ANMAT updates regulations for medicinal oxygen production

Argentina's National Administration of Drugs, Foods and Medical Technology (ANMAT) has updated the regulations for producing medicinal oxygen via the pressure swing adsorption (PSA) method. Through Disposition 7203/2026, published in the Official Gazette, the agency aims to align quality requirements with international standards, such as the United States Pharmacopeia (USP).

The new regulations facilitate the use of PSA technology, which extracts oxygen from ambient air. This method allows health establishments to generate their own oxygen supply on-site for self-consumption or, subject to regulatory conditions, for distribution.

While previous regulations required PSA-derived medicinal oxygen to reach a minimum concentration of 98% by volume, the update incorporates technical requirements for 93% oxygen, which is consistent with the characteristics of this production technology. The measure also establishes new mandates for generating plants, equipment, production processes, quality control, and the requirement for pharmaceutical technical direction and trained personnel.