Will Xylazine Become a Controlled Substance?

There's serious discussion at the highest levels of the U.S. government -- among both congressional lawmakers and the Drug Enforcement Administration (DEA) -- about making the veterinary sedative xylazine a controlled substance.

In a statement, the American Veterinary Medical Association said that it is "closely engaged with the relevant congressional offices and committees" that are discussing scheduling xylazine, noting that it understands that the DEA "has begun its internal process to schedule the drug."

Indeed, one source told MedPage Today that the DEA has conducted an 8-Factor Analysis for xylazine, which is an assessment of the drug's abuse potential that is a required step in the scheduling process.

Additionally, the DEA has said that the "two-part process" to schedule a substance has been in the works since October 2021, according to Fox News. The agency told the news outlet that the process involves sending data to HHS and requesting a scheduling recommendation.

The DEA sent HHS "supplemental information" in September 2022 to "accelerate" the scheduling process, and DEA is "still waiting on HHS to provide a scheduling recommendation," the article noted.

The DEA did not return several requests for comment from MedPage Today.

A spokesperson for the FDA, which is the HHS agency tasked with reviewing the 8-Factor Analysis, said it is "continuing to investigate the impact of xylazine presence in the illicit drug supply and will provide an update when new information is available."

"We defer to DEA to confirm what actions they have taken with regard to the scheduling process, but we are in regular contact with them pursuant to the Memorandum of Understanding between our two agencies," the spokesperson added.

A Congressional Research Service report from February 2 titled, "Xylazine: Considerations for Federal Control," noted that "either Congress or DEA (in conjunction with FDA) could decide to schedule xylazine."

"The CSA [Controlled Substances Act]-required process for DEA and FDA to schedule a substance can be time consuming, whereas Congress may pass (and the President may sign) a bill scheduling a substance and is not bound by the CSA's procedural requirements," according to the report.

The report also noted that regulators would have to consider which schedule it would belong to, from the most restrictive Schedule I to the more lenient Schedules III-V.

It is not known which legislator requested the report.

Xylazine has popped up on regulators' radars as it increasingly has been mixed with the opioid fentanyl. The problem has been particularly prevalent in the Northeast -- especially in Philadelphia, where some 90% of fentanyl samples also contain xylazine -- but is reportedly spreading across the U.S.

Since it's a sedative, one of the problems is that it knocks people out, leaving them vulnerable to assault or robbery. Another challenge is that the opioid overdose reversal agent naloxone (Narcan) may appear not to work. It can still reverse the effects of the opioid, but additional steps may be needed to treat the effects of sedative overdose.

Another area of concern has been the wounds that have been more severe than those seen with injection drug use in the past, physicians said. "With xylazine, the wounds are much more severe, much deeper, and much harder to manage," Joseph D'Orazio, MD, of Temple University Hospital in Philadelphia, previously told MedPage Today.

D'Orazio and others believe the xylazine is mostly pharmaceutical-grade and has likely been diverted. Pictures taken in xylazine hotspots in Philadelphia have shown bottles with the label "VET One," which is distributed by MWI Animal Health, a subsidiary of AmerisourceBergen.

Lauren Esposito, a spokesperson for AmerisourceBergen, said, "We continuously evaluate and expand the measures we have implemented to maintain the integrity of every order we ship. We perform due diligence on all customers and ensure they are appropriately licensed by regulatory agencies."

"We also maintain robust processes and systems that track and monitor the products that move through our distribution channels," Esposito added. "If we identify any patterns of ordering that could indicate the potential for diversion, we evaluate and act appropriately."

Esposito added that xylazine "is stocked and distributed exclusively through our animal health distribution centers and shipped only to licensed veterinary providers and other licensed wholesalers."

She declined to share 10-year sales data for xylazine products.

Andrew Kolodny, MD, an expert in opioid policy and addiction medicine at Brandeis University in Massachusetts, said xylazine is probably widely diverted because it's unscheduled.

"If it were scheduled, distributors would have to have a suspicious order monitoring system. It's a DEA [requirement] that would tell you, for example, your Philadelphia region, or a particular veterinary practice you're distributing to, are outliers and you can't continue to fill that order. You have to report them," he explained.

"For sure, you would not see xylazine all over the place if it was scheduled," Kolodny added.

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