,,ii #aaf? ,,congress #a/ ,session ,s4 #bhie ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,novemb] #ai1 #bjai,mr4 ,grassley 7= himself & ,mr4 ,:iteh\se7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ! ,judici>y ,a ,,bill ,to am5d ! ,controll$ ,sub/ances ,act to m effectively regulate selective &rog5 receptor modulators1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,selective ,&rog5 ,receptor ,modulators ,control ,act ( #bjai or ! ,s,a,r,ms ,control ,act ( #bjai4 #b4 ,am5dm5ts to ! ,controll$ ,sub/ances ,act 7a7 ,def9ition ,section #ajb ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hjb7 is am5d$-- 7#a7 by r$esignat+ p>agraph 7#eh7 z p>agraph 7#ei72 7#b7 by r$esignat+ ! second p>agraph designat$ z p>agraph 7#eg7 z p>agraph 7#eh72 7#c7 by mov+ p>agraphs 7#eg71 7#eh7 7z s r$esignat$71 & 7#ei7 7z s r$esignat$7 #b ems to ! left2 & 7#d7 by add+ at ! end ! foll[+3 7#fj7 7,a7 ,! t]m ,,s>m-- 7i7 means any drug or o!r sub/ance t is a selective &rog5 receptor agoni/ *emically unrelat$ to te/o/]one1 e/rog5s1 proge/9s1 cortico/]oids1 & dehydroepi&ro/]one2 & 7ii7 includes-- 7,i7 7,s7-,n-7#d-;cyano-#c-7trifluorome?yl7ph 5yl7-#c-7d-;cyanoph5oxy7-#b-;hydroxy-#b- me?ylpropanamide 7commonly kn[n z o/>9e or enobos>m72 7,,ii7 #d-77,r7-#b-77,r7-#b1b1b-trifluoro-#a-;h ydroxye?yl7pyrrolid9-#a-yl7-#b-7trifluor ome?yl7b5zonitrile 7commonly kn[n z ,,lgd-#djcc or lig&rol72 7,,iii7 #i-;*loro-#b-;e?yl-#a-me?yl-#c-7b1b1b-tr ifluoroe?yl7-#c1f-;dihydro-#g;,h-pyrrolo #c1b-;fqu9ol9-#g-"o 7commonly kn[n z ,,lgd-#ccjc72 7,,iv7 isopropyl 7,s7-7#g-;cyano-#d-7pyrid9-#b-ylme?yl7-# a1b1c1d-tetrahydrocyclop5tabindol-#b -yl7c>bamate 7commonly kn[n z ,,ly#bdebdgc or ,,tt#gja72 7,v7 #b-;*loro-#d-777a,r1#b,s7-#a-7e-7d-;cyan oph5yl7-#a1c1d-oxadiazol-#b-yl7-#b-;hydr oxypropyl7am9o7-#c-me?ylb5zonitrile 7commonly kn[n z ,,rad-#adj72 7,,vi7 7,s7-#c-7d-;acetamidoph5oxy7-#b-;hydroxy -#b-me?yl-,n-7#d-nitro-#c-7trifluorome?y l7ph5yl7propanamide 7commonly kn[n z &>9e72 7,,vii7 #b-;*loro-#d-77g,r1#g;a,s7-#g-;hydroxy-# a1c-;dioxotetrahydro-#a;,h-pyrrolo#a1b-; cimidazol- #b7c;,h7-yl7-#c-me?ylb5zonitrile 7commonly kn[n z ,,bms-#efdibi72 7,,viii7 #f-;e?yl-#d-7trifluorome?yl7-#f1g1h1i-te trahydropyrido#c1b-;gqu9ol9-#b7a;,h7-"o 7commonly kn[n z ,,lg-#abajga72 7,,ix7 7,s7-#c-7d-;*loro-#c-;fluoroph5oxy7-,n-7 #d-;cyano-#c-7trifluorome?yl7ph5yl7-#b-; hydroxy- #b-me?ylpropanamide 7commonly kn[n z ,s-#bc72 & 7,x7 any salt1 e/]1 e!r1 or sub/itut$ analogue ( a drug or o!r sub/ance describ$ 9 subclauses 7,i7 ?r\gh 7,,ix74 7,b7 ,a sub/ance exclud$ "u subp>agraph 7,a77i7 may at any "t be s*$ul$ by ! ,attorney ,g5]al 9 accordance ) ! au?ority & requirem5ts "u subsections 7a7 ?r\gh 7c7 ( section #bja4 7,c7 7i7 ,a drug or o!r sub/ance 7o!r ?an e/rog5s1 proge/9s1 cortico/]oids1 & dehydroepiandro/]"o1 unless s*$ul$ "u subp>agraph 7,b77 t is n li/$ 9 subp>agraph 7,a77ii7 & is d]iv$ f1 or has a *emical /ructure sub/antially simil> to1 "o or m ,s,a,r,ms li/$ 9 subp>agraph 7,a77ii7 %all be consid]$ to be a ,,s>m = purposes ( ?is title if ! drug or o!r sub/ance-- 7,i7 has be5 creat$ or manufactur$ ) ! int5t ( produc+ a drug or o!r sub/ance t-- 7aa7 promotes muscle gr[?2 or 7bb7 o!rwise causes a ph>macological effect simil> to t ( te/o/]one2 or 7,,ii7 has be51 or is int5d$ to be1 m>ket$ or o!rwise promot$ 9 any mann] sugge/+ t consum+ ! drug or o!r sub/ance w promote muscle gr[? or any o!r ph>macological effect simil> to t ( te/o/]one4 7ii7 ,a drug or o!r sub/ance %all n be consid]$ to be a ,,s>m = purposes ( ?is subp>agraph if ! drug or o!r sub/ance-- 7,i7 is-- 7aa7 an h]b or o!r botanical2 7bb7 a conc5trate1 metabolite1 or extract (1 or a con/itu5t isolat$ directly f1 an h]b or o!r botanical2 or 7cc7 a comb9ation ( two or m sub/ances describ$ 9 item 7aa7 or 7bb72 7,,ii7 is a diet>y +r$i5t = purposes ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq472 & 7,,iii7 is n anabolic or &rog5ic4 7iii7 ,9 accordance ) section #eae7;a71 any p]son claim+ ! b5efit ( an exemption or exception "u clause 7ii7 %all be> ! burd5 ( go+ =w>d ) ! evid5ce ) respect to t exemption or exception4 4 7b7 ,am5dm5t to s*$ule ,,iii ,s*$ule ,,iii 9 section #bjb7;c7 ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hab7;c77 is am5d$ by add+ at ! end ! foll[+3 7f7 ,s,a,r,ms4 4 7c7 ,tempor>y & p]man5t s*$ul+ ( rec5tly em]g$ ,s,a,r,ms ,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*$ul+ ( rec5tly em]g$ ,s,a,r,ms 7#a7 ,tempor>y ord]s 7,a7 ,9 g5]al ,! ,attorney ,g5]al may issue a tempor>y ord] add+ a drug or o!r sub/ance to ! def9ition ( ! t]m ,,s>m "u section #ajb7fj7 if ! ,attorney ,g5]al f9ds t-- 7i7 ! drug or o!r sub/ance satisfies ! crit]ia = be+ consid]$ a ,,s>m b is n li/$ 9 t section or by regulation ( ! ,attorney ,g5]al z be+ a ,,s>m2 & 7ii7 add+ ! drug or o!r sub/ance to ! def9ition ( ! t]m ,,s>m w assi/ 9 prev5t+ abuse or misuse ( ! drug or o!r sub/ance4 7,b7 ,effective date2 duration ,a tempor>y ord] issu$ "u subp>agraph 7,a7-- 7i7 %all take effect n e>li] ?an #cj days aft] ! date ( publication by ! ,attorney ,g5]al ( a notice 9 ! ,f$]al ,regi/] (-- 7,i7 ! int5tion ( ! ,attorney ,g5]al to issue ! tempor>y ord]2 & 7,,ii7 ! gr\nds on :i* ! tempor>y ord] is to be issu$2 & 7ii7 %all expire n lat] ?an #b ye>s aft] ! date on :i* ! tempor>y ord] becomes effective1 except t ! ,attorney ,g5]al may1 dur+ ! p5d5cy ( proce$+s "u p>agraph 7#b71 ext5d ! tempor>y ord] = n m ?an #f mon?s4 7,c7 ,notice to ,secret>y 7i7 ,9 g5]al ,! ,attorney ,g5]al %all transmit notice ( a tempor>y ord] propos$ to be issu$ "u subp>agraph 7,a7 to ! ,secret>y4 7ii7 ,consid]ation ,9 issu+ a tempor>y ord] "u subp>agraph 7,a71 ! ,attorney ,g5]al %all take into consid]ation any comm5ts submitt$ by ! ,secret>y 9 response to a notice transmitt$ "u ?is subp>agraph4 7,d7 ,effect ( p]man5t s*$ul+ ,a tempor>y ord] issu$ "u subp>agraph 7,a7 %all be vacat$ ^u ! issuance ( a p]man5t ord] "u p>agraph 7#b74 7,e7 ,judicial review ,a tempor>y ord] issu$ "u subp>agraph 7,a7 %all n be subject to judicial review4 7#b7 ,p]man5t ord]s 7,a7 ,9 g5]al ,! ,attorney ,g5]al may by rule issue a p]man5t ord] add+ a drug or o!r sub/ance to ! def9ition ( ! t]m ,,s>m "u section #ajb7fj7 if ! drug or o!r sub/ance satisfies ! crit]ia = be+ consid]$ a ,,s>m "u t section4 7,b7 ,tim+ ,! ,attorney ,g5]al may comm5ce a rulemak+ "u subp>agraph 7,a7 simultane\sly ) ! issuance ( a tempor>y ord] "u p>agraph 7#a74 4 7d7 ,label+ requirem5ts 7#a7 ,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,a,r,ms 7#a7 ,prohibition ,x %all be unlawful to import1 export1 manufacture1 di/ribute1 disp5se1 or possess ) int5t to manufacture1 di/ribute1 or disp5se1 a ,,s>m or product conta9+ a ,,s>m1 unless ! ,,s>m or product conta9+ ! ,,s>m be>s a label cle>ly id5tify+ ! ,,s>m or product conta9+ ! ,,s>m by ! nom5clature us$ by ! ,int]national ,union ( ,pure & ,appli$ ,*emi/ry4 7#b7 ,exemption 7,a7 ,9 g5]al ,a ,,s>m or product conta9+ a ,,s>m describ$ 9 subp>agraph 7,b7 %all be exempt f ! ,int]national ,union ( ,pure & ,appli$ ,*emi/ry nom5clature requirem5t "u p>agraph 7#a7 if ! ,,s>m or product conta9+ a ,,s>m is label$ 9 ! mann] requir$ "u ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq474 7,b7 ,exempt products ,a ,,s>m or product conta9+ a ,,s>m is describ$ 9 ?is subp>agraph if ! ,,s>m or product conta9+ a ,,s>m-- 7i7 is ! subject ( an approv$ application z describ$ 9 subsection 7b7 or 7j7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee72 or 7ii7 is exempt f ! provisions ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 relat+ to new drugs because-- 7,i7 ! ,,s>m or product conta9+ a ,,s>m is int5d$ solely = inve/igational use z describ$ 9 subsection 7i7 ( t section2 & 7,,ii7 ! ,,s>m or product conta9+ a ,,s>m is be+ us$ exclusively = purposes ( a cl9ical trial t is ! subject ( an effective inve/igational new drug application4 4 7#b7 ,cl>ification reg>d+ felony drug (f5ses ,section #ajb7dd7 ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hjb7dd77 is am5d$ by ins]t+ ,s,a,r,ms1 aft] anabolic /]oids14 7#c7 ,civil p5alties ,section #djb ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hdb7 is am5d$-- 7,a7 9 subsection 7a77#af7-- 7i7 by ins]t+ or 7f7 aft] subsection 7e72 & 7ii7 by /rik+ #hbe & ins]t+ #cje2 & 7,b7 9 subsection 7c77#a77;,d71 by ins]t+ or a ,,s>m aft] an anabolic /]oid4 #c4 ,am5dm5ts to ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act ,section #dac7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cej;b7c77 is am5d$-- 7#a7 9 p>agraph 7#a71 by /rik+ an anabolic /]oid or an analogue ( an anabolic /]oid & ins]t+ an anabolic /]oid1 a ,,s>m1 an analogue ( an anabolic /]oid1 or an analogue ( a ,,s>m2 & 7#b7 9 p>agraph 7#b7-- 7,a7 9 subp>agraph 7,a71 by /rik+ & at ! end2 7,b7 9 subp>agraph 7,b71 by /rik+ ! p]iod at ! end & ins]t+ a semicolon2 & 7,c7 by add+ at ! end ! foll[+3 7,c7 ! t]m analogue ( a ,,s>m means a sub/ance t has a *emical /ructure t is sub/antially simil> to ! *emical /ructure ( a ,,s>m2 & 7,d7 ! t]m ,,s>m has ! mean+ giv5 ! t]m 9 section #ajb7fj7 ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hjb7fj774 4