Under the import alert, xylazine shipments are subject to heightened FDA scrutiny, and agency staff may detain shipments of xylazine and the ingredients used to make it to ensure they’re meant for legitimate use.
The agency said it is coordinating with animal health stakeholders to ensure that drugs containing xylazine are available to veterinarians.
Xylazine is FDA-approved for use in animals as a sedative and pain reliever.
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, the agency 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,” Commissioner Robert Califf said in a statement.
“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,” Califf said.
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