ANVISA approves mandatory prescription retention for the sale of semaglutide, liraglutide, dulaglutide, exenatide, tirzepatide, and lixisenatide products

On April 16, 2025, the Brazilian Health Regulatory Agency (“ANVISA”) approved two normative acts to establish the mandatory retention of medical prescriptions by pharmacies and drugstores when dispensing GLP-1 receptor agonist medicines. This category includes medicines such as semaglutide, liraglutide, dulaglutide, exenatide, tirzepatide, and lixisenatide – popularly known as “slimming injections” –, but which are indicated initially for treating diabetes. Check out the list of medicines affected by the decision on the ANVISA website.

In the next few days, ANVISA is expected to publish an updated list of medicines subject to prescription retention to include the active ingredients mentioned above, thus updating the following regulations:

• Resolution of the Collegiate Board (“RDC”) No. 471/21, which establishes the criteria for prescribing, selling, controlling, packaging, and labeling medicines based on substances classified as antimicrobials for prescribed use, whether alone or in combination; and
• Normative Instruction (“IN”) No. 244/23, which lists the substances classified as antimicrobials for prescribed use, whether alone or in combination, addressed in RDC No. 471/21.

In his vote, ANVISA’s director, Rômison Mota, mentioned technical opinions indicate the off-label use of these medicines and without a medical prescription, as well as a greater incidence of adverse events in Brazil compared to the global average, in regard to the off-label usage.

Currently, consumers must provide a medical prescription to purchase these “red line” medicines, in compliance with RDC No. 471/21, which establishes and updates the criteria for prescribing, selling, controlling, packaging, and labeling medicines based on substances classified as antimicrobials for prescribed use, whether alone or in combination. However, the new regulation seeks to enhance oversight by requiring the prescription to be submitted and retained at the time of purchase.

In light of the decision, prescriptions will be valid for up to 90 days. Pharmacies must register the purchase and sale of these medicines, whether manufactured or compounded, in the Brazilian National Controlled Products Management System (“SNGPC”).

ANVISA warned that pharmacies that fail to comply with the regulation will be subject to fines and can even have their license suspended. The health regulatory agency will also intensify inspections in collaboration with state and municipal health authorities.

Demarest’s Life Sciences and Healthcare team is available to provide any further clarifications that may be necessary and continues to monitor the developments in this area.