21 C.F.R. § 335.3

Current through November 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