Unlawful xylazine receives more scrutiny to prevent inclusion in illegal drugs

Regulators and legislators are showing greater interest in xylazine, a prescription drug used in multiple sectors of clinical veterinary medicine. News reports indicate illicit xylazine is increasingly showing up in street drugs and being detected in overdose deaths.

On Feb. 28, the Food and Drug Administration announced that the agency has taken action to restrict the unlawful entry of xylazine active pharmaceutical ingredients and finished dosage-form drug products into the country to address the growing public health concern.

Under the import alert, xylazine offered for import is subject to heightened FDA scrutiny, and FDA staff members may detain a shipment if it appears to be in violation of the law.

Needle and syringe next to a drug vial with clear injectable solution
Xylazine is a drug that has critically important uses in veterinary medicine but is not safe for use in people. More recently, the drug has been identified as a contaminant found in street drugs.

The agency’s action is designed to ensure that imports of xylazine into the country are intended for the legitimate veterinary supply, including active pharmaceutical ingredients en route for processing by a manufacturing facility that makes FDA-approved xylazine, active pharmaceutical ingredients for compounding of animal drugs at state-licensed compounding pharmacies or by licensed veterinarians, as well as approved finished products being imported into the U.S.

“We recognize the public health effects of xylazine tainting these illicit drugs and are continuing to ensure that legitimate product is restricted to veterinary use only,” said Tracey Forfa, director of the FDA Center for Veterinary Medicine, in the announcement.

Meanwhile, members of Congress are considering scheduling xylazine as a controlled substance. This change in status to a drug scheduled under the federal Controlled Substances Act is intended to provide additional tools for law enforcement and bring stricter punishments to individuals who sell illicit xylazine on the black market.

While the AVMA recognizes and supports efforts to curtail the public health issues related to illicit xylazine use, scheduling xylazine to help control the illicit trade will also impact the use of the drug in veterinary medicine. Since learning of these congressional efforts, the AVMA has been working with members of Congress, allied veterinary groups, stakeholders, and federal agencies to ensure that veterinarians and their clients continue to have access to xylazine.

“The FDA just issued an import alert as part of the effort to prevent the illicit importation of xylazine,” said Dr. Lori Teller, AVMA president. “The AVMA supports such efforts to combat illicit drug use. At the same time, as mentioned in our recent blog, the AVMA is working with congressional offices and federal agencies to maintain the appropriate access veterinarians have to xylazine, a drug that has critically important uses in veterinary medicine.”

Xylazine is a safe and effective sedative and analgesic used in dogs, cats, cattle, horses as well as elk and deer to calm them and facilitate safe handling, and to perform diagnostic and surgical procedures.

According to the FDA, xylazine is not safe for use in people and may cause serious and life-threatening side effects. The drug has been identified as a contaminant found in combination with opioids, such as fentanyl, or in combination with stimulants such as methamphetamine and cocaine. People who use these drugs may not be aware of the presence of xylazine.

The FDA, including the agency’s Office of Criminal Investigations, is collaborating with federal, state, and local partners to investigate xylazine-related activities that could be subject to criminal prosecution, including online and in-person transactions. Additionally, the agency is coordinating with animal health stakeholders to ensure xylazine remains available to veterinarians for legitimate use.