TITLE 21--FOOD AND DRUGS Chapter I--Food and Drug Administration, Department of Health and Human Services (Parts 1--1299) SUBCHAPTER A--GENERAL Part 1 General enforcement regulations. 2 General administrative rulings and decisions. 3 Product jurisdiction. 5 Delegations of authority and organization. 7 Enforcement policy. 10 Administrative practices and procedures. 11 Electronic records; electronic signatures. 12 Formal evidentiary public hearing. 13 Public hearing before a public board of inquiry. 14 Public hearing before a public advisory committee. 15 Public hearing before the Commissioner. 16 Regulatory hearing before the Food and Drug Administration. 17 Civil money penalties hearings. 19 Standards of conduct and conflicts of interest. 20 Public information. 21 Protection of privacy. 25 Environmental impact considerations. 50 Protection of human subjects. 56 Institutional review boards. 58 Good laboratory practice for nonclinical laboratory studies. 60 Patent term restoration. 70 Color additives. 71 Color additive petitions. 73 Listing of color additives exempt from certification. 74 Listing of color additives subject to certification. 80 Color additive certification. 81 General specifications and general restrictions for provisional color additives for use in foods, drugs, and cosmetics. 82 Listing of certified provisionally listed colors and specifications. SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION 100 General. 101 Food labeling. 102 Common or usual name for nonstandardized foods. 104 Nutritional quality guidelines for foods. 105 Foods for special dietary use. 106 Infant formula quality control procedures. 107 Infant formula. 108 Emergency permit control. 109 Unavoidable contaminants in food for human consumption and food-packaging material. 110 Current good manufacturing practice in manufacturing, packing, or holding human food. 111 Current good manufacturing practice for dietary supplements. 113 Thermally processed low-acid foods packaged in hermetically sealed containers. 114 Acidified foods. 123 Fish and fishery products. 129 Processing and bottling of bottled drinking water. 130 Food standards: General. 131 Milk and cream. 133 Cheeses and related cheese products. 135 Frozen desserts. 136 Bakery products. 137 Cereal flours and related products. 139 Macaroni and noodle products. 145 Canned fruits. 146 Canned fruit juices. 150 Fruit butters, jellies, preserves, and related products. 152 Fruit pies. 155 Canned vegetables. 156 Vegetable juices. 158 Frozen vegetables. 160 Eggs and egg products. 161 Fish and shellfish. 163 Cacao products. 164 Tree nut and peanut products. 165 Beverages. 166 Margarine. 168 Sweeteners and table sirups. 169 Food dressings and flavorings. 170 Food additives. 171 Food additive petitions. 172 Food additives permitted for direct addition to food for human consumption. 173 Secondary direct food additives permitted in food for human consumption. 174 Indirect food additives: General. 175 Indirect food additives: Adhesives and components of coatings. 176 Indirect food additives: Paper and paperboard components. 177 Indirect food additives: Polymers. 178 Indirect food additives: Adjuvants, production aids, and sanitizers. 179 Irradiation in the production, processing and handling of food. 180 Food additives permitted in food or in contact with food on an interim basis pending additional study. 181 Prior-sanctioned food ingredients. 182 Substances generally recognized as safe. 184 Direct food substances affirmed as generally recognized as safe. 186 Indirect food substances affirmed as generally recognized as safe. 189 Substances prohibited from use in human food. 190 Dietary supplements. SUBCHAPTER C--DRUGS: GENERAL 200 General. 201 Labeling. 202 Prescription drug advertising. 205 Guidelines for State licensing of wholesale prescription drug distributors. 206 Imprinting of solid oral dosage form drug products for human use. 207 Registration of producers of drugs and listing of drugs in commercial distribution. 210 Current good manufacturing practice in manufacturing, processing, packing, or holding of drugs: general. 211 Current good manufacturing practice for finished pharmaceuticals. 225 Current good manufacturing practice for medicated feeds. 226 Current good manufacturing practice for Type A medicated articles. 250 Special requirements for specific human drugs. 290 Controlled drugs. 291 Drugs used for treatment of narcotic addicts. 299 Drugs: official names and established names. SUBCHAPTER D--DRUGS FOR HUMAN USE 300 General. 310 New drugs. 312 Investigational new drug application. 314 Applications for FDA approval to market a new drug or an antibiotic drug. 316 Orphan drugs. 320 Bioavailability and bioequivalence requirements. 328 Over-the-counter drug products intended for oral ingestion that contain alcohol. 329 Habit forming drugs. 330 Over-the-counter (OTC) human drugs which are generally recognized as safe and effective and not misbranded. 331 Antacid products for over-the-counter (OTC) human use. 332 Antiflatulent products for over-the-counter human use. 333 Topical Antimicrobial drug products for over-the-counter human use. 336 Antiemetic drug products for over-the-counter human use. 338 Nighttime sleep-aid drug products for over-the-counter human use. 340 Stimulant drug products for over-the-counter human use. 341 Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use. 344 Topical otic drug products for over-the-counter human use. 346 Anorectal drug products for over-the-counter human use. 347 Skin protectant drug products for over-the-counter human use. 348 External analgesic drug products for over-the-counter human use. 349 Ophthalmic drug products for over-the-counter human use. 355 Anticaries drug products for over-the-counter human use. 357 Miscellaneous internal drug products for over-the- counter human use. 358 Miscellaneous external drug products for over-the- counter human use. 361 Prescription drugs for human use generally recognized as safe and effective and not misbranded: drugs used in research. 369 Interpretative statements re: warnings on drugs and devices for over-the-counter sale. 429 Drugs composed wholly or partly of insulin. 430 Antibiotic drugs; general. 431 Certification of antibiotic drugs. 432 Packaging and labeling of antibiotic drugs. 433 Exemptions from antibiotic certification and labeling requirements. 436 Tests and methods of assay of antibiotic and antibiotic- containing drugs. 440 Penicillin antibiotic drugs. 441 Penem antibiotic drugs. 442 Cepha antibiotic drugs. 443 Carbacephem antibiotic drugs. 444 Oligosaccharide antibiotic drugs. 446 Tetracycline antibiotic drugs. 448 Peptide antibiotic drugs. 449 Antifungal antibiotic drugs. 450 Antitumor antibiotic drugs. 452 Macrolide antibiotic drugs. 453 Lincomycin antibiotic drugs. 455 Certain other antibiotic drugs. 460 Antibiotic drugs intended for use in laboratory diagnosis of disease. SUBCHAPTER E--ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS 500 General. 501 Animal food labeling. 502 Common or usual names for nonstandardized animal foods. 509 Unavoidable contaminants in animal food and food- packaging material. 510 New animal drugs. 511 New animal drugs for investigational use. 514 New animal drug applications. 520 Oral dosage form new animal drugs. 522 Implantation or injectable dosage form new animal drugs. 524 Ophthalmic and topical dosage form new animal drugs. 526 Intramammary dosage forms. 529 Certain other dosage form new animal drugs. 530 Extralabel drug use in animals. 556 Tolerances for residues of new animal drugs in food. 558 New animal drugs for use in animal feeds. 564 Definitions and standards for animal food. 570 Food additives. 571 Food additive petitions. 573 Food additives permitted in feed and drinking water of animals. 579 Irradiation in the production, processing, and handling of animal feed and pet food. 582 Substances generally recognized as safe. 584 Food substances affirmed as generally recognized as safe in feed and drinking water of animals. 589 Substances prohibited from use in animal food or feed. SUBCHAPTER F--BIOLOGICS 600 Biological products; general. 601 Licensing. 606 Current good manufacturing practice for blood and blood components. 607 Establishment registration and product listing for manufacturers of human blood and blood products. 610 General biological products standards. 640 Additional standards for human blood and blood products. 660 Additional standards for diagnostic substances for laboratory tests. 680 Additional standards for miscellaneous products. SUBCHAPTER G--COSMETICS 700 General. 701 Cosmetic labeling. 710 Voluntary registration of cosmetic product establishments. 720 Voluntary filing of cosmetic product ingredient and cosmetic raw material composition statements. 740 Cosmetic product warning statements. SUBCHAPTER H--MEDICAL DEVICES 800 General. 801 Labeling. 803 Medical device reporting. 804 Medical device distributor reporting. 805 Cardiac pacemaker registry. 806 Medical device corrections and removals. 807 Establishment registration and device listing for manufacturers and distributors of devices. 808 Exemptions from Federal preemption of State and local medical device requirements. 809 In vitro diagnostic products for human use. 810 Medical device recall authority. 812 Investigational device exemptions. 814 Premarket approval of medical devices. 820 Quality system regulation. 821 Medical device tracking requirements. 860 Medical device classification procedures. 861 Procedures for performance standards development. 862 Clinical chemistry and clinical toxicology devices. 864 Hematology and pathology devices. 866 Immunology and microbiology devices. 868 Anesthesiology devices. 870 Cardiovascular devices. 872 Dental devices. 874 Ear, nose, and throat devices. 876 Gastroenterology-urology devices. 878 General and plastic surgery devices. 880 General hospital and personal use devices. 882 Neurological devices. 884 Obstetrical and gynecological devices. 886 Opthalmic devices. 888 Orthopedic devices. 890 Physical medicine devices. 892 Radiology devices. 895 Banned devices. 897 Cigarettes and smokeless tobacco. 898 Performance standard for electrode lead wires and patient cables. SUBCHAPTER I--MAMMOGRAPHY QUALITY STANDARDS ACT 900 Mammography. SUBCHAPTER J--RADIOLOGICAL HEALTH 1000 General. 1002 Records and reports. 1003 Notification of defects or failure to comply. 1004 Repurchase, repairs, or replacement of electronic products. 1005 Importation of electronic products. 1010 Performance standards for electronic products: General. 1020 Performance standards for ionizing radiation emitting products. 1030 Performance standards for microwave and radio frequency emitting products. 1040 Performance standards for light-emitting products. 1050 Performance standards for sonic, infrasonic, and ultrasonic radiation-emitting products. SUBCHAPTER L--REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION 1210 Regulations under the Federal Import Milk Act. 1220 Regulations under the Tea Importation Act. 1230 Regulations under the Federal Caustic Poison Act. 1240 Control of communicable diseases. 1250 Interstate conveyance sanitation. 1270 Human tissue intended for transplantation. Chapter II--Drug Enforcement Administration, Department of Justice (Parts 1300--1399) 1300 Definitions. 1301 Registration of manufacturers, distributors, and dispensers of controlled substances. 1302 Labeling and packaging requirements for controlled substances. 1303 Quotas. 1304 Records and reports of registrants. 1305 Order forms. 1306 Prescriptions. 1307 Miscellaneous. 1308 Schedules of controlled substances. 1309 Registration of manufacturers, distributors, importers and exporters and List I chemicals. 1310 Records and reports of listed chemicals and certain machines. 1311 Registration of importers and exporters of controlled substances. 1312 Importation and exportation of controlled substances. 1313 Importation and exportation of precursors and essential chemicals. 1316 Administrative functions, practices, and procedures. Chapter III--Office of National Drug Control Policy (Parts 1400--1499) 1401 Public availability of information. 1402 Mandatory declassification review. 1403 Uniform administrative requirements for grants and cooperative agreements to State and local governments. 1404 Governmentwide debarment and suspension (nonprocurement) and Governmentwide requirements for drug-free workplace (grants).