21 CFR 335.3 - Definitions.

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§ 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.

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

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