II
119THCONGRESS
1
STSESSION S. 545
To prohibit certain uses of xylazine, and for other purposes.
IN THE SENATE OF THE UNITED STATES
FEBRUARY12, 2025
Ms. C
ORTEZMASTO(for herself, Mr. GRASSLEY, Ms. HASSAN, Mrs. GILLI-
BRAND, Mrs. HYDE-SMITH, Ms. CANTWELL, Mr. SCOTTof Florida, Mrs.
S
HAHEEN, Ms. KLOBUCHAR, Mrs. BRITT, Mrs. CAPITO, Mr. YOUNG, Mr.
K
ELLY, Mr. KAINE, Mr. RISCH, Ms. ROSEN, Mr. BLUMENTHAL, Mr.
L
UJA´N, and Mr. WICKER) introduced the following bill; which was read
twice and referred to the Committee on the Judiciary
A BILL
To prohibit certain uses of xylazine, and for other purposes.
Be it enacted by the Senate and House of Representa-1
tives of the United States of America in Congress assembled, 2
SECTION 1. SHORT TITLE. 3
This title may be cited as the ‘‘Combating Illicit 4
Xylazine Act’’. 5
SEC. 2. DEFINITIONS. 6
(a) I
NGENERAL.—In this title, the term ‘‘xylazine’’ 7
has the meaning given the term in paragraph (60) of sec-8
tion 102 of the Controlled Substances Act, as added by 9
subsection (b) of this section. 10
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(b) CONTROLLEDSUBSTANCESACT.—Section 102 of 1
the Controlled Substances Act (21 U.S.C. 802) is amend-2
ed by adding at the end the following: 3
‘‘(60) The term ‘xylazine’ means the substance 4
xylazine, including its salts, isomers, and salts of isomers 5
whenever the existence of such salts, isomers, and salts 6
of isomers is possible.’’. 7
SEC. 3. ADDING XYLAZINE TO SCHEDULE III. 8
Schedule III of section 202(c) of the Controlled Sub-9
stances Act (21 U.S.C. 812) is amended by adding at the 10
end the following: 11
‘‘(f) Unless specifically excepted or unless listed in 12
another schedule, any material, compound, mixture, or 13
preparation which contains any quantity of xylazine.’’. 14
SEC. 4. AMENDMENTS. 15
(a) A
MENDMENT.—Section 102 of the Controlled 16
Substances Act (21 U.S.C. 802) is amended by striking 17
paragraph (27) and inserting the following: 18
‘‘(27)(A) Except as provided in subparagraph (B), 19
the term ‘ultimate user’ means a person who has lawfully 20
obtained, and who possesses, a controlled substance for 21
the use by the person or for the use of a member of the 22
household of the person or for an animal owned by the 23
person or by a member of the household of the person. 24
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‘‘(B)(i) In the case of xylazine, other than for a drug 1
product approved under subsection (b) or (j) of section 2
505 of the Federal Food, Drug, and Cosmetic Act (21 3
U.S.C. 355), the term ‘ultimate user’ means a person— 4
‘‘(I) to whom xylazine was dispensed by— 5
‘‘(aa) a veterinarian registered under this 6
Act; or 7
‘‘(bb) a pharmacy registered under this 8
Act pursuant to a prescription of a veterinarian 9
registered under this Act; and 10
‘‘(II) who possesses xylazine for— 11
‘‘(aa) an animal owned by the person or by 12
a member of the household of the person; 13
‘‘(bb) an animal under the care of the per-14
son; 15
‘‘(cc) use in government animal-control 16
programs authorized under applicable Federal, 17
State, Tribal, or local law; or 18
‘‘(dd) use in wildlife programs authorized 19
under applicable Federal, State, Tribal, or local 20
law. 21
‘‘(ii) In this subparagraph, the term ‘person’ in-22
cludes— 23
‘‘(I) a government agency or business where 24
animals are located; and 25
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‘‘(II) an employee or agent of an agency or 1
business acting within the scope of their employment 2
or agency.’’. 3
(b) F
ACILITIES.—An entity that manufactures 4
xylazine, as of the date of enactment of this Act, shall 5
not be required to make capital expenditures necessary to 6
install the security standard required of schedule III of 7
the Controlled Substances Act (21 U.S.C. 801 et seq.) for 8
the purposes of manufacturing xylazine. 9
(c) L
ABELING.—The requirements related to label-10
ing, packaging, and distribution logistics of a controlled 11
substance in schedule III of section 202(c) of the Con-12
trolled Substances Act (21 U.S.C. 812(c)) shall not take 13
effect for xylazine until the date that is 1 year after the 14
date of enactment of this Act. 15
(d) P
RACTITIONERREGISTRATION.—The require-16
ments related to practitioner registration, inventory, and 17
recordkeeping of a controlled substance in schedule III of 18
section 202(c) of the Controlled Substances Act (21 19
U.S.C. 812(c)) shall not take effect for xylazine until the 20
date that is 60 days after the date of enactment of this 21
Act. A practitioner that has applied for registration during 22
the 60-day period beginning on the date of enactment of 23
this Act may continue their lawful activities until such ap-24
plication is approved or denied. 25
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(e) MANUFACTURER TRANSITION.—The Food and 1
Drug Administration and the Drug Enforcement Adminis-2
tration shall facilitate and expedite the relevant manufac-3
turer submissions or applications required by the place-4
ment of xylazine on schedule III of section 202(c) of the 5
Controlled Substances Act (21 U.S.C. 812(c)). 6
(f) C
LARIFICATION.—Nothing in this title, or the 7
amendments made by this title, shall be construed to re-8
quire the registration of an ultimate user of xylazine under 9
the Controlled Substances Act (21 U.S.C. 801 et seq.) in 10
order to possess xylazine in accordance with subparagraph 11
(B) of section 102(27) of that Act (21 U.S.C. 802(27)), 12
as added by subsection (a) of this section. 13
SEC. 5. ARCOS TRACKING. 14
Section 307(i) of the Controlled Substances Act (21 15
U.S.C. 827(i)) is amended— 16
(1) in the matter preceding paragraph (1)— 17
(A) by inserting ‘‘or xylazine’’ after 18
‘‘gamma hydroxybutyric acid’’; 19
(B) by inserting ‘‘or 512’’ after ‘‘section 20
505’’; and 21
(C) by inserting ‘‘respectively,’’ after ‘‘the 22
Federal Food, Drug, and Cosmetic Act,’’; and 23
(2) in paragraph (6), by inserting ‘‘or xylazine’’ 24
after ‘‘gamma hydroxybutyric acid’’. 25
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SEC. 6. SENTENCING COMMISSION. 1
Pursuant to its authority under section 994(p) of title 2
28, United States Code, the United States Sentencing 3
Commission shall review and, if appropriate, amend its 4
sentencing guidelines, policy statements, and official com-5
mentary applicable to persons convicted of an offense 6
under section 401 of the Controlled Substances Act (21 7
U.S.C. 841) or section 1010 of the Controlled Substances 8
Import and Export Act (21 U.S.C. 960) to provide appro-9
priate penalties for offenses involving xylazine that are 10
consistent with the amendments made by this title. In car-11
rying out this section, the Commission should consider the 12
common forms of xylazine as well as its use alongside 13
other scheduled substances. 14
SEC. 7. REPORT TO CONGRESS ON XYLAZINE. 15
(a) I
NITIALREPORT.—Not later than 18 months 16
after the date of the enactment of this Act, the Attorney 17
General, acting through the Administrator of the Drug 18
Enforcement Administration and in coordination with the 19
Commissioner of Food and Drugs, shall submit to Con-20
gress a report on the prevalence of illicit use of xylazine 21
in the United States and the impacts of such use, includ-22
ing— 23
(1) where the drug is being diverted; 24
(2) where the drug is originating; and 25
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(3) whether any analogues to xylazine, or re-1
lated or derivative substances, exist and present a 2
substantial risk of abuse. 3
(b) A
DDITIONALREPORT.—Not later than 4 years 4
after the date of the enactment of this Act, the Attorney 5
General, acting through the Administrator of the Drug 6
Enforcement Administration and in coordination with the 7
Commissioner of Food and Drugs, shall submit to Con-8
gress a report updating Congress on the prevalence and 9
proliferation of xylazine trafficking and misuse in the 10
United States. 11
Æ
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