Rotulagem de medicamentos fitoterápicos industrializados: está adequada às diretrizes legais?

Abstract

The labeling is the first information of drug visualized by the user at time of purchase. The standardization of labeling is important to promote rational use of medicines. The National Health Surveillance Agency (ANVISA) is responsible for drug regulation in Brazil. A total of 100 labels of manufactured herbal medicines was analyzed to verify its suitability to the sanitary legislation, especially, RDC no 71/09. The presence of general items required by the norm was analyzed with the help of a labeling verification worksheet. The survey showed positive results since most items were in accordance with the Brazi-lian legislation. The most absent items on labels were the drug trade name in Braille and the phrase “Herbal Medicine.” As the legal deadline for compliance with the rule was suspended, there are in the market herbal medicines whose labels are still inadequate. Among the herbal medicines analyzed, most had valid sanitary registration, which guarantees the public access to products with safety, quality and efficacy.