# Status of Certain Additional Over-the-Counter Drug Category II and III Active Ingredients
> **Food and Drug Administration** · Final rule. · Published 2002-05-09 · Effective 2002-11-05 · 67 FR 31123
## Document
- **Document number:** 02-11511
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 67 FR 31123
- **CFR reference:** 21 CFR 310
- **Publication date:** 2002-05-09
- **Effective date:** 2002-11-05
- **HHS docket:** Docket No. 80N-0280
## Abstract

The Food and Drug Administration (FDA) is issuing a final rule stating that a certain ingredient in over-the-counter (OTC) drug products is not generally recognized as safe and effective or is misbranded. FDA is issuing this final rule after considering the reports and recommendations of various OTC drug advisory review panels and public comments on proposed agency regulations. This final rule addresses the ingredient octoxynol 9, considered in the rulemaking for OTC vaginal contraceptive drug products. Based on the failure of interested parties to submit new data or information to FDA under the proposed regulation, the agency has determined that the presence of this active ingredient in an OTC drug product would result in that drug product not being generally recognized as safe and effective for its intended use or would result in misbranding. This final rule is part of FDA's ongoing OTC drug product review.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2002/05/09/02-11511/status-of-certain-additional-over-the-counter-drug-category-ii-and-iii-active-ingredients)
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