Brazilian Controlled Drugs and Substances Act

The Brazilian Controlled Drugs and Substances Act ({{langx|pt|Regulamento Técnico sobre substâncias e medicamentos sujeitos a controle especial}}), officially Portaria nº 344/1998,{{Cite web |author=Anvisa |author-link=Brazilian Health Regulatory Agency |title=Portaria nº 344, de 12 de maio de 1998 com atualizações |trans-title=Ordinance No. 344 of May 12, 1998 with amendments |url=https://antigo.anvisa.gov.br/legislacao#/visualizar/26291 |language=pt-BR |access-date=2024-10-03}} 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 May 2024.{{Cite web |author=Anvisa |author-link=Brazilian Health Regulatory Agency |date=2024-05-28 |title=RDC Nº 877 - Listas de Substâncias Entorpecentes, Psicotrópicas, Precursoras e Outras sob Controle Especial |trans-title=Collegiate Board Resolution No. 877 - Lists of Narcotic, Psychotropic, Precursor, and Other Substances under Special Control|url=https://www.in.gov.br/en/web/dou/-/resolucao-da-diretoria-colegiada-anvisa-n-877-de-28-de-maio-de-2024-562758149 |url-status=live |archive-url=https://web.archive.org/web/20240925040323/https://www.in.gov.br/en/web/dou/-/resolucao-da-diretoria-colegiada-anvisa-n-877-de-28-de-maio-de-2024-562758149 |archive-date=2024-09-25 |access-date=2024-09-25 |publisher=Diário Oficial da União |language=pt-BR |publication-date=2024-05-28}}

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 prescription 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.{{Cite web |last=Rodrigo |first=Kleber |date=2020-03-26 |title=Medicamentos controlados: receitas com assinatura digital |url=https://site.abcfarma.org.br/medicamentos-controlados-receitas-com-assinatura-digital/ |url-status=live |archive-url=https://web.archive.org/web/20230816023027/https://site.abcfarma.org.br/medicamentos-controlados-receitas-com-assinatura-digital/ |archive-date=2023-08-16 |access-date=2023-08-16 |website=Abcfarma |language=pt-BR}}

Overview

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|+Controlled goods classes

! Class

! Type of substance

!Rx type

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| A1

| Narcotic drugs: analgesics, opioids, non-opioids, other analgesics

| rowspan="3" | Yellow "A" Prescription Notification form (provided by Anvisa), along with a prescription.

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| A2

| Narcotic drugs: analgesics, opioids and non-opioids

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| A3

| Psychoactive drugs: central nervous system stimulants

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| B1

| Psychoactive drugs: antiepileptics, sleep inducers, anxiolytics, antidepressants, tranquilizers

| rowspan="2" |Blue "B" Prescription Notification form (the doctor request a printing press for it){{Cite web |author=Vigilância Sanitária de Fortaleza |date=April 2017 |title=Orientações para prescrição de medicamentos sujeitos a controle especial |url=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 |url-status=live |archive-url=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 |archive-date=2022-02-22 |access-date=2023-08-15 |website=Conselho Regional de Farmácia do Estado do Ceará}}

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| B2

| Psychoactive drugs: anorectics

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| 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.

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| C2

| Retinoids: treatmeant of severe cystic acne

| White Prescription Notification form (the doctor request a printing press for it)

File:Anvisa teratogenic warning.svg

Contains a teratogenic warning and a sign.

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| 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){{Cite web |date=2011-03-22 |author=Anvisa |title=Dispõe sobre o controle da substância Talidomida e do medicamento que a contenha |url=https://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2011/res0011_21_03_2011.html |url-status=live |archive-url=https://web.archive.org/web/20220818081913/https://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2011/res0011_21_03_2011.html |archive-date=2022-08-18 |access-date=2023-08-15 |website=Biblioteca Virtual em Saúde MS |lang=pt-BR}}

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| C4

| Antiretroviral drugs: management of HIV/AIDS - List revoked in September 2016.{{Cite web |last=Anvisa |author-link=Brazilian Health Regulatory Agency |date=2016-08-31 |title=RDC Nº 103 Control |url=https://www.in.gov.br/web/dou/-/resolucao-rdc-n-103-de-31-de-agosto-de-2016-23522251 |url-status=live |archive-url=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 |archive-date=2023-08-03 |access-date=2023-08-03 |publisher=Diário Oficial da União |language=pt-BR |publication-date=2016-09-01}}

| revoked

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| C5

| Anabolic steroids

| Special control prescription form, filled in two copies. A digital prescription can be used alternatively.

D1

| Drug precursors

|

D2

| Drug precursors

|

E