CFF advocates for magistral manipulation amid changes in Cannabis regulation

The Federal Pharmacy Council (CFF) expressed concern about the proposed update to the Cannabis regulation presented at the last meeting of the National Health Surveillance Agency (Anvisa). The president of the entity, Walter da Silva Jorge João, advocated for maintaining magistral preparations within the scope of the RDC 327 review, warning of risks to patient care.

According to the CFF, the restriction of these preparations would constitute a setback in healthcare access. The entity politically advocated for the request to review the text, which took place on Wednesday (10), to ensure more time for analyzing the revision of RDC 327.

"The removal of magistral preparations in this context would represent a setback, compromising access, therapeutic individualization, and the safety of using these products in the country," stated Walter da Silva Jorge João.

For the Council, Anvisa's proposal should represent a coherent advancement with scientific evolution and clinical practice. The maintenance of manipulation in the review of RDC 327 is seen as essential to ensure personalized and responsible treatments.

According to the entity's president, the Brazilian healthcare model historically recognizes the importance of magistral preparations to:

- Meet patients with specific therapeutic needs;

- Allow fine adjustments of dose, concentration, and volume;

- Ensure options when industrialized products do not offer the desired individual adaptation;

- Enable therapies that follow the principle of treatment personalization.

The CFF reaffirmed its commitment to a patient-centered regulation. "Maintaining magistral preparations based on Cannabis in the regulatory framework is an essential condition to ensure more personalized treatments," concludes the entity's statement.

The progress of the RDC 327 review at Anvisa

Anvisa addressed the changes to the regulation during a meeting of the Collegiate Board (Dicol). The vote on the revision of RDC 327 was suspended after director Thiago Campos requested more time for review. As a result, the process was halted, and the decision was postponed for the regulatory period of 30 consecutive days.

The reporting director, Rômison Rodrigues Mota, emphasized that the current process does not cover Cannabis cultivation in Brazil, a topic that remains under another reporting. Additionally, the manipulation by magistral pharmacies, a central point of CFF's criticism of the RDC 327 review, was not included in the initial vote.