H.R. 1266 — Combating Illicit Xylazine Act

This section provides the short title of the Act as the “Combating Illicit Xylazine Act.”

This section establishes a definition of xylazine for the title by cross-referencing a new Controlled Substances Act definition added to 21 U.S.C. § 802. It amends section 102 of the Controlled Substances Act to add paragraph (60), defining xylazine as the substance xylazine, including its salts, isomers, and salts of isomers whenever such forms are possible.

This section adds xylazine to schedule III of the Controlled Substances Act, unless it is specifically excepted or listed in another schedule. (Thus, any material, compound, mixture, or preparation containing any quantity of xylazine would be subject to the controls that apply to schedule III substances under 21 U.S.C. § 812.)

This section revises the Controlled Substances Act definition of “ultimate user” under 21 U.S.C. § 802(27) to create a xylazine-specific exception for a drug product approved under section 505(b) or (j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 355). For xylazine that is not an approved drug product, an ultimate user is limited to a person to whom xylazine was dispensed by a registered veterinarian or a registered pharmacy pursuant to a veterinarian’s prescription and who possesses it for an animal owned by the person or a household member, an animal under the person’s care, or use in government animal-control or wildlife programs authorized under Federal, State, Tribal, or local law. It also specifies that “person” includes a government agency or business where animals are located and their employees or agents acting within the scope of employment or agency. This section exempts xylazine manufacturers, as of the date of enactment, from having to make the capital expenditures needed to install the security standards required for schedule III controlled substances. It delays the schedule III labeling, packaging, and distribution-logistics requirements for xylazine until 1 year after enactment, and delays the practitioner registration, inventory, and recordkeeping requirements until 60 days after enactment. A practitioner who applies for registration during the 60-day period beginning on enactment may continue lawful activities until the application is approved or denied. It directs the Food and Drug Administration and the Drug Enforcement Administration to facilitate and expedite manufacturer submissions and applications needed to place xylazine in schedule III. It also clarifies that nothing in the title requires an ultimate user of xylazine to register under the Controlled Substances Act in order to possess xylazine consistent with the new definition.

This section revises the controlled substances recordkeeping requirements under 21 U.S.C. § 827(i) to include xylazine in the special tracking provisions for gamma hydroxybutyric acid and related substances. It also updates the cross-reference to the Federal Food, Drug, and Cosmetic Act by adding section 512 after section 505 and inserting “respectively,” in the introductory text, and it makes the same xylazine insertion in paragraph (6). (Thus, the Drug Enforcement Administration’s tracking and recordkeeping requirements would expressly apply to xylazine in the same manner as the existing covered substances.)

This section directs the United States Sentencing Commission to review, and if appropriate amend, the sentencing guidelines, policy statements, and official commentary applicable to offenses under 21 U.S.C. § 841 and 21 U.S.C. § 960 to provide appropriate penalties for offenses involving xylazine that are consistent with the amendments made by this title. As background, 21 U.S.C. § 841 prohibits the manufacture, distribution, or dispensing of controlled substances and sets graduated penalties based on drug type and quantity. The Commission is also directed to consider the common forms of xylazine and its use alongside other scheduled substances.

This section directs the Attorney General, acting through the Administrator of the Drug Enforcement Administration and in coordination with the Commissioner of Food and Drugs, to submit to Congress an initial report on the illicit use of xylazine in the United States not later than 18 months after enactment and a follow-up report not later than 4 years after enactment. The initial report must address the prevalence and impacts of illicit xylazine use, including where the drug is being diverted, where it is originating, and whether xylazine analogues or related or derivative substances exist that present a substantial risk of abuse. The additional report must update Congress on the prevalence and proliferation of xylazine trafficking and misuse in the United States.