I 
119TH CONGRESS 
1ST SESSION 
H. R. 830 
To amend the Controlled Substances Act with respect to fentanyl-related 
substances, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JANUARY 31, 2025 
Mr. PAPPAS (for himself, Ms. SALAZAR, and Mr. NEWHOUSE) introduced the 
following bill; which was referred to the Committee on Energy and Com-
merce, and in addition to the Committee on the Judiciary, for a period 
to be subsequently determined by the Speaker, in each case for consider-
ation 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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Save Americans from 
the Fentanyl Emergency Act’’ or the ‘‘SAFE Act’’. 
VerDate Sep 11 2014 
00:48 Feb 27, 2025
Jkt 059200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H830.IH
H830
ssavage on LAPJG3WLY3PROD with BILLS
SEC. 2. CLASS SCHEDULING OF FENTANYL-RELATED SUB-
STANCES. 
Section 202(c) of the Controlled Substances Act (21 
U.S.C. 812(c)) is amended by adding at the end of sched-
ule I the following: 
‘‘(e)(1) Unless specifically exempted or unless listed 
in another schedule, any material, compound, mixture, or 
preparation which contains any quantity of fentanyl-re-
lated substances, or which contains their salts, isomers, 
and salts of isomers whenever the existence of such salts, 
isomers, and salts of isomers is possible within the specific 
chemical designation. 
‘‘(2) In this subsection, except as provided in para-
graph (3), the term ‘fentanyl-related substance’ means 
any substance that is structurally related to fentanyl by 
one or more of the following modifications: 
‘‘(A) By replacement of the phenyl portion of 
the phenethyl group by any monocycle, whether or 
not further substituted in or on the monocycle. 
‘‘(B) By substitution in or on the phenethyl 
group with alkyl, alkenyl, alkoxyl, hydroxyl, halo, 
haloalkyl, amino, or nitro groups. 
‘‘(C) By substitution in or on the piperidine 
ring with alkyl, alkenyl, alkoxyl, ester, ether, 
hydroxyl, halo, haloalkyl, amino, or nitro groups. 
VerDate Sep 11 2014 
00:48 Feb 27, 2025
Jkt 059200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H830.IH
H830
ssavage on LAPJG3WLY3PROD with BILLS
‘‘(D) By replacement of the aniline ring with 
any aromatic monocycle whether or not further sub-
stituted in or on the aromatic monocycle. 
‘‘(E) By replacement of the N-propionyl group 
with another acyl group. 
‘‘(3) A substance that meets the criteria specified in 
paragraph (2) to be considered a fentanyl-related sub-
stance shall not be so considered as meeting such criteria 
if such substance— 
‘‘(A) is controlled by action of the Attorney 
General pursuant to section 201; 
‘‘(B) is expressly listed in this schedule or an-
other schedule by a statutory provision other than 
this subsection; or 
‘‘(C) is removed from this schedule, or resched-
uled to another schedule, pursuant to section 201(k). 
‘‘(4) The Attorney General shall publish in the Fed-
eral Register a list of individual substances that meet the 
definition of fentanyl-related substances in paragraph (2) 
within 60 days of determining such substances meet such 
definition. The absence of a substance on any such list 
does not negate the control status of such substance if 
the substance meets the criteria specified in paragraph (2) 
to be considered a fentanyl-related substance. 
VerDate Sep 11 2014 
00:48 Feb 27, 2025
Jkt 059200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H830.IH
H830
ssavage on LAPJG3WLY3PROD with BILLS
‘‘(5) Notwithstanding any other provision of this title 
or title III, fentanyl-related substances shall not be subject 
to quantity-based mandatory minimum penalties pursuant 
to subparagraph (A)(vi) or (B)(vi) of section 401(b)(1) of 
this title or paragraph (1)(F) or (2)(F) of section 1010(b) 
of title III.’’. 
SEC. 
3. 
PENALTY 
PROVISIONS 
WITH 
RESPECT 
TO 
FENTANYL-RELATED 
SUBSTANCES—DOMES-
TIC OFFENSES. 
Section 401(b)(1) of the Controlled Substances Act 
(21 U.S.C. 841(b)(1)) is amended— 
(1) in subparagraph (A), by striking clause (vi) 
and inserting the following: 
‘‘(vi)(I) 400 grams or more of a mixture or sub-
stance containing a detectable amount of fentanyl; 
or 
‘‘(II) 100 grams or more of a mixture or sub-
stance containing a detectable amount of any ana-
logue of fentanyl that is controlled in schedule I or 
II or that is treated as a schedule I controlled sub-
stance pursuant to section 203(a), except for a 
fentanyl-related substance as defined in schedule 
I(e) of section 202(c);’’; 
(2) in subparagraph (B), by striking clause (vi) 
and inserting the following: 
VerDate Sep 11 2014 
00:48 Feb 27, 2025
Jkt 059200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H830.IH
H830
ssavage on LAPJG3WLY3PROD with BILLS
‘‘(vi)(I) 40 grams or more of a mixture or sub-
stance containing a detectable amount of fentanyl; 
or 
‘‘(II) 10 grams or more of a mixture or sub-
stance containing a detectable amount of any ana-
logue of fentanyl that is controlled in schedule I or 
II or that is treated as a schedule I controlled sub-
stance pursuant to section 203(a), except for a 
fentanyl-related substance as defined in schedule 
I(e) of section 202(c);’’; and 
(3) in subparagraph (C), by inserting ‘‘, includ-
ing a fentanyl-related substance as defined in sched-
ule I(e) of section 202(c),’’ after ‘‘a controlled sub-
stance in schedule I or II,’’. 
SEC. 
4. 
PENALTY 
PROVISIONS 
WITH 
RESPECT 
TO 
FENTANYL-RELATED 
SUBSTANCES—IMPORT 
AND EXPORT OFFENSES. 
Section 1010(b) of the Controlled Substances Import 
and Export Act (21 U.S.C. 960(b)) is amended— 
(1) in paragraph (1), by striking subparagraph 
(F) and inserting the following: 
‘‘(F)(i) 400 grams or more of a mixture or sub-
stance containing a detectable amount of fentanyl; 
or 
VerDate Sep 11 2014 
00:48 Feb 27, 2025
Jkt 059200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H830.IH
H830
ssavage on LAPJG3WLY3PROD with BILLS
‘‘(ii) 100 grams or more of a mixture or sub-
stance containing a detectable amount of any ana-
logue of fentanyl that is controlled in schedule I or 
II or that is treated as a schedule I controlled sub-
stance pursuant to section 203(a) of the Controlled 
Substances Act, except for a fentanyl-related sub-
stance as defined in schedule I(e) of section 202(c) 
of the Controlled Substances Act;’’; 
(2) in paragraph (2), by striking subparagraph 
(F) and inserting the following: 
‘‘(F)(i) 40 grams or more of a mixture or sub-
stance containing a detectable amount of fentanyl; 
or 
‘‘(ii) 10 grams or more of a mixture or sub-
stance containing a detectable amount of any ana-
logue of fentanyl that is controlled in schedule I or 
II or that is treated as a schedule I controlled sub-
stance pursuant to section 203(a) of the Controlled 
Substances Act, except for a fentanyl-related sub-
stance as defined in schedule I(e) of section 202(c) 
of the Controlled Substances Act;’’; and 
(3) in paragraph (3), by inserting ‘‘including a 
fentanyl-related substance as defined in schedule 
I(e) of section 202(c) of the Controlled Substances 
VerDate Sep 11 2014 
00:48 Feb 27, 2025
Jkt 059200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6201
E:\BILLS\H830.IH
H830
ssavage on LAPJG3WLY3PROD with BILLS
Act,’’ after ‘‘a controlled substance in schedule I or 
II,’’. 
SEC. 5. REMOVAL FROM SCHEDULE I OF FENTANYL-RE-
LATED SUBSTANCES. 
Section 201 of the Controlled Substances Act (21 
U.S.C. 811) is amended by adding at the end the following 
new subsection: 
‘‘(k) REMOVAL FROM SCHEDULE I OF FENTANYL- 
RELATED SUBSTANCES.— 
‘‘(1) DETERMINATION
RESULTING
IN
RE-
MOVAL.—If the Secretary determines, taking into 
consideration factors as set forth in paragraph (3), 
that a fentanyl-related substance has a potential for 
abuse that is less than the drugs or other substances 
in schedule V— 
‘‘(A) the Secretary shall submit to the At-
torney General a scientific and medical evalua-
tion of that fentanyl-related substance sup-
porting that determination; 
‘‘(B) the Secretary shall submit any such 
evaluation and determination in writing and in-
clude the bases therefor; 
‘‘(C) the scientific and medical determina-
tion of the Secretary contained in such evalua-
VerDate Sep 11 2014 
00:48 Feb 27, 2025
Jkt 059200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6201
E:\BILLS\H830.IH
H830
ssavage on LAPJG3WLY3PROD with BILLS
tion shall be binding on the Attorney General; 
and 
‘‘(D) not later than 90 days after receiving 
such evaluation and determination, the Attor-
ney General shall issue an order removing such 
fentanyl-related substance from the schedules 
under section 202. 
‘‘(2) DETERMINATION RESULTING IN RESCHED-
ULING.—If the Secretary determines, taking into 
consideration factors as set forth in paragraph (3), 
that a fentanyl-related substance has a potential for 
abuse that is less than the drugs or other substances 
in schedules I and II— 
‘‘(A) the Secretary shall submit to the At-
torney General a scientific and medical evalua-
tion of that fentanyl-related substance sup-
porting that determination; 
‘‘(B) the Secretary shall submit any such 
evaluation and determination in writing and in-
clude the bases therefor; 
‘‘(C) the scientific and medical determina-
tion of the Secretary contained in such evalua-
tion shall be binding on the Attorney General; 
and 
VerDate Sep 11 2014 
00:48 Feb 27, 2025
Jkt 059200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6201
E:\BILLS\H830.IH
H830
ssavage on LAPJG3WLY3PROD with BILLS
‘‘(D) not later than 90 days after receiving 
such evaluation, the Attorney General shall 
issue an order removing such fentanyl-related 
substance from schedule I and controlling such 
substance under schedule III. 
‘‘(3) EVALUATION FACTORS.— 
‘‘(A) IN
GENERAL.—In making a deter-
mination under paragraph (1) or (2), the Sec-
retary— 
‘‘(i) shall consider— 
‘‘(I) the factor listed in para-
graph (2) of subsection (c); 
‘‘(II) the factors listed in para-
graphs (1), (3), and (6) of such sub-
section to the extent evidence exists 
with respect to such factors; and 
‘‘(III) any information submitted 
to the Secretary by the Attorney Gen-
eral for purposes of such determina-
tion; and 
‘‘(ii) may consider the factors listed in 
paragraphs (4), (5), and (7) of subsection 
(c) if the Secretary finds that evidence ex-
ists with respect to such factors. 
VerDate Sep 11 2014 
00:48 Feb 27, 2025
Jkt 059200
PO 00000
Frm 00009
Fmt 6652
Sfmt 6201
E:\BILLS\H830.IH
H830
ssavage on LAPJG3WLY3PROD with BILLS
‘‘(B) CONSIDERATION OF SCIENTIFIC EVI-
DENCE OF PHARMACOLOGICAL EFFECT.— 
‘‘(i) IN GENERAL.—For the purposes 
of subparagraph (A)(i)(I), consideration by 
the Secretary of the results of an assess-
ment consisting of the studies described in 
clause (ii) shall suffice to constitute consid-
eration of the factor listed in paragraph 
(2) of subsection (c) if— 
‘‘(I) each such study is per-
formed according to scientific methods 
and protocols commonly accepted in 
the scientific community; and 
‘‘(II) the Secretary determines 
that such assessment is adequate for 
such purposes. 
‘‘(ii) 
DESCRIBED
STUDIES.—The 
studies described in this clause are any of 
the following: 
‘‘(I) A receptor binding study 
that can demonstrate whether the 
substance has affinity for the human 
mu opioid receptor. 
‘‘(II) An in vitro functional assay 
that can demonstrate whether the 
VerDate Sep 11 2014 
00:48 Feb 27, 2025
Jkt 059200
PO 00000
Frm 00010
Fmt 6652
Sfmt 6201
E:\BILLS\H830.IH
H830
ssavage on LAPJG3WLY3PROD with BILLS
substance has agonist activity at the 
human mu opioid receptor. 
‘‘(III) One or more in vivo ani-
mal behavioral studies that can dem-
onstrate whether the substance has 
abuse-related drug effects consistent 
with mu opioid agonist activity, such 
as demonstrating similarity to the ef-
fects of morphine. 
‘‘(4) ADVANCE
NOTICE
REGARDING
EVALUA-
TION AND CONCLUSION.—The Secretary shall give 
the Attorney General at least 30 days notice before 
sending the Attorney General an evaluation and de-
termination under paragraph (1) or (2) with respect 
to a fentanyl-related substance. 
‘‘(5) EXCEPTION FOR TREATY OBLIGATIONS.— 
If a fentanyl-related substance is a substance that 
the United States is obligated to control under inter-
national treaties, conventions, or protocols in effect 
on the date of enactment of the Save Americans 
from the Fentanyl Emergency Act, this subsection 
shall not require the Attorney General— 
‘‘(A) to remove such substance from con-
trol; or 
VerDate Sep 11 2014 
00:48 Feb 27, 2025
Jkt 059200
PO 00000
Frm 00011
Fmt 6652
Sfmt 6201
E:\BILLS\H830.IH
H830
ssavage on LAPJG3WLY3PROD with BILLS
‘‘(B) to place such substance in a schedule 
less restrictive than that which the Attorney 
General determines is necessary to carry out 
such obligations. 
‘‘(6) IDENTIFICATION OF FENTANYL-RELATED 
SUBSTANCES.—If the Attorney General or any offi-
cial of the Department of Justice determines that a 
substance is a fentanyl-related substance, the Attor-
ney General shall— 
‘‘(A) within 30 days of such determination, 
notify the Secretary; and 
‘‘(B) include in such notification the iden-
tity of the substance, its structure, and the 
basis for the determination. 
‘‘(7) PETITIONS FOR REMOVING A FENTANYL- 
RELATED SUBSTANCE.— 
‘‘(A) IN GENERAL.—If a person petitions 
the Attorney General to remove a fentanyl-re-
lated substance from schedule I(e) or to re-
schedule such a substance to another schedule, 
the Attorney General shall consider such a peti-
tion in accordance with the procedures and 
standards set forth in— 
‘‘(i) subsections (a) and (b) of this 
section; and 
VerDate Sep 11 2014 
00:48 Feb 27, 2025
Jkt 059200
PO 00000
Frm 00012
Fmt 6652
Sfmt 6201
E:\BILLS\H830.IH
H830
ssavage on LAPJG3WLY3PROD with BILLS
‘‘(ii) section 1308.43 of title 21, Code 
of Federal Regulations (or any successor 
regulations). 
‘‘(B) ATTORNEY
GENERAL
TO
INFORM 
SECRETARY.—Within 30 days of receiving such 
a petition, the Attorney General shall forward a 
copy of the petition to the Secretary. 
‘‘(C) DETERMINATION
PROCEDURE
NOT 
PRECLUDED BY FILING OF PETITION.—The fil-
ing of a petition under this paragraph shall not 
preclude the Secretary from making a deter-
mination and sending an evaluation under para-
graph (1) or (2). 
‘‘(8) RULE
OF
CONSTRUCTION.—Nothing in 
this subsection shall be construed to preclude the At-
torney General from transferring a substance listed 
in schedule I to another schedule, or removing such 
substance entirely from the schedules, pursuant to 
other provisions of this section and section 202. 
‘‘(9) SUBSEQUENT CONTROLLING OF REMOVED 
SUBSTANCE.—A substance removed from schedule I 
pursuant to this subsection may, at any time, be 
controlled pursuant to the other provisions of this 
section and section 202 without regard to the re-
moval pursuant to this subsection. 
VerDate Sep 11 2014 
00:48 Feb 27, 2025
Jkt 059200
PO 00000
Frm 00013
Fmt 6652
Sfmt 6201
E:\BILLS\H830.IH
H830
ssavage on LAPJG3WLY3PROD with BILLS
‘‘(10) EVALUATIONS
OR
STUDIES.—The Sec-
retary may enter into contracts or other agreements 
to conduct or support evaluations or studies of 
fentanyl-related substances. 
‘‘(11) DEFINITION.—In this subsection, the 
term ‘fentanyl-related substance’ means a fentanyl- 
related substance as defined in schedule I(e) of sec-
tion 202(c).’’. 
SEC. 6. PAST CASES INVOLVING REMOVED OR RESCHED-
ULED SUBSTANCES. 
(a) DOMESTIC CASES.—Section 401(b) of the Con-
trolled Substances Act (21 U.S.C. 841(b)) is amended by 
adding at the end the following: 
‘‘(8) PAST CONVICTIONS INVOLVING FENTANYL-RE-
LATED SUBSTANCE.— 
‘‘(A) IN GENERAL.—In the case of a defendant 
whose offense of conviction under this title involved 
a fentanyl-related substance (as defined in schedule 
I(e) of section 202(c) as of the date the offense was 
committed) that has since been removed from des-
ignation as a fentanyl-related substance for purposes 
of this title and has been placed on any schedule 
other than schedule I or II or has been removed 
from the controlled substance schedules, the sen-
tencing court may, on motion of the defendant, the 
VerDate Sep 11 2014 
00:48 Feb 27, 2025
Jkt 059200
PO 00000
Frm 00014
Fmt 6652
Sfmt 6201
E:\BILLS\H830.IH
H830
ssavage on LAPJG3WLY3PROD with BILLS
Bureau of Prisons, the attorney for the Government, 
or on its own motion, after considering the factors 
set forth in section 3553(a) of title 18, United 
States Code, vacate the previously imposed sentence, 
or impose a reduced sentence on any count of con-
viction as if the removal or placement was in effect 
at the time that the offense was committed. Nothing 
in this section may be construed to require a court 
to vacate or reduce any sentence. 
‘‘(B) DEFENDANT
NOT
REQUIRED
TO
BE 
PRESENT.—Notwithstanding rule 43 of the Federal 
Rules of Criminal Procedure, the defendant is not 
required to be present at any hearing on whether to 
vacate or reduce a sentence pursuant to this sec-
tion.’’. 
(b) IMPORT AND EXPORT CASES.—Section 1010(b) 
of the Controlled Substances Import and Export Act (21 
U.S.C. 960(b)) is amended by adding at the end the fol-
lowing: 
‘‘(8) In the case of a defendant whose offense of con-
viction under this title involved a fentanyl-related sub-
stance (as defined in schedule I(e) of section 202(c) of 
the Controlled Substances Act as of the date the offense 
was committed) that has since been removed from des-
ignation as a fentanyl-related substance for purposes of 
VerDate Sep 11 2014 
00:48 Feb 27, 2025
Jkt 059200
PO 00000
Frm 00015
Fmt 6652
Sfmt 6201
E:\BILLS\H830.IH
H830
ssavage on LAPJG3WLY3PROD with BILLS
this title and has been placed on any schedule other than 
schedule I or II or has been removed from the controlled 
substance schedules, the sentencing court may, on motion 
of the defendant, the Bureau of Prisons, the attorney for 
the Government, or on its own motion, after considering 
the factors set forth in section 3553(a) of title 18, United 
States Code, vacate the previously imposed sentence, or 
impose a reduced sentence on any count of conviction as 
if the removal or placement was in effect at the time that 
the offense was committed. Nothing in this section may 
be construed to require a court to vacate or reduce any 
sentence.’’. 
SEC. 7. REGISTRATION REQUIREMENTS RELATED TO RE-
SEARCH. 
(a) ALTERNATIVE
REGISTRATION
PROCESS
FOR 
SCHEDULE I RESEARCH.—Section 303 of the Controlled 
Substances Act (21 U.S.C. 823) is amended by adding at 
the end the following new subsection: 
‘‘(m) SPECIAL PROVISIONS FOR THOSE CONDUCTING 
CERTAIN RESEARCH WITH SCHEDULE I CONTROLLED 
SUBSTANCES.— 
‘‘(1) IN GENERAL.—Notwithstanding subsection 
(f), a practitioner may conduct research that is de-
scribed in paragraph (2) and that is with one or 
VerDate Sep 11 2014 
00:48 Feb 27, 2025
Jkt 059200
PO 00000
Frm 00016
Fmt 6652
Sfmt 6201
E:\BILLS\H830.IH
H830
ssavage on LAPJG3WLY3PROD with BILLS
more controlled substances in schedule I if one of 
the following conditions is satisfied: 
‘‘(A) RESEARCHER
WITH
A
CURRENT 
SCHEDULE I OR II RESEARCH REGISTRATION.— 
If the practitioner is registered to conduct re-
search with a controlled substance in schedule 
I or II, the practitioner may conduct research 
under this paragraph 30 days after the practi-
tioner has sent a notice to the Attorney General 
containing the following information, with re-
spect to each substance with which the research 
will be conducted: 
‘‘(i) The chemical name of the sub-
stance. 
‘‘(ii) The quantity of the substance to 
be used in such research. 
‘‘(iii) Demonstration that the research 
is described in paragraph (2), which dem-
onstration can be satisfied— 
‘‘(I) in the case of research de-
scribed in paragraph (2)(A), by sup-
plying the number of the application 
submitted under section 505(i) of the 
Federal Food, Drug, and Cosmetic 
Act or section 351(a)(3) of the Public 
VerDate Sep 11 2014 
00:48 Feb 27, 2025
Jkt 059200
PO 00000
Frm 00017
Fmt 6652
Sfmt 6201
E:\BILLS\H830.IH
H830
ssavage on LAPJG3WLY3PROD with BILLS