eCFR Reference Browser

---

title: "21 CFR §335.3"

source: "https://www.ecfr.gov/current/title-21/section-335.3"

title_number: "21"

volume_number: "5"

chapter_number: "Unknown"

subchapter_code: "D"

subchapter_subject: "DRUGS FOR HUMAN USE"

part_code: "335"

part_subject: "ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE"

subpart_code: "A"

subpart_subject: "General Provisions"

section_number: "335.3"

section_subject: "Definitions."

cfr_reference: "21 CFR 335.3"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 300 to 499"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

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.

§335.3 - Definitions.