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2 versions
TransformativeWhat changed in REPORTED TO SENATEcompared with INTRODUCED IN SENATE (Feb 12, 2025)
See full diff

A complete substitute amendment, v2 largely retains the core policy objectives of v1 to schedule xylazine and regulate its use. While maintaining most provisions, v2 introduces a new "Control Report" requirement for the Attorney General and Secretary of Health and Human Services, and makes minor structural and definitional adjustments. v2 is effectively a different bill from v1 due to the comprehensive replacement of its text.

S. 545·119th Congress·Introduced Feb 12, 2025

Combating Illicit Xylazine Act

IntroducedCrime and Law EnforcementMajor
View bill text
Sponsor
Sen. Cortez Masto, Catherine [D-NV]
Committees
Judiciary Committee (primary)
Last action
Apr 15, 2026

Bottom line

The Combating Illicit Xylazine Act aims to curb the illicit trafficking and misuse of xylazine by classifying it as a Schedule III controlled substance, while carefully preserving its critical role in veterinary care through tailored exemptions and transition periods.

What it actually does

This bill schedules xylazine, a non-opioid animal tranquilizer, as a Schedule III controlled substance under the Controlled Substances Act (CSA) to combat its increasing illicit use as an adulterant in drugs like fentanyl. It amends the CSA to define xylazine and includes specific provisions to ensure its continued legitimate use in veterinary medicine, such as modified 'ultimate user' definitions and transition periods for compliance. The bill also directs the U.S. Sentencing Commission to update sentencing guidelines for xylazine-related offenses and mandates several reports to Congress on the prevalence and impact of illicit xylazine.

Proponents argue

Proponents argue that this bill is a crucial step in addressing the rapidly escalating public health crisis caused by xylazine's presence in the illicit drug supply, often referred to as 'tranq dope.' They contend that scheduling xylazine will provide law enforcement with necessary tools to interdict its illicit supply and distribution, thereby reducing overdose deaths and severe health complications like necrotic wounds. Supporters emphasize that the bill's carefully crafted exemptions ensure that veterinarians and animal care professionals can continue to access and use xylazine for legitimate purposes without undue burden.

Opponents contend

While the bill enjoys broad bipartisan support, potential concerns, if any, might center on the administrative burden placed on legitimate veterinary practices due to new registration, recordkeeping, and security requirements, despite the provided transition periods. Some might also express apprehension that scheduling could inadvertently drive up the cost or reduce the availability of xylazine for veterinary use, or that illicit drug markets may simply pivot to new, equally dangerous adulterants, without fully solving the underlying public health issue.

The bill is relatively short and clearly structured, making it accessible for an informed reader to understand its core provisions within a reasonable timeframe.

Section 1

Short Title

prominently featuredstraightforward

This section establishes the official short title of the bill as the 'Combating Illicit Xylazine Act.' This title is used for easy reference and identification of the legislation.

GroupImpactMechanismScale
GroupGeneral PublicImpactClarity and identification of legislationMechanismProvides a common name for the billScaleBroad

Supporters argue

Proponents argue that a clear and concise short title helps communicate the bill's purpose to the public and facilitates legislative tracking and discussion.

Critics contend

No specific opposition is typically raised against this provision as it is standard legislative practice.

Tradeoffs

None inherent in establishing a short title.

Section 2(b)

Definition of Xylazine in Controlled Substances Act

mentioned in summarystraightforward

This provision amends Section 102 of the Controlled Substances Act (CSA) to add a new paragraph (61) that formally defines 'xylazine.' The definition includes xylazine itself, along with its salts, isomers, and salts of isomers, ensuring comprehensive coverage under the CSA.

Section 3

Adding Xylazine to Schedule III of the CSA

prominently featuredstraightforward

This section amends Schedule III of the Controlled Substances Act (CSA) to include any material, compound, mixture, or preparation containing any quantity of xylazine, unless specifically excepted or listed in another schedule. This action places xylazine under federal control, subjecting its manufacture, distribution, and possession to the regulatory framework of Schedule III substances.

Section 4(a)

Amendment to 'Ultimate User' Definition for Xylazine

buried in fine printmoderately complex

This provision revises the definition of 'ultimate user' in the Controlled Substances Act specifically for xylazine. For xylazine products not approved under the Federal Food, Drug, and Cosmetic Act, an 'ultimate user' is defined as a person who received xylazine from a registered veterinarian or pharmacy (with a vet's prescription) and possesses it for an animal they own, an animal under their care, or for use in authorized government animal-control or wildlife programs. It explicitly includes government agencies, businesses with animals, and their employees/agents as 'persons' who can be ultimate users.

Section 4(b)

Facility Security Standard Exemption for Existing Manufacturers

buried in fine printstraightforward

This provision exempts entities that are manufacturing xylazine as of the date of the bill's enactment from immediately incurring capital expenditures to install the security standards typically required for Schedule III substances under the Controlled Substances Act. This provides a grace period for existing manufacturers to adapt to the new security requirements.

Section 4(c)

1-Year Transition Period for Labeling, Packaging, and Distribution Logistics

buried in fine printstraightforward

This provision establishes a one-year delay for the implementation of new requirements related to labeling, packaging, and distribution logistics for xylazine as a Schedule III controlled substance. These requirements will not take effect until one year after the bill's enactment, giving manufacturers and distributors ample time to update their processes and materials.

Section 4(d)

60-Day Transition Period for Practitioner Registration and Recordkeeping

buried in fine printstraightforward

This provision grants a 60-day grace period for practitioners (such as veterinarians) regarding the new registration, inventory, and recordkeeping requirements for xylazine as a Schedule III substance. During this 60-day period, practitioners who have applied for registration may continue their lawful activities until their application is approved or denied, preventing immediate interruption of veterinary services.

Section 5

ARCOS Tracking for Xylazine

mentioned in summarystraightforward

This section amends the Controlled Substances Act to require that xylazine be tracked through the Automation of Reports and Consolidated Orders System (ARCOS). ARCOS is a comprehensive system used by the Drug Enforcement Administration (DEA) to monitor the flow of controlled substances from their manufacture through distribution to retail levels, helping to identify diversion.

Section 6

Sentencing Commission Directive for Xylazine Offenses

prominently featuredstraightforward

This section directs the United States Sentencing Commission to review and, if appropriate, amend its sentencing guidelines, policy statements, and official commentary for offenses involving xylazine under the Controlled Substances Act. The Commission is instructed to provide appropriate penalties consistent with the bill's amendments, considering common forms of xylazine and its use alongside other scheduled substances.

Section 7

Reports to Congress on Xylazine

prominently featuredstraightforward

This section mandates several reports to Congress concerning xylazine. Within 30 days, the Attorney General (via DEA) and HHS Secretary must submit an assessment of CSA scheduling factors. Within 18 months, the Attorney General (via DEA) and FDA Commissioner must report on the prevalence of illicit xylazine use, its diversion, origin, and potential analogues. A follow-up report updating this information is required within 4 years.

FOUND

The bill significantly expands the definition of 'ultimate user' specifically for xylazine, allowing government agencies, businesses where animals are located, and their employees/agents to possess xylazine for animal care, animal control, or wildlife programs without requiring full DEA registration, provided it was dispensed by a registered veterinarian or pharmacy.

Section 4(a)

Why it matters:This is standard legislative practice for ensuring precise legal application and avoiding unintended consequences. It's a necessary technical detail to reconcile the scheduling with legitimate uses, rather than an attempt to hide a controversial provision.

Case for: Supporters argue this provision is essential to prevent the criminalization of legitimate animal care and public safety activities. Without it, animal control officers, wildlife managers, and even large animal facilities might inadvertently violate federal law by possessing xylazine, severely disrupting critical services.

Case against: No significant case against this specific clarification exists, as it is designed to mitigate negative impacts on legitimate users. Any opposition would likely be to the scheduling itself, not to the carve-out for legitimate use.

Estimated impact: This provision prevents widespread disruption and potential legal issues for thousands of veterinary professionals, animal control agencies, and wildlife programs across the country, ensuring continued access to a vital animal tranquilizer.

FOUND

The bill includes several transition periods: an exemption for existing manufacturers from immediate capital expenditures for Schedule III security standards (Section 4(b)), a one-year delay for new labeling, packaging, and distribution logistics requirements (Section 4(c)), and a 60-day grace period for practitioner registration, inventory, and recordkeeping (Section 4(d)).

Section 4(b), (c), (d)

Why it matters:These are standard legislative mechanisms to facilitate smooth implementation of new regulations, allowing affected entities time to adapt without immediate disruption. This is a practical accommodation rather than an attempt to obscure controversial policy.

Case for: Proponents argue that these transition periods are crucial for preventing immediate disruptions to the legitimate supply chain and veterinary services. They allow manufacturers, distributors, and practitioners sufficient time to comply with new federal regulations, minimizing economic burden and ensuring continued access to xylazine for animal care.

Case against: No significant case against these transition periods exists, as they are designed to ease the burden of compliance. Arguments, if any, might come from those who believe stricter, immediate enforcement is necessary, but such arguments are rare for implementation details.

Estimated impact: These provisions prevent significant economic and operational disruption for the xylazine manufacturing, distribution, and veterinary sectors, potentially saving millions in immediate compliance costs and ensuring the uninterrupted availability of the drug for legitimate uses.

About this analysis. AI-Generated from the official bill text and available committee reports. Gaps in available data are noted explicitly. Verify important details with the official Congress.gov record.

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