21 CFR § 333.201 Topical Antimicrobial Drug Products for Over-the-Counter Human Use

§ 333.201 Scope.

Current through Sep 8, 2026 · Read all of Part 333

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

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

← § 333.160 Labeling of permitted combinations of active ingredients.§ 333.203 Definitions. →