What This Bill Does
This bill makes it illegal for anyone to use xylazine (a veterinary drug) in humans or distribute it for illicit purposes. The bill also requires government agencies to track xylazine and submit reports to Congress about how the illegal drug is being used and spread across the country.
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Who It Affects
People who use xylazine illegally or distribute it for illegal purposes will face criminal penalties. The Drug Enforcement Administration and Food and Drug Administration must monitor and report on xylazine. Licensed pharmacists and veterinarians may be affected by restrictions on xylazine use.
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Key Provisions
* It is unlawful for any person to use xylazine in humans or engage in any use that is not approved by law (Sec. 424)
* Xylazine is only permitted for use in animals when the drug has government approval or for pharmaceutical manufacturing and compounding by licensed professionals (Sec. 424)
* The Attorney General must submit a report to Congress within one year describing where illegal xylazine comes from, where it is being diverted to, and whether it should be moved to a different control schedule (Sec. 6)
* A second report must be submitted within four years updating Congress on xylazine trafficking and recommending whether it should be moved to a different schedule or removed from schedule III (Sec. 6)
* Xylazine sales and distribution must be tracked using a government system called ARCOS (Sec. 5)
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What Changes
Xylazine becomes defined under federal drug law with specific chemical forms listed. Using xylazine in humans becomes a federal crime. Distributing xylazine for illegal uses becomes subject to the same criminal penalties as distributing controlled substances. The government gains authority to track xylazine shipments and can impose criminal sentences on people who violate these provisions.
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Important Definitions
The bill defines "xylazine" as the base drug plus 17 related chemical forms (called metabolites and isomers), including any mixture containing any quantity of these substances (Sec. 3).
The bill defines "licit use" (legal use) as giving xylazine to animals when approved by government, using it to manufacture approved animal drugs, using it for pharmacy compounding by licensed professionals, or other uses allowed under federal drug law (Sec. 424).
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Effective Date
Not specified in bill text
I
118TH CONGRESS
1ST SESSION H. R. 1839
To prohibit certain uses of xylazine, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
MARCH 28, 2023
Mr. PANETTA (for himself, Mr. PFLUGER, Mr. BILIRAKIS, Mr. BUCK, Mr.
PAPPAS, Mr. BACON, Mr. LAMBORN, Mr. VASQUEZ, Mr. THOMPSON of
California, and Ms. HOULAHAN) 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 deter-
mined by the Speaker, in each case for consideration of such provisions
as fall within the jurisdiction of the committee concerned
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:
7
(1) Illicit xylazine presents an urgent threat to
8
public health and safety.
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•HR 1839 IH
(2) The proliferation of xylazine as an additive
1
to illicit drugs such as fentanyl and other narcotics
2
threatens to exacerbate the opioid public health
3
emergency.
4
(3) There is currently no drug approved by the
5
Food and Drug Administration to reverse the effects
6
of xylazine in humans.
7
(4) The physical effects of use of xylazine in
8
humans can include depressed breathing and heart
9
rate, unconsciousness, and necrosis, sometimes lead-
10
ing to amputation or other permanent physical
11
health consequences.
12
(5) The spread of illicit xylazine use has fol-
13
lowed geographic patterns seen in the spread of rec-
14
reational fentanyl use, with proliferation beginning
15
in the Northeastern United States and later spread-
16
ing south and west.
17
(6) Prompt action to control illicit xylazine will
18
help limit further proliferation of illicit xylazine, sav-
19
ing countless lives.
20
SEC. 3. DEFINITIONS.
21
(a) IN GENERAL.—In this Act, the term ‘‘xylazine’’
22
has the meaning given the term in paragraph (60) of sec-
23
tion 102 of the Controlled Substances Act, as added by
24
subsection (b) of this section.
25
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•HR 1839 IH
(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:
7
‘‘(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:
12
‘‘(A) Xylazine.
13
‘‘(B) Xylazine-M (2,6Mich dimethylaniline).
14
‘‘(C)
Xylazine-M
(N-thiourea-2,6-
15
dimethylaniline).
16
‘‘(D) Xylazine-M (sulfone-HO-) isomer 2.
17
‘‘(E) Xylazine-M (HO-2,6-dimethylaniline iso-
18
mer 1).
19
‘‘(F) Xylazine-M (HO-2,6-dimethylaniline iso-
20
mer 2).
21
‘‘(G) Xylazine M (oxo-).
22
‘‘(H) Xylazine-M (HO-) isomer 1.
23
‘‘(I) Xylazine-M (HO-) isomer 1 glucuronide.
24
‘‘(J) Xylazine-M (HO-) isomer 2.
25
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•HR 1839 IH
‘‘(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.
5
‘‘(O) Xylazine-M (HO-oxo-) isomer 2 glu-
6
curonide.
7
‘‘(P) Xylazine-M (sulfone).
8
‘‘(Q) Xylazine-M (sulfone-HO-) isomer 1.
9
‘‘(R) Any compound, mixture, or preparation
10
which contains any quantity of any of the substances
11
referred to in subparagraphs (A) through (Q).’’.
12
SEC. 4. UNLAWFUL DISTRIBUTION AND PENALTIES RELAT-
13
ING TO XYLAZINE.
14
(a) PROHIBITED ACTS A—PENALTIES.—
15
(1) CONTROLLED
SUBSTANCES
ACT.—Section
16
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’’.
24
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•HR 1839 IH
(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’’;
8
(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’’.
17
(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
22
engage in any of the following illicit uses of xylazine:
23
‘‘(1) Any use in the human species.
24
‘‘(2) Any use that is not a licit use.
25
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•HR 1839 IH
‘‘(b) LICIT USE.—Licit use of xylazine means—
1
‘‘(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.).’’.
23
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•HR 1839 IH
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)—
4
(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’’.
12
SEC. 6. REPORT TO CONGRESS ON XYLAZINE.
13
(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;
25
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•HR 1839 IH
(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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•HR 1839 IH
tional Drug Control Policy Reauthorization Act of 1998
1
(21 U.S.C. 1701), in the United States.
2
Æ
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