Bill would make xylazine a controlled drug under Schedule III, with room for animal-care use

Xylazine, including its salts and isomers, would be added to Schedule III of the Controlled Substances Act. It covers any material, compound, mixture, or preparation that contains any amount of xylazine. It does not apply if the product is specifically excepted or listed in another schedule.

For xylazine that is not an FDA-approved drug product, people who get it from a registered veterinarian, or a registered pharmacy on a veterinarian's prescription, would count as ultimate users. They must keep it for an animal they own, an animal in their care, government animal-control programs, or wildlife programs. The term includes agencies, businesses, and their employees. Ultimate users would not have to register to possess xylazine this way.

The bill would delay or ease some Schedule III requirements for xylazine. It covers current xylazine manufacturers and practitioners who must register. Current manufacturers would not have to pay for capital upgrades to meet the Schedule III security standard. Practitioners who apply for registration within 60 days of enactment may keep working until their application is decided. The Food and Drug Administration and Drug Enforcement Administration must speed up manufacturer filings. Labeling, packaging, and distribution rules would start 1 year after enactment. Practitioner registration, inventory, and recordkeeping rules would start 60 days after enactment.

The bill would add xylazine to a federal tracking provision and require the Sentencing Commission to review penalties for xylazine offenses. The tracking change adds the word xylazine to section 307(i) of the Controlled Substances Act. The review covers guidelines for people convicted under sections 401 and 1010 of the related drug laws. The Commission must amend its guidelines only if appropriate. It should consider the common forms of xylazine and its use alongside other scheduled substances.

The Attorney General, through the Drug Enforcement Administration and with the Food and Drug Administration, must report to Congress on illicit xylazine use. The first report covers how common illicit use is, its impacts, where the drug is diverted and originates, and whether related substances pose a substantial risk of abuse. The first report is due within 18 months of enactment, and an update on trafficking and misuse within 4 years.