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Brazilian Controlled Drugs and Substances Act

From Wikipedia, the free encyclopedia
For other uses, seeNarcotics Control Act (disambiguation).
Brazil's federal drug control statute

TheBrazilian Controlled Drugs and Substances Act (Portuguese:Regulamento Técnico sobre substâncias e medicamentos sujeitos a controle especial), officiallyPortaria nº 344/1998,[1] isBrazil's federal drug control statute, issued by theMinistry of Health through itsNational Health Surveillance Agency (Anvisa). The act also serves as the implementing legislation for theSingle Convention on Narcotic Drugs, theConvention on Psychotropic Substances, and theUnited 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 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.[3]

Overview

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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 cysticacneWhite 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

Class A1

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Class A2

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Class A3

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Class B1

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Class B2

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Class C1

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Class C2

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Class C3

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Class C4

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List revoked in September 2016.[6]

Class C5

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Class D

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Class D1

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Class D2

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Class E

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Class F

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Class F1

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Class F2

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Class F3

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Class F4

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References

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  1. ^abAnvisa."Portaria nº 344, de 12 de maio de 1998 com atualizações" [Ordinance No. 344 of May 12, 1998 with amendments] (in Brazilian Portuguese). Retrieved2024-10-03.
  2. ^abAnvisa (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. Retrieved2024-09-25.
  3. ^abcRodrigo, Kleber (2020-03-26)."Medicamentos controlados: receitas com assinatura digital".Abcfarma (in Brazilian Portuguese).Archived from the original on 2023-08-16. Retrieved2023-08-16.
  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. Retrieved2023-08-15.
  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. Retrieved2023-08-15.
  6. ^abAnvisa (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. Retrieved2023-08-03.
Retrieved from "https://en.wikipedia.org/w/index.php?title=Brazilian_Controlled_Drugs_and_Substances_Act&oldid=1288557317"
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