Naloxone

Naloxone is listed in Anlage 1 of the Arzneimittelverschreibungsverordnung. Under section 1, medicinal products containing it generally may be dispensed only upon presentation of a medical, dental, or veterinary prescription. Since 14 October 2025, the naloxone entry has exempted medicinal products for nasal administration as emergency therapy for a known or suspected opioid overdose from that prescription requirement, unless the particular product was authorized by the European Commission as prescription-only. These provisions regulate the dispensing of medicinal products; they do not by themselves classify naloxone as a narcotic drug or prohibit possession of the substance.

Swissmedic classifies the authorized naloxone-only product Naloxon OrPha injection, authorization 56952, in dispensing category B under the Arzneimittelverordnung. Article 42 defines category B as prescription-only medicines. Article 45 permits pharmacists to dispense specified category-B human medicines without an existing medical prescription in limited circumstances. Swissmedic separately classifies oxycodone/naloxone combination products in category A+.

TİTCK's licensed-products register dated 28 August 2026 lists a standalone naloxone hydrochloride injection, barcode 8699548751332, with an unsuspended licence. Under article 6(d) of the Beşeri Tıbbi Ürünlerin Sınıflandırılmasına Dair Yönetmelik, human medicinal products normally administered parenterally are prescription-only, so the registered naloxone injection is obtainable only by prescription. TİTCK's red-prescription list separately includes buprenorphine/naloxone Suboxone products, but does not classify the standalone injection as a red-prescription medicine.

Naloxone is a prescription-only medicine under the Human Medicines Regulations 2012 and is not available for general over-the-counter sale by pharmacies. Since 2 December 2024, regulation 237A has permitted appropriate suppliers, including people working in qualifying drug treatment services and trained members of specified professions and services, to supply naloxone products without a prescription for specified life-saving purposes throughout the United Kingdom. This supply exception covers medicinal products containing naloxone or a salt, ester, or stereoisomeric form of naloxone. Separately, regulation 238 and Schedule 19 permit emergency administration of naloxone products for the purpose of saving life.

Federal law regulates naloxone as a medicine under § 503(b) of the Federal Food, Drug, and Cosmetic Act, with prescription or nonprescription status determined for each FDA-approved product and application. The current Narcan 4 mg nasal spray label classifies that product as over-the-counter, while a current naloxone hydrochloride 1 mg/mL injection label classifies that product as prescription-only. Naloxone is not a federally controlled substance; the DEA lists naloxone and naloxone hydrochloride as not controlled.

Under the Therapeutic Goods (Poisons Standard—June 2026) Instrument 2026, naloxone is listed in Schedule 3 when used to treat opioid overdose. Schedule 3 is the pharmacist-only classification: it requires professional advice and provides for public availability from a pharmacist without a prescription; naloxone for other uses is included in Schedule 4 as a prescription-only medicine. The Poisons Standard establishes the national scheduling classification, while State and Territory legislation implements supply controls.

Canada's federal Prescription Drug List lists naloxone and its salts, including naloxone hydrochloride, but excludes products indicated for emergency use for opioid overdose from prescription status. Consequently, emergency-overdose naloxone is non-prescription at the federal level, while naloxone for other indications remains subject to the Food and Drug Regulations rule that a prescription drug generally may be sold only under a received verbal or written prescription. The qualifier has been effective since 1 February 2017 and permits anyone witnessing an opioid overdose to administer non-prescription naloxone regardless of setting. Provincial and territorial governments may impose stricter conditions of sale; Health Canada reports that take-home kits are available without a prescription at most pharmacies and that implementation of NAPRA's Schedule II pharmacist-intervention recommendation varies by jurisdiction.