Congress Stalls, Xylazine Spreads

Despite causing necrotic wounds that lead to thousands of preventable amputations annually, the veterinary sedative xylazine remains completely unscheduled at the federal level—creating a regulatory void that traffickers exploit to legally import a substance now found in nearly a quarter of America’s fentanyl supply.

Drug scheduling under the Controlled Substances Act (CSA) classifies substances into five categories based on medical use and abuse potential. Schedule I substances have no accepted medical use and high abuse potential, while Schedule III substances have accepted medical use with moderate abuse potential. Schedule V substances have the lowest abuse potential with accepted medical uses. Scheduling determines criminal penalties, prescribing requirements, and import restrictions—yet xylazine exists entirely outside this framework, allowing unrestricted importation despite its growing role in overdose deaths.

The U.S. Drug Enforcement Administration has detected xylazine in drug seizures across 48 states as of November 2022, particularly affecting the Northeast region of the country. Yet unlike fentanyl-related substances that receive temporary scheduling protection through repeated congressional extensions—now extended ten times with the latest set to expire on September 30, 2025—xylazine exists entirely outside the Controlled Substances Act (CSA), allowing its unrestricted importation from China and Spain.

The Congressional Research Service (CRS) notes that xylazine is regulated under the Federal Food, Drug, and Cosmetic Act, but not the CSA, meaning it faces only Food and Drug Administration oversight for veterinary use while remaining unscheduled at the federal level for human-related enforcement. This regulatory paradox intensifies as prohibition drives drugs into an unregulated underworld populated by increasingly dangerous adulterants (cutting agents added to street drugs): first xylazine, and now medetomidine have already been detected in several states, with traffickers certain to pivot to alternative adulterants if xylazine becomes scheduled.

Various regulatory approaches emerge—emergency scheduling authority that the DEA used for fentanyl analogues to avoid imminent hazards to public safety, pharmacophore-based classification systems like Ohio’s 2014 model that groups substances by chemical structure, or enhanced import controls modeled on precursor chemical regulations—each raising questions about preserving legitimate veterinary use while limiting human harms.

Critics worry that scheduling xylazine could restrict veterinary medicine where it serves as a surgical anesthetic and procedural sedative, either alone or in combination with other medications, potentially pushing traffickers toward even more dangerous adulterants in what becomes an endless game of regulatory whack-a-mole that consumes agency resources.

Public health advocates counter with Philadelphia’s grim statistics—where 79 percent of overdose deaths involve fentanyl often mixed with xylazine—and Florida’s experience where despite designating xylazine as Schedule I in 2016, the state saw xylazine-involved overdose deaths increase by 1,127 percent from 2020 to 2021.

The Combating Illicit Xylazine Act attempts to reconcile both viewpoints and create a novel regulatory category for illicit uses of xylazine, imposing Schedule III penalties without formal scheduling, but faces constitutional challenges in an era when recent Supreme Court decisions limiting agency discretion complicate creative statutory solutions. Meanwhile, harm reduction advocates emphasize addressing immediate needs. For example, xylazine wounds appear at sites distant from injection and resist standard treatments, requiring specialized wound care protocols that many emergency departments lack.

In this week’s Saturday Seminar, scholars examine how drug scheduling frameworks struggle to address synthetic adulterants that blur traditional regulatory categories.

• Olivia K. Sugarman of Johns Hopkins Bloomberg School of Public Health and colleagues find in an article in the International Journal of Drug Policy that state scheduling responses to xylazine cluster geographically but fail systematically. Analyzing 58 policy initiatives across 24 states, they document Schedule III as the dominant classification choice, reflecting attempts to balance veterinary access with public health controls. Florida’s experience proves instructive: despite Schedule I designation in 2016, xylazine-involved deaths increased 1,127 percent by 2021. The authors conclude that once xylazine infiltrates local markets, scheduling alone cannot reverse contamination patterns, suggesting federal coordination may prove essential.
• Joanna Lampe of the Congressional Research Service argues in a Legal Sidebar that xylazine’s unique status—veterinary medicine never approved for humans—defies traditional controlled substances frameworks. Lampe examines the Combating Illicit Xylazine Act’s novel approach of criminalizing illicit uses without formal scheduling, preserving veterinary access while imposing Schedule III penalties. She warns that recent Supreme Court decisions limiting agency discretion complicate enforcement. Although the major questions doctrine requires clear congressional authorization for significant regulatory actions, Gundy v. United States signals renewed scrutiny of broad delegations to agencies, suggesting Congress must provide explicit statutory authority beyond traditional frameworks.
• Claire M. Zagorski of University of Texas at Austin and colleagues argue in Harm Reduction Journal that xylazine wounds require specialized treatment protocols emergency departments lack. They document successful wound management using enzymatic debridement and moisture-retentive dressings, preventing amputations when implemented early. The authors warn that scheduling could drive users underground, accelerating shifts to medetomidine and other untested adulterants already appearing in drug supplies. They propose expanding wound care at syringe exchanges and distributing test strips despite paraphernalia laws. Their clinical data reveals early intervention reduces amputation rates by 60 percent, while delayed treatment often results in irreversible tissue death.
• Lisa N. Sacco of the Congressional Research Service demonstrates in an Insight that temporary scheduling of fentanyl-related substances failed to generate expected prosecutions. Despite ten congressional extensions since 2018, prosecutors applied the class-wide scheduling order in only two cases through 2020, while individual fentanyl sentences quadrupled to 3,639 by 2024. The data reveal that grouping substances by chemical structure rather than individual assessment creates enforcement gaps prosecutors struggle to navigate. Sacco concludes that xylazine scheduling must account for this precedent, as ineffective controls may simply shift resources while traffickers adapt to regulatory changes faster than enforcement can respond.
• Bailey E. Pridgen of the University of Alabama at Birmingham and colleagues argue in Harm Reduction Journal that paraphernalia laws blocking xylazine test strips mirror broader regulatory failures. Four states prohibit fentanyl test strips entirely while 18 provide only substance-specific exemptions that cannot adapt to emerging adulterants such as xylazine. Exemptions limited to specific substances require constant legislative updates as new adulterants emerge in drug supplies. The authors document how legislative delays—typically four to six years following overdose trends—create enforcement gaps traffickers exploit systematically. They recommend federal decriminalization of all drug paraphernalia and state-level reforms permitting drug checking equipment broadly, arguing that narrow exemptions force constant legislative updates while deaths mount.
• Matthew B. Lawrence of Emory Law School and David E. Pozen of Columbia Law School argue in a forthcoming Harvard Law Review article that xylazine exemplifies drug scheduling’s institutional failures. They identify three interlocking problems: prohibition tends to backfire when demand is inelastic, pharmaceutical companies exploit regulatory capture to protect profits, and drug policy involves irreducibly political questions that experts cannot answer objectively. Xylazine sits at this intersection—banned substances create unregulated markets flooded with dangerous adulterants, veterinary manufacturers lobby against scheduling to preserve sales, and no discipline can determine acceptable trade-offs between animal care and human deaths. The authors propose democratizing scheduling decisions while imposing administrative controls on drug manufacturers to prevent both punitive prohibitionism and extractive capitalism.