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Creates a legal definition of xylazine and moves it into Schedule III of the Controlled Substances Act, covering any mixture that contains the substance. It sets short transition rules for manufacturers, labelers, and practitioners, directs FDA and DEA to speed needed processes, asks the U.S. Sentencing Commission to update federal sentencing guidance for xylazine offenses, and requires federal law enforcement and public health agencies to report to Congress on the prevalence, harms, and trafficking of xylazine within set timelines.
States that in this title, the term “xylazine” has the meaning given in paragraph (60) of section 102 of the Controlled Substances Act, as added by subsection (b) of this section.
Amends section 102 of the Controlled Substances Act (21 U.S.C. 802) by adding paragraph (60) defining “xylazine” to mean the substance xylazine, including its salts, isomers, and salts of isomers whenever such salts, isomers, and salts of isomers are possible.
Amend Schedule III of section 202(c) of the Controlled Substances Act (21 U.S.C. 812) by adding at the end a new paragraph (f): "Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of xylazine.." (text as provided).
Amends 21 U.S.C. 802(27) to define "ultimate user." Except as provided in subparagraph (B), "ultimate user" means a person who has lawfully obtained and possesses a controlled substance for their own use, for a household member's use, or for an animal owned by the person or a household member.
Creates a special rule for xylazine (subparagraph (B)): for xylazine (other than FDA-approved drug products under FDCA section 505(b) or (j)), the term "ultimate user" includes certain persons and entities described in subparagraph (B), including government agencies or businesses where animals are located and employees or agents acting within the scope of their employment or agency.
Who is affected and how:
Drug and biologic manufacturers: Will need to adjust production, labeling, and registration practices for any products containing xylazine; the law orders FDA and DEA to accelerate required administrative steps but manufacturers still must comply with Schedule III controls once transition periods end.
Health care providers, pharmacists, and practitioners: Will be subject to Schedule III rules for prescribing, handling, dispensing, and recordkeeping for xylazine-containing products; special “ultimate user” definitions and short transition rules are intended to limit immediate registration or administrative burdens during implementation.
People who use or are exposed to xylazine (including people who use illicit drugs): May experience increased criminal enforcement and different charging/sentencing outcomes because the drug is scheduled and because sentencing guidelines will be reviewed; scheduling may also change availability in illicit markets and could affect harm-reduction and treatment approaches.
Federal law enforcement and public health agencies (DEA, DOJ, FDA, CDC and others): Must coordinate surveillance, reporting to Congress, and enforcement actions; agencies have new statutory reporting duties and implementation responsibilities.
Courts and defendants: Federal sentencing policy for xylazine-related offenses will be reviewed and potentially updated, which could change recommended sentences and punishments for trafficking or distribution offenses involving xylazine.
Public health systems and harm-reduction programs: May need to adapt outreach, testing, wound care, and clinical guidance because scheduling can change surveillance data, treatment protocols, and local law enforcement practices; the statute’s reporting provisions are designed to improve knowledge about xylazine prevalence and harms.
Net effects: The bill creates a federal regulatory and enforcement pathway for xylazine that brings manufacturing, distribution, clinical use, public health surveillance, and criminal penalties into clearer federal control. Short transition rules soften immediate compliance burdens, while reporting and sentencing updates aim to align enforcement and public-health responses with on-the-ground realities. The law may reduce unregulated availability over time but could also shift patterns of use; public-health impacts will depend on enforcement decisions and how harm-reduction and treatment providers respond.
Read twice and referred to the Committee on the Judiciary.
Introduced February 12, 2025 by Catherine Marie Cortez Masto · Last progress February 12, 2025
Amends subsection (i) of 21 U.S.C. 827 (Section 307(i) of the Controlled Substances Act) by inserting additional language: three insertions in the matter preceding paragraph (1) and an insertion after paragraph (6). The exact text to be inserted is not included in this section.
Strikes existing paragraph (27) of 21 U.S.C. 802 and inserts a new paragraph (27) that revises the definition of 'ultimate user', adding an exception and special definition for xylazine (excluding FDA-approved drug products under 21 U.S.C. 355(b) or (j)) and specifying that the term for xylazine includes government agencies or businesses where animals are located and employees or agents acting within the scope of their employment or agency.
Amends Schedule III of 21 U.S.C. 812 by adding a new subsection (f) that places any material, compound, mixture, or preparation containing any quantity of xylazine into Schedule III, unless specifically excepted or listed in another schedule.
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Read twice and referred to the Committee on the Judiciary.
Introduced in Senate