CFR›Title 21›Chapter I›Part 208 ContainsSubparts A–BCorpusDaily eCFRDisplayed edition2026-04-24Last updated2026-04-24 PART 208—MEDICATION GUIDES FOR PRESCRIPTION DRUG PRODUCTS Subparts A Subpart A—General Provisions Sections 208.1–208.3 B Subpart B—General Requirements for a Medication Guide Sections 208.20–208.26 Authority21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 357, 360, 371, 374; 42 U.S.C. 262.Source63 FR 66396, Dec. 1, 1998, unless otherwise noted. Previous 207 Part 207—Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs, and the National Drug Code Next 209 Part 209—Requirement for Authorized Dispensers and Pharmacies to Distribute a Side Effects Statement