美国法规21部分食品和药品目录 CFR PART 21 FOOD AND DRUG Contents

TITLE 21--FOOD AND DRUGSCHAPTER I--FOOD AND DRUG ADMINISTRATIONDEPARTMENT OF HEALTH AND HUMAN SERVICES1. General enforcement regulations2. General administrative rulings3. Product jurisdiction5. Organization7. Enforcement policy10. Administrative practices and procedures11. Format evidentiary public hearing12. Formal evidentiary a public hearing13. Public hearing before a public board of inquiry14. Public hearing before a public advisory committee15. Public hearing before the commissioner16. Regulatory hearing before the food and drug administration17. Civil money penalties hearings19. Standards of conduct and conflicts of interest20. Public information21. Protection of privacy25. Environmental impact considerations26. Mutual recognition of pharmaceutical good manufacturing prac50. Protection of human subjects54. Financial disclosure by clinical investigators56. Institutional review boards58. Good laboratory practice for nonclinical laboratory studies60. Patent term restoration70. Color additives71. Color additive petitions73. Listing of color additives exempt from certification74. Listing of color additives subject to certification80. Color additive certification81. General specifications and general restrictions for provision82. Listing of certified provisionally listed colors and specifications83-98 Reserved99 Dissemination of information on unapproved/new uses for mark100 General101 Food labeling102 Common or usual name for nonstandardized foods104 Nutritional quality guidelines for foods105 Foods for special dietary use106 Infant formula quality control procedures107 Infant formula108 Emergency permit control109 Unavoidable contaminants in food for human consumption and110 Current good manufacturing practice in manufacturing, packing 111 Current good manufacturing practice in manufacturing, package 113 Thermally processed low-acid foods packaged in hermetically114 Acidified foods115 Shell eggs118 Production, storage, and transportation of shell eggs119 Dietary supplements that present a significant or unreasonable120 Hazard analysis and critical control point(haccp) systems123 Fish and fishery products129 Processing and bottling of bottled drinking water130 Food standards: general131 Milk and cream133 Cheeses and related cheese products135 Frozen desserts136 Bakery products137 Cereal flours and related products139 Macaroni and noodle products145 Canned fruits146 Canned fruit juices150 Fruit butters, jellies, preserves, and related products152 Fruit pies155 Canned vegetables156 Vegetable juices158 Frozen vegetables160 Eggs and egg products161 Fish and shellfish163 Cacao products164 Tree nut and peanut products165 Beverages166 Margarine168 Sweeteners and table syrups169 Food dressings and flavorings170 Food additives171 Food additives petitions172 Food additives permitted for direct addition to food for human173 Secondary direct food additives permitted in food for human174 Indirect food additives: general175 Indirect food additives: adhesives and components of coating 176 Indirect food additives: paper and paperboard components177 Indirect food additives: polymers178 Indirect food additives: adjuvants, production aids, and179 Irradiation in the production, processing and handing of180 Food additives permitted in food or in contact with food on181 Prior-sanctioned food ingredients182 Substances generally recognized as safe184 Direct food substance affirmed as generally recognized as186 Indirect food substance affirmed as generally recognized as 189 Substances prohibited from use in human food190 Dietary supplements191-199 reserved200 General201 Labeling202 Prescription drug advertising203 Prescription drug marketing205 Guidelines for stat licensing of wholesale prescription drug206 Imprinting of solid oral dosage form drug products for human 207 Registration of producers of drugs and listing of drugs in208 Medication guides for prescription drug products209 Requirement for authorized dispensers and pharmacies to dist.. 210 Current good manufacturing practice in manufacturing, process 211 Current good manufacturing practice in finished pharmaceuti216 Pharmacy compounding225 Current good manufacturing practice for medicated feeds226 Current good manufacturing practice for type a medicated art… 250 Special requirements for specific human drugs290 Controlled drugs299 Drugs; official names and established names300 General310 New drugs312 Investigational new drug application314 Applications for FDA approval to market a new drug315 Diagnostic radiopharmaceuticals316 Orphan drugs320 Bioavailability and bioequivalence requirements328 Over-the-counter drug products intended for oral ingestion330 Over-the-counter(otc) human drugs which are generally recognize331 Antacid products for over-the-counter(otc) human use332 Antiflatulent products for over-the-counter human use333 Topical antimicrobial drug products for Over-the-counter human335 Antidiarrheal drug products for over-the counter human use336 Antiemetic drug products for over-the-counter human use338 Nighttime sleep-aid drug products for over-the-counter human340 Stimulant drug products for over-the-counter human use341 Cold, cough, allergy, bronchodilator, and antiasthmatic drug343 Internal analgesic, antipyretic, and antirheumatic drug product344 Topical otic drug products for over-the-counter human use346 Anorectal drug products for over-the-counter human use347 Skin protectant drug products for over-the-counter use348 External analgesic drug products for over-the-counter human349 Ophthalmic drug products for over-the-counter human use350 Antiperspirant drug products for over-the-counter human use352 Sunscreen drug products for over-the-counter human use [stay355 Anticaries drug products for over-the-counter human use357 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 safe369 Interpretative statements re warnings on drugs and devices370-499 reserved500 General501 Animal food labeling502 Common or usual names for nonstandardized animal foods509 Unavoidable contaminants in animal food and food-packaging510 New animal drugs511 New animal drugs for investigational use514 New animal drugs applications515 Medicated feed mill license516 New animal drugs for minor use and minor species520 Oral dosage form new animal drugs522 Implantation or injectable dosage form new animal drugs524 Ophthalmic and topical dosage form new animal drugs526 Intramammary dosage forms528 New animal drugs in genetically engineered animals529 Certain other dosage form new animal drugs530 Extralabel drug use in animals556 New animal drugs for use in animal feeds564 reserved570 Food additives571 Food additive petitions573 Food additives permitted in feed and drinking water of animal 579 Irradiation in the production, processing, and handing of582 Substances generally recognized as safe584 Food substances generally recognized as safe589 Substances prohibited from use in animal food or feed590-599 reserved600 Biological products: general601 Licensing606 Current good manufacturing practice for blood and blood comp607 Establishment registration and product listing for manufacturers610 General biological products standards630 General requirements for blood, blood components, and blood640 Additional standards for human blood and blood products660 Additional standards for diagnostic substances for laborator680 Additional standards for miscellaneous products700 General701 Cosmetic labeling710 Voluntary registration of cosmetic product establishments720 Voluntary filing of cosmetic product ingredient composition740 Cosmetic product warning statements741-799 reserved800 General801 Labeling803 Medical device reporting806 Medical devices; reports of corrections and removals807 Establishment registration and device listing for manufacturer808 Exemptions from federal preemption of state and local medical809 In vitro diagnostic products for human use810 Medical device recall authority812 Investigational device exemptions813 reserved814 Premarket approval of medical devices820 Quality system regulation821 Medical device tracking requirements822 Postmarket surveillance860 Medical device classification procedures861 Procedures for performance standards development862 Clinical chemistry and clinical toxicology devices864 Hematology and pathology devices866 Immunology and microbiology devices868 Anesthesiology devices870 Cardiovascular devices872 Dental devices874 Ear, nose, and throat devices876 Gastroenterology-urology devices878 General and plastic surgery devices880 General hospital and personal use devices882 Neurological devices884 Obstetrical and gynecological devices886 Ophthalmic devices888 Orthopedic devices890 Physical medicine devices892 Radiology devices895 Banned devices898 Performance standard for electrode lead wires and patient900 Mammography1000 General1002 Records and reports1003 Notification of defects or failure to comply1004 Repurchase, repairs, or replacement of electronic products 1005 Importation of electronic products1010 Performance standards for electronic products: general1020 Performance standards for ionizing radiation emitting product 1030 Performance standards for microwave and radio frequency emit 1040 Performance standards for light-emitting products1050 Performance standards for sonic, infrasonic, and ultrasonic 1140 Cigarettes and smokeless tobacco1210 Regulations under the federal import milk act1230 Regulations under the federal caustic poison act1240 Control of communicable diseases1250 Interstate conveyance sanitation1251-1269 reserved1270 Human tissue intended for transplantation1271 Human cells, tissues, and cellular and tissue-based products 1272-1299 reserved1300 Definitions1301 Registration of manufacturers, distributors, and dispensers 1302 Labeling and packaging requirements for controlled substance 1303 Quotas1304 Records and reports of registrants1305 Orders for schedule I an ii controlled substances1306 Prescriptions1307 Miscellaneous1308 Schedules of controlled substances1309 Registration of manufacturers, distributors, importers and 1310 Records and reports of listed chemicals and certain machines 1311 Requirements for electronic orders and prescriptions1312 Importation and exportation of controlled substances1313 Importation and exportation of list I and ii chemicals1314 Retail sale of scheduled listed chemical products1315 Administrative functions, practices, and procedures1321 Dea mailing addresses1400 reserved1401 Public availability of information1402 Mandatory declassification review1403 Uniform administrative requirements for grants and cooperation 1404 Governmentwide debarment and suspension(nonprocurement)1405 Governmentwide requirements for drug-free workplace (financial) 1406-1499 reserved.。