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Canada Classifies Epinephrine Spray for Pharmacist-Mediated Sale

The Schedule II classification took effect Nov. 5. ALK Canada says its 2-milligram neffy spray is available without a prescription where one had been required.

Updated 2 min read
A pharmacist hands an epinephrine nasal spray package to a customer at a Toronto pharmacy counter. (AI-generated image / EconoTimes)
A pharmacist hands an epinephrine nasal spray package to a customer at a Toronto pharmacy counter. (AI-generated image / EconoTimes)

Canada’s national pharmacy schedule now places epinephrine nasal spray for emergency anaphylaxis treatment in a pharmacist-mediated category, opening a no-prescription route where the classification applies.

The National Association of Pharmacy Regulatory Authorities (NAPRA) finalized its Schedule II recommendation Nov. 5, 2026, after a 30-day consultation that drew no comments. The final recommendation followed the board’s approval of an interim version.

Under NAPRA’s model, Schedule II products stay behind the pharmacy counter and require a pharmacist’s involvement at sale; customers cannot select them from open shelves. NAPRA says implementation varies by jurisdiction. In British Columbia, the national listing is treated as included in the province’s corresponding schedule until it is reviewed and formally added. Quebec maintains separate drug schedules.

On Nov. 9, 2026, ALK-Abelló Pharmaceuticals Inc. Canada announced that its 2-milligram Neffy nasal spray no longer requires a prescription in provinces and territories that had required one. The company says customers must consult a pharmacist before dispensing. Andrew Desbarats, ALK Canada’s general manager, described the change as giving people at risk and their caregivers “another way to carry and use epinephrine.”

Health Canada’s product monograph authorizes neffy for emergency treatment of allergic reactions, including anaphylaxis, in adults and children weighing at least 30 kilograms (66 pounds). It does not authorize use for children below that limit. The recommended initial dose is one 2-milligram spray in one nostril. The labeling advises seeking emergency medical assistance after use. If symptoms fail to improve or worsen, another spray may be given in the same nostril beginning five minutes later.

The monograph says safety evidence for neffy comes primarily from four clinical pharmacology studies involving 175 adults. Participants were healthy adults or adults with type I allergy; none had experienced anaphylaxis or had structural or anatomical nasal conditions. Health Canada says epinephrine has not been tested in controlled clinical trials as treatment during anaphylaxis.

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