Medicine:Brazilian Controlled Drugs and Substances Act

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Short description: Brazil's federal drug control statute

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
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)
Anvisa teratogenic warning.svg

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 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

=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]


Template:Strikethroughdiv


Class C5


Class D

Class D1


Class D2


Class E


Class F

Class F1


Class F2


Class F3

Class F4


References

  1. ↑ 1.0 1.1 ANVISA. "Portaria n.o 344, de 12 de maio de 1998". http://www.anvisa.gov.br/hotsite/talidomida/legis/Portaria_344_98.pdf. 
  2. ↑ 2.0 2.1 Anvisa (2023-09-15). "RDC Nº 816 - Listas de Substâncias Entorpecentes, Psicotrópicas, Precursoras e Outras sob Controle Especial" (in pt-BR). Diário Oficial da União. https://www.in.gov.br/en/web/dou/-/resolucao-rdc-n-816-de-15-de-setembro-de-2023-510390164. 
  3. ↑ 3.0 3.1 3.2 Rodrigo, Kleber (2020-03-26). "Medicamentos controlados: receitas com assinatura digital" (in pt-BR). https://site.abcfarma.org.br/medicamentos-controlados-receitas-com-assinatura-digital/. 
  4. ↑ Vigilância Sanitária de Fortaleza (April 2017). "Orientações para prescrição de medicamentos sujeitos a controle especial". 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. 
  5. ↑ Anvisa (2011-03-22). "Dispõe sobre o controle da substância Talidomida e do medicamento que a contenha". https://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2011/res0011_21_03_2011.html. 
  6. ↑ Cite error: Invalid <ref> tag; no text was provided for refs named RDC103



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