21 C.F.R. § 335.3 Definitions.
Title 21 - Food and Drugs
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, April 17, 2003, as amended at 69 FR 26302, May 12, 2004]
Title 21: Food and Drugs
PART 335—ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
Subpart A—General Provisions
§ 335.3 Definitions.
