Ophthalmic Drug Products for Over-the-Counter Human Use; Final Monograph; Technical Amendment
other · Food and Drug Administration · Rule · Published 2003-02-19 · Effective 2003-03-21 · 68 FR 7919
Document
Document number
03-3926
Federal Register citation
68 FR 7919
CFR reference
21 CFR 349
Type
Rule
Action
Final rule; technical amendment.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2003-02-19
Effective date
2003-03-21
HHS docket
Docket No. 03N-0008
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.