What This Bill Does
This bill makes xylazine (a veterinary drug) illegal for human use and creates penalties for distributing it illegally. The law treats xylazine similarly to other controlled substances under federal drug laws. Congress declares that illicit xylazine use poses an urgent public health threat.
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Who It Affects
- People who use or distribute xylazine illegally
- Drug traffickers and smugglers
- The Drug Enforcement Administration (the federal agency that enforces drug laws)
- The Food and Drug Administration (the federal agency that regulates drugs)
- Veterinarians and pharmacists who make animal drugs
- Manufacturers and importers of xylazine
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Key Provisions
- It is unlawful for any person to use xylazine in humans or use it for any purpose that is not legally permitted (Sec. 4(b))
- Xylazine is legally permitted only for approved veterinary drugs, pharmaceutical manufacturing for animals, compounding (mixing) by licensed pharmacists or veterinarians, and other uses approved under federal food and drug law (Sec. 4(b))
- The Attorney General must report to Congress within one year on where xylazine is being diverted, where it originates, and whether it should be moved to a different schedule (category) of controlled substances (Sec. 6(a))
- The Attorney General must submit an additional report four years after this law takes effect updating Congress on xylazine trafficking and misuse (Sec. 6(b))
- Congress officially declares illicit xylazine use an emerging drug threat (Sec. 7)
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What Changes
Xylazine becomes a controlled substance with specific legal definitions of what constitutes illegal use. People who distribute xylazine for human use face the same federal penalties as people who distribute other illegal drugs. The government gains authority to track and monitor xylazine distribution through existing federal drug tracking systems. The Attorney General must investigate and report on how widespread illicit xylazine use has become and recommend whether stronger controls are needed.
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Important Definitions
Xylazine is defined to include the drug itself, 17 specific chemical compounds related to xylazine (called metabolites), and any mixture containing these substances (Sec. 3(b))
Licit use means any use approved by the federal government for veterinary animals, manufacturing animal drugs, or pharmaceutical compounding by licensed professionals (Sec. 4(b))
Illicit use means any human use or any use that is not legally permitted (Sec. 4(b))
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Effective Date
Not specified in bill text
II
118TH CONGRESS
1ST SESSION
S. 993
To prohibit certain uses of xylazine, and for other purposes.
IN THE SENATE OF THE UNITED STATES
MARCH 28, 2023
Ms. CORTEZ MASTO (for herself, Mr. GRASSLEY, Ms. HASSAN, Mr. RISCH,
Mrs. SHAHEEN, Mrs. CAPITO, Mr. MARSHALL, and Mr. MANCHIN) intro-
duced the following bill; which was read twice and referred to the Com-
mittee 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 Act may be cited as the ‘‘Combating Illicit
4
Xylazine Act’’.
5
SEC. 2. FINDINGS.
6
Congress finds the following:
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(1) Illicit xylazine presents an urgent threat to
8
public health and safety.
9
(2) The proliferation of xylazine as an additive
10
to illicit drugs such as fentanyl and other narcotics
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•S 993 IS
threatens to exacerbate the opioid public health
1
emergency.
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(3) There is currently no drug approved by the
3
Food and Drug Administration to reverse the effects
4
of xylazine in humans.
5
(4) The physical effects of use of xylazine in
6
humans can include depressed breathing and heart
7
rate, unconsciousness, and necrosis, sometimes lead-
8
ing to amputation or other permanent physical
9
health consequences.
10
(5) The spread of illicit xylazine use has fol-
11
lowed geographic patterns seen in the spread of rec-
12
reational fentanyl use, with proliferation beginning
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in the Northeastern United States and later spread-
14
ing south and west.
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(6) Prompt action to control illicit xylazine will
16
help limit further proliferation of illicit xylazine, sav-
17
ing countless lives.
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SEC. 3. DEFINITIONS.
19
(a) IN GENERAL.—In this Act, the term ‘‘xylazine’’
20
has the meaning given the term in paragraph (60) of sec-
21
tion 102 of the Controlled Substances Act, as added by
22
subsection (b) of this section.
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(b) CONTROLLED SUBSTANCES ACT.—Section 102 of
1
the Controlled Substances Act (21 U.S.C. 802) is amend-
2
ed—
3
(1) by redesignating the second paragraph (57)
4
(relating to serious drug felony) and paragraph (58)
5
as paragraphs (58) and (59), respectively; and
6
(2) by adding at the end the following:
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‘‘(60) The term ‘xylazine’ means any of the following
8
substances, including their salts, isomers, and salts of iso-
9
mers whenever the existence of such salts, isomers, and
10
salts of isomers is possible within the specific chemical
11
designation:
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‘‘(A) Xylazine.
13
‘‘(B) Xylazine-M (2,6Mich dimethylaniline).
14
‘‘(C)
Xylazine-M
(N-thiourea-2,6-
15
dimethylaniline).
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‘‘(D) Xylazine-M (sulfone-HO-) isomer 2.
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‘‘(E) Xylazine-M (HO-2,6-dimethylaniline iso-
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mer 1).
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‘‘(F) Xylazine-M (HO-2,6-dimethylaniline iso-
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mer 2).
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‘‘(G) Xylazine M (oxo-).
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‘‘(H) Xylazine-M (HO-) isomer 1.
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‘‘(I) Xylazine-M (HO-) isomer 1 glucuronide.
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‘‘(J) Xylazine-M (HO-) isomer 2.
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‘‘(K) Xylazine-M (HO-) isomer 2 glucuronide.
1
‘‘(L) Xylazine-M (HO-oxo-) isomer 1.
2
‘‘(M) Xylazine-M (HO-oxo-) isomer 1 glu-
3
curonide.
4
‘‘(N) Xylazine-M (HO-oxo-) isomer 2.
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‘‘(O) Xylazine-M (HO-oxo-) isomer 2 glu-
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curonide.
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‘‘(P) Xylazine-M (sulfone).
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‘‘(Q) Xylazine-M (sulfone-HO-) isomer 1.
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‘‘(R) Any compound, mixture, or preparation
10
which contains any quantity of any of the substances
11
referred to in subparagraphs (A) through (Q).’’.
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SEC. 4. UNLAWFUL DISTRIBUTION AND PENALTIES RELAT-
13
ING TO XYLAZINE.
14
(a) PROHIBITED ACTS A—PENALTIES.—
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(1) CONTROLLED
SUBSTANCES
ACT.—Section
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401 of the Controlled Substances Act (21 U.S.C.
17
841) is amended—
18
(A) in subsection (a)(1), by inserting ‘‘or
19
xylazine for illicit uses under section 424’’ after
20
‘‘controlled substance’’; and
21
(B) in subsection (b)(1)(E)(i), by inserting
22
‘‘or unlawful distribution of xylazine for illicit
23
uses under section 424’’ after ‘‘schedule III’’.
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(2) CONTROLLED
SUBSTANCES
IMPORT
AND
1
EXPORT ACT.—Section 1010 of the Controlled Sub-
2
stances Import and Export Act (21 U.S.C. 960) is
3
amended—
4
(A) in subsection (a)—
5
(i) in paragraph (1), by inserting ‘‘or
6
xylazine for illicit uses under section 424’’
7
after ‘‘controlled substance’’;
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(ii) in paragraph (2), by inserting ‘‘or
9
xylazine for illicit uses under section 424’’
10
after ‘‘controlled substance’’; and
11
(iii) in paragraph (3), by inserting ‘‘or
12
xylazine for illicit uses under section 424’’
13
after ‘‘controlled substance’’; and
14
(B) in subsection (b)(5), by inserting ‘‘or
15
the unlawful distribution of xylazine for illicit
16
uses under section 424’’ after ‘‘schedule III’’.
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(b) ILLICIT USE AND DISTRIBUTION.—Part D of the
18
Controlled Substances Act (21 U.S.C. 401 et seq.) is
19
amended by adding at the end the following:
20
‘‘SEC. 424. ILLICIT USE AND DISTRIBUTION OF XYLAZINE.
21
‘‘(a) ILLICIT USE.—It is unlawful for any person to
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engage in any of the following illicit uses of xylazine:
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‘‘(1) Any use in the human species.
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‘‘(2) Any use that is not a licit use.
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‘‘(b) LICIT USE.—Licit use of xylazine means—
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‘‘(1) any administration to nonhuman species—
2
‘‘(A) of a drug containing xylazine that has
3
been approved by the Secretary of Health and
4
Human Services under section 512 of the Fed-
5
eral Food, Drug, and Cosmetic Act (21 U.S.C.
6
360b); or
7
‘‘(B) that is permissible under section
8
512(a)(4) of the Federal Food, Drug, and Cos-
9
metic Act (21 U.S.C. 360b(a)(4));
10
‘‘(2) the manufacturing, importation, or use of
11
xylazine as an active pharmaceutical ingredient for
12
manufacturing an animal drug approved under sec-
13
tion 512 of the Federal Food, Drug, and Cosmetic
14
Act (21 U.S.C. 360b) or issued an investigation use
15
exemption under subsection (j) of such section 512;
16
‘‘(3) the manufacturing, importation, or use of
17
a
xylazine
bulk
chemical
for
pharmaceutical
18
compounding by licensed pharmacists or veterinar-
19
ians; or
20
‘‘(4) another use approved or permissible under
21
the Federal Food, Drug, and Cosmetic Act (21
22
U.S.C. 301 et seq.).’’.
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SEC. 5. ARCOS TRACKING.
1
Section 307(i) of the Controlled Substances Act (21
2
U.S.C. 827) is amended—
3
(1) in the matter preceding paragraph (1)—
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(A) by inserting ‘‘or xylazine’’ after
5
‘‘gamma hydroxybutyric acid’’;
6
(B) by inserting ‘‘or 512’’ after ‘‘section
7
505’’; and
8
(C) by inserting ‘‘respectively,’’ after ‘‘the
9
Federal Food, Drug, and Cosmetic Act,’’; and
10
(2) in paragraph (6), by inserting ‘‘or xylazine’’
11
after ‘‘gamma hydroxybutyric acid’’.
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SEC. 6. REPORT TO CONGRESS ON XYLAZINE.
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(a) INITIAL REPORT.—Not later than 1 year after
14
the date of the enactment of this Act, the Attorney Gen-
15
eral, acting through the Administrator of the Drug En-
16
forcement Administration and in coordination with the
17
Commissioner of Food and Drugs, shall submit to Con-
18
gress a report on the prevalence of illicit use of xylazine
19
in the United States and the impacts of such use, includ-
20
ing—
21
(1) where the drug is being diverted;
22
(2) where the drug is originating;
23
(3) whether any analogues to such drug present
24
a substantial risk of abuse;
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(4) whether and to what extent the illicit supply
1
of xylazine derives from the licit supply chain; and
2
(5) recommendations for Congress with respect
3
to whether xylazine should be transferred to another
4
schedule under part B of the Controlled Substances
5
Act (21 U.S.C. 811 et seq.).
6
(b) ADDITIONAL REPORT.—Not later than 4 years
7
after the date of the enactment of this Act, the Attorney
8
General, acting through the Administrator of the Drug
9
Enforcement Administration and in coordination with the
10
Commissioner of Food and Drugs, shall submit to Con-
11
gress a report updating Congress on the prevalence of
12
xylazine trafficking, misuse, and proliferation in the
13
United States, including recommendations for Congress
14
with respect to whether xylazine should be transferred to
15
another schedule under part B of the Controlled Sub-
16
stances Act (21 U.S.C. 811 et seq.) or removed from
17
schedule III of such part.
18
(c) DEFINITION.—In this section, the term ‘‘illicit
19
use’’ means any use described in section 424 of the Con-
20
trolled Substances Act, as added by section 3 of this Act.
21
SEC. 7. DECLARATION OF EMERGING THREAT.
22
Congress declares illicit xylazine use an emerging
23
drug threat, as defined in section 702 of the Office of Na-
24
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•S 993 IS
tional Drug Control Policy Reauthorization Act of 1998
1
(21 U.S.C. 1701), in the United States.
2
Æ
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