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Code of Federal Regulations (Last Updated: May 6, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter D - Drugs for Human Use |
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Part 335 - Antidiarrheal Drug Products for over-the-Counter Human Use |
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Subpart A - General Provisions |
§ 335.3 - Definitions.
Latest version.
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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]