Quality begins with the raw material
The New Challenges of the Compounding Pharmacy Sector and the Future of Good Practices in Brazil
By Tatiana Miramontes Ribeiro, Andrey Vilas Boas de Freitas, and Marina Moreira.
Compounding pharmacies are experiencing a pivotal moment. The sector continues to grow, diversify, and strengthen its position as one of the pillars of personalized therapy in Brazil. With more than 8,000 active establishments, it generates billions of reais annually and offers individualized alternatives in a market increasingly focused on patient experience.
However, as the sector advances, challenges related to health safety, traceability, and regulatory compliance are also becoming more complex—challenges that begin long before the compounding process itself. The quality of a compounded medication starts with the raw material, from its origin, integrity, distribution, and repackaging. It is at this initial stage that the greatest risks emerge, but also the greatest opportunities to strengthen the supply chain.
Active Pharmaceutical Ingredients (APIs) have become the most sensitive point in the compounding pharmacy supply chain. This is largely due to the globalization of the active substances market and the increasing complexity of synthesis routes, supplier networks, and distribution channels.
Recent studies show that API quality control and traceability remain the weakest links in the process. Fraudulent reports, inconsistent certificates of analysis, lack of clear manufacturer identification, and failures in repackaging operations continue to be recurring challenges—directly impacting patient safety.
In compounding pharmacies, where production is individualized and flexible, any variation in the raw material can result in a different final product, making the control of origin, identity, and purity even more critical.
The implementation of Good Distribution and Repackaging Practices for Active Pharmaceutical Ingredients (GDP-RP for APIs) represents one of the most strategic initiatives to raise the safety standards of compounded formulations in Brazil.
Still in the process of consolidation, the GDP-RP certification establishes:
I) Strict control of repackaging conditions;
II) Validated cleaning procedures;
III) Auditable and traceable documentation;
IV) Clear identification of the original manufacturer;
V) Mitigation of risks related to cross-contamination and counterfeiting;
VI) Assurance that reports and certificates accurately correspond to the batch actually used.
This framework provides compounding pharmacies with greater predictability and reduces their reliance on documents of questionable origin, strengthening confidence throughout the process.
International experience demonstrates that both the United States and Europe have already recognized the importance of this issue. The global API supply chain is highly regulated, and international models show that quality and compliance must be ensured from the very beginning of the process.
In the United States, the FDA requires specific environmental controls, ongoing qualification of distributors, and validation of every repackaging step. There is no room for repackaging facilities operating without audits, and responsibility for batch integrity is shared across the entire supply chain.
In the European Union, EudraLex guidelines and pharmaceutical anti-counterfeiting mechanisms help ensure:
I) Mandatory audits of manufacturers;
II) Integrated traceability;
III) Independent documentation controls;
IV) Shared accountability among manufacturers, importers, distributors, and hospital pharmacies.
Compared to these systems, Brazil still faces regulatory asymmetries that make oversight more fragmented and increase the risk of adulterated, counterfeit, or uncertified APIs entering the supply chain.
Supplier qualification is currently the most effective tool for reducing health and quality risks. It should include, among other aspects: remote and on-site audits; verification of the authenticity of certificates of analysis; evaluation of the logistics process (including temperature and humidity control); up-to-date manufacturing documentation; proof of chain of custody; and electronic traceability systems.
This process is particularly challenging when dealing with botanically derived products, whose natural variability creates chemical uncertainties and requires additional controls to prevent adulteration, contamination, and violations of Law No. 13,123/2015, which protects Brazil’s genetic heritage and associated traditional knowledge.
In addition, the growing demand for innovative therapeutic solutions—such as cannabinoids, GLP-1 receptor agonists (e.g., semaglutide), and systemic hormones—has pushed the compounding pharmacy sector into areas of significant technical complexity and heightened regulatory risk.
In recent years, Anvisa has reaffirmed that several of these products do not fall within the scope of pharmaceutical compounding, leading to an increasing number of legal disputes. The lack of updates to RDC 67/2007, which governs Good Compounding Practices for Compounded Preparations, RDC 204/2006, which regulates Good Distribution and Repackaging Practices for Pharmaceutical Ingredients, and other regulations that reflect current market realities only widens the gap between market expectations, health safety requirements, and legal boundaries.
To ensure competitiveness while maintaining safety, Brazil’s pharmaceutical and compounding pharmacy sectors must move forward on five key fronts:
– Updating national regulations: the modernization of RDC 67/2007 and RDC 204/2006 is urgently needed to incorporate international quality standards;
– Strengthening Good Distribution and Repackaging Practices (GDP-RP): the certification of distributors and repackaging facilities should become the rule rather than the exception;
– Digital integration of traceability: electronic systems can connect manufacturers, distributors, and pharmacies, reducing counterfeiting risks and documentary inconsistencies;
– Digital integration of traceability: electronic systems can connect manufacturers, distributors, and pharmacies, reducing the risk of counterfeiting and documentary inconsistencies;
Compounding pharmacies play an essential role in personalized patient care, but they must evolve at the same pace as the global market, meeting increasingly stringent quality and safety requirements in the dispensing of effective therapeutic products. Certification in Good Distribution and Repackaging Practices, rigorous supplier qualification, and alignment with international standards form the foundation of a new era for the sector.
It is about building a transparent, integrated, and science-based supply chain—one that is capable of protecting patients, strengthening the market, and providing the compounding pharmacy sector with the credibility and legitimacy needed to continue innovating responsibly.
The future begins at the source of the raw material. And it is there that Brazil must invest, ensuring that the sector’s economic growth translates into health safety, trust, and technical excellence.
