Section 1 Short title
This Act may be cited as the “Combating Illicit Xylazine Act”.
Combating Illicit Xylazine Act
A BILL
To prohibit certain uses of xylazine, and for other purposes.
Sec. 2 Findings
Congress finds the following:
Illicit xylazine presents an urgent threat to public health and safety.
The proliferation of xylazine as an additive to illicit drugs such as fentanyl and other narcotics threatens to exacerbate the opioid public health emergency.
There is currently no drug approved by the Food and Drug Administration to reverse the effects of xylazine in humans.
The physical effects of use of xylazine in humans can include depressed breathing and heart rate, unconsciousness, and necrosis, sometimes leading to amputation or other permanent physical health consequences.
The spread of illicit xylazine use has followed geographic patterns seen in the spread of recreational fentanyl use, with proliferation beginning in the Northeastern United States and later spreading south and west.
Prompt action to control illicit xylazine will help limit further proliferation of illicit xylazine, saving countless lives.
Sec. 3 Definitions
In general— In this Act, 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.
by redesignating the second paragraph (57) (relating to serious drug felony) and paragraph (58) as paragraphs (58) and (59), respectively; and
by adding at the end the following:
“(60) The term xylazine means any of the following substances, including 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:
“(A) Xylazine.
“(B) Xylazine-M (2,6Mich dimethylaniline).
“(C) Xylazine-M (N-thiourea-2,6-dimethylaniline).
“(D) Xylazine-M (sulfone-HO-) isomer 2.
“(E) Xylazine-M (HO-2,6-dimethylaniline isomer 1).
“(F) Xylazine-M (HO-2,6-dimethylaniline isomer 2).
“(G) Xylazine M (oxo-).
“(H) Xylazine-M (HO-) isomer 1.
“(I) Xylazine-M (HO-) isomer 1 glucuronide.
“(J) Xylazine-M (HO-) isomer 2.
“(K) Xylazine-M (HO-) isomer 2 glucuronide.
“(L) Xylazine-M (HO-oxo-) isomer 1.
“(M) Xylazine-M (HO-oxo-) isomer 1 glucuronide.
“(N) Xylazine-M (HO-oxo-) isomer 2.
“(O) Xylazine-M (HO-oxo-) isomer 2 glucuronide.
“(P) Xylazine-M (sulfone).
“(Q) Xylazine-M (sulfone-HO-) isomer 1.
“(R) Any compound, mixture, or preparation which contains any quantity of any of the substances referred to in subparagraphs (A) through (Q).”
Sec. 4 Unlawful distribution and penalties relating to xylazine
Prohibited Acts A—Penalties—
in subsection (a)(1), by inserting “or xylazine for illicit uses under section 424” after “controlled substance”; and
in subsection (b)(1)(E)(i), by inserting “or unlawful distribution of xylazine for illicit uses under section 424” after “schedule III”.
Controlled Substances Import and Export Act— Section 1010 of the Controlled Substances Import and Export Act (21 U.S.C. 960) is amended—
in subsection (a)—
in paragraph (1), by inserting “or xylazine for illicit uses under section 424” after “controlled substance”;
in paragraph (2), by inserting “or xylazine for illicit uses under section 424” after “controlled substance”; and
in paragraph (3), by inserting “or xylazine for illicit uses under section 424” after “controlled substance”; and
in subsection (b)(5), by inserting “or the unlawful distribution of xylazine for illicit uses under section 424” after “schedule III”.
Illicit use and distribution— Part D of the Controlled Substances Act (21 U.S.C. 401 et seq.) is amended by adding at the end the following:
“424. Illicit use and distribution of xylazine
“(a) Illicit use—It is unlawful for any person to engage in any of the following illicit uses of xylazine:
“(1) Any use in the human species.
“(2) Any use that is not a licit use.
“(b) Licit use—Licit use of xylazine means—
“(1) any administration to nonhuman species—
“(A) of a drug containing xylazine that has been approved by the Secretary of Health and Human Services under section 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b); or
“(B) that is permissible under section 512(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(a)(4));
“(2) the manufacturing, importation, or use of xylazine as an active pharmaceutical ingredient for manufacturing an animal drug approved under section 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b) or issued an investigation use exemption under subsection (j) of such section 512;
“(3) the manufacturing, importation, or use of a xylazine bulk chemical for pharmaceutical compounding by licensed pharmacists or veterinarians; or
“(4) another use approved or permissible under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).”
Sec. 5 Arcos tracking
Section 307(i) of the Controlled Substances Act (21 U.S.C. 827) is amended—
in the matter preceding paragraph (1)—
by inserting “or xylazine” after “gamma hydroxybutyric acid”;
by inserting “or 512” after “section 505”; and
by inserting “respectively,” after “the Federal Food, Drug, and Cosmetic Act,”; and
in paragraph (6), by inserting “or xylazine” after “gamma hydroxybutyric acid”.
Sec. 6 Report to Congress on xylazine
Initial report— Not later than 1 year 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—
where the drug is being diverted;
where the drug is originating;
whether any analogues to such drug present a substantial risk of abuse;
whether and to what extent the illicit supply of xylazine derives from the licit supply chain; and
recommendations for Congress with respect to whether xylazine should be transferred to another schedule under part B of the Controlled Substances Act (21 U.S.C. 811 et seq.).
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 of xylazine trafficking, misuse, and proliferation in the United States, including recommendations for Congress with respect to whether xylazine should be transferred to another schedule under part B of the Controlled Substances Act (21 U.S.C. 811 et seq.) or removed from schedule III of such part.
Definition— In this section, the term illicit use means any use described in section 424 of the Controlled Substances Act, as added by section 3 of this Act.
Sec. 7 Declaration of emerging threat
Congress declares illicit xylazine use an emerging drug threat, as defined in section 702 of the Office of National Drug Control Policy Reauthorization Act of 1998 (21 U.S.C. 1701), in the United States.