Drug Products Containing Quinine for the Treatment and/or Prevention of Malaria for Over-the-Counter Human Use
other · Food and Drug Administration · Rule · Published 1998-03-20 · Effective 1998-04-20 · 63 FR 13526
Document
Document number
98-7186
Federal Register citation
63 FR 13526
CFR reference
21 CFR 310
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
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.