CFR›Title 21›Chapter I›Part 346 ContainsSubparts A–CCorpusDaily eCFRDisplayed edition2026-04-15Last updated2026-04-15 PART 346—ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Subparts A Subpart A—General Provisions Sections 346.1–346.3 B Subpart B—Active Ingredients Sections 346.10–346.22 C Subpart C—Labeling Sections 346.50–346.52 Authority21 U.S.C. 321, 351, 352, 353, 355, 360, 371.Source55 FR 31779, Aug. 3, 1990, unless otherwise noted. Previous 344 Part 344—Topical Otic Drug Products for Over-the-Counter Human Use Next 347 Part 347—Skin Protectant Drug Products for Over-the-Counter Human Use