Anvisa approves new Cannabis regulation and allows compounding pharmacies

The National Health Surveillance Agency (Anvisa) approved the new Cannabis regulation in Brazil. On Wednesday, the agency finalized the revision of RDC 327, a rule that establishes the guidelines for the manufacture, importation, and commercialization of medicinal products in the country.

The decision occurred during the 1st Public Meeting of the Collegiate Board (Dicol) of 2026. The main change is the authorization for compounding pharmacies to work with these items. Individual importation (RDC 660) was excluded from this update.

The vote was concluded after the return of the request for review by director Thiago Lopes Cardoso Campos. He presented a favorable opinion on the revision, partially aligning with the vote of former director Rômison Rodrigues Mota, delivered in December 2025.

However, Campos presented specific divergences. The focus of the changes was the inclusion of the compounding sector and the treatment given to individual importation. The approved draft revokes the RDC 327/2019 that was in effect until then. 

After the confirmation of the new RDC, the proposal to open a regulatory process for RDC 660/2022 was also unanimously approved.

Compounding sector in the new Cannabis regulation

One of the central points of the decision was the removal of the prohibition that prevented compounding pharmacies from producing derivatives. Director Thiago Campos argued in his vote that the previous prohibition lacked technical basis.

"No technical and scientific data were presented that demonstrate specific and additional sanitary risk when this [compounding] is carried out under appropriate regulatory requirements by establishments regularly authorized and subject to health surveillance oversight," Campos stated.

The director emphasized that the Agency does not adopt, as a general rule, an abstract prohibition on compounding pharmacies. According to him, regulation should be proportional to risk, and maintaining the prohibition could encourage litigation.

"In light of this set of elements, I believe that this decision is not technically justified, and it is more appropriate to adopt a specific norm for activities with sanitary requirements," he concluded.

This understanding was supported by director Daniel Pereira and president director Leandro Safatle. Pereira reinforced that the exclusion of the sector was not in line with the principles of the new Cannabis regulation.

"The a priori exclusion of compounding lacks proportionality and is not aligned with the principles of sanitary risk analysis that guide the regulatory action of this agency," Pereira declared.

Individual importation excluded from the new Cannabis regulation

Another relevant definition was the exclusion of RDC 660/2022 from the text of the regulation. Although they recognize the importance of the rule that regulates exceptional importation by individuals, the directors understood that its revision requires a separate administrative process.

Thiago Campos pointed out that between 2015 and 2025, the exceptional regime granted more than 600,000 authorizations. The number highlights the relevance of the norm in combating the lack of assistance for patients who depend on these products.

However, he noted the weaknesses of the current model. "The revision of RDC 660, while necessary in light of the evolution of the sanitary regulatory scenario, cannot occur incidentally or in a fragmented manner," Campos explained.

The director added that the current norm "allowed the importation of products that, in many cases, are not registered as medications in their country of origin, not undergoing formal efficacy evaluations."

Director Daniela Marreco supported the vote. She reinforced the need to revisit RDC 660 "as soon as possible," aiming to ensure sanitary safety alongside the new Cannabis regulation.

Composition rules and restrictions maintained

The resolution maintains the requirement that products be predominantly composed of cannabidiol (CBD). The presence of tetrahydrocannabinol (THC) above 0.2% remains restricted to palliative care in irreversible situations and is contraindicated for individuals under 18 years old.

The authorized routes of administration in the new Cannabis regulation remain the same. They are: oral, buccal, sublingual, inhalation, and dermatological. Smoking products, cosmetics, foods, and the sale of the plant in natura remain prohibited.