,,ii #aaeth ,,congress #ast ,session ,s4 #acbg ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,june #h1 #bjag,mr4 ,grassley 7for himself and ,mrs4 ,feinstein7 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 clarify how controlled substance analogues are to be regulated1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,stop the ,importation and ,trafficking of ,synthetic ,analogues ,act of #bjag or the ,,sitsa ,act4 #b4 ,establishment of ,schedule ,a ,section #bjb of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hab7 is amended-- 7#a7 in subsection 7a71 by striking five schedules of controlled substances1 to be known as schedules ,i1 ,,ii1 ,,iii1 ,,iv1 and ,v and inserting six schedules of controlled substances1 to be known as schedules ,i1 ,,ii1 ,,iii1 ,,iv1 ,v1 and ,a2 7#b7 in subsection 7b71 by adding at the end the following3 7#f7 ,schedule ,a 7,a7 ,in general ,the drug or substance-- 7i7 has-- 7,i7 a chemical structure that is substantially similar to the chemical structure of a controlled substance in schedule ,i1 ,,ii1 ,,iii1 ,,iv1 or ,v2 and 7,,ii7 an actual or predicted stimulant1 depressant1 or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the stimulant1 depressant1 or hallucinogenic effect on the central nervous system of a controlled substance in schedule ,i1 ,,ii1 ,,iii1 ,,iv1 or ,v2 and 7ii7 is not-- 7,i7 listed or otherwise included in any other schedule in this section or by regulation of the ,attorney ,general2 and 7,,ii7 with respect to a particular person1 subject to an exemption that is in effect for investigational use1 for that person1 under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 to the extent conduct with respect to such substance is pursuant to such exemption4 7,b7 ,predicted stimulant1 depressant1 or hallucinogenic effect ,for purpose of this paragraph1 a predicted stimulant1 depressant1 or hallucinogenic effect on the central nervous system may be based on-- 7i7 the chemical structure1 structure activity relationships1 binding receptor assays1 or other relevant scientific information about the substance2 7ii7 7,i7 the current or relative potential for abuse of the substance2 and 7,,ii7 the clandestine importation1 manufacture1 or distribution1 or diversion from legitimate channels1 of the substance2 or 7iii7 the capacity of the substance to cause a state of dependence1 including physical or psychological dependence that is similar to or greater than that of a controlled substance in schedule ,i1 ,,ii1 ,,iii1 ,,iv1 or ,v4 2 and 7#c7 in subsection 7c7-- 7,a7 in the matter preceding schedule ,i1 by striking ,,iv1 and ,v and inserting ,,iv1 ,v1 and ,a2 and 7,b7 by adding at the end the following3 ,schedule ,a 7a7 ,unless specifically excepted or unless listed in another schedule1 any of the following substances1 as scheduled in accordance with section #bja7k77#e73 7#a7 #d-;fluoroisobutyryl fentanyl4 7#b7 ,valeryl fentanyl4 7#c7 #d-methoxybutyryl fentanyl4 7#d7 #d-methylphenethyl acetyl fentanyl4 7#e7 #c-;furanyl fentanyl4 7#f7 ,ortho-fluorofentanyl4 7#g7 ,tetrahydrofuranyl fentanyl4 7#h7 ,ocfentanil4 7#i7 #d-;fluorobutyryl fentanyl4 7#aj7 ,methoxyacetyl fentanyl4 7#aa7 ,meta-fluorofentanyl4 7#ab7 ,isobutyryl fentanyl4 7#ac7 ,acryl fentanyl4 4 #c4 ,temporary and permanent scheduling of schedule ,a substances ,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 schedule ,a substances 7#a7 ,the ,attorney ,general may issue a temporary order adding a drug or substance to schedule ,a if the ,attorney ,general finds that-- 7,a7 the drug or other substance satisfies the criteria for being considered a schedule ,a substance2 and 7,b7 adding such drug or substance to schedule ,a will assist in preventing abuse or misuse of the drug or other substance4 7#b7 ,a temporary scheduling order issued under paragraph 7#a7 shall not take effect until #cj days after the date of the publication by the ,attorney ,general of a notice in the ,federal ,register of the intention to issue such order and the grounds upon which such order is to be issued4 ,the temporary scheduling order shall expire not later than #e years after the date it becomes effective1 except that the ,attorney ,general may1 during the pendency of proceedings under paragraph 7#e71 extend the temporary scheduling order for up to #ahj days4 7#c7 ,a temporary scheduling order issued under paragraph 7#a7 shall be vacated upon the issuance of a permanent order issued under paragraph 7#e7 with regard to the same substance1 or upon the subsequent issuance of any scheduling order under this section4 7#d7 ,a temporary scheduling order issued under paragraph 7#a7 shall not be subject to judicial review4 7#e7 ,the ,attorney ,general may1 by rule1 issue a permanent order adding a drug or other substance to schedule ,a if such drug or substance satisfies the criteria for being considered a schedule ,a substance4 ,such rulemaking may be commenced simultaneously with the issuance of the temporary scheduling order issued under paragraph 7#a7 with regard to the same substance4 7#f7 ,before initiating proceedings under paragraph 7#a7 or 7#e71 the ,attorney ,general shall transmit notice of an order proposed to be issued to the ,secretary of ,health and ,human ,services4 ,in issuing an order under paragraph 7#a7 or 7#e71 the ,attorney ,general shall take into consideration any comments submitted by the ,secretary of ,health and ,human ,services in response to a notice transmitted pursuant to this paragraph4 4 #d4 ,penalties 7a7 ,controlled ,substances ,act ,the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hja et seq47 is amended-- 7#a7 in section #dja7;b77#a7 7#ba ,u4,s4,c4 #hda7;b77#a771 by adding at the end the following3 7,f7 7i7 ,in the case of any controlled substance in schedule ,a1 such person shall be sentenced to a term of imprisonment of not more than #aj years and if death or serious bodily injury results from the use of such substance shall be sentenced to a term of imprisonment of not more than #ae years1 a fine not to exceed the greater of that authorized in accordance with the provisions of title #ah1 ,united ,states ,code1 or #ejj1jjj if the defendant is an individual or #b1ejj1jjj if the defendant is other than an individual1 or both4 7ii7 ,if any person commits such a violation after a prior conviction for a felony drug offense has become final1 such person shall be sentenced to a term of imprisonment of not more than #bj years and if death or serious bodily injury results from the use of such substance shall be sentenced to a term of imprisonment of not more than #cj years1 a fine not to exceed the greater of twice that authorized in accordance with the provisions of title #ah1 ,united ,states ,code1 or #a1jjj1jjj if the defendant is an individual or #e1jjj1jjj if the defendant is other than an individual1 or both4 7iii7 ,any sentence imposing a term of imprisonment under this subparagraph shall1 in the absence of such a prior conviction1 impose a term of supervised release of not less than #b years in addition to such term of imprisonment and shall1 if there was such a prior conviction1 impose a term of supervised release of not less than #d years in addition to such term of imprisonment4 2 7#b7 in section #djc7;a7 7#ba ,u4,s4,c4 #hdc7;a77-- 7,a7 in paragraph 7#h71 by striking or at the end2 7,b7 in paragraph 7#i71 by striking the period at the end and inserting 2 or2 and 7,c7 by inserting after paragraph 7#i7 the following3 7#aj7 to export a substance in violation of the controlled substance laws of the country to which the substance is exported4 2 and 7#c7 in section #djd 7#ba ,u4,s4,c4 #hdd71 by inserting after subsection 7a7 the following3 7b7 ,a person shall not be subject to a criminal or civil penalty under this title or under any other ,federal law solely for possession of a schedule ,a controlled substance4 4 7b7 ,controlled ,substances ,import and ,export ,act ,section #ajaj7;b7 of the ,controlled ,substances ,import and ,export ,act 7#ba ,u4,s4,c4 #ifj7;b77 is amended by adding at the end the following3 7#h7 ,in the case of a violation under subsection 7a7 involving a controlled substance in schedule ,a1 the person committing such violation shall be sentenced to a term of imprisonment of not more than #bj years and if death or serious bodily injury results from the use of such substance shall be sentenced to a term of imprisonment for any term of years or for life1 a fine not to exceed the greater of that authorized in accordance with the provisions of title #ah1 ,united ,states ,code1 or #a1jjj1jjj if the defendant is an individual or #e1jjj1jjj if the defendant is other than an individual1 or both4 ,if any person commits such a violation after a prior conviction for a felony drug offense has become final1 such person shall be sentenced to a term of imprisonment of not more than #cj years and if death or serious bodily injury results from the use of such substance shall be sentenced to a term of imprisonment for any term of years or for life1 a fine not to exceed the greater of twice that authorized in accordance with the provisions of title #ah1 ,united ,states ,code1 or #b1jjj1jjj if the defendant is an individual or #aj1jjj1jjj if the defendant is other than an individual1 or both4 ,notwithstanding section #cehc of title #ah1 ,united ,states ,code1 any sentence imposing a term of imprisonment under this paragraph shall1 in the absence of such a prior conviction1 impose a term of supervised release of not less than #c years in addition to such term of imprisonment and shall1 if there was such a prior conviction1 impose a term of supervised release of not less than #f years in addition to such term of imprisonment4 ,notwithstanding the prior sentence1 and notwithstanding any other provision of law1 the court shall not place on probation or suspend the sentence of any person sentenced under the provisions of this paragraph which provide for a mandatory term of imprisonment if death or serious bodily injury results4 4 #e4 ,false labeling of schedule ,a controlled substances 7a7 ,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 schedule ,a controlled substances 7#a7 ,it shall be unlawful to import1 export1 manufacture1 distribute1 dispense1 or possess with intent to manufacture1 distribute1 or dispense1 a schedule ,a substance or product containing a schedule ,a substance1 unless the substance or product bears a label clearly identifying a schedule ,a substance or product containing a schedule ,a substance by the nomenclature used by the ,international ,union of ,pure and ,applied ,chemistry 7,,iupac74 7#b7 7,a7 ,a product described in subparagraph 7,b7 is exempt from the ,international ,union of ,pure and ,applied ,chemistry nomenclature requirement of this subsection if such product is labeled in the manner required under the ,federal ,food1 ,drug1 and ,cosmetic ,act4 7,b7 ,a product is described in this subparagraph if the product-- 7i7 is the subject of an approved application as described in section #eje7;b7 or 7j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 or 7ii7 is exempt from the provisions of section #eje of such ,act relating to new drugs because-- 7,i7 it is intended solely for investigational use as described in section #eje7;i7 of such ,act2 and 7,,ii7 such product is being used exclusively for purposes of a clinical trial that is the subject of an effective investigational new drug application4 4 7b7 ,penalties ,section #djb of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hdb7 is amended-- 7#a7 in subsection 7a77#af71 by inserting or subsection 7f7 after subsection 7e72 and 7#b7 in subsection 7c77#a77;,d71 by inserting or a schedule ,a substance after anabolic steroid4 #f4 ,registration requirements for handlers of schedule ,a substances 7a7 ,controlled ,substances ,act ,section #cjc of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc7 is amended-- 7#a7 in subsection 7f71 in the undesignated matter following paragraph 7#e7-- 7,a7 by inserting or ,a after schedule ,i each place it appears2 and 7,b7 by adding at the end the following3 ,a separate registration for engaging in research with a controlled substance in schedule ,a for practitioners already registered under this part to engage in research with controlled substances in schedule ,i shall not be required4 ,the ,secretary shall determine the merits of the research protocol submitted by the practitioner registering to engage in research with a controlled substance in schedule ,a1 and the ,attorney ,general may deny or revoke the registration only on a ground specified in section #cjd42 and 7#b7 by adding at the end the following3 7k7 7#a7 ,the ,attorney ,general shall register an applicant to manufacture schedule ,a substances if-- 7,a7 the applicant demonstrates that the schedule ,a substances will be used for research1 analytical1 or industrial purposes approved by the ,attorney ,general2 and 7,b7 the ,attorney ,general determines that such registration is consistent with the public interest and with the ,united ,states obligations under international treaties1 conventions1 or protocols in effect on the date of enactment of this subsection4 7#b7 ,in determining the public interest under paragraph 7#a77;,b71 the ,attorney ,general shall consider-- 7,a7 maintenance of effective controls against diversion of particular controlled substances and any controlled substance in schedule ,a compounded therefrom into other than legitimate medical1 scientific1 research1 or industrial channels1 by limiting the importation and bulk manufacture of such controlled substances to a number of establishments which can produce an adequate and uninterrupted supply of these substances under adequately competitive conditions for legitimate medical1 scientific1 research1 and industrial purposes2 7,b7 compliance with applicable ,state and local law2 7,c7 promotion of technical advances in the art of manufacturing substances described in subparagraph 7,a7 and the development of new substances2 7,d7 prior conviction record of applicant under ,federal and ,state laws relating to the manufacture1 distribution1 or dispensing of substances described in paragraph 7,a72 7,e7 past experience in the manufacture of controlled substances1 and the existence in the establishment of effective control against diversion2 and 7,f7 such other factors as may be relevant to and consistent with the public health and safety4 7#c7 ,if an applicant is registered to manufacture controlled substances in schedule ,i or ,,ii under subsection 7a71 the applicant shall not be required to apply for a separate registration under this subsection4 7l7 7#a7 ,the ,attorney ,general shall register an applicant to distribute schedule ,a substances-- 7,a7 if the applicant demonstrates that the schedule ,a substances will be used for research1 analytical1 or industrial purposes approved by the ,attorney ,general2 and 7,b7 unless the ,attorney ,general determines that the issuance of such registration is inconsistent with the public interest4 7#b7 ,in determining the public interest under paragraph 7#a77;,b71 the ,attorney ,general shall consider-- 7,a7 maintenance of effective control against diversion of particular controlled substances into other than legitimate medical1 scientific1 and industrial channels2 7,b7 compliance with applicable ,state and local law2 7,c7 prior conviction record of applicant under ,federal or ,state laws relating to the manufacture1 distribution1 or dispensing of substances described in subparagraph 7,a72 7,d7 past experience in the distribution of controlled substances2 and 7,e7 such other factors as may be relevant to and consistent with the public health and safety4 7#c7 ,if an applicant is registered to distribute a controlled substance in schedule ,i or ,,ii under subsection 7b71 the applicant shall not be required to apply for a separate registration under this subsection4 7m7 7#a7 ,not later than #ij days after the date on which a substance is placed in schedule ,a1 any practitioner who was engaged in research on the substance before the placement of the substance in schedule ,a and any manufacturer or distributor who was handling the substance before the placement of the substance in schedule ,a shall register with the ,attorney ,general4 7#b7 7,a7 ,not later than #fj days after the date on which the ,attorney ,general receives an application for registration to conduct research on a schedule ,a substance1 the ,attorney ,general shall-- 7i7 grant1 or initiate proceedings under section #cjd7;c7 to deny1 the application2 or 7ii7 request supplemental information from the applicant4 7,b7 ,not later than #cj days after the date on which the ,attorney ,general receives supplemental information requested under subparagraph 7,a77ii7 in connection with an application described in subparagraph 7,a71 the ,attorney ,general shall grant or deny the application4 4 7b7 ,controlled ,substances ,import and ,export ,act ,section #ajjh of the ,controlled ,substances ,import and ,export ,act 7#ba ,u4,s4,c4 #ieh7 is amended by adding at the end the following3 7j7 7#a7 ,the ,attorney ,general shall register an applicant to import or export a schedule ,a substance if-- 7,a7 the applicant demonstrates that the schedule ,a substances will be used for research1 analytical1 or industrial purposes approved by the ,attorney ,general2 and 7,b7 the ,attorney ,general determines that such registration is consistent with the public interest and with the ,united ,states obligations under international treaties1 conventions1 or protocols in effect on the date of enactment of this subsection4 7#b7 ,in determining the public interest under paragraph 7#a77;,b71 the ,attorney ,general shall consider the factors described in subparagraphs 7,a7 through 7,f7 of section #cjc7k77#b74 7#c7 ,if an applicant is registered to import or export a controlled substance in schedule ,i or ,,ii under subsection 7a71 the applicant shall not be required to apply for a separate registration under this subsection4 4 #g4 ,additional conforming amendments 7a7 ,controlled ,substances ,act ,the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hja et seq47 is amended-- 7#a7 in section #cjc7;c7 7#ba ,u4,s4,c4 #hbc7;c77-- 7,a7 by striking subsections 7a7 and 7b7 and inserting subsection 7a71 7b71 7k71 or 7l72 and 7,b7 by striking schedule ,i or ,,ii and inserting schedule ,i1 ,,ii1 or ,a2 7#b7 in section #cjf 7#ba ,u4,s4,c4 #hbf7-- 7,a7 in subsection 7a71 in the first sentence1 by striking schedules ,i and ,,ii and inserting schedules ,i1 ,,ii1 and ,a2 7,b7 in subsection 7b71 in the second sentence1 by striking schedule ,i or ,,ii and inserting schedule ,i1 ,,ii1 or ,a2 7,c7 in subsection 7c71 in the first sentence1 by striking schedules ,i and ,,ii and inserting schedules ,i1 ,,ii1 and ,a2 7,d7 in subsection 7d71 in the first sentence1 by striking schedule ,i or ,,ii and inserting schedule ,i1 ,,ii1 or ,a2 7,e7 in subsection 7e71 in the first sentence1 by striking schedule ,i or ,,ii and inserting schedule ,i1 ,,ii1 or ,a2 and 7,f7 in subsection 7f71 in the first sentence1 by striking schedules ,i and ,,ii and inserting schedules ,i1 ,,ii1 and ,a2 7#c7 in section #cjh7;a7 7#ba ,u4,s4,c4 #hbh7;a771 by striking schedule ,i or ,,ii and inserting schedule ,i1 ,,ii1 or ,a2 7#d7 in section #djb7;b7 7#ba ,u4,s4,c4 #hdb7;b771 in the matter preceding paragraph 7#a71 by striking schedule ,i or ,,ii and inserting schedule ,i1 ,,ii1 or ,a2 7#e7 in section #djc7;a77#a7 7#ba ,u4,s4,c4 #hdc7;a77#a771 by striking schedule ,i or ,,ii and inserting schedule ,i1 ,,ii1 or ,a2 and 7#f7 in section #eaa7;f7 7#ba ,u4,s4,c4 #hha7;f771 by striking schedule ,i or ,,ii each place it appears and inserting schedule ,i1 ,,ii1 or ,a4 7b7 ,controlled ,substances ,import ,export ,act ,the ,controlled ,substances ,import and ,export ,act 7#ba ,u4,s4,c4 #iea et seq47 is amended-- 7#a7 in section #ajjb7;a7 7#ba ,u4,s4,c4 #ieb7;a77-- 7,a7 in the matter preceding paragraph 7#a71 by striking schedule ,i or ,,ii and inserting schedule ,i1 ,,ii1 or ,a2 and 7,b7 in paragraph 7#b71 by striking schedule ,i or ,,ii and inserting schedule ,i1 ,,ii1 or ,a2 7#b7 in section #ajjc 7#ba ,u4,s4,c4 #iec7-- 7,a7 in subsection 7c71 in the matter preceding paragraph 7#a71 by striking schedule ,i or ,,ii and inserting schedule ,i1 ,,ii1 or ,a2 and 7,b7 in subsection 7d71 by striking schedule ,i or ,,ii and inserting schedule ,i1 ,,ii1 or ,a2 7#c7 in section #ajjd7a7 7#ba ,u4,s4,c4 #ied7a771 by striking schedule ,i and inserting schedule ,i or ,a2 7#d7 in section #ajje 7#ba ,u4,s4,c4 #iee71 by striking schedule ,i or ,,ii and inserting schedule ,i1 ,,ii1 or ,a2 and 7#e7 in section #ajji7;a7 7#ba ,u4,s4,c4 #iei7;a771 by striking schedule ,i or ,,ii and inserting schedule ,i1 ,,ii1 or ,a4 #h4 ,clarification of the definition of controlled substance analogue under the ,analogue ,enforcement ,act ,section #ajb of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hjb7 is amended-- 7#a7 in paragraph 7#f71 by striking or ,v and inserting ,v1 or ,a2 7#b7 in paragraph 7#ad7-- 7,a7 by striking schedule ,i7c7 and and inserting schedule ,i7c71 schedule ,a1 and2 and 7,b7 by striking schedule ,i7c71 and inserting schedule ,i7c7 and schedule ,a12 and 7#c7 in paragraph 7#cb77;,a71 by striking 7#cb77;,a7 and all that follows through clause 7iii7 and inserting the following3 7#cb7 7,a7 ,except as provided in subparagraph 7,c71 the term controlled substance analogue means a substance whose chemical structure is substantially similar to the chemical structure of a controlled substance in schedule ,i or ,,ii-- 7i7 which has a stimulant1 depressant1 or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the stimulant1 depressant1 or hallucinogenic effect on the central nervous system of a controlled substance in schedule ,i or ,,ii2 or 7ii7 with respect to a particular person1 which such person represents or intends to have a stimulant1 depressant1 or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the stimulant1 depressant1 or hallucinogenic effect on the central nervous system of a controlled substance in schedule ,i or ,,ii4 4 #i4 ,rules of construction ,nothing in this ,act1 or the amendments made by this ,act1 may be construed to limit-- 7#a7 the prosecution of offenses involving controlled substance analogues under the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hja et seq472 or 7#b7 the authority of the ,attorney ,general to temporarily or permanently schedule1 reschedule1 or decontrol controlled substances under provisions of section #bja of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #haa7 that are in effect on the day before the date of enactment of this ,act4