21 C.F.R. § 335.3

Current through September 30, 2024

Section 335.3 - Definitions

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.

21 C.F.R. §335.3

68 FR 18881, Apr. 17, 2003, as amended at 69 FR 26302, May 12, 2004