Fed Regist. 2000 May 26;65(103):34082-9.
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.
美国食品药品监督管理局（FDA）正在修订其法规，要求所有用于口服吸入的处方和非处方（OTC）水性药物产品必须无菌生产。本规定适用于单剂量和多剂量初级包装的水性口服吸入药物产品。压力定量吸入器不受本规定约束。基于受污染的非无菌吸入药物产品的药物不良事件报告以及这些产品的召回情况，FDA采取此行动以帮助确保这些产品的安全性和有效性。
