Narcan over the counter overview:
- Who: The Food and Drug Administration approved over-the-counter sales of Narcan in the form of 4 milligram naloxone hydrochloride nasal spray.
- Why: The FDA said Narcan over the counter sales will help the general public have access to the drug that can reverse the effects of opioid overdoses.
- Where: The announcement was made through the FDA’s Washington, D.C., office.
Narcan will now be available for over the counter sales after the Food and Drug Administration approved the sale of 4 milligram naloxone hydrochloride nasal spray without a prescription to the general public.
The FDA announced the move, saying it will increase public access to the drug, used to combat opioid overdoses. The timeline and price of Narcan over the counter sales will be determined by the manufacturer.
Other forms and dosages of naloxone will remain available only through prescription.
“The FDA remains committed to addressing the evolving complexities of the overdose crisis. As part of this work, the agency has used its regulatory authority to facilitate greater access to naloxone by encouraging the development of and approving an over-the-counter naloxone product to address the dire public health need,” said FDA Commissioner Robert M. Califf, M.D. “Today’s approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it’s available and help reduce opioid overdose deaths throughout the country.”
The Narcan nasal spray was first approved as a prescription drug in 2015 and the manufacturer then had to show data that the drug was effective and safe for use according to its labeling. The company also had to prove that consumers can understand how to safely use the drug without the direction of a medical professional.
The Narcan nasal spray was marked with priority review status and then approved for marketing without a prescription at an advisory committee meeting in February.
Most opioid overdose deaths come from synthetic opioids such as fentanyl
Opioid overdoses led to 101,750 deaths in the year leading up to October 2022, according to the FDA, and those overdoses primarily come from synthetic opioids such as illicit fentanyl.
A recent CVS class action lawsuit claimed that the pharmacy was forcing consumers to purchase opioid overdose reversal meds, such as Naloxone, when filling opiate prescriptions.
Have you ever had to use Narcan to combat an opioid overdose? Let us know in the comments.
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One thought on Narcan to be available for over-the-counter purchase
My better half has a morphine pump attached to his spine so we have to keep Narcon in the house, car, my purse so that anywhere we go we have it accessible in case of emergency. Knock on wood never needed it but am glad we don’t have to go thru a song and dance making doctors appointments to get it refilled when our stock becomes outdated.