Laxative Drug Products for Over-the-Counter Human Use
other · Food and Drug Administration · Rule · Published 1999-01-29 · Effective 1999-01-29 · 64 FR 4535
Document
Document number
99-1938
Federal Register citation
64 FR 4535
CFR reference
21 CFR 310
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1999-01-29
Effective date
1999-01-29
HHS docket
Docket No. 78N-036L
Abstract
The Food and Drug Administration (FDA) is issuing a final rule establishing that the over-the-counter (OTC) stimulant laxative ingredients danthron and phenolphthalein are not generally recognized as safe and effective and are misbranded. FDA is issuing this final rule as part of its ongoing review of OTC drug products after considering data and information on the safety of danthron and phenolphthalein.