Ophthalmic Drug Products for Over-the-Counter Human Use; Final Monograph; Technical Amendment
other · Food and Drug Administration · Rule · Published 2003-06-03 · Effective 2003-07-03 · 68 FR 32981
Document
Document number
03-13827
Federal Register citation
68 FR 32981
CFR reference
21 CFR 349
Type
Rule
Action
Final rule; technical amendment.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2003-06-03
Effective date
2003-07-03
HHS docket
Docket No. 03N-0193
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 updates the monograph to incorporate a United States Pharmacopeia (USP) name change for one active ingredient included in the monograph. This final rule is part of FDA's ongoing review of OTC drug products.