Brazilian Controlled Drugs and Substances Act explained

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:

Overview

Controlled goods classes! Class! Type of substance!Rx type
A1Narcotic drugs

analgesics, opioids, non-opioids, other analgesics

Yellow "A" Prescription Notification form (provided by Anvisa), along with a prescription.<--although most doctors only provide the Prescription Notification without the prescription, but I would need a source/reference for it -->
A2Narcotic drugs

analgesics, opioids and non-opioids

A3Psychoactive drugs: central nervous system stimulants
B1Psychoactive drugs: antiepileptics, sleep inducers, anxiolytics, antidepressants, tranquilizersBlue "B" Prescription Notification form (the doctor request a printing press for it)[4]
B2Psychoactive drugs: anorectics
C1Other controlled substances: antidepressants, antiparkinsonians, anticonvulsants, antiepileptics, neuroleptics and anestheticsSpecial control prescription form, filled in two copies. A digital prescription can be used alternatively.
C2Retinoids: treatmeant of severe cystic acneWhite Prescription Notification form (the doctor request a printing press for it)Contains a teratogenic warning and a sign.
C3Immunosuppressive drugsPrescription 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]
C4Antiretroviral drugs

management of HIV/AIDS - List revoked in September 2016.[6]

revoked
C5Anabolic steroidsSpecial control prescription form, filled in two copies. A digital prescription can be used alternatively.
D1Drug precursors
D2Drug precursors
EControlled Plants and Fungi
FProhibited SubstancesAllowed only in authorized scientific research.
F1Prohibited narcotics
F2Prohibited psychotropics
F3Prohibited precursors
F4Other prohibited substances

Alemerian Aldyhyde

Class A3

Class A1

Class A2

Class A3

Class B1

Class B2

Class C1

Class C2

Class C3

Class C4

List revoked in September 2016.[6]

Class C5

Class D

Class D1

Class D2

Class E

Class F

Class F1

Class F2

Class F3

Class F4

Notes and References

  1. Web site: ANVISA . Portaria n.o 344, de 12 de maio de 1998 . dead . https://web.archive.org/web/20170712184602/http://www.anvisa.gov.br/hotsite/talidomida/legis/Portaria_344_98.pdf . 12 July 2017 . 19 July 2017.
  2. Web site: Anvisa . Brazilian Health Regulatory Agency . 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. live . https://web.archive.org/web/20231019120956/https://www.in.gov.br/en/web/dou/-/resolucao-rdc-n-816-de-15-de-setembro-de-2023-510390164 . 2023-10-19 . 2023-10-19 . . pt-BR . 2023-09-18.
  3. Web site: Rodrigo . Kleber . 2020-03-26 . Medicamentos controlados: receitas com assinatura digital . live . https://web.archive.org/web/20230816023027/https://site.abcfarma.org.br/medicamentos-controlados-receitas-com-assinatura-digital/ . 2023-08-16 . 2023-08-16 . Abcfarma . pt-BR.
  4. Web site: Vigilância Sanitária de Fortaleza . April 2017 . Orientações para prescrição de medicamentos sujeitos a controle especial . live . https://web.archive.org/web/20220222141542/https://crfce.org.br/wp-content/uploads/2018/10/Manual-com-Orienta%C3%A7%C3%B5es-para-Dispensa%C3%A7%C3%A3o-de-Medicamentos-Sujeitos-a-Controle-Especial-%E2%80%93-2015.pdf . 2022-02-22 . 2023-08-15 . Conselho Regional de Farmácia do Estado do Ceará.
  5. Web site: 2011-03-22 . . Dispõe sobre o controle da substância Talidomida e do medicamento que a contenha . live . https://web.archive.org/web/20220818081913/https://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2011/res0011_21_03_2011.html . 2022-08-18 . 2023-08-15 . Biblioteca Virtual em Saúde MS . pt-BR.
  6. Web site: Anvisa . Brazilian Health Regulatory Agency . 2016-08-31 . RDC Nº 103 Control . live . https://web.archive.org/web/20230803143925/https://www.in.gov.br/en/web/dou/-/resolucao-rdc-n-784-de-31-de-marco-de-2023-474904992 . 2023-08-03 . 2023-08-03 . . pt-BR . 2016-09-01.