I 

118TH CONGRESS 

2D SESSION H. R. 9879 

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 

SEPTEMBER 27, 2024 

Mr. PFLUGER (for himself, Mr. PANETTA, Mr. FRY, and Mr. DAVIS of North 

Carolina) 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 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’’. 


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

2 this Act is as follows: 

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 schedule A substances. 

Sec. 7. Additional conforming amendments. 

Sec. 8. Sentencing review. 

Sec. 9. Rules of construction. 

3 SEC. 2. ESTABLISHMENT OF SCHEDULE A. 

4 Section 202 of the Controlled Substances Act (21 

5 U.S.C. 812) is amended— 

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

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

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

9 controlled substances, to be known as schedules I, 

10 II, III, IV, V, and A’’; 

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

12 following: 

13 ‘‘(6) SCHEDULE A.— 

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

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

16 for import, into the United States; 

17 ‘‘(ii) has— 

18 ‘‘(I) a chemical structure that is sub19 stantially similar to the chemical structure 

20 of a controlled substance in schedule I, II, 

21 III, IV, or V; and 


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

2 depressant, or hallucinogenic effect on the 

3 central nervous system that is substantially 

4 similar to or greater than the stimulant, 

5 depressant, or hallucinogenic effect on the 

6 central nervous system of a controlled sub7 stance in schedule I, II, III, IV, or V; and 

8 ‘‘(iii) is not listed or otherwise included in 

9 any other schedule in this section or by regula10 tion of the Attorney General. 

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

12 HALLUCINOGENIC EFFECT.—For purpose of this 

13 paragraph, a predicted stimulant, depressant, or hal14 lucinogenic effect on the central nervous system may 

15 be based on— 

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

17 ‘‘(II)(aa) the structure activity relation18 ships; or 

19 ‘‘(bb) binding receptor assays and other 

20 relevant scientific information about the sub21 stance; 

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

23 abuse of the substance; and 


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1 ‘‘(II) the clandestine importation, manu2 facture, or distribution, or diversion from legiti3 mate channels, of the substance; or 

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

5 cause a state of dependence, including physical 

6 or psychological dependence that is similar to or 

7 greater than that of a controlled substance in 

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

9 (3) in subsection (c)— 

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

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

12 A’’; and 

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

14 ‘‘SCHEDULE A

15 ‘‘Any substance temporarily or permanently sched16 uled by the Attorney General in accordance with section 

17 201(k).’’. 

18 SEC. 3. TEMPORARY AND PERMANENT SCHEDULING OF 

19 SCHEDULE A SUBSTANCES. 

20 Section 201 of the Controlled Substances Act (21 

21 U.S.C. 811) is amended by adding at the end the fol22 lowing: 

23 ‘‘(k) TEMPORARY AND PERMANENT SCHEDULING OF

24 SCHEDULE A SUBSTANCES.— 


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

2 issue a temporary order adding a drug or substance 

3 to schedule A if the Attorney General finds that— 

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

5 the criteria for being considered a schedule A 

6 substance; and 

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

8 schedule A will assist in preventing abuse of the 

9 drug or other substance. 

10 ‘‘(2) DURATION OF TEMPORARY SCHEDULING

11 ORDER.—A temporary scheduling order issued under 

12 paragraph (1) shall— 

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

14 date of the publication by the Attorney General 

15 of a notice in the Federal Register of the inten16 tion to issue such order and the grounds upon 

17 which such order is to be issued; and 

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

19 the date on which the order becomes effective, 

20 except that the Attorney General may, during 

21 the pendency of proceedings under paragraph 

22 (5), extend the temporary scheduling order for 

23 up to 180 days. 

24 ‘‘(3) EFFECT OF ISSUANCE OF PERMANENT

25 SCHEDULING ORDER.—A temporary scheduling 


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1 order issued under paragraph (1) shall be vacated 

2 upon the issuance of a permanent order issued 

3 under paragraph (5) with regard to the same sub4 stance, or upon the subsequent issuance of any 

5 scheduling order under this section. 

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

7 temporary scheduling order issued under paragraph 

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

9 ‘‘(5) PERMANENT SCHEDULING ORDER.— 

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

11 subparagraph (B), not earlier than 3 years 

12 after the date on which the Attorney General 

13 issues an order temporarily scheduling a drug 

14 or substance under this subsection, the Attor15 ney General may, by rule, issue a permanent 

16 order adding the drug or other substance to 

17 schedule A if such drug or substance satisfies 

18 the criteria for being considered a schedule A 

19 substance. 

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

21 Health and Human Services, in consultation 

22 with the Attorney General, has determined, 

23 based on relevant scientific studies and nec24 essary data gathered by the Secretary of Health 

25 and Human Services and gathered by the AtVerDate Sep 11 2014 19:07 Oct 17, 2024 Jkt 059200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H9879.IH H9879

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1 torney General, that a drug or other substance 

2 that has been temporarily placed in schedule A 

3 does not have sufficient potential for abuse to 

4 warrant control in any schedule, and provides 

5 30 day written notice of such determination to 

6 the Attorney General, the Attorney General— 

7 ‘‘(i) may not issue a permanent sched8 uling order under subparagraph (A); and 

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

10 date on which the Attorney General re11 ceives such notice, shall issue an order im12 mediately terminating the temporary 

13 scheduling order for the drug or other sub14 stance. 

15 ‘‘(6) NOTICE TO HHS.—Before initiating pro16 ceedings under paragraph (1), the Attorney General 

17 shall transmit notice of a temporary order proposed 

18 to be issued to the Secretary of Health and Human 

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

20 the Attorney General shall take into consideration 

21 any comments submitted by the Secretary of Health 

22 and Human Services in response to a notice trans23 mitted pursuant to this paragraph.’’. 


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1 SEC. 4. PENALTIES. 

2 Section 1010 of the Controlled Substances Import 

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

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

5 substance in schedule A’’ after ‘‘controlled sub6 stance’’ each place it appears; and 

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

8 following: 

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

10 involving a controlled substance in schedule A, the person 

11 committing such violation shall be sentenced to a term of 

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

13 serious bodily injury results from the use of such sub14 stance shall be sentenced to a term of imprisonment for 

15 any term of years or for life, a fine not to exceed the great16 er of that authorized in accordance with the provisions of 

17 title 18, United States Code, or $1,000,000 if the defend18 ant is an individual or $5,000,000 if the defendant is other 

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

20 a violation after a prior conviction for a felony drug of21 fense has become final, such person shall be sentenced to 

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

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

24 such substance shall be sentenced to a term of imprison25 ment for any term of years or for life, a fine not to exceed 

26 the greater of twice that authorized in accordance with 


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

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

3 $10,000,000 if the defendant is other than an individual, 

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

5 States Code, any sentence imposing a term of imprison6 ment under this paragraph shall, in the absence of such 

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

8 not less than 3 years in addition to such term of imprison9 ment and shall, if there was such a prior conviction, im10 pose a term of supervised release of not less than 6 years 

11 in addition to such term of imprisonment. Notwith12 standing the prior sentence, and notwithstanding any 

13 other provision of law, the court shall not place on proba14 tion or suspend the sentence of any person sentenced 

15 under the provisions of this paragraph which provide for 

16 a mandatory term of imprisonment if death or serious 

17 bodily injury results.’’. 

18 SEC. 5. FALSE LABELING OF SCHEDULE A CONTROLLED 

19 SUBSTANCES. 

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

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

22 the end the following: 

23 ‘‘(f) FALSE LABELING OF SCHEDULE A CON24 TROLLED SUBSTANCES.— 


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

2 with intent to manufacture, distribute, or dispense, 

3 a schedule A substance or product containing a 

4 schedule A substance, unless the substance or prod5 uct bears a label clearly identifying a schedule A 

6 substance or product containing a schedule A sub7 stance by the nomenclature used by the Inter8 national Union of Pure and Applied Chemistry 

9 (IUPAC). 

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

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

12 and Applied Chemistry nomenclature requirement of 

13 this subsection if such product is labeled in the man14 ner required under the Federal Food, Drug, and 

15 Cosmetic Act. 

16 ‘‘(B) A product is described in this subpara17 graph if the product— 

18 ‘‘(i) is the subject of an approved applica19 tion as described in section 505(b) or (j) of the 

20 Federal Food, Drug, and Cosmetic Act; or 

21 ‘‘(ii) is exempt from the provisions of sec22 tion 505 of such Act relating to new drugs be23 cause— 


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1 ‘‘(I) it is intended solely for investiga2 tional use as described in section 505(i) of 

3 such Act; and 

4 ‘‘(II) such product is being used ex5 clusively for purposes of a clinical trial 

6 that is the subject of an effective investiga7 tional new drug application.’’. 

8 (b) PENALTIES.—Section 402 of the Controlled Sub9 stances Act (21 U.S.C. 842) is amended— 

10 (1) in subsection (a)— 

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

12 the end; 

13 (B) by redesignating paragraph (17) as 

14 paragraph (18); and 

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

16 following: 

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

18 (2) in subsection (c)— 

19 (A) in paragraph (1)— 

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

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

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

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

24 place it appears; and 


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

2 ‘‘(17)’’ and inserting ‘‘(18)’’. 

3 SEC. 6. REGISTRATION REQUIREMENTS FOR SCHEDULE A 

4 SUBSTANCES. 

5 (a) REGISTRATION REQUIREMENTS FOR IMPORTERS

6 AND EXPORTERS OF SCHEDULE A SUBSTANCES.—Sec7 tion 1008 of the Controlled Substances Import and Export 

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

9 following: 

10 ‘‘(j)(1) The Attorney General shall register an appli11 cant to import or export a schedule A substance if— 

12 ‘‘(A) the applicant demonstrates that the sched13 ule A substance will be used for research, analytical, 

14 or industrial purposes approved by the Attorney 

15 General; and 

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

17 registration is consistent with the public interest and 

18 with the United States obligations under inter19 national treaties, conventions, or protocols in effect 

20 on the date of enactment of this subsection. 

21 ‘‘(2) In determining the public interest under para22 graph (1)(B), the Attorney General shall consider— 

23 ‘‘(A) maintenance of effective controls against 

24 diversion of particular controlled substances and any 

25 controlled substance in schedule A compounded 


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1 therefrom into other than legitimate medical, sci2 entific, research, or industrial channels, by limiting 

3 the importation and bulk manufacture of such con4 trolled substances to a number of establishments 

5 which can produce an adequate and uninterrupted 

6 supply of these substances under adequately com7 petitive conditions for legitimate medical, scientific, 

8 research, and industrial purposes; 

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

10 law; 

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

12 of manufacturing substances described in subpara13 graph (A) and the development of new substances; 

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

15 Federal and State laws relating to the importation, 

16 manufacture, distribution, or dispensing of sub17 stances described in subparagraph (A); 

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

19 manufacture of controlled substances, and the exist20 ence in the establishment of effective control against 

21 diversion; and 

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

23 and consistent with the public health and safety. 

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

25 a controlled substance in schedule I or II under subsection 


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1 (a), the applicant shall not be required to apply for a sepa2 rate registration under this subsection.’’. 

3 (b) RESEARCH ON SUBSTANCES NEWLY ADDED TO

4 SCHEDULE A.—Section 302(e) of the Controlled Sub5 stances Act (21 U.S.C. 822(e)) is amended by adding at 

6 the end the following: 

7 ‘‘(3)(A) If a person is conducting research on a sub8 stance at the time the substance is added to schedule A, 

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

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

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

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

13 is pursuant to such exemption.’’. 

14 (c) CONTINUATION OF RESEARCH ON SUBSTANCES

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

16 Controlled Substances Act (21 U.S.C. 822(e)), as amend17 ed by subsection (b) of this section, is amended by adding 

18 at the end the following: 

19 ‘‘(B) If a person is conducting research on a sub20 stance at the time the substance is added to schedule A, 

21 and such person is already registered to conduct research 

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

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

24 scheduling of the newly-scheduled substance, submit 

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1 tion of existing registration, to conduct research on 

2 such substance, in accordance with the regulations 

3 issued by the Attorney General; 

4 ‘‘(ii) the person may continue to conduct the re5 search on such substance until the application de6 scribed in clause (i) is withdrawn by the applicant 

7 or until the Attorney General serves on the applicant 

8 an order to show cause proposing the denial of the 

9 application pursuant to section 304(c); and 

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

11 show cause under clause (ii) and the applicant re12 quests a hearing, such hearing shall be held on an 

13 expedited basis and not later than 45 days after the 

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

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

16 ‘‘(C) A person who is registered to conduct research 

17 with a controlled substance in schedule A may conduct re18 search with another controlled substance in schedule I, 

19 only if— 

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

21 the person’s registration to authorize research with 

22 such other controlled substance in accordance with 

23 the regulations issued by the Attorney General; 

24 ‘‘(ii) the Attorney General has obtained 

25 verification from the Secretary that the research 


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1 protocol submitted with the application is meri2 torious; and 

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

4 later than 30 days after receiving the application de5 scribed in clause (i), that such activity is consistent 

6 with United States obligations under the Single Con7 vention on Narcotic Drugs, 1961. 

8 ‘‘(D) Nothing in this paragraph shall be construed 

9 to alter the authority of the Attorney General to initiate 

10 proceedings to deny, suspend, or revoke any registration 

11 in accordance with sections 303 and 304.’’. 

12 SEC. 7. ADDITIONAL CONFORMING AMENDMENTS. 

13 The Controlled Substances Import and Export Act 

14 (21 U.S.C. 951 et seq.) is amended— 

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

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

17 by inserting ‘‘or drug or substance in schedule 

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

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

20 drug or substances in schedule A’’ after ‘‘sched21 ule I or II’’; 

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

23 (A) in subsection (c), in the matter pre24 ceding paragraph (1), by inserting ‘‘or drug or 


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

2 II’’; and 

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

4 drug or substance in schedule A’’ after ‘‘sched5 ule I or II’’; 

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

7 the matter preceding subparagraph (A), by inserting 

8 ‘‘or drug or substance in schedule A’’ after ‘‘sched9 ule I’’; 

10 (4) in section 1005 (21 U.S.C. 955), by insert11 ing ‘‘or drug or substance in schedule A’’ after 

12 ‘‘schedule I or II’’; and 

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

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

15 ‘‘schedule I or II’’. 

16 SEC. 8. SENTENCING REVIEW. 

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

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

19 schedule A substance for which the penalty was estab20 lished under section 4 or 5 of this Act. 

21 (b) SENTENCING REVIEW.— 

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

23 substance that is temporarily or permanently sched24 uled under section 201(k) of the Controlled Sub25 stances Act, as added by this Act, is subsequently 


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1 descheduled or rescheduled on a schedule with lower 

2 penalties, any individual convicted of a covered of3 fense involving such schedule A substance who is 

4 awaiting sentencing or is still serving a term of im5 prisonment for such covered offense on the date of 

6 the descheduling or rescheduling may petition the 

7 court that imposed the sentence for a sentencing re8 duction hearing for such covered offense. 

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

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

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

12 reduction hearing and may modify the sentence of 

13 the petitioner as if the descheduling or rescheduling 

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

15 date the covered offense was committed. 

16 SEC. 9. RULES OF CONSTRUCTION. 

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

18 Act, may be construed to limit— 

19 (1) the prosecution of offenses involving con20 trolled substance analogues under the Controlled 

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

22 (2) the authority of the Attorney General to 

23 temporarily or permanently schedule, reschedule, or 

24 decontrol controlled substances under provisions of 

25 section 201 of the Controlled Substances Act (21 


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

2 date of enactment of this Act. 

Æ 


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