# Drug Products Containing Quinine for the Treatment and/or Prevention of Malaria for Over-the-Counter Human Use
> **Food and Drug Administration** · Final rule. · Published 1998-03-20 · Effective 1998-04-20 · 63 FR 13526
## Document
- **Document number:** 98-7186
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 63 FR 13526
- **CFR reference:** 21 CFR 310
- **Publication date:** 1998-03-20
- **Effective date:** 1998-04-20
- **HHS docket:** Docket No. 94N-0355
## Abstract

The Food and Drug Administration (FDA) is issuing a final rule establishing that over-the-counter (OTC) drug products containing quinine for the treatment and/or prevention of malaria are not generally recognized as safe and are misbranded. FDA is issuing this final rule after considering public comment on the agency's notice of proposed rulemaking and all data and information that have come to the agency's attention on the safety of quinine.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1998/03/20/98-7186/drug-products-containing-quinine-for-the-treatment-andor-prevention-of-malaria-for-over-the-counter)
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