Phenobarbital

The 2025 catalogue is issued under Article 3 and takes effect on publication, 2025-07-28, rather than the agencies’ signature date of 2025-07-21. Its Category II list identifies phenobarbital by Chinese and English name and CAS number at item 58 and is not limited to a named finished product. The catalogue contains no express extension to salts or isomers and no preparation-specific exemption. For authorised Category II psychotropic retail sales, Article 32 requires an attending physician’s prescription and the prescribed dose, prohibits non-prescription or excess-dose sales, and prohibits sales to minors; Article 31 limits such retail business to approved, centrally managed retail-chain enterprises.

Phenobarbital (fenobarbital) is listed as a psychotropic substance in List No. 7 of Government Regulation No. 463/2013 Coll. on lists of addictive substances. Under the Act on Addictive Substances, medicinal preparations containing substances in List No. 7 may be prescribed by physicians, and individuals may acquire them for their own use on a prescription issued under the Medicines Act. The Regulation identifies phenobarbital by the chemical name 5-ethyl-5-phenylbarbituric acid.

Finland lists phenobarbital as a narcotic substance in List IV of the Government Decree on substances, preparations and plants regarded as narcotics. The Narcotics Act prohibits the production, manufacture, import, export, transport, distribution, trade, handling, possession and use of narcotics, subject to statutory exceptions for medical, research, supervisory and industrial purposes. Authorised handling of narcotic-classified medicines remains subject to medicines legislation.

The HPRA's current record for marketed Phenobarbital 15 mg Tablets (PA0126/019/001) classifies that product as a prescription product that may not be renewed and as pharmacy-only supply. Phenobarbitone is within Schedule 3 through the barbituric-acid structural definition, but a preparation containing no more than 100 mg per dosage unit (calculated as base), no other controlled drug, and—if undivided—no more than 0.5% is specifically in Schedule 4 Part 2. This is a product/strength-limited controlled-drug exception: the 2017 Regulations exclude Schedule 4 Part 2 from their controlled-drug prescription-form and supply-on-prescription requirements, while the medicine's separate HPRA marketing-authorisation condition still makes the authorised 15 mg product non-renewable prescription-only. The 2025 Schedule 4 amendment adds only Part 1 substances and does not alter Part 2 paragraph 5.

Japan's current Narcotics and Psychotropics Control Act defines psychotropics as the substances in Schedule III, whose first entry expressly covers phenobarbital (5-ethyl-5-phenylbarbituric acid) and its salts. The current PMDA prescribing information for phenobarbital raw powder and 10% powder, revised April 2026, identifies the products as a psychotropic (third-category psychotropic) and a prescription medicine; it says they are to be used on a physician's or other authorized prescriber's prescription. The Schedule III control attaches to phenobarbital and its salts, while the PMDA prescription classification is direct evidence for the named approved products rather than every possible foreign or unapproved formulation.

The current official Enforcement Decree was promulgated 2026-01-27 and effective 2026-02-01. Article 2(3) maps the Act Article 2(3)(a)-(e) psychotropic categories to Schedules 3-7; Schedule 5 is the Article 2(3)(c) category and expressly names phenobarbital at item 25, with its chemical name. Schedule 5 covers each listed substance and its salts, isomers, and salts of isomers. The Decree separately puts mixtures/preparations containing Schedule 3-6 substances in Schedule 7, subject to exclusions designated by Prime Ministerial Ordinance; this finding makes no claim that every phenobarbital preparation is free of such an exclusion. MFDS's current official record for Hana Phenobarbital Tablets identifies phenobarbital 30 mg per tablet and classifies that licensed product as both 전문의약품 (prescription medicine) and 향정 (psychotropic). The prescription-only conclusion is therefore supported for that current licensed phenobarbital product, while the Schedule 5 classification is substance-level; it does not rely on the superseded Pharmaceutical Affairs Act Article 50(2) citation or assert that the MFDS product classification automatically extends to every possible preparation.

Turkey classifies phenobarbital products Luminal and Luminaletten as medicines subject to a green prescription. The Turkish Medicines and Medical Devices Agency's green-prescription list, updated 29 November 2019, identifies both products' active substance as phenobarbital. Under the Ministry of Health's 2003/137 Circular, green-prescription psychotropic medicines are controlled medicines: pharmacies may not supply a controlled medicine until they have seen and received the prescription, and their sales and consumption movements are subject to official tracking.

ANMAT Disposición 6019/1996 establishes that medicinal specialties containing fenobarbital as their active ingredient have the sale condition "venta bajo receta archivada" (sale under a prescription retained by the pharmacy). The official record identifies the disposition as issued on 9 December 1996 and published in the Official Bulletin on 27 December 1996; it does not state a separate effective date. The official linked-norms record reports no complementary or modifying rules, but the disposition is expressly limited to medicinal specialties containing fenobarbital and does not itself establish a general rule for non-medicinal possession or all cross-border activity.

Phenobarbital is expressly listed in point 2 of Anlage 1 to Austria’s Psychotropenverordnung, the group corresponding to Annex IV of the UN Convention on Psychotropic Substances. The PV applies to listed substances in substance form and, except where it expressly refers to substances in substance form, to preparations containing them; it is therefore not confined to named finished products. Medicines containing listed psychotropic substances are subject to the PV’s medical-science and prescription rules, and pharmacies may not dispense them unless the prescription meets § 10(2). Phenobarbital has no asterisk in Anlage 1 Z 2: the asterisk and the special Suchtgiftrezept rule in § 10(3) apply to Flunitrazepam in Z 1, not Phenobarbital; ordinary prescription-only is the supported classification.

Phenobarbital (Fenobarbital) is expressly listed as item 41 of Lista B1, the list of psychotropic substances normally subject to Notificação de Receita B. The current annex separately provides that medicines containing phenobarbital are prescribed on a two-copy Receita de Controle Especial and must bear the statement that sale is only on medical prescription with retention of the prescription. This special rule is product-specific: it applies to medicines containing phenobarbital; the List B1 general adendo also covers salts, ethers, esters, and isomers where their existence is possible. Anvisa identifies RDC 1.036/2026 as the current version; it entered into force on publication (13 July 2026) and its listed amendments do not concern phenobarbital.

Phenobarbital is expressly listed in the current Annex 1 as a controlled substance (Lista Verde, Lista IV) and in Annex 2 as a substance classified as a State monopoly. The current Annex 3 separately lists phenobarbital and phenobarbital sodium as special-control, State-monopoly medicines, covering authorized combinations, pharmaceutical forms, concentrations, and presentations. Prescribing is limited to the dose required for up to 90 calendar days; dispensing uses the special prescription framework and authorized pharmacies/services.

restricted_other is used because the controlling entry condition is an import-certificate restriction, not the invalid vocabulary value import_certificate_required. The current consolidated primary Rules text says import into India of narcotic drugs and psychotropic substances is prohibited except with an import certificate or export authorisation under Chapter VI; rule 55(1) separately says no psychotropic substance may be imported without an import certificate for the consignment. Phenobarbital is expressly item 69 in the Act Schedule, while section 2(xxiii) defines psychotropic substance to include any scheduled substance and any salt or preparation of it; item 110 independently covers salts and preparations of the listed substances. G.S.R. 224(E) substituted rule 53 and removed from rule 55(1) the prior words limiting that provision to substances specified in the Act Schedule, effective on publication (25 March 2015); the inspected consolidated Rules retain those amendments. The Chapter VI materials inspected contain no passenger/personal-medical import exemption for phenobarbital, its salts, or its preparations. Rule 66(2)'s personal medical possession allowance (100 dosage units, or up to 300 if specifically prescribed for long-term use) governs possession and does not create an import exception. Domestic Drugs Rules/Schedule H prescription control may additionally regulate dispensing but does not displace Chapter VI certification. Section 79 treats these NDPS import restrictions as Customs Act restrictions.

Phenobarbital (Fenobarbital; chemical denomination acido 5-etil-5-fenilbarbiturico) is expressly listed in Tabella IV, rather than Tabella III, of the controlled-substances tables attached to DPR 309/1990. It is also expressly listed as an active pharmaceutical substance in the medicines table, Section B, and medicinal compositions containing it are listed in Section C; both sections require a non-repeatable prescription renewed for each dispensing and retained by the pharmacist. The statutory table rule includes salts where they can exist, and Article 14(2) also extends the tables to isomers, esters, ethers, salts, and relevant stereoisomers unless expressly excepted; the prescription classification is specifically for medicines/compositions, subject to any AIFA marketing-authorisation conditions and Ministry of Health limits or prohibitions.

The current Second Schedule, Part 1 expressly lists ‘Phenobarbitone’ under the heading ‘Active ingredients in prescription-only medicines.’ The Regulations define a prescription-only medicine as a therapeutic product registered under that classification, and impose conditions on its retail supply; thus this finding is limited to therapeutic-product preparations rather than treating every non-product form as a prescription medicine. The same current instrument separately lists ‘Phenobarbital’ in its First Schedule of psychotropic substances; the 2023 Active Ingredients Regulations retain that cross-reference while regulating active ingredients usable in specified health products.

Phenobarbital is expressly named at item 36 of the Ministry of Public Health's Category IV psychotropic-substances notification, which took effect on 5 September 2022. Under the Narcotics Code, Category IV is for psychotropic substances with medical use and a lower abuse risk than Category III; the Code treats preparations containing a scheduled psychotropic substance as being in that schedule. Possession of a Category IV psychotropic substance is exempt from permission only in the amount needed for an individually prescribed treatment, while production, import, export, distribution, possession, and transit otherwise require the relevant authorization; a traveller may carry up to 30 days' prescribed personal treatment without a permit.

Phenobarbital is listed as a psychotropic substance in Table III, List 2 of Ukraine’s controlled-substances schedule, whose circulation is restricted but may receive exceptions from some controls. The current consolidated MOH Order No. 210 places combination medicinal products containing phenobarbital within the non-prescription pharmacy category only at or below 20 mg per unit dose and 600 mg per package, or, for undivided forms, 2% (20 mg/mL) and 600 mg per package. Thus the non-prescription rule is product- and limit-specific; it does not make phenobarbital generally unscheduled or generally OTC.