The Biden administration is designating xylazine an emerging threat to humans as the animal drug becomes increasingly tied to drug overdose deaths.

This is the first time an administration has used this designation after a bipartisan 2018 opioid law granted the authority to the White House Office of National Drug Control Policy. ONDCP Director Rahul Gupta plans to inform Congress of the new designation Wednesday morning for fentanyl-adulterated xylazine.

Between 2020 and 2021, xylazine overdoses increased 1127 percent in the South, 700 percent in the West, 500 percent in the Midwest and 100 percent in the Northeast.

Xylazine was approved by the FDA in 1972 as a veterinary tranquilizer, but it is not approved for human use. The drug has increasingly been used illegally and in conjunction with other illicit drugs. Unlike fentanyl, the drug is not an opioid, meaning an opioid antagonist medication like naloxone would have no effect in counteracting a xylazine overdose.

Gupta said the administration plans to develop a whole-of-government plan to combat xylazine that will be published within 90 days. This would include prioritizing data and education, ramping up testing capacity, standardized testing for medical examiners and coroners, investing in related research and determining harm-reduction best practices.

“We will bring together national experts in the field to guide evidence-based practices to identify the most promising approaches, clinical segmentation, withdrawal management, and treatment protocols,” he said. “The government will also increase efforts to understand the supply chain and determine how to regulate the drug.”

Gupta said the plan will need the support of Congress, including for funding to support these initiatives. The fiscal 2024 budget request, he said, asks for $11 million for emerging threats work.

“We need support from Congress and will continue to work with members of both parties on this issue,” he said.

Xylazine is not restricted under the Controlled Substances Act of 1970, but Gupta said he has been meeting with lawmakers on how to possibly regulate the drug.

A bipartisan group of lawmakers support legislation introduced in March that would classify the drug as a Schedule III drug.

“I’ve had already several meetings on the Hill with members to discuss various ways in which we can move forward,” said Gupta, adding that the administration would also be meeting on this.

“We’re very mindful of the legitimate uses in veterinary medicine of this drug and it is an important drug for the agricultural industry.”

Gupta said the designation announcement also builds on other steps the administration has taken to address xylazine. The Substance Abuse and Mental Health Administration and Drug Enforcement Administration issued alerts about the drug’s illicit use earlier this year and the White House announced that it plans to crack down on the fentanyl supply chain on Tuesday.