Propylhexedrine

Propylhexedrine was removed from Class C under the Misuse of Drugs Act 1971 on 1 September 1995 and is not individually listed in its current Schedule 2. When intended for human consumption for its psychoactive effects and not within an exempt category, it falls within the effect-based definition of a psychoactive substance under the Psychoactive Substances Act 2016. The Act prohibits production, supply, an offer to supply, possession with intent to supply, import, and export for psychoactive consumption, as well as possession for psychoactive consumption in a custodial institution. Ordinary personal possession outside a custodial institution is not an offence under the Act; its restrictions remain subject to the statutory mental and consumption elements, the section 11 and Schedule 2 exemptions, and the Schedule 1 exemption for qualifying medicinal products.

Propylhexedrine appears by exact name in Schedule 4, headed ‘Prescription only medicines and prescription animal remedies’. Part 2 does not apply in the circumstances specified by section 11: exempt preparations and products in Appendix A; specified uses of substances in Appendix B; Appendix G substances at or below their listed concentrations; other Schedule 1–6 substances at concentrations not exceeding 10 mg/L or 10 mg/kg, unless also included in Schedule 7 or 8; and specified pesticide impurities at or below their statutory maximum content. Section 60(1) generally limits Schedule 4 supply to specified practitioners acting lawfully, pharmacists dispensing a legal prescription, or the emergency pharmacist supply permitted by section 60(2), while section 60(3) excludes wholesale supply to specified practitioners or to another person licensed or otherwise authorised under the law of the supplying jurisdiction to possess or supply the poison. The Poisons Standard establishes the national scheduling classification, while State and Territory legislation implements the controls.

In Brazil, propylhexedrine is listed under the name ‘propilexedrina’ at item 81 of Lista B1 in the current version of Annex I to Portaria SVS/MS nº 344, de 12 de maio de 1998. The Lista B1 heading makes its medicines subject to Notificação de Receita B; Article 45 provides that the notification uses a blue form and is valid for dispensing throughout Brazil for 30 days from issuance; the listing also subjects prescription, dispensing, production, distribution, transport, import, and export to controls. The list also covers salts, ethers, esters and isomers of listed substances, and their corresponding salts, when they can exist; however, unlisted isomers that are components of medicines registered with Anvisa, and medicines containing them, are exempt from Lista B1 controls. Units containing no more than 500 mg of propilexedrina as an analytical standard are exempt from import and export authorization requirements, but the substance remains listed in Lista B1.

Propylhexedrine, listed as Propylhexedrin in Anlage 1 of the Arzneimittelverschreibungsverordnung (AMVV), is prescription-only when used in a medicinal product. Under § 1, a medicinal product consisting of, prepared from, or containing propylhexedrine may be dispensed only upon a medical, dental, or veterinary prescription, unless a later provision provides otherwise; unless otherwise specified, this requirement also extends to medicinal products containing or supplemented with the corresponding salts or hydrates. Section 5 exempts qualifying homeopathically manufactured medicinal products when their final-product concentration does not exceed the fourth decimal potency. These provisions regulate medicinal products and their dispensing; they do not prohibit possession of propylhexedrine as a chemical.

Propylhexedrine is not federally scheduled under the Controlled Substances Act. DEA records its removal from Schedule V effective December 3, 1991, and the current Schedule V stimulant provision in 21 CFR § 1308.15 names only pyrovalerone. Section 1308.22 separately lists the 250 mg Benzedrex propylhexedrine inhaler as a nonnarcotic product excluded from all schedules; FDA regulation of the inhaler as an over-the-counter nasal decongestant is distinct from scheduling under the Controlled Substances Act. This federal classification does not determine separate state restrictions.

Propylhexedrine and any salt thereof are named in Schedule I to the Regulations Exempting Certain Precursors and Controlled Substances from the Application of the Controlled Drugs and Substances Act; section 1 has expressly exempted every substance in that schedule from the application of the Act since 14 May 1997. Propylhexedrine was also listed in Schedule V to the Act until that schedule was replaced without it on 18 May 2017. SOR/2025-242 is scheduled to repeal the exemption regulation when the Controlled Substances Regulations come into force on 1 October 2026, but propylhexedrine is not named in the incoming regulations and Health Canada states that it will remain uncontrolled. It is therefore unscheduled for federal control under the Controlled Drugs and Substances Act; the federal classification does not govern provincial or territorial restrictions or authorization requirements for particular drug products.

Standalone propylhexedrine does not appear in lists a–g of the Betäubungsmittelverzeichnisverordnung, consolidated to 13 March 2026, and is therefore unscheduled under that instrument. List b separately names the 1:1 compound Phenobarbital (-)-Propylhexedrin (Barbexaclon), not standalone propylhexedrine. The Annex 6 list-e generic definition for phenethylamine derivatives requires a phenyl ring and does not cover propylhexedrine, whose structure contains a saturated cyclohexyl ring.