用于非处方人类用途的眼科药品；最终专论；技术修订。最终规则；技术修订。
Ophthalmic drug products for over-the-counter human use; final monograph; technical amendment. Final rule; technical amendment.
出版信息
Fed Regist. 2003 Feb 19;68(33):7919-21.
PMID:12593411
Abstract
The Food and Drug Administration (FDA) is amending the regulation that established conditions under which over-the-counter (OTC) ophthalmic drug products are generally recognized as safe and effective and not misbranded. This amendment clarifies the active ingredient in OTC eyewash drug products and the labeling of the active ingredient and its purpose. This final rule is part of FDA's ongoing review of OTC drug products.
摘要
美国食品药品监督管理局（FDA）正在修订一项规定，该规定确立了非处方（OTC）眼科药品通常被认为安全有效且不存在标签错误的条件。本次修订明确了非处方洗眼液药品中的活性成分以及该活性成分的标签及其用途。本最终规则是FDA对非处方药品持续审查的一部分。
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