I 

118TH CONGRESS 

1ST SESSION H. R. 568 

To amend the Controlled Substances Act with respect to fentanyl-related 

substances, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JANUARY 26, 2023 

Mr. PAPPAS (for himself, Mr. NEWHOUSE, Mr. TONY GONZALES of Texas, 

and Ms. SALAZAR) 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 with respect to 

fentanyl-related substances, 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. 

4 This Act may be cited as the ‘‘Save Americans from 

5 the Fentanyl Emergency Act’’ or the ‘‘SAFE Act’’. 


kjohnson on DSK79L0C42PROD with BILLS
2 

•HR 568 IH

1 SEC. 2. CLASS SCHEDULING OF FENTANYL-RELATED SUB2 STANCES. 

3 Section 202(c) of the Controlled Substances Act (21 

4 U.S.C. 812(c)) is amended by adding at the end of sched5 ule I the following: 

6 ‘‘(e)(1) Unless specifically exempted or unless listed 

7 in another schedule, any material, compound, mixture, or 

8 preparation which contains any quantity of fentanyl-re9 lated substances, or which contains their salts, isomers, 

10 and salts of isomers whenever the existence of such salts, 

11 isomers, and salts of isomers is possible within the specific 

12 chemical designation. 

13 ‘‘(2) In this subsection, except as provided in para14 graph (3), the term ‘fentanyl-related substance’ means 

15 any substance that is structurally related to fentanyl by 

16 one or more of the following modifications: 

17 ‘‘(A) By replacement of the phenyl portion of 

18 the phenethyl group by any monocycle, whether or 

19 not further substituted in or on the monocycle. 

20 ‘‘(B) By substitution in or on the phenethyl 

21 group with alkyl, alkenyl, alkoxyl, hydroxyl, halo, 

22 haloalkyl, amino, or nitro groups. 

23 ‘‘(C) By substitution in or on the piperidine 

24 ring with alkyl, alkenyl, alkoxyl, ester, ether, 

25 hydroxyl, halo, haloalkyl, amino, or nitro groups. 


kjohnson on DSK79L0C42PROD with BILLS
3 

•HR 568 IH

1 ‘‘(D) By replacement of the aniline ring with 

2 any aromatic monocycle whether or not further sub3 stituted in or on the aromatic monocycle. 

4 ‘‘(E) By replacement of the N-propionyl group 

5 with another acyl group. 

6 ‘‘(3) A substance that meets the criteria specified in 

7 paragraph (2) to be considered a fentanyl-related sub8 stance shall not be so considered as meeting such criteria 

9 if such substance— 

10 ‘‘(A) is controlled by action of the Attorney 

11 General pursuant to section 201; 

12 ‘‘(B) is expressly listed in this schedule or an13 other schedule by a statutory provision other than 

14 this subsection; or 

15 ‘‘(C) is removed from this schedule, or resched16 uled to another schedule, pursuant to section 201(k). 

17 ‘‘(4) The Attorney General shall publish in the Fed18 eral Register a list of individual substances that meet the 

19 definition of fentanyl-related substances in paragraph (2) 

20 within 60 days of determining such substances meet such 

21 definition. The absence of a substance on any such list 

22 does not negate the control status of such substance if 

23 the substance meets the criteria specified in paragraph (2) 

24 to be considered a fentanyl-related substance. 


kjohnson on DSK79L0C42PROD with BILLS
4 

•HR 568 IH

1 ‘‘(5) Notwithstanding any other provision of this title 

2 or title III, fentanyl-related substances shall not be subject 

3 to quantity-based mandatory minimum penalties pursuant 

4 to subparagraph (A)(vi) or (B)(vi) of section 401(b)(1) of 

5 this title or paragraph (1)(F) or (2)(F) of section 1010(b) 

6 of title III.’’. 

7 SEC. 3. PENALTY PROVISIONS WITH RESPECT TO 

8 FENTANYL-RELATED SUBSTANCES—DOMES9 TIC OFFENSES. 

10 Section 401(b)(1) of the Controlled Substances Act 

11 (21 U.S.C. 841(b)(1)) is amended— 

12 (1) in subparagraph (A), by striking clause (vi) 

13 and inserting the following: 

14 ‘‘(vi)(I) 400 grams or more of a mixture or sub15 stance containing a detectable amount of fentanyl; 

16 or 

17 ‘‘(II) 100 grams or more of a mixture or sub18 stance containing a detectable amount of any ana19 logue of fentanyl that is controlled in schedule I or 

20 II or that is treated as a schedule I controlled sub21 stance pursuant to section 203(a), except for a 

22 fentanyl-related substance as defined in schedule 

23 I(e) of section 202(c);’’; 

24 (2) in subparagraph (B), by striking clause (vi) 

25 and inserting the following: 


kjohnson on DSK79L0C42PROD with BILLS
5 

•HR 568 IH

1 ‘‘(vi)(I) 40 grams or more of a mixture or sub2 stance containing a detectable amount of fentanyl; 

3 or 

4 ‘‘(II) 10 grams or more of a mixture or sub5 stance containing a detectable amount of any ana6 logue of fentanyl that is controlled in schedule I or 

7 II or that is treated as a schedule I controlled sub8 stance pursuant to section 203(a), except for a 

9 fentanyl-related substance as defined in schedule 

10 I(e) of section 202(c);’’; and 

11 (3) in subparagraph (C), by inserting ‘‘, includ12 ing a fentanyl-related substance as defined in sched13 ule I(e) of section 202(c),’’ after ‘‘a controlled sub14 stance in schedule I or II,’’. 

15 SEC. 4. PENALTY PROVISIONS WITH RESPECT TO 

16 FENTANYL-RELATED SUBSTANCES—IMPORT 

17 AND EXPORT OFFENSES. 

18 Section 1010(b) of the Controlled Substances Import 

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

20 (1) in paragraph (1), by striking subparagraph 

21 (F) and inserting the following: 

22 ‘‘(F)(i) 400 grams or more of a mixture or sub23 stance containing a detectable amount of fentanyl; 

24 or 


kjohnson on DSK79L0C42PROD with BILLS
6 

•HR 568 IH

1 ‘‘(ii) 100 grams or more of a mixture or sub2 stance containing a detectable amount of any ana3 logue of fentanyl that is controlled in schedule I or 

4 II or that is treated as a schedule I controlled sub5 stance pursuant to section 203(a) of the Controlled 

6 Substances Act, except for a fentanyl-related sub7 stance as defined in schedule I(e) of section 202(c) 

8 of the Controlled Substances Act;’’; 

9 (2) in paragraph (2), by striking subparagraph 

10 (F) and inserting the following: 

11 ‘‘(F)(i) 40 grams or more of a mixture or sub12 stance containing a detectable amount of fentanyl; 

13 or 

14 ‘‘(ii) 10 grams or more of a mixture or sub15 stance containing a detectable amount of any ana16 logue of fentanyl that is controlled in schedule I or 

17 II or that is treated as a schedule I controlled sub18 stance pursuant to section 203(a) of the Controlled 

19 Substances Act, except for a fentanyl-related sub20 stance as defined in schedule I(e) of section 202(c) 

21 of the Controlled Substances Act;’’; and 

22 (3) in paragraph (3), by inserting ‘‘including a 

23 fentanyl-related substance as defined in schedule 

24 I(e) of section 202(c) of the Controlled Substances 


kjohnson on DSK79L0C42PROD with BILLS
7 

•HR 568 IH

1 Act,’’ after ‘‘a controlled substance in schedule I or 

2 II,’’. 

3 SEC. 5. REMOVAL FROM SCHEDULE I OF FENTANYL-RE4 LATED SUBSTANCES. 

5 Section 201 of the Controlled Substances Act (21 

6 U.S.C. 811) is amended by adding at the end the following 

7 new subsection: 

8 ‘‘(k) REMOVAL FROM SCHEDULE I OF FENTANYL9 RELATED SUBSTANCES.— 

10 ‘‘(1) DETERMINATION RESULTING IN RE11 MOVAL.—If the Secretary determines, taking into 

12 consideration factors as set forth in paragraph (3), 

13 that a fentanyl-related substance has a potential for 

14 abuse that is less than the drugs or other substances 

15 in schedule V— 

16 ‘‘(A) the Secretary shall submit to the At17 torney General a scientific and medical evalua18 tion of that fentanyl-related substance sup19 porting that determination; 

20 ‘‘(B) the Secretary shall submit any such 

21 evaluation and determination in writing and in22 clude the bases therefor; 

23 ‘‘(C) the scientific and medical determina24 tion of the Secretary contained in such evaluaVerDate Sep 11 2014 04:25 Feb 09, 2023 Jkt 039200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H568.IH H568

kjohnson on DSK79L0C42PROD with BILLS
8 

•HR 568 IH

1 tion shall be binding on the Attorney General; 

2 and 

3 ‘‘(D) not later than 90 days after receiving 

4 such evaluation and determination, the Attor5 ney General shall issue an order removing such 

6 fentanyl-related substance from the schedules 

7 under section 202. 

8 ‘‘(2) DETERMINATION RESULTING IN RESCHED9 ULING.—If the Secretary determines, taking into 

10 consideration factors as set forth in paragraph (3), 

11 that a fentanyl-related substance has a potential for 

12 abuse that is less than the drugs or other substances 

13 in schedules I and II— 

14 ‘‘(A) the Secretary shall submit to the At15 torney General a scientific and medical evalua16 tion of that fentanyl-related substance sup17 porting that determination; 

18 ‘‘(B) the Secretary shall submit any such 

19 evaluation and determination in writing and in20 clude the bases therefor; 

21 ‘‘(C) the scientific and medical determina22 tion of the Secretary contained in such evalua23 tion shall be binding on the Attorney General; 

24 and 


kjohnson on DSK79L0C42PROD with BILLS
9 

•HR 568 IH

1 ‘‘(D) not later than 90 days after receiving 

2 such evaluation, the Attorney General shall 

3 issue an order removing such fentanyl-related 

4 substance from schedule I and controlling such 

5 substance under schedule III. 

6 ‘‘(3) EVALUATION FACTORS.— 

7 ‘‘(A) IN GENERAL.—In making a deter8 mination under paragraph (1) or (2), the Sec9 retary— 

10 ‘‘(i) shall consider— 

11 ‘‘(I) the factor listed in para12 graph (2) of subsection (c); 

13 ‘‘(II) the factors listed in para14 graphs (1), (3), and (6) of such sub15 section to the extent evidence exists 

16 with respect to such factors; and 

17 ‘‘(III) any information submitted 

18 to the Secretary by the Attorney Gen19 eral for purposes of such determina20 tion; and 

21 ‘‘(ii) may consider the factors listed in 

22 paragraphs (4), (5), and (7) of subsection 

23 (c) if the Secretary finds that evidence ex24 ists with respect to such factors. 


kjohnson on DSK79L0C42PROD with BILLS
10 

•HR 568 IH

1 ‘‘(B) CONSIDERATION OF SCIENTIFIC EVI2 DENCE OF PHARMACOLOGICAL EFFECT.— 

3 ‘‘(i) IN GENERAL.—For the purposes 

4 of subparagraph (A)(i)(I), consideration by 

5 the Secretary of the results of an assess6 ment consisting of the studies described in 

7 clause (ii) shall suffice to constitute consid8 eration of the factor listed in paragraph 

9 (2) of subsection (c) if— 

10 ‘‘(I) each such study is per11 formed according to scientific methods 

12 and protocols commonly accepted in 

13 the scientific community; and 

14 ‘‘(II) the Secretary determines 

15 that such assessment is adequate for 

16 such purposes. 

17 ‘‘(ii) DESCRIBED STUDIES.—The 

18 studies described in this clause are any of 

19 the following: 

20 ‘‘(I) A receptor binding study 

21 that can demonstrate whether the 

22 substance has affinity for the human 

23 mu opioid receptor. 

24 ‘‘(II) An in vitro functional assay 

25 that can demonstrate whether the 


kjohnson on DSK79L0C42PROD with BILLS
11 

•HR 568 IH

1 substance has agonist activity at the 

2 human mu opioid receptor. 

3 ‘‘(III) One or more in vivo ani4 mal behavioral studies that can dem5 onstrate whether the substance has 

6 abuse-related drug effects consistent 

7 with mu opioid agonist activity, such 

8 as demonstrating similarity to the ef9 fects of morphine. 

10 ‘‘(4) ADVANCE NOTICE REGARDING EVALUA11 TION AND CONCLUSION.—The Secretary shall give 

12 the Attorney General at least 30 days notice before 

13 sending the Attorney General an evaluation and de14 termination under paragraph (1) or (2) with respect 

15 to a fentanyl-related substance. 

16 ‘‘(5) EXCEPTION FOR TREATY OBLIGATIONS.— 

17 If a fentanyl-related substance is a substance that 

18 the United States is obligated to control under inter19 national treaties, conventions, or protocols in effect 

20 on the date of enactment of the Save Americans 

21 from the Fentanyl Emergency Act, this subsection 

22 shall not require the Attorney General— 

23 ‘‘(A) to remove such substance from con24 trol; or 


kjohnson on DSK79L0C42PROD with BILLS
12 

•HR 568 IH

1 ‘‘(B) to place such substance in a schedule 

2 less restrictive than that which the Attorney 

3 General determines is necessary to carry out 

4 such obligations. 

5 ‘‘(6) IDENTIFICATION OF FENTANYL-RELATED

6 SUBSTANCES.—If the Attorney General or any offi7 cial of the Department of Justice determines that a 

8 substance is a fentanyl-related substance, the Attor9 ney General shall— 

10 ‘‘(A) within 30 days of such determination, 

11 notify the Secretary; and 

12 ‘‘(B) include in such notification the iden13 tity of the substance, its structure, and the 

14 basis for the determination. 

15 ‘‘(7) PETITIONS FOR REMOVING A FENTANYL16 RELATED SUBSTANCE.— 

17 ‘‘(A) IN GENERAL.—If a person petitions 

18 the Attorney General to remove a fentanyl-re19 lated substance from schedule I(e) or to re20 schedule such a substance to another schedule, 

21 the Attorney General shall consider such a peti22 tion in accordance with the procedures and 

23 standards set forth in— 

24 ‘‘(i) subsections (a) and (b) of this 

25 section; and 


kjohnson on DSK79L0C42PROD with BILLS
13 

•HR 568 IH

1 ‘‘(ii) section 1308.43 of title 21, Code 

2 of Federal Regulations (or any successor 

3 regulations). 

4 ‘‘(B) ATTORNEY GENERAL TO INFORM

5 SECRETARY.—Within 30 days of receiving such 

6 a petition, the Attorney General shall forward a 

7 copy of the petition to the Secretary. 

8 ‘‘(C) DETERMINATION PROCEDURE NOT

9 PRECLUDED BY FILING OF PETITION.—The fil10 ing of a petition under this paragraph shall not 

11 preclude the Secretary from making a deter12 mination and sending an evaluation under para13 graph (1) or (2). 

14 ‘‘(8) RULE OF CONSTRUCTION.—Nothing in 

15 this subsection shall be construed to preclude the At16 torney General from transferring a substance listed 

17 in schedule I to another schedule, or removing such 

18 substance entirely from the schedules, pursuant to 

19 other provisions of this section and section 202. 

20 ‘‘(9) SUBSEQUENT CONTROLLING OF REMOVED

21 SUBSTANCE.—A substance removed from schedule I 

22 pursuant to this subsection may, at any time, be 

23 controlled pursuant to the other provisions of this 

24 section and section 202 without regard to the re25 moval pursuant to this subsection. 


kjohnson on DSK79L0C42PROD with BILLS
14 

•HR 568 IH

1 ‘‘(10) EVALUATIONS OR STUDIES.—The Sec2 retary may enter into contracts or other agreements 

3 to conduct or support evaluations or studies of 

4 fentanyl-related substances. 

5 ‘‘(11) DEFINITION.—In this subsection, the 

6 term ‘fentanyl-related substance’ means a fentanyl7 related substance as defined in schedule I(e) of sec8 tion 202(c).’’. 

9 SEC. 6. PAST CASES INVOLVING REMOVED OR RESCHED10 ULED SUBSTANCES. 

11 (a) DOMESTIC CASES.—Section 401(b) of the Con12 trolled Substances Act (21 U.S.C. 841(b)) is amended by 

13 adding at the end the following: 

14 ‘‘(8) PAST CONVICTIONS INVOLVING FENTANYL-RE15 LATED SUBSTANCE.— 

16 ‘‘(A) IN GENERAL.—In the case of a defendant 

17 whose offense of conviction under this title involved 

18 a fentanyl-related substance (as defined in schedule 

19 I(e) of section 202(c) as of the date the offense was 

20 committed) that has since been removed from des21 ignation as a fentanyl-related substance for purposes 

22 of this title and has been placed on any schedule 

23 other than schedule I or II or has been removed 

24 from the controlled substance schedules, the sen25 tencing court may, on motion of the defendant, the 


kjohnson on DSK79L0C42PROD with BILLS
15 

•HR 568 IH

1 Bureau of Prisons, the attorney for the Government, 

2 or on its own motion, after considering the factors 

3 set forth in section 3553(a) of title 18, United 

4 States Code, vacate the previously imposed sentence, 

5 or impose a reduced sentence on any count of con6 viction as if the removal or placement was in effect 

7 at the time that the offense was committed. Nothing 

8 in this section may be construed to require a court 

9 to vacate or reduce any sentence. 

10 ‘‘(B) DEFENDANT NOT REQUIRED TO BE

11 PRESENT.—Notwithstanding rule 43 of the Federal 

12 Rules of Criminal Procedure, the defendant is not 

13 required to be present at any hearing on whether to 

14 vacate or reduce a sentence pursuant to this sec15 tion.’’. 

16 (b) IMPORT AND EXPORT CASES.—Section 1010(b) 

17 of the Controlled Substances Import and Export Act (21 

18 U.S.C. 960(b)) is amended by adding at the end the fol19 lowing: 

20 ‘‘(8) In the case of a defendant whose offense of con21 viction under this title involved a fentanyl-related sub22 stance (as defined in schedule I(e) of section 202(c) of 

23 the Controlled Substances Act as of the date the offense 

24 was committed) that has since been removed from des25 ignation as a fentanyl-related substance for purposes of 


kjohnson on DSK79L0C42PROD with BILLS
16 

•HR 568 IH

1 this title and has been placed on any schedule other than 

2 schedule I or II or has been removed from the controlled 

3 substance schedules, the sentencing court may, on motion 

4 of the defendant, the Bureau of Prisons, the attorney for 

5 the Government, or on its own motion, after considering 

6 the factors set forth in section 3553(a) of title 18, United 

7 States Code, vacate the previously imposed sentence, or 

8 impose a reduced sentence on any count of conviction as 

9 if the removal or placement was in effect at the time that 

10 the offense was committed. Nothing in this section may 

11 be construed to require a court to vacate or reduce any 

12 sentence.’’. 

13 SEC. 7. REGISTRATION REQUIREMENTS RELATED TO RE14 SEARCH. 

15 (a) ALTERNATIVE REGISTRATION PROCESS FOR

16 SCHEDULE I RESEARCH.—Section 303 of the Controlled 

17 Substances Act (21 U.S.C. 823) is amended by adding at 

18 the end the following new subsection: 

19 ‘‘(m) SPECIAL PROVISIONS FOR THOSE CONDUCTING

20 CERTAIN RESEARCH WITH SCHEDULE I CONTROLLED

21 SUBSTANCES.— 

22 ‘‘(1) IN GENERAL.—Notwithstanding subsection 

23 (f), a practitioner may conduct research that is de24 scribed in paragraph (2) and that is with one or 


kjohnson on DSK79L0C42PROD with BILLS
17 

•HR 568 IH

1 more controlled substances in schedule I if one of 

2 the following conditions is satisfied: 

3 ‘‘(A) RESEARCHER WITH A CURRENT

4 SCHEDULE I OR II RESEARCH REGISTRATION.— 

5 If the practitioner is registered to conduct re6 search with a controlled substance in schedule 

7 I or II, the practitioner may conduct research 

8 under this paragraph 30 days after the practi9 tioner has sent a notice to the Attorney General 

10 containing the following information, with re11 spect to each substance with which the research 

12 will be conducted: 

13 ‘‘(i) The chemical name of the sub14 stance. 

15 ‘‘(ii) The quantity of the substance to 

16 be used in such research. 

17 ‘‘(iii) Demonstration that the research 

18 is described in paragraph (2), which dem19 onstration can be satisfied— 

20 ‘‘(I) in the case of research de21 scribed in paragraph (2)(A), by sup22 plying the number of the application 

23 submitted under section 505(i) of the 

24 Federal Food, Drug, and Cosmetic 

25 Act or section 351(a)(3) of the Public 


kjohnson on DSK79L0C42PROD with BILLS
18 

•HR 568 IH

1 Health Service Act and the sponsor of 

2 record on such application; or 

3 ‘‘(II) in the case of research de4 scribed in paragraph (2)(B), by iden5 tifying the sponsoring agency and 

6 supplying the number of the grant, 

7 contract, cooperative agreement, other 

8 transaction, or project. 

9 ‘‘(iv) Demonstration that the re10 searcher is authorized to conduct research 

11 with respect to the substance under the 

12 laws of the State in which the research will 

13 take place. 

14 ‘‘(B) RESEARCHER WITHOUT A CURRENT

15 SCHEDULE I OR II RESEARCH REGISTRATION.— 

16 If the practitioner is not currently registered to 

17 conduct research with a controlled substance in 

18 schedule I or II— 

19 ‘‘(i) the practitioner may send a no20 tice to the Attorney General containing the 

21 information listed in subparagraph (A), 

22 with respect to each substance with which 

23 the research will be conducted; 


kjohnson on DSK79L0C42PROD with BILLS
19 

•HR 568 IH

1 ‘‘(ii) the Attorney General shall treat 

2 such notice as a sufficient application for 

3 a research registration; and 

4 ‘‘(iii) within 45 days after receiving 

5 such a notice that contains all information 

6 required by subparagraph (A), the Attor7 ney General shall register the applicant, or 

8 serve an order to show cause upon the ap9 plicant in accordance with section 304(c). 

10 ‘‘(C) VERIFICATION OF INFORMATION.— 

11 On request from the Attorney General, the Sec12 retary of Health and Human Services or the 

13 Secretary of Veterans Affairs, as appropriate, 

14 shall verify information submitted by an appli15 cant under subparagraph (A)(iii). 

16 ‘‘(2) RESEARCH SUBJECT TO EXPEDITED PRO17 CEDURE.—Research described in this paragraph is 

18 research that— 

19 ‘‘(A) is the subject of an application under 

20 section 505(i) of the Federal Food, Drug, and 

21 Cosmetic Act or section 351(a)(3) of the Public 

22 Health Service Act for the investigation of a 

23 drug which is in effect in accordance with sec24 tion 312.40 of title 21, Code of Federal Regula25 tions; or 


kjohnson on DSK79L0C42PROD with BILLS
20 

•HR 568 IH

1 ‘‘(B) is conducted by the Department of 

2 Health and Human Services, the Department of 

3 Justice, or the Department of Veterans Affairs 

4 or is funded partly or entirely by a grant, con5 tract, cooperative agreement, or other trans6 action from the Department of Health and 

7 Human Services, the Department of Justice, or 

8 the Department of Veterans Affairs. 

9 ‘‘(3) ELECTRONIC SUBMISSIONS.—The Attorney 

10 General shall provide a means to allow practitioners 

11 to submit notifications under paragraph (1) elec12 tronically. 

13 ‘‘(4) LIMITATION ON AMOUNTS.—A practitioner 

14 conducting research with a controlled substance in 

15 schedule I pursuant to this subsection shall be al16 lowed to possess only the amounts of the controlled 

17 substance in schedule I identified in— 

18 ‘‘(A) the notification to the Attorney Gen19 eral under paragraph (1); or 

20 ‘‘(B) if the practitioner needs additional 

21 amounts for the research, a supplemental notifi22 cation under this subsection that includes the 

23 practitioner’s name, the additional quantity 

24 needed of the substance, and an attestation 

25 that the research to be conducted with the subVerDate Sep 11 2014 04:25 Feb 09, 2023 Jkt 039200 PO 00000 Frm 00020 Fmt 6652 Sfmt 6201 E:\BILLS\H568.IH H568

kjohnson on DSK79L0C42PROD with BILLS
21 

•HR 568 IH

1 stance is consistent with the scope of the re2 search that was the subject of the notification 

3 under paragraph (1). 

4 ‘‘(5) IMPORTATION AND EXPORTATION RE5 QUIREMENTS NOT AFFECTED.—Nothing in this sec6 tion alters the requirements of part A of title III re7 garding the importation and exportation of con8 trolled substances.’’. 

9 (b) SEPARATE REGISTRATIONS NOT REQUIRED FOR

10 ADDITIONAL RESEARCHER IN SAME INSTITUTION.—Sub11 section (c) of section 302 of the Controlled Substances Act 

12 (21 U.S.C. 822) is amended by adding at the end the fol13 lowing: 

14 ‘‘(4) An agent or employee of a research insti15 tution that is conducting research with a controlled 

16 substance if— 

17 ‘‘(A) such agent or employee is acting 

18 within the scope of his or her professional prac19 tice; 

20 ‘‘(B) another agent or employee of such in21 stitution is registered to conduct research with 

22 a controlled substance in the same schedule; 

23 ‘‘(C) the researcher who is so registered— 

24 ‘‘(i) informs the Attorney General of 

25 the name, position title, and employing inVerDate Sep 11 2014 04:25 Feb 09, 2023 Jkt 039200 PO 00000 Frm 00021 Fmt 6652 Sfmt 6201 E:\BILLS\H568.IH H568

kjohnson on DSK79L0C42PROD with BILLS
22 

•HR 568 IH

1 stitution of the agent or employee who is 

2 not separately registered; 

3 ‘‘(ii) authorizes such agent or em4 ployee to perform research under the reg5 istered researcher’s registration; and 

6 ‘‘(iii) affirms that all acts taken by 

7 such agent or employee involving controlled 

8 substances shall be attributable to the reg9 istered researcher, as if the researcher had 

10 directly committed such acts, for purposes 

11 of any proceeding under section 304(a) to 

12 suspend or revoke the registration of the 

13 registered researcher; and 

14 ‘‘(D) the Attorney General does not, within 

15 30 days of receiving the information, authoriza16 tion, and affirmation described in subparagraph 

17 (C), refuse, for a reason listed in section 

18 304(a), to allow such agent or employee to pos19 sess such substance without a separate registra20 tion.’’. 

21 (c) SINGLE REGISTRATION FOR RELATED RESEARCH

22 SITES.—Such section 302(e) of the Controlled Substances 

23 Act (21 U.S.C. 822(e)) is amended by adding at the end 

24 the following: 


kjohnson on DSK79L0C42PROD with BILLS
23 

•HR 568 IH

1 ‘‘(4)(A) Notwithstanding paragraph (1), a person 

2 registered to conduct research with a controlled substance 

3 under section 303(f) may conduct such research at mul4 tiple sites under a single registration if— 

5 ‘‘(i) such research occurs exclusively at sites 

6 which are all within the same city or county and are 

7 all under the control of the same institution, organi8 zation, or agency; and 

9 ‘‘(ii) the researcher notifies the Attorney Gen10 eral, prior to commencing such research, of all sites 

11 where— 

12 ‘‘(I) the research will be conducted; or 

13 ‘‘(II) the controlled substance will be 

14 stored or administered. 

15 ‘‘(B) A site described by subparagraph (A) shall be 

16 included in such registration only if the researcher has no17 tified the Attorney General of such site— 

18 ‘‘(i) in the application for such registration; or 

19 ‘‘(ii) before the research is conducted, or before 

20 the controlled substance is stored or administered, at 

21 such site. 

22 ‘‘(C) The Attorney General may, in consultation with 

23 the Secretary of Health and Human Services, issue regu24 lations addressing— 


kjohnson on DSK79L0C42PROD with BILLS
24 

•HR 568 IH

1 ‘‘(i) the manner in which controlled substances 

2 may be delivered to research sites described in sub3 paragraph (A); 

4 ‘‘(ii) the storage and security of controlled sub5 stances at such research sites; 

6 ‘‘(iii) the maintenance of records for such re7 search sites; and 

8 ‘‘(iv) any other matters necessary to ensure ef9 fective controls against diversion at such research 

10 sites.’’. 

11 (d) NEW INSPECTION NOT REQUIRED IN CERTAIN

12 SITUATIONS.—Subsection (f) of section 302 of the Con13 trolled Substances Act (21 U.S.C. 822) is amended— 

14 (1) by striking ‘‘(f) The’’ and inserting ‘‘(f)(1) 

15 The’’; and 

16 (2) by adding at the end the following: 

17 ‘‘(2)(A) A new inspection by the Attorney General of 

18 a registered location is not required if a person is reg19 istered under this title to conduct research with a con20 trolled substance and applies for a registration, or for a 

21 modification of a registration, to conduct research with a 

22 second controlled substance that is— 

23 ‘‘(i) in the same schedule as the first controlled 

24 substance; or 


kjohnson on DSK79L0C42PROD with BILLS
25 

•HR 568 IH

1 ‘‘(ii) is in a schedule with a higher numerical 

2 designation than the schedule of the first controlled 

3 substance. 

4 ‘‘(B) Nothing in this paragraph shall prohibit the At5 torney General from conducting any inspection if the At6 torney General deems it necessary to ensure that the reg7 istrant maintains effective controls against diversion.’’. 

8 (e) CONTINUATION OF RESEARCH ON SUBSTANCES

9 NEWLY ADDED TO SCHEDULE I.—Section 302 of the 

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

11 by adding at the end the following: 

12 ‘‘(h) CONTINUATION OF RESEARCH ON SUBSTANCES

13 NEWLY ADDED TO SCHEDULE I.—If a person is con14 ducting research on a substance at the time the substance 

15 is added to schedule I, and such person is already reg16 istered under this title to conduct research with a con17 trolled substance in schedule I, then— 

18 ‘‘(1) the person shall, within 90 days of the 

19 scheduling in schedule I, submit a completed appli20 cation for registration under this title or modifica21 tion of an existing registration under this title, to 

22 conduct research on such substance, in accordance 

23 with regulations issued by the Attorney General; 


kjohnson on DSK79L0C42PROD with BILLS
26 

•HR 568 IH

1 ‘‘(2) the person may, notwithstanding sub2 sections (a) and (b), continue to conduct the re3 search on such substance until— 

4 ‘‘(A) the person withdraws such applica5 tion; or 

6 ‘‘(B) the Attorney General serves on the 

7 person an order to show cause proposing the 

8 denial of the application pursuant to section 

9 304(c); 

10 ‘‘(3) if the Attorney General serves such an 

11 order to show cause and the person requests a hear12 ing, such hearing shall be held on an expedited basis 

13 and not later than 45 days after the request is 

14 made, except that the hearing may be held at a later 

15 time if so requested by the person; and 

16 ‘‘(4) if the person sends a copy of the applica17 tion required by paragraph (1) to a manufacturer or 

18 distributor of such substance, receipt of such copy 

19 by such manufacturer or distributor shall constitute 

20 sufficient evidence that the person is authorized to 

21 receive such substance.’’. 

22 (f) TREATMENT OF CERTAIN MANUFACTURING AC23 TIVITIES AS COINCIDENT TO RESEARCH.—Section 302 of 

24 the Controlled Substances Act (21 U.S.C. 822), as amendVerDate Sep 11 2014 04:25 Feb 09, 2023 Jkt 039200 PO 00000 Frm 00026 Fmt 6652 Sfmt 6201 E:\BILLS\H568.IH H568

kjohnson on DSK79L0C42PROD with BILLS
27 

•HR 568 IH

1 ed by subsection (e), is further amended by adding at the 

2 end the following: 

3 ‘‘(i) TREATMENT OF CERTAIN MANUFACTURING AC4 TIVITIES AS COINCIDENT TO RESEARCH.— 

5 ‘‘(1) IN GENERAL.—Except as specified in 

6 paragraph (3), a person who is registered to perform 

7 research on a controlled substance may perform 

8 manufacturing activities with small quantities of 

9 that substance, including activities listed in para10 graph (2), without being required to obtain a manu11 facturing registration, if such activities are per12 formed for the purpose of the research and if the ac13 tivities and the quantities of the substance involved 

14 in those activities are stated in— 

15 ‘‘(A) a notification submitted to the Attor16 ney General under section 303(m); 

17 ‘‘(B) a protocol filed with an application 

18 for registration approval under section 303(f); 

19 or 

20 ‘‘(C) a notification to the Attorney General 

21 that includes the registrant’s name and an at22 testation that the research to be conducted with 

23 the small quantities of manufactured substance 

24 is consistent with the scope of the research that 

25 is the basis for the registration. 


kjohnson on DSK79L0C42PROD with BILLS
28 

•HR 568 IH

1 ‘‘(2) ACTIVITIES INCLUDED.—Activities per2 mitted under paragraph (1) include— 

3 ‘‘(A) processing the substance to create ex4 tracts, tinctures, oils, solutions, derivatives, or 

5 other forms of the substance consistent with the 

6 information provided as part of a notification 

7 submitted to the Attorney General under sec8 tion 303(m) or a research protocol filed with 

9 the application for registration approval; and 

10 ‘‘(B) dosage form development studies per11 formed for the purpose of satisfying regulatory 

12 requirements of the Food and Drug Adminis13 tration for submitting an investigational new 

14 drug application. 

15 ‘‘(3) EXCEPTION REGARDING MARIHUANA.— 

16 The authority under paragraph (1) to manufacture 

17 substances does not include authority to grow mari18 huana.’’. 

19 (g) TRANSPARENCY REGARDING SPECIAL PROCE20 DURES.—Section 303 of such Act (21 U.S.C. 823), as 

21 amended by subsection (a), is further amended by adding 

22 at the end the following: 

23 ‘‘(n) TRANSPARENCY REGARDING SPECIAL PROCE24 DURES.— 


kjohnson on DSK79L0C42PROD with BILLS
29 

•HR 568 IH

1 ‘‘(1) IN GENERAL.—If the Attorney General de2 termines, with respect to a controlled substance, that 

3 an application by a practitioner to conduct research 

4 with such substance should be considered under a 

5 process, or subject to criteria, different from the 

6 process or criteria applicable to applications to con7 duct research with other controlled substances in the 

8 same schedule, the Attorney General shall make 

9 public, including by posting on the website of the 

10 Drug Enforcement Administration— 

11 ‘‘(A) the identities of all substances for 

12 which such determinations have been made; 

13 ‘‘(B) the process and criteria that will be 

14 applied to applications to conduct research with 

15 such substances; and 

16 ‘‘(C) how such process and criteria differ 

17 from those applicable to applications to conduct 

18 research with other controlled substances in the 

19 same schedule. 

20 ‘‘(2) TIMING OF POSTING.—The Attorney Gen21 eral shall make such information public upon mak22 ing such determination, regardless of whether a 

23 practitioner has submitted such an application at 

24 that time.’’. 


kjohnson on DSK79L0C42PROD with BILLS
30 

•HR 568 IH

1 SEC. 8. RULEMAKING. 

2 (a) INTERIM FINAL RULES.—The Attorney Gen3 eral— 

4 (1) not later than 1 year of the date of enact5 ment of this Act, shall issue rules to implement this 

6 Act and the amendments made by this Act; and 

7 (2) may issue such rules as interim final rules. 

8 (b) PROCEDURE FOR FINAL RULE.—A rule issued by 

9 the Attorney General as an interim final rule under sub10 section (a) shall become immediately effective as an in11 terim final rule without requiring the Attorney General to 

12 demonstrate good cause therefor. The interim final rule 

13 shall give interested persons the opportunity to comment 

14 and to request a hearing. After the conclusion of such pro15 ceedings, the Attorney General shall issue a final rule in 

16 accordance with section 553 of title 5, United States Code. 

17 SEC. 9. GAO REPORT. 

18 (a) IN GENERAL.—Not more than 4 years after the 

19 date of enactment of this Act, the Comptroller General 

20 of the United States shall submit to the Committees on 

21 Energy and Commerce and the Judiciary of the House 

22 of Representatives and the Committee on the Judiciary 

23 of the Senate a report analyzing the implementation and 

24 impact, to the extent information is available, of perma25 nent class scheduling pursuant to schedule I(e) of section 

26 202(c) of the Controlled Substances Act, as added by secVerDate Sep 11 2014 04:25 Feb 09, 2023 Jkt 039200 PO 00000 Frm 00030 Fmt 6652 Sfmt 6201 E:\BILLS\H568.IH H568

kjohnson on DSK79L0C42PROD with BILLS
31 

•HR 568 IH

1 tion 2 of this Act, of fentanyl-related substances (as de2 fined in such schedule I(e)), which report shall include— 

3 (1) an analysis of the impact on research of 

4 fentanyl-related substances; 

5 (2) an analysis of any actions taken to remove 

6 or reschedule in a different class any fentanyl-re7 lated substance; 

8 (3) an analysis of the impact of permanent 

9 scheduling on the unlawful importation, manufac10 ture, trafficking, and use of fentanyl-related sub11 stances, taking into consideration data collected con12 cerning the proliferation of fentanyl-related sub13 stances since class scheduling was instituted; 

14 (4) an analysis of sentences attributable to 

15 criminal charges involving fentanyl-related sub16 stances, comparing those sentences to sentences at17 tributable to criminal charges involving fentanyl and 

18 individually scheduled fentanyl analogues; and 

19 (5) an analysis of the efficacy of class sched20 uling generally, in terms of reducing the prolifera21 tion of new controlled substance analogues. 

22 (b) CONSULTATIONS.—In developing the report re23 quired by subsection (a), the Comptroller General— 

24 (1) shall consider the views of the Secretary of 

25 Health and Human Services, the Attorney General, 


kjohnson on DSK79L0C42PROD with BILLS
32 

•HR 568 IH

1 the Secretary of Homeland Security, the Secretary 

2 of State, the Director of the Office of National Drug 

3 Control Policy, the scientific and medical research 

4 community, the State and local law enforcement 

5 community, and the civil rights and criminal justice 

6 reform communities; and 

7 (2) to the greatest extent possible, should base 

8 such report on reliable data and empirical informa9 tion. 

Æ 


kjohnson on DSK79L0C42PROD with BILLS