LIFE SCIENCES | Council of State on deblistering as a pharmacist’s activity

On 2 September 2025, the Council of State issued Opinion No. 00992/2025 on deblistering. The case began when a pharmacy in Piedmont requested permission to provide deblistering to patients but was denied by local and regional health authorities due to the lack of national or regional rules.

The Court confirmed that deblistering is fully within the pharmacist’s professional role: this activity is lawful, does not require prior authorization (as referred to in a previous judgments of the Council of State), and can be carried out as long as pharmacists follow Good Preparation Practices. In fact, the Court rejected the restrictive interpretation of the Ministry of Health, noting that no law actually prohibits the activity, and that it is analogous to galenic preparations traditionally performed in pharmacies without special authorization. Moreover, the Court recalled that a 2012 national law expressly encouraged Regions to organize experimental projects for the deblistering of medicines, and this applies not only to Regions where administrative acts regulating the activity have already been adopted, but also to Regions where such initiatives have not yet been regulated.

The Court highlighted the public health benefits of deblistering, and it also underlined that denying the service would create regional disparities, since some regions have already implemented deblistering, without objections from the Ministry of Health or AIFA. Pending the adoption of nationwide rules, has actually indicated the precautionary measures adopted by Lombardy as a reference for other Regions.

Newsletter n. 111 – October 2025