C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER D—DRUGS FOR HUMAN USE › PART 333—TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE › Subpart D—Topical Acne Drug Products

21 C.F.R. § 333.301

Scope

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(a) An over-the-counter acne 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 3 cases (3 in the last 5 years), 2024–2026 · leading case: In re Target Corp. BPO Sales & Mktg. Litig. (D. Minnesota 2026).
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In re Target Corp. BPO Sales & Mktg. Litig. (D. Minnesota 2026). · cites it 2× “Kouyate, 2025 WL 2773159, at *7 (citing 21 C.F.R. §§ 333.301–333.350 (the “Acne Monograph”)).”
Williams v. Galderma Labs., LP (N.D. Ill. 2024). “10 (a)(1) (“The Commissioner shall … evaluate the safety and effectiveness of OTC drugs, to review OTC drug labeling, and to advise him on the promulgation of monographs establishing conditions under which OTC drugs are generally recognized as safe and effective and not…”
Navarro v. Walgreens Boots All., Inc. (E.D. Cal. 2025). “evaluate the safety and effectiveness of OTC drugs, to review 18 OTC drug labeling, and to advise him on the promulgation of monographs establishing 19 conditions under which OTC drugs are generally recognized as safe and effective and not 20 misbranded”); see also 21 C.F.R. §…”
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