Brazil's Anvisa advances rules for magistral CBD cannabis preparations

The Agência Nacional de Vigilância Sanitária (Anvisa) confirmed it is finalising a specific norm to regulate the magistral manipulation of preparations containing only cannabidiol (CBD) isolated from Cannabis sativa L. The draft has not been made public and no official publication date has been set, but Anvisa has classified the issue as a priority. The rule follows the RDC 1.015/2025, which introduced the possibility of magistral CBD products but required complementary regulations. Previously, the 2019 RDC 327 excluded compounding pharmacies from working with cannabis‑derived products, leading to extensive judicialisation and a supply bottleneck, as only one supplier could provide the active ingredient under court orders. The forthcoming regulation will permit pharmacies to compound CBD isolate with a minimum purity of 98 %, aiming to reduce legal uncertainty, improve patient access and curb the need for court‑driven approvals.