# Ophthalmic Drug Products for Over-the-Counter Human Use; Final Monograph; Technical Amendment
> **Food and Drug Administration** · Final rule; technical amendment. · Published 2003-02-19 · Effective 2003-03-21 · 68 FR 7919
## Document
- **Document number:** 03-3926
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 68 FR 7919
- **CFR reference:** 21 CFR 349
- **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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2003/02/19/03-3926/ophthalmic-drug-products-for-over-the-counter-human-use-final-monograph-technical-amendment)
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