C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER D—DRUGS FOR HUMAN USE › PART 355—ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE › Subpart A—General Provisions

21 C.F.R. § 355.1

Scope

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

(b) References in this part 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, 2005–2005 · leading case: Coshow v. City of Escondido, 2005 Cal. Daily Op. Serv. 8311 (Cal. Ct. App. 2005).
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Coshow v. City of Escondido, 2005 Cal. Daily Op. Serv. 8311 (Cal. Ct. App. 2005). · cites it 2× “( 21 C.F.R. §§ 355.1 , 355.3 (2005).) In this capacity, the FDA establishes the types of fluoride compounds and their concentrations that may be used in products ( 21 C.”
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