SIMSA

I 116TH CONGRESS 1ST SESSION H. R. 4963 To amend the Controlled Substances Act to clarify how controlled substance analogues that are imported or offered for import are to be regulated, and for other purposes. IN THE HOUSE OF REPRESENTATIVES OCTOBER 31, 2019 Mr. KATKO (for himself, Miss RICE of New York, Mr. WALDEN, Mr. CORREA, and Mr. SOTO) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned A BILL To amend the Controlled Substances Act to clarify how con- trolled substance analogues that are imported or offered for import are to be regulated, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 3 (a) SHORT TITLE.—This Act may be cited as the 4 ‘‘Stop the Importation and Manufacturing of Synthetic 5 Analogues Act of 2019’’ or ‘‘SIMSA’’. 6 VerDate Sep 11 2014 19:24 Nov 10, 2019 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H4963.IH H4963 pamtmann on DSKBC07HB2PROD with BILLS 2 •HR 4963 IH (b) TABLE OF CONTENTS.—The table of contents of 1 this Act is as follows: 2 Sec. 1. Short title; table of contents. Sec. 2. Establishment of schedule A. Sec. 3. Temporary and permanent scheduling of schedule A substances. Sec. 4. Penalties. Sec. 5. False labeling of schedule A controlled substances. Sec. 6. Registration requirements for importers and exporters of schedule A substances. Sec. 7. Additional conforming amendments. Sec. 8. Sentencing review. Sec. 9. Rules of construction. SEC. 2. ESTABLISHMENT OF SCHEDULE A. 3 Section 202 of the Controlled Substances Act (21 4 U.S.C. 812) is amended— 5 (1) in subsection (a), by striking ‘‘five schedules 6 of controlled substances, to be known as schedules I, 7 II, III, IV, and V’’ and inserting ‘‘six schedules of 8 controlled substances, to be known as schedules I, 9 II, III, IV, V, and A’’; 10 (2) in subsection (b), by adding at the end the 11 following: 12 ‘‘(6) SCHEDULE A.— 13 ‘‘(A) IN GENERAL.—The drug or substance— 14 ‘‘(i) is or has been imported, or is offered 15 for import, into the United States; 16 ‘‘(ii) has— 17 ‘‘(I) a chemical structure that is sub- 18 stantially similar to the chemical structure 19 VerDate Sep 11 2014 19:24 Nov 10, 2019 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4963.IH H4963 pamtmann on DSKBC07HB2PROD with BILLS 3 •HR 4963 IH of a controlled substance in schedule I, II, 1 III, IV, or V; and 2 ‘‘(II) an actual or predicted stimulant, 3 depressant, or hallucinogenic effect on the 4 central nervous system that is substantially 5 similar to or greater than the stimulant, 6 depressant, or hallucinogenic effect on the 7 central nervous system of a controlled sub- 8 stance in schedule I, II, III, IV, or V; and 9 ‘‘(iii) is not— 10 ‘‘(I) listed or otherwise included in 11 any other schedule in this section or by 12 regulation of the Attorney General; and 13 ‘‘(II) with respect to a particular per- 14 son, subject to an exemption that is in ef- 15 fect for investigational use, for that person, 16 under section 505 of the Federal Food, 17 Drug, and Cosmetic Act (21 U.S.C. 355) 18 to the extent conduct with respect to such 19 substance is pursuant to such exemption. 20 ‘‘(B) PREDICTED STIMULANT, DEPRESSANT, OR 21 HALLUCINOGENIC EFFECT.—For purposes of this 22 paragraph, a predicted stimulant, depressant, or hal- 23 lucinogenic effect on the central nervous system may 24 be based on— 25 VerDate Sep 11 2014 19:24 Nov 10, 2019 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H4963.IH H4963 pamtmann on DSKBC07HB2PROD with BILLS 4 •HR 4963 IH ‘‘(i)(I) the chemical structure; and 1 ‘‘(II)(aa) the structure activity relation- 2 ships; or 3 ‘‘(bb) binding receptor assays and other 4 relevant scientific information about the sub- 5 stance; 6 ‘‘(ii)(I) the current or relative potential for 7 abuse of the substance; and 8 ‘‘(II) the clandestine importation, manu- 9 facture, or distribution, or diversion from legiti- 10 mate channels, of the substance; or 11 ‘‘(iii) the capacity of the substance to 12 cause a state of dependence, including physical 13 or psychological dependence that is similar to or 14 greater than that of a controlled substance in 15 schedule I, II, III, IV, or V.’’; and 16 (3) in subsection (c)— 17 (A) in the matter preceding schedule I, by 18 striking ‘‘IV, and V’’ and inserting ‘‘IV, V, and 19 A’’; and 20 (B) by adding at the end the following: 21 ‘‘SCHEDULE A 22 ‘‘Any substance temporarily or permanently sched- 23 uled by the Attorney General in accordance with section 24 201(k).’’. 25 VerDate Sep 11 2014 19:24 Nov 10, 2019 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H4963.IH H4963 pamtmann on DSKBC07HB2PROD with BILLS 5 •HR 4963 IH SEC. 3. TEMPORARY AND PERMANENT SCHEDULING OF 1 SCHEDULE A SUBSTANCES. 2 Section 201 of the Controlled Substances Act (21 3 U.S.C. 811) is amended by adding at the end the fol- 4 lowing: 5 ‘‘(k) TEMPORARY AND PERMANENT SCHEDULING OF 6 SCHEDULE A SUBSTANCES.— 7 ‘‘(1) IN GENERAL.—The Attorney General may 8 issue a temporary order adding a drug or substance 9 to schedule A if the Attorney General finds that— 10 ‘‘(A) the drug or other substance satisfies 11 the criteria for being considered a schedule A 12 substance; and 13 ‘‘(B) adding such drug or substance to 14 schedule A will assist in preventing abuse of the 15 drug or other substance. 16 ‘‘(2) DURATION OF TEMPORARY SCHEDULING 17 ORDER.—A temporary scheduling order issued under 18 paragraph (1) shall— 19 ‘‘(A) not take effect until 30 days after the 20 date of the publication by the Attorney General 21 of a notice in the Federal Register of the inten- 22 tion to issue such order and the grounds upon 23 which such order is to be issued; and 24 ‘‘(B) expire not later than 5 years after 25 the date on which the order becomes effective, 26 VerDate Sep 11 2014 19:24 Nov 10, 2019 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H4963.IH H4963 pamtmann on DSKBC07HB2PROD with BILLS 6 •HR 4963 IH except that the Attorney General may, during 1 the pendency of proceedings under paragraph 2 (5), extend the temporary scheduling order for 3 up to 180 days. 4 ‘‘(3) EFFECT OF ISSUANCE OF PERMANENT 5 SCHEDULING ORDER.—A temporary scheduling 6 order issued under paragraph (1) shall be vacated 7 upon the issuance of a permanent order issued 8 under paragraph (5) with regard to the same sub- 9 stance, or upon the subsequent issuance of any 10 scheduling order under this section. 11 ‘‘(4) LIMITATION ON JUDICIAL REVIEW.—A 12 temporary scheduling order issued under paragraph 13 (1) shall not be subject to judicial review. 14 ‘‘(5) PERMANENT SCHEDULING ORDER.— 15 ‘‘(A) IN GENERAL.—Except as provided in 16 subparagraph (B), not earlier than 3 years 17 after the date on which the Attorney General 18 issues an order temporarily scheduling a drug 19 or substance under this subsection, the Attor- 20 ney General may, by rule, issue a permanent 21 order adding the drug or other substance to 22 schedule A if such drug or substance satisfies 23 the criteria for being considered a schedule A 24 substance. 25 VerDate Sep 11 2014 19:24 Nov 10, 2019 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H4963.IH H4963 pamtmann on DSKBC07HB2PROD with BILLS 7 •HR 4963 IH ‘‘(B) LIMITATION.—If the Secretary of 1 Health and Human Services has determined, 2 based on relevant scientific studies and nec- 3 essary data requested by the Secretary of 4 Health and Human Services and gathered by 5 the Attorney General, that a drug or other sub- 6 stance that has been temporarily placed in 7 schedule A does not have sufficient potential for 8 abuse to warrant control in any schedule, and 9 provides written notice of such determination to 10 the Attorney General, the Attorney General— 11 ‘‘(i) may not issue a permanent sched- 12 uling order under subparagraph (A); and 13 ‘‘(ii) not later than 30 days after the 14 date on which the Attorney General re- 15 ceives such notice, shall issue an order im- 16 mediately terminating the temporary 17 scheduling order for the drug or other sub- 18 stance. 19 ‘‘(6) NOTICE TO HHS.—Before initiating pro- 20 ceedings under paragraph (1), the Attorney General 21 shall transmit notice of a temporary order proposed 22 to be issued to the Secretary of Health and Human 23 Services. In issuing an order under paragraph (1), 24 the Attorney General shall take into consideration 25 VerDate Sep 11 2014 19:24 Nov 10, 2019 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H4963.IH H4963 pamtmann on DSKBC07HB2PROD with BILLS 8 •HR 4963 IH any comments submitted by the Secretary of Health 1 and Human Services in response to a notice trans- 2 mitted pursuant to this paragraph.’’. 3 SEC. 4. PENALTIES. 4 Section 1010 of the Controlled Substances Import 5 and Export Act (21 U.S.C. 960) is amended— 6 (1) in subsection (a), by inserting ‘‘or a drug or 7 substance in schedule A’’ after ‘‘controlled sub- 8 stance’’ each place it appears; and 9 (2) in subsection (b), by adding at the end the 10 following: 11 ‘‘(8) In the case of a violation under subsection (a) 12 involving a controlled substance in schedule A, the person 13 committing such violation shall be sentenced to a term of 14 imprisonment of not more than 20 years and if death or 15 serious bodily injury results from the use of such sub- 16 stance shall be sentenced to a term of imprisonment for 17 any term of years or for life, a fine not to exceed the great- 18 er of that authorized in accordance with the provisions of 19 title 18, United States Code, or $1,000,000 if the defend- 20 ant is an individual or $5,000,000 if the defendant is other 21 than an individual, or both. If any person commits such 22 a violation after a prior conviction for a felony drug of- 23 fense has become final, such person shall be sentenced to 24 a term of imprisonment of not more than 30 years and 25 VerDate Sep 11 2014 19:24 Nov 10, 2019 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H4963.IH H4963 pamtmann on DSKBC07HB2PROD with BILLS 9 •HR 4963 IH if death or serious bodily injury results from the use of 1 such substance shall be sentenced to a term of imprison- 2 ment for any term of years or for life, a fine not to exceed 3 the greater of twice that authorized in accordance with 4 the provisions of title 18, United States Code, or 5 $2,000,000 if the defendant is an individual or 6 $10,000,000 if the defendant is other than an individual, 7 or both. Notwithstanding section 3583 of title 18, United 8 States Code, any sentence imposing a term of imprison- 9 ment under this paragraph shall, in the absence of such 10 a prior conviction, impose a term of supervised release of 11 not less than 3 years in addition to such term of imprison- 12 ment and shall, if there was such a prior conviction, im- 13 pose a term of supervised release of not less than 6 years 14 in addition to such term of imprisonment. Notwith- 15 standing the prior sentence, and notwithstanding any 16 other provision of law, the court shall not place on proba- 17 tion or suspend the sentence of any person sentenced 18 under the provisions of this paragraph which provide for 19 a mandatory term of imprisonment if death or serious 20 bodily injury results.’’. 21 VerDate Sep 11 2014 19:24 Nov 10, 2019 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H4963.IH H4963 pamtmann on DSKBC07HB2PROD with BILLS 10 •HR 4963 IH SEC. 5. FALSE LABELING OF SCHEDULE A CONTROLLED 1 SUBSTANCES. 2 (a) IN GENERAL.—Section 305 of the Controlled 3 Substances Act (21 U.S.C. 825) is amended by adding at 4 the end the following: 5 ‘‘(f) FALSE LABELING OF SCHEDULE A CON- 6 TROLLED SUBSTANCES.— 7 ‘‘(1) It shall be unlawful to import or export, 8 with intent to manufacture, distribute, or dispense, 9 a schedule A substance or product containing a 10 schedule A substance, unless the substance or prod- 11 uct bears a label clearly identifying a schedule A 12 substance or product containing a schedule A sub- 13 stance by the nomenclature used by the Inter- 14 national Union of Pure and Applied Chemistry 15 (IUPAC). 16 ‘‘(2)(A) A product described in subparagraph 17 (B) is exempt from the International Union of Pure 18 and Applied Chemistry nomenclature requirement of 19 this subsection if such product is labeled in the man- 20 ner required under the Federal Food, Drug, and 21 Cosmetic Act. 22 ‘‘(B) A product is described in this subpara- 23 graph if the product— 24 VerDate Sep 11 2014 19:24 Nov 10, 2019 Jkt 099200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H4963.IH H4963 pamtmann on DSKBC07HB2PROD with BILLS 11 •HR 4963 IH ‘‘(i) is the subject of an approved applica- 1 tion as described in section 505(b) or (j) of the 2 Federal Food, Drug, and Cosmetic Act; or 3 ‘‘(ii) is exempt from the provisions of sec- 4 tion 505 of such Act relating to new drugs be- 5 cause— 6 ‘‘(I) it is intended solely for investiga- 7 tional use as described in section 505(i) of 8 such Act; and 9 ‘‘(II) such product is being used ex- 10 clusively for purposes of a clinical trial 11 that is the subject of an effective investiga- 12 tional new drug application.’’. 13 (b) PENALTIES.—Section 402 of the Controlled Sub- 14 stances Act (21 U.S.C. 842) is amended— 15 (1) in subsection (a)— 16 (A) in paragraph (16), by striking ‘‘or’’ at 17 the end; 18 (B) by redesignating paragraph (17) as 19 paragraph (18); and 20 (C) by inserting after paragraph (16) the 21 following: 22 ‘‘(17) to violate section 305(f); or’’; and 23 (2) in subsection (c)— 24 (A) in paragraph (1)— 25 VerDate Sep 11 2014 19:24 Nov 10, 2019 Jkt 099200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H4963.IH H4963 pamtmann on DSKBC07HB2PROD with BILLS 12 •HR 4963 IH (i) in subparagraph (B)(i), by striking 1 ‘‘(17)’’ and inserting ‘‘(18)’’; and 2 (ii) in subparagraph (C), by inserting 3 ‘‘or (17)’’ after ‘‘paragraph (16)’’ each 4 place it appears; and 5 (B) in paragraph (2)(D), by striking 6 ‘‘(17)’’ and inserting ‘‘(18)’’. 7 SEC. 6. REGISTRATION REQUIREMENTS FOR IMPORTERS 8 AND EXPORTERS OF SCHEDULE A SUB- 9 STANCES. 10 Section 1008 of the Controlled Substances Import 11 and Export Act (21 U.S.C. 958) is amended by adding 12 at the end the following: 13 ‘‘(j)(1) The Attorney General shall register an appli- 14 cant to import or export a schedule A substance if— 15 ‘‘(A) the applicant demonstrates that the sched- 16 ule A substance will be used for research, anal [Text truncated for display. Full text available on Congress.gov.]