FDA Makes Narcan Nasal Spray Over The Counter

The U.S. Food and Drug Administration announced yesterday they’re approving Narcan, 4 milligram nasal spray for over-the-counter, nonprescription, use.

Narcan is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose.

The action allows those around high risk users to access the opioid reversal medication in places like drug stores, convenience stores, grocery stores and gas stations, as well as online.

The timeline for availability and price of the product will be determined by manufacturers making the medicine.

The FDA will work with all stakeholders to help facilitate the continued availability of narcan nasal spray products during the time needed to implement the Narcan switch from prescription to OTC status, which may take months.

Other formulations and dosages of narcan will remain available by prescription only.

According to the FDA over 100,000 opioid deaths were reported in the United States from September of 2021 to October 2022, primarily driven by synthetic opioids like fentanyl.

Narcan nasal spray was first approved by the FDA in 2015 as a prescription drug. In accordance with a process to change the status of a drug from prescription to nonprescription, the manufacturer provided data demonstrating that the drug is safe and effective for use as directed in its proposed labeling as well as showing that consumers can understand how to use the drug safely and effectively without the supervision of a healthcare professional.