Mefloquine

Mefloquine hydrochloride 250 mg oral tablets are human prescription drugs under current FDA records. Under Federal Food, Drug, and Cosmetic Act § 503(b), a drug limited by its approved application to professional supervision may be dispensed only by prescription and must bear the designation "Rx only." The current DailyMed label bears that designation and reports no DEA schedule.

Mefloquine and its salts or derivatives are listed without qualification on Health Canada's Prescription Drug List for human use, effective 19 December 2013. The Food and Drug Regulations prohibit the sale of a prescription drug except by a person entitled under provincial law to dispense it after receiving a verbal or written prescription, subject to the section C.01.043 exception. Health Canada's Drug Product Database lists the generic 250 mg mefloquine hydrochloride tablet as marketed and prescription-only, while the brand-name Lariam 250 mg tablet remains prescription-only but has a status of Cancelled Post Market.

Mefloquine is listed in Part 1 of the Second Schedule to the Health Products (Therapeutic Products) Regulations 2016 as an active ingredient in prescription-only medicines. Regulation 11 permits retail supply only when: (a) the supply is at or from a licensed retail pharmacy in accordance with the applicable retail-pharmacy rules; (b) a healthcare service licensee supplies its patient in accordance with the written instructions of a qualified practitioner or collaborative prescribing practitioner who is its personnel; (c) a qualified practitioner or collaborative prescribing practitioner, or a person acting in accordance with that practitioner's oral or written instructions, supplies a patient under that practitioner's care; or (d) a person specified in item 1, 2, 2A or 2B of Part 1 of the Third Schedule supplies the corresponding type of prescription-only medicine in accordance with the corresponding conditions. The Health Sciences Authority defines a Prescription Only Medicine as a therapeutic product obtainable only from a doctor or from a pharmacist with a valid prescription.

Mefloquine is a prescription-only medicine in the United Kingdom. Under regulation 214(1) of the Human Medicines Regulations 2012, it may not be sold or supplied except in accordance with a prescription from an appropriate practitioner, subject to the statutory exemptions in Chapter 3 of Part 12.