Sec. 203. Combating illicit xylazine
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In this section, the term xylazine has the meaning given the term in paragraph
(60)of section 102 of the Controlled Substances Act, as added by paragraph (2). 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; by moving the margin of paragraph
(57)2 ems to the left; by moving the margins of paragraphs
(58)and (59), as redesignated, 2 ems to the left; and by adding at the end the following: The term xylazine means the substance xylazine as well as its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible. Except as provided in subparagraph (E), such term does not include a substance described in subparagraph
(A)to the extent— such substance is used or intended for use in animals other than humans and is an animal drug that has been approved by the Secretary of Health and Human Services under section 512 of the Federal Food, Drug, and Cosmetic Act, conditionally approved under section 571 of such Act, index listed under section 573 of such Act, or subject to an exemption for investigational use under section 512(j) of such Act, and such use or intended use conforms to the approved application or index listing, including the manufacturing, importation, holding, or distribution for such use; such substance is used or intended for use in animals other than humans as permitted under section 512(a)(4) of the Federal Food, Drug, and Cosmetic Act; such substance is manufactured, imported, held, distributed, or used— as an active pharmaceutical ingredient for manufacturing an animal drug approved under section 512 of the Federal Food, Drug, and Cosmetic Act, conditionally approved under section 571 of such Act, index listed under section 573 of the such Act, or subject to an exemption for investigational use under section 512(j) of such Act; or as a bulk chemical for pharmaceutical compounding of a new animal drug (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act) by or under the direct supervision of a licensed pharmacist or by or on the lawful written or oral order of a licensed veterinarian within the context of a veterinarian-client-patient relationship, as defined by the Secretary of Health and Human Services; such substance is held or used as a compounded new animal drug described in clause (iii)(II); such substance is otherwise used or intended for use in animals other than humans, and such use is approved or otherwise authorized under the Federal Food, Drug, and Cosmetic Act provided any such use conforms to such approval or authorization; such substance is subject to an exemption for investigational use under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act; such substance is imported, held, distributed, or used for the development, manufacturing, or performance of tests for detection of xylazine (including xylazine used as a control or calibration standard) by persons who are professionally, regularly, and lawfully engaged in such activities; or such substance is held, distributed, or used in a commercially manufactured test for the detection of xylazine, provided such test does not contain xylazine in a form that can be extracted. Notwithstanding subparagraph (B), the Attorney General may place any substance listed in such subparagraph on a schedule under section 202 in accordance with subsections
(a)through
(c)of section 201. Nothing in this paragraph shall be construed as a basis for inferring that a compounded animal drug is not a new animal drug subject to the requirements of section 512(a) of the Federal Food, Drug, and Cosmetic Act. If any person prescribes, dispenses, distributes, manufactures, or imports xylazine for human use, such person shall be considered to have prescribed, dispensed, distributed, manufactured, or imported xylazine not subject to an exclusion under subparagraph (B). . Schedule III in section 202(c) of the Controlled Substances Act ( 21 U.S.C. 812(c) ) is amended by adding at the end the following: Xylazine. . Not later than 1 year after the date of 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 section 202 of the Controlled Substances Act ( 21 U.S.C. 812 ). Not later than 4 years after the date of 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 section 202 of the Controlled Substances Act ( 21 U.S.C. 812 ) or removed from schedule III of such part.
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