Antidiarrheal Drug Products for Over-the-Counter Human Use; Amendment of Final Monograph
other · Food and Drug Administration · Rule · Published 2004-05-12 · Effective 2004-06-11 · 69 FR 26301
Document
Document number
04-10750
Federal Register citation
69 FR 26301
CFR reference
21 CFR 335
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2004-05-12
Effective date
2004-06-11
HHS docket
Docket No. 1978N-036T
Abstract
The Food and Drug Administration (FDA) is issuing a final rule amending the final monograph (FM) for over-the-counter (OTC) antidiarrheal drug products to include relief of travelers' diarrhea as an indication for products containing bismuth subsalicylate. Travelers' diarrhea occurs in travelers and is most commonly caused by an infectious agent. This final rule is part of FDA's ongoing review of OTC drug products.