Viloxazine

FDA records identify Qelbree extended-release capsules under NDA 211964 as prescription drug products containing viloxazine hydrochloride and record their initial approval on April 2, 2021. Under § 503(b) of the Federal Food, Drug, and Cosmetic Act, a human drug limited by an approved application to professional supervision may be dispensed only on a licensed practitioner's prescription and must bear the symbol "Rx only" before dispensing. This prescription classification applies to FDA-approved Qelbree products containing viloxazine hydrochloride; it does not independently classify bulk or unapproved viloxazine or establish separate state-law requirements.

Under regulation 5 and Schedule 1 Part 1 of the Human Medicines Regulations 2012, medicinal products containing viloxazine hydrochloride are prescription only because Schedule 1 of the incorporated Prescription Only Medicines (Human Use) Order 1997 expressly lists Viloxazine Hydrochloride without a strength, route, treatment, or quantity exemption. Regulation 214 restricts sale or supply of a prescription-only medicine to supply in accordance with an appropriate practitioner's prescription, subject to the exemptions in Chapter 3 of Part 12. This classification applies to medicinal products containing viloxazine hydrochloride; it neither establishes that a viloxazine product currently has UK marketing authorisation nor by itself classifies bulk viloxazine as a controlled drug or prohibits simple personal possession.