Over-the-counter (OTC) naloxone nasal spray
FAQ for Washington State organizations that distribute or prescribe naloxone
April 2, 2023
On March 29, 2023, the Food and Drug Administration (FDA) approved an over-the-counter (OTC) naloxone nasal spray product, NARCAN Nasal Spray, which contains 4 mg/mL of naloxone per dose and is manufactured by Emergent Biosolutions. OTC status means that these products do not require a prescription and can be purchased without speaking to a pharmacist or other healthcare provider (e.g., these are products available on drugstore and grocery store shelves like ibuprofen and common cold medicines).
There may be other naloxone products approved for OTC status in the future. Another company, Harm Reduction Therapeutics, is also seeking OTC status for a 3 mg/mL naloxone nasal spray.
Responses to these questions come from staff at the WA Dept of Health (DOH) and the WA Health Care Authority (HCA). For additional questions please contact:
How will this affect the WA Dept of Health Overdose Education and Naloxone Distribution (OEND) Program and community naloxone?
DOH: The OEND Program will continue. Depending on price of the OTC product(s), we may offer different manufacturer products than are currently available. Our goal is to distribute the least expensive versions of naloxone (both nasal and intramuscular) to maximize our resources and get the greatest number of naloxone kits out to the community.
DOH: DOH will update the WA Statewide Standing Order, as needed, to include the OTC products. While people will not need the standing order to purchase OTC naloxone products, people will be able to use the standing order (which functions like a prescription) to obtain health insurance coverage for the medication. (Note: insurance coverage for naloxone varies, so ask your health insurance provider about what is covered and potential co-pays).
HCA: Yes, Apple Health (WA Medicaid) will cover OTC naloxone. Though a prescription will still be needed to bill Apple Health for naloxone, the Statewide Standing Order for naloxone will remain in effect and can be used as that prescription. More details from HCA will be released soon.
HCA does not plan to create new billing codes for naloxone; however, HCA will need to update billing guidance if a new code for nasal naloxone is released.
No. The only over-the-counter naloxone product is NARCAN® Nasal Spray.
While NARCAN® Nasal Spray has been approved for OTC status, it is not currently available on the market in this format. Emergent BioSolutions, the maker of NARCAN® Nasal Spray, states that it should be available to purchase OTC by summer 2023. Other OTC naloxone nasal spray products may follow. When NARCAN® Nasal Spray is available OTC, you will be able to purchase it in the same places you buy things like ibuprofen and common cold medicines, such as drug store shelves, grocery stores, gas stations, and convenience stores.
Emergent Biosolutions, the makers of the approved OTC product (Narcan® Nasal Spray), have not released pricing as of March 30, 2023.
HCA: OTC nasal naloxone will not affect SB 5195; the requirements to dispense and bill for take-home naloxone will remain.