Zdrowie i gospodarka · 26/05/2000
FDA to Require Sterility for Aqueous-Based Oral Inhalation Drug Products
The Food and Drug Administration (FDA) is updating its regulations to mandate that all prescription and over-the-counter (OTC) aqueous-based inhalation medications for oral use be manufactured in a sterile environment. This change aims to prevent contamination and ensure the safety and efficacy of these products, following reports of adverse reactions and product recalls.