Background

The Food and Drug Administration announced Feb. 28 that it has taken action to restrict the unlawful entry into the U.S. of xylazine active pharmaceutical ingredients and finished dosage form drug products to address a growing public health concern. The agency states that this chemical has increasingly been found in illicit drugs such as illicitly manufactured fentanyl and other drugs and is increasingly being detected in overdose deaths.

Accordingly, the FDA has issued an import alert instructing its field staff to detain without physical examination any shipments of xylazine bulk drug, xylazine API (including xylazine hydrochloride), and finished drug products containing xylazine identified in the “red list” to the import alert. Field staff may also detain shipments of xylazine bulk drug or xylazine API (including xylazine hydrochloride) that are, or appear to be, misbranded under section 502(f)(1), as well as shipments of finished drug products containing xylazine that are, or appear to be, adulterated under section 501(a)(5).

The FDA states that this action aims to prevent this drug from entering the U.S. market for illicit purposes while maintaining availability for its legitimate uses in animals.

For more information on this and other FDA issues, please contact FDA consultant Domenic Veneziano at (202) 734-3939 or via email.

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