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 G—Pediculicide Drug Products

21 C.F.R. § 358.601

Scope

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(a) An over-the-counter pediculicide drug product in a form suitable for topical application is generally recognized as safe and effective and is not misbranded if it meets each condition 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 1 case, 2002–2002 · leading case: Kanter v. Warner-Lambert Co., 48 U.C.C. Rep. Serv. 2d (West) 544 (Cal. Ct. App. 2002).
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Kanter v. Warner-Lambert Co., 48 U.C.C. Rep. Serv. 2d (West) 544 (Cal. Ct. App. 2002). “( 21 C.F.R. § 358.601 (a) (2001).) With respect to labeling, the monograph requires the product to state, under the heading “Indications,” the following: “ ‘For the treatment of head, pubic (crab), and body lice.”
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