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United States • Title 21 CFR • Part 335
This part establishes the conditions under which over-the-counter (OTC) antidiarrheal drug products are generally recognized as safe and effective (GRASE) and not misbranded. It specifies the scope, definitions, active ingredients, and detailed labeling requirements for these products.
(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.
The active ingredient of the product consists of any one of the following when used within the dosage limits established for each ingredient in § 335.50(d): (a) Bismuth subsalicylate. (b) Kaolin.
As used in this part: Antidiarrheal.(a) A drug that can be shown by objective measurement to treat or control (stop) the symptoms of diarrhea. Diarrhea.(b) 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. Travelers' diarrhea.(c) 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]
Statement of identity.(a) The labeling of the product contains the established name of the drug, if any, and identifies the product either as an “antidiarrheal” or “for diarrhea.” Indications.(b) The labeling of the product states, under the heading “Use,” one or more of the phrases listed in this paragraph (b), as appropriate. Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this paragraph (b) may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act. For products containing bismuth subsalicylate identified in § 335.10(a).(1) The labeling states [select one of the following: “controls” or “relieves”] [select one or both of the following: “diarrhea” or “travelers' diarrhea”]. If both “diarrhea” and “travelers' diarrhea” are selected, each shall be preceded by a bullet in accordance with §…
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