The Food and Drug Administration (FDA) is restricting the unlawful entry of xylazine active pharmaceutical ingredients and finished dosage form drug products into the US to prevent its use for illicit purposes.
Xylazine is a centrally-acting alpha2-adrenergic agonist that was originally approved in 1972 as a sedative and analgesic for use in veterinary medicine. While not approved for human use, the drug has been detected in combination with opioids such as illicit fentanyl, and in combination with stimulants such as methamphetamine and cocaine.
In November 2022, the FDA issued a safety alert warning about the serious risks associated with xylazine exposure in humans. The signs and symptoms of acute xylazine toxicity include CNS and respiratory depression, hypotension, bradycardia, hypothermia, miosis, and high blood glucose levels. Moreover, individuals who inject drugs containing xylazine can develop necrotic skin ulcerations that may lead to amputation, if left untreated.
The FDA has taken action today to ensure that drugs containing xylazine entering into the US are intended for legitimate veterinary supply, including active pharmaceutical ingredients en route to a manufacturing facility that produces FDA-approved xylazine. Under the import alert, shipments may be detained by the FDA if it is in violation of the law. As part of the entry review, incoming products containing xylazine must be properly labeled, not adulterated, and for legitimate veterinary use.
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.
“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, MD. “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.”
FDA takes action to restrict unlawful import of xylazine. US Food and Drug Administration. Accessed February 28, 2023. https://www.fda.gov/news-events/press-announcements/fda-takes-action-restrict-unlawful-import-xylazine.