Compounding Pharmacy Obtains Court License to Compound Cannabis-Derived Products

Court authorization paves the way for personalized and more accessible products for the population

Published on 07/25/2023

Farmácia de Manipulação obtém licença judicial para manipular produtos derivados da cannabis

By editorial team Sechat

Orthofarma Compounding Pharmacy has a solid track record in the market since 2004 and achieved an important victory on July 29. Through a court authorization, it obtained a license to compound cannabis-derived products. The decision came after about a year of legal proceedings, during which the pharmacy had to appeal to higher courts to obtain the right to produce cannabis-based medications.

The request for authorization was necessary due to the current regulation in the RDC 344 from the Ministry of Health, which allows the sale of cannabis-derived products only by drugstores, preventing compounding pharmacies from engaging in this activity, even though they are qualified to compound any pharmaceutical ingredient, including those that pose health risks. It is worth noting that cannabis-derived products have demonstrated, through studies, their safety and efficacy for the treatment of various medical conditions.

With the court authorization granted, the compounding pharmacy now has the power to compound cannabis-derived products in various pharmaceutical forms and in a personalized manner, according to the therapeutic needs of each patient. Additionally, the pharmacy is authorized to distribute ready-made products from other distributors.

“This achievement is of utmost importance, as it corrected an injustice in the regulation that excluded compounding pharmacies from producing cannabis-based medications, despite their technical capacity and rigorous oversight, which are even more demanding than those for drugstores,” emphasized the pharmacy owner, Renata Monteiro. 

The compounding pharmacy is capable of producing personalized medications at a lower cost than products manufactured by the pharmaceutical industry, providing greater access for the population to these treatments.

The court decision opens a new horizon in the sector, allowing other compounding pharmacies to also offer these medications, expanding access and availability of this important therapeutic resource for the population.

Compounding Pharmacy Obtains Court License to Compound...