S. 545 — Combating Illicit Xylazine Act

This section adds a new definition of "xylazine" as paragraph (60) to the definitions section of the Controlled Substances Act (21 U.S.C. 802), specifying that the term means the substance xylazine, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible. It further defines "xylazine" for purposes of this title using that new statutory definition.

This section adds xylazine to Schedule III of the controlled substances schedules in the Controlled Substances Act (CSA). Schedule III substances have a currently accepted medical use in treatment in the United States, a potential for abuse less than those in Schedules I and II, and abuse may lead to moderate or low physical dependence or high psychological dependence. (Thus, any material, compound, mixture, or preparation containing any quantity of xylazine—primarily a veterinary sedative increasingly found in the illicit fentanyl supply—becomes subject to CSA manufacturing quotas, distribution licensing, prescription requirements, and penalties for unauthorized handling.)

This section amends the definition of "ultimate user" under the Controlled Substances Act (CSA) for xylazine—except FDA-approved drug products (21 U.S.C. 355(b) or (j))—to limit it to persons dispensed xylazine by a registered veterinarian or pharmacy pursuant to a veterinarian's prescription who possess it for specified animal uses (i.e., owned animals, animals under care, or authorized government animal-control or wildlife programs), with "person" including government agencies, businesses with animals, and their employees or agents acting in scope. It further provides the following transitions for xylazine's schedule III placement: (1) exempts current xylazine manufacturers from capital expenditures for schedule III security standards; (2) delays schedule III labeling, packaging, and distribution requirements until one year after enactment; (3) delays schedule III practitioner registration, inventory, and recordkeeping requirements until 60 days after enactment, allowing practitioners applying within the first 60 days to continue lawful activities pending approval or denial; (4) directs the Food and Drug Administration and Drug Enforcement Administration to expedite relevant manufacturer submissions or applications; and (5) clarifies that ultimate users of xylazine need not register under the CSA.

This section expands Automation of Reports and Consolidated Orders System (ARCOS) reporting requirements—under which manufacturers and distributors must report dispositions of specified substances to the Drug Enforcement Administration—to include xylazine regulated under §512 of the Federal Food, Drug, and Cosmetic Act (i.e., new animal drugs), in addition to gamma hydroxybutyric acid regulated under §505 (i.e., new human drugs). (As background, ARCOS is the DEA's system for monitoring the flow of controlled substances from manufacture through distribution.)

This section directs the United States Sentencing Commission, pursuant to 28 U.S.C. 994(p), to review and, if appropriate, amend its sentencing guidelines, policy statements, and commentary applicable to offenses under section 401 of the Controlled Substances Act (21 U.S.C. 841)—which prohibits manufacturing, distributing, dispensing, or possessing with intent to do so a controlled substance—or section 1010 of the Controlled Substances Import and Export Act (21 U.S.C. 960). Amendments must provide penalties for offenses involving xylazine consistent with this title's amendments and consider common forms of xylazine and its use alongside other scheduled substances.

This section directs the Attorney General, acting through the Drug Enforcement Administration (DEA) Administrator and in coordination with the Food and Drug Administration (FDA) Commissioner, to submit two reports to Congress on illicit xylazine use, trafficking, and misuse in the United States (i.e., a veterinary sedative often illicitly combined with opioids such as fentanyl). (1) An initial report, due not later than 18 months after enactment, on the prevalence and impacts of such use, including diversion sources, origins, and any analogues or related substances presenting substantial abuse risks. (2) An updating report, due not later than four years after enactment, on the prevalence and proliferation of xylazine trafficking and misuse.