NDSAC to Consider Schedule II Status for Epinephrine Nasal Spray at Its September 20 Meeting

The National Association of Pharmacy Regulatory Authorities (NAPRA) has posted the agenda for the September 20, 2026 meeting of its National Drug Scheduling Advisory Committee (NDSAC). The single item under review is a “Request for Schedule II status for epinephrine nasal spray, in pre-filled devices intended for emergency administration by nasal spray in the event of anaphylactic reactions to allergens.” The outcome matters mainly to community pharmacy, where Schedule II products are sold from behind the counter after pharmacist involvement, without a prescription; hospital and institutional pharmacies are largely unaffected.

What is on the table

Applications for Interested Party status closed at 4:00 p.m. ET on August 6, 2026. Written comments from anyone else are accepted by the NDSAC Secretariat at ndsac@napra.ca until 4:00 p.m. ET on Friday, September 11, 2026. NAPRA notes that alternate-method submissions receive only a receipt acknowledgment, but that all submissions are shared with NAPRA and the Interested Parties.

The product class behind the request is new to Canada. ARS Pharmaceuticals announced on April 15, 2026 that Health Canada had granted approval for neffy 2 mg (epinephrine nasal spray) “for the emergency treatment of allergic reactions (anaphylaxis) in adults and children who weigh 30 kg or more.” ARS said it would manufacture and supply the product to its Canadian commercial partner, ALK, and expected availability in the summer of 2026; a 1 mg dose for children weighing 15 kg to 30 kg was planned for a later filing. The current scheduling of the nasal spray and how each province will implement an NDSAC recommendation are questions for the provincial regulators, so nothing changes at the counter until a province acts.

Practice guidance for pharmacists

• If your pharmacy or association has a view on non-prescription access, submit written comments to ndsac@napra.ca before 4:00 p.m. ET on September 11, 2026.
• Check your provincial regulator’s drug schedule before selling any epinephrine nasal spray without a prescription; NDSAC recommendations only take effect once a province adopts them.
• Prepare counselling on the nasal route: the approved 2 mg product is for patients weighing 30 kg or more, so confirm weight before recommending it in place of an auto-injector.
• Counsel patients that a nasal device does not replace an emergency plan: call 911 after use and follow the product monograph on repeat dosing.
• Review storage, expiry and stock-rotation practices for a new dosage form before stocking it behind the counter.

NDSAC recommendations feed NAPRA’s National Drug Schedules, which provinces and territories adopt under their own legislation. Watch for the committee’s recommendation after September 20 and for provincial notices that follow.