21 CFR 331.1 - Scope.

Regulations last checked for updates: Feb 06, 2026

Title 21 - Food and Drugs last revised: Dec 18, 2026

Table of Contents

An over-the-counter antacid 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 following conditions and each of the general conditions established in § 330.1 of this chapter.

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

source: 39 FR 19874, June 4, 1974, unless otherwise noted.

cite as: 21 CFR 331.1