Brazilian Drug Regulator Consults on Split Dispensing Plans

Brazilian drug regulator Anvisa has begun a 30-day public consultation on Decree 5.348, which authorises pharmacists to split the contents of drug packets according to a consumer's prescribed dose. The consultations come despite the fact that the presidential decree is already in force, although Anvisa has not yet provided any regulatory guidance on the issue. At present, the controversial new form of dispensing can only be practised by qualified pharmacists, but there are concerns within the drug sector that authorities may seek to extend dispensing to other, less qualified health professionals.

The measure has been beset by controversy and confusion. Research-based companies have highlighted that adding batches of pills to new packets marked only by the pharmacy could open the floodgates to copy and counterfeit drugs, already a serious problem in Brazil. Meanwhile, it is unclear whether an earlier 1993 decree on the subject is also still in force, although Anvisa insists that its guidance will finally decide the issue.