FDA clears first over-the-counter urine test for fentanyl

The Food and Drug Administration the week of Oct. 23 cleared for marketing the first over-the-counter test to detect fentanyl in urine. The five-minute test provides only preliminary results and includes a pre-addressed mailing box for shipping samples to the manufacturer’s laboratory for confirmation testing using an alternative chemical method. The agency expedited review of the Alltest Fentanyl Urine Test Cassette, clearing it only 16 days after the submission was received.

“Opioid abuse, misuse and addiction is one of the most profound public health crises facing the U.S. today,” said Jeff Shuren, M.D., director of FDA’s Center for Devices and Radiological Health. “…This test is an example of the FDA’s continued commitment to authorize tools that can reduce deaths associated with overdoses.”