Brazilian Controlled Drugs and Substances Act
Appearance
The Brazilian Controlled Drugs and Substances Act (Portuguese: Regulamento Técnico sobre substâncias e medicamentos sujeitos a controle especial), officially Portaria nº 344/1998,[1] is Brazil's federal drug control statute, issued by the Ministry of Health through its National Health Surveillance Agency (Anvisa). The act also serves as the implementing legislation for the Single Convention on Narcotic Drugs, the Convention on Psychotropic Substances, and the United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances in the country.
The list was last updated in September 2023.[2]
Terminology:
- Prescription notification - a standardized document intended for notifying Anvisa of the prescription of medications. Written by the doctor and retained by the drugstore
- Prescription - a written medication order that provides usage instructions for the patient.
- Special control prescription - a prescrition that is filled out in two copies, one that is retained by the drugstore, and another stays with the patient for usage guidance. It can be provided in a digital signed form.[3]
Overview
[edit]Class | Type of substance | Rx type |
---|---|---|
A1 | Narcotic drugs: analgesics, opioids, non-opioids, other analgesics | Yellow "A" Prescription Notification form (provided by Anvisa), along with a prescription. |
A2 | Narcotic drugs: analgesics, opioids and non-opioids | |
A3 | Psychoactive drugs: central nervous system stimulants | |
B1 | Psychoactive drugs: antiepileptics, sleep inducers, anxiolytics, antidepressants, tranquilizers | Blue "B" Prescription Notification form (the doctor request a printing press for it)[4] |
B2 | Psychoactive drugs: anorectics | |
C1 | Other controlled substances: antidepressants, antiparkinsonians, anticonvulsants, antiepileptics, neuroleptics and anesthetics | Special control prescription form, filled in two copies. A digital prescription can be used alternatively.[3] |
C2 | Retinoids: treatmeant of severe cystic acne | White Prescription Notification form (the doctor request a printing press for it)
![]() Contains a teratogenic warning and a sign. |
C3 | Immunosuppressive drugs | Prescription notification form, and a consent form regarding teratogenic risks, confirming understanding and agreeing to be the sole user of the drug. (form provided by a local public health organization to the doctor)[5] |
C4 | Antiretroviral drugs: management of HIV/AIDS - List revoked in September 2016.[6] | revoked |
C5 | Anabolic steroids | Special control prescription form, filled in two copies. A digital prescription can be used alternatively.[3] |
D1 | Drug precursors | |
D2 | Drug precursors | |
E | Controlled Plants and Fungi | |
F | Prohibited Substances | Allowed only in authorized scientific research.[1] |
F1 | Prohibited narcotics | |
F2 | Prohibited psychotropics | |
F3 | Prohibited precursors | |
F4 | Other prohibited substances |
Alemerian Aldyhyde
[edit]Class A3
[edit]- Amphetamine
- Cathine
- Chlorphentermine
- Dexamphetamine
- Dronabinol - Synthetic form with no other cannabinoid.
- Phenmetrazine
- Phencyclidine
- Phenethylline
- Levamphetamine
- Levomethamphetamine
- Lisdexamfetamine
- Methylphenidate
- Methylsynephrine
- Thamphetamine
- Cannabis sativa derivates containing up to 30mg/mL THC and 30mg/mL CBD
Class A1
[edit]- Acetylmethadol
- Alphacetylmethadol
- Alphameprodine
- Alphamethadol
- Alphaprodine
- Alfentanil
- Allylprodine
- Anileridine
- Bezitramide
- Benzethidine
- Benzylmorphine
- Benzoylmorphine (CID 10982005 from PubChem)
- Betaacetylmethadol
- Betameprodine
- Betamethadol
- Betaprodine
- Buprenorphine
- Butorphanol
- Clonitazene
- Codoxime
- Concentrated opium poppy straw
- Dextromoramide
- Diampromide
- Diethylthiambutene
- Diphenoxylate
- Difenoxin
- Dihydromorphine
- Dimepheptanol
- Dimenoxadol
- Dimethylthiambutene
- Dioxaphetyl butyrate
- Dipipanone
- Drotebanol
- Ethylmethylthiambutene
- Etonitazene
- Etoxeridine
- Phenadoxone
- Phenampromide
- Phenazocine
- Phenomorphan
- Phenoperidine
- Fentanyl
- Furethidine
- Hydrocodone
- Hydromorphinol
- Hydromorphone
- Hydroxypethidine
- Methadone intermediate
- Moramide intermediate
- Pethidine intermediate A
- Norpethidine (Pethidine intermediate B)
- Pethidinic acid (Pethidine intermediate C)
- Isomethadone
- Levophenacylmorphan
- Levomethorphan
- Levomoramide
- Levorphanol
- Methadone
- Metazocine
- Methyldesorphine
- Methyldihydromorphine
- Metopon
- Myrophine
- Morpheridine
- Morphine
- Morinamide
- Nicomorphine
- Noracymethadol
- Norlevorphanol
- Normethadone
- Normorphine
- Norpipanone
- Codeine-N-oxide
- Morphine-N-oxide
- Opium
- Oripavine
- Oxycodone
- Oxymorphone
- Pethidine
- Piminodine
- Piritramide
- Proheptazine
- Properidine
- Racemethorphan
- Racemoramide
- Racemorphan
- Remifentanil
- Sufentanil
- Tapentadol
- Thebacon
- Thebaine
- Tilidine
- Trimeperidine
Class A2
[edit]Class A3
[edit]- Amphetamine
- Cathine
- Chlorphentermine
- Dexamphetamine
- Dronabinol - Synthetic form with no other cannabinoid.
- Phenmetrazine
- Phencyclidine
- Phenethylline
- Levamphetamine
- Levomethamphetamine
- Lisdexamfetamine
- Methylphenidate
- Methylsynephrine
- Thamphetamine
- Cannabis sativa derivates containing up to 30mg/mL THC and 30mg/mL CBD
Class B1
[edit]- Allobarbital
- Alprazolam
- Amineptine
- Amobarbital
- Aprobarbital
- Armodafinil
- Barbexaclone
- Barbital
- Bromazepam
- Bromazolam
- Brotizolam
- Butabarbital
- Butalbital
- Camazepam
- Ketamine
- Ketazolam
- Cyclobarbital
- Clobazam
- Clonazepam
- Clonazolam
- Chlorazepam (CAS: 34985-87-0 , CID 3084599 from PubChem, UNII: R14J9HX8JT)
- Clorazepate
- Chlordiazepoxide
- Ethyl chloride
- Methylene chloride/dichloromethane
- Clotiazepam
- Cloxazolam
- Delorazepam
- Diazepam
- Diclazepam
- Esketamine
- Estazolam
- Eszopiclone
- Ethchlorvynol
- Ethylamphetamine (N-Ethylamphetamine)
- Ethinamate
- Etizolam
- Phenazepam
- Phenobarbital
- Flualprazolam
- Flubromazolam
- Fludiazepam
- Flunitrazepam
- Flurazepam
- GBL
- GHB
- Glutethimide
- Halazepam
- Haloxazolam
- Lefetamine
- Ethyl loflazepate
- Loprazolam
- Lorazepam
- Lormetazepam
- Medazepam
- Meprobamate
- Mesocarb
- Methylphenobarbital (prominal)
- Methyprylon
- Midazolam
- Modafinil
- Nimetazepam
- Nitrazepam
- Fencamfamin
- Nordazepam
- Oxazepam
- Oxazolam
- Pemoline
- Pentazocine
- Pentobarbital
- Perampanel
- Pinazepam
- Pipradrol
- Pyrovalerone
- Prazepam
- Prolintane
- Propylhexedrine
- Secbutabarbital
- Secobarbital
- Temazepam
- Tetrazepam
- Thiamylal
- Thiopental
- Triazolam
- Trichlorethylene
- Trihexyphenidyl
- Vinylbital
- Zaleplon
- Zolpidem
- Zopiclone
- Cannabis derivates containing up to 0,2% THC
Class B2
[edit]Class C1
[edit]- Acepromazine
- Valproic acid
- Agomelatine
- Amantadine
- Amisulpride
- Amitriptyline
- Amoxapine
- Aripiprazole
- Asenapine
- Atomoxetine
- Azacyclonol
- Beclamide
- Benactyzine
- Benfluorex
- Benzydamine
- Benzoctamine
- Benzquinamide
- Biperiden
- Brexpiprazole
- Brivaracetam
- Bupropion
- Buspirone
- Butaperazine
- Butriptyline
- Cannabidiol - Synthetic form with no other cannabinoid.
- Captodiame
- Carbamazepine
- Caroxazone
- Celecoxib
- Cyclarbamate
- Cyclexedrine (CAS: 532-52-5 , CID 115663 from PubChem)
- Cyclopentolate
- Cisapride
- Citalopram
- Clomacran
- Clomethiazole
- Clomipramine
- Chloralodol
- Chlorpromazine
- Chlorprothixene
- Clotiapine
- Clozapine
- Dapoxetine
- Desflurane
- Desipramine
- Desvenlafaxine
- Deutetrabenazine
- Dexetimide
- Dexmedetomidine
- Dibenzepine
- Dimetacrine
- Disopyramide
- Disulfiram
- Divalproex sodium
- Dixyrazine
- Donepezil
- Doxepin
- Droperidol
- Duloxetine
- Ectylurea (See Acylurea) (CAS: 95-04-5 , CID 5895404 from PubChem)
- Emylcamate
- Enflurane
- Entacapone
- Escitalopram
- Etomidate
- Etoricoxib
- Ethosuximide
- Levophacetoperane
- Phenprobamate
- Phenaglycodol
- Phenelzine
- Pheniprazine
- Phenytoin
- Fluphenazine
- Flumazenil
- Fluoxetine
- Flupentixol
- Fluvoxamine
- Gabapentin
- Galantamine
- Haloperidol
- Halothane
- Chloral hydrate
- Etodroxizine (Hydrochlorbenzethylamine)
- Hydroxydione
- Homofenazine
- Imiclopazine
- Imipramine
- Imipraminoxide
- Iproclozide
- Isocarboxazid
- Isoflurane
- Cenestil (Isopropyl-crotonyl-urea) (CAS: 60364-26-3 , CID 6377520 from PubChem)
- Lacosamide
- Lamotrigine
- Leflunomide
- Levetiracetam
- Levomepromazine
- Levomilnacipran
- Lisuride
- Lithium
- Loperamide
- Loxapine
- Lumiracoxib
- Lurasidone
- Mavacamten
- Maprotiline
- Meclofenoxate
- Mephenoxalone
- Mefexamide
- Memantine
- Mepazine
- Mesoridazine
- Methylnaltrexone
- Methylpentynol
- Methysergide
- Metixene
- Methopromazine (CAS: 61-01-8 , CID 18847 from PubChem)
- Methoxyflurane
- Mianserin
- Milnacipran
- Miltefosine
- Minaprine
- Mirtazapine
- Misoprostol - Hospital authorization only.[2]
- Moclobemide
- Molnupiravir
- Moperone
- Naloxone
- Naltrexone
- Nefazodone
- Nialamide
- Isobutyl nitrite
- Nomifensine
- Nortriptyline
- Noxiptiline
- Olanzapine
- Opipramol
- Oxcarbazepine
- Oxybuprocaine
- Hydroxyphenamate
- Oxypertine
- Paliperidone
- Parecoxib
- Paroxetine
- Penfluridol
- Perphenazine
- Pergolide
- Pericyazine
- Pimozide
- Pipamperone
- Pipotiazine
- Pramipexole
- Pregabalin
- Primidone
- Prochlorperazine
- Promazine
- Propanidid
- Propiomazine
- Propofol
- Prothipendyl
- Protriptyline
- Proparacaine
- Quetiapine
- Ramelteon
- Rasagiline
- Reboxetine
- Ribavirin
- Rimonabant
- Risperidone
- Rivastigmine
- Rofecoxib
- Ropinirole
- Rotigotine
- Rufinamide
- Selegiline
- Sertraline
- Sevoflurane
- Sulpiride
- Sultopride
- Tacrine
- Teriflunomide
- Tetrabenazine
- Tetracaine
- Tiagabine
- Tianeptine
- Tiapride
- Thioproperazine
- Thioridazine
- Thiothixene
- Tolcapone
- Topiramate
- Tranylcypromine
- Trazodone
- Triclofos
- Trifluoperazine
- Trifluperidol
- Trimipramine
- Troglitazone
- Valdecoxib
- Sodium valproate
- Venlafaxine
- Veralipride
- Vigabatrin
- Vilazodone
- Vortioxetine
- Ziprasidone
- Zotepine
- Zuclopenthixol
Class C2
[edit]Class C3
[edit]Class C4
[edit]List revoked in September 2016.[6]
- Abacavir
- Amprenavir
- Atazanavir
- Darunavir
- Delavirdine
- Didanosine (ddI)
- Dolutegravir
- Efavirenz
- Enfuvirtide
- Stavudine (d4T)
- Etravirine
- Fosamprenavir
- Indinavir
- Lamivudine (3TC)
- Lopinavir
- Maraviroc
- Nelfinavir
- Nevirapine
- Raltegravir
- Ritonavir
- Saquinavir
- Tenofovir
- Tipranavir
- Zalcitabine (ddC)
- Zidovudine (AZT)
Class C5
[edit]- Androstanolone
- Bolasterone
- Boldenone
- Chlorodehydromethyltestosterone
- Clostebol
- Dehydrochlormethyltestosterone
- Drostanolone
- Stanolone
- Stanozolol
- Ethylestrenol
- Fluoxymesterone
- Formebolone
- Gestrinone
- Mesterolone
- Methandienone
- Methandranone
- Methandriol
- Methenolone
- Methyltestosterone
- Mibolerone
- Nandrolone
- Norethandrolone
- Oxandrolone
- Oxymesterone
- Oxymetholone
- Prasterone (dehydroepiandrosterone - DHEA)
- Somapacitan
- Somatrogon
- Somatropin (Human Growth Hormone)
- Testosterone
- Trenbolone
Class D
[edit]Class D1
[edit]- 1-Boc-4-AP (CAS: 125541-22-2 , CID 1491502 from PubChem)
- 1-phenyl-2-propanone
- 3,4-MDP-2-P methyl glycidic acid (PMK glycidic acid)
- 3,4-MDP-2-P methyl glycidate (PMK glycidate)
- 3,4-Methylenedioxyphenyl-2-propanone
- 4-AP (N-Phenyl-4-piperidinamine) 23056-29-3
- Anthranilic acid
- Phenylacetic acid
- Lysergic acid
- N-Acetylanthranilic acid
- Alpha-phenylacetoacetonitrile (APAAN) (CAS: 4468-48-8 , CID 20547 from PubChem)
- Alpha-phenylacetoacetamide (APAA) (CAS: 4433-77-6 , CID 12541433 from PubChem)
- 4-ANPP
- Dihydroergometrine
- Dihydroergotamine
- Ephedrine
- Ergometrine
- Ergotamine
- Etafedrine
- Helional
- Isosafrole
- Methyl alpha-acetylphenylacetate (MAPA) - (CAS: 16648-44-5 , CID 13096216 from PubChem)
- Norfentanyl
- Sassafras oil
- Long pepper oil
- Piperidine
- Piperonal
- Pseudoephedrine
- N-phenethyl-4-piperidinone (NPP)
- Safrole
Class D2
[edit]Class E
[edit]- Cannabis sativa - except for registed products under allowed dosage mentioned in Class A3.
- Claviceps paspali (Ergot)
- Datura suaveolens
- Erythroxylum coca
- Lophophora williamsii (Coto Peyote)
- Mitragyna speciosa
- Papaver somniferum
- Prestonia amazonica
- Salvia divinorum
Class F
[edit]Class F1
[edit]- 2-Methyl-AP-237 (methyl analogue of bucinnazine)
- 3-Methylfentanyl
- 3-Methylthiofentanyl
- 4-Fluoroisobutyrfentanyl
- 7-Hydroxymitragynine
- Acetyl-alpha-methylfentanyl
- Acetylfentanyl
- Acetorphine
- Acryloylfentanyl
- AH-7921
- Alpha-methylfentanyl
- Alpha-methylthiofentanyl
- Beta-hydroxy-3-methylfentanyl
- Beta-hydroxyfentanyl
- Brorphine
- Butyrfentanyl
- Butonitazene
- Carfentanil
- Ketobemidone
- Cyclopropylfentanyl
- Cocaine
- Crotonylfentanyl
- Desomorphine
- Dihydroetorphine
- Ecgonine
- Etazene (Etodesnitazene)
- Etonitazepyne
- Etorphine
- Furanylfentanyl
- Heroin
- Isotonitazene
- MDPV
- Metonitazene
- Methoxyacetylfentanyl
- Mitragynine
- MPPP
- MT-45
- Ocfentanil
- Orthofluorofentanyl
- Parafluorobutyrfentanyl
- Parafluorofentanyl
- PEPAP
- Protonitazene
- Tetrahydrofuranylfentanyl
- Thiofentanyl
- U-47700
- Valerylfentanyl
Class F2
[edit]- LSD
- 1B-LSD
- 1cP-LSD
- 1P-LSD
- 2C-B
- 2C-C
- 2C-D
- 2C-E
- 2C-F
- 2C-I
- 2C-T-2
- 2C-T-7
- 2-MeO-Diphenidine
- 3-Fluorophenmetrazine
- 3-MeO-PCP
- 3-MMC
- 4-AcO-DMT
- 4-Bromomethcathinone
- 4-Chloro-alpha-PVP
- 4-Chloromethcathinone (4-CMC)
- 4-Fluoroamphetamine (4-FA)
- 4-Fluoromethcathinone
- 4F-MDMB-BINACA
- 4-HO-MIPT
- 4-MEAPP
- 4-MEC
- 4-Methylaminorex
- 4-MTA
- 4,4'-DMAR
- 5-APB
- 5-APDB
- 5C-MDA-19 (BZO-POXIZID, CAS: 1048973-64-3 , UNII: J8AEQ47LPQ)
- 5-EAPB
- 5F-AB-FUPPYCA
- 5F-ADB
- 5F-AKB48
- 5F-AMB-PINACA
- 5F-MDA-19 (5F-BZO-POXIZID, UNII: HN6S9AD58B)
- 5F-MDMB-PICA
- 5F-PB-22
- 5-IAI
- 5-MAPDB
- 5-MeO-AMT
- 5-MeO-DALT
- 5-MeO-DIPT
- 5-MeO-DMT
- 5-MeO-MIPT
- 25B-NBOH
- 25B-NBOMe
- 25C-NBF
- 25C-NBOH
- 25C-NBOMe
- 25D-NBOMe
- 25E-NBOH
- 25E-NBOMe
- 25H-NBOH
- 25H-NBOMe
- 25I-NBF
- 25I-NBOH
- 25I-NBOMe
- 25N-NBOMe
- 25P-NBOMe
- 25T2-NBOMe
- 25T4-NBOMe
- 25T7-NBOMe
- 30C-NBOMe
- AB-CHMINACA
- AB-FUBINACA
- AB-PINACA
- ADB-BUTINACA
- ADB-CHMINACA
- ADB-FUBIATA
- ADB-FUBINACA
- ALD-52
- Alpha-D2Pv
- Alpha-EAPP
- Alpha-PHP
- alpha-PiHP
- Alpha-PVP
- AKB48
- AM-2201
- AMT
- Benzphetamine
- Bk-DMBDB
- Brolamphetamine
- BZO-4en-POXIZID (4en-pentyl MDA-19)
- BZO-CHMOXIZID
- BZP
- Cathinone
- CH-PIATA (CID 165361915 from PubChem)
- Clobenzorex
- CUMYL-4CN-BINACA
- CUMYL-PEGACLONE
- DET
- Diphenidine
- Dihydro-LSD (ChemSpider ID: 67024742) (8β)-N,N-Diethyl-6-methyl-9,10-didehydro-2,3-dihydroergoline-8-carboxamide
- Dimethylone
- DMA
- DMAA
- DMBA
- DMHP
- DMT
- DOC
- DOET
- DOI
- EAM-2201
- Ergine
- Eticyclidine
- Ethylphenidate
- Ethylone
- Etryptamine
- Eutylone
- FUB-AMB
- Isopropylbenzylamine
- JWH-018
- JWH-071
- JWH-072
- JWH-073
- JWH-081
- JWH-098
- JWH-122
- JWH-210
- JWH-250
- JWH-251
- JWH-252
- JWH-253
- MAM-2201
- MAM-2201 N-(4-hydroxypentyl) (CAS: 1537889-05-6 , CID 131668101 from PubChem, UNII: KZ2BB26N57)
- MAM-2201 N-(5-chloropentyl) (CAS: 1445578-25-5 , CID 91864523 from PubChem, UNII: 22GGZ1S2LF)
- MDMB-4en-PINACA
- MDMB-5Br-INACA
- mCPP
- MDA-19 (BZO-HEXOXIZID)
- MDAI
- MDE
- MDMA
- Mecloqualone
- Mephedrone
- Mescaline
- Methallylescaline
- Methanphetamine
- Methaqualone
- Methcathinone
- Methylone
- Methiopropamine
- MMDA
- MXE
- N-acetyl-3,4-MDMC (CAS: 1227293-15-3 , CID 91693878 from PubChem)
- N-Ethylcathinone
- N-Ethylhexedrone (hexen)
- N-Ethylpentylone
- Parahexyl
- Pentedrone
- Pentylone
- PMA
- PMMA
- Psilocybin
- Psilocin
- RH-34
- Rolicyclidine (PCPy)
- Salvinorin A
- DOM (STP)
- Tenamfetamine
- Tenocyclidine
- THC - except for registed products under allowed dosage mentioned in Class A3.
- TH-PVP
- TMA
- TFMPP
- UR-144
- XLR-11
- Zipeprol
Class F3
[edit]- Phenylpropanolamine (PPA) or norephedrine
Class F4
[edit]References
[edit]- ^ a b ANVISA. "Portaria n.o 344, de 12 de maio de 1998" (PDF). Archived from the original (PDF) on 12 July 2017. Retrieved 19 July 2017.
- ^ a b Anvisa (2023-09-15). "RDC Nº 816 - Listas de Substâncias Entorpecentes, Psicotrópicas, Precursoras e Outras sob Controle Especial" [Collegiate Board Resolution No. 816 - Lists of Narcotic, Psychotropic, Precursor, and Other Substances under Special Control] (in Brazilian Portuguese). Diário Oficial da União (published 2023-09-18). Archived from the original on 2023-10-19. Retrieved 2023-10-19.
- ^ a b c Rodrigo, Kleber (2020-03-26). "Medicamentos controlados: receitas com assinatura digital". Abcfarma (in Brazilian Portuguese). Archived from the original on 2023-08-16. Retrieved 2023-08-16.
- ^ Vigilância Sanitária de Fortaleza (April 2017). "Orientações para prescrição de medicamentos sujeitos a controle especial" (PDF). Conselho Regional de Farmácia do Estado do Ceará. Archived (PDF) from the original on 2022-02-22. Retrieved 2023-08-15.
- ^ Anvisa (2011-03-22). "Dispõe sobre o controle da substância Talidomida e do medicamento que a contenha". Biblioteca Virtual em Saúde MS (in Brazilian Portuguese). Archived from the original on 2022-08-18. Retrieved 2023-08-15.
- ^ a b Anvisa (2016-08-31). "RDC Nº 103 Control" (in Brazilian Portuguese). Diário Oficial da União (published 2016-09-01). Archived from the original on 2023-08-03. Retrieved 2023-08-03.