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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 May 2024.[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
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

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

  1. ^ a b Anvisa. "Portaria nº 344, de 12 de maio de 1998 com atualizações" [Ordinance No. 344 of May 12, 1998 with amendments] (in Brazilian Portuguese). Retrieved 2024-10-03.
  2. ^ a b Anvisa (2024-05-28). "RDC Nº 877 - Listas de Substâncias Entorpecentes, Psicotrópicas, Precursoras e Outras sob Controle Especial" [Collegiate Board Resolution No. 877 - Lists of Narcotic, Psychotropic, Precursor, and Other Substances under Special Control] (in Brazilian Portuguese). Diário Oficial da União. Archived from the original on 2024-09-25. Retrieved 2024-09-25.
  3. ^ 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.
  4. ^ 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.
  5. ^ 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.
  6. ^ 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.
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