This Monday, March 23, Statute #15,357 was published, amending Statute #5,991/1973, which governs the sanitary control of the commercial sale of medications, pharmaceutical inputs, and related products in Brazil, to expressly allow the installation of pharmacies and drugstores within supermarkets.

The Statute does not merely authorize these establishments to coexist in the same physical space; it establishes a legal framework addressing sanitary, technical, and operational requirements for such operations. This highlights lawmakers’ intent to balance broader public access to medications with the preservation of sanitary safety and qualified pharmaceutical care.

The key legislative innovation is the addition of Paragraphs 2 through 7 to Article 6 of Statute #5,991/1973, which set forth conditions for installing a pharmacy or drugstore inside a supermarket. These include the requirement that the pharmaceutical establishment occupy a defined, segregated, and exclusively used physical area, independent of the supermarket’s other sales areas. It must also fully comply with all legal, sanitary, and technical requirements applicable to any pharmacy or drugstore.

Pharmaceutical operations may be conducted (i) directly by the supermarket itself, under the same tax identification, provided licensing and technical responsibility requirements are met; or (ii) by contracting a pharmacy or drugstore that is duly licensed and registered with the competent authorities.

The law explicitly reinforces the obligation to fully comply with existing sanitary regulations, highlighting requirements such as: adequate physical space; a pharmaceutical consultation room, when applicable; proper storage conditions; temperature, ventilation, lighting, and humidity control; and the implementation of mechanisms to ensure product traceability, proper dispensing, and the effective delivery of pharmaceutical care. These elements confirm that the activity remains grounded in the logic of healthcare services, not merely retail.

Another central pillar of the law is the mandatory presence of a duly licensed pharmacist during all operating hours, in accordance with Statute #13,021/2014.

Statute #15,357/2026 also establishes specific rules regarding the display and dispensing of medications, especially those subject to special control. It expressly prohibits the offering, display, or availability of medications in open areas of the supermarket, such as on shelves, counters, or stands located outside the pharmacy space.

With respect to operational modernization, the law allows pharmacies and drugstores installed in supermarkets to use digital channels and e-commerce platforms for logistics and consumer delivery purposes, provided that they fully comply with sanitary regulations, particularly regarding dispensing safety, product traceability, and technical responsibility.

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