StacksVerified U.S. regulatory reference

21 CFR §335.3

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov
As used in this part:
  1. (a)Antidiarrheal. A drug that can be shown by objective measurement to treat or control (stop) the symptoms of diarrhea.
  2. (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.
  3. (c)Travelers' diarrhea. A subset of diarrhea occurring in travelers that is most commonly caused by an infectious agent.