Buprenorphine

The official list classifies buprenorphine as a controlled psychotropic substance but does not specify a detailed prescription pathway.

Current official law controls buprenorphine while permitting regulated prescription medical use in United States.

The October 2024 product information identifies the medicine as prescription-only and pharmacy-only.

Current official law controls buprenorphine while permitting regulated prescription medical use in Canada.

As of 28 August 2026, Government Decree 153/2025 replaced Annex II, issued 10 April 2025 and effective 25 April 2025; it places the 1971 Convention psychotropic-substances Lists I–IV in Annex II and expressly retains buprenorfiini in List III with the stated chemical identity. Government Decree 651/2026, issued 25 June 2026 and effective 10 July 2026, replaced Annexes I, III and IV but did not amend Annex II, so 153/2025 remains the operative Annex II text. Decree 543/2008 section 1 makes substances, preparations and plants listed in Annexes I–IV narcotics. The Narcotics Act defines narcotics to include 1971 Convention Lists I–IV and says detailed entries are set by Government decree; it generally prohibits production, manufacture, import, export, transport, distribution, trade, handling, possession and use, while preserving separately regulated medical, research and supervisory exceptions. Fimea's Temgesic summary identifies 0.2 mg and 0.4 mg sublingual tablets containing buprenorphine hydrochloride equivalent to buprenorphine, indicates treatment of severe and moderate pain, and requires an original prescription. For opioid-dependence withdrawal/substitution treatment, 642/2023 section 3 permits buprenorphine-containing medicines only when prescribed by the responsible or designated physician of the treating unit; such medicines may not be prescribed for pharmacy dispensing and treatment/administration is under the treating unit's supervision, with limited take-home quantities. The same section permits a buprenorphine-naloxone combination to be dispensed by a pharmacy only under a patient-signed Pharmacy Agreement while valid, with an additional prescriber-role entry. Lawful medicinal pathways exist, but non-medical possession/use remains within the narcotics prohibitions and criminal provisions. Chapter 50 section 1 covers unlawful manufacture, import/export/transport, sale/distribution, possession or attempted acquisition and carries a fine or up to two years' imprisonment; section 2 aggravated cases carry one to ten years when a statutory aggravating condition is met and the offence is overall aggravated; section 2a covers unlawful use or small personal-use possession/acquisition and carries a fine or up to six months' imprisonment. Exact liability depends on authorization, conduct, formulation, amount and circumstances.

Prescription by general practitioners and dispensation by pharmacies has been permitted since the mid-1990s as part of harm reduction efforts addressing HIV transmission and overdose risk among people who use drugs.²⁵

Current official law controls buprenorphine while permitting regulated prescription medical use in Germany.

As of 28 August 2026, the operative Opiumwet XML state (9 July 2026) identifies buprenorfine in List II. Article 3 prohibits bringing List II substances into or out of the Netherlands, preparing, processing, selling, delivering, supplying, transporting, possessing or manufacturing them, absent an applicable statutory authorization. The Opiumwetbesluit expressly keeps buprenorfine within the special opium-medicine prescribing and dispensing rules: its Article 8 exception from Articles 3–7 for many List II-only preparations specifically names buprenorfine as an exception, while Article 2 requires each opiumwetmiddel to be prescribed on a separate prescription and Article 4 requires pharmacists to deliver on the prescribed form (with the narrow no-delay/no-misuse exception in Article 4(2)). Geneesmiddelenwet Article 61(9) independently bars a pharmacist from supplying a UR medicine without a prescription except in an emergency where misuse risk is sufficiently excluded. The CBG SmPC records the authorized Temgesic product and its buprenorphine identity and post-operative-pain indication; CBG defines UR as an authorization category for medicines supplied only on prescription. The List II prohibitions continue to apply outside the regulated medical channel. Opiumwet Article 11(2) sets up to two years' imprisonment or a fifth-category fine for intentional List II possession/supply/manufacture conduct under Article 3(B)-(D), Article 11(3) raises professional/business intentional Article 3(B) conduct to up to six years or a fifth-category fine, and Article 11(4) sets up to four years or a fifth-category fine for intentional import/export under Article 3(A); Article 11(5) raises large-quantity cases to up to six years. Article 11(7) excludes the Article 11(2) and (4) penalty provisions for a small List II amount intended for personal use (other than hemp/hashish), but this is not a general authorization to possess or supply buprenorphine.

The current Norwegian narcotics list identifies buprenorfin as P III with CAS 52485-79-7, while P III is the list's international psychotropic-category column and is not itself a Norwegian prescription-group label. Buprenorphine is nevertheless a controlled medicinal active ingredient: DMP's official page (updated 1 June 2026) lists Suboxone, Subutex, Bunalict, Bugnanto, Buprefarm, Buvidal, Norspan, Temgesic and Espranor as examples of medicines containing narcotic active ingredients covered by the Norwegian pharmacy Schengen-attest rules. The narcotics regulation applies to manufacture, trade, import/export, delivery, shipment, storage, possession and use, and its § 5 prohibition applies only to list entries carrying a § 5 reference; buprenorphine's row has no such reference, so buprenorphine is subject to controlled medicinal access rather than a categorical ban. Prescription dispensing remains controlled by the medicines and pharmacy framework. For substitution treatment, § 4-1 of the 2022 prescribing regulation allows individual-patient prescribing only where the patient is admitted to LAR in specialist health services or under a short, clearly defined multidisciplinary tapering plan made with specialist services; LAR treatment is defined as specialist multidisciplinary opioid-dependence treatment in which prescribing an addictive medicine at a specified dose is part of rehabilitation. Current law does not establish identical marketing or prescription status for every possible buprenorphine formulation, and does not establish the former dose-specific Temgesic/Subutex/Suboxone wording as a universal current rule. Unlawful conduct involving this narcotic can fall under Penal Code § 231 (fine or imprisonment up to 2 years; negligent offence up to 1 year) or, when aggravated by substance, quantity or character, § 232 (up to 10 years; very significant quantity 3–15 years, exceptionally up to 21 years; negligent aggravated offence up to 6 years).

The current Roszdravnadzor copy of Resolution No. 681 identifies the 30 June 1998 resolution in the edition amended 11 June 2025 and places the exact entry «Бупренорфин» in List II under Narcotic Drugs. Federal Law No. 3-FZ Article 14(2) allows List II circulation for medical and specified statutory purposes, Article 25(2) requires List II narcotic drugs supplied to individuals for medical purposes to be dispensed by prescription, and Article 31(1) limits medical use to List II substances registered in Russia as medicines. Article 31(6) separately prohibits treating drug dependence with List II narcotic drugs, so the general prescription route must not be read as authorization for opioid-substitution/addiction treatment. Resolution No. 1002's current table (edition amended 11 June 2025) gives buprenorphine significant, large and especially large values of 0.005 g, 0.025 g and 5 g, respectively, for Articles 228, 228.1, 229 and 229.1; these are criminal-law quantity thresholds, not lawful possession allowances. Article 228 covers unauthorized acquisition, storage, transport, manufacture or processing without intent to supply: up to 3 years at significant quantity, 3–10 years at large quantity, and 10–15 years at especially large quantity. Article 228.1 covers unauthorized production, supply or forwarding independently of amount at 4–8 years under part 1; significant, large and especially large quantities trigger 8–15, 10–20 and 15–20 years or life imprisonment under parts 3–5, subject to their statutory conditions. Article 229 covers theft or extortion (3–7 years basic; 6–10 years for listed aggravating circumstances including significant quantity; 8–15 years for organized-group/large-quantity or dangerous-violence cases; 15–20 years at especially large quantity), and Article 229.1 covers cross-border smuggling (3–7 years basic; 5–10 years significant; 10–20 years large; 15–20 years or life especially large). Article 6.8 administrative liability applies to unauthorized possession/handling without intent to supply where the criminal provision is not established: 4,000–5,000 rubles or up to 15 days administrative arrest, with foreign nationals additionally subject to removal. The schedule names the exact substance; not every buprenorphine formulation is registered or marketed, and lawful possession still depends on a valid medical prescription and the applicable licensed dispensing rules.

LVFS 2011:10 lists buprenorfin in Swedish narcotics list IV and international list P IV. VARA records Temgesic 0.2 mg sublingual tablets and Buprenorphine Orifarm 2 mg as on the market, while the Temgesic 0.3 mg/ml injection and Subutex 0.4 mg and 8 mg products are not on the market. Buprenorphine Orifarm 2 mg is prescription-only and controlled as list IV, with a specialist/LARO-clinic or Läkemedelsverket-dispensation dispensing restriction except for another approved indication.

Buprenorphine has the official Swiss designation 'Verzeichnis a' and prescription-only status. Buprenorphine is not in the prohibited Verzeichnis d: the current schedule places it in Verzeichnis a, while Swissmedic's list dated 31 July 2026 shows authorized buprenorphine medicines in Swiss trade. A+ means one-time dispensing on a physician prescription using a narcotic prescription; this is a controlled medical route, not unrestricted possession or supply. Physicians may prescribe only for patients they have examined and only as medically necessary; pharmacies dispense on the qualifying prescription and repeat dispensing of Verzeichnis-a medicines is not allowed unless the prescriber states otherwise. For treatment of narcotic-dependent persons, BetmG Art. 3e(1) separately requires a cantonal permit for prescribing, dispensing and administering narcotics; this additional treatment authorization applies only to treatment of narcotic-dependent persons. Unauthorised possession, acquisition, supply, import/export or similar handling is punishable under BetmG Art. 19 by up to three years' imprisonment or a monetary penalty, with a minimum one-year custodial term for qualifying commercial trade; a medical professional who uses or dispenses contrary to Arts. 11 or 13, or prescribes contrary to Art. 11, is punishable under Art. 20 by up to three years or a monetary penalty, with the same aggravated commercial-trade minimum. The legal position applies to exact buprenorphine and authorized formulations, not analogues or unlisted products.

In Turkey, buprenorphine/naloxone (Suboxone) treatment is subject to prescription requirements. The Ministry of Health ALO 191 page, updated 12 October 2023, says Suboxone is a red-prescription medicine used for heroin- and morphine-type opioid (narcotic) dependence, prescribed within legal limits according to physician-determined rules, is personal to the patient, and that obtaining it outside a prescription leads to unlawful processes. A Ministry hospital page updated 21 January 2026 states that its specialist outpatient clinic provides buprenorphine/naloxone (Suboxone) treatment to adults with opiate-use disorder, confirming a current medical pathway. The 2025 National Police drug report's current synthetic-medicine section describes medicines subject to red or green prescription and lists Suboxone among seized synthetic medicines; its synthetic-opioid discussion identifies Subutex as buprenorphine. TCK Article 188(1) sets 20–30 years' imprisonment and 2,000–20,000 days' judicial fine for unlicensed or licence-contrary manufacture, import or export of narcotic or stimulant substances; Article 188(3) sets at least 10 years and 1,000–20,000 days for unlicensed or licence-contrary domestic sale, offering, giving, dispatch, transport, storage, purchase, acceptance or possession. Article 188(6) expressly applies those provisions to substances producing narcotic or stimulant effects whose production requires official permission or whose sale depends on a prescription issued by an authorised physician, preserving the distinction between authorised medical supply and unauthorised conduct. Article 191(1) provides 2–5 years for purchase, acceptance, possession for use, or use; paragraphs (2)–(3) also provide a five-year postponement of public prosecution and at least one year of probation with possible treatment. A separate generic Turkish schedule entry for every buprenorphine substance or formulation is not established in the current schedules.

Current official law controls buprenorphine while permitting regulated prescription medical use in United Kingdom.