FDA approves life-saving Narcan for over-the-counter nonprescription use
By Bethany Blankley | The Center Square contributor – March 29, 2023
The U.S. Food and Drug Administration on Wednesday followed through with its plan to approve Narcan for over-the-counter, nonprescription use, after saying it would do so last month.
Its advisory panel unanimously voted to recommend that Americans have wider and easier access to purchasing Narcan/Naloxone, the brand and generic versions of the drug, which have proven to reverse an opioid overdose if administered quickly enough.
This is the first over-the-counter nasal spray approved to combat opioid overdoses. The FDA said it authorized the approval as part of its ongoing efforts “to take critical steps to reduce drug overdose deaths being driven primarily by illicit opioids.”
“Drug overdose persists as a major public health issue in the United States, with more than 101,750 reported fatal overdoses occurring in the 12-month period ending in October 2022, primarily driven by synthetic opioids like illicit fentanyl,” the FDA said.
FDA Commissioner Robert Califf, M.D., said in a statement that the approval of OTC naloxone nasal spray would “help improve access to naloxone, increase the number of locations where it’s available and help reduce opioid overdose deaths throughout the country.”
The 4-milligram dosage of naloxone hydrochloride nasal spray was approved for over-the-counter nonprescription use. Other formulations and dosages of naloxone will only be accessible by prescription, the FDA said.
The timeline for availability and price of OTC Narcan will be determined by the manufacturer, Emergent BioSolutions, the FDA said. However, Califf said the FDA was encouraging Emergent BioSolutions “to make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”
The FDA will also be working with stakeholders “to help facilitate the continued availability of naloxone nasal spray products during the time needed to implement the Narcan switch from prescription to OTC status, which may take months.”
Emergent BioSolutions was first authorized to sell NARCAN Nasal Spray in 2015 as a prescription drug. Since then, Narcan/Naloxone has become accessible for free and low cost online, through a range of community organizations, and through pharmacies with and without a prescription and with or without insurance.
Here’s how Americans can get it.
All 50 states and the District of Columbia have “access laws or alternate arrangements in place that allow persons to obtain naloxone from a pharmacist without an individualized, in-person prescription,” Narcan.com reports. The majority of states and the District of Columbia have Naloxone standing orders, which allow adults to purchase the drug from a licensed pharmacy without a prescription, Rehabs.org explains.
The majority of states have also authorized third-party prescriptions, meaning pharmacists and doctors can prescribe and dispense Naloxone. All state health departments also have information about Naloxone training programs and resources to acquire the drug, including free access.
The OTC status will allow consumers to have even more avenues to purchase the drug, including at convenience stores, grocery stores, gas stations and online, the FDA said.