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Brazil: Antibiotics to Be Sold with Prescription Only

(Nov. 5, 2010) On October 26, 2010, the Brazilian National Health Surveillance Agency (Anvisa – Agência Nacional de Vigilância Sanitária) issued an Administrative Act (Resolução da Diretoria Colegiada – RDC No. 44, de 26 de Outubro de 2010) regulating the issuance of prescriptions for antibiotics. The purpose of the Act is to fight super-bacteria and the indiscriminate use of antibiotics in the country.

The Act states that antibiotics can only be sold with a prescription issued in duplicate. Starting November 28, 2010, one copy of the prescription must be retained by the drugstore and the second must be stamped, indicating that the prescription has been used, and returned to the customer. Packaging and medication directions must indicate that the medicine can only be sold with a prescription and that one copy of the prescription must be retained by the drugstore. The Act also determines that prescriptions are only valid for ten days and drugstores will have 180 days to start registering all prescriptions with the National Management System of Controlled Products (SNGPC – Sistema Nacional de Gerenciamento de Produtos Controlados).

The institutional purpose of the Surveillance Agency is to foster protection of the health of the population by exercising sanitary control over the production and marketing of certain products and services that are subject to sanitary surveillance. (Antibióticos Só Poderão Ser Vendidos com Retenção da Receita na Farmácia, CORREIO DO POVO (Oct. 28, 2010),