# Ophthalmic Drug Products for Over-the-Counter Human Use; Final Monograph; Technical Amendment
> **Food and Drug Administration** · Final rule; technical amendment. · Published 2003-06-03 · Effective 2003-07-03 · 68 FR 32981
## Document
- **Document number:** 03-13827
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 68 FR 32981
- **CFR reference:** 21 CFR 349
- **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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2003/06/03/03-13827/ophthalmic-drug-products-for-over-the-counter-human-use-final-monograph-technical-amendment)
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