21 CFR 335.1 - Scope.

Regulations last checked for updates: Nov 22, 2024

Title 21 - Food and Drugs last revised: Nov 19, 2024

Table of Contents

§ 335.1 - Scope.

(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.

§ 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]

authority: 21 U.S.C. 321,351,352,353,355,360,371

source: 68 FR 18881, April 17, 2003, unless otherwise noted.

cite as: 21 CFR 335.1