21 C.F.R. § 357.101 Scope.
Title 21 - Food and Drugs
(a) An over-the-counter anthelmintic drug product in a form suitable for oral administration 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. (b) References in this subpart to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.
Title 21: Food and Drugs
PART 357—MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
Subpart B—Anthelmintic Drug Products
§ 357.101 Scope.