S993-118

1. Short title This Act may be cited as the Combating Illicit Xylazine Act.

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.

3. Definitions 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. Section 102 of the Controlled Substances Act (21 U.S.C. 802) is amended— 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: 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: Xylazine. Xylazine-M (2,6Mich dimethylaniline). Xylazine-M (N-thiourea-2,6-dimethylaniline). Xylazine-M (sulfone-HO-) isomer 2. Xylazine-M (HO-2,6-dimethylaniline isomer 1). Xylazine-M (HO-2,6-dimethylaniline isomer 2). Xylazine M (oxo-). Xylazine-M (HO-) isomer 1. Xylazine-M (HO-) isomer 1 glucuronide. Xylazine-M (HO-) isomer 2. Xylazine-M (HO-) isomer 2 glucuronide. Xylazine-M (HO-oxo-) isomer 1. Xylazine-M (HO-oxo-) isomer 1 glucuronide. Xylazine-M (HO-oxo-) isomer 2. Xylazine-M (HO-oxo-) isomer 2 glucuronide. Xylazine-M (sulfone). Xylazine-M (sulfone-HO-) isomer 1. Any compound, mixture, or preparation which contains any quantity of any of the substances referred to in subparagraphs (A) through (Q). (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)..

4. Unlawful distribution and penalties relating to xylazine Section 401 of the Controlled Substances Act (21 U.S.C. 841) is amended— 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. 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. Part D of the Controlled Substances Act (21 U.S.C. 401 et seq.) is amended by adding at the end the following: It is unlawful for any person to engage in any of the following illicit uses of xylazine: Any use in the human species. Any use that is not a licit use. Licit use of xylazine means— any administration to nonhuman species— 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 that is permissible under section 512(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(a)(4)); 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; the manufacturing, importation, or use of a xylazine bulk chemical for pharmaceutical compounding by licensed pharmacists or veterinarians; or another use approved or permissible under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). 424.Illicit use and distribution of xylazine(a)Illicit useIt 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 useLicit 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.)..

424. Illicit use and distribution of xylazine It is unlawful for any person to engage in any of the following illicit uses of xylazine: Any use in the human species. Any use that is not a licit use. Licit use of xylazine means— any administration to nonhuman species— 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 that is permissible under section 512(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(a)(4)); 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; the manufacturing, importation, or use of a xylazine bulk chemical for pharmaceutical compounding by licensed pharmacists or veterinarians; or another use approved or permissible under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).

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.

6. Report to Congress on xylazine 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.). 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. 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.

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.