C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER D—DRUGS FOR HUMAN USE › PART 358—MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE › Subpart H—Drug Products for the Control of Dandruff, Seborrheic Dermatitis, and Psoriasis

21 C.F.R. § 358.701

Scope

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(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.

Notes of Decisions
Cited in 2 cases (2 in the last 5 years), 2025–2025 · leading case: Jordan Eisman v. Johnson & Johnson Consum. Companies, Inc. (C.D. Cal. 2025).
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Jordan Eisman v. Johnson & Johnson Consum. Companies, Inc. (C.D. Cal. 2025). · cites it 3× “Defendants contend Eisman seeks to use state 10 laws to force Defendants to include disclosures and comply with conditions that are 11 different from and additional to those that the FDA requires in the applicable OTC 12 Coal Tar drug product monograph.”
Pineda v. Lake Consum. Prods., Inc. (E.D. Pa. 2025). “21 C.F.R. § 358.701 (a). Section 330.1 specifies that OTC drugs must meet the conditions described therein concerning manufacture, labeling, dosage, containers, and language permitted and prohibited.”
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