THIS TITLE Title 21-FOOD AND DRUGS is composed of nine volumes. The parts in these volumes are arranged in the following order: Parts 1-99, 100-169, 170-199, 200-299, 300-499, 500-599, 600-799, 800-1299 and 1300-end. The first eight volumes, containing parts 1-1299, comprise Chapter I-Food and Drug Administration, Department of Health and Human Services. The ninth volume, containing part 1300 to end, includes Chapter II-Drug Enforcement Administration, Department of Justice, and Chapter III-Office of National Drug Control Policy. The contents of these volumes represent all current regulations codified under this title of the CFR as of April 1, 2001. Redesignation tables for Chapter I-Food and Drug Administration appear in the Finding Aids section for the volumes containing parts 170-199 and 500-599. know.. if any changes have been made to the Code of Federal Regulations or what documents have been published in the Federal Register without reading the Federal Register every day? If so, you may wish to subscribe to the LSA (List of CFR Sections Affected), the Federal Register Index, or both. LSA The LSA (List of CFR Sections Affected) is designed to lead users of the Code of Federal Regulations to amendatory actions published in the Federal Register. The LSA is issued monthly in cumulative form. Entries indicate the nature of the changes-such as revised, removed, or corrected. $31 per year. Federal Register Index The index, covering the contents of the daily Federal Register, is issued monthly in cumulative form. Entries are carried primarily under the names of the issuing agencies. Significant subjects are carried as cross-references. $28 per year. A finding aid is included in each publication which lists Federal Register page numbers with the date of publication in the Federal Register. Order Processing Code: *5421 Superintendent of Documents Subscription Order Form YES, send me the following indicated subscriptions for one year: Title 21-Food and Drugs (This book contains parts 300 to 499) Part CHAPTER I—Food and Drug Administration, Department of 300 CROSS REFERENCES: Food Safety and Inspection Service, Department of Agriculture: See 9 CFR chapter III. Federal Trade Commission: See Commercial Practices, 16 CFR chapter I. United States Customs Service, Department of the Treasury: See Customs Duties, 19 CFR chapter I. Internal Revenue Service, Department of the Treasury: See Internal Revenue, 26 CFR chapter I. Bureau of Alcohol, Tobacco, and Firearms, Department of the Treasury: See Alcohol, Tobacco Products and Firearms, 27 CFR chapter I. CHAPTER I-FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES-Continued (Parts 300 to 499) EDITORIAL NOTE: The Food and Drug Administration published a document at 49 FR 41019, Oct. 19, 1984, establishing July 1, 1987, as a uniform effective date for compliance for regulations affecting the labeling of food products. At 51 FR 34085, Sept. 25, 1986, FDA established January 1, 1989, as a new uniform effective date for compliance. The new uniform effective date will apply only to final FDA food labeling regulations published after July 1, 1986, and before January 1, 1988. At 55 FR 276, Jan. 4, 1990, FDA established January 1, 1993 as a new uniform effective date for compliance. The new uniform effective date will apply only to final FDA food labeling regulations published after January 1, 1990 and before January 1, 1992. 312 314 320 328 Investigational new drug application Applications for FDA approval to market a new Diagnostic radiopharmaceuticals Bioavailability and bioequivalence requirements 57 95 172 .... 174 186 200 329 Habit-forming drugs 202 330 Over-the-counter (OTC) human drugs which are 206 331 Antacid products for over-the-counter (OTC) Topical antimicrobial drug products for over-the- 224 336 Antiemetic drug products for over-the-counter human use 231 |