controll$ sub/ance 9 s*$ule ,a comp\nd$ !refrom into o!r ?an legitimate m$ical1 sci5tific1 rese>*1 or indu/rial *annels1 by limit+ ! importation & bulk manufacture ( su* controll$ sub/ances to a numb] ( e/abli%m5ts :i* c produce an adequate & un9t]rupt$ supply ( ^! sub/ances "u adequately competitive conditions = legitimate m$ical1 sci5tific1 rese>*1 & indu/rial purposes2 7,b7 compliance ) applicable ,/ate & local law2 7,c7 promotion ( te*nical advances 9 ! art ( manufactur+ sub/ances describ$ 9 subp>agraph 7,a7 & ! developm5t ( new sub/ances2 7,d7 prior conviction record ( applicant "u ,f$]al & ,/ate laws relat+ to ! importation1 manufacture1 di/ribution1 or disp5s+ ( sub/ances describ$ 9 subp>agraph 7,a72 7,e7 pa/ exp]i5ce 9 ! importation & manufacture ( controll$ sub/ances1 & ! exi/5ce 9 ! e/abli%m5t ( effective control aga9/ div]sion2 & 7,f7 su* o!r factors z may be relevant to & consi/5t ) ! public heal? & safety4 7#c7 ,if an applicant is regi/]$ to import or export a controll$ sub/ance 9 s*$ule ,i or ,,ii "u subsection 7a71 ! applicant %all n be requir$ to apply = a sep>ate regi/ration "u ?is subsection4 4 #g4 ,additional con=m+ am5dm5ts ,! ,controll$ ,sub/ances ,import & ,export ,act 7#ba ,u4,s4,c4 #iea et seq47 is am5d$-- 7#a7 9 section #ajjb7;a7 7#ba ,u4,s4,c4 #ieb7;a77-- 7,a7 9 ! matt] prec$+ p>agraph 7#a71 by ins]t+ or drug or sub/ance 9 s*$ule ,a aft] s*$ule ,i or ,,ii2 & 7,b7 9 p>agraph 7#b71 by ins]t+ or drug or sub/ances 9 s*$ule ,a aft] s*$ule ,i or ,,ii2 7#b7 9 section #ajjc 7#ba ,u4,s4,c4 #iec7-- 7,a7 9 subsection 7c71 9 ! matt] prec$+ p>agraph 7#a71 by ins]t+ or drug or sub/ance 9 s*$ule ,a aft] s*$ule ,i or ,,ii2 & 7,b7 9 subsection 7d71 by ins]t+ or drug or sub/ance 9 s*$ule ,a aft] s*$ule ,i or ,,ii2 7#c7 9 section #ajjd7a7 7#ba ,u4,s4,c4 #ied7a771 9 ! matt] prec$+ subp>agraph 7,a71 by ins]t+ or drug or sub/ance 9 s*$ule ,a aft] s*$ule ,i2 7#d7 9 section #ajje 7#ba ,u4,s4,c4 #iee71 by ins]t+ or drug or sub/ance 9 s*$ule ,a aft] s*$ule ,i or ,,ii2 & 7#e7 9 section #ajji7;a7 7#ba ,u4,s4,c4 #iei7;a771 by ins]t+ or drug or sub/ance 9 s*$ule ,a aft] s*$ule ,i or ,,ii4 #h4 ,s5t5c+ review 7a7 ,cov]$ (f5se def9$ ,9 ?is section1 ! t]m cov]$ (f5se means an (f5se involv+ a s*$ule ,a sub/ance = :i* ! p5alty 0 e/abli%$ "u section #d or #e ( ?is ,act4 7b7 ,s5t5c+ review 7#a7 ,petition = review ,if a s*$ule ,a sub/ance t is tempor>ily or p]man5tly s*$ul$ "u section #bja7k7 ( ! ,controll$ ,sub/ances ,act1 z add$ by ?is ,act1 is subsequ5tly des*$ul$ or res*$ul$ on a s*$ule ) l[] p5alties1 any individual convict$ ( a cov]$ (f5se involv+ su* s*$ule ,a sub/ance :o is await+ s5t5c+ or is /ill s]v+ a t]m ( imprisonm5t = su* cov]$ (f5se on ! date ( ! des*$ul+ or res*$ul+ may petition ! c\rt t impos$ ! s5t5ce = a s5t5c+ r$uction he>+ = su* cov]$ (f5se4 7#b7 ,s5t5c+ review ,n lat] ?an #cj days aft] ! date on :i* a petition is fil$ "u p>agraph 7#a71 ! c\rt %all conduct a s5t5c+ r$uction he>+ & may modify ! s5t5ce ( ! petition] z if ! des*$ul+ or res*$ul+ describ$ 9 p>agraph 7#a7 _h be5 9 effect on ! date ! cov]$ (f5se 0 committ$4 #i4 ,rules ( con/ruction ,no?+ 9 ?is ,act1 or ! am5dm5ts made by ?is ,act1 may be con/ru$ to limit-- 7#a7 ! prosecution ( (f5ses involv+ controll$ sub/ance analogues "u ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hja et seq472 or 7#b7 ! au?ority ( ! ,attorney ,g5]al to tempor>ily or p]man5tly s*$ule1 res*$ule1 or decontrol controll$ sub/ances "u provisions ( section #bja ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #haa7 t are 9 effect on ! day be=e ! date ( enactm5t ( ?is ,act4