[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 545 Reported in Senate (RS)]
<DOC>
Calendar No. 372
119th CONGRESS
2d Session
S. 545
To prohibit certain uses of xylazine, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
February 12, 2025
Ms. Cortez Masto (for herself, Mr. Grassley, Ms. Hassan, Mrs.
Gillibrand, Mrs. Hyde-Smith, Ms. Cantwell, Mr. Scott of Florida, Mrs.
Shaheen, Ms. Klobuchar, Mrs. Britt, Mrs. Capito, Mr. Young, Mr. Kelly,
Mr. Kaine, Mr. Risch, Ms. Rosen, Mr. Blumenthal, Mr. Lujan, Mr. Wicker,
Mr. Gallego, Mr. Tillis, Mr. Fetterman, Mr. Bennet, Ms. Lummis, Mr.
Budd, Mr. King, Mr. Justice, Mr. Crapo, Mr. McCormick, Mr. Lankford,
Mrs. Moody, Mrs. Blackburn, Mr. Cornyn, Mr. Durbin, and Mr. Cruz)
introduced the following bill; which was read twice and referred to the
Committee on the Judiciary
April 15 (legislative day, April 14), 2026
Reported by Mr. Grassley, with an amendment
[Strike out all after the enacting clause and insert the part printed
in italic]
_______________________________________________________________________
A BILL
To prohibit certain uses of xylazine, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
<DELETED>SECTION 1. SHORT TITLE.</DELETED>
<DELETED> This title may be cited as the ``Combating Illicit
Xylazine Act''.</DELETED>
<DELETED>SEC. 2. DEFINITIONS.</DELETED>
<DELETED> (a) In General.--In this title, the term ``xylazine'' has
the meaning given the term in paragraph (60) of section 102 of the
Controlled Substances Act, as added by subsection (b) of this
section.</DELETED>
<DELETED> (b) Controlled Substances Act.--Section 102 of the
Controlled Substances Act (21 U.S.C. 802) is amended by adding at the
end the following:</DELETED>
<DELETED> ``(60) The term `xylazine' means the substance xylazine,
including its salts, isomers, and salts of isomers whenever the
existence of such salts, isomers, and salts of isomers is
possible.''.</DELETED>
<DELETED>SEC. 3. ADDING XYLAZINE TO SCHEDULE III.</DELETED>
<DELETED> Schedule III of section 202(c) of the Controlled
Substances Act (21 U.S.C. 812) is amended by adding at the end the
following:</DELETED>
<DELETED> ``(f) Unless specifically excepted or unless listed in
another schedule, any material, compound, mixture, or preparation which
contains any quantity of xylazine.''.</DELETED>
<DELETED>SEC. 4. AMENDMENTS.</DELETED>
<DELETED> (a) Amendment.--Section 102 of the Controlled Substances
Act (21 U.S.C. 802) is amended by striking paragraph (27) and inserting
the following:</DELETED>
<DELETED> ``(27)(A) Except as provided in subparagraph (B), the term
`ultimate user' means a person who has lawfully obtained, and who
possesses, a controlled substance for the use by the person or for the
use of a member of the household of the person or for an animal owned
by the person or by a member of the household of the person.</DELETED>
<DELETED> ``(B)(i) In the case of xylazine, other than for a drug
product approved under subsection (b) or (j) of section 505 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), the term
`ultimate user' means a person--</DELETED>
<DELETED> ``(I) to whom xylazine was dispensed by--
</DELETED>
<DELETED> ``(aa) a veterinarian registered under
this Act; or</DELETED>
<DELETED> ``(bb) a pharmacy registered under this
Act pursuant to a prescription of a veterinarian
registered under this Act; and</DELETED>
<DELETED> ``(II) who possesses xylazine for--</DELETED>
<DELETED> ``(aa) an animal owned by the person or by
a member of the household of the person;</DELETED>
<DELETED> ``(bb) an animal under the care of the
person;</DELETED>
<DELETED> ``(cc) use in government animal-control
programs authorized under applicable Federal, State,
Tribal, or local law; or</DELETED>
<DELETED> ``(dd) use in wildlife programs authorized
under applicable Federal, State, Tribal, or local
law.</DELETED>
<DELETED> ``(ii) In this subparagraph, the term `person' includes--
</DELETED>
<DELETED> ``(I) a government agency or business where
animals are located; and</DELETED>
<DELETED> ``(II) an employee or agent of an agency or
business acting within the scope of their employment or
agency.''.</DELETED>
<DELETED> (b) Facilities.--An entity that manufactures xylazine, as
of the date of enactment of this Act, shall not be required to make
capital expenditures necessary to install the security standard
required of schedule III of the Controlled Substances Act (21 U.S.C.
801 et seq.) for the purposes of manufacturing xylazine.</DELETED>
<DELETED> (c) Labeling.--The requirements related to labeling,
packaging, and distribution logistics of a controlled substance in
schedule III of section 202(c) of the Controlled Substances Act (21
U.S.C. 812(c)) shall not take effect for xylazine until the date that
is 1 year after the date of enactment of this Act.</DELETED>
<DELETED> (d) Practitioner Registration.--The requirements related
to practitioner registration, inventory, and recordkeeping of a
controlled substance in schedule III of section 202(c) of the
Controlled Substances Act (21 U.S.C. 812(c)) shall not take effect for
xylazine until the date that is 60 days after the date of enactment of
this Act. A practitioner that has applied for registration during the
60-day period beginning on the date of enactment of this Act may
continue their lawful activities until such application is approved or
denied.</DELETED>
<DELETED> (e) Manufacturer Transition.--The Food and Drug
Administration and the Drug Enforcement Administration shall facilitate
and expedite the relevant manufacturer submissions or applications
required by the placement of xylazine on schedule III of section 202(c)
of the Controlled Substances Act (21 U.S.C. 812(c)).</DELETED>
<DELETED> (f) Clarification.--Nothing in this title, or the
amendments made by this title, shall be construed to require the
registration of an ultimate user of xylazine under the Controlled
Substances Act (21 U.S.C. 801 et seq.) in order to possess xylazine in
accordance with subparagraph (B) of section 102(27) of that Act (21
U.S.C. 802(27)), as added by subsection (a) of this section.</DELETED>
<DELETED>SEC. 5. ARCOS TRACKING.</DELETED>
<DELETED> Section 307(i) of the Controlled Substances Act (21 U.S.C.
827(i)) is amended--</DELETED>
<DELETED> (1) in the matter preceding paragraph (1)--
</DELETED>
<DELETED> (A) by inserting ``or xylazine'' after
``gamma hydroxybutyric acid'';</DELETED>
<DELETED> (B) by inserting ``or 512'' after
``section 505''; and</DELETED>
<DELETED> (C) by inserting ``respectively,'' after
``the Federal Food, Drug, and Cosmetic Act,'';
and</DELETED>
<DELETED> (2) in paragraph (6), by inserting ``or xylazine''
after ``gamma hydroxybutyric acid''.</DELETED>
<DELETED>SEC. 6. SENTENCING COMMISSION.</DELETED>
<DELETED> Pursuant to its authority under section 994(p) of title
28, United States Code, the United States Sentencing Commission shall
review and, if appropriate, amend its sentencing guidelines, policy
statements, and official commentary applicable to persons convicted of
an offense under section 401 of the Controlled Substances Act (21
U.S.C. 841) or section 1010 of the Controlled Substances Import and
Export Act (21 U.S.C. 960) to provide appropriate penalties for
offenses involving xylazine that are consistent with the amendments
made by this title. In carrying out this section, the Commission should
consider the common forms of xylazine as well as its use alongside
other scheduled substances.</DELETED>
<DELETED>SEC. 7. REPORT TO CONGRESS ON XYLAZINE.</DELETED>
<DELETED> (a) Initial Report.--Not later than 18 months after the
date of the enactment of this Act, the Attorney General, acting through
the Administrator of the Drug Enforcement Administration and in
coordination with the Commissioner of Food and Drugs, shall submit to
Congress a report on the prevalence of illicit use of xylazine in the
United States and the impacts of such use, including--</DELETED>
<DELETED> (1) where the drug is being diverted;</DELETED>
<DELETED> (2) where the drug is originating; and</DELETED>
<DELETED> (3) whether any analogues to xylazine, or related
or derivative substances, exist and present a substantial risk
of abuse.</DELETED>
<DELETED> (b) Additional Report.--Not later than 4 years after the
date of the enactment of this Act, the Attorney General, acting through
the Administrator of the Drug Enforcement Administration and in
coordination with the Commissioner of Food and Drugs, shall submit to
Congress a report updating Congress on the prevalence and proliferation
of xylazine trafficking and misuse in the United States.</DELETED>
SECTION 1. SHORT TITLE.
This title may be cited as the ``Combating Illicit Xylazine Act''.
SEC. 2. DEFINITIONS.
(a) In General.--In this Act--
(1) the term ``practitioner'' has the meaning given the
term under section 102 of the Controlled Substances Act (21
U.S.C. 802); and
(2) the term ``xylazine'' has the meaning given the term in
paragraph (61) of section 102 of the Controlled Substances Act,
as added by subsection (b) of this section.
(b) Controlled Substances Act.--Section 102 of the Controlled
Substances Act (21 U.S.C. 802) is amended by adding at the end the
following:
``(61) The term `xylazine' means the substance xylazine, including
its salts, isomers, and salts of isomers whenever the existence of such
salts, isomers, and salts of isomers is possible.''.
SEC. 3. ADDING XYLAZINE TO SCHEDULE III.
Schedule III of section 202(c) of the Controlled Substances Act (21
U.S.C. 812) is amended by adding at the end the following:
``(f) Unless specifically excepted or unless listed in another
schedule, any material, compound, mixture, or preparation which
contains any quantity of xylazine.''.
SEC. 4. AMENDMENTS.
(a) Amendment.--Section 102 of the Controlled Substances Act (21
U.S.C. 802) is amended by striking paragraph (27) and inserting the
following:
``(27)(A) Except as provided in subparagraph (B), the term
`ultimate user' means a person who has lawfully obtained, and who
possesses, a controlled substance for the use by the person or for the
use of a member of the household of the person or for an animal owned
by the person or by a member of the household of the person.
``(B)(i) In the case of xylazine, other than for a drug product
approved under subsection (b) or (j) of section 505 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355), the term `ultimate user'
means a person--
``(I) to whom xylazine was dispensed by--
``(aa) a veterinarian registered under this Act; or
``(bb) a pharmacy registered under this Act
pursuant to a prescription of a veterinarian registered
under this Act; and
``(II) who possesses xylazine for--
``(aa) an animal owned by the person or by a member
of the household of the person;
``(bb) an animal under the care of the person;
``(cc) use in government animal-control programs
authorized under applicable Federal, State, Tribal, or
local law; or
``(dd) use in wildlife programs authorized under
applicable Federal, State, Tribal, or local law.
``(ii) In this subparagraph, the term `person' includes--
``(I) a government agency or business where animals are
located; and
``(II) an employee or agent of an agency or business acting
within the scope of their employment or agency.''.
(b) Facilities.--An entity that manufactures xylazine, as of the
date of enactment of this Act, shall not be required to make capital
expenditures necessary to install the security standard required of
schedule III of the Controlled Substances Act (21 U.S.C. 801 et seq.)
for the purposes of manufacturing xylazine.
(c) Labeling.--The requirements related to labeling, packaging, and
distribution logistics of a controlled substance in schedule III of
section 202(c) of the Controlled Substances Act (21 U.S.C. 812(c))
shall not take effect for xylazine until the date that is 1 year after
the date of enactment of this Act.
(d) Practitioner Registration.--The requirements related to
practitioner registration, inventory, and recordkeeping of a controlled
substance in schedule III of section 202(c) of the Controlled
Substances Act (21 U.S.C. 812(c)) shall not take effect for xylazine
until the date that is 60 days after the date of enactment of this Act.
A practitioner that has applied for registration during the 60-day
period beginning on the date of enactment of this Act may continue
their lawful activities until such application is approved or denied.
(e) Manufacturer Transition.--The Food and Drug Administration and
the Drug Enforcement Administration shall facilitate and expedite the
relevant manufacturer submissions or applications required by the
placement of xylazine on schedule III of section 202(c) of the
Controlled Substances Act (21 U.S.C. 812(c)).
(f) Clarification.--Nothing in this Act, or the amendments made by
this Act, shall be construed to require the registration of an ultimate
user of xylazine under the Controlled Substances Act (21 U.S.C. 801 et
seq.) in order to possess xylazine in accordance with subparagraph (B)
of section 102(27) of that Act (21 U.S.C. 802(27)), as added by
subsection (a) of this section.
SEC. 5. ARCOS TRACKING.
Section 307(i) of the Controlled Substances Act (21 U.S.C. 827(i))
is amended--
(1) in the matter preceding paragraph (1)--
(A) by inserting ``or xylazine'' after ``gamma
hydroxybutyric acid'';
(B) by inserting ``or 512'' after ``section 505'';
and
(C) by inserting ``respectively,'' after ``the
Federal Food, Drug, and Cosmetic Act,''; and
(2) in paragraph (6), by inserting ``and xylazine'' after
``gamma hydroxybutyric acid''.
SEC. 6. SENTENCING COMMISSION.
Pursuant to its authority under section 994(p) of title 28, United
States Code, the United States Sentencing Commission shall review and,
if appropriate, amend its sentencing guidelines, policy statements, and
official commentary applicable to persons convicted of an offense under
section 401 of the Controlled Substances Act (21 U.S.C. 841) or section
1010 of the Controlled Substances Import and Export Act (21 U.S.C. 960)
to provide appropriate penalties for offenses involving xylazine that
are consistent with the amendments made by this Act. In carrying out
this section, the Commission should consider the common forms of
xylazine as well as its use alongside other scheduled substances.
SEC. 7. REPORT TO CONGRESS ON XYLAZINE.
(a) Control Report.--
(1) In general.--Not later than 30 days after the date of
enactment of this Act, the Attorney General, acting through the
Administrator of the Drug Enforcement Administration and in
coordination with the Secretary of Health and Human Services,
shall submit to Congress a report with an assessment of the
factors listed in section 201(c) of the Controlled Substances
Act (21 U.S.C. 811(c)) for xylazine, which includes a
scientific and medical evaluation and recommendations from the
Secretary of Health and Human Services and a law enforcement
and abuse evaluation by the Drug Enforcement Administration.
(2) Requirements.--The report required under paragraph (1)
shall--
(A) include the full text of the scientific and
medical evaluation and recommendations regarding
whether xylazine should be controlled as a controlled
substance, submitted by the Secretary of Health and
Human Services to the Attorney General pursuant to
section 201(b) of the Controlled Substances Act (21
U.S.C. 811(b)) on or before December 31, 2025; and
(B) be published on the websites of the Department
of Health and Human Services and the Department of
Justice.
(b) Initial Report.--Not later than 18 months after the date of the
enactment of this Act, the Attorney General, acting through the
Administrator of the Drug Enforcement Administration and in
coordination with the Commissioner of Food and Drugs, shall submit to
Congress a report on the prevalence of illicit use of xylazine in the
United States and the impacts of such use, including--
(1) where the drug is being diverted;
(2) where the drug is originating; and
(3) whether any analogues to xylazine, or related or
derivative substances, exist and present a substantial risk of
abuse.
(c) Additional Report.--Not later than 4 years after the date of
the enactment of this Act, the Attorney General, acting through the
Administrator of the Drug Enforcement Administration and in
coordination with the Commissioner of Food and Drugs, shall submit to
Congress a report updating Congress on the prevalence and proliferation
of xylazine trafficking and misuse in the United States.
Calendar No. 372
119th CONGRESS
2d Session
S. 545
_______________________________________________________________________
A BILL
To prohibit certain uses of xylazine, and for other purposes.
_______________________________________________________________________
April 15 (legislative day, April 14), 2026
Reported with an amendment