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Brazilian Controlled Drugs and Substances Act

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

Controlled goods classes
ClassType of substanceRx type
A1Narcotic drugs: analgesics, opioids, non-opioids, other analgesicsYellow "A" Prescription Notification form (provided by Anvisa), along with a prescription.
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.[3]
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.[3]
D1Drug precursors
D2Drug precursors
EControlled Plants and Fungi
FProhibited SubstancesAllowed only in authorized scientific research.[1]
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

References

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