Sterility requirement for aqueous-based drug products for oral inhalation. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is amending its regulations to require that all prescription and over-the-counter (OTC) aqueous-based drug products for oral inhalation be manufactured sterile. This rule applies to aqueous-based oral inhalation drug products in both single-dose and multiple-use primary packaging. Pressurized metered-dose inhalers are not subject to this rule. Based on reports of adverse drug experiences from contaminated nonsterile inhalation drug products and recalls of these products, FDA is taking this action to help ensure the safety and effectiveness of these products.