Brazil's Anvisa to Reform Pharmacy-Formulated Drug Rules

Brazilian drug regulator Anvisa is to issue new guidelines on so-called "manipulation pharmacies," or the Brazilian dispensing system whereby pharmacists prepare unique prescription drug formulations at the point of sale. The measures are expected to separate pharmacists according to their area of expertise, as currently dispensers are able to mix and prepare often powerful drugs which, when used in combination, may carry extreme safety risks.

The new regulations will divide pharmacies into seven groups, ranging from outlets which formulate cocktails of cosmetic products to those which dispense controlled substances. Furthermore, pharmacies will be obliged to provide comprehensive product information, including details of active ingredients and the product's originator, on all packaging supplied under the practice.

Apart from greatly reducing the obvious health risks, a key effect of the reform will be to clarify boundaries between the prescription market and the US$2.5bn OTC sector, which are already somewhat blurred in Brazil. Further, the measures should allow consumers to differentiate between products made by an original manufacturer and those which have been prepared by pharmacists.

It is thus hoped that the measures will increase confidence in the drug retail sector, at a time when the government has acted to decrease consumption of branded imports via a series of controversial pharmacy packaging reforms.