Part 1General Enforcement RegulationsPart 2General Administrative Rulings and DecisionsPart 3Product JurisdictionPart 4Regulation of Combination ProductsPart 5OrganizationPart 7Enforcement PolicyPart 10Administrative Practices and ProceduresPart 11Electronic Records; Electronic SignaturesPart 12Formal Evidentiary Public HearingPart 13Public Hearing Before a Public Board of InquiryPart 14Public Hearing Before a Public Advisory CommitteePart 15Public Hearing Before the CommissionerPart 16Regulatory Hearing Before the Food and Drug AdministrationPart 17Civil Money Penalties HearingsPart 19Standards of Conduct and Conflicts of InterestPart 20Public InformationPart 21Protection of PrivacyPart 25Environmental Impact ConsiderationsPart 50Protection of Human SubjectsPart 54Financial Disclosure by Clinical InvestigatorsPart 56Institutional Review BoardsPart 58Good Laboratory Practice for Nonclinical Laboratory StudiesPart 60Patent Term RestorationPart 70Color AdditivesPart 71Color Additive PetitionsPart 73Listing of Color Additives Exempt from CertificationPart 74Listing of Color Additives Subject to CertificationPart 80Color Additive CertificationPart 81General Specifications and General Restrictions for Provisional Color Additives for Use in Foods, Drugs, and CosmeticsPart 82Listing of Certified Provisionally Listed Colors and SpecificationsPart 99Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and DevicesPart 100GeneralPart 101Food LabelingPart 102Common or Usual Name for Nonstandardized FoodsPart 104Nutritional Quality Guidelines for FoodsPart 105Foods for Special Dietary UsePart 106Infant Formula Requirements Pertaining to Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Records and Reports, and NotificationsPart 107Infant FormulaPart 108Emergency Permit ControlPart 109Unavoidable Contaminants in Food for Human Consumption and Food-Packaging MaterialPart 110Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human FoodPart 111Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary SupplementsPart 112Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human ConsumptionPart 113Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed ContainersPart 114Acidified FoodsPart 115Shell EggsPart 117Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human FoodPart 118Production, Storage, and Transportation of Shell EggsPart 119Dietary Supplements That Present a Significant or Unreasonable RiskPart 120Hazard Analysis and Critical Control Point (HACCP) SystemsPart 121Mitigation Strategies to Protect Food Against Intentional AdulterationPart 123Fish and Fishery ProductsPart 129Processing and Bottling of Bottled Drinking WaterPart 130Food Standards: GeneralPart 131Milk and CreamPart 133Cheeses and Related Cheese ProductsPart 135Frozen DessertsPart 136Bakery ProductsPart 137Cereal Flours and Related ProductsPart 139Macaroni and Noodle ProductsPart 145Canned FruitsPart 146Canned Fruit JuicesPart 150Fruit Butters, Jellies, Preserves, and Related ProductsPart 155Canned VegetablesPart 156Vegetable JuicesPart 158Frozen VegetablesPart 160Eggs and Egg ProductsPart 161Fish and ShellfishPart 163Cacao ProductsPart 164Tree Nut and Peanut ProductsPart 165BeveragesPart 166MargarinePart 168Sweeteners and Table SirupsPart 169Food Dressings and FlavoringsPart 170Food AdditivesPart 171Food Additive PetitionsPart 172Food Additives Permitted for Direct Addition to Food for Human ConsumptionPart 173Secondary Direct Food Additives Permitted in Food for Human ConsumptionPart 174Indirect Food Additives: GeneralPart 175Indirect Food Additives: Adhesives and Components of CoatingsPart 176Indirect Food Additives: Paper and Paperboard ComponentsPart 177Indirect Food Additives: PolymersPart 178Indirect Food Additives: Adjuvants, Production Aids, and SanitizersPart 179Irradiation in the Production, Processing and Handling of FoodPart 180Food Additives Permitted in Food or in Contact with Food on an Interim Basis Pending Additional StudyPart 181Prior-Sanctioned Food IngredientsPart 182Substances Generally Recognized as SafePart 184Direct Food Substances Affirmed as Generally Recognized as SafePart 186Indirect Food Substances Affirmed as Generally Recognized as SafePart 189Substances Prohibited from Use in Human FoodPart 190Dietary SupplementsPart 200GeneralPart 201LabelingPart 202Prescription Drug AdvertisingPart 203Prescription Drug MarketingPart 205Guidelines for State Licensing of Wholesale Prescription Drug DistributorsPart 206Imprinting of Solid Oral Dosage Form Drug Products for Human UsePart 207Requirements 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 CodePart 208Medication Guides for Prescription Drug ProductsPart 209Requirement for Authorized Dispensers and Pharmacies to Distribute a Side Effects StatementPart 210Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; GeneralPart 211Current Good Manufacturing Practice for Finished PharmaceuticalsPart 212Current Good Manufacturing Practice for Positron Emission Tomography DrugsPart 213Current Good Manufacturing Practice for Medical GasesPart 216Human Drug CompoundingPart 225Current Good Manufacturing Practice for Medicated FeedsPart 226Current Good Manufacturing Practice for Type a Medicated ArticlesPart 230Certification and Postmarketing Reporting for Designated Medical GasesPart 250Special Requirements for Specific Human DrugsPart 251Section 804 Importation ProgramPart 290Controlled DrugsPart 299Drugs; Official Names and Established NamesPart 300GeneralPart 310New DrugsPart 312Investigational New Drug ApplicationPart 314Applications for FDA Approval to Market a New DrugPart 315Diagnostic RadiopharmaceuticalsPart 316Orphan DrugsPart 317Qualifying PathogensPart 320Bioavailability and Bioequivalence RequirementsPart 328Over-the-Counter Drug Products Intended for Oral Ingestion That Contain AlcoholPart 329Nonprescription Human Drug Products Subject to Section 760 of the Federal Food, Drug, and Cosmetic ActPart 330Over-the-Counter (OTC) Human Drugs Which Are Generally Recognized as Safe and Effective and Not MisbrandedPart 331Antacid Products for Over-the-Counter (OTC) Human UsePart 332Antiflatulent Products for Over-the-Counter Human UsePart 333Topical Antimicrobial Drug Products for Over-the-Counter Human UsePart 335Antidiarrheal Drug Products for Over-the-Counter Human UsePart 336Antiemetic Drug Products for Over-the-Counter Human UsePart 338Nighttime Sleep-Aid Drug Products for Over-the-Counter Human UsePart 340Stimulant Drug Products for Over-the-Counter Human UsePart 341Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human UsePart 343Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human UsePart 344Topical Otic Drug Products for Over-the-Counter Human UsePart 346Anorectal Drug Products for Over-the-Counter Human UsePart 347Skin Protectant Drug Products for Over-the-Counter Human UsePart 348External Analgesic Drug Products for Over-the-Counter Human UsePart 349Ophthalmic Drug Products for Over-the-Counter Human UsePart 350Antiperspirant Drug Products for Over-the-Counter Human UsePart 352Sunscreen Drug Products for Over-the-Counter Human Use [Stayed Indefinitely]Part 355Anticaries Drug Products for Over-the-Counter Human UsePart 357Miscellaneous Internal Drug Products for Over-the-Counter Human UsePart 358Miscellaneous External Drug Products for Over-the-Counter Human UsePart 361Prescription Drugs for Human Use Generally Recognized as Safe and Effective and Not Misbranded: Drugs Used in ResearchPart 369Interpretative Statements Re Warnings on Drugs and Devices for Over-the-Counter SalePart 500GeneralPart 501Animal Food LabelingPart 502Common or Usual Names for Nonstandardized Animal FoodsPart 507Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for AnimalsPart 509Unavoidable Contaminants in Animal Food and Food-Packaging MaterialPart 510New Animal DrugsPart 511New Animal Drugs for Investigational UsePart 514New Animal Drug ApplicationsPart 515Medicated Feed Mill LicensePart 516New Animal Drugs for Minor Use and Minor SpeciesPart 520Oral Dosage Form New Animal DrugsPart 522Implantation or Injectable Dosage Form New Animal DrugsPart 524Ophthalmic and Topical Dosage Form New Animal DrugsPart 526Intramammary Dosage Form New Animal DrugsPart 528Intentional Genomic Alterations in AnimalsPart 529Certain Other Dosage Form New Animal DrugsPart 530Extralabel Drug Use in AnimalsPart 556Tolerances for Residues of New Animal Drugs in FoodPart 558New Animal Drugs for Use in Animal FeedsPart 570Food AdditivesPart 571Food Additive PetitionsPart 573Food Additives Permitted in Feed and Drinking Water of AnimalsPart 579Irradiation in the Production, Processing, and Handling of Animal Feed and Pet FoodPart 582Substances Generally Recognized as SafePart 584Food Substances Affirmed as Generally Recognized as Safe in Feed and Drinking Water of AnimalsPart 589Substances Prohibited from Use in Animal Food or FeedPart 600Biological Products: GeneralPart 601LicensingPart 606Current Good Manufacturing Practice for Blood and Blood ComponentsPart 607Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed DevicesPart 610General Biological Products StandardsPart 630Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing UsePart 640Additional Standards for Human Blood and Blood ProductsPart 660Additional Standards for Diagnostic Substances for Laboratory TestsPart 680Additional Standards for Miscellaneous ProductsPart 700GeneralPart 701Cosmetic LabelingPart 710Voluntary Registration of Cosmetic Product EstablishmentsPart 720Voluntary Filing of Cosmetic Product Ingredient Composition StatementsPart 740Cosmetic Product Warning StatementsPart 800GeneralPart 801LabelingPart 803Medical Device ReportingPart 806Medical Devices; Reports of Corrections and RemovalsPart 807Establishment Registration and Device Listing for Manufacturers and Initial Importers of DevicesPart 808Exemptions from Federal Preemption of State and Local Medical Device RequirementsPart 809In Vitro Diagnostic Products for Human UsePart 810Medical Device Recall AuthorityPart 812Investigational Device ExemptionsPart 814Premarket Approval of Medical DevicesPart 820Quality Management System RegulationPart 821Medical Device Tracking RequirementsPart 822Postmarket SurveillancePart 830Unique Device IdentificationPart 860Medical Device Classification ProceduresPart 861Procedures for Performance Standards DevelopmentPart 862Clinical Chemistry and Clinical Toxicology DevicesPart 864Hematology and Pathology DevicesPart 866Immunology and Microbiology DevicesPart 868Anesthesiology DevicesPart 870Cardiovascular DevicesPart 872Dental DevicesPart 874Ear, Nose, and Throat DevicesPart 876Gastroenterology-Urology DevicesPart 878General and Plastic Surgery DevicesPart 880General Hospital and Personal Use DevicesPart 882Neurological DevicesPart 884Obstetrical and Gynecological DevicesPart 886Ophthalmic DevicesPart 888Orthopedic DevicesPart 890Physical Medicine DevicesPart 892Radiology DevicesPart 895Banned DevicesPart 898Performance Standard for Electrode Lead Wires and Patient CablesPart 900MammographyPart 1000GeneralPart 1002Records and ReportsPart 1003Notification of Defects or Failure to ComplyPart 1004Repurchase, Repairs, or Replacement of Electronic ProductsPart 1005Importation of Electronic ProductsPart 1010Performance Standards for Electronic Products: GeneralPart 1020Performance Standards for Ionizing Radiation Emitting ProductsPart 1030Performance Standards for Microwave and Radio Frequency Emitting ProductsPart 1040Performance Standards for Light-Emitting ProductsPart 1100GeneralPart 1105GeneralPart 1107Exemption Requests and Substantial Equivalence ReportsPart 1114Premarket Tobacco Product ApplicationsPart 1140Cigarettes, Smokeless Tobacco, and Covered Tobacco ProductsPart 1141Required Warnings for Cigarette Packages and AdvertisementsPart 1143Minimum Required Warning StatementsPart 1150User FeesPart 1210Regulations Under the Federal Import Milk ActPart 1230Regulations Under the Federal Caustic Poison ActPart 1240Control of Communicable DiseasesPart 1250Interstate Conveyance SanitationPart 1271Human Cells, Tissues, and Cellular and Tissue-Based ProductsPart 1300DefinitionsPart 1301Registration of Manufacturers, Distributors, and Dispensers of Controlled SubstancesPart 1302Labeling and Packaging Requirements for Controlled SubstancesPart 1303QuotasPart 1304Records and Reports of RegistrantsPart 1305Orders for Schedule I and II Controlled SubstancesPart 1306PrescriptionsPart 1307MiscellaneousPart 1308Schedules of Controlled SubstancesPart 1309Registration of Manufacturers, Distributors, Importers and Exporters of List I ChemicalsPart 1310Records and Reports of Listed Chemicals and Certain Machines; Importation and Exportation of Certain MachinesPart 1311Requirements for Electronic Orders and PrescriptionsPart 1312Importation and Exportation of Controlled SubstancesPart 1313Importation and Exportation of List I and List II ChemicalsPart 1314Retail Sale of Scheduled Listed Chemical ProductsPart 1315Importation and Production Quotas for Ephedrine, Pseudoephedrine, and PhenylpropanolaminePart 1316Administrative Functions, Practices, and ProceduresPart 1317DisposalPart 1318Controls to Satisfy the Requirements of the Act Applicable to the Manufacturing of MarihuanaPart 1321DEA Mailing AddressesPart 1401Public Availability of InformationPart 1402Mandatory Declassification Review