II 

117TH CONGRESS 

1ST SESSION S. 2351 

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 SENATE OF THE UNITED STATES 

JULY 15, 2021 

Mr. GRASSLEY (for himself, Mrs. FEINSTEIN, Ms. ERNST, and Ms. HASSAN) 

introduced the following bill; 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 that are imported or offered 

for import are to be regulated, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Stop the Importation and Manufacturing of Synthetic 

6 Analogues Act of 2021’’ or the ‘‘SIMSA Act of 2021’’. 

7 (b) TABLE OF CONTENTS.—The table of contents of 

8 this Act is as follows: 

Sec. 1. Short title; table of contents. 


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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 schedule A substances. 

Sec. 7. Additional conforming amendments. 

Sec. 8. Sentencing review. 

Sec. 9. Rules of construction. 

1 SEC. 2. ESTABLISHMENT OF SCHEDULE A. 

2 Section 202 of the Controlled Substances Act (21 

3 U.S.C. 812) is amended— 

4 (1) in subsection (a), by striking ‘‘five schedules 

5 of controlled substances, to be known as schedules I, 

6 II, III, IV, and V’’ and inserting ‘‘six schedules of 

7 controlled substances, to be known as schedules I, 

8 II, III, IV, V, and A’’; 

9 (2) in subsection (b), by adding at the end the 

10 following: 

11 ‘‘(6) SCHEDULE A.— 

12 ‘‘(A) IN GENERAL.—The drug or substance— 

13 ‘‘(i) is or has been imported, or is offered 

14 for import, into the United States; 

15 ‘‘(ii) has— 

16 ‘‘(I) a chemical structure that is sub17 stantially similar to the chemical structure 

18 of a controlled substance in schedule I, II, 

19 III, IV, or V; and 

20 ‘‘(II) an actual or predicted stimulant, 

21 depressant, or hallucinogenic effect on the 


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1 central nervous system that is substantially 

2 similar to or greater than the stimulant, 

3 depressant, or hallucinogenic effect on the 

4 central nervous system of a controlled sub5 stance in schedule I, II, III, IV, or V; and 

6 ‘‘(iii) is not— 

7 ‘‘(I) listed or otherwise included in 

8 any other schedule in this section or by 

9 regulation of the Attorney General; and 

10 ‘‘(II) with respect to a particular per11 son, subject to an exemption that is in ef12 fect for investigational use, for that person, 

13 under section 505 of the Federal Food, 

14 Drug, and Cosmetic Act (21 U.S.C. 355) 

15 to the extent conduct with respect to such 

16 substance is pursuant to such exemption. 

17 ‘‘(B) PREDICTED STIMULANT, DEPRESSANT, OR

18 HALLUCINOGENIC EFFECT.—For purpose of this 

19 paragraph, a predicted stimulant, depressant, or hal20 lucinogenic effect on the central nervous system may 

21 be based on— 

22 ‘‘(i)(I) the chemical structure; and 

23 ‘‘(II)(aa) the structure activity relation24 ships; or 


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1 ‘‘(bb) binding receptor assays and other 

2 relevant scientific information about the sub3 stance; 

4 ‘‘(ii)(I) the current or relative potential for 

5 abuse of the substance; and 

6 ‘‘(II) the clandestine importation, manu7 facture, or distribution, or diversion from legiti8 mate channels, of the substance; or 

9 ‘‘(iii) the capacity of the substance to 

10 cause a state of dependence, including physical 

11 or psychological dependence that is similar to or 

12 greater than that of a controlled substance in 

13 schedule I, II, III, IV, or V.’’; and 

14 (3) in subsection (c)— 

15 (A) in the matter preceding schedule I, by 

16 striking ‘‘IV, and V’’ and inserting ‘‘IV, V, and 

17 A’’; and 

18 (B) by adding at the end the following: 

19 ‘‘SCHEDULE A

20 ‘‘Any substance temporarily or permanently sched21 uled by the Attorney General in accordance with section 

22 201(k).’’. 


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1 SEC. 3. TEMPORARY AND PERMANENT SCHEDULING OF 

2 SCHEDULE A SUBSTANCES. 

3 Section 201 of the Controlled Substances Act (21 

4 U.S.C. 811) is amended by adding at the end the fol5 lowing: 

6 ‘‘(k) TEMPORARY AND PERMANENT SCHEDULING OF

7 SCHEDULE A SUBSTANCES.— 

8 ‘‘(1) IN GENERAL.—The Attorney General may 

9 issue a temporary order adding a drug or substance 

10 to schedule A if the Attorney General finds that— 

11 ‘‘(A) the drug or other substance satisfies 

12 the criteria for being considered a schedule A 

13 substance; and 

14 ‘‘(B) adding such drug or substance to 

15 schedule A will assist in preventing abuse of the 

16 drug or other substance. 

17 ‘‘(2) DURATION OF TEMPORARY SCHEDULING

18 ORDER.—A temporary scheduling order issued under 

19 paragraph (1) shall— 

20 ‘‘(A) not take effect until 30 days after the 

21 date of the publication by the Attorney General 

22 of a notice in the Federal Register of the inten23 tion to issue such order and the grounds upon 

24 which such order is to be issued; and 

25 ‘‘(B) expire not later than 5 years after 

26 the date on which the order becomes effective, 


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1 except that the Attorney General may, during 

2 the pendency of proceedings under paragraph 

3 (5), extend the temporary scheduling order for 

4 up to 180 days. 

5 ‘‘(3) EFFECT OF ISSUANCE OF PERMANENT

6 SCHEDULING ORDER.—A temporary scheduling 

7 order issued under paragraph (1) shall be vacated 

8 upon the issuance of a permanent order issued 

9 under paragraph (5) with regard to the same sub10 stance, or upon the subsequent issuance of any 

11 scheduling order under this section. 

12 ‘‘(4) LIMITATION ON JUDICIAL REVIEW.—A 

13 temporary scheduling order issued under paragraph 

14 (1) shall not be subject to judicial review. 

15 ‘‘(5) PERMANENT SCHEDULING ORDER.— 

16 ‘‘(A) IN GENERAL.—Except as provided in 

17 subparagraph (B), not earlier than 3 years 

18 after the date on which the Attorney General 

19 issues an order temporarily scheduling a drug 

20 or substance under this subsection, the Attor21 ney General may, by rule, issue a permanent 

22 order adding the drug or other substance to 

23 schedule A if such drug or substance satisfies 

24 the criteria for being considered a schedule A 

25 substance. 


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1 ‘‘(B) LIMITATION.—If the Secretary of 

2 Health and Human Services has determined, 

3 based on relevant scientific studies and nec4 essary data requested by the Secretary of 

5 Health and Human Services and gathered by 

6 the Attorney General, that a drug or other sub7 stance that has been temporarily placed in 

8 schedule A does not have sufficient potential for 

9 abuse to warrant control in any schedule, and 

10 provides written notice of such determination to 

11 the Attorney General, the Attorney General— 

12 ‘‘(i) may not issue a permanent sched13 uling order under subparagraph (A); and 

14 ‘‘(ii) not later than 30 days after the 

15 date on which the Attorney General re16 ceives such notice, shall issue an order im17 mediately terminating the temporary 

18 scheduling order for the drug or other sub19 stance. 

20 ‘‘(6) NOTICE TO HHS.—Before initiating pro21 ceedings under paragraph (1), the Attorney General 

22 shall transmit notice of a temporary order proposed 

23 to be issued to the Secretary of Health and Human 

24 Services. In issuing an order under paragraph (1), 

25 the Attorney General shall take into consideration 


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1 any comments submitted by the Secretary of Health 

2 and Human Services in response to a notice trans3 mitted pursuant to this paragraph.’’. 

4 SEC. 4. PENALTIES. 

5 Section 1010 of the Controlled Substances Import 

6 and Export Act (21 U.S.C. 960) is amended— 

7 (1) in subsection (a), by inserting ‘‘or a drug or 

8 substance in schedule A’’ after ‘‘controlled sub9 stance’’ each place it appears; and 

10 (2) in subsection (b), by adding at the end the 

11 following: 

12 ‘‘(8) In the case of a violation under subsection (a) 

13 involving a controlled substance in schedule A, the person 

14 committing such violation shall be sentenced to a term of 

15 imprisonment of not more than 20 years and if death or 

16 serious bodily injury results from the use of such sub17 stance shall be sentenced to a term of imprisonment for 

18 any term of years or for life, a fine not to exceed the great19 er of that authorized in accordance with the provisions of 

20 title 18, United States Code, or $1,000,000 if the defend21 ant is an individual or $5,000,000 if the defendant is other 

22 than an individual, or both. If any person commits such 

23 a violation after a prior conviction for a felony drug of24 fense has become final, such person shall be sentenced to 

25 a term of imprisonment of not more than 30 years and 


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1 if death or serious bodily injury results from the use of 

2 such substance shall be sentenced to a term of imprison3 ment for any term of years or for life, a fine not to exceed 

4 the greater of twice that authorized in accordance with 

5 the provisions of title 18, United States Code, or 

6 $2,000,000 if the defendant is an individual or 

7 $10,000,000 if the defendant is other than an individual, 

8 or both. Notwithstanding section 3583 of title 18, United 

9 States Code, any sentence imposing a term of imprison10 ment under this paragraph shall, in the absence of such 

11 a prior conviction, impose a term of supervised release of 

12 not less than 3 years in addition to such term of imprison13 ment and shall, if there was such a prior conviction, im14 pose a term of supervised release of not less than 6 years 

15 in addition to such term of imprisonment. Notwith16 standing the prior sentence, and notwithstanding any 

17 other provision of law, the court shall not place on proba18 tion or suspend the sentence of any person sentenced 

19 under the provisions of this paragraph which provide for 

20 a mandatory term of imprisonment if death or serious 

21 bodily injury results.’’. 


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1 SEC. 5. FALSE LABELING OF SCHEDULE A CONTROLLED 

2 SUBSTANCES. 

3 (a) IN GENERAL.—Section 305 of the Controlled 

4 Substances Act (21 U.S.C. 825) is amended by adding at 

5 the end the following: 

6 ‘‘(f) FALSE LABELING OF SCHEDULE A CON7 TROLLED SUBSTANCES.— 

8 ‘‘(1) It shall be unlawful to import or export, 

9 with intent to manufacture, distribute, or dispense, 

10 a schedule A substance or product containing a 

11 schedule A substance, unless the substance or prod12 uct bears a label clearly identifying a schedule A 

13 substance or product containing a schedule A sub14 stance by the nomenclature used by the Inter15 national Union of Pure and Applied Chemistry 

16 (IUPAC). 

17 ‘‘(2)(A) A product described in subparagraph 

18 (B) is exempt from the International Union of Pure 

19 and Applied Chemistry nomenclature requirement of 

20 this subsection if such product is labeled in the man21 ner required under the Federal Food, Drug, and 

22 Cosmetic Act. 

23 ‘‘(B) A product is described in this subpara24 graph if the product— 


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1 ‘‘(i) is the subject of an approved applica2 tion as described in section 505(b) or (j) of the 

3 Federal Food, Drug, and Cosmetic Act; or 

4 ‘‘(ii) is exempt from the provisions of sec5 tion 505 of such Act relating to new drugs be6 cause— 

7 ‘‘(I) it is intended solely for investiga8 tional use as described in section 505(i) of 

9 such Act; and 

10 ‘‘(II) such product is being used ex11 clusively for purposes of a clinical trial 

12 that is the subject of an effective investiga13 tional new drug application.’’. 

14 (b) PENALTIES.—Section 402 of the Controlled Sub15 stances Act (21 U.S.C. 842) is amended— 

16 (1) in subsection (a)— 

17 (A) in paragraph (16), by striking ‘‘or’’ at 

18 the end; 

19 (B) by redesignating paragraph (17) as 

20 paragraph (18); and 

21 (C) by inserting after paragraph (16) the 

22 following: 

23 ‘‘(17) to violate section 305(f); or’’; and 

24 (2) in subsection (c)— 

25 (A) in paragraph (1)— 


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1 (i) in subparagraph (B)(i), by striking 

2 ‘‘(17)’’ and inserting ‘‘(18)’’; and 

3 (ii) in subparagraph (C), by inserting 

4 ‘‘or (17)’’ after ‘‘paragraph (16)’’ each 

5 place it appears; and 

6 (B) in paragraph (2)(D), by striking 

7 ‘‘(17)’’ and inserting ‘‘(18)’’. 

8 SEC. 6. REGISTRATION REQUIREMENTS FOR SCHEDULE A 

9 SUBSTANCES. 

10 (a) REGISTRATION REQUIREMENTS FOR IMPORTERS

11 AND EXPORTERS OF SCHEDULE A SUBSTANCES.—Sec12 tion 1008 of the Controlled Substances Import and Export 

13 Act (21 U.S.C. 958) is amended by adding at the end the 

14 following: 

15 ‘‘(j)(1) The Attorney General shall register an appli16 cant to import or export a schedule A substance if— 

17 ‘‘(A) the applicant demonstrates that the sched18 ule A substance will be used for research, analytical, 

19 or industrial purposes approved by the Attorney 

20 General; and 

21 ‘‘(B) the Attorney General determines that such 

22 registration is consistent with the public interest and 

23 with the United States obligations under inter24 national treaties, conventions, or protocols in effect 

25 on the date of enactment of this subsection. 


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1 ‘‘(2) In determining the public interest under para2 graph (1)(B), the Attorney General shall consider— 

3 ‘‘(A) maintenance of effective controls against 

4 diversion of particular controlled substances and any 

5 controlled substance in schedule A compounded 

6 therefrom into other than legitimate medical, sci7 entific, research, or industrial channels, by limiting 

8 the importation and bulk manufacture of such con9 trolled substances to a number of establishments 

10 which can produce an adequate and uninterrupted 

11 supply of these substances under adequately com12 petitive conditions for legitimate medical, scientific, 

13 research, and industrial purposes; 

14 ‘‘(B) compliance with applicable State and local 

15 law; 

16 ‘‘(C) promotion of technical advances in the art 

17 of manufacturing substances described in subpara18 graph (A) and the development of new substances; 

19 ‘‘(D) prior conviction record of applicant under 

20 Federal and State laws relating to the importation, 

21 manufacture, distribution, or dispensing of sub22 stances described in subparagraph (A); 

23 ‘‘(E) past experience in the importation and 

24 manufacture of controlled substances, and the existVerDate Sep 11 2014 23:12 Jul 19, 2021 Jkt 019200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6201 E:\BILLS\S2351.IS S2351

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1 ence in the establishment of effective control against 

2 diversion; and 

3 ‘‘(F) such other factors as may be relevant to 

4 and consistent with the public health and safety. 

5 ‘‘(3) If an applicant is registered to import or export 

6 a controlled substance in schedule I or II under subsection 

7 (a), the applicant shall not be required to apply for a sepa8 rate registration under this subsection.’’. 

9 (b) CONTINUATION OF RESEARCH ON SUBSTANCES

10 NEWLY ADDED TO SCHEDULE A.—Section 302(e) of the 

11 Controlled Substances Act (21 U.S.C. 822(e)) is amended 

12 by adding at the end the following: 

13 ‘‘(3)(A) If a person is conducting research on a sub14 stance at the time the substance is added to schedule A, 

15 and such person is already registered to conduct research 

16 with a controlled substance in schedule I or II, then— 

17 ‘‘(i) the person shall, within 30 days of the 

18 scheduling of the newly-scheduled substance, submit 

19 a completed application for registration or modifica20 tion of existing registration, to conduct research on 

21 such substance, in accordance with the regulations 

22 issued by the Attorney General; 

23 ‘‘(ii) the person may continue to conduct the re24 search on such substance until the application de25 scribed in clause (i) is withdrawn by the applicant 


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1 or until the Attorney General serves on the applicant 

2 an order to show cause proposing the denial of the 

3 application pursuant to section 304(c); and 

4 ‘‘(iii) if the Attorney General serves order to 

5 show cause under clause (ii) and the applicant re6 quests a hearing, such hearing shall be held on an 

7 expedited basis and not later than 45 days after the 

8 request is made, except that the hearing may be held 

9 at a later time if so requested by the applicant. 

10 ‘‘(B) A person who is registered to conduct research 

11 with a controlled substance in schedule A may conduct re12 search with another controlled substance in schedule I, 

13 only if— 

14 ‘‘(i) the person has applied for a modification of 

15 the person’s registration to authorize research with 

16 such other controlled substance in accordance with 

17 the regulations issued by the Attorney General; 

18 ‘‘(ii) the Attorney General has obtained 

19 verification from the Secretary that the research 

20 protocol submitted with the application is meri21 torious; and 

22 ‘‘(iii) the Attorney General has determined, not 

23 later than 30 days after receiving the application de24 scribed in clause (i), that such activity is consistent 


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1 with United States obligations under the Single Con2 vention on Narcotic Drugs, 1961. 

3 ‘‘(C) Nothing in this paragraph shall be construed to 

4 alter the authority of the Attorney General to initiate pro5 ceedings to deny, suspend, or revoke any registration in 

6 accordance with sections 303 and 304.’’. 

7 SEC. 7. ADDITIONAL CONFORMING AMENDMENTS. 

8 The Controlled Substances Import and Export Act 

9 (21 U.S.C. 951 et seq.) is amended— 

10 (1) in section 1002(a) (21 U.S.C. 952(a))— 

11 (A) in the matter preceding paragraph (1), 

12 by inserting ‘‘or drug or substance in schedule 

13 A’’ after ‘‘schedule I or II’’; and 

14 (B) in paragraph (2), by inserting ‘‘or 

15 drug or substances in schedule A’’ after ‘‘sched16 ule I or II’’; 

17 (2) in section 1003 (21 U.S.C. 953)— 

18 (A) in subsection (c), in the matter pre19 ceding paragraph (1), by inserting ‘‘or drug or 

20 substance in schedule A’’ after ‘‘schedule I or 

21 II’’; and 

22 (B) in subsection (d), by inserting ‘‘or 

23 drug or substance in schedule A’’ after ‘‘sched24 ule I or II’’; 


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1 (3) in section 1004(1) (21 U.S.C. 954(1)), in 

2 the matter preceding subparagraph (A), by inserting 

3 ‘‘or drug or substance in schedule A’’ after ‘‘sched4 ule I’’; 

5 (4) in section 1005 (21 U.S.C. 955), by insert6 ing ‘‘or drug or substance in schedule A’’ after 

7 ‘‘schedule I or II’’; and 

8 (5) in section 1009(a) (21 U.S.C. 959(a)), by 

9 inserting ‘‘or drug or substance in schedule A’’ after 

10 ‘‘schedule I or II’’. 

11 SEC. 8. SENTENCING REVIEW. 

12 (a) COVERED OFFENSE DEFINED.—In this section, 

13 the term ‘‘covered offense’’ means an offense involving a 

14 schedule A substance for which the penalty was estab15 lished under section 4 or 5 of this Act. 

16 (b) SENTENCING REVIEW.— 

17 (1) PETITION FOR REVIEW.—If a schedule A 

18 substance that is temporarily or permanently sched19 uled under section 201(k) of the Controlled Sub20 stances Act, as added by this Act, is subsequently 

21 descheduled or rescheduled on a schedule with lower 

22 penalties, any individual convicted of a covered of23 fense involving such schedule A substance who is 

24 awaiting sentencing or is still serving a term of im25 prisonment for such covered offense on the date of 


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1 the descheduling or rescheduling may petition the 

2 court that imposed the sentence for a sentencing re3 duction hearing for such covered offense. 

4 (2) SENTENCING REVIEW.—Not later than 30 

5 days after the date on which a petition is filed under 

6 paragraph (1), the court shall conduct a sentencing 

7 reduction hearing and may modify the sentence of 

8 the petitioner as if the descheduling or rescheduling 

9 described in paragraph (1) had been in effect on the 

10 date the covered offense was committed. 

11 SEC. 9. RULES OF CONSTRUCTION. 

12 Nothing in this Act, or the amendments made by this 

13 Act, may be construed to limit— 

14 (1) the prosecution of offenses involving con15 trolled substance analogues under the Controlled 

16 Substances Act (21 U.S.C. 801 et seq.); or 

17 (2) the authority of the Attorney General to 

18 temporarily or permanently schedule, reschedule, or 

19 decontrol controlled substances under provisions of 

20 section 201 of the Controlled Substances Act (21 

21 U.S.C. 811) that are in effect on the day before the 

22 date of enactment of this Act. 

Æ 


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