Pharmacy authorized to manipulate phytocannabinoids; Anvisa evaluates changes in RDC 327

Judicial decision expands Ephiciencia's activities; ongoing Anvisa review may allow magistral production of medicinal cannabis

Published on 06/19/2025

Farmácia é autorizada a manipular fitocanabinóides; Anvisa avalia mudanças na RDC 327

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The Ephiciencia Pharmacy, one of the first in Brazil to manipulate formulas with cannabidiol (CBD), received judicial authorization to work with a wider variety of phytocannabinoids, in concentrations higher than those currently allowed in the magistral sector. The company already had an injunction for cannabis manipulation and, with the new injunction, expanded the authorization to obtain other oils in different concentrations and manipulate various phytocannabinoids.

According to an official statement from the company on a social network:

"The Ephiciencia Pharmacy, already a pioneer in CBD manipulation, has now also been authorized by the court to import, produce, and market other phytocannabinoids and in other concentrations beyond those available in the magistral market.
With this, and combining the experience and knowledge of the best products in the national and international market, we will bring the best oils for manipulation, always under professional prescription.
This expands the possibilities for more product options for our customers. It is an important step to broaden access to cannabis treatments in Brazil."

In the last two years, other compounding pharmacies have also obtained favorable court decisions to work with cannabis-based products. Among them are Nitratus Homeopatia, in Mogi das Cruzes (SP), and Pharmacia Antiga e Avanzata, in Assis (SP), both authorized to manipulate and commercialize phytocannabinoids even with the restrictions of RDC 327.

Anvisa received 1,476 contributions for the review of RDC 327

In parallel with the judicial decision, the National Health Surveillance Agency (Anvisa) concluded, on June 2, the Public Consultation No. 1,316/2025. The process is part of the review of RDC 327/2019, which establishes the criteria for the manufacture, commercialization, and prescription of cannabis-based products in Brazil.

Anvisa reported that it received 1,476 contributions, including proposed changes, opinions, comments, and suggestions. One of the main demands was precisely the inclusion of compounding pharmacies in the new regulation — which would allow more establishments to produce formulas with phytocannabinoids, with a prescription.

Main changes suggested for the new RDC 327/2019

The new draft of the resolution was prepared by a technical team from Anvisa and reported by the acting president-director, Rômison Rodrigues Mota. Among the highlights of the normative proposal are:

- Limitation of THC content in products;

- New criteria for the import of inputs and cannabis products;

- Updated Good Manufacturing Practices (GMP) requirements;

- Rules for the administration and manipulation of magistral preparations in pharmacies;

- Guidelines for the prescription and dispensing of products;

- Advertising rules, validity of sanitary authorization, and post-authorization petitions.

Changes in the regulated market

Currently, the products available in Brazilian pharmacies under RDC No. 327/2019, from Anvisa, are exclusively industrialized, registered, or with sanitary authorization from the agency, and can only be dispensed with a medical prescription with prescription retention.

The standard prohibits compounding in magistral pharmacies and requires that these products contain, at most, 0.2% THC — except in cases of palliative care or patients with no therapeutic alternatives, with a medical justification. In addition, it requires that pharmacies and drugstores follow strict control, storage, and traceability criteria, ensuring safety in supplying patients.