Antidiarrheal Drug Products for Over-the-Counter Human Use; Final Monograph; Correction
other · Food and Drug Administration · Rule · Published 2003-06-26 · Effective 2004-04-19 · 68 FR 37963
Document
Document number
03-16111
Federal Register citation
68 FR 37963
CFR reference
21 CFR 310
Type
Rule
Action
Final rule; correction.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2003-06-26
Effective date
2004-04-19
HHS docket
Docket No. 78N-036D
Abstract
The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of April 17, 2003 (68 FR 18869). That document issued a final monograph that established conditions under which over-the-counter (OTC) antidiarrheal drug products (to control the symptoms of diarrhea) are generally recognized as safe and effective and not misbranded as part of its ongoing review of OTC drug products. The document published with an inadvertent error. This document corrects that error.