United States Federal Register
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 to 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, 2022. Title 21 of the Code of Federal Regulations (CFR) is a set of regulations issued by the Food and Drug Administration (FDA) and other agencies under the Department of Health and Human Services. It contains regulations governing various aspects of food, drugs, medical devices, cosmetics, and dietary supplements. Some key areas covered in Title 21 include: Food Safety: Title 21 sets standards for food safety, including regulations on food additives, labeling requirements, good manufacturing practices, and food handling procedures. Drug Approval and Regulation: It outlines the processes and requirements for the approval, manufacturing, labeling, and marketing of pharmaceutical drugs. It covers aspects such as clinical trials, drug labeling, drug safety, and post-marketing surveillance. Medical Devices: Title 21 includes regulations related to the design, manufacturing, testing, and marketing of medical devices. It covers topics such as pre-market clearance or approval, labeling requirements, and quality system regulations for medical device manufacturers. Cosmetics: The regulation addresses the labeling, safety, and manufacturing standards for cosmetics. It includes requirements for ingredient labeling, product testing, and safety assessment. Dietary Supplements: Title 21 also covers regulations for dietary supplements, including labeling requirements, ingredient safety, and good manufacturing practices for supplement manufacturers.
