FDA Restricts Unlawful Import Of Xylazine

The U.S. Food and Drug Administration said it has taken steps to restrict unlawful imports of xylazine, an animal tranquilizer that has increasingly been found in illicit drugs, into the United States.

With this, the Federal regulator aims to prevent the drug from entering the U.S. market for illicit purposes, while maintaining availability for legitimate use in animals.

Xylazine, commonly manufactured in China, is a pharmaceutical drug legitimately used by veterinarians to sedate large animals such as horses and deer. It is not safe for use in people and may cause serious and life-threatening side effects.

However, the FDA noted that the presence of chemical xylazine is found in many illicit drugs such as illicitly manufactured fentanyl and other drugs and increasingly detected in overdose deaths. People who use illicit drugs may not be aware of the presence of xylazine.

It has been identified as a contaminant found in combination with opioids and other illicit products that contain stimulants such as methamphetamine and cocaine.

Xylazine is not an opioid, but it is dangerous because it can depress breathing, blood pressure, heart rate and body temperature to critical levels. In addition, people who inject drugs containing xylazine can develop severe skin wounds and patches of dead and rotting tissue that may become life-threatening.

In a statement, the agency said it is restriciting unlawful entry of xylazine active pharmaceutical ingredients and finished dosage form drug products into the country.

The agency will make sure that imports of drugs containing xylazine are intended for the legitimate veterinary supply to manufacturing facility that makes FDA-approved xylazine, state-licensed compounding pharmacies or licensed veterinarians.

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

The regulators are investigating xylazine-related activities that could be subject to criminal prosecution, including online and in-person conduct.

FDA Commissioner Robert Califf said, “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. 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.”

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