Compounded cannabis: understand how costs could drop by 50%
Click to learn how compounded Cannabis enters the Brazilian market with the potential to reduce treatment costs by up to 50% following Anvisa's decision.
Compounded cannabis could change the national market. The entry into force of RDC No. 1,015/2026, published by Anvisa, marks the beginning of a new era for compounded cannabis in Brazil. The regulation authorized the use of isolated Cannabidiol (CBD) with a minimum purity level of 98% as an Active Pharmaceutical Ingredient (API) in the compounding sector. In practice, the measure allows compounding pharmacies to develop tailored personalized medicines, reducing treatment costs for patients by up to 50% compared to manufactured products sold in traditional pharmacies.
In addition to democratizing access, the regulation transforms medical prescribing dynamics and expands the reach of therapy in the country, enabling unprecedented dosage forms such as capsules, gels, sublingual sprays, and dermatological ointments.
Compounded cannabis is a medicine or therapeutic product based on cannabinoids (such as isolated CBD) prepared in a customized way by a compounding pharmacy, meeting the specific needs of an individual medical prescription
Article Content
Anvisa regulation for compounded cannabis (RDC No. 1,015/2026).
Reasons that make treatment with compounded CBD up to 50% more affordable.
Adaptation and operational transition of the prescribing physician.
Quality assurance, reproducibility, and control rules in the compounding sector.
Complementarity between the pharmaceutical industry and compounding in Brazil.
How Does Compounded Cannabis Work and What Are Its Benefits?
Until the consolidation of the new regulations, cannabinoid therapy in Brazil depended almost exclusively on imported finished products or off-the-shelf brands authorized under RDC 327/2019. With isolated CBD in crystalline powder — odorless and tasteless —, the compounding sector begins transforming medical prescriptions into customized treatments according to the specific needs of each body.
According to pharmacist and PhD in Pharmacology Dr. Fabricio Pamplona, managing partner of Brascann Farmacêutica, the change shifts the axis of therapy:
"Until now, the market was dominated by the industry. With the entry of CBD into the compounding sector, cannabis stops being just a brand on the shelf and becomes a sea of possible solutions, centered on patient needs. The compounding pharmacy transforms medical prescriptions into tailored solutions. Manufactured products can work very well in certain situations, but they cannot always offer the level of customization required for all cases."
He also highlights that this change focuses on the sector's infrastructure:
"The great transformation is not just in the product, but in the infrastructure that will make this market reliable. Now, it becomes part of a supply chain, with quality control, medical education, pharmaceutical training, and the supply of authorized pharmacies."
Cost Reduction: Why Is Compounded CBD Up to 50% Cheaper?
One of the main questions from patients and doctors is whether the price reduction reflects a loss of quality. In Pamplona's technical assessment, the savings result from eliminating logistical intermediaries in the industrial and import supply chains.
"It is worth breaking down where the price of a manufactured product comes from. You have an imported finished product, with margins for the foreign brand, importer, distributor, retail, regulatory costs, packaging, marketing, inventory, and logistics for a final good. It turns out that the molecule is a small fraction of that value. In the compounding sector, you cut out many intermediaries, and the cost ends up substantially lower. It's not like a 'cheap version of the product,' but rather an equivalent product obtained through a chain with far fewer links."
In the case of isolated CBD, criticism regarding efficacy loses ground due to the technical specifications of the active ingredient:
"In the specific case of isolated CBD, the quality argument becomes even weaker: the active ingredient is chemically identical and analytically defined, with the same minimum purity specification. Anyone wanting to uphold criticism will rely on the process, which, let's face it, is quite simple for most CBD formulations. Assuming that a compounding pharmacy is not competent enough to ensure the dilution of a powder in oil seems like a fairly groundless criticism, if not prejudice."
[LEARN MORE: Understand the impact of RDC 1,015/2026 on Brazilian compounding pharmacies]
Is the Prescriber Ready for Compounding Freedom?
The regulatory transition requires an adaptation period for the medical community. Although many professionals are already accustomed to adjusting cannabinoid dosages and ratios, the logic of compounding prescriptions demands new operational parameters.
"Regulations and clinical practice never take effect on the same date. The rule has been valid since May, but the medical adoption curve will still depend on appropriate education. I see that pharmacies are moving to guide the prescribers closest to them," emphasizes Dr. Fabricio Pamplona.
The pharmacologist adds regarding the initial resistance from prescribing physicians:
"Uncertainty is understandable; after all, even physicians experienced in cannabis have grown accustomed to thinking in terms of ready-made presentations and concentrations. They may master pharmacology and the therapeutic aspects, but still not necessarily be used to the compounding mindset, which was never central in neurology, for example."
On the other hand, he emphasizes that the treatment philosophy is already aligned with the personalization of compounded cannabis:
"There is an important aspect here: cannabis prescribers already tend to think in a personalized way, at least regarding dose, cannabinoid ratios, and individualized treatment regimens. Compounding is conceptually familiar to this profile, so it will be more of an operational change than a shift in mindset."
To support the medical community in this transition, Pamplona suggests practical strategies for compounding establishments:
"To facilitate and standardize the process, I have been advising pharmacies to maintain a small, pre-defined portfolio of formulations. It is not a limitation, but rather a starting point for the doctor. It reduces cognitive load, serving as education on what is common, while organizing the pharmacy's operation, allowing it to repeat established processes rather than improvising with every prescription."
Reproducibility and Quality Control in the Compounding Sector
Another frequent point of debate among specialists concerns the lot-to-lot reproducibility of compounded medication compared to manufactured products.
"This is a legitimate question and a long-standing concern in the compounding sector. It didn't start with CBD; it just became more visible now because we are talking about a slightly more expensive active ingredient, surrounded by taboo and a perception of complexity that, truth be told, is often unjustified.", Pamplona reflects.
The fundamental difference lies in the approach to quality assurance:
"The honest answer starts by recognizing the difference: compounding pharmacies do not perform batch quality control, partly because there is no batch. There is an individual preparation for an identified patient, based on a prescription. It is another quality assurance model, governed by Good Compounding Practices and process standardization."
According to the expert, strict control of raw materials and processes guarantees therapeutic equivalence:
"What replaces finished product testing is a set of process controls, such as supplier qualification and raw material quality control, with a certificate of analysis per API batch, equipment calibration and qualification, and strict adherence to standardized processes.
[LEARN MORE: How to ensure quality when purchasing CBD raw materials for compounding pharmacies]
Integration without Rivalry: The Future of Medical Cannabis in Brazil
Although the entry of compounding pharmacies brings dynamism and competition, the market tends to organize itself complementarily between the compounding sector and the pharmaceutical industry.
"That said, I think it's important not to turn this dispute into a zero-sum game (where everyone loses). In my view, compounded products will not replace manufactured ones; they segment the market. While the industry will necessarily pursue evidence generation, clinical research, and bringing its products to the most robust regulatory tier of pharmaceuticals, compounding pharmacies will end up specializing in dosage forms that do not exist on pharmacy shelves today, such as topicals, fine dosage adjustments, and likely providing access to patients who currently do not get treated due to price or product availability (the reach of compounding pharmacies will certainly help popularize CBD treatment).", concludes Pamplona.
With projections to generate over R$ 1 billion in 2026 in Brazil, the sector moves toward a more mature level of technical integration and accessibility.
Sources and Bibliographic References
Agência Nacional de Vigilância Sanitária (Anvisa). Collegiate Board Resolution - RDC No. 1,015/2026 and RDC No. 327/2019.
Exclusive Interview: Dr. Fabricio Pamplona, PhD in Pharmacology and managing director of Brascann Farmacêutica.
Kaya Mind. Market Intelligence Report and Projections for Medical Cannabis in Brazil (2025–2027).
Compounded cannabis brings new opportunities to the market.