,,ii #aafth ,,congress #ast ,session ,s4 #bhie ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,november #ai1 #bjai,mr4 ,grassley 7for himself and ,mr4 ,whitehouse7 introduced the following bill2 which was read twice and referred to the ,committee on the ,judiciary ,a ,,bill ,to amend the ,controlled ,substances ,act to more effectively regulate selective androgen receptor modulators1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,selective ,androgen ,receptor ,modulators ,control ,act of #bjai or the ,s,a,r,ms ,control ,act of #bjai4 #b4 ,amendments to the ,controlled ,substances ,act 7a7 ,definition ,section #ajb of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hjb7 is amended-- 7#a7 by redesignating paragraph 7#eh7 as paragraph 7#ei72 7#b7 by redesignating the second paragraph designated as paragraph 7#eg7 as paragraph 7#eh72 7#c7 by moving paragraphs 7#eg71 7#eh7 7as so redesignated71 and 7#ei7 7as so redesignated7 #b ems to the left2 and 7#d7 by adding at the end the following3 7#fj7 7,a7 ,the term ,,sarm-- 7i7 means any drug or other substance that is a selective androgen receptor agonist chemically unrelated to testosterone1 estrogens1 progestins1 corticosteroids1 and dehydroepiandrosterone2 and 7ii7 includes-- 7,i7 7,s7-,n-7#d-;cyano-#c-7trifluoromethyl7p henyl7-#c-7d-;cyanophenoxy7-#b-;hydroxy- #b-methylpropanamide 7commonly known as ostarine or enobosarm72 7,,ii7 #d-77,r7-#b-77,r7-#b1b1b-trifluoro-#a-;h ydroxyethyl7pyrrolidin-#a-yl7-#b-7triflu oromethyl7benzonitrile 7commonly known as ,,lgd-#djcc or ligandrol72 7,,iii7 #i-;chloro-#b-;ethyl-#a-methyl-#c-7b1b1b -trifluoroethyl7-#c1f-;dihydro-#g;,h-pyr rolo#c1b-;fquinolin-#g-one 7commonly known as ,,lgd-#ccjc72 7,,iv7 isopropyl 7,s7-7#g-;cyano-#d-7pyridin-#b-ylmethyl7 -#a1b1c1d-tetrahydrocyclopentabindol-#b -yl7carbamate 7commonly known as ,,ly#bdebdgc or ,,tt#gja72 7,v7 #b-;chloro-#d-777a,r1#b,s7-#a-7e-7d-;cya nophenyl7-#a1c1d-oxadiazol-#b-yl7-#b-;hy droxypropyl7amino7-#c-methylbenzonitrile 7commonly known as ,,rad-#adj72 7,,vi7 7,s7-#c-7d-;acetamidophenoxy7-#b-;hydrox y-#b-methyl-,n-7#d-nitro-#c-7trifluorome thyl7phenyl7propanamide 7commonly known as andarine72 7,,vii7 #b-;chloro-#d-77g,r1#g;a,s7-#g-;hydroxy- #a1c-;dioxotetrahydro-#a;,h-pyrrolo#a1b- ;cimidazol- #b7c;,h7-yl7-#c-methylbenzonitrile 7commonly known as ,,bms-#efdibi72 7,,viii7 #f-;ethyl-#d-7trifluoromethyl7-#f1g1h1i- tetrahydropyrido#c1b-;gquinolin-#b7a;,h7 -one 7commonly known as ,,lg-#abajga72 7,,ix7 7,s7-#c-7d-;chloro-#c-;fluorophenoxy7-,n -7#d-;cyano-#c-7trifluoromethyl7phenyl7- #b-;hydroxy- #b-methylpropanamide 7commonly known as ,s-#bc72 and 7,x7 any salt1 ester1 ether1 or substituted analogue of a drug or other substance described in subclauses 7,i7 through 7,,ix74 7,b7 ,a substance excluded under subparagraph 7,a77i7 may at any time be scheduled by the ,attorney ,general in accordance with the authority and requirements under subsections 7a7 through 7c7 of section #bja4 7,c7 7i7 ,a drug or other substance 7other than estrogens1 progestins1 corticosteroids1 and dehydroepiandrosterone1 unless scheduled under subparagraph 7,b77 that is not listed in subparagraph 7,a77ii7 and is derived from1 or has a chemical structure substantially similar to1 one or more ,s,a,r,ms listed in subparagraph 7,a77ii7 shall be considered to be a ,,sarm for purposes of this title if the drug or other substance-- 7,i7 has been created or manufactured with the intent of producing a drug or other substance that-- 7aa7 promotes muscle growth2 or 7bb7 otherwise causes a pharmacological effect similar to that of testosterone2 or 7,,ii7 has been1 or is intended to be1 marketed or otherwise promoted in any manner suggesting that consuming the drug or other substance will promote muscle growth or any other pharmacological effect similar to that of testosterone4 7ii7 ,a drug or other substance shall not be considered to be a ,,sarm for purposes of this subparagraph if the drug or other substance-- 7,i7 is-- 7aa7 an herb or other botanical2 7bb7 a concentrate1 metabolite1 or extract of1 or a constituent isolated directly from1 an herb or other botanical2 or 7cc7 a combination of two or more substances described in item 7aa7 or 7bb72 7,,ii7 is a dietary ingredient for purposes of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq472 and 7,,iii7 is not anabolic or androgenic4 7iii7 ,in accordance with section #eae7;a71 any person claiming the benefit of an exemption or exception under clause 7ii7 shall bear the burden of going forward with the evidence with respect to that exemption or exception4 4 7b7 ,amendment to schedule ,,iii ,schedule ,,iii in section #bjb7;c7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hab7;c77 is amended by adding at the end the following3 7f7 ,s,a,r,ms4 4 7c7 ,temporary and permanent scheduling of recently emerged ,s,a,r,ms ,section #bja of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #haa7 is amended by adding at the end the following3 7k7 ,temporary and permanent scheduling of recently emerged ,s,a,r,ms 7#a7 ,temporary orders 7,a7 ,in general ,the ,attorney ,general may issue a temporary order adding a drug or other substance to the definition of the term ,,sarm under section #ajb7fj7 if the ,attorney ,general finds that-- 7i7 the drug or other substance satisfies the criteria for being considered a ,,sarm but is not listed in that section or by regulation of the ,attorney ,general as being a ,,sarm2 and 7ii7 adding the drug or other substance to the definition of the term ,,sarm will assist in preventing abuse or misuse of the drug or other substance4 7,b7 ,effective date2 duration ,a temporary order issued under subparagraph 7,a7-- 7i7 shall take effect not earlier than #cj days after the date of publication by the ,attorney ,general of a notice in the ,federal ,register of-- 7,i7 the intention of the ,attorney ,general to issue the temporary order2 and 7,,ii7 the grounds on which the temporary order is to be issued2 and 7ii7 shall expire not later than #b years after the date on which the temporary order becomes effective1 except that the ,attorney ,general may1 during the pendency of proceedings under paragraph 7#b71 extend the temporary order for not more than #f months4 7,c7 ,notice to ,secretary 7i7 ,in general ,the ,attorney ,general shall transmit notice of a temporary order proposed to be issued under subparagraph 7,a7 to the ,secretary4 7ii7 ,consideration ,in issuing a temporary order under subparagraph 7,a71 the ,attorney ,general shall take into consideration any comments submitted by the ,secretary in response to a notice transmitted under this subparagraph4 7,d7 ,effect of permanent scheduling ,a temporary order issued under subparagraph 7,a7 shall be vacated upon the issuance of a permanent order under paragraph 7#b74 7,e7 ,judicial review ,a temporary order issued under subparagraph 7,a7 shall not be subject to judicial review4 7#b7 ,permanent orders 7,a7 ,in general ,the ,attorney ,general may by rule issue a permanent order adding a drug or other substance to the definition of the term ,,sarm under section #ajb7fj7 if the drug or other substance satisfies the criteria for being considered a ,,sarm under that section4 7,b7 ,timing ,the ,attorney ,general may commence a rulemaking under subparagraph 7,a7 simultaneously with the issuance of a temporary order under paragraph 7#a74 4 7d7 ,labeling requirements 7#a7 ,in general ,section #cje of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbe7 is amended by adding at the end the following3 7f7 ,false labeling of ,s,a,r,ms 7#a7 ,prohibition ,it shall be unlawful to import1 export1 manufacture1 distribute1 dispense1 or possess with intent to manufacture1 distribute1 or dispense1 a ,,sarm or product containing a ,,sarm1 unless the ,,sarm or product containing the ,,sarm bears a label clearly identifying the ,,sarm or product containing the ,,sarm by the nomenclature used by the ,international ,union of ,pure and ,applied ,chemistry4 7#b7 ,exemption 7,a7 ,in general ,a ,,sarm or product containing a ,,sarm described in subparagraph 7,b7 shall be exempt from the ,international ,union of ,pure and ,applied ,chemistry nomenclature requirement under paragraph 7#a7 if the ,,sarm or product containing a ,,sarm is labeled in the manner required under the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq474 7,b7 ,exempt products ,a ,,sarm or product containing a ,,sarm is described in this subparagraph if the ,,sarm or product containing a ,,sarm-- 7i7 is the subject of an approved application as described in subsection 7b7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee72 or 7ii7 is exempt from the provisions of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 relating to new drugs because-- 7,i7 the ,,sarm or product containing a ,,sarm is intended solely for investigational use as described in subsection 7i7 of that section2 and 7,,ii7 the ,,sarm or product containing a ,,sarm is being used exclusively for purposes of a clinical trial that is the subject of an effective investigational new drug application4 4 7#b7 ,clarification regarding felony drug offenses ,section #ajb7dd7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hjb7dd77 is amended by inserting ,s,a,r,ms1 after anabolic steroids14 7#c7 ,civil penalties ,section #djb of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hdb7 is amended-- 7,a7 in subsection 7a77#af7-- 7i7 by inserting or 7f7 after subsection 7e72 and 7ii7 by striking #hbe and inserting #cje2 and 7,b7 in subsection 7c77#a77;,d71 by inserting or a ,,sarm after an anabolic steroid4 #c4 ,amendments to the ,federal ,food1 ,drug1 and ,cosmetic ,act ,section #dac7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cej;b7c77 is amended-- 7#a7 in paragraph 7#a71 by striking an anabolic steroid or an analogue of an anabolic steroid and inserting an anabolic steroid1 a ,,sarm1 an analogue of an anabolic steroid1 or an analogue of a ,,sarm2 and 7#b7 in paragraph 7#b7-- 7,a7 in subparagraph 7,a71 by striking and at the end2 7,b7 in subparagraph 7,b71 by striking the period at the end and inserting a semicolon2 and 7,c7 by adding at the end the following3 7,c7 the term analogue of a ,,sarm means a substance that has a chemical structure that is substantially similar to the chemical structure of a ,,sarm2 and 7,d7 the term ,,sarm has the meaning given the term in section #ajb7fj7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hjb7fj774 4