II 

118TH CONGRESS 

2D SESSION S. 5056 

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 

SEPTEMBER 16, 2024 

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

Mrs. CAPITO) 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 2024’’ or the ‘‘SIMSA Act of 2024’’. 

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 listed or otherwise included in 

7 any other schedule in this section or by regula8 tion of the Attorney General. 

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

10 HALLUCINOGENIC EFFECT.—For purpose of this 

11 paragraph, a predicted stimulant, depressant, or hal12 lucinogenic effect on the central nervous system may 

13 be based on— 

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

15 ‘‘(II)(aa) the structure activity relation16 ships; or 

17 ‘‘(bb) binding receptor assays and other 

18 relevant scientific information about the sub19 stance; 

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

21 abuse of the substance; and 

22 ‘‘(II) the clandestine importation, manu23 facture, or distribution, or diversion from legiti24 mate channels, of the substance; or 


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

2 cause a state of dependence, including physical 

3 or psychological dependence that is similar to or 

4 greater than that of a controlled substance in 

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

6 (3) in subsection (c)— 

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

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

9 A’’; and 

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

11 ‘‘SCHEDULE A

12 ‘‘Any substance temporarily or permanently sched13 uled by the Attorney General in accordance with section 

14 201(k).’’. 

15 SEC. 3. TEMPORARY AND PERMANENT SCHEDULING OF 

16 SCHEDULE A SUBSTANCES. 

17 Section 201 of the Controlled Substances Act (21 

18 U.S.C. 811) is amended by adding at the end the fol19 lowing: 

20 ‘‘(k) TEMPORARY AND PERMANENT SCHEDULING OF

21 SCHEDULE A SUBSTANCES.— 

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

23 issue a temporary order adding a drug or substance 

24 to schedule A if the Attorney General finds that— 


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

2 the criteria for being considered a schedule A 

3 substance; and 

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

5 schedule A will assist in preventing abuse of the 

6 drug or other substance. 

7 ‘‘(2) DURATION OF TEMPORARY SCHEDULING

8 ORDER.—A temporary scheduling order issued under 

9 paragraph (1) shall— 

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

11 date of the publication by the Attorney General 

12 of a notice in the Federal Register of the inten13 tion to issue such order and the grounds upon 

14 which such order is to be issued; and 

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

16 the date on which the order becomes effective, 

17 except that the Attorney General may, during 

18 the pendency of proceedings under paragraph 

19 (5), extend the temporary scheduling order for 

20 up to 180 days. 

21 ‘‘(3) EFFECT OF ISSUANCE OF PERMANENT

22 SCHEDULING ORDER.—A temporary scheduling 

23 order issued under paragraph (1) shall be vacated 

24 upon the issuance of a permanent order issued 

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1 stance, or upon the subsequent issuance of any 

2 scheduling order under this section. 

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

4 temporary scheduling order issued under paragraph 

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

6 ‘‘(5) PERMANENT SCHEDULING ORDER.— 

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

8 subparagraph (B), not earlier than 3 years 

9 after the date on which the Attorney General 

10 issues an order temporarily scheduling a drug 

11 or substance under this subsection, the Attor12 ney General may, by rule, issue a permanent 

13 order adding the drug or other substance to 

14 schedule A if such drug or substance satisfies 

15 the criteria for being considered a schedule A 

16 substance. 

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

18 Health and Human Services, in consultation 

19 with the Attorney General, has determined, 

20 based on relevant scientific studies and nec21 essary data gathered by the Secretary of Health 

22 and Human Services and gathered by the At23 torney General, that a drug or other substance 

24 that has been temporarily placed in schedule A 

25 does not have sufficient potential for abuse to 


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1 warrant control in any schedule, and provides 

2 30 day written notice of such determination to 

3 the Attorney General, the Attorney General— 

4 ‘‘(i) may not issue a permanent sched5 uling order under subparagraph (A); and 

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

7 date on which the Attorney General re8 ceives such notice, shall issue an order im9 mediately terminating the temporary 

10 scheduling order for the drug or other sub11 stance. 

12 ‘‘(6) NOTICE TO HHS.—Before initiating pro13 ceedings under paragraph (1), the Attorney General 

14 shall transmit notice of a temporary order proposed 

15 to be issued to the Secretary of Health and Human 

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

17 the Attorney General shall take into consideration 

18 any comments submitted by the Secretary of Health 

19 and Human Services in response to a notice trans20 mitted pursuant to this paragraph.’’. 

21 SEC. 4. PENALTIES. 

22 Section 1010 of the Controlled Substances Import 

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


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

2 substance in schedule A’’ after ‘‘controlled sub3 stance’’ each place it appears; and 

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

5 following: 

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

7 involving a controlled substance in schedule A, the person 

8 committing such violation shall be sentenced to a term of 

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

10 serious bodily injury results from the use of such sub11 stance shall be sentenced to a term of imprisonment for 

12 any term of years or for life, a fine not to exceed the great13 er of that authorized in accordance with the provisions of 

14 title 18, United States Code, or $1,000,000 if the defend15 ant is an individual or $5,000,000 if the defendant is other 

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

17 a violation after a prior conviction for a felony drug of18 fense has become final, such person shall be sentenced to 

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

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

21 such substance shall be sentenced to a term of imprison22 ment for any term of years or for life, a fine not to exceed 

23 the greater of twice that authorized in accordance with 

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

25 $2,000,000 if the defendant is an individual or 


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1 $10,000,000 if the defendant is other than an individual, 

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

3 States Code, any sentence imposing a term of imprison4 ment under this paragraph shall, in the absence of such 

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

6 not less than 3 years in addition to such term of imprison7 ment and shall, if there was such a prior conviction, im8 pose a term of supervised release of not less than 6 years 

9 in addition to such term of imprisonment. Notwith10 standing the prior sentence, and notwithstanding any 

11 other provision of law, the court shall not place on proba12 tion or suspend the sentence of any person sentenced 

13 under the provisions of this paragraph which provide for 

14 a mandatory term of imprisonment if death or serious 

15 bodily injury results.’’. 

16 SEC. 5. FALSE LABELING OF SCHEDULE A CONTROLLED 

17 SUBSTANCES. 

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

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

20 the end the following: 

21 ‘‘(f) FALSE LABELING OF SCHEDULE A CON22 TROLLED SUBSTANCES.— 

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

24 with intent to manufacture, distribute, or dispense, 

25 a schedule A substance or product containing a 


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1 schedule A substance, unless the substance or prod2 uct bears a label clearly identifying a schedule A 

3 substance or product containing a schedule A sub4 stance by the nomenclature used by the Inter5 national Union of Pure and Applied Chemistry 

6 (IUPAC). 

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

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

9 and Applied Chemistry nomenclature requirement of 

10 this subsection if such product is labeled in the man11 ner required under the Federal Food, Drug, and 

12 Cosmetic Act. 

13 ‘‘(B) A product is described in this subpara14 graph if the product— 

15 ‘‘(i) is the subject of an approved applica16 tion as described in section 505(b) or (j) of the 

17 Federal Food, Drug, and Cosmetic Act; or 

18 ‘‘(ii) is exempt from the provisions of sec19 tion 505 of such Act relating to new drugs be20 cause— 

21 ‘‘(I) it is intended solely for investiga22 tional use as described in section 505(i) of 

23 such Act; and 

24 ‘‘(II) such product is being used ex25 clusively for purposes of a clinical trial 


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1 that is the subject of an effective investiga2 tional new drug application.’’. 

3 (b) PENALTIES.—Section 402 of the Controlled Sub4 stances Act (21 U.S.C. 842) is amended— 

5 (1) in subsection (a)— 

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

7 the end; 

8 (B) by redesignating paragraph (17) as 

9 paragraph (18); and 

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

11 following: 

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

13 (2) in subsection (c)— 

14 (A) in paragraph (1)— 

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

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

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

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

19 place it appears; and 

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

21 ‘‘(17)’’ and inserting ‘‘(18)’’. 

22 SEC. 6. REGISTRATION REQUIREMENTS FOR SCHEDULE A 

23 SUBSTANCES. 

24 (a) REGISTRATION REQUIREMENTS FOR IMPORTERS

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1 tion 1008 of the Controlled Substances Import and Export 

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

3 following: 

4 ‘‘(j)(1) The Attorney General shall register an appli5 cant to import or export a schedule A substance if— 

6 ‘‘(A) the applicant demonstrates that the sched7 ule A substance will be used for research, analytical, 

8 or industrial purposes approved by the Attorney 

9 General; and 

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

11 registration is consistent with the public interest and 

12 with the United States obligations under inter13 national treaties, conventions, or protocols in effect 

14 on the date of enactment of this subsection. 

15 ‘‘(2) In determining the public interest under para16 graph (1)(B), the Attorney General shall consider— 

17 ‘‘(A) maintenance of effective controls against 

18 diversion of particular controlled substances and any 

19 controlled substance in schedule A compounded 

20 therefrom into other than legitimate medical, sci21 entific, research, or industrial channels, by limiting 

22 the importation and bulk manufacture of such con23 trolled substances to a number of establishments 

24 which can produce an adequate and uninterrupted 

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1 petitive conditions for legitimate medical, scientific, 

2 research, and industrial purposes; 

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

4 law; 

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

6 of manufacturing substances described in subpara7 graph (A) and the development of new substances; 

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

9 Federal and State laws relating to the importation, 

10 manufacture, distribution, or dispensing of sub11 stances described in subparagraph (A); 

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

13 manufacture of controlled substances, and the exist14 ence in the establishment of effective control against 

15 diversion; and 

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

17 and consistent with the public health and safety. 

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

19 a controlled substance in schedule I or II under subsection 

20 (a), the applicant shall not be required to apply for a sepa21 rate registration under this subsection.’’. 

22 (b) RESEARCH ON SUBSTANCES NEWLY ADDED TO

23 SCHEDULE A.—Section 302(e) of the Controlled Sub24 stances Act (21 U.S.C. 822(e)) is amended by adding at 

25 the end the following: 


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1 ‘‘(3)(A) If a person is conducting research on a sub2 stance at the time the substance is added to schedule A, 

3 and such person, subject to an exemption that is in effect 

4 for investigational use, for that person, under section 505 

5 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

6 355) to the extent conduct with respect to such substance 

7 is pursuant to such exemption.’’. 

8 (c) CONTINUATION OF RESEARCH ON SUBSTANCES

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

10 Controlled Substances Act (21 U.S.C. 822(e)), as amend11 ed by subsection (b) of this section, is amended by adding 

12 at the end the following: 

13 ‘‘(B) 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 ‘‘(C) 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 ‘‘(D) Nothing in this paragraph shall be construed 

4 to alter the authority of the Attorney General to initiate 

5 proceedings to deny, suspend, or revoke any registration 

6 in 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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