Agency Aims to Maintain Availability for Legitimate Use in Animals while Preventing Importation for Illicit Purposes
Today, the U.S. Food and Drug Administration announced that it has taken action to restrict the unlawful entry of xylazine active pharmaceutical ingredients and finished dosage form drug products into the country to address a growing public health concern. The chemical xylazine has increasingly been found in illicit drugs such as illicitly manufactured fentanyl and other drugs and increasingly detected in overdose deaths.
This action aims to prevent the drug from entering the U.S. market for illicit purposes, while maintaining availability for its legitimate uses in animals.
Veterinarians legitimately use drug products containing xylazine to sedate large animals such as horses and deer, but it is not safe for use in people and may cause serious and life-threatening side effects. It has been identified as a contaminant found in combination with opioids such as illicit fentanyl and in combination with other illicit products that contain stimulants such as methamphetamine and cocaine. People who use illicit drugs may not be aware of the presence of xylazine.
While xylazine is not an opioid, it is dangerous because it can depress breathing, blood pressure, heart rate and body temperature to critical levels. Additionally, people who inject drugs containing xylazine can develop severe skin wounds and patches of dead and rotting tissue that easily become infected and, if left untreated, may lead to amputation. These wounds can develop in areas of the body away from the injection site and may become life-threatening. The agency previously communicated to health care providers about the risks to patients exposed to xylazine in illicit drugs.
“The FDA remains concerned about the increasing prevalence of xylazine mixed with illicit drugs, and this action is one part of broader efforts the agency is undertaking to address this issue,” said FDA Commissioner Robert M. Califf, M.D. “We will continue to use all tools at our disposal and partner with the Drug Enforcement Administration and other federal, state, local agencies and stakeholders as appropriate to stem these illicit activities and protect public health.”
The action taken today is designed to ensure that imports of drugs containing 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, 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. Under the import alert, xylazine offered for import is subject to heightened FDA scrutiny, and FDA staff may detain the shipment if it appears to be in violation of the law. As part of their entry review, FDA staff will consider specific evidence offered by importers that the incoming product is properly labeled, not adulterated, and for legitimate veterinary use.
“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, J.D., director of the FDA’s Center for Veterinary Medicine.
The FDA and its 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 conduct. Additionally, the agency is coordinating with animal health stakeholders to ensure that drugs containing xylazine are available to veterinarians for legitimate use. The FDA will continue to provide updates on this work as appropriate.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.