Anvisa is studying requiring CPF from patients who want manipulated weight loss pens

The National Health Surveillance Agency (Anvisa) announced this Monday (6) that it will tighten the regulation of the import and handling of pens used to treat diabetes and obesity. “This is the most important focus, bringing safe products with guaranteed quality and effectiveness to the Brazilian population”, stated the CEO of Anvisa, Leandro Safatle, during a press conference.

Director Daniel Pereira stated that Anvisa will establish new “individualization elements” as a requirement to authorize the manipulation of tirzepatide, but did not detail what they will be. This year, Anvisa carried out 11 inspections in the largest compounding pharmacies in the country. Eight pharmacies and one importer were closed due to irregularities. In one of them, the agency seized all batches of tirzepatide imported for the production of pens.

The agency wants to require, for example, a mandatory certificate of good manufacturing practices aligned with its guidelines so that the active pharmaceutical ingredient (IFA) of pens enters the country. The body is studying, for example, requiring the patient’s CPF when requesting to handle the substance.

At the moment, Only the pharmaceutical company Eli Lilly has authorization to market tirzepatide in Brazil, under the name Mounjaro. But the current rule provides for authorization for the compound to be manipulated and sold by compounding pharmacies in specific cases, to serve a certain patient who does not adapt to the doses made available by the industry, for example. What Anvisa has verified, however, is large-scale production that is not compatible with individualized use.