21 CFR § 358.701 Miscellaneous External Drug Products for Over-the-Counter Human Use

§ 358.701 Scope.

Current through Sep 8, 2026 · Read all of Part 358

(a) An over-the-counter dandruff, seborrheic dermatitis, or psoriasis drug product in a form suitable for topical application 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) References in this subpart to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.

← § 358.650 Labeling of pediculicide drug products.§ 358.703 Definitions. →