21 C.F.R. § 335.3
Definitions.
Cite as 21 C.F.R. § 335.3 (2026)
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.
[68 FR 18881, Apr. 17, 2003, as amended at 69 FR 26302, May 12, 2004]