[Code of Federal Regulations] [Title 21, Volume 5] [Revised as of April 1, 2008] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR355.1] [Page 301] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF PART 355_ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE--Table of Contents Subpart A_General Provisions Sec. 355.1 Scope. (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 Sec. 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.