21 CFR 336.1 - Scope.

Regulations last checked for updates: Nov 25, 2024

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

Table of Contents

§ 336.1 - Scope.

(a) An over-the-counter antiemetic drug product in a form suitable for oral administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this part and each of the general conditions established in § 330.1.

(b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.

§ 336.3 - Definition.

As used in this part:

Antiemetic. An agent that prevents or treats nausea and vomiting.

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

source: 52 FR 15892, Apr. 30, 1987, unless otherwise noted.

cite as: 21 CFR 336.1