The regulatory change aims to simplify patient access to treatments for mild health conditions while encouraging responsible product use, though the decision has drawn direct opposition from provincial pharmacists.
Regulatory Changes and Included Medications
According to Disposición 4714/2026, the updated over-the-counter designation applies strictly to registered medicinal specialties that maintain the specific concentrations, pharmaceutical forms, and active ingredients stipulated by the national health agency. The deregulation covers several distinct active pharmaceutical ingredients and combination formulas.
The newly reclassified medications include:
- Trimebutine maleate
- Levocetirizine dihydrochloride
- Fexofenadine hydrochloride
- Dimenhydrinate
- Olopatadine hydrochloride
- Naphazoline hydrochloride combined with pheniramine maleate
- Carboxymethylcysteine
- Aluminum chloride hexahydrate
- Specific formulations of ivermectin
- Combinations of calcium carbonate, arnica montana tincture, and silver nitrate
Professional Opposition and Public Health Concerns
COLFARMA expressed deep concern over what it termed a public hazard, arguing that the government treats medications as harmless consumer goods rather than sensitive, complex therapeutic tools that require strict sanitary management and oversight.
Furthermore, the provincial pharmacists’ association stated that the ANMAT resolution exacerbates public health and household economic strains caused by broader national deregulation of non-prescription drug sales. COLFARMA representatives emphasized that the organization will continue advocating for expert medical and pharmaceutical consultations, scientific validation of treatments, and pharmacist-led distribution and dispensing to uphold existing laws and ensure patient safety.