FDA Approves Opioid Overdose-Reversing Narcan for OTC Sale

The nasal spray that can reverse fatal ODs has been available over the counter in California since 2015

The Food and Drug Administration on Wednesday approved Narcan, a name-brand version of naloxone, for over-the-counter sales in the United States, ensuring that the drug designed to reverse the effects of an opioid overdose is available without a prescription.

The move, the FDA says, will bring Narcan sales to “drug stores, convenience stores, grocery stores and gas stations, as well as online.” Increasing naloxone access (Narcan is the name-brand version of the drug) has been a priority for the FDA, as experts and advocates both attested to the ability of the drug to save lives.

Fatal overdoses from opioids have become a major public health challenge in the United States. From November 2021 to October 2022, the FDA reported more than 101,750 fatalities from people taking opioids.

“Naloxone is a critical tool in addressing opioid overdoses and today’s approval underscores the extensive efforts the agency has undertaken to combat the overdose crisis,” Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, said in the FDA’s statement.

In California, pharmacists have been free to dispense Narcan without a prescription since 2015, but the national order adds locations where buyers don’t have to fill out forms or announce in front of their neighbors that they are buying medication for a stigmatized illness, Dr. Sid Puri, Associate Medical Director of Prevention for the L.A. County Department of Public Health, Substance Abuse Prevention and Control tells LAMag.

In California, pharmacists have been free to dispense Narcan without a prescription since 2015, but the national order formalizes the local practice across the country. The move from the FDA also validates the reasoning in a 2022 state of California standing order that allows “community organizations and other entities” to distribute naloxone to people in need.

In the order, it’s explained that “many community organizations and entities in California can help reduce deaths associated with opioid overdose by distributing naloxone but find it difficult to obtain the required standing order from an appropriate health care provider.”

Even closer to home, a November 2022 report underlined the dire need for Narcan availability in Los Angeles. In L.A. County alone, “accidental fentanyl overdose deaths increased 1,280% from 109 in 2016 to 1,504 in 2021.” The standing order from the state, community efforts to make Narcan available, and a recent move to allow L.A. students to carry Narcan in school will now be complemented by the FDA’s decision to allow over-the-counter Narcan sales.

Altogether, the national and local levels emphasize the near-universal acceptance of naloxone as a critical tool in the fight to stem opioid deaths. Speaking candidly, Dr. Puri said that when he saw the FDA announcement today, he felt a wave of relief.

“This is a really good step. This is a very safe, life-saving, and effective medication that I teach four-year-olds how to administer,” he says. “So when it came out, I was like, finally.”

Stay on top of the latest in L.A. news, food, and culture. Sign up for our newsletters today.