21 C.F.R. Subpart A—General Provisions
Title 21 - Food and Drugs
(a) An over-the-counter antidiarrheal drug product in a form suitable for oral administration is generally recognized as safe and effective and is not misbranded if it meets each condition in this part and each general condition established in §330.1 of this chapter. (b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted. 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
§ 335.1 Scope.
§ 335.3 Definitions.
