21 CFR §335.3
Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
As used in this part:
- (a)Antidiarrheal. A drug that can be shown by objective measurement to treat or control (stop) the symptoms of diarrhea.
- (b)Diarrhea. A condition characterized by increased frequency of loose, watery stools (three or more daily) during a limited period (24 to 48 hours), usually with no identifiable cause.
- (c)Travelers' diarrhea. A subset of diarrhea occurring in travelers that is most commonly caused by an infectious agent.