FDA Approves OTC Narcan

“Doctors don’t always prescribe it to patients who need it, pharmacies don’t always stock it, the price may be prohibitive when they do stock it,” she says. “While many states now have standing orders allowing anyone to get it from the pharmacist without a [patient-specific] prescription, people often do not know that.”

First OTC Approvals

In 2022, the FDA announced its determination that some naloxone formulations could be safely and effectively used without a prescription. Narcan is the first naloxone product to receive FDA authorization for over-the-counter sales. In approving OTC sales, FDA Commissioner Robert M. Califf, M.D., says the FDA hopes to “help improve access to naloxone, increase the number of locations where it’s available, and help reduce opioid overdose deaths throughout the country.”

Supply Questions

While the pricing and availability of OTC naloxone products remain to be determined, the FDA anticipates that the overdose reversal products will eventually be available from nonpharmacy retailers like grocery stores, convenience stores, and gas stations. By the end of 2023, New York City officials even hope to make OTC naloxone available through vending machines.

Making Narcan available over the counter may temporarily disrupt sales of some prescription generic naloxone nasal sprays. Generic manufacturers will have to adjust their labeling and decide whether to apply for FDA permission to sell their products over the counter. Some formulations, like injectable naloxone, will likely remain prescription-only.

Patrizia Cavzzoni, M.D., director of the FDA Center for Drug Evaluation and Research, says the FDA “will work with any sponsor seeking to market a nonprescription naloxone product, including through an Rx to OTC switch.”

AARON SEVERSON is the associate editor of Working Nurse.

In this Article: FDA, Legislation and Public Policy, Substance Abuse and Opioids