UCM142644

Compliance Policy Guides Index

395395

Index

1000 ML WATER METHODSurgeon's Gloves & Patient Exam Gloves - 335.700

1989 GENERIC DRUG CASESOrders for Post-Approval Record Reviews - 470.100

A CLINICAL REPERTORY TO THE DICTIONARY OF MATERIA MEDICA Homeopathic Drugs - 400.400

ABBREVIATEDConsistent Application of CGMP Determinations - 400.200Fraud, Untrue Statements of Material Facts, Bribery - 120.100Marketed New Drugs Without Approved NDAs or ANDAs - 440.100Reconditioning New Drugs Lacking Approved NDA - 448.100Salmonella Contamination of Dry Dog Food - 690.700

ABDOMINALDefinition of General Purpose Radiographic X-Ray System - 398.100Positive Beam Limitation (PBL) Requirements - 398.450Turtles - 170.100

ABRADEDKaraya Gum Powder and Related Devices for Use by Ostomates - 325.100

ABSOLUTE MINIMUM CRITERIAAssemblers Who Install Noncompliant Equipment - 398.325

ABUSEDetermination by Secretary that Product Fails to Comply - 390.200Obligations of Factory-based Manufacturers and Assemblers - 398.375

RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200ACCEPT/ REJECT

Condoms; Defects - Criteria for Direct Reference Seizure - 345.100Retention of Microwave Oven Test Records - 394.100Surgeon's Gloves and Patient Examination Gloves - 335.700

ACCEPTABLE QUALITY LEVEL (AQL)Condoms; Defects - Criteria for Direct Reference Seizure - 345.100GWQAP Pre-Award Evaluation - 100.700Surgeon's Gloves and Patient Examination Gloves - 335.700

ACCESSORIESAcupuncture Devices and Accessories - 305.100Denture Cleaners, Adhesives, Cushions, & Repair Materials - 315.200

ACCIDENTAL RADIATION OCCURRENCES Electronic Products Subject to 21 CFR 1001.15(a) - 390.400

ACCURACYClinical Thermometers - 370.200Compressed Medical Gases - Warning Letters - 435.100Computerized Drug Processing - Input/Output - 425.400Cytotoxic Testing for Allergic Diseases - 370.100Fraud, Untrue Statements, Bribery - 120.100I.D. of "Persons" - 425.500Metric Declarations of Quantity of Contents - 140.500Process Validation Requirements for Drug Products - 490.100RIA Analysis of Hair - 370.200Source Plasma - Overbleeding - 252.100Temporal - Maximum Ultrasonic Power - 397.100

ACCURATEClinical Thermometer - Misbranding Defects - 335.800Computerized Rx Records by Pharmacies - 460.400Determination of Donor Suitability - 230.130Foods - FPLA Compliance - 562.200Registration of Blood Banks & Other Firms - 230.110Source Plasma - Guidelines - 250.100

ACETIC ACIDAcetic Acid-Use in Foods-Labeling of Foods in Which Used - 562.100Sauerkraut - Definition; Adulteration by Thrips - 585.750Vinegar, Definitions - Adulteration with Vinegar Eels - 525.825

ACIDAcetic Acid - Use In Foods - 562.100Acidified Low-Acid Canned Foods - 520.300Canned Pet Food - 690.300Cumin Seed Adulteration - 525.325Food Storage & Warehousing - 580.100Imported Low-Acid Canned Foods - 560.450Jellies NonStandardized- 550.475Labeling of Seasonings - 525.650Large Volume Parenteral (LVP's) - 635.100Nutritional Supplements for Pets - 690.100Potato Chips, Ingredients - 585.710Pottery - Cadmium Contamination - 545.400Prepared Mustard, Composition - 525.575Sauerkraut - Definition - 585.750Silage Ingredients - 687.500Silver-Plated Hollowware - 545.500Spices - Definitions - 525.750Vinegar, Definitions - 525.825

Vitamin B-15, Pangamic Acid - 457.100ACIDIFIED LOW-ACID CANNED FOODS

High pH - 520.300ACIDIFIERS

Sauerkraut - Definition - 585.750Urinary Preparations - 430.400

ACTION LEVELAction Levels for Aflatoxin in Animal Feeds - 683.100Aflatoxin in Peanuts and Peanut Products - 570.375Ammoniated Cottonseed Meal - Interpretation of 21 CFR 573.14 - 670.500Apricot, Peach and Pear Nectars and Purees - Mold - 550.155Dimethylnitrosamine (DMNA) in Barley Malt - 578.500Diversion of Adulterated Food to Acceptable Animal Feed Use - 675.200Food Storage & Warehousing, Adulteration, Filth - 580.100Pesticide Residues in Food and Feed - 575.100Pottery (Ceramics) - Cadmium Contamination - 545.400Red Meat Adulterated with PCB's - 565.200Revocation of Tolerances for Cancelled Pesticides - 555.700Streptomycin Residues in Cattle Tissues - 616.100Tree Nuts - Adulteration Involving Rejects - 570.425Volatile N-Nitrosamine in Rubber Baby Bottle Nipples - 500.450

ACUPUNCTUREDevices & Accessories - 305.100Lasers for Facelift, etc. - 393.200

ACUTEOTC Ear Drops - 454.100Proper Drug Use & Residue Avoidance - 615.200Salt-Cured, Air-Dried, Uneviscerated Fish - 540.650Sunlamp Performance Standard - 396.100

ADDITIVESAdditives - Labeling with Adequate Directions for Many Uses - 500.100Ammoniated Cottonseed Meal - Interpretation of 21 CFR 573.140 - 670.500Approved by FDA - Labeling of a Food Additive - 500.300Brandy Containing Methyl Alcohol - Food Additive - 510.200 Caviar, Use of Term - Labeling - 540.150Color Additives - 587.300Color Additives in Paper and Paperboard for Use With Food - 500.425Confectionery Decorations (Nutritive and Non-Nutritive) - 545.200Direct-Fed Microbial Products - 689.100FDA Jurisdiction Over Meat and Poultry Products - 565.100Food Additives - Labeling Directions Necessary for SafeUse - 500.250Food and Drug Guaranty - Imports - 110.500Fraud, Untrue Statements of Material Facts, Bribery - 120.100Imports - Identity of Ingredients - 560.250Label Declaration of Artificial Color - 587.100Pesticide Residues in Food and Feed - 575.100Plastic Containers for Injectable Animal Drugs - 637.100Pottery (Ceramics) - Cadmium Contamination - 545.400Pottery (Ceramics) - Lead Contamination - 545.450Preservatives; Use in Nonstandardized Foods; Label Declaration - 562.600Recycled Animal Waste - 685.100Silage Ingredients - 687.500Silver-Plated Hollowware - Lead Contamination - 545.500Starches--Common or Usual names - 578.100Sweet Potatoes, Dyeing of Yellow and Red Varieties - 585.825Teat Dips and Udder Washes for Dairy Cows and Goats - 654.200Vitamins and Minerals in Feed - 670.200

ADEQUATE DIRECTIONS FOR USEAcupuncture Devices and Accessories - 305.100Additives - Labeling with Adequate Directions for Many Uses - 500.100Adequate Directions for Use-Animal Drugs and Devices - 607.100Adequate Directions for Use - Veterinary Devices - 655.200 Availability of Bulk Chemicals for Animal Drug Use - 625.200Checklist Labeling for Custom Mixed Medicated Feeds - 665.200Chloramphenicol - 654.300Compressed Medical Gases -- Warning Letters - 435.100Cytotoxic Testing for Allergic Diseases - 370.100Diaphragms - Rx Devices - 345.200Electrical Muscle Stimulators - 355.200Homeopathic Drugs - 400.400Hypnotherapy Devices - Self Hypnotic Tape Recordings - 335.300Illegal Sales of Veterinary Prescription Drugs - 608.500Ineffective Devices - 502(f)(l) Labeling Requirements - 300.300Inert Glandular Preparations - OTC - 455.100Large Volume Parenteral (LVP's) for Animal Use - 635.100Over-The-Counter Sale of Injectable Animal Drugs - 608.200RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200 Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100Warning Label Required on Sunlamp Products - 396.400

Index Compliance Policy Guides

396396

ADHESIVESDenture Cleaners, Repair Materials - 315.200Tamper-Resistant Packaging Requirements - 450.500

ADMINISTRATIVE DETENTIONDefective Suntanning Booths & Beds - 396.300

ADRENALGrandular Preparations - 455.100

ADULTERATEDAcupuncture Devices and Accessories - 305.100Adulterated Food Mixed with Good Food - 555.200Adulteration of Drugs Under Sec. 501(b) and 501(c) - 420.100Apple Butter - Adulteration with Mold; Rodent Filth, Insects - 550.100Apricots - Canned - Adulteration with Insects - 550.150Apricot, Peach and Pear Nectars and Purees - mold - 550.155Asparagus, Canned or Frozen - Adulteration with Insect Filth - 585.150Availability of Bulk Chemicals for Animal Drug Use - 625.200 Bay (Laurel) Leaves - Insect Filth; Mold; etc. - 525.150Beets, Canned - Adulteration with Rot - 585.200 Black-Eyed Peas (Cow Peas, Field Peas); Dried - 585.225Broccoli, Frozen - Adulteration with Insects - 585.260Brussels Sprouts, Frozen - Adulteration by Insects - 585.275Butter - Adulteration Involving Low Fat - 527.100Candy - Mixed with Trinkets and Sold in Vending Machines - 515.350Canned Salmon - Adulteration Involving Decomposition - 540.375Canned Foods - Seam Defects - 520.200Capsicum Pods, etc. - Adulteration - 525.200Cheese and Cheese Products - Adulteration with Filth - 527.200Cherries - 550.225Cherry Jam - Adulteration with Mold - 550.235Chloramphenicol - 654.300Chocolate & Chocolate Liquor - Adulteration - 515.700Cinnamon-Flavored Toothpicks - 545.600Citrus Fruit Juices, Canned - Fly Filth and Mold - 550.250Class III Devices Subject to 5l5(b) Requirements - 300.750Clinical Thermometer - Adulteration; Misbranding Defects - 335.800Cloudberries (Multer Berries), canned - Adulteration - 550.590Cloves - Adulteration with Stems - 525.250Cocoa Beans - Mold, Insect Infestation, and Mammalian Excreta - 515.750Coffee and Cocoa Bean Sweeps - 560.350Compendium Revisions and Deletions - 420.200Compressed Medical Gases - Warning Letters - 435.100Computerized Drug Processing - Vendor responsibility - 425.200

Computerized Drug Processing - Input/Output Checking - 425.400Condimental Seeds Other than Fennel Seeds and Sesame Seeds - 525.300Condoms; Defects - Criteria for Direct Reference Seizure - 345.100 Confectionery Decorations (Nutritive and Non-Nutritive) - 545.200 Confectionery - Use of Non-Nutritive Substances as Ingredients. - 515.100Contamination of Devices Labeled as Sterile - 300.400Corn Meal - Adulteration by Insect and Rodent Filth - 578.200Corn Husks (for Tamales) - Adulteration with Filth - 585.350Corn, Sweet; Canned - Adulteration - 585.300Cowpeas (Black-Eyed Peas); Canned (Succulent Peas); Insects - 585.400Crabmeat Products, Labeling - 540.285Crabmeat - Adulteration with Filth - Escherichia coli - 540.275Cranberry Sauce - Adulteration with Mold - 550.260 Cumin Seed - Adulteration with Sand and Grit - 525.325Currants - Adulteration Involving Wormy Fruits - 550.270Curry Powder - Adulteration by Insect and Rodent Filth - 525.330Cytotoxic Testing for Allergic Diseases - 370.100Dates and Date Material; Imported and Domestic - 550.300Decomp. & Histamine in Albacore, Skipjack & Yellowfin Tuna - 540.525Devices for Use in Animals - 655.100Dimethyl Sulfoxide (DMSO) for Animal Use - 654.100Dimethylnitrosamine in Malt Beverages - 510.600Direct Reference Authority for Class III Medical Devices - 300.700 Direct Reference Authority for Pseudomonas Contamination - 590.300Direct-Fed Microbial Products - 689.100Diversion of Contaminated Food for Animal Use - 675.100Diversion of Adulterated Food to Acceptable Animal Feed Use - 675.200Dried Prunes, Dehydrated Low Moisture Prunes, and Pitted Prunes - 550.700Drupelet Berries (Blackberries, Raspberries, etc.) - 550.200Eggnog; Eggnog Flavored Milk--Common Usual Names - 527.350Eggs and Other Egg Products - Frozen - Decomposition - 537.100Enriched or Fortified Foods - Potency - 555.550Ethylenediamine Dihydroiodide (EDDI) - 651.100Extra-Label Use of New Animal Drugs in Food-Producing Animals - 615.100Fennel Seed - Adulteration by Mammalian Excreta; Insects - 525.350Figs; Fig Paste - Insect Infestation; Mold, Dirt - 550.350Fish - Fresh and Frozen-Adulteration Involving Decomp. - 540.575Fish - Fresh and Frozen, as Listed; Adulteration by Parasites - 540.590Food Storage & Warehousing - Adulteration - Filth - 580.100Food Additives -"GRAS" - 500.200Foods, Except Dairy Products - Adulteration with Salmonella - 555.300Foods, Rail Car Sanitation - Adulteration - 545.300Green Coffee Beans - Adulteration with Insects; Mold - 510.500Greens, Canned - Adulteration by Mildew - 585.450

Hops - Adulteration Involving Aphid Infestation - 525.425Hospital Pharmacies - 460.100Human-Labeled Drugs Distributed & Used in Animal Medicine - 608.100Importation of Unlabeled Foods - *21 CFR 101.100(d)* - 560.100Imported Low-Acid Canned Foods - 560.450Imports - Identity of Ingredients - 560.250Interference with Compendial Tests - 420.500Jam, Black Currant - Adulteration with Mold - 550.450Jams, Jellies and Related Products - Imports - 560.500

Lack of Expiration Date or Stability Data - 480.300Large volume parenteral (LVP's) for animal use - 635.100Leafy Spices, Other than Bay Leaves - 525.500Lingon Berries, Canned - Adulteration by Insects - 550.500Macaroni and Noodle Products - 505.500Mace-Insect Filth; Mold, Foreign Matter; Mammalian Excreta - 525.550Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200Marjoram - 525.900Medicated Feeds - Formula Information - 670.100Medicated Feeds - Combined Batches - 680.400Milk and Milk Products Containing Penicillin - 527.450Natural Bristle Brushes - Nit Contamination - 590.400Nutritional Supplements for Companion Animals - 690.100Olives - Adulteration Involving Pits; Rot; Insect Infestation - 550.600Oranges - Artificial Coloring - 550.625Oregano - 525.850Pathogens in Dairy Products - 527.300Peanut Butter - Adulteration with Filth; Grit - 570.300Peanuts, Shelled and Unshelled - Filth and Reject Nuts - 570.350Peas and Beans; Dried - Storage Insect Damage, Rocks - 585.575Pesticide Residues in Food and Feed - 575.100Pineapple, Canned; Pineapple Juice-Adulterated with Mold - 550.680Plastic Containers for Injectable Animal Drugs - 637.100Plums, Canned - Adulteration with Rot - 550.690Popcorn - Adulteration with Rodent Filth and Field Corn - 585.675Potato Chips - Adulteration with Rot - 585.700Pottery (Ceramics) - Cadmium Contamination - 545.400Pottery (Ceramics) - Lead Contamination - 545.450Products Composed of Interstate Ingredients - 100.200Proper Drug Use and Residue Avoidance - 615.200

Radionuclides in Imported Foods - Levels of Concern - 560.750Raisins - Adulteration Involving Mold, Sand, Grit, and Insects - 550.750Reconditioners/Rebuilders of Medical Devices - 300.200Reconditioning of Foods Adulterated Under 402(a)(4) - 160.700Reconditioning of Articles Found in Violation of GMP's - 160.750Reconditioning of New Animal Drugs Seized Under Sec. 501(a)(5) - 625.400Red Meat Adulterated with PCB's - 565.200Rendered Animal Feed Ingredients - 675.400RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200Rodent Contaminated Pet Foods - 690.600Sage - 525.950Salmonella Contamination of Dry Dog Food - 690.700Salt-Cured, Air-Dried, Uneviscerated Fish - 540.650Seeds for Sprouting Prior to Food Use - 555.750Sesame Seeds - Adulteration - 525.700Shrimp-Fresh or Frozen Raw Headless, Peeled or Breaded - 540.400Silage Ingredients - 687.500Silver-Plated Hollowware - Lead Contamination - 545.500Spinach, Canned or Frozen - Insects, Decomposition - 585.775Strawberries; Frozen, Whole, or Sliced - Sand, Mold - 550.850Streptomycin Residues in Cattle Tissues - 616.100Surgeon's Gloves and Patient Examination Gloves - 335.700Sweet Potatoes, Dyeing of Yellow and Red Varieties - 585.825Thyme - 525.925Tomato Products - Adulteration with Mold - 585.900Tomato Products - Drosophila Fly Eggs and Maggots - 585.890Treated Grain Seed - Mercury Residue - 578.400Tree Nuts - Adulteration Involving Rejects - 570.425Tree Nuts - Escherichia coli - 570.450Unapproved New Animal Drugs - Follow-up Action - 625.300Uncertified or Delisted Colors - 587.200Uncooked Meat for Animal Food - 690.500Unsafe Contamination of Animal Feed from Drug Carry-Over - 680.500Vinegar, Definitions - Adulteration with Vinegar Eels - 525.825Water in Food Products (Ingredient or Adulterant) - 555.875Water-Damaged Food Products - 555.850Water and Gravy in Pet Food - 690.400Wheat - Adulteration by Insect and Rodent Filth - 578.300Wheat Flour - 578.450Whole Cassia or Whole Cinnamon, Ground Cinnamon - 525.225Whole Ginger - Insect Filth; Mold; Mammalian Excreta - 525.375Whole and Ground Allspice Mold; Insect and Rodent Filth - 525.100Whole and Ground Pepper - Adulteration - 525.625Whole and Ground Nutmeg-Insect Filth; Mold; Rodent Filth - 525.600

ADULTERATIONSee Adulterated

ADVANCEMENT OF MEDICAL INSTRUMENTATION (AAMI)


397397

Sphygmomanometers - Accuracy - 310.210ADVERTISED

Acupuncture Devices & Accessories - 305.100Commercial Distribution - 300.600

ADVERTISINGBulk Chemicals for Animal Drugs - 625.200Certification for Export - 110.100Drug Product - 400.700Health Fraud - 120.500Human-Labeled Drugs for Animals - 608.100Lasers for Facelift - 393.200Literature for Mercury Vapor Lamps - 391.100Mercury Vapor Lamps - 391.200NADA Approval - 605.100Promotion by Pharmacies - 460.200

ADVISABILITYSphygmomanometers - Rx Legend - 310.200

ADVISORY OPINIONColor Additives in Paperboard for Use with Foods - 500.425Commercial Distribution - 300.600Drug Product Entries in Periodic Publications - 400.700Fortification of Standardized Juices - 510.700Labeling: "Chocolate" or "Chocolate Flavored" - 515.800Microfiche and/or Microfilm - Records Retention - 130.400Override of Positive Beam Limitation - 398.425Plastic Containers for Injectable Animal Drugs - 637.100Seeds for Sprouting Prior to Food Use - 555.750

AEROBIC PLATE COUNTSRaw Breaded Shrimp - Microbiological - 540.420

AEROSOL PRODUCTSTamper-Resistant Packaging Requirements - 450.500

AFFIRMATIONImportation - TV Receivers & Microwave Ovens - 394.500

AFLATOXINAction Levels for Aflatoxin in Animal Feeds - 683.100Ammoniated Cottonseed Meal - 670.500in Foods - 555.400in Pistachio Nuts - 570.500in Peanut Products - 570.375in Brazil Nuts - 570.200Milk - 527.400Moisture Damaged Grain - 675.300

AIR-DRIED, AIR-DRYINGUneviscerated Fish - 540.650

AIR-LIQUEFACTIONCompressed Medical Gases - Warning Letters - 435.100

ALBACOREDecomposition & Histamine - 540.525

ALBUMENConfectionery Decorations - 545.200

ALBUMINRegistration of Blood Bands & Other Firms - 230.110Standards & Minimum Requirements for Biologic Products - 205.100

ALBUTEROL SULFATEManufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200

ALCOHOLAcetic Acid Use in Foods - 562.100Brandy - 510.200Confectionery - 515.100Labeling Wines and Cider - 510.450Large Volume Parenteral (LVP's) - 635.100Use in Foods - 555.100Vinegar, Definitions - 525.825Wine and Malt Beverages - 510.400

ALDEHYDESpices - Definitions - 525.750

ALFALFA SEEDSSeeds For Sprouting - 555.750

ALGAL "BLOOMS"Paralytic Shellfish - 540.250

ALLERGENIC PRODUCTSStandards & Minimum Requirements for Biologic Products - 205.100

ALLERGIC DISEASESCytotoxic Testing - 370.100

ALLERGIESHypnotherapy Devices - 335.300Immune Milk - 275.100

ALLERGY CLINICSCytotoxin Testing - 370.100

ALLSPICESpices - Definitions - 525.750Whole and Ground - 525.100

ALMONDSConfectionery Decorations - 545.200Jordan Almonds - Common or Usual Name - 570.100Maraschino Cherries - 550.550

Tree Nuts - Adulteration - 570.425ALTERNATE PROCEDURES AND PRECAUTIONS

Hazardous Diagnostic X-Ray Systems - 398.200AMERICAN CITRON

Candied Citron - Labeling - 515.600AMERICAN SPICE TRADE ASSOCIATION

Spices - Definitions - 525.750AMERICAN NATIONAL STANDARDS INSTITUTE

Sphygmomanometers - Accuracy - 310.210AMINE

Barley Malt - 578.500AMINO ACID

LVP's for Animals - 635.100AMMONIATED

Cottonseed Meal - 670.500Medicated Feeds - 670.100

AMMONIUM CHLORIDEUrinary Preparations - 430.400

AMPROLIUMMedicated Feeds - 670.100

AMPLITUDE-MODULATED (PULSED)Temporal-Maximum Ultrasonic Power - 397.100

AMYGDALINArticles of Foreign Origin Not Intended for Entry - 110.700

ANALGESICSHuman Labeled Drugs for Animals - 608.100Urinary Preparations - 430.400

ANALYTICALAction Levels for Aflatoxin in Animal Feeds - 683.100Adulteration of Drugs under Sec. 501(b) and 501(c) - 420.100Aflatoxin in Peanuts and Peanut Products - 570.375Analytical Methodology Used by FDA - Drugs - 150.500Apple Butter - Adulteration with Mold; Rodent Filth, Insects - 550.100Apricots - Canned - Adulteration with Insects - 550.150Apricot, Peach and Pear Nectars and Purees - Mold - 550.155Black-Eyed Peas (Cow Peas, Field Peas); Dried - 585.225Brazil Nuts - Adulteration with Aflatoxin - 570.200Brussels Sprouts, Frozen - Adulteration by Insects - 585.275 Canned Green Beans & Canned Wax Beans - Standards - 585.475Cherries, Canned-Misbranding Involving Food Standards - 550.230 Chubs, Hot Process Smoked with Added Nitrite - 540.200Clams, Mussels, Oysters - Paralytic Shellfish Poison - 540.250Compendium Revisions and Deletions - 420.200Compressed Medical Gases -- Warning Letters - 435.100Corn, Sweet; Canned - Adulteration - 585.300Cowpeas (Black-Eyed Peas); Canned (Succulent Peas)-Insects - 585.400Decomp. & Histamine in Canned Albacore, Skipjack & Yellowfin Tuna - 540.525Dimethylnitrosamine in Malt Beverages - 510.600Direct Reference Authority for Pseudomonas Contamination - 590.300Diversion of Adulterated Food to Acceptable Animal Feed Use - 675.200Dried Prunes, Dehydrated Low Moisture Prunes, and Pitted Prunes - 550.700Drupelet Berries (Blackberries, Raspberries, etc.) - 550.200Eggs and Other Egg Products - Frozen - Decomposition - 537.100Figs; Fig Paste - Insect Infestation; Mold, Dirt - 550.350Fish-Fresh and Frozen, as Listed-Adulteration by Parasites - 540.590Fish, Shellfish, Crustaceans, etc. - Methyl Mercury - 540.600Fish-Fresh and Frozen-Adulteration Involving Decomposition - 540.575Foods, Except Dairy Products - Adulteration with Salmonella - 555.300Foods, Adulteration with Aflatoxin - 555.400Imported Frozen Products of Multiple Sizes - 560.700Lingon Berries, Canned - Adulteration by Insects - 550.500Milk and Milk Products Containing Penicillin - 527.450Oleomargarine - Misbranding Due to Low Fat - 535.100Olives - Adulteration Involving Pits; Rot; InsectInfestation - 550.600Pathogens in Dairy Products - 527.300Peaches, Canned-Misbranding Involving Food Standards - 550.655Peanut Butter - Adulteration with Filth; Grit - 570.300Peanuts, Shelled and Unshelled - Filth and Reject Nuts - 570.350Peas and Beans; Dried - Storage Insect Damage, Rocks - 585.575Pesticide Residues in Food and Feed - 575.100Pistachio Nuts - Aflatoxin Adulteration - 570.500Plastic Containers for Injectable Animal Drugs - 637.100Plums, Canned - Adulteration with Rot - 550.690Pottery (Ceramics) - Lead Contamination - 545.450Raisins-Adulteration involving Mold, Sand, Grit, & Insects - 550.750Repacking of Drug Products -- CGMP's - 430.200RIA Analysis of Hair to Detect the Presence of Drugs Abuse - 370.200Salmonella Contamination of Dry Dog Food - 690.700Shrimp-Fresh/Frozen Raw Headless, Peeled or Breaded - 540.400Shrimp - Frozen, Raw, Breaded or Lightly Breaded - 540.410Spinach, Canned or Frozen - Insects, Decomposition - 585.775Standardized Canned Fruit - Packing Medium - 550.800 Strawberries; Frozen, Whole, or Sliced - Sand, Mold - 550.850Tomato Products - Drosophila Fly Eggs and Maggots - 585.890Tomato Products - Adulteration with Mold - 585.900


398398

Tomatoes-Canned-Misbranding Involving Food Standards (Peel) - 585.875Tree Nuts - Adulteration Involving Rejects - 570.425Tuna, Sable, Salmon, Shad-Smoked, Cured-Sodium Nitrite - 540.500Unsafe Contamination of Animal Feed from Drug Carry-Over - 680.500Vitamin B-15, Pangamic Acid and Pangamic Acid Products - 457.100Whole Milk, Low Fat Milk, Skim Milk - Aflatoxin M1 - 527.400

ANEROIDSphygmomanometers - Accuracy - 310.210

ANESTHETICSHuman-Labeled Drugs for Pet Medicine - 608.100

ANETHOLESpices Definitions - 525.750

ANIMAL FEEDAmmoniated Cottonseed Meal - 670.500Common Names for Animal Feed - 665.100Direct-Fed Microbial Products - 689.100Diversion/Food to Pet Feed Use - 675.200Diversion of Food for Pets - 675.100Ethylenediamine Dihydroiodide - 651.100Imported Milk and Cream - 560.400Medicated Feeds Information - 670.100Moisture Damaged Grain - 675.300Pesticide Residues in Food - 575.100Radionuclides in Foods - 560.750Reconditioning Foods for Pets - 555.650Recycled Animal Waste - 685.100Rendered Pet Feed Ingredients - 675.400Sequencing in Production - 680.600Tracers in Animal Feed - 680.100Unsafe Contamination from Drug - 680.500Use of Drug-Contaminated Products - 682.100Use of Antibiotic Drug - 682.200Use of Type A Medicated Article Brand Names - 665.300Vitamins and Minerals in Feed - 670.200

ANIMAL DRUGS - SEE ATTACHED LISTAdequate Directions for Use - Veterinary Devices - 655.200Adequate Directions for Use - Animal Drugs and Devices - 607.100Animal Drugs for Euthanasia - 650.100Availability of Bulk Chemicals for Animal Drug Use - 625.200Biological Drugs for Animal Use - 645.100Certification for Exports - 110.100Chloramphenicol - 654.300 Direct-Fed Microbial Products - 689.100Drugs for Odor Control in Animals - 642.100Ethylenediamine Dihydroiodide (EDDI) - 651.100Extra-Label Use of New Animal Drugs in Food-Producing Animals - 615.100Human-Labeled Drugs Distributed & Used in Animal Medicine - 608.100 Imported Products - Labeling - 110.900Large Volume Parenteral (LVP's) for Animal Use - 635.100Medicated Feeds -- Formula Information - 670.100Nutritional Supplements for Companion Animals - 690.100Oral Iron Products for Baby Pigs - 643.100Over-The-Counter Sale of Injectable Animal Drugs - 608.200Plastic Containers for Injectable Animal Drugs - 637.100Proper Drug Use and Residue Avoidance - 615.200Reconditioning of New Animal Drugs Seized Under Sec. 501(a)(5) - 625.400Reconditioning of Articles Found in Violation of GMP's - 160.750Sequencing in Medicated Feed Production - 680.600 Teat Dips and Udder Washes for Dairy Cows and Goats - 654.200Unapproved New Animal Drugs - Follow-up Action - 625.300

ANIMAL MEDICINEBulk Chemicals - 625.200Human-Labeled Drugs Distributed and Used in Animal Medicine - 608.100

ANISESpices Definitions - 525.750

ANTI-INFLAMMATORYHuman-Labeled Drugs for Animals - 608.100

ANNUAL REPORTSElectronic Products Subject to 21 CFR 1001.15(a) - 390.400

ANTHRAXCommunicable Disease Hazards - 100.300Standards & Minimum Requirements for Biologic Products - 205.100

ANTHRAX VACCINE ADSORBEDStandards and Minimum Requirements for Biologic Products - 205.100

ANTI-RABIES SERUMStandards & Minimum Requirements for Biologic Products - 205.100

ANTIBIOTIC CERTIFICATIONHospital Pharmacies -460.100

ANTIBIOTIC DRUGChloramphenicol - 654.300Export of Uncertified Antibiotics - 405.200Use Antibiotic Drug Residues By Products in Animal Feed - 2.200

ANTIBIOTICSAnalytical Methodology Used by FDA - Drugs - 150.500Drugs for Odor Control in Animals - 642.100Expiration Dating of Unit Dose Repackaged Drugs - 480.200

Export of Uncertified Antibiotics - 405.200Marketed New Drugs w/o Approved NDAs or ANDAs - 440.100Prescriptions Prepared from Certified Antibiotics - 405.100Regulatory Action Regarding ANDAs - 446.100Returned Antibiotics Exported Under 801 (d) of The Act - 405.210Unit Dose Labels for Solid & Liquid Oral Dose Form - 430.100Use of Antibiotic Drug Residue - 682.200

ANTIBODYRegistration of Blood Banks & Other Firms - 230.110Standards & Minimum Requirements for Biologic Products - 205.100

ANTICOAGULANTSource Plasma - Overbleeding - 252.100

ANTIGENImmune Milk - 275.100Source Plasma Guidelines Informed Consent Form - 250.100Standards & Minimum Requirements for Biologic Products - 205.100

ANTIPASTOCommon or Usual Name - 567.100Foreign Language Declarations - 562.400

ANTIVENINStandards & Minimum Requirements for Biologic Products - 205.100

AOACApricot, Peach & Pear Nectars & Purees - Mold - 550.155Capsicum Products, etc. - Adulteration - 525.200Figs; Fig Paste - Insect Infestation; Mold, Dirt - 550.350Raw Breaded Shrimp - Microbiological - 540.420Whole Milk, Low Fat Milk, Skim Milk - Aflatoxin M1 - 527.400

APHIDHops - Adulteration - 525.425

APLASTIC ANEMIAChloramphenicol - 654.300

APPEARANCECherries - Canned - Misbranding Involving Food Standard - 550.500Cytotoxic Testing for Allergic Diseases - 370.100Health Fraud - 120.500Imports - Identity of Ingredients - 560.250Jellies - Nonstandardized - 550.475Oriental Noddles - 505.400Payment of Expert Witnesses - 160.600Snapper - Labeling - 540.475Spices - Definitions - 525.750Squash Seeds - Labeling as Pumpkin Seeds - 585.800

APPLE BUTTERAdulteration with Mold; Filth - 550.100

APPLE VINEGARVinegar Definitions - Adulteration with Vinegar Eels - 525.825

APPLESAUCESilver-Plated Hollowware - 545.500

APPLICATION TO RELABEL OR PERFORMReturned Antibiotics Exported Under 801(d) of the Act - 405.210

APRICOTContamination with Mold - 550.155Apricots - Canned - Adulteration with Insects - 550.150

ARIZONATurtles - 170.100

ARTICHOKECommon or Usual Name - 585.100

ARTIFICIAL TEETHDentures - Sale by Persons Not Licensed - 315.100

ASEPTIC PROCESSINGProcess Validation Requirements for Drug Products - 490.100

ASIAGOCheese Moisture and Fat - 527.225

ASPARAGUSCanned or Frozen Adultration With Filth - 585.150

ASPERGILLUSMoisture Damaged Grain - 675.300

AQUEOUS SOLUTIONSLVP's for Animals - 635.100

ASSEMBLAGE OF COMPONENTSCertification and Identification of X-Ray Components - 398.600

ASSEMBLER CERTIFICATIONRegistration of Assemblers of Diagnostic X-Ray Systems - 398.300

ASSEMBLERS OF X-RAY EQUIPMENTAssemblers Who Install Noncompliant Equipment - 398.325Assessment of Civil Penalties - 390.300Certification & Identification of X-ray Components - 398.600

Obligations of Factory-Based Manufacturers & Assemblers - 398.375Reconditioners/Rebuilders of Medical Devices - 300.200Registration of Assemblers of Diagnostic X-ray Systems - 398.300Regulatory Actions Against Assemblers of X-ray Equip.- 398.350Reloaders of X-Ray Tube Housing Assemblies - 398.700

ASSEMBLERSAssemblers Who Install Noncompliant Equipment - 398.325Assessment of Civil Penalties - 390.300Certification and Identification of X-Ray Components - 398.600


399399

Laser Light Shows, etc. - 393.100Obligations of Factory-Based Manufacturers and Assemblers - 398.375Reconditioners/Rebuilders of Medical Devices - 300.200Registration of Assemblers of Diagnostic X-Ray Systems - 398.300

Regulatory Actions Against Assemblers of X-ray Equipment - 398.350Reloaders of X-Ray Tube Housing Assemblies - 398.700

ASSEMBLYAssemblers Who Install Noncompliant Equipment - 398.325Certification and Identification of X-Ray Components - 398.600Definition of "Commerce" - 21 CFR 1000.3(g) - 390.100Definition of "High-Voltage Vacuum Switch - 390.500 Laser Light Shows, etc. - 393.100Obligations of Factory-Based Manufacturers and Assemblers - 398.375Registration of Assemblers of Diagnostic X-Ray Systems - 398.300 Regulatory Actions Against Assemblers of X-Ray Equipment - 398.350Reloaders of X-Ray Tube Housing Assemblies - 398.700

ASSESSMENTAssemblers Who Install Noncompliant Equipment - 398.325Assessment of Civil Penalties - 390.300Consistent Application of CGMP Determinations - 400.200Diversion of Adulterated Food to Acceptable Animal Feed Use - 675.200Fraud, Untrue Statements of Material Facts, Bribery - 120.100GWQAP Pre-Award Evaluation - 100.700Pesticide Residues in Food and Feed - 575.100Reloaders of X-Ray Tube Housing Assemblies - 398.700

ASSOCIATION OF OFFICIAL ANALYTICAL CHEMISTSAction Levels for Aflatoxin in Animal Feeds - 683.100Aflatoxin in peanuts and peanut products - 570.375Brazil nuts - Adulteration with Aflatoxin - 570.200Clams, Mussels, Oysters - Paralytic Shellfish Poison - 540.250Decomp. & Histamine in Albacore, Skipjack & Yellowfin Tuna - 540.525Fish, Shellfish, Crustaceans, etc. - Methyl Mercury - 540.600Foods, Adulteration with Aflatoxin - 555.400Pesticide Residues in Food and Feed - 575.100Pistachio Nuts - Aflatoxin Adulteration - 570.500Pottery (Ceramics) - Lead Contamination - 545.450Shrimp - Fresh or Frozen Raw Headless, Peeled or Breaded- 540.400

ASSURANCEAccess to Results of Quality Assurance Audits - 130.300Compendial Requirements - 420.400Computerized Drug Processing -- I.D. of "Persons" - 425.500Consistent Application of CGMP Determinations - 400.200Direct Reference Authority for Class III Medical Devices - 300.700Diversion of Adulterated Food to Acceptable Animal Feed Use - 675.200Expiration Dating and Stability Testing - 480.100Expiration Dating of Unit Dose Repackaged Drugs - 480.200Fraud, Untrue Statements of Material Facts, Bribery - 120.100GWQAP Pre-Award Evaluation - 100.700Lack of Expiration Date or Stability Data - 480.300Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200Medicated Feeds -- Combined Batches - 680.400Process Validation Requirements for Drug Products - 490.100Regulatory Action Regarding Approved New Drugs - 446.100Regulatory Actions and Small Business - 160.100Return of Unused Rx Drugs to Pharmacy Stock - 460.300 Tracers in Animal Feed - 680.100

ATROPHY THERAPYElectrical Muscle Stimulators - 355.200

ATTEMPTED REPAIRSObligations of Factory-based Manufacturers & Assemblers - 398.375

AURICULAR STIMULATION THERAPYLasers for Facelift, Wrinkle Removal, Acupuncture, etc - 393.200

AUTOCLAVINGValidation Requirements for Drugs - 490.100

AUTOIMMUNEBlood & Blood Products - Definitions - 230.100

AUTOLOGOUS COLLECTIONSRegistration of Blood Banks & Other Firms - 230.110

AUTOSOMAL RECESSIVE TRAITFructose-Containing Drugs - 400.335

BACTERIALImmune Milk - 275.100Imported Milk and Cream - 560.400Plastic Containers for Injectable Animal Drugs - 637.100Standards for Biologic Products - 205.100

BACTERIAL VACCINESStandards & Minimum Requirements for Biologic Products - 205.100

BAKERY PRODUCTSBakery products, Candy "Shotgun" Ingredients Declaration - 505.100Honey Bread, Honey Buns - 505.350

BARBECUE SEASONINGLabeling of Seasonings - 525.650

BARE QUARTZSunlamp Performance Standard - 396.100

BARLEY MALTDimethylnitrosamine (DMNA) in Barley Malt - 578.500

Malted Milk - 527.500Vinegar, Definitions; Adulteration - 525.825

BARRIERAssemblers Who Install Noncompliant Equipment - 398.325Surgeons' Gloves & Patient Examination Gloves - 335.700Tamper-Resistant Packaging Requirements - 450.500

BARYTESConfectionery - 515.100

BAY LEAVESFilth, Mold - 525.150Leafy Spices - 525.500Spices - Definitions - 525.750

BAY OF FUNDYClams, Mussels, Oysters - Paralytic Shellfish Poison - 540.250

BCG VACCINEStandards & Minimum Requirements for Biologic Products - 205.100

BEAM LIMITING DEVICEAutomatic Adjustment of the X-ray Field Size - 398.400

BEANSBean Products - Labeling - 567.200Canned Green and Wax Beans - 585.475Cocoa Beans- Mold, Filth - 515.750Coffee and Coca Bean Sweeps - 560.350Green Coffee Beans - Adulteration - 510.500Labeling "Chocolate Flavored" - 515.800Pesticide Residues in Food - 575.100Proper Drug Use and Residue - 615.200Reconditioning of Coffee - 560.300Seeds for Sprouting - 550.750

BEEFAflatoxin in Animal Feeds - 683.100Ethylenediamine Dihydroiodide - 651.100

BEEF AND GRAVY WITH RICEFDA Meat & Poultry Products - 565.100

BEEF STEWFDA Meat & Poultry Products - 565.100

BEETS, CANNEDBeets, Canned - Adulteration with Rot - 585.200

BEHAVIOR MODIFICATIONHypnotherapy Devices-Self-Hypnotic Tape Recordings - 335.300

BENTONITEMedicated Feeds - 670.100

BENZYL ALCOHOLLVP's for Animals - 635.100

BENZOCAINEOTC Anti-Obesity Preparations - 456.100

BERRIESCloudberries, Canned Filth Adulteration - 550.590Drupelet Berries - 550.200Lingon Berries, Canned Filth - 550.500Pesticide Residues - 575.100Spices - Definitions - 525.750Strawberries; Sand, Mold - 550.850Whole and Ground Allspice - Mold Filth - 525.100

BEVERAGEBeverage Bases - 510.100Dealcoholized Wine, Malt Beverages - 510.400Malted Milk - 527.500Use of Synthetic Alcohol - 555.100Vending Machine Food - Labeling - 562.800

BIENNIAL INSPECTIONContract Sterilizers - 100.550Reconditioners/Rebuilders of Medical Devices - 300.200Reloaders of X-ray Tube Housing Assemblies - 398.700

BIO-PROBLEM DRUGSMarketed New Drugs without NDAs or ANDAs Approval - 440.100

BIO-RELATED DRUGSMarketed New Drugs Wthout Approved NDAs or ANDAs - 440.100

BIOEQUIVALENCEFraud, Untrue Statements of Material Facts, Bribery - 120.100Marketed New Drugs without Approved NDAs or ANDAs - 440.100

BIOLOGICAL INDICATORSParametric Release of Terminally Heat-Sterilized Drugs - 460.800

BIOLOGICS48-hour Period Between Plasmapheresis Procedures - 256.100Allergenic Extracts Containing Glycerin - 270.100Biological Drugs for Animal Use - 645.100Blood and Blood Products - Definitions - 230.100 Certification for Exports - 110.100Communicable Disease Hazards - 100.300Contract Sterilizers - 100.550Human Blood and Blood Products as Drugs - 230.120Immune Milk - 275.100Importation of Licensed Biologic Products for Human Use - 210.150IND Filings - 215.100Licensing - Changes to be Reported - 210.100


400400

Medical Emergencies - 220.100Plasma Brokers - Registration and Compliance - 250.500 Plastic Containers for Injectable Animal Drugs - 637.100Platelets, Pooled - 231.110Quality Control Testing - 231.110QuantitativeTesting for Serum Proteins in Plasmapheresis Donors - 255.100Registration of Blood Banks and Other Firms - 230.110Source Plasma - Syphilis - 254.100Source Plasma - Overbleeding - 252.100Standards and Minimum Requirements for Biologic Products - 205.100Storage of Platelets - 231.130Time Period for Separation of Platelets - 231.120Use of Units Which Have Been Thawed - 253.100

BIOSTIMULATIONLasers for Facelift, Wrinkle Removal, Acupuncture etc - 393.200

BIPIN FLUORESCENTSunlamp Performance Standard - 396.100

BIRD, BIRD CONTAMINATION, BIRD EXCRETAFood Storage & Warehousing - 580.100

BIRTH CONTROLHypnotherapy Devices-Self-Hypnotic Tape Recordings - 335.300

BITTER ALMONDSMaraschino Cherries - 550.550

BIVALVEClams, Mussels & Oysters - 540.250

BLACK CURRANTGrenadine - 550.400Jam, Black Currant - Adulteration - 550.450Jellies, Nonstandardized - 550.475

BLACK-EYED PEASCow Peas, Field Peas); Dried - 585.225

BLACKBERRIESDrupelet Berries - 550.200

BLADDERDefinition of General Purpose Radiographic X-Ray System- 398.100

BLEMISHCanned Green and Wax Beans - 585.475Cherries, Canned Misbranding - 550.230Pineapple, Canned; Food - 550.685

BLISTERTamper-Resistant Packaging Requirements - 450.500

BLOODBlood and Blood Products - Definitions - 230.100Electrical Muscle Stimulators - 355.200Human Blood and Blood Products as Drugs - 230.120Hypnotherapy Devices - Self Hypnotic Tape Recordings - 335.300IND Filings - 215.100Oral Iron Products for Baby Pigs - 643.100Plasma Brokers - Registration and Compliance - 250.500 Platelets, Pooled - 231.100Processed and/or Blended Seafood Products - 540.700Quality Control Testing - 231.110Registration of Blood Banks and Other Firms - 230.110Source Plasma - Overbleeding - 252.100Source Plasma - Guidelines for Informed Consent Forms - 250.100Sphygmomanometers - Rx Legend - 310.200Sphygmomanometers - Accuracy - 310.210Standards and Minimum Requirements for Biologic Products - 205.100Storage of Platelets - 231.130Surgeons' Gloves and Patient Examination Gloves - 335.700Time Period for Separation of Platelets - 231.120Use of Units Which Have Been Thawed - 253.100

BLOOD BANKSPlasma Brokers - Registration & Compliance - 255.500Platelets, Pooled - 231.100Registration of Blood Banks & Other Firms - 230.110Storage of Platelets - 231.130Time Period for Separation of Platelets - 231.120Use of Units Which Have Been Thawed - 253.100

BLOOD CELLSRegistration of Blood Banks & Other Firms - 230.110Source Plasma-Guidelines for Informed Consent Form - 250.100Standards & Minimum Requirements for Biologic Products - 205.100

BLOOD GROUPING SUBSTANCESStandards & Min.Requirements - Biologic Products - 205.100

BLOOD PRESSUREHypnotherapy Devices-Self-Hypnotic Tape Recordings - 335.300Source Plasma - Overbleeding - 252.100Sphygmomanometers - Accuracy - 310.210Sphygmomanometers - Rx Legend - 310.200

BLOOD PRODUCTSBlood & Blood Products - 230.100Human Blood & Blood Products as Drugs - 230.120Plasma Brokers - Registration & Compliance - 250.500Registration of Blood Banks & Other Firms - 230.110

BLUE FIN

Fish Fresh and Frozen - 540.590BLUE CRAB

Crabmeat - 540.300BODY FLUIDS

Pacemaker Reuse - 310.100BODY SHAPING AND CONTOURING

Electrical Muscle Stimulators - 355.200BODY SLIMMING AND TRIMMING

Electrical Muscle Stimulators - 355.200BOND

Export From U.S. Foreign Trade Zones - 110.200Foreign Trade Zones, Bonded Warehouses or Carriers - 110.600Importation of TV Receivers & Microwave Ovens - 394.500Imports - Post Detention Sampling - 110.800Tamper-Resistant Packaging Requirements - 450.500

BONDEDDiversion of Adulterated Food to Acceptable Animal Feed Use - 675.200Foreign Trade Zones, Bonded Warehouses or Carriers - 110.600Olives Stuffed w/Minced Pimentos - Labeling - 550.605

BOOKSHollandaise Sauce - Common or Usual Name - 525.400Seizure of Books That Constitute Misleading Labeling - 140.100

BOTTLE CONTAINER CAPSTamper-Resistant Packaging Requirements - 450.500

BOUILLON Bouillon Cubes, Granulated Bouillon - 567.300

BOYSENBERRIESDrupelet, Raspberries - 550.200

BRAINInert Glandular Preparations - OTC - 455.100

BRAND NAMESUse of Type A Medicated Article Brand Names in Feed Labels - 665.300Identical or Similar Product Names - 400.500

BRANDYContaining Methyl Alcohol - 510.200

BRASSICA HIRTA, B. NIGRA, B. JUNCEAPrepared Mustard, Composition - 525.575Spices - Definitions - 525.750

BRAZIL NUTSAdulteration with Aflatoxin - 570.200

BREADEDImitation Breaded Shrimp - 540.450Processed, Blended Seafood Products - 540.700Raw Breaded Shrimp - Microbiological - 540.420Shrimp Frozen, Raw, Breaded - 540.410

BRIBERYFraud, Untrue Statements of Material Facts, Bribery - 120.100

BRICKCheese Moisture and Fat - 527.225

BRINE Salted Dried, Uneviscerated Fish - 540.650

BRIXCanned Fruit Packing Medium - 550.800Pineapple, Canned; Food Standards - 550.685Sweet Potatoes - Sirup Pack - 585.850

BROCCOLIAdulteration with Insect - 585.260

BROCHUREAdditives-Labeling/Adequate Directions for Many Uses - 500.100Mercury Vapor Lamps That Aren't Self-Extinguishing - 391.200

BROKENCanned Green & Wax Beans - Standards - 585.475Coffee & Cocoa Bean Sweeps - 560.350Contamination of Devices Labeled as Sterile - 300.400Denture Cleaners & Repair Materials - 315.2300Mercury Vapor Lamps-Not Self-Extinguishing - 391.200Olives-Adulteration Involving Insect Infestation - 550.600Retention of Microwave Oven Test Records - 394.100Spices - Definitions - 525.750Tamper-Resistant Packaging Requirements - 450.500

BRUSSELS SPROUTSAdulteration w/Insects - 585.275Pesticide Residues - 575.100

BUBBLE PACKSTamper-Resistant Packaging Requirements - 450.500

BUCKLINGKipper and Kipper Unsplit - 540.550

BULK BUTTERButter Involving Low Fat - 527.100

BULK DRUGAvailability of Bulk Chemical for Animal Drug Use - 625.200Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200Extra Label Use-New Drugs in Food-Producing Animals - 615.100

BULK OXYGENCompressed Medical Gases- Warning Letters - 435.100

BULK PHARMACEUTICAL CHEMICALS (BPC)


401401

Process Validation Requirements for Drug Products - 450.500BURDEN OF PROOF

Determination by Secretary that Product Fails to Comply - 390.200Unsafe Contamination of Animal Feed from Drug Carry-Over - 680.500

BURGUNDYDealcoholized Wine & Malt Beverages-Labeling - 510.400

BUSINESSCollection and Charitable Distribution of Drugs - 400.800Common Carrier as a Relabeler, Repacker, Reprocessor, etc. - 100.500Definition of "Commerce" - 21 CFR 1000.3(g) - 390.100Guaranties Over Printed Signatures - 100.800Homeopathic Drugs - 400.400Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200Menstrual Sponges - 345.300Reconditioners/Rebuilders of Medical Devices - 300.200Refusal to Permit Inspection. - 130.100Regulatory Actions and Small Business - 160.100Turtles - 170.100Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100

BUST DEVELOPMENTElectrical Muscle Stimulators - 355.200

BUTTERApple Butter - with Mold; Rodent Filth - 550.100Butter-Nut Bread - 505.300Butter Featured in Product Name - 505.200Butter Involving Low Fat - 527.100Declaration of Artificial Color - 587.100Hollandaise Sauce Common or Usual - 525.400Jams, Jellies and Related Products - 560.500Peanut Butter Filth; Grit - 570.300Peas and Carrots, Labeling of Mixture - 585.600

BUTTER COOKIESButter Featured in Product Name - 505.200

BUTTER SHORTBREADButter Featured in Product Name - 505.200

BUTTER-NUT BREAD Butter-Nut Bread - 505.300

BUTTONAutomatic Adjustment of X-Ray Field Size - 398.400

BUTYLATED HYDROXYANIXOLELabeling of Seasonings - 525.650

BY-PRODUCTSAflatoxin in Pet Feeds - 683.100Antibiotic Drug Residue in Pet Feed - 682.200Milk, Aflatoxin - 527.400

C. BOTULINUMSalted, Dried Uneviscerated Fish - 540.650

CACAO BEANSChocolate or Chocolate Flavored - 515.800

CACHEXIAFructose-Containing Drugs - 400.335

CADMIUMPottery (Ceramics) - 545.400

CAKE DECORATIONSConfectionery Decorations - 545.200

CALCIUM GLUCONATEVitamin B-15, Pangamic Acid - 457.100

CALCIUM PANGAMATEVitamin B-15, Pangamic Acid & Products - 457.100

CALCIUM SOLUTIONSLVP for Animal Use - 635.100

CALCULATED VALUETemporal-Maximum Ultrasonic Power - 397.100

CALF MUSCLESElectrical Muscle Stimulators - 355.200

CALIFORNIA CHAMPAGNEUnfermented Beverages - 510.300

CALLINECTES SAPIDUSCrabmeat - Product Name - 540.300

CAMPYLOBACTER JEJUNIPathogens in Dairy Products - 527.300

CAMPYLOBACTER COLIPathogens in Dairy Products - 527.300

CANADAAflatoxin in Peanuts - 570.375

CANDIED CITRONCandied Citron - Labeling - 515.600

CANDLEHOLDERSConfectionery Decorations - 545.200

CANDYBarley Sugar and Barley Sugar Candy - 515.500Candy Pills - 400.325Confectionery - 515.100Jordan Almonds - Common or Usual Name - 570.100Labeling "Chocolate Flavored - 515.800Mixed with Trinkets, in Machines - 515.350

Shotgun Ingredients Declaration - 505.100CANDY PILLS

Candy "Pills" - 400.325CANE SUGAR

Labeling of Seasonings - 525.700CANNED

Acidified Low-Acid Canned Foods - High pH - 520.300Apple Butter - Adulteration with Mold; Rodent Filth, Insects - 550.100Apricots - Canned - Adulteration with Insects - 550.150Artichoke; Jerusalem Artichoke - Common or Usual Name - 585.100Asparagus, Canned or Frozen - Adulteration with Insect Filth - 585.150Beets, Canned - Adulteration with Rot - 585.200Canned Peas - Label Designation of Sizes - 585.625Canned Green Beans and Canned Wax Beans-Standards - 585.475 Canned Pimentos & Red Sweet Peppers-Seeds Should be Removed - 585.650Canned Foods - Seam Defects - 520.200Canned Salmon - Adulteration Involving Decomposition - 540.375Canned Foods, Use of the Term "Solid Pack" - 520.100Canned Pet Food - 690.300Canned Shrimp: Size Designations and Corresponding Counts - 540.390Cherries - 550.225Cherries, Canned - Misbranding Involving Food Standards - 550.230Citrus Fruit Juices, Canned - Fly Filth and Mold - 550.250Cloudberries (Multer Berries), Canned - Adulteration - 550.590Corn, Sweet; Canned - Adulteration - 585.300Corn on the Cob, Canned - Quantity of Contents Declaration - 585.325Cowpeas (Black-Eyed Peas); Canned (Succulent Peas) - Insects - 585.400Decomposition & Histamine in Albacore, Skipjack & Yellowfin Tuna - 540.525Drupelet Berries (Blackberries, Raspberries, etc.) - 550.200Greens, Canned - Adulteration by Mildew - 585.450Identity of Foods--Terms such as Fresh, Frozen, Dried, Canned - 562.450Imported Low-Acid Canned Foods - 560.450Lingon Berries, Canned - Adulteration by Insects - 550.500Maraschino Cherries - 550.550Mushrooms, Canned or Dried (Freeze-Dried or Dehydrated) - 585.500Peaches, Canned, Frozen-Adulteration Due to Insects and Mold - 550.650Peaches, Canned - Misbranding Involving Food Standards - 550.655 Peas and

Carrots, Labeling of Canned Mixture - 585.600Pineapple, Canned; Imported and Domestic - Food Standards - 550.685Pineapple, Canned; Pineapple Juice - Adulteration with Mold - 550.680Plums, Canned - Adulteration with Rot - 550.690Pork and Beans and Similar Bean Products--Labeling - 567.200Processing - Use of Term in Section 405 of the FD&C Act - 562.650Pumpkin - Articles Made from Certain Varieties of Squash - 585.725Spinach, Canned or Frozen - Insects, Decomposition - 585.775Squash Seeds - Labeling as Pumpkin Seeds - 585.800Standardized Canned Fruit - Packing Medium - 550.800Sweet Potatoes - Sirup Pack - 585.850Tomato Products - Drosophila Fly Eggs and Maggots - 585.890Tomato Products - Adulteration with Mold - 585.900Tomatoes-Canned-Misbranding Involving Food Standards (Peel) - 585.875Water in Food Products (Ingredient or Adulterant) - 555.875

CANSCanned Foods - Seam Defects - 520.200Canned Salmon - Adulteration Involving Decomposition - 540.375Cheese and Cheese Products - Adulteration with Filth - 527.200Cherries, Canned - Misbranding Involving Food Standards - 550.230Corn, Sweet; Canned - Adulteration - 585.300Decomp. & Histamine in Albacore, Skipjack & Yellowfin Tuna - 540.525Eggs and Other Egg Products - Frozen - Decomposition - 537.100Identity of Foods--Terms such as Fresh, Frozen, Dried, Canned - 562.450Imported Milk and Cream. Import Milk Act - 560.400Peaches, Canned, Frozen -- Adulteration Due to Insects and Mold - 550.650Peaches, Canned - Misbranding Involving Food Standards - 550.655 Pineapple,Canned; Imported and Domestic - Food Standards - 550.685Proper Drug Use and Residue Avoidance - 615.200Tamper-Resistant Packaging Requirements - 450.500Tomatoes - Canned - Misbranding Involving Food Standards (Peel) - 585.875

CAPELINProhibited From Being Labeled as Smelt - 540.100

CAPSTamper-Resistant Packaging Requirements - 450.500

CAPSICUMCapsicum Pods, etc. - Adulteration - 525.200Spices - Definitions - 525.750Unfermented Beverages, "Champagne" - 510.300

CAPSULEContent Uniformity Testing of Tabs & Capsules - 460.600Controlled-Release Dosage Form Drugs - 430.100Nutritional Supplements for Companion Animals - 690.100Tamper-Resistant Packaging Requirements - 450.500Unit Dose Labeling for Solid & Liquid Oral Dosage Forms - 430.100

CAPTURED KEY SWITCHESOverride of Positive Beam Limitation - 398.425

CARAWAY SEEDSpices - Definitions - 525.750


402402

CARBADOXAnimal Feeds - 680.500

CARCINOGENICCGMP'S for Medicated Feeds - 680.200Contamination of Animal Feed - 680.500Moisture Damaged Grain - 675.300

CARDAMOMSpices - Definitions - 525.750

CARDIAC PACERSPacemaker Reuse - 310.100

CARDIOVASCULAR DEVICESSphygmomanometers - Accuracy - 310.210

CARRIERCommon Carrier as Relabeler,Repacker,Reprocess,etc - 100.500Direct-Fed Microbial Products - 689.100Foods; Railcar Sanitation - Adulteration - 545.300Foreign Trade Zones, Bonded Warehouses or Carriers - 110.600Parametric Release of Terminally Heat Sterilized Drugs - 460.800

CARTONSFDA Jurisdiction over Meat & Poultry Products - 565.100Labeling-Food Bearing Residues of Pesticides Chemicals - 562.700Shrimp-Fresh/Frozen Raw Headless, Peeled,or Breaded - 540.400Water-Damaged Food Products - 555.850

CASHEWSCashews, Insect Infested - Reconditioning - 570.250Tree Nuts - Adulteration Involving Rejects - 570.425

CASSETTE HOLDERDefinition of General Purpose Radiographic X-Ray System - 398.100

CASSETTE TRAY OR BUCKYDefinition of General Purpose Radiographic X-Ray System - 398.100

CASSETTE TUNNELDefinition of General Purpose Radiographic X-Ray System - 398.100

CASSIASpices - Definitions - 525.750Whole Cassia or Whole & Ground Cinnamon - 525.225

CATALOGCertification & Identification of X-Ray Components - 398.600Mercury Vapor Lamps -Not Self-Extinguishing - 391.200

CATALOG NUMBERSCertification & Identification of -X-Ray Components - 398.600

CATEGORIESClass III Devices Subject to 5l5(b) Requirements - 300.750Control/Accountability of TRP Materials - 450.550Foods, Except Dairy Products - Adulteration with Salmonella - 555.300Marketed New Drugs Without Approved NDAs or ANDAs - 440.100OTC Drugs - Combination Products - 450.300Pottery (Ceramics) - Cadmium Contamination - 545.400Radionuclides in Imported Foods - Levels of Concern - 560.750Retention of Microwave Oven Test Records - 394.100Silage Ingredients - 687.500

"CATCH ALL" OR "SHOTGUN" INGREDIENTSBakery Products, Candy "Shotgun" Ingredients Declaration - 505.100

CATHETERSReuse of Medical Disposable Devices - 300.500

CAUTIONARY INFORMATIONNADA Labeling - 605.100

CAVIARUse of Term - Labeling - 540.150

CAYENNE PEPPERTomato Sauce or Tomato Hot Sauce Labeling - 525.800

CELERY SEEDSpices - Definitions - 525.750

CELLULITE REMOVALElectrical Muscle Stimulators - 355.200

CELLULITISCellutron Machine - 355.100

CELLUTRON MACHINECellutron Machine - 355.100

CEPHALOMETRIC X-RAY SYSTEMDefinition of General Purpose Radiographic X-ray System - 398.100

CERAMICSPottery (Ceramics) - Cadmium Contamination - 545.400Pottery (Ceramics) - Lead Contamination - 545.450

CERTIFICATIONAccess to Results of Quality Assurance Audits - 130.300Assessment of Civil Penalties - 390.300Certification for Exports - 110.100Certification and Identification of X-Ray Components - 398.600Color Additives in Paper and Paperboard for Use with Food - 500.425Definition of "Commerce" - 21 CFR 1000.3(g) - 390.100 Hospital Pharmacies - 460.100Importation of Television Receivers and Microwave Ovens - 394.500Prescriptions Prepared from Certified Antibiotics - 405.100Registration of Blood Banks and Other Firms - 230.110Registration of Assemblers of Diagnostic X-Ray Systems - 398.300Returned Antibiotics Exported Under 801(d) of the Act - 405.210

Uncertified or Delisted Colors - 587.200CERTIFICATE

Aflatoxin in Peanuts & Peanut Products - 570.375Compressed Medical Gases -Warning Letters - 435.100

CERTIFICATE OF ANALYSIS (COA)Compressed Medical Gases -Warning Letters - 435.100

CERTIFIED ANTIBIOTICSPrescriptions from Certified Antibiotics - 405.100

CERTIFIED COLORLabeling of Seasonings - 525.650

CERVIMUNDA JOHNNames for Crustaceans - 540.350

CGMP REGULATIONSCGMP Applicability to Hardware and Software - 425.100 CGMP Enforcement Policy - OTC vs Rx Drugs - 450.100 CGMP's for Medicated Feeds - Daily Inventory Requirements - 680.200Color Additives in Paper and Paperboard for Use With Food - 500.425Compendial Requirements - 420.400Consistent Application of CGMP Determinations - 400.200Contract Sterilizers - 100.550Control/Accountability of TRP Materials - 450.550Expiration Dating of Unit Dose Repackaged Drugs - 480.200Finished Dosage Form Drugs in Bulk Containers - 410.100Hospital Pharmacies - 460.100Lack of Expiration Date or Stability Data - 480.300Process Validation Requirements for Drug Products - 490.100Repacking of Drug Products -- CGMP's - 430.200Returned Antibiotics Exported Under 801(d) of the Act - 405.210Sequencing in Medicated Feed Production - 680.600

CHAMPAGNEUnfermented Beverages - 510.300

CHARACTERISTICSBouillon, Bouillon Cubes, Granulated Bouillon - 567.300Adulteration of Drugs under Sec. 501(b) and 501(c) - 420.100Confectionery - Use of Nonnutritive Substances as Ingredients. - 515.100Jellies, Nonstandardized - 550.475Jordan Almonds - Common or Usual Name - 570.100Parametric Release of Terminally Heat Sterilized Drugs - 460.800Regulatory Action and Small Business - 160.100Reuse of Medical Disposable Devices - 300.500 Salmonella Contamination of Dry Dog Food - 690.700 Sequencing in Medicated Feed Production - 680.600 Spices - Definitions - 525.750 Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100 CHEATHealth Fraud - 120.500

CHEDDARCheese Moisture and Fat - 527.225Labeling of Seasonings - 525.650

CHEESECheese Moisture and Fat - 527.225Cheese and Cheese Products - 527.200Misbranding Involving Net Contents - 527.250Pathogens in Dairy Products - 527.300

CHEESE PRODUCTSCheese and Cheese Products - 527.200Misbranding Involving Net Contents - 527.250Pathogens in Dairy Products - 527.300

CHELATEDSupplements for Pets - 690.100

CHEMICAL PRESERVATIVES"Chocolate" or Chocolate Flavored" - 515.800Preservatives; Use in Foods; Label - 562.600

CHERRIESCherries Brined, Fresh, Canned and Frozen - 550.225Cherries, Canned-Misbranding - 550.230Maraschino Cherries - 550.550

CHERRY JAMAdulteration with Mold - 550.235

CHERVILSpices - Definitions - 525.750

CHEST OR SPINAL RADIOGRAPHYDefinition of General Purpose Radiographic X-RaySystem - 398.100

CHESTNUTSTree Nuts-Involving Rejects - 570.425

CHEWABLEUnit Dose Labeling for Solid & Liquid Oral Dose Forms - 430.100

CHINESE NOODLESChow Mein and Other Oriental Noodles - 505.400

CHIROPRACTORSLasers for Facelift, Wrinkle Removal, Acupuncture, etc. - 393.200

CHLORAMPHENICOLChloramphenicol - 654.300Extra-Label Use of Animal Drugs - 615.100

CHLORMADINONE ACETATEContamination of Pet Feed - 680.500


403403

CHLOROPHYIIOdor Control in Animals - 642.100

CHLORTETRACYCLINEOdor Control in Animals - 642.100

CHOCOLATEChocolate and Chocolate Liquor - 515.700Labeling - 515.800Malted Milk - 527.500

CHOCOLATE-FLAVOREDLabeling Chocolate Flavored - 515.800Malted Milk - 527.500

CHOCOLATE LIQUORChocolate and Chocolate Liquor - 515.700

CHOCOLATE MANUFACTURERS ASSOCIATIONLabeling: "Chocolate" or "Chocolate Flavored" - 515.800

CHOCOLATE PUDDINGLabeling: "Chocolate" or "Chocolate Flavored" - 515.800

CHOLERA VACCINEStandards & Minimum Requirements for Biologic Products - 205.100

CHROME YELLOWConfectionery - 515.100

CHRONIC EXPOSURELasers for Facelift, Wrinkle Removal, Acupuncture, etc. - 393.200

CHUBSAdulteration by Parasites - 540.590Hot Smoked with Nitrite - 540.200

CHURN MARKButter-Adulteration Involving Low Fat - 527.100

CIDERUnfermented Beverages - 510.300Vinegar, Adulteration with Vinegar Eels - 525.825Wines and Cider Less Than 7% Alcohol - 510.450

CIMETADINE HC1Unit Dose Labeling for Solid & Liquid Oral Dose Forms - 430.100

CINEOLESpices-Definitions - 525.750

CINNAMALDEHYDECinnamon-Flavored Toothpicks - 545.600Spices-Definitions - 525.750

CINNAMONCinnamon-Flavored Toothpicks - 545.600Spices-Definitions - 525.750Whole and Ground Cinnamon - 525.225

CINNAMON BARKWhole Cassia or Whole & Ground Cinnamon - 525.225

CISCOESFish-Fresh-Frozen - 540.590

CITRIC ACIDJellies, Nonstandardized - 550.475Labeling of Seasonings - 525.650

CITRUS FRUIT JUICESFly Filth and Mold - 550.250

CITRUS FRUIT MARMALADEMarmalade - 550.575

CITRUS MEDICA L., VARIETY GENUINACandied Citron - Labeling - 515.600

CITRUS MELONCandied Citron - Labeling - 515.600

CIVIL PENALTIESAssemblers Who Install Noncompliant Equipment - 398.325Assessment of Civil Penalties - 390.300Importation of TV Receivers & Microwave Ovens - 394.500

CLAIMSDealcoholized Wine and Malt Beverages - Labeling - 510.400 Fortification of Standardized Juices - 510.700

CLAMSParalytic Shellfish Poison - 540.250

CLARETDealcoholized Wine & Malt Beverages - 510.400

CLASS A NONCOMPLIANCE Hazardous Diagnostic X-Ray Systems - 398.200

CLASS I RECALLSClass I Recalls of Prescription Drugs - 400.900

CLASS IIICanned Salmon-Adulteration Involving Decomposition - 540.375Direct Reference Authority for Class III MedicalDevices - 300.700Lasers for Facelift, Wrinkle Removal, Acupuncture, etc. - 393.200Reconditioners/Rebuilders of Medical Devices - 300.200

CLEANERSDenture Cleaners, Adhesives, & Repair Materials - 315.200

CLEARANCEDevices for Use in Animals - 655.100Hospital Pharmacies - 460.100Importation of Licensed Biological Products for Human

Use - 210.150 Pottery (Ceramics) - Lead Contamination - 545.450Pottery (Ceramics) - Cadmium Contamination - 545.400Vitamin B-15, Pangamic Acid & Products - 457.100

CLENBUTEROLExtra-Label Use in Producing Animals - 615.100

CLINGSTONE PEACHESPeaches, Canned - 550.655

CLINICAL INVESTIGATORIND Filings - 215.100

CLINICAL LABORATORIESRegistration of Blood Banks & Other Firms - 230.110

CLINICAL STUDIESDirect Reference Authority for Class III Medical Devices - 300.700IND Filings - 215.100

CLINICAL THERMOMETERAdulteration; Misbranding Defects - 335.800

CLOUDBERRIESCloudberries Adulteration - 550.590

CLOVER HONEYSource Declaration - 515.300

CLOVESAdulteration with Stems - 525.250Spices - Definitions - 525.750

COCOA BEANSCoffee & Cocoa Bean Sweeps - 560.350Mold, Insect Infestation & Mammalian Excretion - 515.750Pesticide Residues in Food & Feed - 575.100

COCOA POWDERPress Cake - Insect & Rodent Filth - 515.775

CODCrab & Crabmeat Product.s w/Other Seafood Labeling - 540.285Pet Food Labeling - 690.200

COFFEE BEANSAdulteration with Insects; Mold - 510.500Coffee and Cocoa Bean Sweeps - 560.350Proper Drug Use and Residue Avoidance - 615.200Reconditioning of Imported Coffee Beans - 560.300

COLBYCheese - Misbranding Due to Moisture & Fat - 527.225

COLLIMATION PROBLEMS IN RADIOGRAPHICAssemblers Who Install Noncompliant Equipment - 398.325

COLLIMATOR LIGHT BULBSAssemblers Who Install Noncompliant Equipment - 398.325

COLOR ADDITIVESColor Additives - 587.300Confectionery - 515.100In Paper and Paperboard - 500.425Unapproved Additives for Exported Grains - 578.600

COLORANTSIn Paper and Paperboard - 500.425

COLORINGSBakery Products, Candy - 505.100Labeling Chocolate/Chocolate Flavored - 515.800

COLOSSALCanned Shrimp; Size Designation - 540.390

COMMERCECompressed Medical Gases -- Warning Letters - 435.100 Definition of "Commerce" - 21 CFR 1000.3(g) - 390.100 Dentures -- Sale by Persons not Licensed to Practice - 315.100 Products Composed of Interstate Ingredients - 100.200

COMMERCIALChloramphenicol - 654.300 Coffee and Cocoa Bean Sweeps - 560.350 Commercial Distribution -- Premarket Notification - 300.600 Compendial Requirements - 420.400Cytotoxic Testing for Allergic Diseases - 370.100 Definition of "Commerce" - 21 CFR 1000.3(g) - 390.100 Direct Reference Authority for Pseudomonas Contamination - 590.300 Direct Reference Authority for Class III Medical Devices - 300.700 Fish - Fresh and Frozen, as Listed - Adulteration by Parasites - 540.590 Hospital Pharmacies - 460.100 Importation of Television Receivers and Microwave Ovens - 394.500 Inert Glandular Preparations - OTC - 455.100 Lasers for Facelift, Wrinkle Removal, Acupuncture, etc. - 393.200Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200 New Drugs - Export - 442.100 Oral Iron Products for Baby Pigs - 643.100RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200Salt-Cured, Air-Dried, Uneviscerated Fish - 540.650 Sugar - Water Damaged - Reconditioning - 515.425 Turtles - 170.100Water and Gravy in Pet Food - 690.400

COMMERCIAL DISTRIBUTIONCommercial Distribution-Premarket Notification - 300.600Cytotoxic Testing for Allergic Diseases - 370.100


404404

Direct Reference Authority for Class III Medical Devices - 300.700Importation of TV Receivers & Microwave Ovens - 394.500Lasers for Facelift, Wrinkle Removal, Acupuncture, etc - 393.200New Drugs - Export - 442.100RIA Analysis of Hair to Detect Presence of Drugs - 370.200Salt-Cured, Air-Dried, Uneviscerated Fish - 540.650Turtles - 170.100

COMMISSIONCommunicable Disease Hazards - 100.300Cytotoxic Testing for Allergic Diseases - 370.100Health Fraud - 120.500Responsibility for Illegal Drug Residues in Meat & Milk - 615.300

COMMON Anthelmintics - 640.100

Antipasto, Common or Usual Name - 567.100 Artichoke; Jerusalem Artichoke - Common or Usual Name - 585.100 Assemblers Who Install Noncompliant Equipment - 398.325 Bakery Products, Candy "Shotgun" Ingredients Declaration - 505.100 Beverage Bases - 510.100 Bouillon, Bouillon Cubes, Granulated Bouillon - 567.300 Canned Foods, Use of the Term "Solid Pack" - 520.100 Caviar, Use of Term - Labeling - 540.150 Checklist Labeling for Custom Mixed Medicated Feeds - 665.200 Common Carrier as a Relabeler, Repacker, Reprocessor, etc. - 100.500Common or Usual Names for Crustaceans - 540.350 Compressed Medical Gases -- Warning Letters - 435.100 Crab and Crabmeat Products with Other Seafood - Labeling - 540.285 Crabmeat - Product Name - 540.300 Drupelet Berries (Blackberries, Raspberries, etc.) - 550.200 Eggnog; Eggnog Flavored Milk-Common Usual Names - 527.350 Foreign Language Declarations on Food Labels - 562.400 Fortification of Standardized Juices - 510.700 Hollandaise Sauce - Common or Usual Name - 525.400 Homeopathic Drugs - 400.400 Human-Labeled Drugs Distributed & Used in Animal Medicine - 608.100 Identity of Foods--Terms Such as Fresh, Frozen, Dried, Canned - 562.450 Jellies, Nonstandardized - 550.475 Jordan Almonds - Common or Usual Name - 570.100 Label Declaration of Artificial Color - 587.100 Labeling of Food Bearing Residues of Pesticide Chemicals - 562.700 Labeling of Seasonings - 525.650 Malted Milk - 527.500 Maraschino Cherries - 550.550Marmalade - 550.575 Oral Iron Products for Baby Pigs - 643.100 Oranges - Artificial Coloring - 550.625 Pet Food Labeling - 690.200 Polysorbate 20, 40, 60, 65, 80, 85 - Common or Usual Names - 555.800 Pork and Beans and Similar Bean Products--Labeling - 567.200Potato Chips, Ingredients - Labeling - 585.710 Preservatives; Use in Nonstandardized Foods; Label Declaration - 562.600 Processed and/or Blended Seafood Products - 540.700 Pumpkin - Articles Made from Certain Varieties of Squash.- 585.725 Recycled Animal Waste - 685.100 Regulatory Action Regarding Approved New Drugs - 446.100 Rendered Animal Feed Ingredients - 675.400 Sauerkraut - Definition; Adulteration by Thrips - 585.750 Source Plasma - Guidelines for Informed Consent Forms - 250.100Spices - Definitions - 525.750 Starches--Common or Usual Names - 578.100 Sweet Potatoes - Sirup Pack - 585.850 Unsafe Contamination of Animal Feed from Drug Carry-over - 680.500 Vitamins and Minerals in Feed - 670.200 Water and Gravy in Pet Food - 690.400 Whole Milk, Low Fat Milk, Skim Milk - Aflatoxin M1 - 527.400

COMPATIBILITY TESTINGRegistration of Blood Banks & Other Firms - 230.110

COMPENDIAL PRODUCTSCompendial Requirements - 420.400

COMPENDIAL TESTSAdulteration of Drugs Under 501(b) & (c) - 420.100Interference with Compendial Tests - 420.500

COMPENDIUMAdulteration of Drugs Under 501(b) & (c) - 420.100Changes-Compendial Specifications & NDA Supplements - 420.300Homeopathic Drugs - 400.400Interference with Compendial Tests - 420.500Lack of Expiration Date of Stability Data - 480.300Revisions & Deletions - 420.200Unit Dose Labeling for Solid & Liquid Oral Dose Forms - 430.100

COMPENDIUM OF HOMEOTHERAPEUTICSHomeopathic Drugs - 400.400

COMPLAINT FILESGWQAP Pre-Award Evaluation - 100.700Reloaders of X-Ray Tube Housing Assemblies - 398.700

COMPLETE SYSTEMCertification and Identification of X-Ray Components - 398.600 Exemption for Certain Sunlamp Product Purchaser Records - 396.300Metric Declarations of Quantity of Contents - 140.500Sequencing in Medicated Feed Production - 680.600

COMPLIANCE POLICY GUIDESCPG # Sec. #CPG 7101.01 510.100CPG 7101.02 DeletedCPG 7101.03 510.300CPG 7101.04 510.400CPG 7101.05 510.450 RevisedCPG 7101.06 510.500 RevisedCPG 7101.07 510.600 RevisedCPG 7101.08 510.700 RevisedCPG 7102.01 505.100 RevisedCPG 7102.02 505.400 RevisedCPG 7102.03 505.350CPG 7102.04 505.300CPG 7102.05 505.200CPG 7102.06 505.500 RevisedCPG 7103.01 580.100 RevisedCPG 7104.01 578.100 CPG 7104.02 578.200 CPG 7104.03 578.300 CPG 7104.04 578.350CPG 7104.05 578.400 CPG 7104.06 578.450 CPG 7104.07 578.500 CPG 7104.08 578.600CPG 7105.01 515.100CPG 7105.02 515.200 RevisedCPG 7105.03 515.300CPG 7105.04 515.350 CPG 7105.05 515.400 CPG 7105.06 Deleted CPG 7105.07 515.500 CPG 7105.08 Deleted CPG 7105.09 515.600 CPG 7105.10 Deleted CPG 7105.11 515.700 RevisedCPG 7105.12 515.750 RevisedCPG 7105.13 515.775 RevisedCPG 7105.14 515.425CPG 7105.15 515.800 CPG 7106.01 527.500 RevisedCPG 7106.02 527.350 CPG 7106.03 527.450 CPG 7106.04 527.600 RevisedCPG 7106.05 527.100 RevisedCPG 7106.06 527.225 RevisedCPG 7106.07 527.200 RevisedCPG 7106.08 527.300 RevisedCPG 7106.09 527.250CPG 7106.10 527.400 RevisedCPG 7107.02 537.100 RevisedCPG 7108.01 540.150 CPG 7108.02 540.275CPG 7108.03 540.285 CPG 7108.04 540.300 CPG 7108.05 540.575CPG 7108.06 540.590CPG 7108.07 540.600CPG 7108.08 540.550 CPG 7108.10 540.375 CPG 7108.11 540.400CPG 7108.12 540.410CPG 7108.13 540.390 CPG 7108.14 540.450 CPG 7108.15 540.200CPG 7108.16 540.700 CPG 7108.17 540.650 CPG 7108.18 540.500CPG 7108.19 Deleted CPG 7108.20 540.250CPG 7108.21 540.475 CPG 7108.22 540.100 CPG 7108.23 540.350CPG 7108.24 540.525 Revised 7/26/95CPG 7108.25 540.420CPG 7109.01 525.100CPG 7109.02 525.150CPG 7109.03 525.200CPG 7109.04 525.225CPG 7109.05 525.250CPG 7109.06 525.300


405405

CPG 7109.07 525.325CPG 7109.08 525.330CPG 7109.09 525.350CPG 7109.10 525.375CPG 7109.11 525.400CPG 7109.12 525.425CPG 7109.13 525.500CPG 7109.14 525.550CPG 7109.15 525.575CPG 7109.16 525.600CPG 7109.17 525.625CPG 7109.18 525.650CPG 7109.19 525.700CPG 7109.20 525.750CPG 7109.21 525.800CPG 7109.22 525.825CPG 7109.23 525.850CPG 7109.24 525.900CPG 7109.25 525.925CPG 7109.26 525.950CPG 7110.01 550.100CPG 7110.02 550.150CPG 7110.03 550.200CPG 7110.04 550.225CPG 7110.05 550.230CPG 7110.06 550.250CPG 7110.07 550.260CPG 7110.08 550.270CPG 7110.09 550.300CPG 7110.10 550.350CPG 7110.11 550.400CPG 7110.12 550.235CPG 7110.13 550.450CPG 7110.14 550.475CPG 7110.15 550.500CPG 7110.16 550.550CPG 7110.17 550.575CPG 7110.18 550.590CPG 7110.19 550.600CPG 7110.20 550.605CPG 7110.21 550.625CPG 7110.22 550.650CPG 7110.23 550.655CPG 7110.24 550.680CPG 7110.25 550.685CPG 7110.26 550.690CPG 7110.27 550.700CPG 7110.28 550.750CPG 7110.29 550.800CPG 7110.30 550.850CPG 7110.31 550.155CPG 7111.01 565.100 RevisedCPG 7111.03 565.200CPG 7112.01 570.100CPG 7112.02 570.375CPG 7112.03 570.300CPG 7112.04 570.350CPG 7112.05 570.425CPG 7112.06 570.700CPG 7112.07 570.200CPG 7112.08 570.500CPG 7112.09 570.550CPG 7112.10 570.250CPG 7112.11 570.450CPG 7113.01 535.100 RevisedCPG 7114.01 585.100CPG 7114.02 585.150CPG 7114.03 585.475CPG 7114.04 585.200CPG 7114.05 585.225CPG 7114.06 585.260CPG 7114.07 585.275CPG 7114.08 585.300CPG 7114.09 585.325CPG 7114.10 585.350CPG 7114.11 585.400CPG 7114.12 585.450CPG 7114.13 585.500CPG 7114.14 585.525CPG 7114.15 585.575CPG 7114.16 585.600CPG 7114.17 585.625CPG 7114.18 585.650CPG 7114.19 585.675 RevisedCPG 7114.20 585.700CPG 7114.21 585.710

CPG 7114.22 585.725CPG 7114.23 585.750CPG 7114.24 585.775CPG 7114.25 585.800CPG 7114.26 585.825CPG 7114.27 585.850CPG 7114.28 585.875CPG 7114.29 585.890CPG 7114.30 585.900 RevisedCPG 7116.01 567.100CPG 7116.02 567.200CPG 7116.03 567.300CPG 7117.01 500.100CPG 7117.02 500.400CPG 7117.03 545.200CPG 7117.04 DeletedCPG 7117.05 545.500CPG 7117.06 545.400 Revised 12/12/95CPG 7117.07 545.450 Revised12/12/95CPG 7117.08 500.300CPG 7117.09 500.300 RevisedCPG 7117.10 500.425CPG 7117.11 500.450CPG 7117.12 500.200 RevisedCPG 7117.13 500.250 RevisedCPG 7118.01 DeletedCPG 7119.01 560.100CPG 7119.02 560.200CPG 7119.03 560.250CPG 7119.04 560.300CPG 7119.05 560.400CPG 7119.06 560.450CPG 7119.08 560.350CPG 7119.09 510.200CPG 7119.10 560.700 RevisedCPG 7119.11 560.500CPG 7119.12 560.600CPG 7119.13 560.650 DeletedCPG 7119.14 562.750CPG 7120.01 562.400CPG 7120.02 555.450CPG 7120.03 562.650CPG 7120.04 562.750CPG 7120.05 520.100CPG 7120.06 562.450CPG 7120.07 555.875CPG 7120.08 562.550CPG 7120.09 555.800CPG 7120.10 555.100CPG 7120.11 562.100CPG 7120.12 562.200CPG 7120.13 562.600CPG 7120.14 555.200CPG 7120.15 562.800CPG 7120.16 520.200CPG 7120.17 555.850CPG 7120.18 555.600CPG 7120.19 562.300CPG 7120.20 555.300CPG 7120.21 555.650CPG 7120.22 555.550CPG 7120.24 555.500CPG 7120.25 520.300CPG 7120.26 555.400CPG 7120.27 562.700CPG 7120.28 550.750CPG 7120.29 550.700CPG 7121.01 457.100CPG 7121.02 530.400CPG 7121.03 530.500CPG 7122.01 405.100CPG 7122.02 405.200CPG 7122.03 405.210CPG 7124.01 300.400CPG 7124.02 355.300CPG 7124.03 355.100CPG 7124.04 335.500CPG 7124.05 315.300CPG 7124.06 370.200CPG 7124.07 315.100 RevisedCPG 7124.08 300.300CPG 7124.09 345.200CPG 7124.11 305.100CPG 7124.12 310.100CPG 7124.13 320.100CPG 7124.14 398.300


406406

CPG 7124.15 300.100CPG 7124.16 300.500CPG 7124.17 325.100CPG 7124.18 300.350CPG 7124.19 300.600CPG 7124.20 335.800CPG 7124.21 345.100CPG 7124.22 310.200CPG 7124.23 310.210CPG 7124.24 345.300CPG 7124.25 335.300CPG 7124.26 355.200CPG 7124.27 355.200CPG 7124.28 300.200CPG 7124.29 350.100CPG 7124.30 300.700CPG 7124.31 335.700CPG 7125.01 605.100CPG 7125.02 DeletedCPG 7125.03 DeletedCPG 7125.04 DeletedCPG 7125.05 615.300CPG 7125.06 615.100CPG 7125.07 DeletedCPG 7125.08 DeletedCPG 7125.09 608.200CPG 7125.10 DeletedCPG 7125.11 642.100CPG 7125.12 640.100CPG 7125.14 645.100CPG 7125.15 DeletedCPG 7125.16 643.100 CPG 7125.17 650.100CPG 7125.18 651.100CPG 7125.19 625.400CPG 7125.20 625.200CPG 7125.21 653.100CPG 7125.22 616.100CPG 7125.23 654.100CPG 7125.24 607.100CPG 7125.25 625.500CPG 7125.26 608.300CPG 7125.27 DeletedCPG 7125.28 641.100CPG 7125.29 608.500CPG 7125.30 654.200CPG 7125.31 635.100CPG 7125.32 637.100CPG 7125.33 654.300 RevisedCPG 7125.34 625.600CPG 7125.35 608.100CPG 7125.36 625.300CPG 7125.37 615.200CPG 7125.38 638.100CPG 7125.39 634.100CPG 7125.40 608.400 NewCPG 7125a.01 655.100CPG 7125a.02 655.300CPG 7125a.03 655.400CPG 7125a.04 655.200CPG 7126.01 680.100 CPG 7126.02 DeletedCPG 7126.03 660.100CPG 7126.04 690.100 CPG 7126.05 675.100 CPG 7126.06 DeletedCPG 7126.07 DeletedCPG 7126.08 665.100CPG 7126.09 690.200CPG 7126.10 675.300CPG 7126.11 670.200CPG 7126.12 665.300CPG 7126.13 DeletedCPG 7126.14 DeletedCPG 7126.15 DeletedCPG 7126.16 670.100CPG 7126.17 690.700CPG 7126.18 690.300CPG 7126.19 680.200CPG 7126.20 675.200CPG 7126.21 687.500CPG 7126.22 690.400CPG 7126.23 690.500CPG 7126.24 675.400CPG 7126.25 670.500CPG 7126.26 665.200

CPG 7126.27 681.100CPG 7126.28 682.100CPG 7126.29 680.500CPG 7126.30 DeletedCPG 7126.31 682.200CPG 7126.32 DeletedCPG 7126.33 683.100CPG 7126.34 685.100CPG 7126.35 680.600CPG 7126.36 666.100CPG 7126.37 680.400CPG 7126.38 690.600 RevisedCPG 7126.39 DeletedCPG 7126.40 688.100CPG 7126.41 689.100CPG 7127.01 587.100CPG 7127.02 587.200CPG 7127.03 587.300CPG 7128.01 DeletedCPG 7128.02 545.600CPG 7128.03 590.300 RevisedCPG 7128.04 590.400 RevisedCPG 7128.05 590.600CPG 7128.06 590.500CPG 7129.01 170.100CPG 7132.01 400.900CPG 7132.02 420.200CPG 7132.03 400.600CPG 7132.04 400.325CPG 7132.05 420.400CPG 7132.06 460.100CPG 7132.07 400.100CPG 7132.08 400.800CPG 7132.09 460.300CPG 7132.10 450.100CPG 7132.11 460.500CPG 7132.12 400.200CPG 7132.13 430.200CPG 7132.14 450.550CPG 7132.15 400.400CPG 7132.16 460.200CPG 7132a.01 420.500CPG 7132a.02 460.700CPG 7132a.03 420.100CPG 7132a.04 480.100CPG 7132a.06 410.100CPG 7132a.07 425.400CPG 7132a.08 425.500CPG 7132a.10 480.300CPG 7132a.11 425.100CPG 7132a.12 425.200CPG 7132a.13 460.800CPG 7132a.14 460.600CPG 7132a.15 425.300CPG 7132a.16 435.100CPG 7132a.17 450.500CPG 7132b.01 454.100CPG 7132b.02 400.335CPG 7132b.03 DeletedCPG 7132b.04 430.400CPG 7132b.05 456.100CPG 7132b.06 450.400CPG 7132b.07 460.450CPG 7132b.08 460.425CPG 7132b.09 460.400CPG 7132b.10 430.100CPG 7132b.11 480.200CPG 7132b.12 455.100CPG 7132b.13 430.300CPG 7132b.14 400.500CPG 7132b.15 450.200CPG 7132b.16 450.300CPG 7132b.17 400.700CPG 7132c.01 442.100CPG 7132c.02 440.100CPG 7132c.03 448.100CPG 7132c.04 420.300CPG 7132c.05 444.100CPG 7132c.06 446.100CPG 7132c.07 470.100CPG 7132c.08 490.100CPG 7133.01 390.400CPG 7133.02 390.100CPG 7133.03 398.600CPG 7133.04 390.500CPG 7133.05 390.200


407407

CPG 7133.06 390.225CPG 7133.07 390.425CPG 7133.08 398.425CPG 7133.09 398.400CPG 7133.10 393.100CPG 7133.11 398.100CPG 7133.12 398.325CPG 7133.13 391.100CPG 7133.14 397.100CPG 7133.15 391.200CPG 7133.16 396.100CPG 7133.17 398.475CPG 7133.18 396.300CPG 7133.19 394.100CPG 7133.20 398.700CPG 7133.21 393.200CPG 7133.22 394.500CPG 7133.23 390.300CPG 7133.24 396.300CPG 7133.25 398.200CPG 7133.26 398.450CPG 7133.27 398.375CPG 7133.28 398.350CPG 7133.29 396.400CPG 7134.01 230.110CPG 7134.02 230.120CPG 7134.03 205.100CPG 7134.04 275.100CPG 7134.05 210.100CPG 7134.06 270.100CPG 7134.07 215.100CPG 7134.08 250.100CPG 7134.09 210.150CPG 7134.10 255.100CPG 7134.11 220.100CPG 7134.12 230.100CPG 7134.13 231.100CPG 7134.14 252.100CPG 7134.15 254.100CPG 7134.16 231.110CPG 7134.17 230.130CPG 7134.18 251.100CPG 7134.19 253.100CPG 7134.20 231.120CPG 7134.21 231.130CPG 7134.22 250.500CPG 7134.23 256.100CPG 7141.01 575.100CPG 7150.01 110.100CPG 7150.02 100.600CPG 7150.03 100.500CPG 7150.04 110.800CPG 7150.05 100.100CPG 7150.06 100.350CPG 7150.07 100.700CPG 7150.08 100.300CPG 7150.09 120.100CPG 7150.10 120.500CPG 7150.11 110.200CPG 7150.12 100.800CPG 7150.13 130.400CPG 7150.14 110.600CPG 7150.15 110.900 RevisedCPG 7150.16 100.550CPG 7150.17 140.500CPG 7150.18 150.100CPG 7150.19 100.900 NewCPG 7151.01 130.100CPG 7151.02 130.300 Revised1/3/96CPG 7152.01 150.500CPG 7153.01 130.200CPG 7153.02 160.300CPG 7153.03 160.400CPG 7153.04 160.700CPG 7153.05 160.500 RevisedCPG 7153.07 160.600CPG 7153.08 110.700CPG 7153.09 160.200CPG 7153.10 110.500CPG 7153.11 100.200CPG 7153.12 160.100CPG 7153.13 140.100CPG 7153.14 160.750 Revised

COMPONENTAssemblers Who Install Noncompliant Equipment - 398.325 Certification and Identification of X-Ray Components - 398.600

Compressed Medical Gases -- Warning Letters - 435.100 Definition of "High-Voltage Vacuum Switch" - 390.500 Direct-Fed Microbial Products - 689.100Homeopathic Drugs - 400.400 Milk and Milk Products Containing Penicillin - 527.450 Obligations of Factory-based Manufacturers and Assemblers - 398.375 Processed and/or Blended Seafood Products - 540.700 Registration of Blood Banks and Other Firms - 230.110 Repacking of Drug Products -- CGMP's - 430.200 Safety and Labeling of Waxed (Coated) Fruits and Vegetables - 562.550 Tracers in Animal Feed - 680.100

COMPOSITE-MOLDEDProcessed and/or Blended Seafood Products - 540.700

COMPOSITIONBouillon, Bouillon Cubes, Granulated Bouillon - 567.300 Chow Mein Noodles, Chinese Noodles and Other Oriental Noodles - 505.400 Cloudberries (Multer Berries), Canned - Adulteration - 550.590 Crab and Crabmeat Products with Other Seafood - Labeling - 540.285 Homeopathic Drugs - 400.400Identical or Similar Product Names - 400.500 Imports - Identity of Ingredients - 560.250 Marmalade - 550.575 Medicated Feeds - Formula Information - 670.100 Pork and Beans and Similar Bean Products-Labeling - 567.200 Potato Chips, Ingredients - Labeling - 585.710 Prepared Mustard, Composition - 525.575 Processed and/or Blended Seafood Products - 540.700 Quantitative Testing for Serum Proteins in Plasmapheresis Donors - 255.100Source Plasma - Overbleeding - 252.100

COMPOUNDED DRUGSManufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200

COMPRESSED MEDICAL GASESWarning Letters - 435.100

COMPUTER FILESRegulatory Actions Against Assemblers of X-Ray Equipment - 398.350

COMPUTERIZED DRUG PROCESSINGCGMP Applicability to Hardware & Software - 425.100I.D. of "Persons" - 425.500Input/Output Checking - 425.400Source Code for Process Control Application Programs - 425.300Vendor Responsibility - 425.200

CONCENTRATIONSBlood Definitions - 230.100Drugs and Residue Avoidance - 615.200Vitamins in Feed - 670.200

CONDIMENTAL SEEDSOther than Fennel & Sesame Seeds - 525.300

CONDIMENTSPrepared Mustard, Composition - 525.575

CONDOMSCondoms;Defects-Criteria for Direct Reference Seizure - 345.100

CONFECTIONERYCandy-Mixed w/Trinkets & Sold in Vending Machines - 515.350Confectionery Decorations (Nutritive & Non-Nutritive) - 545.200Use of Nonnutritive Substances as Ingredients - 515.100

CONFECTIONERY DECORATIONSNutritive & Non-Nutritive - 545.200

CONFUSIONArtichoke; Jerusalem Artichoke - Common or Usual Name - 585.100Blood and Blood Products - Definitions - 230.100CGMP's for Medicated Feeds - Daily Inventory Requirements - 680.200 Content Uniformity Testing of Tablets and Capsules - 460.600 Crabmeat - Product Name - 540.300 Drupelet Berries (Blackberries, Raspberries, etc.) - 550.200 Fortification of Standardized Juices - 510.700 Identical or Similar Product Names - 400.500 Inspection of Firms when Legal Action is Pending - 130.200 Karaya Gum Powder and Related Devices for Ose by Sstomates- 325.100 Schedule of Physical Examination- 251.100Source Plasma - Syphilis - 254.100Squash Seeds - Labeling as Pumpkin Seeds - 585.800 Sweet Potatoes - Sirup Pack - 585.850 Temporal-Maximum Ultrasonic Power - 397.100

CONSIGNEESAcupuncture Devices & Accessories - 305.100Class I Recalls of Rx Drugs - 400.900Communicable Disease Hazards - 100.300Failure to Register - 625.500Plasma Brokers - Registration & Compliance - 250.500Reconditioning New Drugs Lacking Approved NDA - 448.100

CONSPICUOUSAntipasto, Common or Usual Name - 567.100Beverage Bases - 510.100Certification & Identification of X-Ray Components - 398.600Statements Regarding NDA Approved-Labeling & Advertising - 605.100

CONSTITUENTS


408408

LVP's for Animals - 635.100Malt Products - 515.200

CONSTRUCTION BY THE FACTORY-BASED MANUFACTURERObligations-Factory-Based Manufacturers & Assemblers - 398.375

CONTACT LENSPackaging - Contact Lens Solutions & Tablets - 350.100Tamper-Resistant Packaging Requirements - 450.500

CONTACT LENS SOLUTIONSPackaging - Contact Lens Solutions & Tablets - 350.100Tamper-Resistant Packaging Requirements - 450.500

CONTAINER, SCREW-TOP, CRIMPED-CAPWater-Damaged Food Products - 555.850

CONTAMINATIONAflatoxin in Peanuts and Peanut Products - 570.375Calcium Chloride - 500.400 Canned Foods - Seam Defects - 520.200 Clams, Mussels, Oysters - Bacteriological Contamination - 560.600Classification of Establishments - 555.500 Communicable Disease Hazards - 100.300 Contamination of Devices Labeled as Sterile - 300.400 Dimethylnitrosamine (DMNA) in Barley Malt - 578.500 Direct Reference Authority for Pseudomonas Contamination - 590.300 Diversion of Adulterated Food to Acceptable Animal Feed Use - 675.200 Food Storage & Warehousing - Adulteration - Filth - 580.100 Foods - Adulteration Involving Infestation and 1080 Rodenticide - 555.450 Foods, Rail Car Sanitation - Adulteration - 545.300 Interpretation of Insect Filth in Foods - 555.600 Large Volume Parenteral (LVP's) for Animal Use - 635.100 Natural Bristle Brushes - Nit Contamination - 590.400 Parametric Release of Terminally Heat Sterilized Drugs - 460.800 Pesticide Residues in Food and Feed - 575.100 Plastic Containers for Injectable Animal Drugs - 637.100 Pottery (Ceramics) - Cadmium Contamination - 545.400 Pottery (Ceramics) - Lead Contamination - 545.450 Radionuclides in Imported Foods - Levels of Concern - 562.750 Raw Breaded Shrimp - Microbiological - 540.420 Reconditioning of Foods Adulterated Under 402(a)(4) - 160.700Recycled Animal Waste - 685.100 Return of Unused Rx Drugs to Pharmacy Stock - 460.300Revocation of Tolerances for Cancelled Pesticides - 555.700 Rodent Contaminated Pet Foods - 690.600 Salmonella Contamination of Dry Dog Food - 690.700 Sequencing in Medicated Feed Production - 680.600 Silver-Plated Hollowware - Lead Contamination - 545.500 Unsafe Contamination of Animal Feed from Drug Carryover - 680.500 Volatile N-Nitrosamine in Rubber Baby Bottle Nipples - 500.450Whole Milk, Low Fat Milk, Skim Milk - Aflatoxin M1 - 527.400

CONTENT Adulteration of Drugs Under Sec. 501(b) and 501(c) - 420.100Brazil Nuts - Adulteration with Aflatoxin - 570.200 Chow Mein Noodles, Chinese Noodles and Other Oriental Noodles - 505.400Compendial Requirements - 420.400 Content Uniformity Testing of Tablets and Capsules - 460.600 Dealcoholized Wine and Malt Beverages - Labeling - 510.400 Decomposition & Histamine in Albacore, Skipjack & Yellowfin Tuna - 540.525 Dimethylnitrosamine (DMNA) in Barley Malt - 578.500 Direct-Fed Microbial Products - 689.100 Homeopathic Drugs - 400.400 Imitation Breaded Shrimp - 540.450 Inert Glandular Preparations - OTC - 455.100 Jellies, Nonstandardized - 550.475 Labeling - Diluted Wines and Cider with Less Than 7% Alcohol - 510.450 Nutritional Supplements for Companion Animals - 690.100 Oleomargarine - Misbranding Due to Low Fat - 535.100 Oral Iron Products for Baby Pigs - 643.100 Pesticide Residues in Food and Feed - 575.100 Rendered Animal Feed Ingredients - 675.400 Spices - Definitions - 525.750 Tomato Products - Adulteration with Mold - 585.900 Vitamins and Minerals in Feed - 670.200 Water in Food Products (Ingredient or Adulterant) - 555.875

CONTRACTBlood & Blood Products - Definitions - 230.100Commercial Distribution-Premarket Notification - 300.600Consistent Application of CGMP Determinations - 400.200Contract Sterilizers - 100.550GWQAP Pre-Award Evaluation - 100.700Marketed New Drugs w/o Approved NDAs or ANDAs - 440.100Records & Reports -Applicability-21 CFR 1002.1 - 390.425

CONTRACT OF SALECommercial Distribution -- Premarket Notification - 300.600

CONTRAINDICATEDKaraya Gum Powder & Devices for Use by Ostomates - 325.100

CONTROL OF ALLERGIESHypnotherapy Devices - Self Hypnotic Tape Recordings - 335.300

CONTROLLED CONDITIONS

Importation of TV Receivers & Microwave Ovens - 394.500Registration of Blood Banks & Other Firms - 230.110

CONVENTIONAL RS (REFLECTOR SPOT)Sunlamp Performance Standard - 396.100

COOK CHEESECheese - Misbranding Due to Moisture and Fat - 527.225

COOPERATIVE OR CONTRACTUAL ARRANGEMENTSRecords and Reports - Applicability - 21 CFR 1002.1 - 390.425

CORDIALMaraschino Cherries - 550.550

CORIANDERLabeling of Seasonings - 525.650

CORNAflatoxin in Animal Feeds - 683.100Corn, Sweet; Canned - 585.300Corn Husks Filth - 585.350Corn Meal - Adulteration by Filth - 578.200Foods, Adulteration with Aflatoxin - 555.400Malt Products - 515.200On The Cob, Canned Contents Declaration - 585.325Pesticide Residues - 575.100Popcorn - Adulteration with Filth - 585.675Potato Chips, Ingredients - Labeling - 585.710Seeds for Sprouting Prior to Food Use - 555.750Silage Ingredients - 687.500Starches--Common or Usual Names - 578.100Whole, Low Fat and Skim Milk - 527.400

CORN MEALCornmeal-Adulteration by Insect & Rodent Filth - 578.200Foods, Adulteration w/ Aflatoxin - 555.400Pesticide Residues in Food & Feed - 575.100

CORRECTIVE ACTIONAccess to Results of Quality Assurance Audits - 130.300Assessment of Civil Penalties - 390.300 Communicable Disease Hazards - 100.300 Early Correction of Defects or Noncompliance - 390.225 Fraud, Untrue Statements of Material Facts, Bribery - 120.100 Health Fraud- 120.500Obligations of Factory-Based Manufacturers and Assemblers - 398.375 Section 305 Meeting - 160.400 Storage of Platelets - 231.130

COSMETICSAnimal Grooming Aids - 653.100 Denture Cleaners, Adhesives, Cushions, and Repair Materials- 315.200 Direct Reference Authority for Pseudomonas Contamination - 590.300 Drugs for Odor Control in Animals - 642.100 Health Fraud - 120.500Imported Products - Lack of English Labeling - 110.900Metric Declarations of Quantity of Contents - 140.500Tamper-Resistant Packaging - 450.500 Wigs - 590.600

COW PEASBlack-Eyed Peas (Cow Peas, Field Peas); Dried - 585.225

CRAB AND COD CAKESCrab Products with Other Seafood - 540.285

CRAB CAKESCrab Products with Other Seafood - 540.285

CRAB NEWBURGCrab Products with Other Seafood - 540.285

CRABMEATCrabmeat - Product Name - 540.300Filth E. Coli - 540.275Pesticide Residues - 575.100Processed Blended Seafood Products - 540.700With Other Seafood -- Labeling - 540.285

CRABMEAT COCKTAILCrab Products with Other Seafood - 540.285

CRANBERRY SAUCEAdulteration - 550.260

CRAWFISHCommon or Usual Names for Crustaceans - 540.350

CRAYFISHCommon or Usual Names for Crustaceans - 540.350

CRUSTACEANSMethyl Mercury - 540.600Common or Usual Names for Crustaceans - 540.350

CRYOGENIC CONTAINERCompressed Medical Gases - Warning Letters - 435.100

CRYOPRECIPITATED ANTIHEMOPHILIC FACTORQuality Control Testing - 231.110Standards & Min. Requirements for Biologic Products - 205.100

CRYOPROTECTANTSProcessed, Blended Seafood Products - 540.700

CULTURESIntermediate or End Products of Sample Analysis - 150.100

CUMIN SEED


409409

Adulteration with Sand and Grit - 525.325Spices - Definitions - 525.750

CURCUMINSpices - Definitions - 525.750

CURE OF DISEASEDirect-Fed Microbial Products - 689.100Homeopathic Drugs - 400.400 Human Blood and Blood Products as Drugs - 230.120 Hypnotherapy Devices - Self Hypnotic Tape Recordings - 335.300 Razor Blades, Manicuring Instruments - 335.500 Vitamin B-15, Pangamic Acid and Pangamic Acid Products - 457.100

CURING"Processing"-Use of Term - 562.650Salt-Cured, Air-Dried, Uneviscerated Fish - 540.650

CURRANTSAdulteration - 550.270Jellies, Nonstandardized - 550.475Pesticide Residues in Food and Feed - 575.100

CURRICULUM VITAELicensing - Changes to be Reported - 210.100

CURRY POWDERAdulteration by Insect & Rodent Filth - 525.330

CUSHIONSDenture Cleaners, Cushions, & Repair Materials - 315.200

CUSTOMSArticles of Foreign Origin Not Intended for Entry - 110.700Coffee & Cocoa Bean Sweeps - 560.350Country of Origin Labeling - 560.200Exports from U.S. Foreign Trade Zones - 110.200Foreign Trade Zones Bonded Warehouses or Carriers - 110.600Importation of TV Receivers & Microwave Ovens - 394.500Imports - Post Detention Sampling - 110.800Returned Antibiotics Exported Under 801(d) of the Act - 405.210

CYLINDER PLATE METHODMilk & Milk Products Containing Penicillin - 527.450

CYSTOGRAPHICDefinition-General Purpose Radiographic X-Ray System - 398.100

CYSTSFish Adulteration by Parasite - 540.590

CYTOTOXICAllergic Diseases - 370.100

CYTOTOXIC TESTINGAllergic Diseases - 370.100

D-CARVONESpices - Definitions - 525.750

DACUSOlives - 550.600

DAIRYExtra-Label Use of New Animal Drugs - 615.100Ethylenediamine Dihydroiodide - 651.100

DAIRY INDUSTRYImported Milk & Cream - 560.400

DAIRY PRODUCTSFoods, Adulteration with Salmonella - 555.300Imported Milk and Cream. Import Milk Act - 560.400Pathogens in Dairy Products - 527.300Teat Dips and Udder Washes - 654.200Whole Low Fat, Skim Milk - 527.400

DAMAGEBlack-Eyed Peas (Cow Peas, Field Peas); Dried - 585.225 Canned Green Beans and Canned Wax Beans -Standards - 585.475Corn Husks (for Tamales) - Adulteration with Filth - 585.350 Determination by Secretary that Product Fails to Comply - 390.200Fructose-Containing Drugs - 400.335 Green Coffee Beans - Adulteration with Insects; Mold - 510.500 Olives - Adulteration Involving Pits; Rot; Insect Infestation - 550.600 Peas and Beans; Dried - Storage Insect Damage, Rocks - 585.575 Preservatives; Use in Nonstandardized Foods; Label Declaration - 562.600 Returned Antibiotics Exported Under 801(d) of the Act - 405.210 Sweet Potatoes, Dyeing of Yellow and Red Varieties - 585.825 Tamper-Resistant Packaging Requirements - 450.500 Water-Damaged Food Products - 555.850 Whole Milk, Low Fat Milk, Skim Milk - Aflatoxin M1 - 527.400

DATAAcupuncture Devices and Accessories - 305.100 Analytical Methodology Used by FDA - Drugs - 150.500Animal Drugs for Euthanasia - 650.100 Chubs, Hot Process Smoked with Added Nitrite - 540.200 Computerized Rx Recordkeeping by Pharmacies - 460.400 Consistent Application of CGMP Determinations - 400.200 Crab and Crabmeat Products with Other Seafood - Labeling - 540.285 Decomposition & Histamine in Albacore, Skipjack & Yellowfin Tuna - 540.525 Dimethylnitrosamine (DMNA) in Barley Malt - 578.500 Direct Reference Authority for Class III Medical Devices - 300.700 Diversion of Adulterated Food to Acceptable Animal Feed Use - 675.200

Drug Product Entries in Periodic Publications - 400.700Drugs for Odor Control in Animals - 642.100 Ear Piercing Devices - 320.100Electrical Muscle Stimulators- 355.200 Ethylenediamine Dihydroiodide (EDDI) - 651.100 Products for Control of Fleas and Ticks - 641.100 Fraud, Untrue Statements of Material Facts, Bribery - 120.100 Health Fraud - 120.500Human-Labeled Drugs Distributed & Used in Animal Medicine - 608.100 IND Filings - 215.100 Lack of Expiration Date or Stability Data - 480.300 Large Volume Parenterals (LVP's) for Animal Use - 635.100 Macaroni and Noodle Products - 505.500 OTC Drugs - Combination Products - 450.300 Plastic Containers for Injectable Animal Drugs - 637.100 Process Validation Requirements for Drug Products - 490.100 Reuse of Medical Disposable Devices - 300.500 Shrimp - Frozen, Raw, Breaded or Lightly Breaded, - 540.410Silage Ingredients - 687.500 Source Code for Process Control Application Programs - 425.300 Storage of Platelets - 231.130 Streptomycin Residues in Cattle Tissues - 616.100 Sweet Potatoes - Sirup Pack - 585.850 Tuna, Sable, Salmon, Shad - Smoked, Cured - Sodium Nitrite - 540.500 Unsafe Contamination of Animal Feed from Drug Carry-over - 680.500 Use of DDVP (Vapona) Strips in Milkhouses and Milkrooms - 527.600 Vitamins and Minerals in Feed - 670.200 Volatile N-Nitrosamine in Rubber Baby Bottle Nipples - 500.450

DATESDates and Date Material - 550.300

DDVPUse of (Vapona) Strips in Milkhouses & Milkrooms - 527.600

DEALCOHOLIZED WINEDealcoholized Wine and Malt Beverages - 510.400

DEBILITATEDContamination of Devices Labeled as Sterile - 300.400

DEBRISIntermediate or End Products of Sample Analysis - 150.100

DECLARATIONBakery Products, Candy "Shotgun" Ingredients Declaration - 505.100 Caviar, Use of Term - Labeling - 540.150 Corn on the Cob, Canned - Quantity of Contents Declaration - 585.325 Drugs - Metric and Apothecary System Declarations - 400.600 Foods - FPLA Compliance - 562.200 Fortification of Standardized Juices - 510.700 Hollandaise Sauce - Common or Usual Name - 525.400 Homeopathic Drugs - 400.400 Honey - Source Declaration - 515.300 Importation of Television Receivers and Microwave Ovens - 394.500 Label Declaration of Artificial Color - 587.100 Labeling of Food Bearing Residues of Pesticide Chemicals - 562.700 Labeling: "Chocolate" or "Chocolate Flavored" - 515.800 Malted Milk - 527.500 Maraschino Cherries - 550.550 Marmalade - 550.575 Metric Declarations of Quantity of Contents - 140.500Mixed Nuts - Misbranding Involving Food Standards - 570.700 Nutritional Supplements for Companion Animals - 690.100Pineapple, Canned; Imported and Domestic - Food Standards - 550.685 Polysorbate 20, 40, 60, 65, 80, 85 - Common or Usual Names - 555.800 Preservatives; Use in Nonstandardized Foods; Label Declaration - 562.600 Safety and Labeling of Waxed (Coated) Fruits and Vegetables - 562.550 Sauerkraut - Definition; Adulteration by Thrips - 585.750 Standardized Canned Fruit - Packing Medium - 550.800Sweet Potatoes - Sirup pack - 585.850 Tomato Sauce or Tomato Hot Sauce Labeling - 525.800 Tracers in Animal Feed - 680.100 Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100 Water in Food Products (Ingredient or Adulterant) - 555.875

DECLARATION OF NET QUANTITY OF CONTENTSHomeopathic Drugs - 400.400 Metric Declarations of Quantity of Contents - 140.500

DECOMPOSEDApple Butter - Adulteration with Mold; Rodent Filth, Insects - 550.100 Apricot, Peach and Pear Nectars and Purees - Mold - 550.155 Bay (Laurel) Leaves - Insect Filth; Mold; Mammalian Excreta - 525.150Beets, Canned - Adulteration with Rot - 585.200 Canned Salmon - Adulteration Involving Decomposition - 540.375 Canned Foods - Seam Defects - 520.200 Canned Pet Food - 690.300 Capsicum Pods, etc. - Adulteration - 525.200 Cherries - 550.225 Cherry Jam - Adulteration with Mold - 550.235 Citrus Fruit Juices, Canned - Fly Filth and Mold - 550.250 Cocoa Beans - Mold, Insect Infestation, and Mammalian Excreta - 515.750


410410

Corn Husks (for Tamales) - Adulteration with Filth - 585.350 Cranberry Sauce - Adulteration with Mold - 550.260 Dates and Date Material; Imported and Domestic - 550.300 Dried Prunes, Dehydrated Low Moisture Prunes, and Pitted Prunes - 550.700 Drupelet Berries (Blackberries, Raspberries, etc.) - 550.200 Eggs and Other Egg Products - Frozen - Decomposition - 537.100 Figs; Fig Paste - Insect Infestation; Mold, Dirt - 550.350 Fish-Fresh and Frozen-Adulteration Involving Decomposition - 540.575 Green Coffee Beans - Adulteration with Insects; Mold - 510.500 Greens, Canned - Adulteration by Mildew - 585.450 Jam, Black Currant - Adulteration with Mold - 550.450 Leafy Spices, Other than Bay Leaves - 525.500 Mace-Insect Filth; Mold, Foreign Matter; Mammalian Excreta - 525.550Marjoram - 525.900 Mushrooms, Canned or Dried (Freeze-Dried or Dehydrated) - 585.500Olives - Adulteration Involving Pits; Rot; Insect Infestation - 550.600 Oregano - 525.850 Peanuts, Shelled and Unshelled - Filth and Reject Nuts - 570.350 Pineapple, Canned; Pineapple Juice - Adulteration with Mold - 550.680 Pistachio Nuts - Aflatoxin Adulteration - 570.500 Plums, Canned - Adulteration with Rot - 550.690 Potato Chips - Adulteration with Rot - 585.700 Raisins - Adulteration Involving Mold, Sand, Grit, & Insects - 550.750 Sage - 525.950Sesame Seeds - Adulteration - 525.700 Shrimp - Fresh or Frozen Raw Headless, Peeled or Breaded - 540.400 Spinach, Canned or Frozen - Insects, Decomposition - 585.775 Strawberries; Frozen, Whole, or Sliced - Sand, Mold - 550.850 Thyme - 525.925 Tomato Products - Adulteration with Mold - 585.900 Tree Nuts - Adulteration Involving Rejects - 570.425 Whole Ginger - Insect Filth; Mold; Mammalian Excreta - 525.375Whole Cassia or Whole Cinnamon, Ground Cinnamon - 525.225 Whole and Ground Pepper - Adulteration - 525.625 Whole and Ground Nutmeg - Insect Filth; Mold; Rodent Filth - 525.600 Whole and Ground Allspice - Mold; Insect and Rodent Filth - 525.100

DECOMPOSITION (see Decomposed)DECORATIVE CAKE LETTERS

Confectionery Decorations - 545.200DEEP SEA LOBSTER

Usual Names for Crustaceans - 540.350DEFECT ACTION LEVELS

Diversion of Food to Pet Feed - 675.200Interpretation of Insect Filth in Foods - 555.600Macaroni and Noodle Products - 505.500

DEFECTIVE PACKAGINGContamination of Devices Labeled as Sterile - 300.400

DEFECTSCanned Foods - Seam defects - 520.200 Clinical Thermometer - Adulteration; Misbranding Defects - 335.800 Condoms; Defects - Criteria for Direct Reference Seizure - 345.100Contamination of Devices Labeled as Sterile - 300.400 Determination by Secretary that Product Fails to Comply - 390.200Early Correction of Defects or Noncompliance - 390.225 Hazardous Diagnostic X-Ray Systems - 398.200 Marjoram - 525.900Obligations of Factory-based Manufacturers and Assemblers - 398.375 Oregano - 525.850 Reconditioning of Articles Found in Violation of GMP's - 160.750Sage - 525.950 Surgeons' Gloves and Patient Examination Gloves - 335.700 Thyme - 525.925 Whole Cassia or Whole Cinnamon, Ground Cinnamon - 525.225 Whole and Ground Nutmeg - Insect Filth; Mold; Rodent Filth - 525.600 Whole and Ground Allspice - Mold; Insect and Rodent Filth- 525.100

DEHYDRATEDDried, Dehydrated Low Moisture & Pitted Prunes - 550.700 Identity-Foods-Terms Such Fresh,Frozen,Dried - 562.450Imported Milk & Cream. Import Milk Act - 560.400Labeling of Seasonings - 525.650Mushrooms, Canned or Dried - 585.500Potato Chips, Ingredients - Labeling - 585.710Spices - Definitions - 525.750

DELIVERYAdulteration of Drugs Under Sec.501(b) & (c) - 420.100Commercial Distribution -Premarket Notification - 300.600Common Carrier as Relabelers, Repacker,Reprocessor, etc - 100.500Compressed Medical Gases -Warning Letters - 435.100Hazardous Diagnostic X-Ray Systems - 398.200Hospital Pharmacies - 460.100Registration of Blood Banks & Other Firms - 230.110Sequencing in Medicated Feed Production - 680.600Unit Dose Labeling for Solid & Liquid Oral Dose Forms - 430.100

DENTAL X-RAY SYSTEMDefinition of General Purpose Radiographic X-Ray System - 398.100

DENTIFRICESTamper-Resistant Packaging Requirements - 450.500

DENTUREDenture Cleaners, Adhesives, & Repair Materials - 315.200Dentures-Sale by Persons Not Licensed in Dentistry - 315.100

DEPARTMENT OF JUSTICEAnswering Inquiries on Status of Criminal Referrals - 160.500 Dentures -- Sale by Persons Not Licensed to Practice Dentistry - 315.100Failure to Register - 625.500 Imported Milk and Cream. Import Milk Act - 560.400 Payment of Expert Witness - 160.600

DEPARTMENT OF TRANSPORTATIONFoods, Rail Car Sanitation - Adulteration - 545.300

DEPENDABLEClinical Thermometer-Adulteration ; Misbranding Defects - 335.800

DEPLETION DATAHuman-Labeled Drugs Used in Pet Medicine - 608.100

DERMATOLOGICSTamper-Resistant Packaging Requirements - 450.500

DESIMarketed New Drugs w/o Approved NDAs or ANDAs - 440.100Reconditioning New Drugs Lacking Approved NDA - 448.100

DETAINEDAflatoxin in Peanuts and Peanut Products - 570.375 Dates and Date Material; Imported and Domestic - 550.300 Diversion of Adulterated Food to Acceptable Animal Feed Use - 675.200 Foods, Adulteration with Aflatoxin - 555.400 Importation of Television Receivers and Microwave Ovens - 394.500 Imported Products - Lack of English Labeling - 110.900Imported Frozen Products of Multiple Sizes or Codes - 560.700 Imported Low-Acid Canned Foods - 560.450 Imports -- Post Detention Sampling - 110.800Jams, Jellies and Related Products - Imports - 560.500 Pistachio Nuts - Aflatoxin Adulteration - 570.500 Pottery (Ceramics) - Lead Contamination - 545.450 Pottery (Ceramics) - Cadmium Contamination - 545.400Reconditioning of Imported Coffee Beans - 560.300 Returned Antibiotics Exported Under 801(d) of the Act - 405.210 Silver-Plated Hollowware - Lead Contamination - 545.500 Sphygmomanometers - Rx Legend - 310.200

DETENTION Dates and Date Material; Imported and Domestic - 550.300

Defective Suntanning Booths and Beds - 396.300 Diversion of Adulterated Food to Acceptable Animal Feed Use - 675.200 Food Storage & Warehousing - Adulteration - Filth - 580.100 Hazardous Diagnostic X-Ray Systems - 398.200 Importation of Television Receivers and Microwave Ovens - 394.500 Imported Products - Lack of English Labeling - 110.900Imported Low-Acid Canned Foods - 560.450 Imports -- Post Detention Sampling - 110.800Jams, Jellies and Related Products - Imports - 560.500 Pesticide Residues in Food and Feed - 575.100 Pineapple, Canned; Imported and Domestic - Food Standards - 550.685 Pistachio Nuts - Aflatoxin Adulteration - 570.500 Pottery (Ceramics) - Lead Contamination - 545.450 Pottery (Ceramics) - Cadmium Contamination - 545.400Radionuclides in Imported Foods - Levels of Concern - 560.750 Silver-Plated Hollowware - Lead Contamination - 545.500

DETERIORATEReloaders of X-Ray Tube Housing Assemblies - 398.700

DETOXIFICATIONAmmoniated, Cottonseed Meal - 670.500

DEVICE COMPONENTSInspection of Manufacturers of Device Components - 300.100

DEVICESAccess to Results of Quality Assurance Audits - 130.300Acupuncture Devices and Accessories - 305.100 Adequate Directions for Use - Animal Drugs and Devices - 607.100 Adequate

Directions for Use - Veterinary Devices - 655.200 Assemblers Who Install Noncompliant Equipment - 398.325 Automatic Adjustment of the X-Ray Field Size - 398.400CGMP Applicability to Hardware and Software - 425.100Class III Devices Subject to 5l5(b) Requirements - 300.750 Computerized Drug Processing -- Vendor Responsibility - 425.200 Condoms; Defects - Criteria for Direct Reference Seizure - 345.100 Contamination of Devices Labeled as Sterile - 300.400 Contract Sterilizers - 100.550Cytotoxic Testing for Allergic Diseases - 370.100 Defective Suntanning Booths and Beds - 396.300 Definition of General Purpose Radiographic X-Ray System - 398.100 Definition of "High-Voltage Vacuum Switch" - 390.500 Dentures -- Sale by Persons not Licensed to Practice Dentistry - 315.100Denture Cleaners, Adhesives, Cushions, and Repair Materials - 315.200 Devices for Use in Animals - 655.100 Diaphragms - Rx Devices - 345.200Direct Reference Authority for Class III Medical Devices - 300.700Ear Piercing Devices - 320.100 Electrical Muscle Stimulators - 355.200


411411

Failure to Register - 400.100 Health Fraud - 120.500

Hypnotherapy Devices - Self Hypnotic Tape Recordings - 335.300 Imported Products - Lack of English Labeling - 110.900Ineffective Devices - 502(f)(l) Labeling Requirements - 300.300 Inspection of Manufacturers of Device Components - 300.100 Ion Generating Devices - 355.300 Karaya Gum Powder and Related Devices for Use by Ostomates - 325.100 Laser Light Shows, etc. - 393.100 Lasers for Facelift, Wrinkle Removal, Acupuncture, etc. - 393.200Menstrual Sponges - 345.300 Metric Declarations of Quantity of Contents - 140.500Microfiche and/or Microfilm for Records Retention - 130.400OTC Drugs in Vending Machines - 450.400 Pacemaker Reuse - 310.100 Products Composed of Interstate Ingredients - 100.200Razor Blades, Manicuring Instruments - 335.500 Reconditioners/Rebuilders of Medical Devices - 300.200 Regulatory Actions and Small Business - 160.100Regulatory Actions Against Assemblers of X-Ray Equipment - 398.350Reloaders of X-Ray Tube Housing Assemblies - 398.700 Reuse of Medical Disposable Devices - 300.500 RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200Sphygmomanometers - Rx Legend - 310.200 Sphygmomanometers - Accuracy - 310.210 Sunlamp Performance Standard - 396.100 Surgeons' Gloves and Patient Examination Gloves - 335.700 Temporal-Maximum Ultrasonic Power - 397.100The Status of Syringes and Needles for Animal Use - 655.400 Warning Label Required on Sunlamp Products - 396.400 X-Ray Field Size for Spot-Film - 398.475

DEVILED CRABCrab & Crabmeat Products w/Other Seafood-Labeling - 540.285

DEWBERRIESDrupelet Berries - 550.200

DEXTRANSLVP's for Animal Use - 635.100

DEXTROSEFructose-Containing Drugs - 420.200LVP's for Animal Use - 635.100Marmalade - 550.575Potato Chips, Ingredients Labeling - 585.710Prepared Mustard, Composition - 525.575Sweet Potato Sirup Pack - 585.850

DIAGNOSTIC X-RAY EQUIPMENTAssemblers Who Install Noncompliant Equipment - 398.325Assessment of Civil Penalties - 390.300Certification & Identification of X-Ray Components - 398.600Obligations of Factory-Based Manufactures & Assemblers - 398.375Regulatory Actions Against Assemblers of X-Ray Equipment - 398.350

DIAGNOSTIC X-RAY SYSTEMSHazardous Diagnostic X-Ray Systems - 398.200Obligation of Factory-Based Manufactures & Assemblers - 398.375Reconditioners/Rebuilders of Medical Devices - 300.200Registration of Assemblers of Diagnostic X-Ray Systems - 398.300Regulatory Actions Against Assemblers of X-Ray Equipment - 398.350

DATE MATERIALDates and Date Material - 550.300

DATES PERTAINING TO DRUGSExpiration Dating of Unit Dose Drugs - 480.200Labeling for Oral Dosages - 430.100Manufacture, Distribution, Promotion - 460.200Repacking of Drug Products - 430.200

DAIRY INDUSTRYImported Milk & Cream - 560.400

DIAPHRAGMSRx Devices - 345.200

DICTIONARY OF PRACTICAL MATERIAL MEDICAHomeopathic Drugs - 400.400

DIETARY SUPPLEMENTSNutritional Supplements - 690.100

DIETHYLSTILBESTROL (DES)Extra-Label Use of Drugs in Animals - 615.100Unsafe Contamination of Pet Feed/Carryover - 680.500

DIFFERENT COMPOSITIONIdentical or Similar Product Names - 400.500

DIHYDROSTREPTOMYCINStreptomycin Residues in Cattle Tissues - 616.100

DILL SEEDSpices - Definitions - 525.750

DILUTED WINESLabeling - 510.450

DIMETHYL GLYCENEPangamic Acid - 457.100

DIMETHYL SULFOXIDE (DMSO)For Animal Use - 654.100

DIMETHYLNITROSAMINE (DMNA)In Malt Beverages - 510.600In Barley Malt - 578.500

DIMETRIDAZOLEExtra-Label Use of New Animal Drugs - 615.100Unsafe Contamination of Animal Feed - 680.500

DINNERWAREPottery Cadmium - 545.400Pottery Lead - 545.450

DINOFLAGELLATAClams, Mussels, Oysters - 540.250

DIPHTHERIA ANTITOXINStandards & Min.Requirements - Biologic Products - 205.100

DIPHTHERIA TOXINStandards & Min.Requirements - Biologic Products - 205.100

DIPHTHERIA TOXOIDStandards & Min.Requirements - Biologic Products - 205.100

DIRECT REFERENCE AUTHORITYDirect Reference Authority for Pseudomonas Contamination - 590.300For Class III Medical Devices - 300.700Illegal Sales of Veterinary Prescriptions - 608.500

DIRECT REFERENCE SEIZUREAdulteration of Drugs Under Sec. 501(b) and 501(c) - 420.100 Direct Reference Authority for Pseudomonas Contamination - 590.300 Direct Reference Authority for Class III Medical Devices - 300.700 DIRECTEDAccess to Results of Quality Assurance Audits - 130.300Aflatoxin in Peanuts and Peanut Products - 570.375 Animal Drugs for Euthanasia - 650.100 Determination by Secretary that Product Fails to Comply - 390.200Ethylenediamine Dihydroiodide (EDDI) - 651.100 Health Fraud - 120.500Jams, Jellies and Related Products - Imports - 560.500 Lasers for Facelift, Wrinkle Removal, Acupuncture, etc. - 393.200Marketed New Drugs Without Approved NDAs or ANDAs - 440.100OTC Drugs - Combination Products - 450.300 OTC Anti-Obesity Preparations - 456.100 Regulatory Actions and Small Business - 160.100 Sequencing in Medicated Feed Production - 680.600 Statements Regarding NADA Approval in Labeling and Advertising - 605.100 Urinary Preparations

DIRECTIONS FOR USEAcupuncture Devices and Accessories - 305.100 Additives - Labeling with Adequate Directions for Many Uses - 500.100 Adequate Directions for Use - Animal Drugs and Devices - 607.100 Adequate Directions for Use - Veterinary Devices - 655.200 Alternate Feeding of Different Medicated Feeds - 666.100Availability of Bulk Chemicals for Animal Drug Use - 625.200 Cellutron Machine - 355.100 Checklist Labeling for Custom Mixed Medicated Feeds - 665.200 Chloramphenicol - 654.300 Compressed Medical Gases -- Warning Letters - 435.100 Cytotoxic Testing for Allergic Diseases - 355.200 Diaphragms - Rx Devices - 345.200 Direct-Fed Microbial Products - 689.100Electrical Muscle Stimulators - 355.200 Extra-Label Use of New Animal Drugs in Food-Producing Animals - 615.100 Food Additives - Labeling Directions Necessary for Safe Use - 500.250 Homeopathic Drugs - 400.400 Human-Labeled Drugs Distributed & Used in Animal Medicine - 608.100 Hypnotherapy Devices - Self Hypnotic Tape Recordings - 335.300 Illegal Sales of Veterinary Prescription Drugs - 608.500 Ineffective Devices - 502(f)(l) Labeling Requirements - 300.300Inert Glandular Preparations - OTC - 455.100 Over-The-Counter Sale of Injectable Animal Drugs - 608.200 Repacking of Drug Products -- CGMP's - 430.200 RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200 Seizure of Books that Constitute Misleading Labeling - 140.100Teat Dips and Udder Washes for Dairy Cows and Goats - 654.200 Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100 Warning Label Required on Sunlamp Products - 396.400

DISCLOSURE AND CLAIMSInert Glandular Preparations - OTC - 455.100Unit Dose Labeling for Solid & Liquid Oral Dose Forms - 430.100Urinary Preparations-Lack of Rx Legend Claims - 430.400

DISPLAYCommercial Distribution -- Premarket Notification - 300.600 Dealcoholized Wine and Malt Beverages - Labeling - 510.400 Foods - FPLA Compliance - 562.200 Homeopathic Drugs - 400.400 Identity of Foods--Terms Such as Fresh, Frozen, Dried, Canned - 562.450 Labeling of Food Articles Distributed Solely in Puerto Rico - 562.750 Laser Light Shows, etc. - 393.100 Mercury Vapor Lamps That are Not Self-Extinguishing - 391.200Metric Declarations of Quantity of Contents - 140.500Pottery (Ceramics) - Lead Contamination - 545.450 Pottery (Ceramics) - Cadmium Contamination - 545.400 Processed and/or Blended Seafood Products - 540.700


412412

Safety and Labeling of Waxed (Coated) Fruits and Vegetables - 562.550 Silver-Plated Hollowware - Lead Contamination - 545.500 Tamper-Resistant Packaging Requirements - 450.500

DISPLAYEDDistribution - Premarket Notification - 300.600Identity of Foods-Terms Like Fresh, Frozen, Dried - 562.450Labeling-Food w/ Residues of Pesticide Chemicals - 562.700Oranges - Artificial Coloring - 550.625OTC Drugs in Vending Machines - 450.400Safety & Labeling of Waxed (Coated) Fruits & Vegetables - 562.550Seizure of Books That Constitute Misleading Labeling - 140.100Tamper-Resistant Packaging Requirements - 450.500Vending Machine Food - Labeling - 562.800Warning Label required on Sunlamp Products - 396.400

DISPOSABLE GUIDEWIRESReuse of Medical Disposable Devices - 300.500

DISTILLED VINEGARAcetic Acid Use in Foods-Labeling - 562.100Vinegar, Adulteration with Vinegar Eels - 525.825

DISUSEElectrical Muscle Stimulators - 355.200

DIURETICSUrinary Preparations-Lack of Rx Legend Claims - 430.400

DOCUMENTED EVIDENCEDecomposition & Histamine in Albacore,Skipjack, Tuna - 540.525Karaya Gum Powder & Devices for Use by Ostomates - 325.100Obligations of Factory-Based Manufactures & Assemblers - 398.375

DONORBlood & Blood Products - Definitions - 230.100Quantitative Testing for Serum Proteins-Plasmapheresis - 255.100Registration of Blood Banks & Other Firms - 230.110Source Plasma Guideline for Informed ConsentForm - 250.100Standards & Min. Requirements - Biologic Products - 205.100

DONOR SUITABILITYDetermination of Donor Suitability - 230.130

DOSAGEAdulteration of Drugs under Sec. 501(b) and 501(c) - 420.100Chloramphenicol - 654.300Compendium Revisions and Deletions - 420.200Content Uniformity Testing of Tablets and Capsules - 460.600Controlled-Release Dosage Form Drugs - 460.700 Expiration Dating of Unit Dose Repackaged Drugs - 480.200Expiration Dating and Stability Testing - 480.100Extra-Label Use of New Animal Drugs in Food-Producing Animals - 615.100Finished Dosage Form Drugs in Bulk Containers - 410.100 Fructose-ContainingDrugs - 400.335Homeopathic Drugs - 400.400Hospital Pharmacies - 460.100Identical or Similar Product Names - 400.500 Interference with Compendial Tests - 420.500Lack of Expiration Date or Stability Data - 480.300Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200Marketed New Drugs Without Approved NDAs - 440.100Oral Iron Products for Baby Pigs - 643.100Process Validation Requirements for Drug Products - 490.100Proper Drug Use and Residue Avoidance - 615.200Regulatory Action Regarding Approved New Drugs - 446.100Repacking of Drug Products -- CGMP's - 430.200Returned Antibiotics Exported under 801(d) of the Act - 405.210Tamper-Resistant Packaging Requirements - 450.500Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100

DOSAGE FORM (See Dosage above)DRIED

Black-Eyed Peas (Cow Peas, Field Peas); Dried - 585.225Canned Green Beans and Canned Wax Beans-Standards - 585.475Communicable Disease Hazards - 100.300Dried Prunes, Dehydrated Low Moisture Prunes, and Pitted Prunes - 550.700 FDA Jurisdiction Over Meat and Poultry Products - 565.100Identity of Foods--Terms Such as Fresh, Frozen, Dried, Canned - 562.450Imported Milk and Cream. Import Milk Act - 560.400Labeling of Seasonings - 525.650Malt Products - 515.200Mushrooms, Canned or Dried (Freeze-Dried or Dehydrated) - 585.500Pathogens in Dairy Products - 527.300Peas and Beans; Dried - Storage Insect Damage, Rocks - 585.575Pork and Beans and Similar Bean Products--Labeling - 567.200Potato Chips, Ingredients - Labeling - 585.710Processing - Use of Term in Section 405 of the FD&C Act - 562.650Salmonella Contamination of Dry Dog Food - 690.700Salt-Cured, Air-Dried, Uneviscerated Fish - 540.650Seeds for Sprouting Prior to Food Use - 555.750Spices - Definitions - 525.750Tomato Products - Adulteration with Mold - 585.900Tree Nuts - Adulteration Involving Rejects - 570.425Vinegar, Definitions - Adulteration with Vinegar Eels - 525.825

Water in Food Products (Ingredient or Adulterant) - 555.875

DRIED MALTMalt Products - 515.200

DRIED MUNG BEANSSeeds for Sprouting Prior to Food Use - 555.750

DROSOPHILACitrus Fruit Juices, Canned-Fly Filth & Mold - 550.250Raisins-Adulteration Involving Mold, & Insect Filth - 550.750Tomato Products-Drosophila Fly Eggs & Maggots - 585.890

DRUG CONTAMINATIONSequencing in Medicated Feed - 680.600

DRUG DISTRIBUTIONExpiration Dating of Unit Dose Repackaged Drugs - 480.200

DRUG INTERACTIONSExtra-Label Use of New Pet Drugs - 615.100

DRUG MARKETING APPLICATIONSConsistent Application of CGMP Determinations - 400.200

DRUGSAdequate Directions for Use - Animal Drugs and Devices - 607.100

Adequate Directions for Use - Veterinary Devices - 655.200Adulterated Food Mixed with Good Food - 555.200Adulteration of Drugs under Sec. 501(b) and 501(c) - 420.100Alcohol; Use of Synthetic Alcohol in Foods - 555.100Alternate Feeding of Different Medicated Feeds - 666.100Analytical Methodology Used by FDA - Drugs - 150.500Animal Drugs for Euthanasia - 650.100Animal Grooming Aids - 653.100Availability of Bulk Chemicals for Animal Drug Use - 625.200Biological Drugs for Animal Use - 645.100Blood and Blood Products - Definitions - 230.100 Candy "Pills" - 400.325 Certification for Exports - 110.100CGMP Applicability to Hardware and Software - 425.100CGMP Enforcement Policy - OTC vs Rx Drugs - 450.100CGMP's for Medicated Feeds - Daily Inventory Requirements -680.200Changes in Compendial Specifications and NDA Supplements - 420.300Checklist Labeling for Custom Mixed Medicated Feeds - 665.200 Chloramphenicol - 654.300Class I Recalls of Rx Drugs - 400.900Collection and Charitable Distribution of Drugs - 400.800Color Additives - 587.300Compendial Requirements - 420.400Compendium Revisions and Deletions - 420.200Compressed Medical Gases -- Warning Letters - 435.100 Computerized Rx Recordkeeping by Pharmacies - 460.400Computerized Drug Processing -- Vendor Responsibility - 425.200Computerized Drug Processing -- Input/Output Checking - 425.400Computerized Drug Processing -- I.D. of "Persons" - 425.500Confectionery - Use of Nonnutritive Substances as Ingredients - 515.100Consistent Application of CGMP Determinations - 400.200Content Uniformity Testing of Tablets and Capsules - 460.600Contract Sterilizers - 100.550Control/Accountability of TRP Materials - 450.550Controlled-release dosage form drugs - 460.700 Dimethyl Sulfoxide (DMSO) for Animal Use - 654.100Direct-Fed Microbial Products - 689.100Drug Product Entries in Periodic Publications - 400.700Drugs for Odor Control in Animals - 642.100Ethylenediamine Dihydroiodide (EDDI) - 651.100Expiration Dating of Unit Dose Repackaged Drugs - 480.200Expiration Dating and Stability Testing - 480.100Export of Uncertified Antibiotics - 405.200Extra-Label Use of New Animal Drugs in Food-Producing Animals - 615.100Failure to Register - 400.100Failure to Register - 625.500Finished Dosage Form Drugs in Bulk Containers - 410.100Flea and Tick Products Containing a Pesticide - 641.100Fraud, Untrue Statements of Material Facts, Bribery - 120.100Fructose-Containing Drugs - 400.335 Health Fraud - 120.500 Homeopathic Drugs - 400.400Hospital Pharmacies - 460.100Human Blood and Blood Products as Drugs - 230.120Human-Labeled Drugs Distributed & Used in Animal Medicine - 608.100Identical or Similar Product Names - 400.500Illegal Sales of Veterinary Prescription Drugs - 608.500Imported Products - Lack of English Labeling - 110.900Inert Glandular Preparations - OTC - 455.100Interference with Compendial Tests - 420.500Labeling of Shipping Containers for Drugs - 430.300Lack of Expiration Date or Stability Data - 480.300Large Volume Parenteral (LVP's) for Animal Use - 635.100Lay Use of Veterinary Prescription Drugs - 608.300Mail-Order Filling of Prescriptions - 460.450Malted Milk - 527.500Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200Maraschino Cherries - 550.550


413413

Marketed New Drugs Without Approved NDAs - 440.100Marmalade - 550.575Medicated Feeds -- Formula Information - 670.100Metric Declarations of Quantity of Contents - 140.500Microfiche and/or Microfilm for Records Retention - 130.400New Drugs - Export - 442.100Nutritional Supplements for Companion Animals - 690.100 Oral Iron Products for Baby Pigs - 643.100Orders for Post-Approval Record Reviews - 470.100OTC Drugs in Vending Machines - 450.400OTC Anti-Obesity Preparations - 456.100OTC Drugs - Recognition as Safe and Effective - 450.200OTC Drugs - Combination Products - 450.300OTC Ear Drops - 454.100Over-The-Counter Sale of Injectable Animal Drugs - 608.200Parametric Release of Terminally Heat Sterilized Drugs - 460.800Plasma Brokers - Registration and Compliance - 250.500Plastic Containers for Injectable Animal Drugs - 637.100 Prepared Mustard, Composition - 525.575Prescription Status - Telephone Answering Machine - 460.425Process Validation Requirements for Drug Products - 490.100Products Composed of Interstate Ingredients - 100.200Proper Drug Use and Residue Avoidance - 615.200 Reconditioning of New Animal Drugs Seized Under Sec. 501(a)(5) - 625.400Reconditioning New Drugs Lacking Approved NDA - 448.100Reconditioning of Articles Found in Violation of GMP's - 160.750Recovery of IND's from Clinical Investigators - 444.100Recycled Animal Waste - 685.100Registration of Blood Banks and Other Firms - 230.110Regulatory Action Regarding Approved New Drugs - 446.100Repacking of Drug Products -- CGMP's - 430.200Responsibility for Illegal Drug Residues in Meat, Milk and Eggs -615.300Return of Unused Rx Drugs to Pharmacy Stock - 460.300 RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200Rx Drugs for Ships' Medicine Chests - 460.500 Sequencing in Medicated Feed Production - 680.600Source Code for Process Control Application Programs - 425.300Spices - Definitions - 525.750Statements Regarding NADA Approval in Labeling and advertising - 605.100Sweet Potatoes, Dyeing of Yellow and Red Varieties - 585.825Tamper-Resistant Packaging Requirements - 450.500Teat Dips and Udder Washes for Dairy Cows and Goats - 654.200The Use of Antibiotic Drug Residue By-Products in Animal Feed - 682.200The Status of Syringes and Needles for Animal Use - 655.400Unapproved New Animal Drugs - Follow-up Action - 625.300Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100Unsafe Contamination of Animal Feed from Drug Carry over -680.500Urinary Preparations - Lack of Rx Legend - Claims - 430.400Vinegar, Definitions - Adulteration with Vinegar Eels - 525.825

DRUGS OF ABUSERIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200

DRUPELET BERRIES(Blackberries, Raspberries, etc...) - 550.200

DRYINGCalcium Chloride - 500.400Dimethylnitrosamine in Malt Beverages - 510.600DMNA in Barley Malt - 578.500Salt-Cured, Air-Dried, Uneviscerated Fish - 540.650Tomato Products - Adulteration w/ Mold - 585.900

DRYING AGENTCalcium Chloride - 500.400

DUODENUMInert Glandular Preparations - OTC - 455.100

DURUM FLOURMacaroni & Noodle Products - 505.500

E. COLIClams, Muscles, Oysters-Bacterial Contamination - 560.600Pathogens in Dairy Products - 527.300Reconditioning Tree Nuts Contaminated w/ E.coli - 570.550

EAR DROP PREPARATIONSOTC Eardrops - 454.100

EARLOBEEar Piercing Devices - 320.100

EARLY CORRECTION OF DEFECTSEarly Correction of Defects or Noncompliance - 390.225

EASY READINGClinical Thermometer-Adulteration;Misbranding Defects - 335.800

ECONOMICHealth Fraud - 120.500Human Labeled Drugs Distributed & Used-Animal Medicine - 608.100Regulatory Actions & Small Business - 160.100

EDAMCheese - Misbranding Due to Moisture & Fat - 527.225

EDIBLE TISSUEAction Levels for Aflatoxin in Pet Feeds - 683.100Proper Drug Use and Residue Avoidance - 615.200

Streptomycin Residues in Cattle - 616.100EFFECTIVENESS

Adequate Directions for Use - Animal Drugs and Devices - 607.100Alternate Feeding of Different Medicated Feeds - 666.100Cytotoxic Testing for Allergic Diseases - 370.100Direct Reference Authority for Class III Medical Devices - 300.700Expiration Dating and Stability Testing - 480.100Fraud, Untrue Statements of Material Facts, Bribery - 120.100Health Fraud - 120.500Lasers for Facelift, Wrinkle Removal, Acupuncture, Etc. - 393.200Marketed New Drugs Without Approved NDAs - 440.100Orders for Post-Approval Record Reviews - 470.100Process Validation Requirements for Drug Products - 490.100Regulatory Action Regarding Approved New Drugs - 446.100Reuse of Medical Disposable Devices - 300.500RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200Surgeons' Gloves and Patient Examination Gloves - 335.700

EFFERVESCENTUnfermented Beverages, Use of Word "Champagne" - 510.300

EGGChow Mein, Chinese Noodle - 505.400Eggnog, Eggnog Flavored Milk - 527.350Eggs and Other Egg Products - 537.100Hollandaise Sauce - 525.400Processed Blended Seafood Products - 540.700Processing Use of Term - 562.650Vitamins and Minerals in Feed - 670.200

EGG CONTENTOriental Noodles - 505.400

EGG YOLKEggnog Flavored Milk - 527.350Hollandaise Sauce - 525.400

EGGNOG FLAVORED MILKImported Milk & Cream - 560.400

ELECTROLYTE SOLUTIONLVP's for Animal Use - 635.100

ELECTRONICAssessment of Civil Penalties - 390.300Certification for Exports - 110.100Computerized Drug Processing -- Input/Output Checking - 425.400Defective Suntanning Booths and Beds - 396.300Definition of "Commerce" - 21 CFR 1000.3(g) - 390.100Determination by Secretary that Product Fails to Comply - 390.200Electronic Products Subject to 21 CFR 1001.15(a) - 390.400Exemption for Certain Sunlamp Product Purchaser Records - 396.200Hazardous Diagnostic X-Ray Systems - 398.200Importation of Television Receivers and Microwave Ovens - 394.500Peanuts, Shelled and Unshelled - Filth and Reject Nuts - 570.350Records and Reports - Applicability - 21 CFR 1002.1 - 390.425Retention of Microwave Oven Test Records - 394.100Sphygmomanometers - Accuracy - 310.210Tree Nuts - Adulteration Involving Rejects - 570.425Warning Label Required on Sunlamp Products - 396.400

ELECTRONIC PRODUCTSAssessment of Civil Penalties - 390.300Defective Suntanning Booths & Beds - 396.300Determination by Secretary: Product Fails to Comply - 390.200Electronic Products Subject to 21 CFR 1001.15(a) - 390.400Hazardous Diagnostic X-Ray Systems - 398.200Importation of TV Receivers & Microwave Ovens - 394.500Warning Label Required on Sunlamp Products - 396.400

ELECTROPHORETICQuantitative Testing for Serum Proteins-Plasmapheresis - 255.100

ELIXIRSUnit Dose Labeling for Solid & Liquid Oral Dose Forms - 430.100

EMBRYOAflatoxin in Peanuts & Peanut Products - 570.375Inert Glandular Preparations - OTC - 455.100

EMERGENCYClass I Recalls of Rx Drugs - 400.900Licensing - Changes to be Reported - 210.100Medical Emergencies - 220.100Pesticide Residues in Food and Feed - 575.100Radionuclides in Imported Foods - Levels of Concern - 560.750Registration of Blood Banks and Other Firms - 230.110

EMOTIONAL HEALTHHypnotherapy Devices-Self Hypnotic Tape Recordings - 335.300

EMULSIFYINGHollandaise Sauce - 525.400

ENDURANCE TESTINGRetention of Microwave Oven Test Records - 394.100

ENFORCEMENT ACTIONSAction Levels for Aflatoxin in Animal Feeds - 683.100CGMP Enforcement Policy - OTC vs Rx Drugs - 450.100Defective Suntanning Booths and Beds - 396.300Direct-Fed Microbial Products - 689.100


414414

Human-Labeled Drugs Distributed & Used in AnimalMedicine - 608.100Laser Light Shows, etc. - 393.100Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200Marketed New Drugs Without Approved NDAs - 440.100Pesticide Residues in Food and Feed - 575.100Process Validation Requirements for Drug Products - 490.100Proper Drug Use and Residue Avoidance - 615.200Red Meat Adulterated with PCB's - 565.200Regulatory Action Regarding Approved New Drugs - 446.100Safety and Labeling of Waxed (Coated) Fruits and Vegetables - 562.550Sunlamp Performance Standard - 396.100

ENGAGED IN THE BUSINESSDefinition of "Commerce" - 21 CFR 1000.3(g) - 390.100

ENRICHEDEnriched or Fortified Foods - 555.550Fortification of Standardized Juices - 510.700

ENSUREConsistent Application of CGMP Determinations - 400.200Dealcoholized Wine *and Malt Beverages* - Labeling - 510.400Dimethylnitrosamine (DMNA) in Barley Malt - 578.500Direct Reference Authority for Class III Medical Devices - 300.700

Expiration Dating of Unit Dose Repackaged Drugs - 480.200Fraud, Untrue Statements of Material Facts, Bribery - 120.100

Human-Labeled Drugs Distributed & Used in Animal Medicine - 608.100Process Validation Requirements for Drug Products - 490.100Proper Drug Use and Residue Avoidance - 615.200Recycled Animal Waste - 685.100Regulatory Actions and Small Business - 160.100Regulatory Action Regarding Approved New Drugs - 446.100Rendered Animal Feed Ingredients - 675.400Salt-Cured, Air-Dried, Uneviscerated Fish - 540.650

ENTERIC COATEDUnit Dose Labeling for Solid & Liquid Oral Dose Forms - 430.100

ENTRANCE EXPOSURE RATESAssemblers Who Install Noncompliant Equipment - 398.325

ENURESISHypnotherapy Devices-Self Hypnotic Tape Recordings - 335.300

ENVIRONMENT SENSITIVITY TO LOAD PLACEMENT CAVITYRetention of Microwave Oven Test Records - 394.100

EPIDURALOTC Sale of Injectable Pet Drugs - 608.200

EQUIVALENTApple Butter - Adulteration with Mold; Rodent Filth, Insects - 550.100Asparagus, Canned or Frozen - Adulteration with Insect Filth - 585.150Canned Salmon - Adulteration Involving Decomposition - 540.375Class III Devices Subject to 5l5(b) Requirements - 300.750Commercial Distribution -- Premarket Notification - 300.600Compressed Medical Gases -- Warning Letters - 435.100Computerized Drug Processing -- I.D. of "Persons" - 425.500Consistent Application of CGMP Determinations - 400.200Corn Meal - Adulteration by Insect and Rodent Filth - 578.200Corn, Sweet; Canned - Adulteration - 585.300Cowpeas (Black-Eyed Peas); Canned (Succulent Peas) - Insects - 585.400Dates and Date Material; Imported and Domestic - 550.300Dealcoholized Wine *and Malt Beverages* - Labeling - 510.400Dimethylnitrosamine (DMNA) in Barley Malt - 578.500Direct Reference Authority for Class III Medical Devices - 300.700Drupelet Berries (Blackberries, Raspberries, etc.) - 550.200Expiration Dating of Unit Dose Repackaged Drugs - 480.200Foreign Language Declarations on Food Labels - 562.400Fraud, Untrue Statements of Material Facts, Bribery - 120.100Green Coffee Beans - Adulteration with Insects; Mold - 510.500Health Fraud - 120.500Human-Labeled Drugs Distributed & Used in Animal Medicine - 608.100Peaches, Canned, Frozen -- Adulteration Due to Insects and Mold - 550.650Peanuts, Shelled and Unshelled - Filth and Reject Nuts - 570.350Process Validation Requirements for Drug Products - 490.100Proper Drug Use and Residue Avoidance - 615.200Raisins - Adulteration Involving Mold, Sand, Grit, & Insects - 550.750Recycled Animal Waste - 685.100Regulatory Actions and Small Business - 160.100Regulatory Action Regarding Approved New Drugs - 446.100Rendered Animal Feed Ingredients - 675.400Responsibility for Reporting Violations - 100.100RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200Salt-Cured, Air-Dried, Uneviscerated Fish - 540.650Tomato Products - Drosophila Fly Eggs and Maggots - 585.890Vitamin B-15, Pangamic Acid and Pangamic Acid Products - 457.100

ERYTHEMASunlamp Performance Standard - 396.100

ESCHERICHIA COLICrabmeat - Adulteration with Filth - Escherichia Coli - 540.275Raw Breaded Shrimp - Microbiological - 540.420Tree Nuts - Escherichia Coli - 570.450

ESSENTIAL ACCESSORY

Karaya Gum Powder & Devices for Use by Ostomates - 325.100ESTABLISHMENT, CLASSIFICATION OF

Classification of establishment - 555.500ESTRUS

Drugs for Odor Control in Pet - 642.100ETHER EXTRACT

Spices- Definitions - 525.750ETHYLENE OXIDE

Karaya Gum Powder & Devices for Use by Ostomates - 325.100Parametric Release of Terminally Heat Sterilized Drugs - 460.800

ETIOLOGIC AGENTSBlood & Blood Products - Definitions - 230.100

EUROPEAN LOBSTERCommon or Usual Names for Crustaceans - 540.350

EUTHANASIAAnimal Drugs for Euthanasia - 650.100Lay Use of Veterinary Prescription Drugs - 608.300

EXCESSIVE HARDNESSPeaches, Canned Misbranding Standards - 550.655

EXCORIATEDKaraya Gum Powder & Devices for Use by Ostomates - 325.100

EXEMPTION FROM REGISTRATIONInspection of Manufacturers of Device Components - 300.100Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200Pesticide Residues in Food and Feed - 575.100Registration of Blood Banks and Other Firms - 230.110

EXEMPTS THEM FROM INSPECTIONInspection of Manufacturers of Device Components - 300.100Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200

EXHAUST RATESphygmomanometers - Accuracy - 310.210

EXHIBITSPeas & Beans, Dried-Storage Insect Damage, Rocks - 585.575Contamination of Devices Labeled as Sterile - 300.400Foods, Rail Car Sanitation - Adulteration - 545.300

EXPERTDecomposition & Histamine in Albacore, Skipjack, Tuna - 540.525Drugs for Odor Control in Animals - 642.100Payment of Expert Witness - 160.600Squash Seeds - Labeling as Pumpkin Seeds - 585.800

EXPIRATION DATEExpiration Dating & Stability Testing - 480.100Lack of Expiration Date or Stability Data - 480.300Parametric Release of Terminally Heat Sterilized Drugs - 460.800

EXPIRATION DATINGExpiration Dating & Stability Testing - 480.100Expiration Dating of Unit Dose Repackaged Drugs - 480.200Homeopathic Drugs - 400.400Regulatory Action Regarding Approved New Drugs - 7132c.16Unit Dose Labeling for Solid&Liquid Oral Dose Forms - 430.100

EXPORTExports from U.S. Foreign Trade Zones - 110.200

EXPORTATIONArticles of Foreign Origin Not Intended for Entry - 110.700Class III Devices Subject to 515 (b) Requirements - 300.750Coffee & Cocoa Bean Sweeps - 560.350Foreign Traded Zones,Bonded Warehouses or Carriers - 110.600Importation of TV Receivers & Microwave Ovens - 394.500Imported Frozen Products of Multiple Sizes or Codes - 560.700Imports - Post Detention Sampling - 110.800New Drugs - Export - 442.100Unapproved Additives For Exported Grains - 578.600

EXPORTERClass III Devices Subject To 515 (b) Requirements - 300.750Returned Antibiotics Exported Under 801(d)of The Act - 405.210Unapproved Additives for Exported Grains - 578.600

EXPOSUREAction Levels for Aflatoxin in Animal Feeds - 683.100Assemblers Who Install Noncompliant Equipment - 398.325Assessment of Civil Penalties - 390.300Automatic Adjustment of the X-Ray Field Size - 398.400Blood and Blood Products - Definitions - 230.100Dimethylnitrosamine in Malt Beverages - 510.600Hazardous Diagnostic X-Ray Systems - 398.200Lasers for Facelift, Wrinkle Removal, Acupuncture, etc. - 393.200Preservatives; Use in Nonstandardized Foods; Label Declaration - 562.600Salmonella Contamination of Dry Dog Food - 690.700Sunlamp Performance Standard - 396.100Use of DDVP (Vapona) Strips in Milkhouses and Milkrooms - 527.600Volatile N-Nitrosamine in Rubber Baby Bottle Nipples - 500.450Whole Milk, Low Fat Milk, Skim Milk - Aflatoxin M1 - 527.400

EXPOSURE RATEAssemblers Who Install Nocompliant Equipment - 398.325

EXTEMPORANEOUSLY COMPOUNDED OTC PRODUCTSHomeopathic Drugs - 400.400

EXTERIOR SURFACE


415415

Warning Label Required on Sunlamp Products - 396.400EXTRACTED FOOD ANTIGENS

Cytotoxic Testing For Allergic Diseases - 370.100EXTRACTS

Allergenic Extracts Containing Glycerin - 270.100Bouillon, Bouillon Cubes, Granulated Bouillon - 567.300Dealcoholized\Wine Malt Beverages - Labeling - 510.400Inert Glandular Preparations - OTC - 455.100Intermediate or End Products of Sample Analysis - 150.100Lack of Expiration Date or Stability Data - 480.300Malt Products - 515.200

EXTRA-LABELExtra Label Use of New Pet Drugs - 615.100Proper Drug Use Residue Avoidance - 615.200Unapproved New Animal Drugs - 625.300

EXTREMITIESPositive Beam Limitation (PBL) Requirements - 398.450

EXTRAORAL IMAGE RECEPTORSDefinition of General Purpose Radiographic X-RaySystem - 398.100

EYE INFLAMMATIONMercury Vapor Lamps--Not Self-Extinguishing - 391.200

FAA ACTLabeling-Diluted Wines & Cider w/ < 7%Alcohol - 510.450

FACIALFacial Tissue, Paper Napkins, Paper Towels, etc. - 100.600Lasers for Facelift, Wrinkle Removal, Acupuncture, etc - 393.200

FACIAL CARE ESTABLISHMENTSLasers for Facelift, Wrinkle Removal, Acupuncture, etc. - 393.200

FACSIMILECanned Peas - Label Designation of Sizes - 585.625Food Storage & Warehousing -Adulteration-Filth - 580.100Guaranties Over Printed Signatures - 100.800Tamper-Resistant Packaging Requirements - 450.500

FACTORY-BASED MANUFACTURERS AND ASSEMBLERSObligations of Factory-Based Manufacturers & Assemblers - 398.375

FAILURE ANALYSIS RECORDSReloaders of X-ray Tube Housing Assemblies - 398.700

FAIR PACKAGING AND LABELING ACTAntipasto, Common or Usual Name - 567.100Beverage Bases - 510.100Confectionery Decorations - 545.200Food Distributed in Puerto Rico - 562.750Labeling Diluted Wines and Cider - 510.450Pumpkin Articles from Squash - 585.725Starches-Common or Usual Names - 578.100

FAST TURNAROUND TIME Reloaders of X-Ray Tube Housing Assemblies - 398.700

FATButter Adulteration - 527.100Cheese Misbranding - 527.225Hollandaise Sauce - 525.400Nutritional Supplements for Animals - 690.100Oleomargarine-Misbranding - 535.100Pesticide Residues in Food and Feed - 575.100Potato Chips, Ingredients-Labeling - 585.710Prepared Mustard, Composition - 525.575Red Meat with PCB's - 565.200Rendered Animal Feed Ingredients - 675.400Seafood Products - 540.700Whole Low and Skim Milk - 527.400

FATTY ACIDNutritional Supplements for Pets - 690.100

FD&C ACTOrigin of Country Labeling - 560.200

FDA JURISDICTIONCertificate for Exports - 110.100Condoms; Defects-Criteria for Direct Reference Seizure - 345.100Country of Origin Labeling - 560.200On Indian Reservations - 100.350Over Meat & Poultry Products - 565.100Products Composed of Interstate Ingredients - 100.200Recondition-New Animal Drugs Seized Under 501(a)(5) - 625.400

FEDERAL TRADE COMMISSION (FTC)Cytotoxic Testing For Allergic Diseases - 370.100Health Fraud - 120.500

FENNEL SEEDSpices - Definition - 525.750

FENUGREEKSpices - Definition - 525.750

FERMENTATIONAlcohol Use of Synthetic Alcohol in Foods - 555.100Dealcoholized Wine Labeling - 510.400Direct-Fed Microbial Products - 689.100Maraschino Cherries - 550.550Sauerkraut-Adulteration by Thrips - 585.750

Silage Ingredients - 687.500The Use of Antibiotic Drug Residue By-Products - 682.200Unfermented Beverages "Champagne" - 510.300Vinegar, Definitions with Vinegar Eels - 525.825

FIELD LIMITATION AND ALIGNMENTAutomatic Adjustment of the X-Ray Field Size - 398.400

FIELD PEASBlack-Eyed Peas - 585.225

FIELD SURVEILLANCE ACTIVITIESDefective Suntanning Booths & Beds - 396.300

FIELD TESTINGAssemblers Who Install Noncompliant Equipment - 398.325

FIG PASTEInsect Infestation - 550.350

FIGSInsect Infestation - 550.350Pesticide Residues - 575.100

FILBERTSTree Nuts-Adulteration for Rejects - 570.425

FILLETSFish-Adulteration Decomposition - 540.575Fish by Parasites - 540.590Identity of Foods - 562.450

FILM WRAPPERSTamper-Resistant Packaging Requirements - 450.500

FILTH- See attached listApple Butter - Adulteration with Mold; Rodent Filth, Insects - 550.100Apricot, Peach and Pear Nectars and Purees - Mold - 550.155Articles of Foreign Origin Not Intended for Entry - 110.700Asparagus, Canned or Frozen - Adulteration with Insect Filth - 585.150Bay (Laurel) Leaves - Insect Filth; Mold; Mammalian etc - 525.150 Capsicum Pods, Etc. - Adulteration - 525.200Cheese and Cheese Products - Adulteration with Filth - 527.200Chocolate & Chocolate Liquor - Adulteration - 515.700Citrus Fruit Juices, Canned - Fly Filth and Mold - 550.250Cocoa Powder, Press Cake - Insect and Rodent Filth and Shell - 515.775Coffee and Cocoa Bean Sweeps - 560.350Corn Husks (for Tamales) - Adulteration with Filth - 585.350Corn Meal - Adulteration by Insect and Rodent Filth - 578.200Crabmeat - Adulteration with Filth - Escherichia coli - 540.275Curry Powder - Adulteration by Insect and Rodent Filth - 525.330

Diversion of Adulterated Food to Acceptable Animal Feed Use - 675.200Dried Prunes, Dehydrated Low Moisture Prunes, and Pitted Prunes - 550.700Food Storage & Warehousing - Adulteration-Filth - 580.100Foods - Adulteration Involving Infestation and 1080 Rodenticide - 555.450Foods, Rail Car Sanitation - Adulteration - 545.300Green Coffee Beans - Adulteration with Insects; Mold - 510.500Intermediate or End Products of Sample Analysis - 150.100Interpretation of Insect Filth in Foods - 555.600Leafy Spices, Other Than Bay Leaves - 525.500Macaroni and Noodle Products - 505.500Mace - Insect Filth; Mold, Foreign Matter; Mammalian Excreta - 525.550Marjoram - 525.900Oregano - 525.850Peanut Butter - Adulteration with Filth; Grit - 570.300Peanuts, Shelled and Unshelled - Filth and Reject Nuts - 570.350Popcorn - Adulteration with Rodent Filth and Field Corn - 585.675Proper Drug Use and Residue Avoidance - 615.200Raw Sugar - 515.400Reconditioning of Foods Adulterated Under 402(a)(4) - 160.700Reconditioning - Tree Nuts Contaminated with E. coli - 570.550Rodent Contaminated Pet Foods - 690.600Sage - 525.950Sesame Seeds - Adulteration - 525.700Thyme - 525.925Tree Nuts - Escherichia coli - 570.450Water-Damaged Food Products - 555.850Wheat - Adulteration by Insect and Rodent Filth - 578.300Whole and Ground Pepper - Adulteration - 525.625Whole Ginger - Insect Filth; Mold; Mammalian Excreta - 525.375Whole Cassia or Whole Cinnamon, Ground Cinnamon - 525.225Whole and Ground Nutmeg - Insect Filth; Mold; Rodent Filth - 525.600Whole and Ground Allspice - Mold; Insect and Rodent Filth - 525.100

FILTRATIONParametric Release of Terminally Heat Sterilized Drugs - 460.800Vinegar, Definitions-Adulteration w/ Vinegar Eels - 525.825

FINAL CLASSIFICATIONClass III Devices Subject to 515 (b) Requirements - 300.750

FINAL COMPLIANCE TESTRetention of Microwave Oven Test Records - 394.100

FINISHED UNITSRecords & Reports-Applicability-21 CFR 1002.1 - 390.425

FISH - FRESH AND FROZENFish-Fresh and Frozen-Adulteration Involving Decomposition - 540.575Fish - Fresh and Frozen, as Listed - Adulteration by Parasites - 540.590

FISH FLAKES


416416

Crabmeat Product Labeling - 540.285FIXED SID

Definition of General Purpose Radiographic X-Ray System - 398.100X-Ray Field Size for Spot-Film - 398.475

FLATWAREPottery Cadmium Contamination - 545.400Pottery Lead Contamination - 545.450

FLAVORING AGENTSDenture Cleaners, Adhesives, & Repair Materials - 315.200

FLAVORINGSBakery Products - 505.100Labeling of Seasonings - 525.650Spices - Definitions - 525.750

FLEXIBILITYAutomatic Adjustment of X-Ray Field Size - 398.400Computerized Drug Processing-Input/Output Checking - 425.400Regulatory Actions & Small Business - 160.100

FLOUNDERCrabmeat Products Labeling - 540.285

FLUID-BORNE INFECTIOUS AGENTSSurgeons' Gloves and Patient Examination Gloves - 335.700

FLUOROSCOPICAssemblers Who Install Noncompliant Equipment - 398.325Automatic Adjustment of X-Ray Field Size - 398.400X-Ray Field Size for Spot-Film - 398.475

FLUOROSCOPISTAutomatic Adjustment of X-Ray Field Size - 398.400

FLY FILTHIn Citrus Fruit Juices - 550.250

FOOD ADDITIVEAmmoniated Cottonseed Meal - 670.500Approved by FDA - 510.200Brandy Containing Methyl Alcohol - 510.200Confectionery Decorations - 545.200Direct-Fed Microbial Products - 689.100Fraud, Untrue Statements, Facts, Bribery - 120.100Imports Identity of Ingredients - 560.250Labeling with Directions for Use - 500.100Labeling Directions Necessary - 500.250Meat and Poultry - 565.100Pesticide Residues - 575.100Pottery Cadmium Contamination - 545.400Pottery Lead Contamination - 545.450Preservatives; In Nonstandard Foods - 562.600Recycled Animal Waste - 685.100Silage Ingredients - 687.500Silver-Plated Hollowware Lead - 545.500Teat Dips and Udder Washes - 654.200Vitamin B-15, Pangamic Acid - 457.100Vitamins and Minerals in Feed - 670.200

FOOD ADDITIVES - GRASFood Additives -"GRAS" - 500.200Safety and Labeling of Waxed (Coated) Fruits and Vegetables - 562.550

FOOD ADDITIVES - LABELING DIRECTIONSAdditives Labeling Directions - 500.100Approved by FDA - 500.300Food Additives Labeling Directions - 500.250

FOOD, ADULTERATED - MIXED WITH GOOD FOODAdulterated Food Mixed w/ Good Food - 555.200Diversion-Adulterated Food to Acceptable Animal Feed Use - 675.200Proper Drug Use & Residue Avoidance - 615.200Seeds for Sprouting Prior to Food Use - 555.750

FOOD LABELS - FOREIGN LANGUAGE DECLARATIONForeign Language Declarations - 562.400

FOOD STORAGE - WAREHOUSINGAdulteration Filth - 580.100Cocoa Beans Mold Filth - 515.750Coffee and Cocoa Bean Sweeps - 560.350Green Coffee Beans - 510.500Interpretation of Filth in Foods - 555.600Rodent Contaminated Pet Foods - 690.600

FOOD, WATER DAMAGEDWater Damaged Food Products - 555.850

FOODSAction Levels for Aflatoxin in Pet Feeds - 683.100Enriched of Fortified Foods - 555.550Foods, Adulteration with Aflatoxin - 555.400Foods Adulteration with Salmonella - 555.300Moisture Damaged Grain - 675.300Salmonella Contamination of Dry Dog Food - 690.700

FOODS - ADULTERATION INVOLVING MISBRANDINGEnriched or Fortified Foods - Potency - 555.550

FOODS - ADULTERATION WITH AFLATOXINAction Levels for Aflatoxin in Animal Feeds - 683.100Brazil Nuts - Adulteration with Aflatoxin - 570.200Foods, Adulteration with Aflatoxin - 555.400

Pistachio Nuts - Aflatoxin Adulteration - 570.500FOODS

FPLA Compliance - 562.200FOODS - NET WEIGHT

Cheese & Cheese Products - Misbranding Involving Net Contents - 527.250Corn on the Cob, Canned - Quantity of Contents Declaration - 585.325Foods - Net Weight - 562.300Lingon Berries, Canned - Adulteration by Insects - 550.500Metric Declarations of Quantity of Contents - 140.500Mixed Nuts - Misbranding Involving Food Standards - 570.700Mixed Nuts - Misbranding Involving Food Standards - 570.700

FOODS-PRODUCING ANIMALSAlternate Feeding of Medicated Feeds - 666.100Extra-Label Use of Pet Drugs in Pets - 615.100Human-Labeled Drugs in Pet Medicine - 608.100Illegal Sales of Veterinary Prescription Drugs - 608.500Proper Drug Use and Residue Avoidance - 615.200Use of Antibiotic Drug Residue - 682.200Unsafe Contamination of Pet Feed Carryover - 680.500

FOODS - STANDARDIZEDEnriched or Fortified Foods - 555.550Fortification of Juices - 510.700Honey Bread, Honey Buns - 505.350Malted Milk - 527.500

FOOT ROTEthylenediamine Dihydroiodide - 651.100

FOREIGNAcupuncture Devices and Accessories - 305.100Articles of Foreign Origin Not Intended for Entry - 110.700Bouillon, Bouillon Cubes, Granulated Bouillon - 567.300Brandy Containing Methyl Alcohol - Food Additive - 510.200Certificate for Exports - 110.100Exports from U.S. Foreign Trade Zones - 110.200Food and Drug Guaranty - Imports - 110.500Foreign Language Declarations on Food Labels - 562.400Foreign Trade Zones, Bonded Warehouses or Carriers - 110.600Homeopathic Drugs - 400.400Importation of Unlabeled Foods -- *21 CFR 101.100(d)* - 560.100Importation of Licensed Biologic Products for Human Use - 210.150Imported Products - Lack of English Labeling - 110.900Imported Milk and Cream. Import Milk Act - 560.400Imported Low-Acid Canned Foods - 560.450Mace - Insect Filth; Mold, Foreign Matter; Mammalian Excreta - 525.550Metric Declarations of Quantity of Contents - 140.500New Drugs - Export - 442.100Olives Stuffed with Minced Pimentos - Labeling - 550.605Pacemaker Reuse - 310.100Pesticide Residues in Food and Feed - 575.100Returned Antibiotics Exported Under 801(d) of the Act - 405.210Sesame Seeds - Adulteration - 525.700Surgeons' Gloves and Patient Examination Gloves - 335.700Unapproved Additives for Exported Grains - 578.600Uncertified or Delisted Colors - 587.200Whole and Ground Pepper - Adulteration - 525.625

FOREIGN MATTERMace Filth; Mold, Mammalian Excreta - 525.550Sesame Seeds - 525.700Whole and Ground Pepper - 525.625

FOREIGN NAMESForeign Language of Food Labels - 562.400

FOREIGN PROTEIN MATTERPacemaker Reuse - 310.100

FORMULATIONCertificate for Exports - 110.100Large Volume Parenteral (LVPs) for Animal Use - 635.100Marketed New Drugs w/oApprovd NDAs - 440.100Nutritional Supplements for Companion Animals - 690.100OTC Anti-Obesity Preparations - 456.100Processed and/or Blended Seafood Products - 540.700Source Code for Process Control Application Programs - 425.300Urinary Preparations-Lack of Rx Legend-Claims - 430.400

FORTIFIEDEnriched or Fortified Foods-Potency - 555.550Fortification of Juices - 510.700Imported Milk and Cream - 560.400

FRACTIONATIONBlood & Blood Products - Definitions - 230.100Registration of Blood Banks & Other Firms - 230.110Source Plasma - Syphilis - 254.100

FRAUDArticles of Foreign Origin Not Intended for Entry - 110.700Electrical Muscle Stimulators - 355.200Fraud, Untrue Statements of Material Facts, Bribery - 120.100 Health Fraud - 120.500Homeopathic Drugs - 400.400Hypnotherapy Devices - Self Hypnotic Tape Recordings - 335.300


417417

Ineffective Devices - 502(f)(l) Labeling Requirements - 300.300Ion Generating Devices - 355.300Orders for Post-Approval Record Reviews - 470.100

FREEFoods - FPLA Compliance - 562.200Identity of Foods - 562.450Metric Declarations of Contents - 140.500Water in Food Products - 555.875

FREEDOM FROM HAZARD Sunlamp Performance Standard - 396.100

FREEDOM OF INFORMATION (FOI)Regulatory Actions and Small Business - 160.100Statements Regarding NADA Approval - 605.100

FREESTONE PEACHESCanned Misbranding Food Products - 550.655

FREEZE DRIEDFDA Over Meat & Poultry Products - 565.100Mushrooms, Canned or Dried - 585.500

FRESHCherries - 550.225Classification of Establishments - 555.500Crabmeat Filth Coli - 540.275Fish Adulteration by Parasites - 540.590Fish Decomposition - 540.300Identify of Foods - 562.450Peas and Carrots Labeling - 585.600Pesticide Residues in Food Feed - 575.100Shrimp - 540.400Sugar Water Damaged - 515.425Time Period Separation of Platelets - 231.120Use of Units Which Have Been Thawed - 253.100

FRESHENING THE MOUTHDenture Cleaners, Adhesives, Cushions, and Repair Materials- 315.200

FROZENAsparagus, Canned Frozen Filth - 585.150Broccoli, Adulteration with Insects - 585.260Brussels Sprouts, Insects - 585.275Canned and Cooked Shrimp - 560.650Cherries - 550.225Crabmeat Filth E. coli - 540.275Drupelet Berries - 550.200Eggs and Egg Products Decomposition - 537.100Fish Adulteration/Decomposition - 540.575Fish Adulteration by Parasites - 540.590Identity of Foods - 562.450Imitation Breaded Shrimp - 540.450Immune Milk - 275.100Imported Milk and Cream - 560.400Imported Frozen Products - 560.700Metric Declarations of Contents - 140.500Peaches, Canned, Frozen Insects - 550.650Peas and Carrots, Labeling - 585.600Pesticide Residues in Food and Feed - 575.100Pet Food Labeling - 690.200Raw Breaded Shrimp-Microbiological - 540.420Seafood Products - 540.700Shrimp- Raw, Breaded - 540.410Shrimp-Fresh Frozen - 540.400Spinach Insects, Decomposition - 585.775Strawberries Sand, Mold - 550.850Time Period Separation of Platelets - 231.120Uncooked Meat for Animal Food - 690.500Use of Units Thawed - 253.100

FRUCTOSEFructose-Containing Drugs - 400.335Jerusalem Artichoke-Common or Usual Name - 585.100

FRUITAlcohol; Use of Synthetic Alcohol in Foods - 555.100Apricot, Peach and Pear Nectars and Purees - Mold - 550.155Apricots - Canned - Adulteration with Insects - 550.150Bakery Products, Candy "Shotgun" Ingredients Declaration - 505.100Candied Citron - Labeling - 515.600Citrus Fruit Juices, Canned - Fly Filth and Mold - 550.250Dealcoholized Wine *and Malt Beverages* - Labeling - 510.400Drupelet Berries (Blackberries, Raspberries, Etc.) - 550.200Figs; Fig Paste - Insect Infestation; Mold, Dirt - 550.350Grenadine - 550.400Jams, Jellies and Related Products - Imports - 560.500Jellies, Nonstandardized - 550.475Marmalade - 550.575Olives - Adulteration Involving Pits; Rot; Insect Infestation - 550.600Peaches, Canned, Frozen--Adulteration Due to Insects and Mold - 550.650Pineapple, Canned; Imported and Domestic - Food Standards - 550.685Pottery (Ceramics) - Lead Contamination - 545.450Spices - Definitions - 525.750

Standardized Canned Fruit - Packing Medium - 550.800FRUIT PEEL

Marmalade - 550.575FULL RESPONSIBILITY

Reuse of Medical Disposable Devices - 300.500FULLY ASSEMBLED UNIT

Retention of Microwave Oven Test Records - 394.100FURAZOLIDONE

Extra-Label use of New Pet Drugs - 615.100Unsafe Contamination of Pet Feed Carryover - 680.500

GAS CHROMATOGRAPHRIA Analysis of Hair to Detect Presence-Drugs of Abuse - 370.200

GASTROENTERITISImmune Milk - 275.100

GELATINSilver Plated Hollowware - 545.500Tamper Resistant Packaging - 450.500

GELATIN CAPSULE PRODUCTSTamper-Resistant Packaging Requirements - 450.500

GENERAL COUNSELAmmoniated Cottonseed Meal - Interpretation of 21 CFR 573.140 - 670.500

Answering Inquiries on Status of Criminal Referrals - 160.500 Chloramphenicol - 654.300Cocoa Beans - Mold, Insect Infestation, and Mammalian Excreta - 515.750Dentures -- Sale by Persons Not Licensed to Practice dentistry - 315.100Direct Reference Authority for Pseudomonas Contamination - 590.300FDA Jurisdiction Over Meat and Poultry Products - 565.100Food Storage & Warehousing - Adulteration - Filth - 580.100Foods, Rail Car Sanitation - Adulteration - 545.300Imported Products - Lack of English Labeling - 110.900Natural Bristle Brushes -- Nit Contamination - 590.400Popcorn - Adulteration with Rodent Filth and Field Corn - 585.675Rodent Contaminated Pet Foods - 690.600Tomato Products - Adulteration with Mold - 585.900

GENERAL LABELING REQUIREMENTSHomeopathic Drugs - 400.400

GENERAL PUBLICClass I Recalls of Rx Drugs - 400.900Electrical Muscle Stimulators - 355.200Mail-Order Filing of Prescriptions - 460.450Mercury Vapor Lamps--Not Self-Extinguishing - 391.200Unit Dose Labeling for Solid & Liquid Oral Dose Forms - 430.100

GENERAL PURPOSE RADIOGRAPHIC X-RAY SYSTEMDefinition - 398.100

GENERAL TESTSExpiration Dating of Unit Dose Repackaged Drugs - 480.200Unit Dose Labeling for Solid & Liquid Oral Dose Forms - 430.100

GENERALLY RECOGNIZED AS SAFE (GRAS)Ethylenediamine Dihydroiodide (EDDI) - 651.100Food Additives-"GRAS" - 500.200Recycled Animal Waste - 685.100Silage Ingredients - 687.500Spices Definitions - 525.750Teat Dips and Udder Washes - 654.200Vitamins and Minerals in Feed - 670.200Waxed Fruits - 562.550

GENERICCrab & Crabmeat Products w/Other Seafood-Labeling - 540.285Fraud, Untrue Statements of Material Facts, Bribery - 120.100Manufacturer, Distribution, Promotion of Drugs by Pharmacies - 460.200Orders for Post-Approved Record Reviews - 470.100Water & Gravy in Pet Food - 690.400

GENTIAN VIOLETUnapproved Additives - 578.600

GEOGRAPHICAL ORIGIN OF A FOODCountry of Origin Labeling - 560.200

GINGERSpices-Definition - 525.750Whole Ginger- Filth - 525.375

GLANDULAR PREPARATIONInert Glandular Preparations - OTC - 455.100

GLUCOSE VINEGARVinegar, Definitions Vinegar Eels - 525.825

GLYCERINAllergenic Extracts Containing Glycerin - 270.100Malt Products - 515.200

GLYCOSIDE SINIGRINSpices - Definitions - 525.750

GOLDEN BLEACHED RAISINSRaisins-Adulteration with Filth - 550.750

GOOD MANUFACTURING PRACTICE REGULATIONSCGMP Applicability to Hardware and Software - 425.100Compressed Medical Gases -- Warning Letters - 435.100Computerized Drug Processing -- Input/Output Checking - 425.400

Computerized Drug Processing -- I.D. of "Persons" - 425.500Content Uniformity Testing of Tablets and Capsules - 460.600


418418

Control/Accountability of TRP Materials - 450.550Expiration Dating of Unit Dose Repackaged Drugs - 480.200Finished Dosage Form Drugs in Bulk Containers - 410.100Lack of Expiration Date or Stability Data - 480.300Orders for Post-Approval Record Reviews - 470.100Raw Breaded Shrimp - Microbiological - 540.420Reconditioning of Articles Found in Violation of GMP's - 160.750Source Code for Process Control Application Programs - 425.300Unsafe Contamination of Animal Feed from Drug Carryover - 680.500

GOUDACheese Misbranded Due to Moisture & Fat - 527.225

GOVERNMENT WIDE QUALITY ASSURANCE PROGRAMCompendial Requirements - 420.400GWQAP Pre-Award Evaluation - 100.700

GOVERNMENT-WIDEConsistent Application of CGMP Determinations - 400.200GWQAP Pre-Award Evaluation - 100.700Compendial Requirements - 420.400

GOVERNMENTSCertification for Exports - 110.100Common or Usual Names for Animal Feed Ingredients - 665.100Imitation Breaded Shrimp - 540.450Imported Milk and Cream Import Milk Act - 560.400Lay Use of Veterinary Prescription Drugs - 608.300Responsibility for Reporting Violations - 100.100Water-Damaged Food Products - 555.850

GRADE 'A' PASTEURIZED MILK ORDINANCEAcetic Acid-Use in Foods - 562.100Antibiotic Drug Residue by Products - 682.200Canned Peas-Label Designation of Sizes - 585.625Dimethyl Sulfoxide for Animal Use - 654.100Eggnog; Eggnog Flavored Milk - 527.350Food Additives "GRAS" - 500.200Food Additives Labeling Directions - 500.250Green Coffee Beans, Mold - 510.500Imported Milk and Cream - 560.400Peas and Beans; Dried Rocks - 585.575Preservatives; Label Declaration - 562.600Responsibility for Reporting Violations - 100.100Teat Dips and Udder Washes - 654.200

GRAIN VINEGARVinegar, Definitions - 525.825

GRANULARBouillon, Bouillon Cubes - 567.300Cheese - 527.225

GLUCOSEFructose-Containing Drugs - 400.335LVP's for Animal Use - 635.100Malt Products - 515.200Vinegar, Definitions with Vinegar Eels - 525.825

GRAPE JUICEUnfermented Beverages - 510.300

GRAPE VINEGARVinegar, Definitions - 525.825

GRATUITIESFraud, Untrue Statements of Material Fact, Bribery - 120.100

GREEN BEANS, CANNEDCanned Wax Beans - 585.475

GREEN COFFEE BEANSAdulteration with Filth - 510.500Reconditioning - 560.300

GREENS, CANNEDAdulteration by Mildew - 585.450

GRITCumin Seed Adulteration - 525.325Menstrual Sponges - 345.300Peanut Butter Adulteration - 570.300Raisins Adulteration - 550.750

GROSS NEGLIGENCEAssemblers Who Install Noncompliant Equipment - 398.325

GROUND CAPSICUMSCapsicum Pods- Adulteration - 525.200

GROUND OREGANOLabeling of Seasonings - 525.650Oregano - 525.850

GROUND PAPRIKA Capsicum Pods - Adulteration - 525.200

GRUYERECheese - 527.225

GUARANTYFood & Drug Guaranty - Imports - 110.500Guaranties Over Printed Signatures - 100.800

HABIT CORRECTIONHypnotherapy Devices-Self-Hypnotic Tape Recordings - 335.300

HAIR LOSSHypnotherapy Devices-Self-Hypnotic Tape Recordings - 335.300

HAIR SAMPLERIA Analysis-Hair to Detect Presence of Drugs of Abuse - 370.200

HALVEDOlives-Adulteration Involving Pits; Rot; Insect infestation - 550.600

HARDENERDenture Cleaners, Adhesives, & Repair Materials - 315.200

HAZARDAdulteration of Drugs under Sec. 501(b) and 501(c) - 420.100Articles of Foreign Origin Not Intended for Entry - 110.700Canned Pet Food - 690.300CGMP Enforcement Policy - OTC vs Rx Drugs - 450.100Clams, Mussels, Oysters - Paralytic Shellfish Poison - 540.250Communicable Disease Hazards - 100.300Contamination of Devices Labeled as Sterile - 300.400Defective Suntanning Booths and Beds - 396.300Hazardous Diagnostic X-Ray Systems - 398.200Health Fraud - 120.500Identical or Similar Product Names - 400.500Importation of Television Receivers and Microwave Ovens - 394.500Karaya Gum Powder and Related Devices for Use by Ostomates - 325.100Lasers for Facelift, Wrinkle Removal, Acupuncture, Etc. - 393.200Nutritional Supplements for Companion Animals - 690.100OTC Drugs - Combination Products - 450.300OTC Drugs - Recognition as Safe and Effective - 450.200Pottery (Ceramics) - Cadmium Contamination- 545.400Pottery (Ceramics) - Lead Contamination - 545.450Recycled Animal Waste - 685.100Rendered Animal Feed Ingredients - 675.400Responsibility for Illegal Drug Residues in Meat, Milk and Eggs - 615.300Responsibility for Reporting Violations - 100.100 Salmonella Contamination of Dry Dog Food - 690.700Salt-Cured, Air-Dried, Uneviscerated Fish - 540.650Sequencing in Medicated Feed Production - 680.600Silver-Plated Hollowware - Lead Contamination - 545.500Source Plasma - Overbleeding - 398.450Sphygmomanometers - Rx Legend - 310.200Sunlamp Performance Standard - 396.100Uncooked Meat for Animal Food - 690.500Unsafe Contamination of Animal Feed from Drug Carryover - 680.500 Vitaminsand Minerals in Feed - 670.200Whole Milk, Low Fat Milk, Skim Milk - Aflatoxin M1 - 527.400Wigs - 590.600

HAZARDOUS UNITSDefective Suntanning Booths & Beds - 396.300

HBSAG TEST KITSBlood & Blood Products - Definitions - 230.100

HEAD AND NECKDefinition-General Purpose Radiographic X-Ray System - 398.100Positive Beam Limitation (PBC) Requirements - 398.450

HEALTHAction Levels for Aflatoxins in Animal Feeds - 683.100Acupuncture Devices and Accessories - 305.100Adulteration of Drugs under Sec. 501(b) and 501(c) - 420.100Articles of Foreign Origin Not Intended for Entry - 110.700

Assemblers Who Install Noncompliant Equipment - 398.325Assessment of Civil Penalties - 390.300Automatic Adjustment of the X-Ray Field Size - 398.400Barking Dog Collars - 655.300Biological Drugs for Animal Use - 645.100Blood and Blood Products - Definitions - 230.100 Candy - Mixed with Trinkets and Sold in Vending Machines - 515.350Canned Pet Food - 690.300Certification for Export - 110.100Certification and Identification of X-Ray Components - 398.600Clams, Mussels, Oysters - Paralytic Shellfish Poison - 540.250

Class III Devices Subject to 5l5(b) Requirements - 750.350 Collection and Charitable Distribution of Drugs - 400.800

Communicable Disease Hazards - 100.300Confectionery - Use of Nonnutritive Substances as Ingredients - 515.100Contamination of Devices Labeled as Sterile - 300.400 Cytotoxic Testing for Allergic Diseases - 370.100Decomp. & Histamine in Albacore, Skipjack & Yellowfin Tuna - 540.525Defective Suntanning Booths and Beds - 396.300Definition of "Commerce" - 21 CFR 1000.3(g) - 390.100Definition of General Purpose Radiographic X-Ray System - 398.100

Definition of "High-Voltage Vacuum Switch - 390.500Dentures -- Sale by Persons Not Licensed to Practice Dentistry - 315.100Determination by Secretary that Product Fails to Comply - 390.200

Direct Reference Authority for Class III Medical Devices - 300.700Diversion of Contaminated Food for Animal Use - 675.100Drug Product Entries in Periodic Publications - 400.700Early Correction of Defects or Noncompliance - 390.225Eggnog; Eggnog Flavored Milk--Common Usual Names - 527.350

Electrical Muscle Stimulators - 355.200Electronic Products Subject to 21 CFR 1001.15(a) - 390.400Exemption for Certain Sunlamp Product Purchaser Records -396.300


419419

Expiration Dating of Unit Dose Repackaged Drugs - 480.200Extra-Label Use of New Animal Drugs in Food-Producing Animals - 615.100FDA Jurisdiction Over Meat and Poultry Products - 565.100Foods, Except Dairy Products - Adulteration with Salmonella - 555.300Fortification of Standardized Juices - 510.700Fraud, Untrue Statements of Material Facts, - 120.100,Hazardous Diagnostic X-Ray Systems - 398.200Health Fraud - 120.500Homeopathic Drugs - 400.400Human-Labeled Drugs Distributed & Used in Animal Medicine - 608.100Human Blood and Blood Products as Drugs - 230.120Hypnotherapy Devices - Self Hypnotic Tape Recordings - 335.300Identical or Similar Product Names - 400.500Illegal Sales of Veterinary Prescription Drugs - 608.500Immune Milk - 275.100Importation of Television Receivers and Microwave Ovens - 394.500Imported Low-Acid Canned Foods - 560.450Imported Milk and Cream Import Milk Act - 560.400Ineffective Devices - 502(f)(l) Labeling Requirements - 300.300Inspection of Manufacturers of Device Components - 300.100Intermediate or End Products of Sample Analysis - 150.100Ion Generating Devices - 355.100Jams, Jellies and Related Products - Imports - 560.500Karaya Gum Powder and Related Devices for Use by Ostomates - 325.100Laser Light Shows, etc. - 393.100Lasers for Facelift, Wrinkle Removal, Acupuncture, Etc. - 393.200Literature for High-Intensity Mercury Vapor Lamps - 391.100Manufacture, Distribution, Promotion of Drugs by Pharmacies -460.200Marketed New Drugs Without Approved NDAs - 440.100Medical Emergencies - 220.100Menstrual Sponges - 345.300Mercury Vapor Lamps that are Not Self-Extinguishing - 391.200Milk and Milk Products Containing Penicillin - 527.450 Nutritional Supplements for Companion Animals - 655.300Obligations of Factory-Based Manufacturers and Assemblers - 398.375OTC Drugs - Combination Products - 450.300OTC Anti-Obesity Preparations - 456.100OTC Drugs - Recognition as Safe and Effective - 450.200Override of Positive Beam Limitation - 398.425Pathogens in Dairy Products - 527.300 Positive Beam Limitation (PBL) Requirements - 398.450Pottery (Ceramics) - Lead Contamination - 545.450Process Validation Requirements for Drug Products - 490.100Proper Drug Use and Residue Avoidance - 615.200Radionuclides in Imported Foods - Levels of Concern - 562.750Reconditioning New Drugs Lacking Approved NDA - 448.100Records and Reports - Applicability - 21 CFR 1002.1 - 390.425Recycled Animal Waste - 685.100Red Meat Adulterated with PCB's - 565.200Registration of Blood Banks and Other Firms - 230.110Registration of Assemblers of Diagnostic X-Ray systems - 398.300 Regulatory Action Regarding Approved New Drugs - 446.100Regulatory Actions Against Assemblers of X-Ray Equipment - 398.350Reloaders of X-Ray Tube Housing Assemblies - 398.700Rendered Animal Feed Ingredients - 675.400Responsibility for Illegal Drug Residues in Meat, Milk and Eggs - 615.300Responsibility for Reporting Violations - 100.100Retention of Microwave Oven Test Records - 394.100Return of Unused Rx Drugs to Pharmacy Stock - 460.300Reuse of Medical Disposable Devices - 300.500Revocation of Tolerances for Cancelled Pesticides - 550.700RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 315.100 Salmonella Contamination of Dry Dog Food - 690.700

Salt-Cured, Air-Dried, Uneviscerated Fish - 540.650Sequencing in Medicated Feed Production - 680.600Source Plasma - Overbleeding - 252.100Sphygmomanometers - Rx Legend - 310.200Standards and Minimum Requirements for Biologic Products - 205.100 Sunlamp Performance Standard - 396.100Surgeons' Gloves and Patient Examination Gloves - 335.700Teat Dips and Udder Washes for Dairy Cows and Goats - 654.200Temporal-Maximum Ultrasonic Power - 397.100Turtles- 170.100Unapproved Additives for Exported Grains - 578.600Uncooked Meat for Animal Food - 690.500Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100 Unsafe

Contamination of Animal Feed from Drug Carry-Over - 680.500Urinary Preparations - Lack of Rx Legend - Claims - 430.400Vitamins and Minerals in Feed - 670.200Warning Label Required on Sunlamp Products - 396.400Whole Milk, Low Fat Milk, Skim Milk - Aflatoxin M1 - 527.400X-Ray Field Size for Spot-Film - 398.475

HEALTH CARE FINANCING ADMINISTRATION (HCFA)Cytotoxic Testing for Allergic Diseases - 370.100Registration of Blood Banks & Other Firms - 230.110

HEALTH CARE WORKERS

Surgeon's Gloves & Patient Examination Gloves - 335.700HEALTH CENTERS

Cytotoxic Testing For Allergic Diseases - 370.100HEALTH FRAUD

Electrical Muscle Stimulators - 355.200Health Fraud - 120.500Homeopathic Drugs - 400.400Hypnotherapy Devices-Self-Hypnotic Tape Recordings - 335.300Ineffective Devices-502(f)(l) Labeling Requiremts - 300.300Ion Generating Devices - 355.300

HEALTH HAZARDAdulteration of Drugs under Sec. 501(b) and 501(c) - 420.100Articles of Foreign Origin not Intended for Entry - 110.700Clams, Mussels, Oysters - Paralytic Shellfish Poison - 540.250Communicable Disease Hazards - 100.300Contamination of Devices Labeled as Sterile - 300.400Defective Suntanning Booths and Beds - 396.300Hazardous Diagnostic X-Ray Systems - 398.200Health Fraud - 120.500Identical or Similar Product Names - 400.500Importation of Television Receivers and Microwave Ovens - 394.500Lasers for Facelift, Wrinkle Removal, Acupuncture, Etc. - 393.200Nutritional Supplements for Companion Animals - 690.100OTC Drugs - Combination Products - 450.300OTC Drugs - Recognition as Safe and Effective - 450.200Recycled Animal Waste - 685.100Rendered Animal Feed Ingredients - 675.400Responsibility for Reporting Violations - 100.100Responsibility for Illegal Drug Residues in Meat, Milk and Eggs - 615.300 Salt-Cured, Air-Dried, Uneviscerated Fish - 540.650Sequencing in Medicated Feed Production - 680.600Source Plasma - Overbleeding - 252.100Sphygmomanometers - Rx Legend - 310.200Uncooked Meat for Animal Food - 690.500Unsafe Contamination of Animal Feed from Drug Carry-Over - 680.500Vitamins and Minerals in Feed - 670.200Whole Milk, Low Fat Milk, Skim Milk - Aflatoxin M1 - 527.400

HEALTH PROFESSIONALSAcupuncture Devices & Accessories - 305.100Drug Product Entries in Periodic Publications - 400.700Laser for Facelift, Wrinkle Removal, Acupuncture, etc - 393.200Surgeon's Gloves & Patient Examination Gloves - 355.700

HEALTH SPA OWNER OPERATORDefective Suntanning Booths & Beds - 396.300

HEALTH SPASDefective Suntanning Booths & Beds - 396.300

HEARING LOSSHynotherapy Devices-Self-Hypnotic Tape Recordings - 335.300

HEARTInert Glandular Preparations - OTC - 455.100

HEAT SHRINK BANDSTamper-Resistant Packaging Requirements - 450.500

HEAT STERILIZEDParametric Release of Terminally Heat Sterilized Drugs - 460.800

HEATING VENTILATION AIR CONDITIONING (HVAC)Process Validation Requirements for Drug Products - 490.100

HEMATOCRITSource Plasma - Overbleeding - 252.100

HEMOGLOBINOral Iron Products for Baby Pigs - 643.100Source Plasma -Guidelines for Informed Consent Forms - 250.100

HEMOLYTIC TRANSFUSION REACTIONSource Plasma Guidelines for Informed Consent Forms - 250.100

HEMOPHILUS INFLUENZA TYPING SERUMStandards & Min. Requirements for Biologic Products - 205.100

HEPARIN SOLUTIONSource Plasma - Overbleeding - 252.100

HEPATITISCommunicable Disease Hazards - 100.300Registration of Blood Banks & Other Firms - 230.110Source Plasma Guidelines for Informed Consent Forms - 250.100Standards & Minimum Requiremets for Biologic Products - 205.100

HEPATITIS BCommunicable Disease Hazards - 100.300Standards & Min. Requiremts for Biologic Products - 205.100

HEPATITIS B SURFACE ANTIGENStandards & Min.Requiremts for Biologic Products - 205.100

HERRINGFish - Adulteration by Parasite - 540.590Kipper & Kipper Unsplit - 540.550

HIGH BLOOD PRESSUREHypnotherapy Devices-Self-Hypnotic Tape Recordings - 335.300

HIGH EFFICIENCY PARTICULATE AIR (HEPA)Process Validation Requirements - Drug Products - 490.100

HIGH-INTENSITY MERCURY VAPOR LAMPSLiterature for High-Intensity Mercury Vapor Lamps - 391.100


420420

HIGH PRESSURE CYLINDERSCompressed Medical Gases -Warning Letters - 435.100

HIGH VOLTAGE VACUUM SWITCHDefinition - 390.500

HISTAMINEIn Albacore, Skipjack & Yellowfin - 540.525

HIVSurgeon's Gloves & Patient Examination Gloves - 335.700

HOLESCondoms; Defects - 345.100Contamination of Devices Labeled as Sterile - 300.400Pottery (Ceramics) - Cadmium Contamination - 545.400Pottery (Ceramics) - Lead Contamination - 545.450Silver-Plated Holloware - Lead Contamination - 545.500Surgeon's Gloves & Patient Examination Gloves - 335.700

HOLLANDAISE SAUCECommon or Usual Name - 525.400

HOLLOWWAREPottery Cadmium Contamination - 545.400Pottery Lead Contamination - 545.450Silver-Plated Lead Contamination - 545.500

HOMARUS AMERICANUS/HOMARUS VULGARISUsual Names for Crustaceans - 540.350

HOME REMEDY KITSHomeopathic Drugs - 400.400

HOME RESPIRATORY CARE COMPANIES (HRC)Compressed Medical Gases - Warning Letters - 435.100

HOMEOPATHIC DRUGSDefinition - 400.400Lack of Expiration Date or Stability Data - 480.300

HOMEOPATHIC PHARMACOPEIA OF THE UNITED STATESHomeopathic Drugs - 400.400

HOMEOTHERAPEUTICSHomeopathic Drugs - 400.400

HONEYHoney Bread, Honey Buns - 505.350Honey - Source Declaration - 515.300Pesticide Residues - 575.100

HOPSAdulteration with Aphid Infestation - 525.425Pesticide Residues in Food and Feed - 575.100

HORSERADISHPesticide Residues in Food and Feed - 575.100Spices - 525.750

HOSPITALClass I Recalls of Rx Drugs - 400.900Expiration Dating of Unit Dose Repackaged Drugs - 480.200Hospital Pharmacies - 460.100Manfacture, Distrbution, Promotion Of Drugs by Pharmacies - 460.200Registration of Blood Banks & Other Firms - 230.110Unit Dose Labeling for Solid & Liquid Oral Dose Forms - 430.100Volatile N-Nitrosamines in Rubber Baby Bottle Nipples - 500.450

HOWARD MOLD COUNTApricot, Peach, Pear, Nectars and Purees - 550.155Cherry Jam - 550.235Cranberry Sauce - 550.260Jam, Black Currant - 550.450Pineapple, Canned; Pineapple Juice - 550.680

HUMAN IMMUNODEFICIENCY VIRUS Surgeon's Gloves and Patient Examination Gloves - 335.700

HUMAN-LABELED DRUG PRODUCTSDistributed & Used in Pet Medicine - 608.100

HYDROCHLORIC ACIDPrepared Mustard, Compositions - 525.575

HYDROLYZED YEASTLabeling of Seasonings - 525.650

HYDROPHONETemporal-Maximun Ultrasonic Power - 397.100

HYGIENIC SPONGESMenstrual Sponges - 345.300

HYPERACTIVE CHILDRENHypnotherapy Devices-Self-Hypnotic Tape Recordings - 335.300

HYPNOTHERAPY DEVICESHypnotherapy Devices-Self-Hypnotic Tape Recordings - 335.300

HYPOGLYCEMIAFructose-Containing Drugs - 400.335

IBACUS CILIATUSCommon or Usual Names for Crustaceans - 540.350

IDENTITY OF FOODS - USE OF TERMS AS FRESH, FROZEN,Identity of Foods--Terms Such as Fresh, Frozen, Dried, Canned - 562.450

IDENTITY OF INGREDIENTSBakery Products Candy Ingredients - 505.100Canned Pimentos and Red Sweet Peppers - 585.650Caviar, Use of Term-Labeling - 540.150Chocolate or Chocolate Flavored - 515.800Compressed Medical Gases--Warning Letters - 435.100

Food--Terms Such as Fresh, Frozen, Dried, Canned - 562.450Hollandaise Sauce- Usual Name - 525.400Homeopathic Drugs - 400.400Imports - 560.250Malted Milk - 527.500Marmalade - 550.575Peas and Carrots, Labeling Mixture - 585.600Prepared Mustard, Composition - 525.575Regulatory Action Regarding Approved Drugs - 446.100Repacking of Drug Products -- CGMP's - 430.200Tomato Sauce or Tomato Hot Sauce Labeling - 525.800

IDIOPATHIC THROMBOCYTOPENICBlood & Blood Products - Definitions - 230.100

ILLEGAL RESIDUESAlternate Feeding of Medicated Feeds - 666.100Diversion of Adulterated Food in Pet Feed - 675.200Extra-Label Use of New Pet Drug - 615.100Human-Labeled Drugs Used in Pet Medicine - 608.100Proper Drug Use and Residue Avoidance - 615.200Recycled Animal Waste - 685.100Responsibility for Illegal Drug in Meat, Milk - 615.300Sequencing in Medication Feed Production - 680.600

ILLUMINANCEAssemblers Who Install Noncompliant Equipment - 398.325

INADAvailability of Bulk Chemicals for Pet Drug - 625.200Recovery of IND's from Clinical Investigators - 444.100

INJECTABLEOral Iron Products for Baby Pigs - 643.100OTC Sale of Injectable Animal Drugs - 608.200

IMAGE-INTENSIFIED FLUOROSCOPYX-Ray Field Size for Spot-Film - 398.475

IMITATIONImitation Breaded Shrimp - 540.450Seafood Products - 540.700Maraschino Cherries -550.550

IMMUNE GLOBULINSBlood & Blood Products - Definitions - 230.100

IMMUNE SERUM GLOBULIN (HUMAN)Standards & Minimum Requirements for Biologic Products - 205.100

IMMUNIZATIONSource Plasma -Guidelines for Informed Consent Form - 250.100Schedule of Physical Examination - 251.100

IMMUNIZATION INJECTIONSSchedule of Physical Examination - 251.100

IMMUNODIFFUSIONQuantitatveTesting for Serum Proteins - 255.100

IMPAIRMENT OF HUMAN HEALTHDirect Reference Authority for Class III Medical Devices - 300.700

IMPORTAction Levels for Aflatoxins in Animal Feeds - 683.100Bay (Laurel) Leaves - Insect Filth; Mold; Mammalian Excreta - 525.150Brandy Containing Methyl Alcohol - Food Additive - 510.200Capsicum Pods, Etc. - Adulteration - 525.200Cloves - Adulteration with Stems - 525.250Coffee and Cocoa Bean Sweeps - 560.350Condimental Seeds Other Than Fennel Seeds and Sesame Seeds - 525.300Cumin Seed - Adulteration with Sand and Grit - 525.325Curry Powder - Adulteration by Insect and Rodent Filth - 525.330Fennel Seed - Adulteration by Mammalian Excreta; Insects - 525.350Food Storage & Warehousing - Adulteration - Filth - 580.100Foreign Trade Zones, Bonded Warehouses or Carriers - 110.600Hops - Adulteration Involving Aphid Infestation - 525.425Importation of Licensed Biologic Products for Human Use - 210.150Importation of Television Receivers and Microwave Ovens - 394.500Imported Milk and Cream. Import Milk Act - 560.400Imported Products - Lack of English Labeling - 110.900Interpretation of Insect Filth in Foods - 555.600Jams, Jellies and Related Products - Imports - 560.500Leafy Spices, Other Than Bay Leaves - 525.500Mace - Insect Filth; Mold, Foreign Matter; Mammalian Excreta - 525.550Marjoram - 525.900Oregano - 525.850Pesticide Residues in Food and Feed - 575.100Pistachio Nuts - Aflatoxin Adulteration - 570.500Pottery (Ceramics) - Cadmium Contamination - 545.500Pottery (Ceramics) - Lead Contamination - 545.450Radionuclides in Imported Foods - Levels of Concern - 560.750Returned Antibiotics Exported Under 801(d) of the Act - 405.210Sage - 525.950 Sesame Seeds - Adulteration - 525.700Silver-Plated Hollowware - Lead Contamination - 545.500Thyme - 525.925Vitamin B-15, Pangamic Acid and Pangamic Acid Products - 457.100Whole and Ground Allspice - Mold; Insect and Rodent Filth - 525.100Whole Cassia or Whole Cinnamon, Ground Cinnamon - 525.225


421421

Whole and Ground Pepper - Adulteration - 525.625Whole Ginger - Insect Filth; Mold; Nammalian Excreta - 525.375Whole and Ground Nutmeg - Insect Filth; Mold; Rodent Filth - 525.600

IMPORT DETENTION STATUSImportation of Television Receivers and Microwave Ovens - 394.500

IMPORT FOODSFood Storage and Warehousing Filth - 580.100

IMPORT FOODS - LABELINGLack of English Labeling - 110.900

IMPORT MILK ACTImported Milk & Cream - 560.400

IMPORTEDAcidified Low-Acid Canned Foods - High pH - 520.300Acupuncture Devices and Accessories - 305.100Availability of Bulk Chemicals for Animal Drug Use - 625.200Bay (Laurel) Leaves - Insect Filth; Mold; Mammalian Excreta - 525.150 Biological Drugs for Animal Use - 645.100Brazil Nuts - Adulteration with Aflatoxin - 570.200Canned and Cooked/Frozen Shrimp - Decomposition - 540.375Capsicum Pods, Etc. - Adulteration - 525.200Caviar, Use of Term - Labeling - 540.150Class III Devices Subject to 5l5(b) Requirements - 300.750Cloves - Adulteration with Stems - 525.250Condimental Seeds Other Than Fennel Seeds and Sesame Seeds - 525.300Country of Origin Labeling - 560.200Crabmeat - Product Name - 540.300Cumin Seed - Adulteration with Sand and Grit - 525.325Curry Powder - Adulteration by Insect and Rodent Filth - 525.330Dates and Date Material; Imported and Domestic - 550.300Fennel Seed - Adulteration by Mammalian Rct; Insects - 525.350Foreign Trade Zones, Bonded Warehouses or Carriers - 110.600Hops - Adulteration Involving Aphid Infestation - 525.425Importation of Television Receivers and Microwave Ovens - 394.500Importation of Unlabeled Foods -- *21 CFR 101.100(d)* - 560.100 Imported Products - Lack of English Labeling - 110.900Imported Low-Acid Canned Foods - 560.450Imported Frozen Products of Multiple Sizes - 560.700Imported Milk and Cream. Import Milk Act - 560.400Imports -- Post Detention Sampling - 110.800Jams, Jellies and Related Products - Imports - 560.500Leafy Spices, Other Than Bay Leaves - 525.500Mace - Insect Filth; Mold, Foreign Matter; Mammalian Excreta - 525.550Marjoram - 525.900Olives - Adulteration Involving Pits; Rot; Insect Infestation - 550.600Oregano - 525.850Pesticide Residues in Food and Feed - 575.100Pineapple, Canned; Imported and Domestic - Food Standards - 550.685Pistachio Nuts - Aflatoxin Adulteration - 570.500Pottery (Ceramics) - Cadmium Contamination - 545.400Pottery (Ceramics) - Lead Contamination - 545.450Radionuclides in Imported Foods - Levels of Concern - 560.750Reconditioning of Imported Coffee Beans - 560.300Sage - 525.950 Sesame Seeds - Adulteration - 525.700Silver-Plated Hollowware - Lead Contamination - 545.500Sphygmomanometers - Rx Legend - 310.200Surgeon's Gloves and Patient Examination Gloves - 335.700Thyme - 525.925Unapproved Additives for Exported Grains - 578.600Warning Label Required on Sunlamp Products - 396.400Whole and Ground Allspice - Mold; Insect and Rodent Filth - 525.100Whole Cassia or Whole Cinnamon, Ground Cinnamon - 525.225Whole Ginger - Insect Filth; Mold; Mammalian Excreta - 525.375Whole and Ground Nutmeg - Insect Filth; Mold; Rodent Filth - 525.600Whole and Ground Pepper - Adulteration- 525.625

IMPORTERSee Imported Above

IMPORTERS ENTRY NOTICEImportation of TV Receivers & Microwave Ovens - 394.500

IMPORTSSee Imported Above

IMPRESSIONCanned Peas - Label Designation of Sizes - 585.625Dentures - Sale by Persons Not Licensed - 315.100

IMPRISONEDDentures - Sale by Persons Not Licensed - 315.100

IMPROPERAssemblers Who Install Noncompliant Equipment - 398.325Determination by Secretary: Product Fails to Comply - 390.200FDA Jurisdiction Over Meat & Poultry Products - 565.100Lasers for Facelift, Wrinkle Removal, Acupuncture, Etc - 393.200Obligations of Factory-Based Manfacturers & Assemblers - 398.375Pineapple,Canned;Imported & Domestic-Food Standards - 550.685Proper Drug Use & Residue Avoidance - 615.200Rx Drugs for Ships' Medicine Chests - 460.500Standardized Canned Fruit - Packing Medium - 550.800

IMPROPER MAINTENANCEAssemblers Who Install Noncompliant Equipment - 398.325Obligations of Factory-Based Manufacturers & Assemblers - 398.375

IMPROVING VISIONHypnotherapy Devices-Self-Hypnotic Tape Recordings - 335.300Extra Lable Use of New Animal Drugs - 615.100

IMVICCrabmeat - Adulteration w/ Filth - E. coli - 540.275Tree Nuts - E. coli - 570.450

INCH-POUNDMetric Declarations of Quantity of Contents - 140.500

INCONNUSFish Fresh & Frozen - 540.590

INDIANFDA Jurisdiction on Indian Reservations - 100.350

INDICATIONS FOR USEExpiration Dating & Stability Testing - 480.100Homeopathic Drugs - 400.400Large Volume Parenterals (LVPs) for Animal Use - 635.100Reconditioning-Tree Nuts Contaminated w/ E.coli - 570.550Source Plasma - Overbleeding - 252.100Temporal-Maximum Ultra-Sonic Power - 397.100

INDISCRIMINATE USEEar Piercing Devices - 320.100

INDOLEShrimp - 540.400Canned & Cooked Frozen Shrimp - 540.390

INEFFECTIVE DEVICES502(f)(l) Labeling Requirements - 300.300

INEFFECTIVE DRUGSMarketed New Drugs w/o Approved NDAs - 440.100

INFESTATIONCashews, Reconditioning - 570.250Cocoa Beans - 515.750Dates and Date Material - 550.300Figs, Fig Paste - 550.350Food Storage & Warehousing - 580.100Foods Infestation - 555.450Green Coffee Beans Mold - 510.500Hops - 525.425Olives - Adulteration - 550.600Pistachio Nuts - Aflatoxin - 570.500Reconditioning of Foods Under 402(a)(4) - 160.700Reconditioning Coffee Beans - 560.300Tree Nuts - 570.425

INFLUENZA VIRUS VACCINEStandards & Minimum Requirements for Biologic Products - 205.100

INFORMED CONSENTSchedule of Physical Examination - 251.100Source Plasma-Guidelines for Infomed Consent Form - 250.100

INFORMED DECISIONWarning Label Required on Sunlamp Products - 396.400

INHALATION THERAPY DRUGSManufacture, Distribution, Promotion of Drugs by Pharmcies - 460.200

INITIAL DISTRIBUTORClass III Devices Subject to 515 (b) Requiremts - 300.750

INITIAL IMPLANTATIONPacemaker Reuse - 310.100

INITIAL REPORTSCertification & Identification of X-Ray Components - 398.600Electronic Products Subject to 21 CFR 1001.15(a) - 390.400

INJECTABLEOral Iron Products for Baby Pigs - 643.100OTC Sale of Injectable Pet Drugs - 608.200Plastic Containers for Injectable Pet Drugs - 637.100Status of Syringes, Needles for Pet Drugs - 655.400

INJUNCTIONAnimal Drugs for Euthanasia - 650.100Blood and Blood Products - Definitions - 230.100Schedule of Physical Examination - 251.100

INJURYAcupuncture Devices and Accessories - 305.100Assessment of Civil Penalties - 390.300 Candy - Mixed with Trinkets and Sold in Vending Machines - 515.350Cherries, Canned - Misbranding Involving Food Standards - 550.230Cinnamon-Flavored Toothpicks - 545.600Diaphragms - Rx Devices - 345.200Direct Reference Authority for Class III Medical Devices - 300.700 Health Fraud - 120.500Illegal Sales of Veterinary Prescription Drugs - 608.500Lasers for Facelift, Wrinkle Removal, Acupuncture, etc. - 393.200Proper Drug Use and Residue Avoidance - 615.200Reloaders of X-Ray Tube Housing Assemblies - 398.700Sequencing in Medicated Feed Production - 680.600Sphygmomanometers - Rx Legend - 310.200

INJURY REPORTS


422422

Reloaders of X-ray Tube Housing Assemblies - 398.700INNOVATIVE PHARMACY CARE

Computerized Rx Record Keeping by Pharmacies - 460.400INCREASING RANGE OF MOTION

Electrical Muscle Stimulators - 355.200INSECT CONTAMINATION

Food Storage & Warehousing - 580.100Interpretation of Insect Filth - 555.600

INSECT FRAGMENTSApricots - Canned - Adulteration with Insects - 550.150Asparagus, Canned or Frozen - Adulteration with Insect Filth - 585.150Bay (Laurel) Leaves - Insect Filth; Mold; Mammalian Excreta - 525.150 Capsicum Pods, Etc. - Adulteration - 525.200Cheese and Cheese Products - Adulteration with Filth - 527.200Chocolate & Chocolate Liquor - Adulteration - 515.700Cocoa Beans - Mold, Insect Infestation, and Mammalian Excreta - 515.750Cocoa Powder, Press Cake - Insect and Rodent Filth and Shell - 515.775Corn Meal - Adulteration by Insect and Rodent Filth - 578.200Corn, Sweet; Canned - Adulteration - 585.300Curry Powder - Adulteration by Insect and Rodent Filth - 525.330Dates and Date Material; Imported and Domestic - 550.300Green Coffee Beans - Adulteration with Insects; Mold - 510.500Interpretation of Insect Filth in Foods - 555.600Macaroni and Noodle Products - 505.500Marjoram - 525.900Oregano - 525.850Peanut Butter - Adulteration with Filth; Grit - 570.300Sage - 525.950Thyme - 525.925Wheat Flour - 578.450Wheat - Adulteration by Insect and Rodent Filth - 578.300Whole and Ground Nutmeg - Insect Filth; Mold; Rodent Filth - 525.600Whole and Ground Allspice - Mold; Insect and Rodent Filth - 525.100Whole Cassia or Whole Cinnamon, Ground Cinnamon - 525.225Whole and Ground Pepper - Adulteration - 525.625

INSECT FILTHAsparagus, Canned or Frozen - 585.150Bay (Laurel) Leaves - 525.150Chocolate & Chocolate Liqour - 515.700Cocoa Powder, Press Cake - 515.775Coffee and Coca Bean Sweeps - 560.350Curry Powder Filth - 525.330Food Storage & Warehousing - 580.100Green Coffee Beans Filth - 510.500Interpretation of Insect Filth in Foods - 555.600Leafy Spices, Other Than Bay Leaves - 525.500Mace - 525.550Marjoram - 525.900Oregano - 525.850Sage - 525.950Sesame Seeds - 525.700Thyme - 525.925Wheat - 578.300Whole Cinnamon, Ground Cinnamon - 525.225Whole Ginger - 525.375Whole and Ground Pepper-Adulteration - 525.625Whole and Ground Nutmeg - 525.600

INSECT INFESTEDApricots - Canned - Adulteration with Insects - 550.150Capsicum Pods, Etc. - Adulteration - 525.200Cashews, Insect Infested - Reconditioning - 570.250Corn Husks (for Tamales) - Adulteration with Filth - 585.350Dried Prunes, Dehydrated Low Moisture Prunes, and Pitted Prunes - 550.700

Figs; Fig Paste - Insect Infestation; Mold, Dirt - 550.350Peanuts, Shelled and Unshelled - Filth and Reject Nuts - 570.350Peas and Beans; Dried - Storage Insect Damage, Rocks - 585.575Tree Nuts - Adulteration Involving Rejects - 570.425

INSECT WEBBING (See Insect References Above)INSECTS - (See Insect References Above)INSOLUBLE ASH

Cumin Seed Adulteration - 525.325Dates & Date Material - 550.300Foods Adulteration with Salmonella - 555.300Spices Definition - 525.750

INSOMNIAHypnotherapy Devices-Self-Hypnotic Tape Recordings - 335.300

INSPECTIONAccess to Results of Quality Assurance Audits - 130.300Acetic Acid - Use in Foods - Labeling of Foods in Which Used - 562.100Assessment of Civil Penalties - 390.300Biological Drugs for Animal Use - 645.100Bouillon, Bouillon Cubes, Granulated Bouillon - 567.300Canned Peas - Label Designation of Sizes - 585.625Canned Pet Food - 690.300Canned Shrimp: Size Designations and Corresponding Counts - 540.390Cheese and Cheese Products - Adulteration with Filth - 527.200

Classification of Establishments - 555.500Compressed Medical Gases -- Warning Letters - 435.100Condoms; Defects - Criteria for Direct Reference Seizure - 345.100Consistent Application of CGMP Determinations - 400.200Contamination of Devices Labeled as Sterile - 300.400Contract Sterilizers - 100.550Failure to Register - 400.100Failure to Register - 625.500FDA Jurisdiction Over Meat and Poultry Products - 565.100Finished Dosage Form Drugs in Bulk Containers - 410.100Food Storage & Warehousing - Adulteration - Filth - 580.100Foods, Rail Car Sanitation - Adulteration - 545.300Foods - Adulteration Involving Infestation and 1080 Rodenticide - 555.450GWQAP Pre-Award Evaluation - 100.700Importation of Unlabeled Foods-*21 CFR 101.100(d)* - 560.100Imported Milk and Cream Import Milk Act - 560.400Imported Products - Lack of English Labeling - 110.900Inspection of Manufacturers of Device Components - 300.100Malted Milk - 527.500Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200Maraschino Cherries - 550.550Medicated Feeds -- Formula Information - 670.100Menstrual Sponges - 345.300Pathogens in Dairy Products - 527.300Pesticide Residues in Food and Feed - 575.100Plasma Brokers - Registration and Compliance - 250.500 Prepared Mustard, Composition - 525.575Process Validation Requirements for Drug Products - 490.100Proper Drug Use and Residue Avoidance - 615.200Radionuclides in Imported Foods - Levels of Concern - 560.750Raw Breaded Shrimp - Microbiological - 540.420Reconditioners/Rebuilders of Medical Devices - 300.200Reconditioning of Imported Coffee Beans - 560.300Red Meat Adulterated with PCB's - 565.200Refusal to Permit Inspection - 130.100Registration of Blood Banks and Other Firms - 230.110Regulatory Actions Against Assemblers of X-Ray Equipment - 398.350Regulatory Action Regarding Approved New Drugs - 446.100Reloaders of X-Ray Tube Housing Assemblies - 398.700Salmonella Contamination of Dry Dog Food - 690.700 Salt-Cured, Air-Dried, Uneviscerated Fish - 540.650Sauerkraut - Definition; Adulteration by Thrips - 585.750Spices - Definitions - 525.750Surgeon's Gloves and Patient Examination Gloves - 335.700Turtles - 170.100Unapproved Additives for Exported Grains - 578.600

INSPECTION BY ATTRIBUTESCondoms; Defects - Criteria for Direct Reference Seizure - 345.100Surgeon's Gloves and Patient Examination Gloves - 335.700

INSPECTION REPORTSContamination of Devices - Labeled as Sterile - 300.400Pesticide Residues in Food & Feed - 575.100

INSPECTOR OPERATIONS MANUALDates & Date Material; Imported & Domestic - 550.300Foods, Except Dairy Products - Adulteration w/ Salmonella - 555.300

INSTALL NONCOMPLIANT EQUIPMENTAssemblers Who Install Noncompliant Equipment - 398.325

INSTALLATIONAssemblers Who Install Noncompliant Equipment - 398.325Determinatin by Secretary: Product Fails to Comply - 390.200Obligations of Factory-Based Manufacturers & Assemblers - 398.375

INSTITUTIONAL REVIEW BOARD (IRB)Acupuncture Devices & Accessories - 305.100Lasers for Facelift, Wrinkle Removal, Acupuncture, etc. - 393.200

INSULINCertification for Exports - 110.100Human-Labeled Drugs in Pet Medicine - 608.100Tamper-Resistant Packing Requirements - 450.500

INTRAARTICULAROTC Sale of Injectable Pet Drugs - 608.200

INTRAPERITIONEALLVP's for Animal Use - 635.100

INTRAVENOUSLVP's for Animal Use - 635.100OTC Sale of Injectable Pet Drugs - 608.200

INTENDED PURPOSECommercial Distribution-Premarket Notification - 300.600Fortification of Standardized Juices - 510.700IneffectiveDevices-502(f)(l) Labeling Requirements - 300.300Karaya Gum Powder & Devices for Use by Ostmates - 325.100

INTERIM MARKETINGOTC Drugs - Combination Products - 450.300

INTERLOCK MISSASSEMBLIESAssemblers Who Install Noncompliant Equipment - 398.325

INTERLOCK OPERATINGRetention of Microwave Oven Test Records - 394.100


423423

INTERLOCKSRetention of Microwave Oven Test Records - 394.100

INTERNALAlcohol; Use of Synthetic Alcohol in Foods - 555.100Brandy Containing Methyl Alcohol - Food Additive - 510.200Cashews, Insect Infested - Reconditioning - 570.250Fraud, Untrue Statements of Material Facts, Bribery - 120.100Lack of Expiration Date or Stability Data - 480.300Medicated Feeds -- Combined Batches - 680.400Oral Iron Products for Baby Pigs - 643.100Pottery (Ceramics) - Cadmium Contamination - 545.400Pottery (Ceramics) - Lead Contamination - 545.450Use of Income Tax Information from IRS - 160.200

INTERVALControlled-Release Dosage Form Drugs - 460.700Sunlamp Performance Standard - 396.100

INTERVENTIONHazardous Diagnostic X-Ray Systems - 398.200

INTOLERANCE TO FOODCytotoxic Testing for Allergic Diseases - 370.100Fructose-Containing Drugs - 400.335

INTRAORALDefnition of General Purpose Radiographc X-Ray System - 398.100

INVALIDAcupuncture Devices & Accessories - 305.100

INVERT SUGARFructose-Containing Drugs - 400.335

INVESTIGATION EXEMPTION Hospital Pharmacies - 460.100

INVESTIGATIONAL ANIMAL DRUGReconditioning of New Pet Drugs - 625.400

INVESTIGATIONAL DEVICE EXEMPTIONAcupuncture Devices & Accessories - 305.100Class III Devices Subject to 515 (b) Requirements - 300.750Cytotoxic Testing for Allergic Diseases - 370.100Direct Reference Authority for Class III Medical Devices - 300.700Lasers for Facelift, Wrinkle Removal, Acupuncture, etc - 393.200Menstrual Sponges - 345.300RIA Anlysis:Hair to Detect Presence of Drugs of Abuse - 370.200

INVESTIGATIONAL DRUGSCollection of Charitable Distribution of Drugs - 400.800Hospital Pharmacies - 460.100Recovery of INDs from Clinical Investigators - 444.100

INVESTIGATIONAL NEW DRUGSRecovery of INDs from Clinical Investigators - 444.100

INVESTIGATIONAL USECommercial Distribution-Premarket Notification - 300.600Food Additives - "GRAS" - 500.200New Drugs - Export - 442.100

IONIZATIONAction Levels for Aflatoxins in Pet Feeds - 683.100Foods, Adulteration with Aflatoxin - 555.400

IPRONIDAZOLEExtra-Label Use of New Pet Drug - 615.100Unsafe Cont. of Pet Drug/Carryover - 680.500

IRIS FAMILYSpices - Definitions - 525.750

IRRADIATIONKaraya Gum Powder & Devices - Use by Ostomates - 325.100Sunlamp Performance Standard - 396.100

IRRITATIONDenture Cleaners,Adhesives, & Repair Materials - 315.200

IRON DEFICIENCY ANEMIAOral Iron Products for Baby Pigs - 643.100

ISOEUGENOLLabeling of Seasonings - 525.650

ISOLATESDirect Refrence Authority for Pseudnomas Contamintion - 590.300Intermediate or End Products of Sample Analysis - 150.100Labeling of Seasonings - 525.650

JAMJams, Jellies & Related Products - 560.500

JAPANESE NOODLESChow Mein Noodles - 505.400

JAUNDICEFructose-Containing Drugs - 400.335

JASUS LALUNDICommon or Usual Names for Crustaceans - 540.350

JELLIESJams, Jellies and Related Products - 560.500Jellies, Nonstandardized - 550.475

JERUSALEM ARTICHOKEArtichoke - Common or Usual Name - 585.100

JOINT COUNCIL OF ALLERGY AND IMMUNOLOGYCytotoxic Testing for Allergic Diseases - 370.100

JORDAN ALMONDS

Common or Usual Name - 570.100JUNIPER

Labeling of Seasonings - 525.650KAPCHUNKA

Salted Dried, Uneviserated Fish - 540.650KARAYA GUM POWDER

Related Devices for Use by Ostomates - 325.100KEGANI CRABMEAT

Crabmeat - Product Name - 540.300KERNELS

Jordan Almonds Usual Name - 570.100Peanuts, Shelled and Unshelled - 570.350Pistachio Nuts - 570.500Popcorn - 585.675Spices-Definitions - 525.750Treated Grain Seed-Mecury Residue - 578.400Wheat for Human Consumption - 578.350Wheat-Adulteration by Insect Rodent Filth - 578.300

KETCHUPSilver-Plated Holloware - Lead Contamination - 545.500

KETOSISHuman-Labeled Drugs in Pet Medicine - 608.100

KIDNEYBlood & Blood Products - Definitions - 230.100Defniton of General Purpose Radiographic X-Ray System - 398.100Inert Glandular Preparations - OTC - 455.100Pork & Beans & Similar Bean Products -Labeling - 567.200Streptomycin Residues in Cattle Tissues - 616.100

KIDNEY DISEASEBlood & Blood Products - Definitions - 230.100

KING CRABMEATCrabmeat-Product Name - 540.300

KIPPERKipper and Kipper Unsplit Definitions - 540.550

LABELING - FOREIGN LANGUAGE DECLARATIONSFood Labels - 562.400Homeopathic Drugs - 400.400Quanity of Contents - 140.500

LABELING-NET WEIGHTCheese and Cheese Products - 527.250Corn on the Cob, Canned - 585.325Foods-Net Weight - 562.300Lingon Berries, Canned - 550.500Metric Declaration - 140.500Mixed Nuts - 570.700

LABELING REQUIREMENTSAdditives - Labeling with Adequate Directions for Many Uses - 500.100Adequate Directions for Use - Animal Drugs and Devices - 607.100Bakery Products, Candy "Shotgun" Ingredients Declaration - 505.100Biological Drugs for Animal Use - 645.100Certification for Exports - 110.100Compressed Medical Gases -- Warning Letters - 435.100Country of Origin Labeling - 560.200Drug Product Entries in Periodic Publications - 400.700Food Additives - Labeling Directions Necessary for Safe Use - 500.250Homeopathic Drugs - 400.400Illegal Sales of Veterinary Prescription Drugs - 608.500Importation of Unlabeled Foods-*21 CFR 101.100(d)* - 560.100Ineffective Devices - 502(f)(l) Labeling Requirements - 300.300Labeling - Diluted Wines and Cider with Less than 7% Alcohol - 510.450Labeling of Food Articles Distributed Solely in Puerto Rico - 562.750Labeling of Food Bearing Residues of Pesticide Chemicals - 562.700Metric Declarations of Quantity of Contents - 140.500Platelets, Pooled - 231.100Preservatives; Use in Nonstandardized Foods; Label Declaration - 562.600Processing" - Use of Term in Section 405 of the FD&C Act - 562.650Reconditioners/Rebuilders of Medical Devices - 300.200Regulatory Action Regarding Approved New Drugs - 446.100Repacking of Drug Products -- CGMP's - 430.200Tamper-Resistant Packaging Requirements - 450.500Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100

LABELING - SPANISH ONLYFoods Distributed in Puerto Rico - 562.750Imported Products - 110.900

LABORATORYAccess to Results of Quality Assurance Audits - 130.300Acetic Acid - Use in Foods - Labeling of Foods in Which Used - 562.100Action Levels for Aflatoxins in Animal Feeds - 683.100Adulteration of Drugs under Sec. 501(b) and 501(c) - 420.100Analytical Methodology Used by FDA - Drugs - 150.500CGMP Applicability to Hardware and Software - 425.100Cheese and Cheese Products - Adulteration with Filth - 527.200Compressed Medical Gases -- Warning Letters - 435.100Dimethylnitrosamine in Malt Beverages - 510.600Direct-Fed Microbial Products - 689.100Homeopathic Drugs - 400.400


424424

Imported Frozen Products of Multiple Sizes or Codes - 560.700Menstrual Sponges - 345.300Microfiche and/or Microfilm for Records Retention - 130.400Milk and Milk Products Containing Penicillin - 527.450Pineapple, Canned; Imported and Domestic - Food Standards - 550.685Pottery (Ceramics) - Cadmium Contamination - 545.400Pottery (Ceramics) - Lead Contamination - 545.450Quantitative Testing for Serum Proteins in Plasmapheresis Donors - 255.100Reconditioning New Drugs Lacking Approved NDA - 448.100Registration of Blood Banks and Other Firms - 230.110Repacking of Drug Products -- CGMP's - 430.200Rodent Contaminated Pet Foods - 690.600Shrimp - Fresh or Frozen Raw Headless, Peeled or Breaded - 540.400Silver-Plated Hollowware - Lead Contamination - 545.500Source Plasma - Overbleeding - 252.100Unapproved Additives for Exported Grains - 578.600

LACTIC ACIDJellies, Nonstandardized - 550.475Labeling of Seasonings - 525.650Sauerkraut-Definition; Adulteration - 585.750

LAMP VOLTAGEAssemblers Who Install Noncompliant Equipment - 398.325

LANGOSTINOSUsual Names for Crustaeans - 540.350

LANGUAGEForeign Language Declarations of Food Labels - 562.400Homeopathic Drugs - 400.400Imported Products - Lack of English Labeling - 110.900Labeling-Food Articals Distributed Soley in Puerto Rico - 562.750Metric Declaration of Quantity of Contents - 140.500Source Code for Process Control Application Programs - 425.300Source Plasma Guidelines for Informed Consent Form - 250.100

LAUREL LEAVESBay (Laurel) Leaves Filth - 525.150

LAWFUL INVESTIGATIONAcupuncture Devices & Accessories - 305.100

LAXTES CONDOMCondoms; Defects-Crteria for Direct Refrence Seizure - 345.100

LAYMANExtra Label Use-new Animal Drug-Food-Producing Animals - 615.100

LEACHABLE LEADSilver-Plated Holloware - 545.500

LEADCanned Foods-Seam Defects - 520.200Caviar, Use of Term - 540.150Fortification of Standard Juices - 510.700Pottery-Lead Contamination - 545.450Silver-Plated Holloware-Lead Contamination - 545.500Squash Seeds-Labeling as Pumpkin Seeds - 585.800Vitamin B-15, Pangamic Acid and Products - 457.100Water in Food Products - 555.875

LEAFY SPICESMajoram - 525.900Oregano - 525.850Other than Bay Leaves - 525.500Sage - 525.950Thyme - 525.925

LEAKAGECanned Foods - Seam Defects - 520.200Calcium Chloride - 500.400Comdoms; Defects-Criteria for Direct Reference Seizure - 345.100Determination by Secretary: Product Fails to Comply - 390.200Reloaders of X-Ray Tube Housing Assemblies - 396.400Retention of Microwave Oven Test Records - 394.100Surgeons' Gloves & Patient Examination Gloves - 335.700

LEARNING TECHNIQUESHypnotherapy Devices-Self-Hypnotic Tape Recordings - 335.300

LEGALAcidified Low-Acid Canned Foods - High pH - 520.300Aflatoxin in Peanuts and Peanut Products - 570.375 Apricot, Peach and Pear Nectars and Purees - Mold - 550.155Assemblers Who Install Noncompliant Equipment - 398.325Brazil Nuts - Adulteration with Aflatoxin - 570.200Canned Salmon - Adulteration Involving Decomposition - 540.375 Canned Foods - Seam Defects - 520.200Cheese & Cheese Products - Misbranding Involving Net Contents - 527.250Chloramphenicol - 654.300Chubs, Hot Process Smoked with Added Nitrite - 540.200Clams, Mussels, Oysters - Paralytic Shellfish Poison - 540.250Cocoa Powder, Press Cake - Insect and Rodent Filth and Shell - 515.775Cocoa Beans - Mold, Insect Infestation, and Mammalian ect -515.750Collection and Charitable Distribution of Drugs - 400.800Color Additives - 587.300Common or Usual Names for Animal Feed Ingredients - 665.100Controlled-Release Dosage Form Drugs - 460.700Crabmeat - Adulteration with Filth - Escherichia coli - 540.275

Decomposition & Histamine in Albacore, Skipjack & Yellowfin Tuna -540.525 Dimethylnitrosamine in Malt Beverages - 510.600Dimethylnitrosamine (DMNA) in Barley Malt - 578.500Electrical Muscle Stimulators - 355.200Failure to Register - 625.500Fish, Shellfish, Crustaceans, etc. - Methyl Mercury - 540.600Foods - FPLA Compliance - 562.200Foods, Adulteration with Aflatoxin - 555.400Foods - Net Weight - 562.300Foods, Rail Car Sanitation - Adulteration - 545.300Foreign Trade Zones, Bonded Warehouses or Carriers - 110.600Health Fraud - 120.500Identical or Similar Product Names - 400.500Imitation Breaded Shrimp - 540.450Ineffective Devices - 502(f)(l) Labeling Requirements - 300.300Inert Glandular Preparations - OTC - 455.100Interference with Compendial Tests - 420.500Mail-Order Filling of Prescriptions - 460.450Marjoram - 525.900Marketed New Drugs without Approved NDAs or ANDAs - 440.100Metric Declarations of Quantity of Contents - 140.500Mixed Nuts - Misbranding Involving Food Standards - 570.700Mushrooms, Canned or Dried (Freeze-Dried or Dehydrated) - 585.500Oral Iron Products for Baby Pigs - 643.100Orders for Post-Approval Record Reviews - 470.100Oregano - 525.850OTC Ear Drops - 454.100Pathogens in Dairy Products - 527.300Peaches, Canned, Frozen -- Adulteration Due to Insects and Mold - 550.650Peas and Beans; Dried - Storage Insect Damage, Rocks - 585.575Pistachio Nuts - Aflatoxin Adulteration - 570.500Pottery (Ceramics) - Cadmium Contamination - 545.400Pottery (Ceramics) - Lead Contamination - 545.450Raisins - Adulteration Involving Mold, Sand, Grit, & Insects - 550.750Raw Sugar - 515.400Raw Breaded Shrimp - Microbiological - 540.420Sage - 525.950Sauerkraut - Definition; Adulteration by Thrips - 585.750Shrimp - Fresh or Frozen Raw Headless, Peeled or Breaded - 540.400Shrimp - Frozen, Raw, Breaded or Lightly Breaded, - 540.410Silage Ingredients - 687.500Silver-Plated Hollowware - Lead Contamination - 545.500Source Plasma Guidelines for Informed Consent Forms - 250.100Sphygmomanometers - Accuracy - 310.210Streptomycin Residues in Cattle Tissues - 616.100Thyme - 525.925Tomato Products - Adulteration with Mold - 585.900Tree Nuts - Escherichia coli - 570.450Tuna, Sable, Salmon, Shad - Smoked, Cured - Sodium Nitrite - 540.500Turtles - 170.100Uncertified or Delisted Colors - 587.200Vitamin Products for Human Use - Low Potency - 530.400Vitamin B-15, Pangamic Acid and Pangamic Acid Products - 457.100Volatile N-Nitrosamines in Rubber Baby Bottle Nipples - 500.450Wheat Germ Containing Nonwheat Germ Tissue - 530.500Whole and Ground Pepper - Adulteration - 525.625Whole and Ground Nutmeg - Insect Filth; Mold; Rodent Filth - 525.600Whole Cassia or Whole Cinnamon, Ground Cinnamon - 525.225Whole and Ground Allspice - Mold; Insect and Rodent Filth - 525.100Whole Milk, Low Fat Milk, Skim Milk - Aflatoxin M1 - 527.400

LEGAL ACTION (see legal above)LEGIBLE AND ACCESSIBLE TO VIEW

Certification and Identification of X-Ray Components - 398.600Warning Label Required on Sunlamp Products - 396.400

LEMONCandied Citron-Labeling - 515.600Citrus Fruit Juices, Canned - 550.250Hollandaise Sauce-Common or Usual Name - 525.400Jellies, Nonstandardized - 550.475Marmalade - 550.575

LEMON JUICEHollandaise Sauce-Common or Usual Name - 525.400Jellies, Nonstandardized - 550.475

LESS-THAN-EFFECTIVE PRESCRIPTION DRUGSMarketed New Drugs Without Approved NDAs or ANDAs - 440.100

LEUKOCYTE TESTCytotoxic Testing for Allergic Diseases - 370.100

LEUKOCYTE TYPING SERUMStandards & Min. Requiremts for Biologic Products - 205.100

LEUKOCYTESCytotoxic Testing for Allergic Diseases - 370.100Registration of Blood Banks & Other Firms - 230.110

LEUKOCYTIC FOOD ALLERGY TESTCytotoxic Testing for Allergic Diseases - 370.100

LEUKOCYTOTOXICITY TESTCytotoxic Testing for Allergic Diseases - 370.100


425425

LEVULOSEFructose-Containing Drugs - 400.335

LICENSEAcupuncture Devices and Accessories - 305.100Allergenic Extracts Containing Glycerin - 270.100Biological Drugs for Animal Use - 645.100Blood and Blood Products - Definitions - 230.100IND Filings - 215.100Licensing - Changes to be Reported - 210.100Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200Medical Emergencies - 220.100Source Plasma - Overbleeding - 252.100Storage of Platelet Concentrate - 231.130

LICENSEDAcupuncture Devices and Accessories - 305.100Allergenic Extracts Containing Glycerin - 270.100Biological Drugs for Animal Use - 645.100Blood and Blood Products - Definitions - 230.100Certification for Exports - 110.100CGMP Enforcement Policy - OTC vs Rx Drugs - 450.100Chloramphenicol - 654.300Collection and Charitable Distribution of Drugs - 400.800Contract Sterilizers - 100.550Dentures -- Sale by Persons Not Licensed to Practice Dentistry - 315.100Ear Piercing Devices - 320.100Electrical Muscle Stimulators - 355.200Extra-Label Use of New Animal Drugs in Food-Producing Animals - 615.100Homeopathic Drugs - 400.400Hospital Pharmacies - 460.100Human-Labeled Drugs Distributed & Used in Animal Medicine - 608.100Illegal Sales of Veterinary Prescription Drugs - 608.500Importation of Licensed Biologic Products for Human Use - 210.150Ineffective Devices - 502(f)(l) Labeling Requirements - 300.300Licensing - Changes to be Reported - 210.100Mail-Order Filling of Prescriptions - 460.450Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200Over-The-Counter Sale of Injectable Animal Drugs - 608.200Platelets, Pooled, - 231.100Proper Drug Use and Residue Avoidance - 615.200Registration of Blood Banks and Other Firms - 230.110Regulatory Action Regarding Approved New Drugs - 446.100 Source Plasma - Guidelines for Informed Consent Forms - 250.100Standards and Minimum Requirements for Biologic Products - 205.100

LICENSED BLOOD BANK REAGENTSBlood & Blood Products - Definitions - 230.100

LICENSED PRACTITIONERSAcupuncture Devices & Accessories - 305.100Homeopathic Drugs - 400.400Manfacture, Distribution, Promotion of Drugs by Pharmacies - 460.200

LICENSING (See Licensed Above)LICHEE NUTS

Tree Nuts Involving Rejects - 570.425LICORICE-LIKE-

Spices - 525.750LIME JUICE

Citrus Fruit Juices, Canned - 550.250Jellies, Nonstandardized - 550.475

LIMITATIONSAlcohol; Use of Synthetic Alcohol in Foods - 555.100Color Additives in Paper & Paperboard for Use w/Food - 500.425Commercial Distribution -Premarket Notification - 300.600Food Additives-Labeling Directions Necessary for Safe Use - 500.250Manfacture, Distribution, Promotion of Drugs by Pharmcies - 460.200Medicated Feeds - Formula Info - 670.100Over-The-Counter Sale of Injectable Animal Drugs - 608.200

LINGON BERRIESAdulteration by insects - 550.500

LIQUEURMaraschino Cherries - 550.550

LIQUID AND GASEOUS OXYGENCompressed Medical Gases-Warning Letters - 435.100

LIQUID MALTMalt Products - 515.200

LIQUID OXYGEN (LOX)Compressed Medical Gases -Warning Letters - 435.100

LIQUIDATIONImportation of TV Receivers & Microwave Ovens - 394.500

LISTED ELECTRONIC PRODUCTElectronic Products Subject to 21 CFR 1001.15(a) - 390.400

LISTERIA MONOCYTOGENESPathogens in Dairy Products - 527.300

LISTERIOSISPathogens in Dairy Products - 527.300

LIVERFructose-Containing Drugs - 400.335Inert Glandular Preparations - OTC - 455.100

Whole Milk, Low Fat Milk, Skim Milk-Aflatoxin MI - 527.400LOBSTER

Processed Seafood Products - 540.700Usual Names for Crustaceans - 540.350

LOCAL BLOOD CIRCULATIONElectrical Muscle Stimulators - 355.200

LOGANBERRIESDrupelet Berries - 550.200

LONG-TERM LIFERetention of Microwave Oven Test Records - 394.100

LONGER WAVELENGTH UVA RADIATIONSunlamp Performance Standard - 396.100

LOOSE FITDenture Cleaners, Adhesives, & Repair Materials - 315.200

LOW ACID CANNED FOODSAcidifred Low-Acid Canned Foods High ph - 520.300Imported - 560.450

LOW FATImported Milk and Cream - 560.400

LOW POWER LASERSLasers for Facelift, Wrinkle Removal, Acupuncture, etc. - 393.200

LOWFAT MILKImported Milk/Cream. Import Milk Act - 560.400Pathogens in Dairy Products - 527.300

LOZENGESTamper-Resistant Packaging Requirements - 450.500

LUMPY JAWEthylenediamine Dihydrolodide - 651.100

LUTJANIDAESnapper - Labeling - 540.475

LUTJANUS CAMPECHANUSSnapper - Labeling - 540.475

LYGUS BUG DAMAGEBlack-Eyed Peas - 585.225

LYMPHInert Glandular Preparations - OTC - 455.100

MACARONIMacaroni & Noodle Products - 505.500

MACROANALYTICAL PROCEDURES MANUALBlack-Eyed Peas; Dried - 585.225Dates and Date Material - 550.300Marjoram - 525.900Peanuts, Shelled and Unshelled - 570.350Sage - 525.950Thyme - 525.925Tree Nuts - Audlteration - 570.425Whole and Ground Allspice - 525.100

MAINTENANCEAssemblers Who Install Noncompliant Equipment - 398.325Compressed Medical Gases -Warning Letters - 435.100Computerized Drug Processing-Vender Responsbilty - 425.200Exemption for Certain Sunlamp Prod. Purchase Records - 396.2300Hospital Pharmacies - 460.100Microfiche and/or Microfilm for Records Retention - 130.400Obligations-Factory-Based Manufacturers & Assemblers - 398.375

MALIC ACIDJellies, Nonstandardized - 550.475

MALLOTUS VILLOSUSCapelin - 540.100

MALTConfectionery - 515.100Dimethylnitrosamine (DMNA) in Barley Malt - 578.500Dimethylnitrosamine - 510.600Malt Products - 515.200Malted Milk - 527.500Vinegar, Definitions - 525.825Wine and Malt Beverages - 510.400

MALT BEVERAGESDealcoholized Wine and Malt Beverages - 510.400Dimethylnitrosamine in Malt Beverages - 510.600Dimryhylnitrosamine (DMNA) in Barley Malt - 578.500

MALT EXTRACTMalt Products - 515.200Malted Milk - 527.500

MALT SYRUP Malt Products - 515.200

MALT VINEGARVinegar Definitions - 525.825

MALTED CEREAL SYRUPMalt Products - 515.200

MAMMALIAN EXCRETABay (Laurel) Leaves - Insect Filth; Mold; Mammalian ect. - 525.150 Capsicum Pods, etc. - Adulteration - 525.200Cocoa Beans - Mold, Insect Infestation, and Mammalian Excreta - 515.750Condimental Seeds Other Than Fennel Seeds and Sesame Seeds - 525.300Fennel Seed - Adulteration by Mammalian Excreta; Insects - 525.350


426426

Leafy Spices, Other Than Bay Leaves - 525.500Mace - Insect Filth; Mold, Foreign Matter; Mammalian Excreta - 525.550Marjoram - 525.900Oregano - 525.850Sage - 525.950Sesame Seeds - Adulteration - 525.700Thyme - 525.925Whole Cassia or Whole Cinnamon, Ground Cinnamon - 525.225Whole and Ground Pepper - Adulteration - 525.625Whole Ginger - Insect Filth; Mold; Mammalian Excreta - 525.375

MAMMARYInert Glandular Preparations - OTC - 455.100

MAMMOGRAPHY X-RAY SYSTEMDefinition: General Purpose Radiographc X-Ray System - 398.100

MANDATORY RECALLAssessment of Civil Penalties - 390.300

MANICURING INSTRUMENTSRazor Blades, Manicuring Instruments - 335.500

MANUAL COLLIMATIONPositive Beam Limitation (PBL) Requirements - 398.450

MANUFACTURERSAcupuncture Devices and Accessories - 305.100Allergenic Extracts Containing Glycerin - 270.100Anthelmintics - 640.100Assessment of Civil Penalties - 390.300Automatic Adjustment of the X-Ray Field Size - 398.400Biological Drugs for Animal Use - 645.100Blood and Blood Products - Definitions - 230.100Brandy Containing Methyl Alcohol - Food Additive - 510.200Certification and Identification of X-Ray Components - 398.600CGMP's for Medicated Feeds - Daily Inventory Requirements - 680.200Compendial Requirements - 420.400Condoms; Defects - Criteria for Direct Reference Seizure - 345.100Consistent Application of CGMP Determinations - 400.200Crab and Crabmeat Products with Other Seafood - Labeling - 540.285Electrical Muscle Stimulators - 355.200Exemption for Certain Sunlamp Product Purchaser Records - 396.200Expiration Dating of Unit Dose Repackaged Drugs - 480.200Extra-Label Use of New Animal Drugs in Food - Producing Animals - 615.100

Fortification of Standardized Juices - 510.700Fraud, Untrue Statements of Material Facts, Bribery - 120.100Homeopathic Drugs - 400.400Hospital Pharmacies - 460.100Human-Labeled Drugs Distributed & Used in Animal Medicine - 608.100Hypnotherapy Devices - Self Hypnotic Tape Recordings - 335.300Importation of Licensed Biologic Products for Human Use - 210.150Importation of Television Receivers and Microwave Ovens - 394.500Inspection of Manufacturers of Device Components - 300.100Karaya Gum Powder and Related Devices for Use by Ostomates - 325.100Label Declaration of Artificial Color - 587.100Labeling: "Chocolate" or "Chocolate Flavored" - 515.800Laser Light Shows, etc. - 393.100Licensing - Changes to be Reported - 210.100Literature for High-Intensity Mercury Vapor Lamps - 31.100Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200Marketed New Drugs without Approved NDAs or ANDAs - 440.100Medicated Feeds -- Formula Information - 670.100Medicated Feeds -- Combined Batches - 680.400Mercury Vapor Lamps that are not Self-Extinguishing - 391.200Metric Declarations of Quantity of Contents - 140.500Obligations of Factory-Based Manufacturers and Assemblers - 398.375Orders for Post-Approval Record Reviews - 470.100Override of Positive Beam Limitation - 398.425Pet Food Labeling - 690.200Positive Beam Limitation (PBL) Requirements - 398.450Potato Chips, Ingredients - Labeling - 585.710Records and Reports - Applicability - 21 CFR 1002.1 - 390.425Registration of Blood Banks and Other Firms - 230.110Regulatory Actions and Small Business - 160.100Reloaders of X-Ray Tube Housing Assemblies - 398.700Repacking of Drug Products -- CGMP's - 430.200Retention of Microwave Oven Test Records - 394.100Salmonella Contamination of Dry Dog Food - 690.700Standards and Minimum Requirements for Biologic Products - 205.100Sunlamp Performance Standard - 396.100Surgeon's Gloves and Patient Examination Gloves - 335.700Tamper-Resistant Packaging Requirements - 450.500Teat Dips and Udder Washes for Dairy Cows and Goats - 654.200 Temporal-Maximum Ultrasonic Power - 397.100Uncooked Meat for Animal Food - 690.500Vitamin B-15, Pangamic Acid and Pangamic Acid Products - 457.100Volatile N-Nitrosamines in Rubber Baby Bottle Nipples - 500.450Water in Food Products (Ingredient or Adulterant) - 555.875Water and Gravy in Pet Food - 690.400

MARANTA ARUNDICACEA L (arrow root).Starches--Common or Usual Names - 578.100

MARGARINEHollandaise Sauce 525.- 400

MARINE CRAYFISHCommon or Usual Names for Curstaceans - 540.350

MARJORAMLeafy Spices, Other Than Bay Leaves - 525.500Marjoram - 525.900Spices-Definitions - 525.750

MASTITISTeat Dips & Washes for Cows & Goats - 654.200

MEATAflatoxins in Animal Feeds - 683.100Bouillon, Bouillon Cubes, Granulated - 567.300Canned Pet Food - 690.300Clams, Mussels, Oysters - 540.250Diversion of Adulterated Food - 675.200Drug Use and Residue Avoidance - 615.200Extra-Label Use of New Animal Drugs - 615.100FDA Jurisdiction - 565.100Foreign Language Declarations - 562.400Human-Labeled Drugs - 608.100Illegal Drug Residues - 615.300Processed Seafood Products - 540.700Radionuclides - 560.750Red Meat with PCB's - 565.200Rendered Animal Feed Ingredients - 675.400Uncooked Meat for Animal Food - 690.500Unsafe Contamination of Animal Feed - 680.500Usual Names for Crustaceans - 540.350

MEDICATED FEEDAdequate Use Drugs and Devices - 607.100Alternate Feeding of Medicated Feeds - 666.100CGMP's for Medicated Feeds - 680.200Checklist Labeling for Medicated Feeds - 665.200Medicated Feeds --Formula Information - 670.100Medicated Feeds--Combined Batches - 680.400Sequencing in Medicated Feed Production - 680.600Type A Medicated Article in Feed Labels - 665.300Unsafe Contamination of Pet Feed - 680.500Use of Drug Contaminated Products - 682.100Vitamins and Minerals in Feed - 670.200

MENADIONE DIMETHYLPYRIMIDINOL BISULFITEMedicated Feeds Formulation - 670.100

MERCURY RESIDUETreated Grain Seed - 578.400

METHYLENE CHLORIDESpices Definitions - 525.750

MEASLES IMMUNE GLOBULINStandards & Min. Requirements for Biologic Products - 205.100

MEASLES VIRUS VACCINE, INACTIVATEDStandards & Min. Requirements for Biologic Products - 205.100

MEASLES VIRUS VACCINE, LIVE, ATTENUATEDStandards & Min. Requirements for Biologic Products - 205.100

MEASURED VALUETemporal-Maximum Ultrasonic Power - 397.100

MEASUREMENT DEVICESSphygmomanometers - Accuracy - 310.210

MEASUREMENTSMetric Declarations of Quantity of Contents - 140.500Sweet Potatoes - Sirup Pack - 585.850Temporal-Maximum Ultrasonic Power - 397.100

MEDICAL CLAIMSHypnotherapy Devices-Self-Hypnotic Tape Recordings - 335.300Ion Generating Devices - 355.300Lasers for Facelift, Wrinkle Removal, Acupuncture, etc - 393.200

MEDICAL DEVICE REPORTING (MDR)Reconditioners/Rebuilders of Medical Devices - 300.200

MEDICAL DISPOSABLE DEVICESReuse of Medical Disposable Devices - 300.500

MEDICAL GAS DRUGCompressed Medical Gases -Warning Letters - 435.100

MEDICAL LASERS DEVICESLasers for Facelift, Wrinkle Removal, Acupuncture, - 393.200

MEDICAL MODALITYHypnotherapy Devices-Self-Hypnotic Tape Recordings - 335.300

MEDICAL PROCEDUREBlood & Blood Products - Definitions - 230.100Ear-Piercing Devices - 320.100

MEDICARERegistration of Blood Banks & Other Firms - 230.110

MENSTRUAL CONTROLHypnotherapy Devices-Self-Hypnotic Tape Recordings - 335.300Menstral Sponges - 345.300

MENSTRUAL TAMPONSMenstrual Sponges - 345.300

MERCURY


427427

Adulterated Food Mixed w/ Good Food - 555.200Clincal Thermometer-Adulteration - 335.800Literature for High-Intensity Mercury Vapor Lamps - 391.100Mercury Vapor Lamps--Not Self-Extinguishing - 391.200Seeds for Sprouting Prior to Food Use - 555.750Sphygmomanometers - Accuracy - 310.210Treated Grain Seed - Mercury Residue - 578.400

MERCURY-IN-GLASSClinical Thermometer-Adultration - 335.800

MERCURY RESIDUETreated Grain Seed - Mercury Residue - 578.400

METHODAdulteration of Drugs under Sec. 501(b) and 501(c) - 420.100Alcohol; Use of Synthetic Alcohol in Foods - 555.100Ammoniated Cottonseed Meal - Interpretation of 21 CFR 573.140 - 670.500

Analytical Methodology Used by FDA - Drugs - 150.500Apricot, Peach and Pear Nectars and Purees - Mold - 550.155 Capsicum Pods, etc. - Adulteration - 525.200Caviar, Use of Term - Labeling - 540.150Changes in Compendial Specifications and NDA - 420.300Cherries, Canned - Misbranding Involving Food Standards - 550.230Chloramphenicol - 654.300Compendial Requirements - 420.400Compressed Medical Gases -- Warning Letters - 435.100Controlled-Release Dosage Form Drugs - 460.700Cytotoxic Testing for Allergic Diseases - 370.100Decomposition & Histamine in Albacore, Skipjack and Yellowfin Tuna - 540.525Direct-Fed Microbial Products - 689.100Direct Reference Authority for Pseudomonas Contamination - 590.300Dried Prunes, Dehydrated Low Moisture Prunes, and Pitted Prunes - 550.700

Illegal Sales of Veterinary Prescription Drugs - 608.500Metric Declarations of Quantity of Contents - 140.500Microfiche and/or Microfilm for Records Retention - 130.400Milk and Milk Products Containing Penicillin - 527.450Oleomargarine - Misbranding Due to Low Fat - 535.100Over-The-Counter Sale of Injectable Animal Drugs - 608.200Pathogens in Dairy Products - 527.300Peaches, Canned - Misbranding Involving Food Standards - 550.655Pesticide Residues in Food and Feed - 575.100Pistachio Nuts - Aflatoxin Adulteration - 570.500Pottery (Ceramics) - Cadmium Contamination - 545.400Pottery (Ceramics) - Lead Contamination - 545.450Raw Breaded Shrimp - Microbiological - 540.420Reconditioning - Tree Nuts Contaminated with E. coli - 570.550RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200 Sequencing in Medicated Feed Production - 680.600Silver-Plated Hollowware - Lead Contamination - 545.500Sugar - Water Damaged - Reconditioning - 515.425Surgeon's Gloves and Patient Examination Gloves -335.700Tracers in Animal Feed - 680.100Turtles - 170.100Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100 Use of

DDVP (Vapona) Strips in Milkhouses and Milkrooms - 527.600Vitamin B-15, Pangamic Acid and Pangamic Acid Products - 457.100Volatile N-Nitrosamines in Rubber Baby Bottle Nipples - 500.450Water-Damaged Food Products - 555.850Whole Milk, Low Fat Milk, Skim Milk - Aflatoxin M1 - 527.400

METHYL MERCURYFish, Shellfish, Crustaceans, etc - Methyl Mercury - 540.600

METHYLCELLULOSEOTC Anti-Obesity Preparations - 456.100

METHYLENE CHLORIDESpices - Definitions - 525.750

METRICMetric Declarations of Quantity of Contents - 140.500

MICROBIAL BIOBURDENParametric Release of Terminally Heat Sterilized Drug Products - 460.800

MICROBIOLOGICALDiversion of Adultrated Food to Accetable Animal FeedUse - 675.200Intermediate or End Products of Sample Analysis - 150.100Karaya Gum Powder & Devices for Use by Ostomates - 325.100Raw Breaded Shrimp - Microbiological - 540.420Rodent Contaminated Pet Foods - 690.600

MICROBIOLOGICAL ATTRIBUTESKaraya Gum Powder & Devices - Use by Ostomates - 325.100

MICROBIOLOGICAL CRITERIARaw Breaded Shrimp - Microbiological - 540.420

MICROFICHEMicrofiche and/or Microfilm - Records Retention - 130.400

MICROFILMMicrofiche and/or Microfilm Records Retention - 130.400

MICROOGANISMDirect-Fed Microbial Products - 689.100Foods, Except Dairy Products - 555.300Pathogens in Dairy Products - 527.300

Rodent Contaminated Pet Foods - 690.600MICROWAVE OVENS

Certification for Exports - 110.100Importation of TV Receivers & Microwave Ovens - 394.500Retention of Microwave Oven Test Records - 394.100

MIGRAINE HEADACHESHypnotherapy Devices-Self-Hypnotic Tape Recordings - 335.300

MIL-STD-105DCondoms; Defects-Criteria - Direct Reference Seizure - 345.100

MILDEWGreens, Canned - 585.450Spinach, Canned or Frozen - 585.775

MILKAflatoxin M1 - 527.400Butter-Adulteration - 527.100Cheese and Cheese Products - 527.200Cheese-Misbranding - 527.225Chocolate or Chocolate Flavored - 515.800Containing Penicillin - 527.450Contaminated Products in Pet Food - 682.100DDVP (Vapona) Strips in Milkhouses - 527.600Drug Use and Residue Avoidance - 615.200Eggnog; Eggnog Flavored Milk - 527.350Extra-Label Use of New Pet Drugs - 615.100Human-Labeled Drugs in Pet Medicine - 608.100Illegal Drug Residues - 615.300Immune Milk - 275.100Imported Milk and Cream - 560.400Iron Products for Baby Pigs - 643.100Malted Milk - 527.500N-Nitrosamines in Rubber Baby Bottle Nipples - 500.450Pathogens in Dairy Products - 527.300Pesticide Residues - 575.100Radionuclides - 560.750Rendered Animal Feed Ingredients - 675.400Teat Dips and Udder Washes - 654.200Unsafe Contamination of Pet Feed - 680.500Vitamins and Minerals Infeed - 670.200

MILKHOUSESUse of DDVP (Vapona) Strips-Milk Houses & Rooms - 527.600

MILKROOMSUse of DDVP (Vapona) Strips-Milk Houses & Rooms - 527.600

MINCED PIMENTOOlives - 550.605

MINOR VIOLATIONAssessment of Civil Penalites - 390.300

MISBRANDED-See Attached ListAcupuncture Devices and Accessories - 305.100 Canned Green Beans and Canned Wax Beans - Standards - 585.475Capelin; Prohibited from Being Labeled as Smelt - 540.100Cheese - Misbranding Due to Moisture and Fat - 527.225 Cherries, Canned - Misbranding Involving Food Standards - 550.230Clinical Thermometer - Adulteration; Misbranding Defects - 335.800Compressed Medical Gases -- Warning Letters - 435.100Computerized Drug Processing -- Input/Output Checking - 425.400Computerized Drug Processing -- Vendor Responsibility - 425.200 Condoms; Defects - Criteria for Direct Reference Seizure - 345.100Contamination of Devices Labeled as Sterile - 300.400Country of Origin Labeling - 560.200Crab and Crabmeat Products with Other Seafood - Labeling - 540.285Crabmeat - Product Name - 540.300Cytotoxic Testing for Allergic Diseases - 370.100Defective Suntanning Booths and Beds. - 396.300Devices for Use in Animals - 655.100Diaphragms - Rx Devices - 345.200Direct-Fed Microbial Products - 689.100Direct Reference Authority for Class III Medical Devices - 300.700Dried Prunes, Dehydrated Low Moisture Prunes, and Pitted Prunes - 550.700

Eggnog; Eggnog Flavored Milk--Common Usual Names - 527.350 Electrical Muscle Stimulators - 355.200Enriched or Fortified Foods - Potency - 555.550Ethylenediamine Dihydroiodide (EDDI) - 651.100Failure to Register - 625.500Food Additives - Labeling Directions Necessary for Safe Use - 500.250Foods, Rail Car Sanitation - Adulteration - 545.300Hazardous Diagnostic X-Ray Systems - 398.200Homeopathic Drugs - 400.400Human-Labeled Drugs Distributed & Used in Animal Medicine - 608.100Hypnotherapy Devices - Self Hypnotic Tape Recordings - 335.300Identical or Similar Product Names - 400.500Illegal Sales of Veterinary Prescription Drugs - 608.500Importation of Unlabeled Foods - 21 CFR 101.100(d) - 560.100 Imported Products - Lack of English Labeling - 110.900Imports - Identity of Ingredients - 560.250Ineffective Devices - 502(f)(l) Labeling Requirements - 300.300Ion Generating Devices - 355.300


428428

Jams, Jellies and Related Products - Imports - 560.500Lack of Expiration Date or Stability Data - 480.300Malt Products - 515.200Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200Medicated Feeds -- Formula Information - 670.1001Nutritional Supplements for Companion Animals - 690.100Oleomargarine - Misbranding Due to Low Fat - 535.100Olives - Adulteration Involving Pits; Rot; Insect Infestation - 550.600OTC Drugs - Combination Products - 450.300OTC Drugs - Recognition as Safe and Effective - 450.200Peaches, Canned - Misbranding Involving Food Standards - 550.655Pet Food Labeling - 690.200Prescription Status - Telephone Answering Machine - 460.425Products Composed of Interstate Ingredients - 100.200Reconditioners/Rebuilders of Medical Devices - 300.200Returned Antibiotics Exported Under 801(d) of the Act - 405.210RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200Safety and Labeling of Waxed (Coated) Fruits and Vegetables - 562.550 Silage Ingredients - 687.500Standardized Canned Fruit - Packing Medium - 550.800Tomatoes - Canned - Misbranding Involving Food Standards (Peel) - 585.875Uncertified or Delisted Colors - 587.200Unfermented Beverages, Use of Word "Champagne" - 510.300Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100 Vitamins

and Minerals in Feed - 670.200Warning Label Required on Sunlamp Products - 396.400Water in Food Products (Ingredient or Adulterant) - 555.875Water and Gravy in Pet Food - 690.400

MISCALIBRATIONAssemblers Who Install Noncompliant Equipment - 398.325

MISUSEAcupuncture Devices & Accessories - 305.100Determination by Secretary: Product Fails to Comply - 390.200Extra-Label Use-New Animal Drugs-Food-Producing Animals - 615.100Illegal Sales of Veterinary Prescription Drugs - 608.500Proper Drug Use & Residue Avoidance - 615.200Seizure of Books That Constitute Misleading Labeling - 140.100

MITESApple Butter-Adulteration - 550.100Broccoli, Frozen Adulteration - 585.260Drupelet Berries - 550.200Food Storage & Warehousing - 580.100Interpretation of Insect Filth in Foods - 555.600Mushrooms, Canned or Dried - 585.500Spinach, Canned or Frozen - 585.775

MITIGATIONDirect-Fed Microbial Products - 689.100Homeopathic Drugs - 400.400Human Blood & Blood Products as Drugs - 230.120Hypnotherapy Devices-Self-Hypnotic Tape Recordings - 335.300Razor Blades, Manicuring Instruments - 335.500Vitamin B-5, Pangamic Acid & P.A. Products - 457.100

MIXED NUTSMixed Nuts-Misbranding Involving Food Standards - 570.700Tree Nuts -Adulteration Involving Rejects - 570.425

MODEL CHANGE REPORTSElectronic Products Subject to 21 CFR 1001.15(a) - 390.400

MODEL DESIGNATIONCertification & Identification of X-Ray Components - 398.600

MODES OF OPERATION Automatic Adjustment of the X-Ray Field Size - 398.400 X-Ray Field Size for Spot-Film - 398.475

MOISTURECalcium Chloride - 500.400Cheese - Misbranding Due to Moisture and Fat - 527.225Collection and Charitable Distribution of Drugs - 400.800Dimethylnitrosamine (DMNA) in Barley Malt - 578.500Dried Prunes, Dehydrated Low Moisture Prunes, and Pitted Prunes - 550.700

Malted Milk - 527.500Moisture Damaged Grain - 675.300Spices - Definitions - 525.750Tomato Products - Adulteration with Mold - 585.900Water in Food Products (Ingredient or Adulterant) - 555.875

MOLD- See Attached ListAction Levels for Aflatoxins in Animal Feeds - 683.100Apple Butter - Adulteration with Mold; Rodent Filth, Insects - 550.100Apricot, Peach and Pear Nectars and Purees - Mold - 550.155Bay (Laurel) Leaves - Insect Filth; Mold; Mammalian Etc. - 525.150 Capsicum Pods, etc. - Adulteration - 525.200Cherry Jam - Adulteration with Mold - 550.235Citrus Fruit Juices, Canned - Fly Filth and Mold - 550.250Cocoa Beans - Mold, Insect Infestation, and Mammalian Eexcreta - 515.750Coffee and Cocoa Bean Sweeps - 560.350Cranberry Sauce - Adulteration with Mold - 550.260Dates and Date Material; Imported and Domestic - 550.300Drupelet Berries (Blackberries, Raspberries, etc.) - 550.200

Figs; Fig Paste - Insect Infestation; Mold, Dirt - 550.350 Green Coffee Beans - Adulteration with Insects; Mold - 510.500Jam, Black Currant - Adulteration with Mold - 550.450Leafy Spices, Other Than Bay Leaves - 525.500Mace - Insect Filth; Mold, Foreign Matter; Mammalian Excreta - 525.550Marjoram - 525.900Menstrual Sponges - 345.300Moisture Damaged Grain - 675.300Olives - Adulteration Involving Pits; Rot; Insect Infestation - 550.600Oregano - 525.850Peaches, Canned, Frozen -- Adulteration Due to Insects and Mold - 550.650Pineapple, Canned; Pineapple Juice - Adulteration with Mold - 550.680Plums, Canned - Adulteration with Rot - 550.690Preservatives; Use in Nonstandardized Foods; Label Declaration - 562.600Raisins - Adulteration Involving Mold, Sand, Grit, & Insects - 550.750Sage - 525.950Strawberries; Frozen, Whole, or Sliced - Sand, Mold - 550.850The Use of Antibiotic Drug Residue By-Products in Animal Feed - 682.200Thyme - 525.925Tomato Products - Adulteration with Mold - 585.900Whole Milk, Low Fat Milk, Skim Milk - Aflatoxin M1 - 527.400Whole and Ground Nutmeg - Insect Filth; Mold; Rodent Filth - 525.600Whole and Ground Pepper - Adulteration - 525.625Whole Ginger - Insect Filth; Mold; Mammalian Excreta - 525.375Whole Cassia or Whole Cinnamon, Ground Cinnamon - 525.225Whole and Ground Allspice - Mold; Insect and Rodent Filth - 525.100

MONENSINSequencing in Medicated Feed - 680.600

MONITOR CIRCUITRetention of Microwave Oven Test Recordes - 394.100

MONOGRAPHSAdulteration of Drugs Under 501(b) & (c) - 420.100Compendium Revisions & Deletions - 420.200Health Fraud - 120.500Homeopathic Drugs - 400.400OTC Drugs - Recognition as Safe & Effective - 450.200

MONOSODIUM GLUTAMATELabeling of Seasoning - 525.650

MONTEREY, MOZZARELLA, MUENSTERCheese - 527.225

MOST RESPONSIBLE OWNER OPERATORDefective Suntanning Booth & Beds - 396.300

MOUTH TISSUESDenture Cleaners, Adhesives, & Repair Materials - 315.230

MULTER BERRIESCloudberries - 550.590

MULTIPLE BATCH PROCESS VALIDATIONProcess Validation Requiremts - Drug Products - 490.100

MULTIPLE SAMPLINGCondoms; Defects-Criteria-Direct Reference Seizure - 345.100Surgeons' Gloves & Patient Examination Gloves - 335.700

MULTIPLE SCLEROSISImmune Milk - 275.100

MUMPS VIRUS VACCINE, LIVEStandards & Min. Requirements - Biologic Products - 205.100

MUNG BEANSSprouting Prior to Food Use - 555.750

MUSCLEChubs, Hot Process Smoked w/ Added Nitrite - 540.200Electrical Muscle Stimulators - 355.200

MUSHROOM MYCELIUMFitness for Food - 585.525

MUSHROOMSCanned or Dried - 585.500Fitness for Food; Labeling - 585.525Pesticide Residues - 575.100

MUSSELSBacteriological Contamination - 560.600Paralytic Shellfish Poison - 540.250

MUSTARDComposition - 525.575Spices-Definitions - 525.750

MUSTARD CAKEPrepared Mustard, Composition - 525.575

MUSTARD FLOURPrepared Mustard, Composition - 525.575Spices - Definitions - 525.750

MUSTARD OILPrepared Mustard - 525.575Spices-Definitions - 525.750

MYCELIAUse of Antibiotic Drug Residue - 682.200

NADAAnimal Drugs for Euthanasia - 608.300Availability of Bulk Chemicals - 625.200Chloramphenicol - 654.300


429429

Dimethyl Sulfoxide for Animal Use - 654.100Direct-Fed Microbial Products - 689.100LVP's for Animal Use - 635.100Oral Iron Products for Baby Pigs - 643.100Proper Drug Use and Residue Avoidance - 615.200Reconditioning of New Pet Drugs - 625.400Silage Ingredients - 687.500Statements Regarding NADA - 605.100Teat Dips and Udder Washes Cows/Goats - 654.200Tracers in Pet Feed - 680.100

NANOMETERSSunlamp Performance Standard - 396.100

NAPKINSFacial Tissue, Paper Napkins & Towels, etc. - 100.600

NARCOTICSArticles not Intended for Entry - 110.700Confectionery - 515.100

NATIONAL ASSOCIATION OF BOARDS OF PHARMACY (NABP)Computerized Rx Recordkeeping by Pharmacies - 460.400

NATIONAL CANNERS ASSOCIATIONCorn on the Cob, Canned - 585.325Sweet Potatoes-Sirup Pack - 585.850

NATIONAL DRUG CODEUnit Dose Labeling Solid & Liquid Oral Dose Forms - 430.100

NATIONAL FORMULARY XIVHomeopathic Drugs - 400.400Malt Products - 515.200Spices-Definitions - 525.750

NATIONAL MARINE FISHERIES SERVICEFish-Involving Decomposition - 540.575Processed Seafood Products - 540.700

NATURAL CHOCOLATE FLAVOREDLabeling: "Chocolate" or "Chocolate Flavored" - 515.800

NATURAL FERMENTATIONUnfermented Beverages, "Champagne" - 510.300Dealcoholized Wine, Malt Beverages - 510.400Alcohol; Use of Synthetic in Foods - 555.100

NATURAL SEA SPONGESMenstrual Sponges - 345.300

NEEDLESRegulatory Action Approved New Drugs - 446.100Status of Syringes & Needles - 655.400

NEGATIVEAdulteration of Drugs Under 501(b) & (c) - 420.100Food,Except Dairy Products-Adulteration w/ Salmonella - 555.300Foods, Adulteration w/ Aflatoxin - 555.400Ion Generating Devices - 355.300Milk & Milk Products Containing Penicillin - 527.450

NEPHROPS NORWEGICUSCommon or Usual Names for Crustaceans - 540.350

NET WEIGHT/NET CONTENTSCorn on the Cob, Canned - 585.325Foods-Net Weight - 562.300Lingon Berries, Canned - 550.500Metric Declarations - 140.500Mixed Nuts - 570.700

NEW ANIMAL DRUGAdequate Directions for Drugs/Devices - 607.100Animal Grooming Aids - 653.100Anthelmintics - 640.100Availability/Bulk Chemicals for Pet Drugs - 625.200Chloramphenicol - 654.300Dimethyl Sulfoxide for Pet Use - 654.100Direct-Fed Microbial Products - 689.100Drugs for Odor Control in Pets - 642.100Ethylenediamine Dihydroiodide (EDDI) - 651.100Extra-Label Use of New Pet Drugs - 615.100Fraud, Untrue Statements of Material - 120.100Human-Labeled Drugs Used in Pet Medicine - 608.100Milk Products Containing Penicillin - 527.450Orders for Post-Approval Record Reviews - 470.100Proper Drug Use and Residue Avoidance - 615.200Reconditioning of New Pet Drugs Seized - 625.400Silage Ingredients - 687.500Statements Regarding NADA Approval - 605.100Tracers in Animal Feed - 680.100Unapproved New Animal Drugs - 625.300Unsafe Contamination of Pet Feed - 680.500

NEW DRUGAdequate Directions for Use - Animal Drugs and Devices - 607.100Adulteration of Drugs under Sec. 501(b) and 501(c) - 420.100Analytical Methodology Used by FDA - Drugs - 150.500Compendial Requirements - 420.400Compressed Medical Gases -- Warning Letters - 435.100Consistent Application of CGMP Determinations - 400.200Content Uniformity Testing of Tablets and Capsules - 460.600

Controlled-Release Dosage Form Drugs - 460.700Export of Uncertified Antibiotics - 405.200Fraud, Untrue Statements of Material Facts, Bribery - 120.100Hospital Pharmacies - 460.100Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200Marketed New Drugs without Approved NDAs or ANDAs - 440.100New Drugs - Export - 442.100Orders for Post-Approval Record Reviews - 470.100OTC Drugs - Recognition as Safe and Effective - 450.200OTC Drugs - Combination Products - 450.300Parametric Release of Terminally Heat Sterilized Drugs - 460.800Reconditioning New Drugs Lacking Approved NDA - 448.100Recovery of IND's from Clinical Investigators - 444.100Regulatory Action Regarding Approved New Drugs - 446.100Unit Dose Labeling for Solid and Liquid Oral DosageForms - 430.100 Vitamin B-15, Pangamic Acid and Pangamic Acid Products - 457.100

NEW DRUG APPLICATIONSAnalytical Methodology Used by FDA - Drugs - 150.500Changes in Compendial Specifications and NDA - 420.300Compendial Requirements - 420.400Content Uniformity Testing of Tablets and Capsules - 460.600Export of Uncertified Antibiotics - 405.200Hospital Pharmacies - 460.100Jellies, Nonstandardized - 550.475Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200Marketed New Drugs without Approved NDAs or ANDAs - 440.100OTC Drugs - Combination Products - 450.300Reconditioning New Drugs Lacking Approved NDA - 448.100Regulatory Action Regarding Approved New Drugs - 446.100Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100Vitamin B-15, Pangamic Acid and Pangamic Acid Products - 457.100

NEW YORK GREEN COFFEE ASSOCIATIONGreen Coffee Beans-Adulteration w/ Insects; Mold - 510.500

NIHYDRAZONEUnsafe Contamination of Pet Feed - 680.500

NITROFURAZONEExtra-Label Use of New Pet Drug - 615.100Unsafe Contamination of Pet Feed - 680.500

NITROIMIDAZOLESExtra-Label Use of New Pet Drug - 615.100

N-NITROSAMINESIn Rubber Baby Bottles - 500.450

NITRITEClubs - 540.200Tuna, Sable, Salmon Shad - 540.500

NITROGEN OXICES (NOX)DMNA in Barley Malt - 578.500

NITROGLYCERINExpiration Dating of Unit Dose Repackaged Drugs - 480.200Unit Dose Labeling - Solid & Liquid Oral Dose Forms - 430.100

NITROSATING AGENTDimethylnitrosamme in Barley Malt - 578.500

NON-AUTOMATESphygmomanometers - Accuracy - 310.210

NON-HEALTH PROFESSIONALSLasers for Facelift, Wrinkle Removal, Acupuncture, etc. - 393.200

NON-STERILE PHARMACEUTICAL PRODUCTSKaraya Gum Powder and Related Devices for Use by Ostomates - 325.100

NONCOMPLIANCEAssemblers Who Install Noncompliant Equipment - 398.325Assessment of Civil Penalties - 390.300Blood and Blood Products - Definitions - 230.100Contract Sterilizers - 100.550Determination by Secretary that Product Fails to Comply - 390.200Early Correction of Defects or Noncompliance - 390.225Fraud, Untrue Statements of Material Facts, Bribery - 120.100Hazardous Diagnostic X-Ray Systems - 398.200Obligations of Factory-Based Manufacturers and Assemblers - 398.375Orders for Post-Approval Record Reviews - 470.100Shrimp - Frozen, Raw, Breaded or Lightly Breaded - 540.410

NONFAT DRYImported Milk and Cream. Import Milk Act - 560.400Pathogens in Dairy Products - 527.300Use of Drug-Contaminated Products in Animal Feed - 682.100

NONNUTRITIVE SWEETENERSConfectionery - 515.100

NONREACTIVESource Plasma - Syphilis - 254.100

NONSIGNIFICANT RISK DEVICESAcupuncture Devices and Accessories - 305.100

NONSTERILEContamination of Devices Labeled as Sterile - 300.400Karaya Gum Powder and Related Devices for Use by Ostomates - 325.100

NONSTERILITYContamination of Devices Labeled as Sterile - 300.400


430430

NONSURGICAL PROCEDURESLasers for Facelift, Wrinkle Removal, Acupuncture, etc. - 393.200

NOODLE PRODUCTSMacaroni and Noodle Products - 505.500Water in Food Products (Ingredient or Adulterant) - 555.875

NORMAL INSPECTIONCondoms; Defects - Criteria for Direct Reference Seizure - 345.100

NORMAL SERUM ALBUMINStandards and Minimum Requirements for Biologic Products - 205.100

NORMAL WEARAssemblers Who Install Noncompliant Equipment - 398.325Determination by Secretary that Product Fails to Comply - 390.200

NORTH ATLANTIC LOBSTER/NORWEGIAN LOBSTERCommon or Usual Names for Crustaceans - 540.350

NOTICEAcupuncture Devices and Accessories - 305.100Assemblers Who Install Noncompliant Equipment - 398.325Assessment of Civil Penalties - 390.300Class III Devices Subject to 5l5(b) Requirements - 300.750Confectionery - Use of Nonnutritive Substances as Ingredients - 515.100Crabmeat - Adulteration with Filth - Escherichia coli - 540.275Cytotoxic Testing for Allergic Diseases - 370.100Direct Reference Authority for Class III MedicalDevices - 300.700Failure to Register - 625.500Fish-Fresh and Frozen-Adulteration Involving Decomposition - 640.575 Health Fraud - 120.500Homeopathic Drugs - 400.400Hospital Pharmacies - 460.100Importation of Television Receivers and Microwave Ovens - 394.500Imported Milk and Cream. Import Milk Act - 560.400Imported Products - Lack of English Labeling - 110.900Large Volume Parenterals (LVP's) for Animal Use - 635.100Marketed New Drugs without Approved NDAs or ANDAs - 440.100Menstrual Sponges - 345.300OTC Drugs - Combination Products - 450.300Refusal to Permit Inspection - 130.100Regulatory Actions Against Assemblers of X-Ray Equipment - 398.350Revocation of Tolerances for Cancelled Pesticides - 550.700Section 305 Meeting - 160.400Shrimp - Fresh or Frozen Raw Headless, Peeled or Breaded - 540.400Water and Gravy in Pet Food - 690.40022

NOTICE OF ADVERSE FINDINGSFailure to Register - 625.500 Health Fraud - 120.500Homeopathic Drugs - 400.400Large Volume Parenterals (LVP's) for Animal Use - 635.100Menstrual Sponges - 345.300Regulatory Actions Against Assemblers of X-Ray Equipment - 398.350

NUMBERSBlood and Blood Products - Definitions - 230.100Certification and Identification of X-Ray Components - 398.600Cheese - Misbranding Due to Moisture and Fat - 527.225Clams, Mussels, Oysters - Bacteriological Contamination - 560.600Common or Usual Names for Animal Feed Ingredients - 665.100Contamination of Devices Labeled as Sterile - 300.400Diversion of Adulterated Food to Acceptable Animal Feed Use - 675.200Metric Declarations of Quantity of Contents - 140.500Olives Stuffed with Minced Pimentos - Labeling - 550.605Pathogens in Dairy Products - 527.300Platelets, Pooled - 231.100

NUTBakery Products, Candy "Shotgun" - 505.100Butter Nut Bread - 505.300Mixed Nuts-Misbranding - 570.700Names for Crustaceans - 540.350Reconditioning Tree Nuts - 570.550Tree Nuts-Escherichia coli - 570.450

NUTMEGSpices-Definitions - 525.750Whole and Ground Filth; Mold - 525.600

OBJECTIONABLE PRACTICEPacemaker Reuse - 310.100

OBLIGATIONSResponsibility for Reporting Violations - 100.100Inspection of Firms When Legal Action is Pending - 130.200

OCEAN PERCHFish - Adulteration by Parasite - 540.590

OFFICE OF GENERAL COUNSELAmmoniated Cottonseed Meal - Interpretation of 21 CFR 573.140 - 670.500

Answering Inquiries on Status of Criminal Referrals - 160.500Chloramphenicol - 654.300Dentures -- Sale by Persons not Licensed to Practice Dentistry - 315.100

OIL OF BITTER ALMONDSMaraschino Cherries - 550.550

OIL OF CORIANDER

Labeling of Seasonings - 525.650Spices - Definitions - 525.750

OIL OF JUNIPERLabeling of Seasonings - 525.650

OLALLIE BLACKBERRIES Drupelet Berries (Blackberries, Raspberries, etc.) - 550.200

OLEOMARGARINEOleomargarine - Misbranding Due to Low Fat - 535.100Products Composed of Interstate Ingredients - 100.200

OLEORESIN CELERYLabeling of Seasonings - 525.650

OLEORESIN SWEET BASILLabeling of Seasonings - 525.650

OLIVESOlives - Adulteration Involving Pits; Rot; Insect Infestation - 550.600

OLIVES STUFFED WITH MINCED PIMENTOSOlives Stuffed with Minced Pimentos - Labeling - 550.605

OMISSIONAssessment of Civil Penalties - 390.300Country of Origin Labeling - 560.200Determination by Secretary that Product Fails to Comply - 390.200Responsibility for Illegal Drug Residues in Meat, Milk and Eggs - 615.300

ONE-FOR-ONE EXCHANGECompressed Medical Gases -- Warning Letters - 435.100Reloaders of X-Ray Tube Housing Assemblies - 398.700

ONION POWDER Labeling of Seasonings - 525.650

ONION RINGS MADE FROM DICED ONIONSOlives Stuffed with Minced Pimentos - Labeling - 550.605

OPINIONAdulterated Food Mixed with Good Food - 555.200Alcohol; Use of Synthetic Alcohol in Foods - 555.100Canned Peas - Label Designation of Sizes - 585.625Caviar, Use of Term - Labeling - 540.150Collection and Charitable Distribution of Drugs - 400.800Color Additives in Paper and Paperboard for Use with Food - 500.425Commercial Distribution -- Premarket Notification - 300.600Crab and Crabmeat Products with Other Seafood - Labeling - 540.285Cytotoxic Testing for Allergic Diseases - 370.100Drug Product Entries in Periodic Publications - 400.700Drupelet Berries (Blackberries, Raspberries, etc.) - 550.200Ear Piercing Devices - 320.100Electrical Muscle Stimulators - 355.200FDA Jurisdiction Over Meat and Poultry Products - 565.100Foods, Rail Car Sanitation - Adulteration - 545.300Fortification of Standardized Juices - 510.700Hollandaise Sauce - Common or Usual Name - 525.400Hospital Pharmacies - 460.100Importation of Television Receivers and Microwave Ovens - 394.500Imported Milk and Cream. Import Milk Act - 560.400Jordan Almonds - Common or Usual Name - 570.100Karaya Gum Powder and Related Devices for Use by Ostomates - 325.100Labeling: "Chocolate" or "Chocolate Flavored" - 515.800Malt Products - 515.200Marmalade - 550.575Microfiche and/or Microfilm for Records Retention - 130.400Override of Positive Beam Limitation - 398.425Peas and Carrots, Labeling of Canned Mixture - 585.600Pet Food Labeling - 690.200Plastic Containers for Injectable Animal Drugs - 637.100RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200Seeds for Sprouting Prior to Food Use - 555.750Sphygmomanometers - Rx Legend - 310.200Unfermented Beverages, Use of Word "Champagne" - 510.300Use of DDVP (Vapona) Strips in Milkhouses and Milkrooms - 527.600

OPPORTUNISTIC PATHOGENSKaraya Gum Powder and Related Devices for Use by Ostomates -325.100

ORAL HYGIENE PRODUCTSTamper-Resistant Packaging Requirements - 450.500

ORAL PRESCRIPTIONPrescription Status - Telephone Answering Machine - 460.425

ORANGE BLOSSOM HONEYHoney - Source Declaration - 515.300

ORANGE MARMALADEMarmalade - 550.575

ORANGESMarmalade - 550.575Oranges - Artificial Coloring - 550.625Pesticide Residues in Food and Feed - 575.100

ORCHICInert Glandular Preparations - OTC - 455.100

OREGANOLabeling of Seasonings - 525.650Leafy Spices, Other Than Bay Leaves - 525.500Oregano - 525.850Spices - Definitions - 525.750


431431

ORGANOLEPTIC ANALYSISCanned Salmon - Adulteration Involving Decomposition - 540.375 Shrimp - Fresh or Frozen Raw Headless, Peeled or Breaded - 540.400

ORGANOLEPTIC CHARACTERISTICSJellies, Nonstandardized - 550.475

ORIENTAL NOODLESChow Mein Noodles, Chinese Noodles and Other Oriental Noodles - 505.400 OSTOMATESKaraya Gum Powder and Related Devices for Use by Ostomates - 325.100

OSTOMY APPLIANCESKaraya Gum Powder and Related Devices for Use by Ostomates - 325.100

OTCCGMP Enforcement Policy - OTC vs Rx Drugs - 450.100Control/Accountability of TRP Materials - 450.550Health Fraud - 120.500Homeopathic Drugs - 400.400Inert Glandular Preparations - OTC - 455.100Lack of Expiration Date or Stability Data - 480.300Marketed New Drugs without Approved NDAs or ANDAs - 440.100Nutritional Supplements for Companion Animals - 690.100OTC Drugs - Combination Products - 450.300OTC Anti-Obesity Preparations - 456.100OTC Drugs - Recognition as Safe and Effective - 450.200OTC Drugs in Vending Machines - 450.400OTC Ear Drops - 454.100 Packaging -- Contact Lens Solutions and Tablets - 350.100 Tamper-Resistant Packaging Requirements - 450.500

OTC DRUG MONOGRAPH IMPLEMENTATIONOTC Drugs - Recognition as Safe and Effective - 450.200

OTHER IDENTICAL DESI-EFFECTIVE PRESCRIPTION DRUGSMarketed New Drugs without Approved NDAs or ANDAs - 440.100

OTHER SAUCESTomato Products - Drosophila Fly Eggs and Maggots - 585.890

OUTER ENVELOPEMercury Vapor Lamps that are Not Self-Extinguishing - 391.200

OUTPUT WAVEFORMTemporal-Maximum Ultrasonic Power - 397.100

OVARYInert Glandular Preparations - OTC - 455.100

OVENRetention of Microwave Oven Test Records - 394.100Importation of Television Receivers and Microwave Ovens - 394.500

OVER-THE-COUNTERAcupuncture Devices and Accessories - 305.100Control/Accountability of TRP Materials - 450.550Extra-Label Use of New Animal Drugs in Food-Producing Animals -615.100Homeopathic Drugs - 400.400Metric Declarations of Quantity of Contents - 140.500Nutritional Supplements for Companion Animals - 690.100OTC Ear Drops - 454.100OTC Drugs in Vending Machines - 450.400Over-The-Counter Sale of Injectable Animal Drugs - 608.200Packaging -- Contact Lens Solutions and Tablets - 350.100 Tamper-Resistant Packaging Requirements - 450.500Tamper-Resistant Packaging - 590.500The Status of Syringes and Needles for Animal Use - 655.400Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100

OVERBLEEDINGSource Plasma - Overbleeding - 252.100

OVERRIDEOverride of Positive Beam Limitation - 398.425

OXYGEN ANALYZERCompressed Medical Gases -- Warning Letters - 435.100

OYSTERSClams, Mussels, Oysters - Paralytic Shellfish Poison - 540.250Clams, Mussels, Oysters - Bacteriological Contamination - 560.600Water in Food Products (Ingredient or Adulterant) - 555.875

OZONEIon Generating Devices - 355.300

PACKAGE INSERTSTamper-Resistant Packaging Requirements - 450.500

PACKING MEDIUMCanned Foods, Use of the Term "Solid Pack" - 520.100Corn on the Cob, Canned - Quantity of Contents Declaration - 585.325Maraschino Cherries - 550.550Pineapple, Canned; Imported and Domestic - Food Standards - 550.685Pork and Beans and Similar Bean Products--Labeling - 567.200Processing" - Use of Term in Section 405 of the FD&C Act - 562.650Standardized Canned Fruit - Packing Medium - 550.800Sweet Potatoes - Sirup Pack - 585.850Tomato Products - Adulteration with Mold - 585.900

PAIN CONTROLHypnotherapy Devices - Self Hypnotic Tape Recordings - 335.300

PANELBakery Products, Candy "Shotgun" Ingredients Declaration -505.100Certification and Identification of X-Ray Components - 398.600

Dealcoholized Wine and Malt Beverages - Labeling - 510.400Foods - FPLA Compliance - 562.200Homeopathic Drugs - 400.400Identity of Foods--Terms such as Fresh, Frozen, Dried, Canned - 562.450Labeling of Food Articles Distributed Solely in Puerto Rico - 562.750Metric Declarations of Quantity of Contents - 140.500OTC Drugs - Combination Products - 450.300Processed and/or Blended Seafood Products - 540.700Statements Regarding NADA Approval in Labeling and Advertising - 605.100

Time Period for Separation of Platelets - 231.120Warning Label Required on Sunlamp Products - 396.400

PANULIRUS ARGUS, RISSONII, ORNATUSCommon or Usual Names for Crustaceans - 540.350

PAPERApproved by FDA" - Labeling of a Food Additive -500.300Color Additives in Paper and Paperboard for Use with Food -500.425Dimethyl Sulfoxide (DMSO) for Animal Use - 654.100Facial Tissues, Paper Napkins, Paper Towels, etc. - 100.600Food Storage & Warehousing - Adulteration - Filth - 580.100Tamper-Resistant Packaging Requirements - 450.500

PAPERBOARDColor Additives in Paper and Paperboard for Use with Food - 500.425Tamper-Resistant Packaging Requirements - 450.500

PAPRIKACapsicum Pods, etc. - Adulteration - 525.200Labeling of Seasonings - 525.650Pesticide Residues in Food and Feed - 575.100Spices - Definitions - 525.750

PARAGRAPH XIV PRESCRIPTION DRUGSMarketed New Drugs without Approved NDAs or ANDAs - 440.100

PARALYTIC SHELLFISH POISONClams, Mussels, Oysters - Paralytic Shellfish Poison - 540.250

PARAMETRIC RELEASEParametric Release of Terminally Heat Sterilized Drugs - 460.800

PARAPROTEINEMIC Blood and Blood Products - Definitions - 230.100

PARASITESFish - Fresh and Frozen, as listed - Adulteration by Parasites - 540.590Flea and Tick Collars Containing a Pesticide - 641.100

PARATHYROIDInert Glandular Preparations - OTC - 455.100

PARENTERAL DRUGSFructose-Containing Drugs - 400.335

PARENTERAL USEInert Glandular Preparations - OTC - 455.100

PAROTIDInert Glandular Preparations - OTC - 455.100

PARSLEYSpices - Definitions - 525.750

PART NUMBERSCertification and Identification of X-Ray Components - 398.600

PASTEURIZATIONProcessing" - Use of Term in Section 405 of the FD&C Act - 562.650Immune Milk - 275.100

PASTEURIZED BLENDED (CHEESE)Cheese - Misbranding Due to Moisture and Fat - 527.225

PASTEURIZED PROCESSCheese - Misbranding Due to Moisture and Fat - 527.225

PATHOGENSImmune Milk - 275.100Karaya Gum Powder and Related Devices for Use by Ostomates - 325.100Pathogens in Dairy Products - 527.300

PATIENT EXAMINATION GLOVESSurgeon's Gloves and Patient Examination Gloves - 335.700

PATIENT POPULATIONMarketed New Drugs without Approved NDAs or ANDAs - 440.100

PBL LOGIC SYSTEMOverride of Positive Beam Limitation - 398.425

PDPClass III Devices Subject to 5l5(b) Requirements - 300.750Metric Declarations of Quantity of Contents - 140.500

PEACHPeaches, Canned - Misbranding Involving Food Standards - 550.655 Apricot,

Peach and Pear Nectars and Purees - Mold - 550.155 PEANUT

Action Levels for Aflatoxins in Animal Feeds - 683.100Aflatoxin in Peanuts and Peanut Products - 570.375Foods, Adulteration with Aflatoxin - 555.400Peanut Butter - Adulteration with Filth; Grit - 570.300Peanuts, Shelled and Unshelled - Filth and Reject Nuts - 570.350Pesticide Residues in Food and Feed - 575.100

PEANUT BUTTERPeanut Butter - Adulteration with Filth; Grit - 570.300

PEANUT PRODUCTSAction Levels for Aflatoxins in Animal Feeds - 683.100Aflatoxin in Peanuts and Peanut Products - 570.375


432432

Foods, Adulteration with Aflatoxin - 555.400PEAR NECTARS

Apricot, Peach and Pear Nectars and Purees - Mold - 550.155PEAR PUREES

Apricot, Peach and Pear Nectars and Purees - Mold - 550.155PEAS AND CARROTS

Peas and Carrots, Labeling of Canned Mixture - 585.600Pesticide Residues in Food and Feed - 575.100

PECANSPesticide Residues in Food and Fruit - 575.100Tree Nuts - Adulteration Involving Rejects - 570.425

PECTINConfectionery - Use of Nonnutritive Substances as Ingredients. - 515.100Jellies, Nonstandardized - 550.475

PENDENCY Commercial Distribution -- Premarket Notification - 300.600

PENICILLINMilk and Milk Products Containing Penicillin - 527.450Repacking of Drug Products -- CGMP's - 430.200Use of Drug-Contaminated Products in Animal Feed - 682.100

PEPPERCapsicum Pods, etc. - Adulteration - 525.200Spices - Definitions - 525.750

PEPPER, REDCapsicum Pods, etc. - Adulteration - 525.200Spices - Definitions - 525.750

PERCHFish - Fresh and Frozen, as listed - Adulteration by Parasites - 540.590

PERFORMANCE STANDARDAssemblers who Install Noncompliant Equipment - 398.325Assessment of Civil Penalties - 390.300Certification and Identification of X-Ray Components - 398.600Defective Suntanning Booths and Beds - 396.300Definition of General Purpose Radiographic X-Ray System - 398.100

Determination by Secretary that Product Fails to Comply - 390.200Early Correction of Defects or Noncompliance - 390.225Exemption for Certain Sunlamp Product Purchaser Records - 396.230Importation of Television Receivers and Microwave Ovens - 394.500Laser Light Shows, etc. - 393.100Lasers for Facelift, Wrinkle Removal, Acupuncture, etc. - 393.200Literature for High-Intensity Mercury Vapor Lamps - 391.100Obligations of Factory-Based Manufacturers and Assemblers - 398.375Sunlamp Performance Standard - 396.100Temporal-Maximum Ultrasonic Power - 397.100Warning Label Required on Sunlamp Products - 396.400

PERSONAcupuncture Devices and Accessories - 305.100Answering Inquiries on Status of Criminal Referrals - 160.500Assessment of Civil Penalties - 390.300Blood and Blood Products - Definitions - 230.100Computerized Drug Processing -- I.D. of "Persons" - 425.500Confectionery - Use of Nonnutritive Substances as Ingredients - 515.100Contamination of Devices Labeled as Sterile - 300.400Definition of "Commerce" - 21 CFR 1000.3(g) - 390.100Dentures -- Sale by Persons not licensed to Practice Dentistry - 315.100Ear Piercing Devices - 320.100Extra-Label Use of New Animal Drugs in Food-Producing Animals - 615.100Food and Drug Guaranty - Imports - 110.500Fraud, Untrue Statements of Material Facts, Bribery - 120.100 Guaranties Over Printed Signatures - 100.800Health Fraud - 120.500Hospital Pharmacies - 460.100Illegal Sales of Veterinary Prescription Drugs - 608.500Importation of Unlabeled Foods -- *21 CFR 101.100(d) - 560.100 Intermediate or End Products of Sample Analysis - 150.100Lasers for Facelift, Wrinkle Removal, Acupuncture, etc. - 393.200Obligations of Factory-Based Manufacturers and Assemblers - 398.375Reconditioners/Rebuilders of Medical Devices - 300.200Refusal to Permit Inspection. - 130.100Registration of Blood Banks and Other Firms - 230.110Requests for Records under Section 703 - 160.300RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200 Section 305 Meeting - 160.400Turtles - 170.100

PERTUSSIS VACCINEStandards and Minimum Requirements for Biologic Products - 205.100

PESTICIDE CHEMICALSFlea and Tick Collars Containing a Pesticide - 641.100Foods, Rail Car Sanitation - Adulteration - 545.300Labeling of Food Bearing Residues of Pesticide Chemicals - 562.700

PESTICIDE RESIDUES IN FOOD - 575.100PESTICIDES, CANCELLED

Revocation of Tolerances for Cancelled Pesticides - 555.700PETITION

Approved by FDA" - Labeling of a Food Additive - 510.300Confectionery - Use of Nonnutritive Substances as Ingredients. - 515.100

Fraud, Untrue Statements of Material Facts, Bribery - 120.100Silage Ingredients - 687.500

PHAcidified Low-Acid Canned Foods - High pH - 520.300Immune Milk - 275.100Large Volume Parenterals (LVP's) for Animal Use - 635.100

PHARMACEUTICALSAdulteration of Drugs under Sec. 501(b) and 501(c) - 420.100Compendium Revisions and Deletions - 420.200Karaya Gum Powder and Related Devices for Use by Ostomates - 325.100 Process Validation Requirements for Drug Products - 490.100Regulatory Action Regarding Approved New Drugs - 446.100Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100

PHARMACOLOGYExtra-Label Use of New Animal Drugs - 615.100

PHENAZOPYRIDINEUrinary Preparations - Lack of Rx Legend - Clains - 430.400

PHENOLImmune Milk - 275.100Pathogens in Dairy Products - 527.300

PHOSPHATASEPathogens in Dairy Products - 527.300

PHYSICALBlood and Blood Products - Definitions - 230.100Canned Green Beans and Canned Wax Beans - Standards - 585.475CGMP Applicability to Hardware and Software - 425.100 Confectionery - Use of Nonnutritive Substances as Ingredients - 515.100Diversion of Adulterated Food to Acceptable Animal Feed Use - 675.200Failure to Register - 625.500Food Additives -"GRAS" - 500.200Identity of Foods--Terms Such as Fresh, Frozen, Dried, Canned - 562.450Imports -- Post Detention Sampling - 100.800Jordan Almonds - Common or Unual Name - 570.100Plastic Containers for Injectable Animal Drugs - 637.100Registration of Blood Banks and Other Firms - 230.110Reuse of Medical Disposable Devices - 300.500Schedule of Physical Examination - 251.100Sequencing in Medicated Feed Production - 680.600Use of Income Tax Information from IRS - 160.200

PHYSICAL EXAMINATIONSchedule of Physical Examination - 251.100

PILFERAGELabeling of Shipping Containers for Drugs - 430.300

PILI NUTSAdulteration Involving Rejects - 570.425

PIMENTASpices - 525.750

PIMPINELLA ANISUMSpices-Definitions - 525.750

PINEALInert Glandular Preparations OTC - 455.100

PINEAPPLEPesticide Residues in Food and Feed - 575.100Pineapple, Canned; Imported and Domestic - Food Standards - 550.685Pineapple, Canned; Pineapple Juice - Adulteration with Mold - 550.680

PIPERINESpices - 525.750

PISTACHIO NUTSAflatoxin and Adulteration - 570.500

PITCherries, Canned - 550.230Dates and Date Material - 550.300Dried Prunes - 550.700Olives - Pits; Rot; Insect Infestation - 550.600

PIT FRAGMENTS (see pits)PITTED DATES

Dates and Date Material - 550.300PITTED SALAD OLIVES

Olives - 550.600PITUITARY

Inert Glandular Preperations OTC - 455.100PIZZA

Labeling of Seasonings - 525.650Tomato Products - Drosophila Fly Eggs and Maggots - 585.890Tomato Products - Adulteration with Mold - 585.900

PIZZA SEASONING (see pizza)PLACENTA

Inert Glandular Preperation OTC - 455.100PLASMA

Blood and Blood Products - Definitions - 230.100Communicable Disease Hazard - 100.300Large Volume Parenterals (LVP's) for Animal Use - 635.100Plasma Brokers - Registration and Compliance - 250.500Quantitative Testing for Serum Proteins in Plasmapheresis Donors - 255.100Registration of Blood Banks and Other Firms - 230.110Source Plasma - Overbleeding - 252.100


433433

Source Plasma - Guidelines for Informed Consent Forms - 250.100Source Plasma - Syphilis - 254.100Standards and Minimum Requirements for Biologic Products - 205.100Time Period for Separation of Platelets - 231.120Use of Units which have been Thawed - 253.100

PLASMA BROKERSPlasma Brokers - Registration and Compliance - 255.500Registration of Blood Banks and Other Firms - 230.110

PLASMAPHERESIS48-hour Period between Plasmapheresis Procedures - 256.100Blood and Blood Products - Definitions - 230.100Quantitative Testing for Serum Proteins in Plasmapheresis Donors - 255.100Registration of Blood Banks and Other Firms - 230.110Schedule of Physical Examination - 251.100Source Plasma - Guidelines for Informed Consent Forms - 250.100Source Plasma - Syphilis - 254.100Source Plasma - Overbleeding - 252.100

PLASMAPROTEIN FRACTIONStandards and Minimum Requirements for Biologic Products - 205.100

PLASTICSDenture Cleanres, Adhesives, Cushions, & Repair Materials - 315.200

PLATELET CONCENTRATEPlatelets, Pooled - 231.100Standards & Minimum Requirements for Biological Products - 205.100Storage of Platelet Concentrate - 231.130Time Period of Seperation of Platlets - 231.120

PLEURONCODES MONODONCommon or Usual Names for Crustaceans - 540.350

PLUGGINGWheat Filth - 578.300

PLUMS, CANNEDAdulteration with Rot - 550.690Pesticide Residues - 575.100

PMAClass III Devices Subject to 515(b) Requirements - 300.350Direct Reference Authority for Class III Medical Devices - 300.700RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200

POLIOMYELITIS VACCINEStandards & Minimum Requirements for Biological Products - 205.100

POLIOVIRUS VACCINE, LIVE, ORALStandards & Minimum Requirements for Biological Products - 205.100

POLLOCKCrab and Other Seafood Products - Labeling - 540.285Petfood Labeling - 690.200Processed Seafood Products - 540.700Red Meat - 565.200

POLYVALENT ANTIGENSImmune Milk - 275.100

POOR DESIGNObligations of Factory Based Manufacturers & Assemblers - 398.375

POPCORNFilth - 585.675Pesticide Residues and Feed - 575.100

POPPY SEEDSSpices - 525.750

PORK AND BEANSSimilar Bean Products - 567.200

PORTABLE HOME SUNLAMP PRODUCTS ANDULTRAVIOLET LAMPS

Exemptions for Certain Sunlamp Product Purchaser Records - 396.200Sunlamp Performance Standard - 396.100

POSITIVE BEAM LIMITATION (PBL)Override of Positive Beam Limitation - 398.425Positive Beam Limitation (PBL) Requirements - 398.450

POSTALHealth Fraud - 120.500

POSTAMENDMENT DEVICESClass III Devices Subject to 515(b) Requirements - 300.350

POSTIVEAdulteration of Drugs under Sec. 501(b) and 501(c) - 420.100Direct Reference Authority for Pseudomonas Contamination - 590.300Food Storage & Warehousing - Adulteration - Filth - 580.100Foods, Except Dairy Products - Adulteration with Salmonella - 555.300Fraud, Untrue Statements of Material Facts, Bribery -120.100Ion Generating Devices - 355.300Milk and Milk Products Containing Penicillin - 527.450Override of Positive Beam Limitation - 398.425Pathogens in Dairy Products - 527.300Positive Beam Limitation (PBL) Requirements - 398.450Salmonella Contamination of Dry Dog Food - 690.700Source Plasma - Syphilis - 254.100

POSTSURGICAL STIMULATIONElectrical Muscle Stimulators - 355.200

POTATO CHIPSUse of Calcium Cholride as Drying Agent - 500.400 Adulteration with Rot - 585.700

Ingredients - Labeling - 585.710POTATO STARCH

Starches, Common and Usual Names - 578.100POTENCY

Adulteration of Drugs under Sec. 501(b) and 501(c) - 420.100Biological Drugs for Animal Use - 645.100Blood and Blood Products - Definitions - 230.100Compendial Requirements - 420.400Enriched or Fortified Foods - Potency - 555.550Extra-Label Use of New Animal Drugs in Food-Producing Animals - 615.100Homeopathic Drugs - 400.400Lack of Expiration Date or Stability Data - 480.300Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200Medicated Feeds -- Combined Batches - 680.400Reconditioning New Drugs Lacking Approved NDA - 448.100Repacking of Drug Products -- CGMP's - 430.200Standards and Minimum Requirements for Biologic Products - 205.100Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100 Vitamin

Products for human use - low potency - 530.400 POTENTIAL

Alternate Feeding of Different Medicated Feeds - 666.100 Answering Inquiries on Status of Criminal Referrals - 160.500 CGMP Enforcement Policy - OTC vs Rx Drugs - 450.100CGmp's for Medicated Feeds - Daily Inventory Requirements - 680.200Clams, Mussels, Oysters - Paralytic Shellfish Poison - 540.250Communicable Disease Hazards - 100.300Direct Reference Authority for Class III Medical Devices - 300.700 Human-Labeled Drugs Distributed & Used in Animal Medicine - 608.100Identical or Similar Product Names - 400.500Illegal Sales of Veterinary Prescription Drugs - 608.500Imitation Breaded Shrimp - 540.450Karaya Gum Powder and Related Devices for Use by Ostomates - 325.100Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200Marketed New Drugs without Approved NDAs or ANDAs - 440.100Mercury Vapor Lamps that are not Self-Extinguishing - 391.200OTC Drugs - Combination Products - 450.300OTC Drugs - Recognition as Safe and Effective - 450.200Pottery (Ceramics) - Cadmium Contamination - 545.400Pottery (Ceramics) - Lead Contamination - 545.450Radionuclides in Imported Foods - Levels of Concern - 562.750Raw Breaded Shrimp - Microbiological - 540.420Responsibility for Reporting Violations - 100.100 Sequencing in Medicated Feed Production - 680.600 Silver-Plated Hollowware - Lead Contamination - 545.500Surgeon's Gloves and Patient Examination Gloves - 335.700Teat Dips and Udder Washes for Dairy Cows and Goats - 654.200 Uncooked Meat for Animal Food - 690.500Whole Milk, Low Fat Milk, Skim Milk - Aflatoxin M1 - 527.400

POTENTIAL HAZARDSKaraya Gum Powder and Related Devices for Use by Ostomates - 325.100

POTTERYCadmium Contamination - 545.400Lead Contamination - 545.450

POUCHESTamper Resistant Packaging Requirements - 450.500

POULTRYAction Levels for Aflatoxins in Animal Feeds - 683.100Canned Pet Food - 690.300Common or Usual Names for Animal Feed Ingredients - 665.100Diversion of Adulterated Food to Acceptable Animal Feed Use - 675.200FDA Jurisdiction Over Meat and Poultry Products - 565.100 Human-Labeled Drugs Distributed & Used in Animal Medicine - 608.100Nutritional Supplements for Companion Animals - 690.100Proper Drug Use and Residue Avoidance - 615.200Radionuclides in Imported Foods - Levels of Concern - 560.750Recycled Animal Waste - Alternate Feeding of Different MedicatedFeeds - 666.100Red Meat Adulterated with PCB's - 565.200Rendered Animal Feed Ingredients - 675.400Responsibility for Illegal Drug Residues in Meat, Milk and Eggs - 615.300Revocation of Tolerances for Cancelled Pesticides - 555.700Vitamins and Minerals in Feed - 670.200

PRE-AMENDMENTS DEVICECommercial Distribution - 300.600

PREMARKETCertification for Exports - 110.100Class III Devices Subject to 5l5(b) Requirements - 300.350Commercial Distribution -- Premarket Notification - 300.600Cytotoxic Testing for Allergic Diseases - 370.100Direct Reference Authority for Class III Medical Devices - 300.700Fraud, Untrue Statements of Material Facts, Bribery - 120.100Menstrual Sponges - 345.300Reconditioners/Rebuilders of Medical Devices - 300.200Regulatory Action Regarding Approved New Drugs - 446.100RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200

PREMARKET APPROVAL


434434

Class III Devices Subject to 5l5(b) Requirements - 300.750Cytotoxic Testing for Allergic Diseases - 370.100Direct Reference Authority for Class III Medical Devices - 300.700Fraud, Untrue Statements of Material Facts, Bribery - 120.100Menstrual Sponges - 345.300Regulatory Action Regarding Approved New Drugs - 446.100RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200

PREMARKET NOTIFICATIONClass III Devices Subject to 5l5(b) Requirements - 300.750Commercial Distribution -- Premarket Notification - 300.600Direct Reference Authority for Class III Medical Devices - 300.700Fraud, Untrue Statements of Material Facts, Bribery - 120.100Reconditioners/Rebuilders of Medical Devices - 300.200

PREPACKAGED DRUGSHospital Pharmacies - 460.100

PREPACKAGING (see prepackaged drugs)PRESCRIPTION DEVICES

Diaphragms - Rx Devices - 345.200Ear Piercing Devices - 320.100Electrical Muscle Stimulators - 355.200Hypnotherapy Devices - Self Hypnotic Tape Recordings - 335.300Reconditioners/Rebuilders of Medical Devices - 300.200RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200Sphygmomanometers - Rx Legend - 310.200

PRESCRIPTION DISPENSINGEar Piercing Devices - 320.100

PRESCRIPTION DRUGSClass I Recalls of Rx Drugs - 400.900Collection and Charitable Distribution of Drugs - 400.800Compressed Medical Gases -- Warning Letters - 435.100Failure to Register - 625.500Homeopathic Drugs - 400.400Illegal Sales of Veterinary Prescription Drugs - 608.500Lay Use of Veterinary Prescription Drugs - 608.300Marketed New Drugs without Approved NDAs or ANDAs - 440.100OTC Ear Drops - 454.100Proper Drug Use and Residue Avoidance - 615.200Return of Unused Rx Drugs to Pharmacy Stock - 460.300Rx Drugs for Ships' Medicine Chests - 460.500 Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100

PRESCRIPTION HOMEOPATHIC DRUGS Homeopathic Drugs - 400.400

PRESERVATIVESChocklet or Chocklet Flavored - 515.800Potato Chips - Ingredients Labeling - 585.710Use in Nonstandard Foods- 562.600

PRESS CAKEFilth - 515.750

PRICE SCHEDULESMercury Vapor Lamps that are Not Self Extinguishing - 391.200

PRIMARY BARRIERAssemblers who Install Noncompliant Equipment - 398.325

PRINCIPAL DISPLAY PANELDealcoholized Wine and Malt Beverages - Labeling - 510.400Foods - FPLA Compliance - 562.200Homeopathic Drugs - 400.400Identity of Foods--Terms such as Fresh, Frozen, Dried, Canned - 562.450Metric Declarations of Quantity of Contents - 140.500Processed and/or Blended Seafood Products - 540.700

PRINTEDCommunicable Disease Hazards - 100.300Foods - FPLA Compliance - 562.200Guaranties Over Printed Signatures - 100.800Labeling of Food Articles Distributed Solely in Puerto Rico - 562.750 Literature

for High-Intensity Mercury Vapor Lamps - 391.100Metric Declarations of Quantity of Contents - 140.500Seizure of Books that Constitute Misleading Labeling - 140.100

PROCEEDDirect-Fed Microbial Products - 689.100Fraud, Untrue Statements of Material Facts, Bribery - 120.100 Imported Products - Lack of English Labeling - 110.900Marketed New Drugs without approved NDAs or ANDAs - 440.100Milk and Milk Products Containing Penicillin - 527.450Pathogens in Dairy Products - 527.300Pineapple, Canned; Imported and Domestic - Food Standards - 550.685

PROCESS VALIDATIONCompendial Requirement - 420.400Contract Sterilizer - 100.550Process Validation Requirements for Drug Products - 490.100

PROCESSED GRAINPesticide Residues - 575.100

PROCESSING - USE OF THE TERMAflatoxin in Peanuts and Peanut Products - 570.375Answering Inquiries on Status of Criminal Referrals - 160.500Bay (Laurel) Leaves - Insect Filth; Mold; Mammalian Excreta - 525.150 Canned and Cooked/Frozen Shrimp - Decomposition - 540.400

Canned Foods - Seam Defects - 520.200CGMP Applicability to Hardware and Software - 425.100 Cherries, Canned - Misbranding Involving Food Standards - 550.230Coffee and Cocoa Bean Sweeps - 560.350Compressed Medical Gases -- Warning Letters - 435.100 Computerized Drug Processing -- Input/Output Checking - 425.200Computerized Drug Processing -- i.d. of "Persons" - 425.500Computerized Drug Processing -- Vendor Responsibility - 460.800 Dates and Date Material; Imported and Domestic - 550.300Decomp. & Histamine in Albacore, Skipjack and Yellowfin Tuna - 540.525Failure to Register - 625.500Finished Dosage Form Drugs in Bulk Containers - 410.100Food Storage & Warehousing - Adulteration - Filth - 580.100Hospital Pharmacies - 460.100Identity of Foods--Terms such as Fresh, Frozen, Dried, Canned - 562.450Importation of Licensed Biologic Products for Human Use - 210.150Inspection of Manufacturers of Device Components - 300.100Lack of Expiration Date or Stability Data - 480.300Laser Light Shows, etc. - 393.100Leafy Spices, other than Bay Leaves - 525.500Oranges - Artificial Coloring - 550.625Pesticide Residues in Food and Feed - 575.100Plasma Brokers - Registration and Compliance - 250.500Platelets, Pooled - 231.100Process Validation Requirements for Drug Products - 490.100Processing" - Use of Term in Section 405 of the FD&C Act - 562.650Raw Breaded Shrimp - Microbiological - 540.420Reconditioning -Tree Nuts Contaminated with E. coli - 570.550Reconditioning of Imported Coffee Beans - 560.300Registration of Blood Banks and other Firms - 230.110Regulatory Action Regarding Approved New Drugs - 446.100Rendered Animal Feed Ingredients - 675.400Salt-Cured, Air-Dried, Uneviscerated Fish - 540.650Source Code for Process Control Application Programs - 425.300Tomato Products - Adulteration with Mold - 585.900Tracers in Animal Feed - 680.100Uncertified or Delisted Colors - 587.200Uncooked Meat for Animal Food - 690.500Use of DDVP (Vapona) Strips in Milkhouses and Milkrooms - 527.600Water in Food Products (Ingredient or Adulterant) - 555.875Water and Gravy in Pet Food - 690.400

PRODUCT DESIGNRetention of Microwave Oven Test Records - 394.100

PRODUCT DEVELOPMENT PROTOCOLClass III Device Subject to 515(b) Requirements - 300.350

PRODUCT SAFETYCompendial Requirements - 420.400Communicable Disease Hazards - 100.300Retention of Microwave Oven Records - 394.100

PRODUCTION PERIODRetention of Microwave Oven Test Records - 394.100

PROGRAMAccess to Results of Quality Assurance Audits - 130.300Aflatoxin in Peanuts and Peanut Products - 570.375Assemblers who install Noncompliant Equipment - 398.325Assessment of Civil Penalties - 390.300 Brazil Nuts - Adulteration with Aflatoxin - 570.200Canned Pet Food - 690.300Compendial Requirements - 420.400Compressed Medical Gases -- Warning Letters - 435.100 Computerized Drug Processing - I.D. of "Persons" - 425.500Consistent Application of CGMP Determinations - 400.200Expiration Dating and Stability Testing - 480.100Fraud, Untrue Statements of Material Facts, Bribery - 120.100GWQAP Pre-Award Evaluation - 100.700Human-Labeled Drugs Distributed & Used in Animal Medicine - 608.100Illegal Sales of Veterinary Prescription Drugs - 608.500Jams, Jellies and Related Products - Imports - 560.500Lack of Expiration Date or Stability Data - 480.300Marketed New Drugs without Approved NDAs or ANDAs - 440.100OTC Drugs - Combination Products - 450.300OTC Drugs - Recognition as Safe and Effective - 450.200 Pistachio Nuts - Aflatoxin Adulteration - 570.500Process Validation Requirements for Drug Products - 490.100Proper Drug Use and Residue Avoidance - 615.200Quantitative Testing for Serum Proteins in Plasmapheresis Donors - 255.100Radionuclides in Imported Foods - Levels of Concern - 560.750Reconditioning New Drugs Lacking Approved NDA - 448.100Registration of Blood Banks and other Firms - 230.110Regulatory Actions and Small Business - 160.100Salmonella Contamination of Dry Dog Food - 690.700Schedule of Physical Examination - 251.100Source Code for Process Control Application Programs - 425.300Source Plasma - Guidelines for Informed Consent Forms - 250.100 Use of DDVP (Vapona) Strips in Milkhouses and Milkrooms - 527.600Vitamins and Minerals in Feed - 670.200


435435

Whole Milk, Low Fat Milk, Skim Milk - Aflatoxin M1 - 527.400PROMINENT PART

Warning Label Required on Sunlamp Products - 396.400PROMISED FUTURE DATE

Commercial Distribution Premarket Notification - 300.600PROMOTIONAL ACTIVITIES

Commercial Distribution Premarket Notification - 300.600Manufacture Distribution Promotion of Drugs by Pharmacies - 460.200

PROPHYLACTICSCondoms, Defects Criteria for Direct Reference Seizure - 345.100

PROPYLENE GLYCOLLabeling of Seasonings - 525.650

PROSTATEInert Glandular Preparations - 455.100

PROSTHETIC DENTAL APPLIANCEDentures Sale by Persons not licensed to Practice Dentistry - 315.100

PROTECTIVE EYEWEARDefective Suntanning Booths and Beds - 396.300

PROTEINAmmoniated Cottonseed Meal - Interpretation of 21 CFR 573.140 - 670.500Blood and Blood Products - Definitions - 230.100Bouillon, Bouillon Cubes, Granulated Bouillon - 567.300Canned Pet Food - 690.300Large Volume Parenterals (LVP's) for Animal Use - 635.100Nutritional Supplements for Companion Animals - 690.100Pacemaker Reuse - 310.100Pineapple, Canned; Imported and Domestic - FoodStandards - 550.685 Quantitative Testing for Serum Proteins in Plasmapheresis Donors - 255.100Recycled Animal Waste - 685.100Registration of Blood Banks and Other Firms - 230.110Rendered Animal Feed Ingredients - 675.400Source Plasma Guidelines for Informed Consent Forms - 250.100Source Plasma - Overbleeding - 252.100Standards and Minimum Requirements for Biologic Products - 205.100

PROTEIN SOLUTIONSLVP's for Animal Use - 635.100

PROTOTYPESRecords and Reports Applicability 21CFR 1002.1 - 390.425

PRUNES, DEHYDRATEDDried Prunes, Dehydrated Low Moisture Prunes & Pitted Prunes - 550.700

PSOCIDSFood Storage & Warehousing - 580.100In Green Coffee Beans - 510.500

PSYCHIC HEALINGHypnotherapy Devices Self Hypnotic Tape Recordings - 335.300

PUBLIC HEALTHAction Levels for Aflatoxins in Animal Feeds - 683.100Biological Drugs for Animal Use - 645.100Blood and Blood Products - Definitions - 230.100Class III Devices Subject to 5l5(b) Requirements - 300.350Communicable Disease Hazards - 100.300Determination by Secretary that Product Fails to Comply - 390.200Eggnog; Eggnog Flavored Milk--Common Usual Names - 527.350Hazardous Diagnostic X-Ray Systems - 398.200Health Fraud - 120.500Human Blood and Blood Products as Drugs - 230.120Human-Labeled Drugs Distributed & Used in Animal Medicine - 608.100Illegal Sales of Veterinary Prescription Drugs - 608.500Immune Milk - 275.100Importation of Television Receivers and Microwave Ovens - 394.500Imported Low-Acid Canned Foods - 560.450Imported Milk and Cream. Import Milk Act - 560.400Intermediate or End Products of Sample Analysis - 150.100Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200Marketed New Drugs Without Approved NDAs or ANDAs - 440.100Medical Emergencies - 220.100 Process Validation Requirements for Drug Products - 490.100Proper Drug Use and Residue Avoidance - 615.200Radionuclides in Imported Foods - Levels of Concern - 562.750Reconditioning New Drugs Lacking approved NDA - 448.100Red Meat Adulterated with PCB's - 565.200Regulatory Action Regarding Approved New Drugs - 446.100Responsibility for Reporting Violations - 100.100Retention of Microwave Oven Test Records - 394.100Return of Unused Rx Drugs to Pharmacy Stock - 460.300Reuse of Medical Disposable Devices - 300.500Revocation of Tolerances for Cancelled Pesticides - 555.700Surgeon's Gloves and Patient Examination Gloves - 335.700Teat Dips and Udder Washes for Dairy cows and Goats - 654.200Turtles - 170.100Unapproved Additives for Exported Grains - 578.600Whole Milk, Low Fat Milk, Skim Milk - Aflatoxin M1 - 527.400

PUDDINGSSilver Plated Holloware - 545.500

PUERTO

Labeling of Food Articles Distributed soley in Puerto Rico - 562.750Imported Milk & Cream. Import Milk Act - 560.400Imported Products Lack of English Labeling - 110.900

PULSED OR CONTINOUS MODETemporal Maximum Ultrasonic Power - 397.100

PUMPKINAction Levels for Aflatoxin - 683.100Adulteration with Aflatoxin - 555.400Articles from Certain Varieties of Squash - 585.725Squash Seeds Labeling as Pumpkin Seeds - 585.800

PUNCTURED OUTER WRAPContamination of Devices Labeled as Sterile - 300.400

PUNGENCY RATINGSpices - Definitions - 525.750

PURCHASER RECORDSExemption for Certain Sunlamp Porduct Purchaser Records - 396.200

PURCHASERSAssessment of Civil Penalties - 390.300Calcium Chloride - 500.400Canned Shrimp: Size Designations and Corresponding Counts - 540.390Commercial Distribution -- Premarket Notification - 300.600Exemption for Certain Sunlamp Product Purchaser Records - 396.200Mercury Vapor Lamps that are not Self-Extinguishing - 391.200Safety and Labeling of Waxed (Coated) Fruits and Vegetables - 562.550Unfermented Beverages, Use of word "Champagne" - 510.300

PURITYAcetic Acid - Use in Foods - Labeling of Foods in which Used - 562.100Adulteration of Drugs under Sec. 501(b) and 501(c) - 420.100Biological Drugs for Animal Use - 645.100Blood and Blood Products - Definitions - 230.100Compendial Requirements - 420.400Compendium Revisions and Deletions - 420.200Compressed Medical Gases -- Warning Letters - 435.100Contamination of Devices Labeled as Sterile - 300.400Homeopathic Drugs - 400.400Interference with Compendial Tests - 420.500Lack of Expiration Date or Stability Data - 480.300Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200Plastic Containers for Injectable Animal Drugs - 637.100Preservatives; Use in Nonstandardized Foods; Label Declaration - 562.600Reconditioning New Drugs Lacking Approved NDA - 448.100Regulatory Action Regarding Approved New Drugs - 446.100Repacking of Drug Products -- CGMP's - 430.200Return of Unused Rx Drugs to Pharmacy Stock - 460.300Starches--Common or Usual Names - 578.100Tracers in Animal Feed - 680.100

PURPURABlood and Blood Products Definitions - 230.100

PYROLIGNEOUS ACIDLabeling of Seasoning - 525.650

QUACKERYHealth Fraud - 120.500

QUALITYAccess to Results of Quality Assurance Audits - 130.300Adulteration of Drugs under Sec. 501(b) and 501(c) - 420.100Analytical Methodology Used by FDA - Drugs - 150.500Canned Peas - Label Designation of Sizes - 585.625Canned and Cooked/Frozen Shrimp - Decomposition - 540.400Canned Foods - Seam Defects - 520.200Canned Green Beans and Canned Wax Beans - Standards - 585.475Cheese and Cheese Products - Adulteration with Filth - 527.200Cherries, Canned - Misbranding Involving Food Standards - 550.230Clinical Thermometer - Adulteration; Misbranding Defects - 335.800Collection and Charitable Distribution of Drugs - 400.800Compendial Requirements - 420.400Compendium Revisions and Deletions - 420.200Compressed Medical Gases -- Warning Letters - 435.100 Computerized Drug Processing -- input/output Checking - 425.400Condoms; Defects - Criteria for Direct Reference Seizure - 345.100Consistent Application of CGMP Determinations - 400.200Contamination of Devices Labeled as Sterile - 300.400Content Uniformity Testing of Tablets and Capsules - 460.600Electronic Products Subject to 21 CFR 1001.15(a) - 390.400Food additives -"GRAS" - 500.200Fraud, Untrue Statements of Material Facts, Bribery - 120.100GWQAP Pre-Award Evaluation - 100.700Homeopathic Drugs - 400.400Interference with Compendial Tests - 420.500Lack of Expiration Date or Stability Data - 480.300Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200Medicated Feeds -- Combined Batches - 680.400Microfiche and/or Microfilm for Records Retention - 130.400Peaches, Canned - Misbranding Involving Food Standards - 550.655Pineapple, Canned; Imported and Domestic - Food Standards - 550.685Process Validation Requirements for Drug Products - 490.100Quality Control Testing - 231.110


436436

Records and Reports - Applicability - 21 CFR 1002.1 - 390.425Regulatory Action Regarding Approved New Drugs - 446.100Repacking of Drug Products -- CGMP's - 430.200Return of Unused Rx Drugs to Pharmacy Stock - 460.300Reuse of Medical Disposable Devices - 300.500 Salt-Cured, Air-Dried, Uneviscerated Fish - 540.650Source Code for Process Control Application Programs - 425.300Spices - Definitions - 525.750Storage of Platelet Concentrate - 231.130Streptomycin Residues in Cattle Tissues - 616.100Surgeon's Gloves and Patient Examination Gloves - 335.700Time Period for Separation of Platelets - 231.120Tomatoes - Canned - Misbranding Involving Food standards (Peel) - 585.875Tracers in Animal Feed - 680.100Unfermented Beverages, Use of word "Champagne" - 510.300Water in Food Products (Ingredient or Adulterant) - 555.875

QUALITY CONTROLAccess to Results of Quality Assurance Audits - 130.300Compendial Requirements - 420.400Electronic Products Subject to 21 CFR 1001.15(a) - 390.400Medicated Feeds -- Combined Batches - 680.400Microfiche and/or Microfilm for Records Retention - 130.400Quality Control Testing - 231.110Records and Reports - Applicability - 21 CFR 1002.1 - 390.425Salt-Cured, Air-Dried, Uneviscerated Fish - 540.650Storage of Platelet Concentrate - 231.130

QUARANTINEDiversion of Adulterated Food to Acceptable Animal Feed USA - 675.200Proper Drug Use & Residue Avoidance - 615.200

QUARTERED, SLICED AND CHIPPED OR MINCEDOlives - Adulteration Involving Pits; Rat, Insect Infestation - 550.600

QUESTIONABLE CLAIMSLasers for Facelift, Wrinkle Removal, Acupuncture etc. - 393.200Silage Ingredients - 687.500

QUESTIONSAlcohol; Use of Synthetic Alcohol in Foods - 555.100Artichoke; Jerusalem Artichoke - Common or Usual Name - 585.100Availability of Bulk Chemicals for Animal Drug Use - 625.200CGMP Applicability to Hardware and Software - 425.100Checklist Labeling for Custom Mixed Medicated Feeds - 665.200Collection and Charitable Distribution of Drugs - 400.800Color Additives in Paper and Paperboard for Use with Food -500.425Commercial Distribution -- Premarket Notification - 300.600Common or Usual Names for Animal Feed Ingredients - 665.100Computerized Drug Processing -- Vendor Tesponsibility - 425.200Computerized Drug Processing -- input/output Checking - 425.400

Computerized Drug Processing -- i.d. of "Persons" - 425.500Contamination of Devices Labeled as Sterile - 300.400Contract Sterilizers - 100.550Control/Accountability of TRP Materials - 450.550Dealcoholized Wine *and Malt Beverages* - Labeling - 510.400Definition of General Purpose Radiographic X-Ray System - 398.100 Definition

of "Commerce" - 21 CFR 1000.3(g) - 390.100Determination of Donor Suitability - 230.130Direct-Fed Microbial Products - 689.100Expiration Dating of Unit Dose Repackaged Drugs - 480.200Export of Uncertified Antibiotics - 405.200Finished Dosage Form Drugs in Bulk Containers - 410.100Foreign Trade Zones, Bonded Warehouses or Carriers - 110.600Fraud, Untrue Statements of Material Facts, Bribery - 120.100 Human Blood and Blood Products as Drugs - 230.120Imported Low-Acid Canned Foods - 560.450Jams, Jellies and Related Products - Imports - 560.500Label Declaration of Artificial Color - 587.100Labeling - Diluted Wines and Cider with Less than 7% Alcohol -510.450Labeling of Shipping Containers for Drugs - 430.300Marketed New Drugs Without Approved NDAs or NDAs - 440.100Microfiche and/or Microfilm for Records Retention - 130.400Orders for Post-Approval Record Reviews - 470.100Override of Positive Beam Limitation - 398.425Prescription Status - Telephone Answering Machine - 460.425Reconditioning Foods by Diversion for Animal Feed - 555.650Reconditioning of Foods Adulterated under 402(a)(4) - 160.700Refusal to Permit Inspection - 130.100Registration of Assemblers of Diagnostic X-Ray systems - 398.300 Regulatory Action Regarding Approved New Drugs - 446.100Repacking of Drug Products -- CGMP's - 430.200Responsibility for Reporting Violations - 100.100Source Plasma - Guidelines for Informed Consent Forms - 250.100Spices -Definitions - 525.750Time Period for Separation of Platelets - 231.120

RABIES VACCINEStandards & Minimum Requirements for Biologic Products - 205.100

RADIATION FORCE TECHNIQUESTemporal Maximum Ultrasonic Power - 394.100

RADIATION SAFETY DEFECTS AND NONCOMPLIANCES

Early Correction of Defects or Noncompliance - 390.225Obligations of Factory Based Manufacturers & Assemblers - 398.375

RADIATION SHIELDED SHOCK PROOF HOUSINGReloders of X-Ray Tube Housing Assemblies - 398.700

RADIATION-EMITTINGReconditioners/Rebuilders of Medical Devices - 300.200

RADIOGRAPHIC EXAMINATIONDefinition of General Purpose Radiographic X-Ray System - 398.100

RADIOGRAPHIC TIMER NONTERMINATIONHazardous Diagnostic X-Ray System - 398.200

RADIOIMMUNOASSAYRIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200

RADIONUCLIDES In Imported Foods - 562.750

RAIL CAR SANITATIONFoods in - 545.300

RAISINSAdulteration with Mold, Filth - 550.750

RASPBERRIESDrupelet Berries - 550.200

RAZOR BLADESRazer Blades, Manicuring Instruments - 335.500

REACTIVEPlastic Containers for Injectable Animal Drugs - 637.100Source Plasma Syphilis - 254.100

READY-TO-EATSalt, Dried Unevicerated Fish - 540.650

REAGENT RED BLOOD CELLSStandards & Minimum Requirements for Biologic Products - 205.100

REAGENTSBlood & Blood Product Definition - 230.100Registration of Blood Banks and other Firms - 230.110RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200

REBUILDERSReconditioners/Rebuilders of Medical Devices - 300.200

RECALLAdulteration of Drugs under Sec. 501(b) and 501(c) - 420.100Assessment of Civil Penalties - 390.300Clams, Mussels, Oysters - Paralytic Shellfish Poison - 540.250Class I Recalls of Rx Drugs - 400.900Color Additives - 587.300Contamination of Devices Labeled as Sterile - 300.400Direct Reference Authority for Class III Medical Devices - 300.700 Diversion of Adulterated Food to Acceptable Animal Feed Use - 675.200Exemption for Certain Sunlamp Product Purchaser Records - 396.200Fraud, Untrue Statements of Material Facts, Bribery - 120.100Identical or Similar Product Names - 400.500Jordan Almonds - Common or Usual Name - 570.100Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200OTC Drugs - Combination Products - 450.300Reconditioning New Drugs Lacking Approved NDA - 448.100Recovery of IND's from Clinical Investigators - 444.100 Salmonella Contamination of Dry Dog Food - 690.700

RECALLED DRUGClass I Recalls of Rx Drugs - 400.900

RECLASSIFICATIONDirect reference Authority for Class III Medical Devices - 300.700

RECONDITIONERSReconditioner/Rebuilders of Medical Devices - 300.200

RECONDITIONINGAmmoniated Cottonsseed Meal - 670.500Articles - 160.750Brazil Nuts with Aflatoxin - 570.200Builders of Medicdal Devices - 300.200By Diversion for Animal Feed - 555.650Cashews, Insect Infested - 570.250Diversion to - 675.200Foods Adulterated under 402(a)(4) - 160.500Imported Coffee Beans - 560.300Imports - Post Detention Sampling - 100.800Milk and Milk Products - 527.450New Drugs Lacking Aproved NDA - 448.100New Animal Drugs Seized - 625.400Reconditioning - 578.350Sugar - Water Damaged - 515.425Tree Nuts with E. Coli - 570.550Water Damaged Food Products - 555.850

RECORD PRESERVATION GUIDANCERetention of Microwave Oven Test Records - 394.100

RECORDSAccess to Results of Quality Assurance Audits - 130.300Assemblers who install Noncompliant Equipment - 398.325Assessment of Civil Penalties - 390.300Blood and Blood Products - Definitions - 230.100CGMP Applicability to Hardware and Software - 425.100CGmp's for Medicated Feeds - Daily Inventory Requirements -680.200


437437

Chloramphenicol - 654.300Class I Recalls of Rx Drugs - 400.900Compressed Medical Gases -- Warning Letters - 435.100Computerized Drug Processing -- Input/Output Checking - 425.400 Computerized Rx Recordkeeping by Pharmacies - 460.400Computerized Drug Processing -- I.D. of "Persons" - 425.500Contract Sterilizers - 100.550Cytotoxic Testing for Allergic Diseases - 370.100Exemption for Certain Sunlamp Product Purchaser Records - 396.200Guaranties Over Printed Signatures - 100.800GWQAP Pre-Award Evaluation - 100.700Hospital Pharmacies - 460.100Large volume parenterals (LVP's) for animal use - 635.100Marketed New Drugs Without Approved NDAs or ANDAs - 440.100Medicated Feeds -- Formula Information - 670.100Medicated Feeds -- Combined Batches - 680.400Microfiche and/or Microfilm for Records Retention - 130.400Orders for Post-Approval Record Reviews - 470.100Pineapple, Canned; Imported and Domestic - Food Standards -550.685Plasma Brokers - Registration and Compliance - 250.500Proper Drug Use and Residue Avoidance - 615.200Reconditioning New Drugs Lacking Approved NDA - 448.100Records and Reports - Applicability - 21 CFR 1002.1 - 390.425Regulatory Actions Against Assemblers of X-Ray Equipment - 398.350Reloaders of X-Ray Tube Housing Assemblies - 398.700Requests for Records Under Section 703 - 160.300Retention of Microwave Oven Test Records - 394.100

Returned Antibiotics Exported under 801(d) of the Act - 405.210RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200Source Code for Process Control Application Programs - 425.300Source Plasma - Syphilis - 254.100Uncertified or Delisted Colors - 587.200

RECOVERED HUMAN PLASMABlood and Blood Products Definition - 230.100Use of Units Which Have Been Thawed - 253.100

RECOVERED PLASMARegistration of Blood Banks and other Firms - 230.110Source plasma Guidelines for Informed Consent Form - 250.100Standards and Minimum Requirements for Biologic Products - 205.100

RED BLOOD CELLS (See recovered plasma)RED FISH

Adulteration by Parasites - 540.590RED MEAT

Adulterated with PCBs - 565.200RED SNAPPER

Labeling - 540.475RED SWEET PEPPERS

Canned Pimentos, Red Sweet Peppers - 585.650REDDENED

Karaya Gum Powder & Related Devices for Use by Ostomates - 325.100REDELIVERY

Imports-Post Detention Sampleing - 100.800REEDUCATION

Electrical Muscle Stimulators - 355.200REFRACTOMETER

Marmalade - 550.575Source Plasma Overbleeding - 252.100

REFURBISHESReconditioners/Rebuilders of Medical Devices - 300.200

REFUNDDetermination by Secretary that Product Fails to Comply - 390.200Early Correction of Defects or Noncompliance - 390.225

REFUSALAssessment of Civil Penalties - 390.300Importation of Unlabeled Foods *21CFR 101.100(d)* - 560.100Imports - Identity of Ingredients - 560.250Radionuclitides in Imported Foods - Levels of Concern - 560.750Refusal to Permit Inspection - 130.100

REGISTRATIONBiological Drugs for Animal Use - 645.100Blood and Blood Products - Definitions - 230.100Contract Sterilizers - 100.550Failure to Register - 625.500Flea and Tick Collars Containing a Pesticide - 641.100Hospital Pharmacies - 460.100Imported Low-Acid Canned Foods - 560.450Inspection of Manufacturers of Device Components - 300.100Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200Pesticide Residues in Food and Feed - 575.100Plasma Brokers - Registration and Compliance - 250.500Reconditioners/Rebuilders of Medical Devices - 300.200Registration of Assemblers of Diagnostic X-Ray Systems - 398.300 Registration of Blood Banks and Other Firms - 230.110Regulatory Actions and Small Business - 160.100Reloaders of X-Ray Tube Housing Assemblies - 398.700Revocation of Tolerances for Cancelled Pesticides - 555.700

Teat Dips and Udder Washes for Dairy Cows and Goats - 654.200Use of DDVP (Vapona) Strips in Milkhouses and Milkrooms - 527.600

REGULATORY FOLLOWUPReconditioners/Rebuilders of Medical Devices - 300.200

REGULATORY LETTERAssessment of Civil Penalties - 390.300Consistent Application of CGMP Determinations - 400.200Direct-Fed Microbial Products - 689.100Direct Reference Authority for Class III Medical Devices - 300.700 Expiration Dating and Stability Testing - 480.100Failure to Register - 625.500Failure to Register - 400.100Health Fraud - 120.500Homeopathic Drugs - 400.400Identical or Similar Product Names - 400.500Illegal Sales of Veterinary Prescription Drugs - 608.500Lack of Expiration Date or Stability Data - 480.300Large Volume Parenterals (LVP's) for Animal Use - 635.100Lasers for Facelift, Wrinkle Removal, Acupuncture, etc. - 393.200Manufacture, Distribution, Promotion of Drugs by Pharmacies -460.200Nutritional Supplements for Companion Animals - 690.100Oral Iron Products for Baby Pigs - 643.100Plasma Brokers - Registration and Compliance - 250.500Proper Drug Use and Residue Avoidance - 615.200Reconditioning New Drugs Lacking Approved NDA - 448.100Registration of Blood Banks and other Firms - 230.110Regulatory Actions Against Assemblers of X-Ray Equipment - 398.350Regulatory Actions and Small Business - 160.100Turtles - 170.100Unapproved New Animal Drugs - Follow-up Action - 625.300

REJECTCheese and Cheese Products - 527.200Cocoa Beans - 515.750Condoms; Defects - 345.100Dates and Date Material - 550.300Peanuts Filth - 570.350Pineapple, Canned - 550.685Pistachio Nuts - 570.500Retention of Microwave - 394.100Shirmp - 540.400Surgeon's and Patient Examination Gloves - 335.700Tree Nuts - 570.425

REJECT NUTSPeanuts Filth - 570.350

REJECTION see rejectRELAXACISOR

Cellutron Machine - 355.100RELEASE

Articles of Foreign Origin not intended for Entry - 110.700Brazil Nuts - Adulteration with Aflatoxin - 570.200Compendial Requirements - 420.400Compressed Medical Gases -- Warning Letters - 435.100 Controlled-Release Dosage Form Drugs - 460.700Diversion of Adulterated Food to Acceptable Animal Feed Use -675.200Homeopathic Drugs - 400.400Imported Frozen Products of Multiple Sizes or Codes - 560.700Marketed New Drugs without approved NDAs or ANDAs - 440.100Natural Bristle Brushes -- Nit Contamination - 590.400Nutritional Supplements for Companion Animals - 690.100Parametric Release of Terminally Heat Sterilized Drugs - 460.800Pottery (Ceramics) - Cadmium Contamination - 545.400Pottery (Ceramics) - Lead Contamination - 545.450Radionuclides in Imported Foods - Levels of Concern - 560.750Reconditioning New Drugs Lacking Approved NDA - 448.100Repacking of Drug Products -- CGMP's - 430.200Silver-Plated Hollowware - Lead Contamination - 545.500Source Plasma - Guidelines for Informed Consent Forms - 250.100Turtles - 170.100Unit Dose Labeling for Solid and Liquid Oral Dosage forms - 430.100

RELIEF OF MUSCLE SPASMElectrical Muscle Stimulators - 355.200Retention of Microwave Oven Test Records - 394.100

RELOADERSReconditioners/Rebuilders of Medical Devices - 300.200Reloders of X-Ray Tube Housing Assemblies - 398.700

RELOADING (see Reloaders)RELOADING STATIONS (see Reloaders)RELOCATE

Certification & Identification of X-Ray Components - 398.600RENAL IMPAIRMENT

Fructose Containing Drugs - 400.335REPACKAGING

Expiration Dating of Unit Dose Repackaged Drugs - 480.200Failure to Register - 625.500Regulatory Action Regarding Approved New Drugs - 446.100Unit Dose Labeling for Solid & Liquid Oral Dosage Forms - 430.100


438438

REPACKAGING REQUIREMENTSExpiration Dating of Unit Dose Repackaged Drugs - 480.200Unit Dose Labeling of Solid & Liquid Oral Dosage Forms - 430.100

REPACKERSCountry of Origin Labeling - 560.200Repacking of Durg Products - CGMPs - 430.200Vitamin B-15, Pargamic Acid & Pargamic Acid Products - 457.100

REPACKINGCollection and Charitable Distribution of Drugs - 400.800Condoms; Defects - Criteria for Direct Reference Seizure - 345.100Country of Origin Labeling - 560.200Finished Dosage Form Drugs in Bulk Containers - 410.100Hospital Pharmacies - 460.100Regulatory Action Regarding Approved New Drugs - 446.100Repacking of Drug Products -- CGMP's - 430.200Sauerkraut - Definition; Adulteration by Thrips - 585.750Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100

REPAIRAssemblers who Install Noncompliant Equipment - 398.325Compressed Medical Gases -- Warning Letters - 435.100Denture Cleaners, Adhesives, Cushions, and Repair Materials - 315.300Determination by Secretary that Product Fails to Comply - 390.200Early Correction of Defects or Noncompliance - 390.225Obligations of Factory-Based Manufacturers and Assemblers -398.375Override of Positive Beam Limitation - 398.425Reloaders of X-Ray Tube Housing Assemblies - 398.700

REPAIR MATERIALSDenture Cleaners Adhesives, Cushions, & Repair Materials - 315.200

REPLACEAssessment of Civil Penalties - 390.300Determination by Secretary that Product Fails to Comply - 390.200Early Correction of Defects or Noncompliance - 390.225Fraud, Untrue Statements of Material Facts, Bribery - 120.100

REPLACEDBlood and Blood Products - Definitions - 230.100Jellies, Nonstandardized - 550.475Preservatives; Use in Nonstandardized Foods; Label Declaration - 562.600Reloaders of X-Ray Tube Housing Assemblies - 398.700Revocation of Tolerances for Cancelled Pesticides - 555.700Tamper-Resistant Packaging Requirements - 450.500

REPLACEMENT PARTSDetermination by the Secretary that Product Fails to Comply - 390.200

REPORTING REQUIREMENTSDates and Date Material; Imported & Domestic - 550.300Electronic Products Subject to 21 CFR 1001.15(a) - 390.400Obligations of Factory Based Manufacturers & Assemblers - 398.375Regulatory Actions & Small Business - 160.100

RESEARCH48-hour Period Between Plasmapheresis Procedures - 256.100Adulteration of drugs under Sec. 501(b) and 501(c) - 420.100Allergenic Extracts Containing Glycerin - 270.100Availability of Bulk Chemicals for Animal Drug Use - 625.200Commercial Distribution -- Premarket Notification - 300.600Common or Usual Names for Animal Feed Ingredients - 665.100Communicable Disease Hazards - 100.300Compressed Medical Gases -- Warning Letters - 435.100 Ethylenediamine Dihydroiodide (EDDI) - 651.100Flea and Tick Collars Containing a Pesticide - 641.100Fraud, Untrue Statements of Material Facts, Bribery - 120.100 Homeopathic Drugs - 400.400Immune Milk - 275.100Importation of Licensed Biologic Products for Human Use - 210.150Importation of Television Receivers and Microwave Ovens - 394.500IND Filings - 215.100Jordan Almonds - Common or Usual Name - 570.100Licensing - Changes to be Reported - 210.100Microfiche and/or Microfilm for Records Retention - 130.400Nutritional Supplements for Companion Animals - 690.100Platelets, Pooled - 231.100Process Validation Requirements for Drug Products - 490.100Quality Control Testing - 231.110Quantitative Testing for Serum Proteins in Plasmapheresis Donors - 255.100Registration of Blood Banks and other Firms - 230.110RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200Source Plasma - Overbleeding - 252.100Standards and Minimum Requirements for Biologic Products -205.100Storage of Platelet Concentrate - 231.130Time Period for Separation of Platelets - 231.120Unapproved Additives for Exported Grains - 578.600Use of Units Which Have Been Thawed - 253.100Vitamins and Minerals in Feed - 670.200

RESERVATIONSFDA Jurisdiction on Indian Reservations - 100.350

RESISTANCEContamination of Devices Labeled as Sterile - 300.400Parametric Release of Terminally Heat Sterlized Drugs - 460.800

Tamper Resistant Packaging Requirements - 450.500RESPONSIBLE HEAD

Compressed Medical Gases - Warning Letters - 435.100Licensing Changes to be Reported - 210.100

RESTORESReconditioner/Rebuilders of Medicdal Devices - 300.200

RESTRICTEDBlood and Blood Products - Definitions - 230.100 Color Additives in Paper and Paperboard for Use with Food - 500.425Ear Piercing Devices - 320.100Labeling of Food Articles Distributed Solely in Puerto Rico - 562.750 The

Status of Syringes and Needles for Animal Use - 655.400RETAIL ESTABLISHMENTS

Menstral Sponges - 345.300Safety & Labeing of Waxed (Coated) Fruits and Vegtables - 562.550

REUSEReuse of Disposable Medical Devices - 300.500

REVENUEAlcohol Use of Synthetic Alcohol in Foods - 555.100Brandy Containing Methyl Alcohol - Food Additive - 510.200Use of Incom Tax Information from IRS - 160.200

REVOCATIONLicensing Changes to be Reported - 210.100Recycled Animal Waste - 685.100Revocation of Tolerance for Cancelled Pesticides - 555.700

RHEUMATOID ARTHRITISImmune Milk - 275.100

RICOImported Milk & Cream ; Imported Milk Act - 560.400Imported Products Lack of English Labeling - 110.900Labeling of Food Articles Distributed Solely in Puerto Rico - 562.750

RIFAMPINUnit Dose Labeling for Solid & Liquid Oral Dose Forms - 430.100

ROCK LOBSTER Common or Usual Names for Crustaceans - 540.350

ROCKY MOUNTAIN SPOTTED FEVER VACCINEStandards & Minimum Requirements for Biologic Products - 205.100

RODENT URINE, RODENT EXCRETA PELLETS, RODENT HAIRSFood Storage & Warehouseing - 580.100Rodent Contamination Pet Foods - 690.600

RODENTICIDEFoods - Adulteration Involving Infestation and 1080 Rodent - 555.450Pesticide Residues in Food and Feed - 575.100Revocation of Tolerance for Canceled Pesticides - 555.700Silage Ingredients - 687.500

ROSE FISHAdulteration by Parasitse - 540.590

ROSEMARYSpices - Definition - 525.750

ROSTOVSalt Curred Air Dried Uneviscerated Fish - 540.650

ROTBeets, Canned - Adulteration with Rot - 585.200Cherries - 550.225Drupelet Berries - 550.200Ethylenediamine Dihydroiodide (EDDI) - 651.100Olives - 550.600Plums, Canned - Adulteration with Rot - 550.690Potato Chips - Adulteration with Rot - 585.700

RUBBER BABY BOTTLE NIPPLESVolatile N-Nitrosamines - 500.450

RUBBER CONTRACEPTIVESCondoms; Defects - Criteria for Direct Reference Seizure - 345.100

RUBELLA VIRUS VACCINE, LIVEStandards & Minimum Requirements for Biologic Products - 205.100

RX DRUGSCGMP Enforcement Policy - OTC vs Rx Drugs - 450.100Class I Recalls of Rx Drugs - 400.900Illegal Sales of Veterinary Prescription Drugs - 608.500OTC Anti-Obesity Preparations - 456.100Return of Unused Rx Drugs to Pharmacy Stock - 460.300Rx Drugs for Ships' Medicine Chests - 460.500

RYBETZSalt-Cured, Air-Dried, Uneviscerated Fish - 540.650

SABLESmoked, Cured - 540.500

SACCHARINEJellies, Nonstandardized - 550.475

SAFETY AND EFFECTIVENESSAlternate Feeding of Different Medicated Feeds - 666.100Direct Reference Authority for Class III Medical Devices - 300.700 Fraud, Untrue Statements of Material Facts, Bribery - 120.100Health Fraud - 120.500Lasers for Facelift, Wrinkle Removal, Acupuncture, etc. - 393.200Marketed New Drugs without approved NDAs or ANDAs - 440.100Orders for Post-Approval Record Reviews - 470.100


439439

Regulatory Action Regarding Approved New Drugs - 446.100Reuse of Medical Disposable Devices - 300.500RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200

SAFFRONSpices Definition - 525.750

SAGELeafy Spices other than Bay Leaves - 525.500Spices - Definition - 525.750

SALMONCanned Decomposition - 540.375Sodium Nitrite - 540.500

SALMONELLADiversion of Contaminated Food for Animal Use - 675.100Foods, Except Dairy Products - Adulteration with Salmonella - 555.300Pathogens in Dairy Products - 527.300Recycled Animal Waste - 685.100Salmonella Contamination of Dry Dog Food - 690.700Turtles - 170.100Wheat for Human Consumption - Reconditioning - 578.350

SALMONELLA, ADULTERATION OF FOODS (See Salmonella)SALMONELLOSIS (See Salmonella)SALONS

Electrical Muscle Stimulators - 355.200SALT CURED

Salt-Cured, Air-Dried, Uneviscerated Fish - 540.650Olives - Adulteration Involving Pits; Rot; Insect Infestation - 550.600

SALT CURED OLIVES (see salt cured above)SALVAGED HUMAN PLASMA

Blood & Blood Products Definitions - 230.100SAMSOE

Cheese - 527.200SAND

Cumin Seeds - 525.325Mace - 525.550Menstral sponges - 345.300Raisins - 550.750Sesame Seeds - 525.700Strawberries - 550.850Whole and Ground Pepper - 525.625

SANITARY SPONGESMenstral Sponges - 345.300

SAP SAGO CHEESE Cheese - Misbranding Due to Moisture and Fat - 527.225

SATELLITE PACKSStorage of Platelet Concentrate - 231.130

SATISFACTIONAction Levels for Aflatoxins in Animal Feeds - 683.100Commercial Distribution Premarket Notification - 300.600

SAVORYSpices Definition - 525.750

SCALE INSECTSApple Butter - Filth - 550.100Olives...Pits, Rot & Infestation - 550.600

SCALLOPSProcessed Seafood Products - 540.700Water in Food Products - 555.875

SCIENTIFIC REVIEWDirect Reference Authority for Class III Medical Devices - 300.700Fraud, Untrue Statements of Material Facts, Bribery - 120.100Orders for Post-Approval Record Reviews - 470.100

SCOVILLE UNITSSpices Definition - 525.750

SEAFOOD COCKTAILCrab & other Seafood Products - Labeling - 540.285

SEALSControl/Accountability of TRP Materials - 450.550Tamper Resistant Packaging Requirements - 450.500

SEAMSCanned Foods - Seam Defects - 520.200Contamination of Devices Labeled as Sterile - 300.400Tamper Resistant Packaging Requirements - 450.500

SEASONINGSLabeling of Seasonings - 525.650Potato Chips, Ingredients, Labeling - 585.710Sweet Potatoes Sirup Packed - 585.850Tomato Sauce or Tomato Hot Sauce Labeling - 585.850

SEBASTESSnapper Labeling - 540.475

SECOND RECIPIENT -Pacemaker Reuse - 310.100

SECTION 305Answering Inquiries on Status of Criminal Referrals - 160.500Canned Salmon - Adulteration Involving Decomposition - 540.375Crabmeat - Adulteration with Filth - Escherichia coli - 540.275Fish-Fresh and Frozen-Adulteration Involving Decomposition -540.300Section 305 Meeting - 160.400

Shrimp - Fresh or Frozen Raw Headless, Peeled or Breaded - 540.400SEDATION

Human Labeled Drugs Distributed & Used in Animal Medicine - 608.100SEGREGATION

Cashews Reconditioning - 570.250Drug Use & Residue Avoidance - 615.200Medicated Feeds Combined Batches - 680.400

SEIZURE RECOMMENDATIONCompressed Medical Gases -- Warning Letters - 435.100Direct Reference Authority for Class III Medical Devices - 300.700 Diversion of Adulterated Food to Acceptable Animal Feed Use - 675.200Unapproved New Animal Drugs - Follow-up Action - 625.300

SELECTED FORMATAutomatic Adjustment of the X-Ray Field Size - 398.400

SELF HYPNOTIC TAPE RECORDINGSHypnotherapy Devices - 335.300

SELF-EXTINGUISHING LAMPSLiterature for High Intensity Mercury Vapor Lamps - 391.100

SELF-IMPROVEMENTHypnotherapy Devices Self Hypnotic Tape Recordings - 335.300

SEMOLINAMacaroni and Noodle Products - 505.500

SENSING MECHANISMOverride of Positive Beam Limitation - 398.425

SEPTRA/BACTRIMUnit Dose Labeling for Solid & Liquid Oral Dosage Form - 430.100

SERIOUS ADVERSE HEALTH CONSEQUENCESAssessment of Civil Penalties - 390.300

SERIOUS DEFICIENCESAssessment of Civil Penalties - 390.300

SERIOUS RADIATION HAZARDHazardous Diagnostic X-Ray Systems - 398.200

SEROLOGIC TEST FOR SYPHILIS (STS)Source Plasma Syphilis - 254.100

SERUMBiological Drugs for Animal Use - 645.100

SERUM PROTEINQuantative Testing for Serium Protein in Plasmapheresis - 255.100Registration of Blood Banks and Other Firms - 230.110Standards and Minimum Requirements for Biologic Products - 205.100

SERVICEAlcohol; use of Synthetic Alcohol in Foods - 555.100Articles of Foreign Origin not intended for Entry - 110.700Biological Drugs for Animal Use - 645.100Blood and Blood Products - Definitions - 230.100Brandy Containing Methyl Alcohol - Food Additive - 510.200Canned Shrimp: Size Designations and Corresponding Counts -540.390Caviar, use of Term - Labeling - 540.150Communicable Disease Hazards - 100.300Contract Sterilizers - 100.550Country of Origin Labeling - 560.200Defective Suntanning Booths and Beds - 396.300Determination by Secretary that Product Fails to Comply - 390.200Eggnog; Eggnog Flavored Milk--Common Usual Names - 527.350Expiration Dating of Unit Dose Repackaged Drugs - 480.200Exports from U. S. Foreign Trade Zones - 110.200FDA Jurisdiction Over Meat and Poultry Products - 565.100Fish-Fresh and Frozen-Adulteration Involving Decomposition -540.300Foreign Trade Zones, Bonded Warehouses or Carriers - 110.600Hazardous Diagnostic X-Ray Systems - 398.200Health Fraud - 120.500Human Blood and Blood Products as Drugs - 230.120Immune Milk - 275.100Importation of Television Receivers and Microwave Ovens - 394.500Malted Milk - 527.500Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200Medical Emergencies - 220.100Override of Positive Beam Limitation - 398.425Pottery (Ceramics) - Cadmium Contamination - 545.400Pottery (Ceramics) - Lead Contamination - 545.450Prepared Mustard, Composition - 525.575Processed and/or Blended Seafood Products - 540.700Proper Drug Use and Residue Avoidance - 615.200Radionuclides in Imported Foods - Levels of Concern - 562.750Red Meat Adulterated with PCB's - 565.200Registration of Blood Banks and Other Firms - 230.110Revocation of Tolerances for Cancelled Pesticides - 550.700Sauerkraut - Definition; Adulteration by Thrips - 585.750Silver-Plated Hollowware - Lead Contamination - 545.500Spices - Definitions - 525.750Streptomycin Residues in Cattle Tissues -616.100Teat Dips and Udder Washes for Dairy Cows and Goats - 654.200Turtles - 170.100Unapproved Additives for Exported Grains - 578.600Use of DDVP (Vapona) Strips in Milkhouses and Milkrooms - 527.600Use of Income Tax Information from IRS - 160.200


440440

SERVOMEX OXYGEN ANALYZERCompressed Medicdal Gases Warning Letters - 435.100

SEVERE SUNBURNSunlamp Performance Standards - 396.100

SHADSmoked Cured - 540.500

SHELLFISHMethyl Mercury - 540.600Paralytic Shellfish Poisioning - 540.250Pesticide Residues - 575.100Processed and/or Blended - 540.700

SHIELDINGMercury Vapor Lamps that are not Self Extinguishing - 391.200

SHIPPING CARTONImportation of Television Receivers and Microwave Ovens - 394.500Labeling of Shipping Containers for Drugs - 430.300

SHIPS' MEDICINE CHESTSRx Drugs for Ships Medicine Chests - 460.500

SHORTBlood and Blood Products - Definitions -230.100Cheese & Cheese Products - Misbranding Involving Net Contents - 527.250Controlled-Release Dosage Form Drugs - 460.700Failure to Register - 625.500Foods - Net Weight - 562.300Importation of Licensed Biologic Products for Human Use - 210.150Radionuclides in Imported Foods - Levels of Concern - 560.750Retention of Microwave Oven Test Records - 394.100Spices - Definitions - 525.750

SHORT SUPPLYBlood and Blood Products - 230.100Failure to Register - 625.500Importation of Licensed Biologic Products for Human Use - 210.150

SHORT WEIGHTCheese Misbranding - 527.250Foods Net Weight - 562.300

SHORTWAVE ULTRAVIOLET RADIATIONMercury Vapor Lamps that are not Self Extinguishing - 391.200

SHUTTER SYSTEMElectronic Products Subject to 21 CFR 1001.15(a) - 390.400

SID SENSING MECHANISMOverride of Positive Limitation - 398.425

SIDE EFFECTS OF TRANSPORATIONRetention of Microwave Oven Test Records - 394.100

SILAGEDirect Fed Microbial Products - 689.100Silage Ingrediesnts - 687.500

SIGNATURECompressed Medical Gases -- Warning Letters - 435.100Orders for Post-Approval Record Reviews - 470.100

SILVER DRAGEESConfectionery - 515.100

SILVER-PLATED HOLLOWWARELead Contamination - 545.500

SIMPLE RELAXATIONHyonotherapy Devices Self Hypnotic Tape Records - 335.300

SIMPLIFIED AND EXPEDITED VARIANCE PROCEDURELaser Light Shows etc. - 393.100

SINGLE DONOR PLASMABlood & Blood Products - 230.100Standards & Minimum Requirements for Biologic Products - 205.100

SINGLE SAMPLINGCondoms Defects - Criteria for Direct Reference Seizure - 345.100Surgeons Gloves, Patient Examination Gloves - 335.700

SINGLE UNIT CONTAINERSTime Period for Separation of Platelets - 231.120Use of Units which have been Thawed - 253.100

SIRUPMalt Products - 505.200Marachinio Cherries - 550.550Sugar - Water Damaged - 515.425Sweet Potatoes, Sirup Packed - 585.850Vinegar Definitions - 515.825

SKIM MILKAflatoxin M1 - 527.400Importated Milk Act - 560.400

SKINCorn, Sweet; Canned - Adulteration - 585.300Dimethyl Sulfoxide (DMSO) for Animal Use - 654.100Hypnotherapy Devices - Self Hypnotic Tape Recordings - 625.300Karaya Gum Powder and Related Devices for Use by Ostomates - 325.100Mercury Vapor Lamps that are not Self-Extinguishing - 391.200Oranges - Artificial Coloring - 550.625Pet Food Labeling - 690.200Sunlamp Performance Standard - 396.100Sweet Potatoes, Dyeing of Yellow and Red Varieties - 585.825Warning Label Required on Sunlamp Products - 396.400

SKIN BURNSMercury Vaper Lamps that aren't Self Extinguishing - 391.200

SKIN PROBLEMSHypnotherapy Devices Self Hypnotic Tape Recordings - 335.300

SKIN TANNINGSunlamp Performance Standards - 396.100Warning label Required on Sumlamp Products - 396.400

SKIPJACKDecomposition & Histamine - 540.525

SLIPPER LOBSTERSCommon or Usual Names for Crustaceans - 540.350

SMALLCanned Shrimp: Size Designations and Corresponding Counts - 540.390Canned Peas - Label Designation of Sizes - 585.625Compressed Medical Gases -- Warning Letters - 435.100Confectionery decorations (nutritive and non-nutritive) - 545.200Drugs for Odor Control in Animals - 642.100Failure to Register - 625.500GWQAP Pre-Award Evaluation - 100.700Homeopathic Drugs - 400.400Importation of Television Receivers and Microwave Ovens - 394.500Labeling of Seasonings - 525.650Large Volume Parenterals (LVP's) for Animal Use - 635.100Malt Products - 515.200Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200Maraschino Cherries - 550.550Menstrual Sponges - 345.300Over-The-Counter Sale of Injectable Animal Drugs - 608.200Pesticide Residues in Food and Feed - 575.100Pottery (Ceramics) - Cadmium Contamination - 545.400Pottery (Ceramics) - Lead Contamination - 545.450Registration of Blood Banks and other Firms - 230.110Regulatory Actions and Small Business - 160.100Regulatory Action Regarding Approved New Drugs - 446.100Reloaders of S-Ray Tube Housing Assemblies - 398.700RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200Seizure of Books that Constitute Misleading Labeling - 140.100Spices - Definitions - 525.750 The use of Antibiotic Drug Residue by-products in Animal Feed -682.200Tomato Products - Adulteration with Mold - 585.900Turtles - 170.100Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100

SMALLPOX VACCINEStandards and Minimum Requirements for Biologic Products - 205.100

SMELTCapelin - 540.100

SMOKE FLAVORLabeling of Seasonings - 525.650

SMOKEDChubs Hot Process Smoked w/Added Nitrite - 540.200Classification of Establishments - 555.500Kipper & Kipper Unsplit Definitions - 540.550Salt-Cured, Air Dried Unevicerated Fish - 540.650Tuna Sable, Salmon, Shad, Smoked Cured Sodium Nitrite - 540.500

SMOKED CUREDSodium Nitrite - 540.500

SNAPPERLabeling - 540.475

SNOW CRABMEATCrab Meat - Product Name - 540.300

SODA WATERUnfermented Beverages - 510.300

SODIUM BICARBONATELVP's for Animal Use - 635.100Malted Milk - 527.500

SODIUM BIPHSOPHATEUrinary Preparations lack of Rx Legend Claims - 430.400

SODIUM CHLORIDELVP's for Animal Use - 635.100Malted Milk - 527.500

SODIUM NITRITETuna, Sable, Salmon, Shad - 540.500

SODIUM PENTOBARBITALAnimak Drugs for Euthanasia - 650.100

SODIUM PHOSPHAGELabeling of Seasonings - 525.650Potato Chips Labeling - 585.710

SOFT WHEAT FLOURMacaroni and Noodle Products - 505.500

SOLID AND LIQUID ORAL DOSAGE FORMSUnit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100

Regulatory Action Regarding Approved New Drugs - 446.100 SOLID-PACK

Canned Foods - 520.100Pinapple Food Standards - 550.685Sweet Potatoes - 585.850


441441

SOLUTIONChloramphenicol - 654.300Imported Products - Lack of English Labeling - 110.900Large Volume Parenterals (LVP's) for Animal Use - 635.100Malt Products - 515.200Pottery (Ceramics) - Cadmium Contamination - 545.400Pottery (Ceramics) - Lead Contamination - 545.450Silver-Plated Hollowware - Lead Contamination - 545.500Source Plasma - Overbleeding - 252.100Teat Dips and Udder Washes for Dairy Cows and Goats - 654.200Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100 Vinegar,

Definitions - Adulteration with Vinegar Eels - 525.825Volatile N-Nitrosamines in Rubber Baby Bottle Nipples - 500.450

SOURCE PLASMABlood and Blood Products Definitions - 230.100Registration of Blood Banks and other Firms - 230.110Source Plasma Syphilis - 254.100Source Plasma Overbleeding - 252.100Source Plasma Guidelines for Informed Consent Form - 250.100Standards & Minimum Requirements for Biologic Products - 205.100

SPARKLING WINEUnfermented Beverages, Use of Word "champagne" - 510.300

SPECIFIC ANATOMICAL REGIONSDefinition of General Purpose Radiographic X-RaySystem - 398.100

SPECIFICATION SHEETMercury Vaper Lamps that are Not Self Extinguishing - 391.200

SPECIMEN CHARGESCanned Salmon - Adulteration Involving Decomposition - 540.375 Canned Green Beans and Canned Wax Beans-Standards - 585.475 Cherries, Canned - Misbranding Involving Food Standards - 550.230Clinical Thermometer - Adulteration; Misbranding Defects - 335.800Condoms; Defects - Criteria for Direct Reference Seizure - 345.100Dates and Date Material; Imported and Domestic - 550.300Direct Reference Authority for Class III Medical Devices - 300.700Dried Prunes, Dehydrated Low Moisture Prunes, and Pitted Prunes - 550.700

Drupelet Berries (Blackberries, Raspberries, etc.) - 550.200Fish-Fresh and Frozen-Adulteration Involving Decomposition - 540.300Marjoram - 525.900Olives - Adulteration involving Pits; Rot; Insect Infestation - 550.600Oregano - 525.850Peaches, Canned - Misbranding Involving FoodStandards - 550.655Peanut Butter - Adulteration with Filth; Grit - 570.300Pesticide Residues in Food and Feed - 575.100Raisins - Adulteration Involving Mold, Sand, Grit, & Insects -550.750Sage - 525.950Standardized Canned Fruit - Packing Medium - 550.800Surgeon's Gloves and Patient Examination Gloves - 335.700Thyme - 525.925Tree Nuts - Adulteration Involving Rejects - 570.425Tree Nuts - Escherichia coli - 570.450Vitamin B-15, Pangamic Acid and Pangamic Acid Products - 457.100

SPEECHSeizusre of Books that Constitute Misleading Labeling - 140.100

SPHYGMOMANOMETERSRx Legend - 310.200Accuracy - 310.210

SPICEGrenadine - 550.100Labeling of Seasonings - 525.650Leafy Spices - 525.500Mace - 525.550Marjoram - 525.900Oregano - 525.850Spices - Definitions - 525.750Thyme - 525.925Tomatoe Sauce or Tomatoe Hot Sauce Labeling - 525.800Whole Ground Cinnamon - 525.200

SPINACH, CANNED OR FROZENDecomposition - 585.775Pesticide Residues - 575.100

SPINACH WORMSSpinach, Canned or Frozen Insects, Decomposition - 585.775

SPINY LOBSTERCommon or Usual Names - 540.350SPIRIT VINEGAR

Adulteration with Vinegar Eels - 525.825SPIRITUOUS LIQUOR

Confectionery - 515.100SPIROCHETES

Source Plasma Syphilis - 254.100SPLEEN

Inert Glandular Preparations - OTC - 455.100SPOILAGE

Identity of Foods - 562.450

Imported Milk - 560.400Preservatives - 562.600Salt cured, Uneviscerated Fish - 540.350

SPONSORAccess to Results of Quality Assurance Audits - 130.300Acupuncture Devicses and Accessories - 305.100Hospital Pharmacies - 275.100Illegal Sales of Veterinary Prescription Drugs - 608.500IND Findings - 215.100Menstral Sponges - 345.300Recovery of IND's from Clinical Investigators - 444.100

SPONSOR-INVESTIGATORSAcupuncture Devices and Accessories - 305.100

SPOT FILM MODESAssemblers who installed Noncompliant Equipment - 398.325X-Ray Field Size for Spot Film - 398.475

SQUASHLabeling as Pumpkin Seeds - 585.800

SQUASH SEEDSPesticide Residues - 575.100Pumpkin - 585.725Squash Seeds Labeling - 585.800

STABILITY TESTINGExpiration Dating and Stability Testing - 480.100Lack of Expiration Date or Stability Data - 480.300Repacking of Drug Products - CGMPs - 430.200

STABILIZERSInterference w/Compendial Tests - 420.500

STANDARD OF IDENTITYArtichoke; Jerusalem Artichoke - Common or UsualName - 585.100Bakery Products, Candy "Shotgun" Ingredients Declaration -505.100 Canned Pimentos & Red Sweet Peppers - Seeds should be Removed -585.650Canned Peas - Label Designation of Sizes - 585.625Canned Foods, Use of the Term "Solid Pack" - 520.100Caviar, Use of Term - Labeling - 540.150Cheese - Misbranding Due to Moisture and Fat - 527.225Chow mein Noodles, Chinese Noodles and Other Oriental Noodles - 505.400Compendium Revisions and Deletions - 420.200Dealcoholized Wine *and Malt Beverages* - Labeling - 510.400Drupelet Berries (Blackberries, Raspberries, etc.) - 550.200Eggnog; Eggnog Flavored Milk--Common Usual Names - 527.350 Enriched or Fortified Foods - Potency - 555.550Foreign Language Declarations on Food Labels - 562.400Fortification of Standardized Juices - 510.700Hollandaise Sauce - Common or Usual Name - 525.400Honey Bread, Honey Buns - 505.350Imitation Breaded Shrimp* - 540.450Jellies, Nonstandardized - 550.475Malted Milk - 527.500Maraschino Cherries - 550.550Marmalade - 550.575Oleomargarine - Misbranding Due to Low Fat - 535.100Peas and Carrots, Labeling of Canned Mixture - 585.600Prepared Mustard, Composition - 525.575Sauerkraut - Definition; Adulteration by Thrips - 585.750Standardized Canned Fruit - Packing Medium - 550.800Starches--Common or Usual Names - 587.100Sweet Potatoes - Sirup Pack - 585.850Tomato Sauce or Tomato Hot Sauce Labeling - 525.800Water in Food Products (Ingredient or Adulterant) - 555.875

STAPHYLOCOCCUS AUREUSMenstrual Sponges - 345.300Raw Breaded Shrimp - 540.420

STAR ANISEEDSpices - 525.750

STARCHESCommon or usual name - 578.100

STATE AUTHORITYAction Levels for Aflatoxins in Animal Feeds - 683.100Acupuncture Devices & Accessories - 305.100

STATE INTERVENTIONHazardous Diagnostic X-Ray Systems - 398.200

STATE LICENSINGAcupuncture Devices and Accessories - 305.100Ear Piercing Devices - 320.100Electrical Muscle Stimulators - 355.200Lasers for Facelift, Wrinkle Removal, Acupuncture, etc. - 393.200

STATE LICENSING BOARDSLasers for Facelift, Wrinkle Removal, Acupuncture, etc - 393.200

STATEMENT OF IDENTITYBakery Products, Candy "Shotgun" Ingredients Declaration - 505.100Canned Foods, Use of the Term "Solid Pack" - 520.100Caviar, use of term - labeling - 540.150Compressed Medical Gases -- Warning Letters - 435.100Dealcoholized Wine *and Malt Beverages* - Labeling - 510.400


442442

Homeopathic Drugs - 400.400Identity of Foods--Terms such as Fresh, Frozen, Dried, Canned - 562.450Malted Milk - 527.500Peas and Carrots, Labeling of Canned Mixture - 585.600Processed and/or Blended Seafood Products - 540.700

STATUSAccess to Results of Quality Assurance Audits - 130.300Action Levels for Aflatoxins in Animal Feeds - 683.100Animal grooming aids - 653.100Answering Inquiries on Status of Criminal Referrals -160.500Anthelmintics -640.100 Certification for Export -110.100Checklist Labeling for Custom Mixed Medicated Feeds - 665.200Classification of Establishments - 555.500Coffee and Cocoa Bean Sweeps - 560.350Contract Sterilizers - 100.500Crab and Crabmeat Products withOther Seafood -- Labeling - 540.285Denture Cleaners, Adhesives, Cushions, and Repair Materials - 315.200Dimethyl Sulfoxide (DMSO) for Animal Use - 654.100Direct-Fed Microbial Products - 689.100Facial Tissues, Paper Napkins, Paper Towels, etc. - 100.600Foreign Trade Zones, Bonded Warehouses or Carriers - 110.600Homeopathic Drugs - 400.400Hospital Pharmacies - 460.100Importation of Television Receivers and Microwave Ovens - 394.500Imported Products - Lack of English Labeling - 110.900Imported Low-Acid Canned Foods - 560.450Interference with Compendial Tests - 420.500Jams, Jellies and Related Products - Imports - 560.500Labeling of Seasonings - 525.650Lasers for Facelift, Wrinkle Removal, Acupuncture, etc. - 393.200Mail-Order Filling of Prescriptions - 460.450Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200Marketed New Drugs Without Approved NDAs or ANDAs - 440.100Nutritional Supplements for Companion Animals - 690.100 OTC Drugs - Recognition as Safe and Effective - 450.200 Pistachio Nuts - Aflatoxin Adulteration - 570.500Prescription Status - Telephone Answering Machine - 460.425Returned Antibiotics Exported Under 801(d) of the Act - 405.210RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 310.200Safety and Labeling of Waxed (Coated) Fruits and Vegetables - 562.550Silage Ingredients - 687.500Sphygmomanometers - Rx Legend - 310.200Teat Dips and Udder Washes for Dairy Cows and Goats - 654.200The Status of Syringes and Needles for Animal Use - 655.400Uncertified or Delisted Colors - 587.200Vitamins and Minerals in Feed - 665.300Water-Damaged Food Products - 555.850

STEAM STERILIZATIONProcess Validation Requirements for Drug Products - 490.100

STEMSCloves - 525.250Radionuclides in Imported Foods - 560.750Spices - 525.750

STEPLESS ADJUSTMENTX-Ray Field Size for Spot Film - 398.475

STERILEAdulteration of Drugs Under Sec. 501(b) and 501(c) - 420.100Compressed Medical Gases -- Warning Letters - 435.100Contamination of Devices Labeled as Sterile - 300.400Expiration Dating and Stability Testing - 480.100Finished Dosage Form Drugs in Bulk Containers - 410.100Karaya Gum Powder and Related Devices for Use by Ostomates - 325.100Large Volume Parenterals (LVP's) for Animal Use - 635.100Parametric Release of Terminally Heat Sterilized Drugs - 460.800Process Validation Requirements for Drug Products - 490.100Regulatory Action Regarding Approved New Drugs - 446.100Reuse of Medical Disposable Devices - 300.500

STERILE DRUG PRODUCTSProcess Validation Requirements for Drug Products - 490.100Regulatory Action Regarding Approved New Drugs - 446.100

STERILE PRODUCTSAdulteration of Drugs Under Section 501(b) & 501(c) - 420.100Contamination of Devices Labeled as Sterile - 300.400

STERILITYCadmium Contamination - 545.400Compendial Requirements - 390.200Contamination of Devices Labeled as Stesrile - 300.400Contract Sterilizers - 100.550Lead Contamination - 545.450Parametric Release of Terminally Heat Sterilized Drugs - 410.100Pesticide Residues and Feed - 575.100Petfood Labeling - 690.200Process Validation Requirements for Drug Products - 490.100Processed Seafood Products - 540.700

Regulatory Action Regarding Approved New Drugs - 446.100Similar Bean Products - 567.200Source Plasma Guidelines for Informed Consent Form - 250.100

STERILITY RELEASEParametric Release of Terminally Heat Sterilized Drugs - 460.800

STERILITY TESTINGContamination of Devices Labeled as Stesrile - 300.400Parametric Release of Terminally Heat Sterilized Drugs - 460.800Regulatory Action Regarding Approved New Drugs - 446.100

STERILIZATIONContract Sterilizers - 100.550Karaya Gum Powder and Related Devices for Use by Ostomates - 325.100 Parametric Release of Terminally Heat Sterilized Drugs - 460.800Process Validation Requirements for Drug Products - 490.100Regulatory Action Regarding Approved New Drugs - 446.100Volatile N-Nitrosamines in Rubber Baby Bottle Nipples - 500.450

STERILIZER (see sterilization above)STOCK

Bouillon, Bouillon Cubes, Granulated Bouillon - 567.300Condoms; Defects - Criteria for Direct Reference Seizure - 345.100Homeopathic Drugs - 400.400Hospital Pharmacies - 460.100Raw Breaded Shrimp - Microbiological - 540.420Reconditioning of Foods Adulterated Under 402(a)(4) - 160.700Recovery of IND's from Clinical Investigators - 444.100Reloaders of X-Ray Tube Housing Assemblies - 398.700Return of Unused Rx Drugs to Pharmacy Stock - 460.300Uncertified or Delisted Colors - 587.200Vinegar, Definitions - Adulteration with Vinegar Eels - 525.825

STOCK RECOVERYRecovery of INDs from Clinical Investigators - 444.100

STOMACHInert Glandular Preparations - 455.100

STORAGE CONDITIONSCollection & Charitable Distribution of Drugs - 400.800Expiration Dating & Stability Testing - 480.100Food Storage and Warehousing - Adulteration Filth - 580.100Interpretation of Insect Filth in Foods - 555.600Lack of Expiration Date or Stability Data - 480.300Parametric Release of Terminally Heat Sterilized Drugs - 460.800Plasma Brokers - Registration and Compliance - 250.500Unit Dose Labeling for Solid & Liquid Oral Dosage Forms - 430.100

STRAWBERRIESSand or Mold - 550.850

STREPTOMYCESUse of Antibiotic Drug Residue by-Products in Animal Feed - 682.200

STREPTOMYCINResidues in Cattle Tissue - 616.100

STREPTOKINASE-STREPTODORNASE Standards and Minimum Requirements for Biologic Products -205.100

STRIP PACKSTamper Resistant Packaging Requirements - 450.500

STYLE NUMBERSCertification & Identification of X-Ray Components - 398.600

SUBCONJUNCTIVALOTC Sale Injectable Animal Drugs - 608.200

SUBCUTANEOUSLVPs for Animal Use - 635.100

SUBLINGUALCytotoxic Testing for Allergic Diseases - 370.100Expiration Dasting of Unit Dose Repackaged Drugs - 480.200Unit Dose Labeling for Solid & Liquid Oral Dosage Form - 430.100

SUBSTANTIALLYCaviar, Use of Term - Labeling - 540.150Class III Devices Subject to 5l5(b) Requirements - 300.750Commercial Distribution -- Premarket Notification - 300.600Dimethylnitrosamine in Malt Beverages - 510.600Imitation Breaded Shrimp - 540.450 RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200Salt-Cured, Air-Dried, Uneviscerated Fish - 540.650Unfermented Beverages, Use of Word "Champagne" - 510.300

SUBSTANTIALLY EQUIVALENTClass III Devices Subject to 515(b) Requirements - 300.750Commercial Distribution - Premarket Notification - 300.600RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200

SUBSYSTEMAssemblers Who Install Noncompliant Equipment - 398.325

SUGAR VINEGARAdulteration with Vinegar Eels - 525.825

SUGARBarley Sugar - Definition, and Barley Sugar Candy - 515.500Beverage Bases - 510.100Confectionery Decorations (Nutritive and Non-Nutritive) - 545.200Fructose-Containing Drugs - 400.335Grenadine - 550.400Jellies, Nonstandardized - 550.475


443443

Jordan Almonds - Common or Usual Name - 570.100Labeling of Seasonings - 525.650Large Volume Parenterals (LVP's) for Animal Use - 635.100Maraschino Cherries - 550.550Marmalade - 550.575Pesticide Residues in Food and Feed - 575.100Prepared Mustard, Composition - 525.575Processed and/or Blended Seafood Products - 540.700Raw Sugar - 515.400Silver-Plated Hollowware - Lead Contamination - 545.500

Spices - Definitions - 525.750Sugar - Water Damaged - Reconditioning - 515.425Sweet Potatoes - Sirup Pack - 585.850Vinegar, Definitions - Adulteration with Vinegar Eels - 525.825

SULFAETHOXY-PYRIDAZINEExtra Label Use of New Animal Drugs in Food Producing Animals - 615.100

SULFAMETHOXAZOLEUnit Dose Labeling for Solid & Liquid Oral Dosage Forms - 430.100

SULFONAMIDEExtra Label Use of New Animal Drugs in Food Producing Animals - 615.100

SULFURDimethylnitrosamine in Malt Beverages - 510.600DMNA in Barley Malt - 578.500

SUN BEDSExemption for Certain Sunlamp Product Purchaser Records - 396.200

SUNLAMP PERFORMANCE STANDARDDefective Suntanning Booths & Beds - 396.300Exemption for Certain Sunlamp Product Purchaser Records - 396.200

SUNTANNING BOOTHS (see performance standard above)SURGEON'S GLOVES

And Patients Examination Gloves - 335.700SURIMI

Processed and/or Blended Seafood Products - 540.700SURIMI-BASED

Processed Seafood Products - 540.700SUSPENSION

Blood and Blood Products - Definitions - 230.100Licensing - Changes to be Reported - 210.100Source Plasma - Overbleeding - 252.100Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100 SUSTAINEDUnit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100 SWEETBASILLabeling of Seasonings - 525.650Spices Definitions - 525.750

SWEET CIDERUnfermented Beverages - 510.300

SWEET ORANGESMarmalade - 550.575

SWEET POTATOESDyeing - 585.825Pesticide Residues - 575.100Sirup Packed - 585.850Water in Food Products - 555.875

SWISSCheese - Misbranding Due to Moisture and Fat - 527.225

SWITCHAutomatic Adjustment of the X-Ray Field Size - 398.400Definition of "High-Voltage Vacuum Switch" - 390.500Override of Positive Beam Limitation - 398.425

SWITCHGEARDefinition of "High-Voltage Vacuum Switch" - 390.500

SYNTHETIC ALCOHOLUse of Alcohol in Foods - 555.100

SYPHILISRegistration of Blood Banks and Other Firms - 230.110Source Plasma - Syphilis - 254.100

SYRUPGrenadine - 550.400Malt Products - 515.200Standardized Canned Fruit Packing Medium - 550.800

SYSTEMAssemblers Who Install Noncompliant Equipment - 398.325Assessment of Civil Penalties - 390.300Automatic Adjustment of the X-Ray Field Size - 398.400Certification and Identification of X-Ray Components - 398.600CGMP Applicability to Hardware and Software - 425.100Computerized Drug Processing -- I.D. of "Persons" - 425.500Computerized Drug Processing -- Input/Output Checking - 425.400Computerized Drug Processing -- Vendor Responsibility - 425.200Computerized Rx Recordkeeping by Pharmacies - 460.400Control/Accountability of TRP Materials - 450.550Definition of General Purpose Radiographic X-Ray System - 398.100 Electronic

Products Subject to 21 CFR 1001.15(a) - 390.400Exemption for Certain Sunlamp Product Purchaser Records - 396.200Expiration Dating of Unit Dose Repackaged Drugs - 480.200

Hazardous Diagnostic X-Ray Systems - 398.200Metric Declarations of Quantity of Contents - 140.500Microfiche and/or Microfilm for Records Retention - 130.400Obligations of Factory-Based Manufacturers and Assemblers - 398.375Override of Positive Beam Limitation - 398.425Parametric Release of Terminally Heat Sterilized Drugs - 460.800Plastic Containers for Injectable Animal Drugs -637.100Positive Beam Limitation (PBL) Requirements - 398.450Proper Drug Use and Residue Avoidance - 615.200Radionuclides in Imported Foods - Levels of Concern - 562.750Repacking of Drug Products -- CGMP's - 430.200Sequencing in Medicated Feed Production - 680.600Source Code for Process Control Application Programs - 425.300Sphygmomanometers - Accuracy - 310.210Tamper-Resistant Packaging Requirements - 450.500Uncertified or Delisted Colors - 587.200Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100Vinegar, Definitions - Adulteration with Vinegar Eels - 525.825

SYSTEM FAILUREOverride of Positive Beam Limitations - 398.425

TABLETOPDefinition of General Purpose Radiographic X-Ray System - 398.100

TABLETSContent Uniformity Testing of Tablets and Capsules - 460.600Expiration Dating of Unit Dose Repackaged Drugs - 480.200Finished Dosage Form Drugs in Bulk Containers - 410.100Oral Iron Products for Baby Pigs - 643.100Packaging -- Contact Lens Solutions and Tablets - 350.100Products Composed of Interstate Ingredients - 100.200Regulatory Action Regarding Approved New Drugs - 446.100Tamper-Resistant Packaging Requirements - 450.500Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100

TALCConfectionery - 515.100

TAMALESAdulteration with Filth - 585.350Foreign Language Declarations - 562.400

TAMPER-RESISTANT PACKAGINGControl/Accountability of TRP Materials - 450.550Packaging-Contact Lens Solutions & Tablets - 350.100Tamper Resistant Packaging Requirements - 450.500

TAPIOCA STARCHStarches Common or Usual Name - 578.100

TARRAGONSpices Definitions - 525.750

TARTARIC ACIDJellies Nonstandardized - 550.475

TAXAlcohol; Use of Synthetic Alcohol in Foods - 555.100Brandy Containing Methyl Alcohol -Food Additive - 510.200Exports from U.S. Foreign Trade Zones - 110.200Foreign Trade Zones, Bonded Warehouses or Carriers - 110.600Use of Income Tax Information from IRS - 160.200

TECHNICALLY TRAINED INDIVIDUALSImportation of Television Receivers & Microwave Ovens - 394.500

TELEVISION RECEIVERSImportation of Television Receivers & Microwave Ovens - 394.500

TEMPERATURECollection and Charitable Distribution of Drugs - 400.800Expiration Dating and Stability Testing - 480.100Imported Milk and Cream. Import Milk Act - 560.400Malt Products - 515.200Metric Declarations of Quantity of Contents - 140.500Parametric Release of Terminally Heat Sterilized Drugs - 460.800Pottery (Ceramics) - Lead Contamination - 545.450Retention of Microwave Oven Test Records - 394.100Salt-Cured, Air-Dried, Uneviscerated Fish - 540.650Source Plasma - Overbleeding - 252.100Sphygmomanometers - Accuracy - 310.210Sugar - Water Damaged - Reconditioning - 515.425Tamper-Resistant Packaging Requirements - 450.500Time Period for Separation of Platelets - 231.120

TEMPORARY IMPORT BOND (TIB)Importation of TV Receivers and Microwave Ovens - 394.500

TEREBINTHICSpices Definitions - 525.750

TERMINAL LEADSPacemaker Reuse - 310.100

TERMINALLYParametric Release of Terminally Heat Sterilized Drugs - 460.800

TERMINOLOGYAnthelmintics - 640.100Blood & Blood Products Definitions - 230.100Certification & Identification of X-Ray Components - 398.600CGMPs for Medicated Feed Daily InventoryRequirements - 680.200


444444

Fraud, Untrue Statements of Material Facts, Bribery - 120.100TERRA ALBA

Confectionery - 515.100TERRITORY

Dentures -Sale by Persons Not Licensed to Practice Dentistry - 315.100Imported Products - Lack of English Labeling - 110.900Labeling of Food Articles Dstributed Slely in Puerto Rico - 562.750

TESTING EVALUATION RECEIVERImportation of TV Receivers and Microwave Ovens - 394.500

TETANUS ANTITOXINStandards and Minimum Requirements for Biologic Products - 205.100

TETANUS TOXOIDStandards and Minimum Requirements for Biologic Products - 205.100

THERAPEUTIC CLAIMSAnimal Grooming Aids - 653.100Ethylenediamine Dihydroiodide (EDDI) - 651.100Health Fraud - 120.500Reconditioning of New Animal Drugs - 625.400Silage Ingredients - 687.500Vitamin B-15, Pangamic Acid and Pangamic Acid Products - 457.100Vitamins and Minerals in Feed - 670.200

THERAPEUTIC EXCHANGE PLASMABlood and Blood Products Definitions - 230.100

THERAPEUTIC PLASMAPHERESISBlood and Blood Products Definitions - 230.100

THERAPEUTIC USEAcupuncture Devices and Accessories - 305.100Hypnotherapy Devices - Self Hypnotic Tape Recordings - 335.300

THEUS ORIENTALISCommon or Usual Names for Crustaceans - 540.350

THORACICDefinition of General Purpose Radiographic X-Ray System - 398.100Positive Beam Limitation (PBL) Requirements - 398.450

THRIPSApple Butter - 550.100Asparagus, Canned or Frozen - 585.150Broccoli, Frozen - 585.260Brussel Sprouts, Frozen - 585.275Cloudberries (Multer Berries) Canned - 550.590Drupelet Berries - 550.200Food Storage and Warehousing - 580.100Interpretation of Insect Filth in Foods - 555.600Sauerkraut-Definition - 585.750Spinach, Canned or Frozen - 585.775

THROAT LOZENGESTamper Resistant Packaging Requirements - 450.500

THYMELeafy Spices - 525.500Spices - 525.750

THYMOLSpices - 525.750

THYMUSInert Glandular Preparations - OTC - 455.100Spices - 525.750

THYROIDInert Glandular Preparations - OTC - 455.100Radionuclides in Imported Foods -Levels of Concern - 560.750

TISSUESTOLERANCE

Adulteration of Drugs - 420.100Alternate Feeding of Medicated Feeds - 666.100Brushes -- Nit Contamination - 590.400CGMPs for Medicated Feeds - 680.200Chubs, Smoked with Added Nitrite - 540.200Diversion of Adulterated Food - 675.200Pesticide Residues - 575.100Red Meat with PCBs - 565.200Sequencing in Medicated Feed Production - 680.600Sodium Nitrite - 540.500Streptomycin in Cattle Tissues - 616.100Treated Grain Seed -Mercury Residue - 578.400Use of DDVP (Vapona) Strips - 527.600

TOMATO PRODUCTSTomato Products - Adulteration w/Mold - 585.900Tomato Products Drosophila Fly Eggs and Maggots - 585.890Tomato Sauce or Tomato Hot Sauce Labeling - 525.800

TOMATO PUREE - (see tomato products)TOMATO SAUCE

Filth - 585.890Labeling - 525.800Mold - 585.900

TOMATOES, CANNEDMisbranding - 585.875Mold - 585.900

TOMOGRAPHIC X-RAY SYSTEMDefinition of General Purpose Radiographic X-Ray System - 398.100

TOMOGRAPHY (see tomographic above)TOP 200 PRESCRIPTION DRUGS

Marketed New drugs without Approved NDAs orANDAs - 440.100

TOPICAL OINTMENTS/CREAMS OPHTHALMICUnit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100

TORNCoffee & Cocoa Bean Sweeps - 560.350Contamination of Devices Labeled as Sterile - 300.400Tamper Resistant Packaging Requirements - 450.500

TOTAL AND ACID INSOLUBLE ASHCumin Seed - 525.325Spices - 525.750

TOTAL PROTEINQuantitative Testing for Serum Proteins in plasmapheresis - 255.100Source Plasma Overbleeding - 252.100

TOWELSFacial Tissues, Paper Napkins, Paper Towels etc - 100.600

TOXIC SHOCK SYNDROMEMenstral Sponges - 345.300

TOXICITYDecomposition & Histamine in Albacore, Skipjack and Yellowfin Tuna - 540.525Illegal Sales of Veterinary Prescription Drugs - 608.500Over The Counter Sale of Injectable Animal Drugs - 608.200Sequencing in Medicated Feed Production - 680.600

TRACINGExemption for Certain Sunlamp Product Purchaser Records - 396.200

TRADEArtichoke; Jerusalem Artichoke - Common or Usual Name - 585.100Availability of Bulk Chemicals for Animal Drug Use - 625.200Bouillon, Bouillon Cubes, Granulated Bouillon - 567.300Candied Citron - Labeling - 515.600 Canned Foods, Use of the Term "Solid Pack" - 520.100Cytotoxic Testing for Allergic Diseases - 370.100Exports from U. S. Foreign Trade Zones - 110.200Food Additives -"GRAS" - 500.200Foreign Trade Zones, Bonded Warehouses or Carriers - 110.600Foreign Language Declarations on Food Labels - 562.400Health Fraud - 120.500Jordan Almonds - Common or Usual Name - 570.100Kipper and Kipper Unsplit - Definitions - 540.550Labeling of Food Bearing Residues of Pesticide Chemicals - 562.700Malt Products - 515.200Malted Milk - 527.500Maraschino Cherries - 550.550Medicated Feeds -- Formula Information - 670.100New Drugs - Export - 442.100Peas and Carrots, Labeling of Canned Mixture - 585.600Pesticide Residues in Food and Feed - 575.100Pork and Beans and Similar Bean Products--Labeling - 567.200Potato Chips, Ingredients - Labeling - 585.710Processed and/or Blended Seafood Products - 540.700Processing" - Use of Term in Section 405 of the FD&C Act - 562.650Reconditioning New Drugs Lacking Approved NDA - 448.100Reconditioning of Articles Found in Violation of GMP's - 160.750Spices - Definitions - 525.750Use of Type A Medicated Article Brand Names in Feed Labels - 665.300

TRADE CORRESPONDENCEArtichoke; Jerusalem Artichoke -585.100Bouillon, Bouillon Cubes - 567.300Canned Foods, Use of "Solid Pack" - 520.100Malt Products - 515.200Malted Milk - 527.500Peas and Carrots, Labeling of Mixture - 585.600

TRANSFILLINGCompressed Medical Gases Warning Letters - 435.100

TRANSFORMER NUMBERSCertification & Identification of X-Ray Components - 398.600

TRANSFUSIONRegistration of Blood Banks & Other Firms - 230.110Source Plasma Guidelines for Informed Consent Forms - 250.100Use of Units Which Have Been Thawed - 253.100

TRANSFUSION SERVICERegistration of Blood Banks & Other Firms - 230.110

TRANSMISSIONRendered Animal Feed Ingredients - 675.400Source Plasma Guidelines for Informed Consent Forms - 250.100Surgeon's Gloves & Patient Examination Gloves - 335.700

TREASURY DEPT.Labeling - Diluted Wines & Cider w/Less Than 7% Alcohol - 510.450

TREATED GRAIN SEEDMercury Residue - 578.400

TREATMENTAdequate Directions for Use - Animal Drugs and Devices - 607.100


445445

Biological Drugs for Animal Use - 645.100Cellutron Machine - 355.100Chloramphenicol - 654.300Direct-Fed Microbial Products - 689.100Diversion of Contaminated Food for Animal Use - 675.100Diversion of Adulterated Food to Acceptable Animal Feed Use - 675.200Ethylenediamine Dihydroiodide (EDDI) - 651.100Extra-Label Use of New Animal Drugs in Food-Producing Animals - 615.100Health Fraud - 120.500Homeopathic Drugs - 400.400Human Blood and Blood Products as Drugs - 230.120Human-Labeled Drugs Distributed & Used in Animal Medicine - 608.100Hypnotherapy Devices - Self Hypnotic Tape Recordings - 335.300Ion Generating Devices - 355.300Lasers for Facelift, Wrinkle Removal, Acupuncture, etc. - 393.200Marketed New Drugs Without Approved NDAs or ANDAs - 440.100Oral Iron Products for Baby Pigs - 643.100OTC Drugs - Recognition as Safe and Effective - 450.200OTC Drugs - Combination Products - 450.300Proper Drug Use and Residue Avoidance - 615.200Razor Blades, Manicuring Instruments - 335.500Reconditioning Foods by Diversion for Animal Feed - 555.650Source Plasma - Syphilis - 254.100Sugar - Water Damaged - Reconditioning - 515.425Vitamin B-15, Pangamic Acid and Pangamic Acid Products - 457.100

TREE NUTSAdulteration Involving Rejects - 570.425Pistachio Nuts - 570.500Reconditioning - 570.550

TRICALCIUM PHOSPHATELabeling of Seasonings - 525.650

TRIMETHOPRIMUnit Dose Labeling for Solid & Liquid Oral Dosage Forms - 430.100

TRINKETSCandy Mixed With Trinkets - 515.350

TRIVALENT ORGANIC ARSENICALSStandards & Minimum Requirements for Biologic Products - 205.100

TSSMenstrual Sponges - 345.300

TUBE HOUSING ASSEMBLYCertification & Identification of X-Ray Components - 398.600Reloaders of X-Ray Tube Housing Assemblies - 398.700

TUBERCULINImported Milk & Cream. Import Milk Act - 560.400Standards & Minimum Requirements for BiologicProducts - 205.100

TUBESTamper Resistant Packaging Requirements - 450.500

TULLIBEESFish, Adulteration by Parasites - 540.590

TUNADecomposition and Histamine - 540.525Smoked Cured - 540.500

TYPHOID VACCINEStandards & Minimum Requirements for Biologic Products - 205.100

U.S. STANDARD OF POTENCYLack of Expiration Date or Stability Data - 480.300Standards and Minimum Requirements for Biologic Products - 205.100

ULTRA HIGH TEMPERATURE PROCESSED MILKImported Milk and Cream - 560.400

ULTRAVIOLET LAMPExemption for Certain Sunlamp Product Purchaser Records - 396.200Sunlamp Performance Standard - 396.100

ULTRAVIOLET RADIATIONMercury Vapor Lamps That are Not Self Extinguishing - 391.200Sunlamp Performance Standards - 396.100

UNACCEPTABLE RATE OF FAILURE Assemblers Who Install Noncompliant Equipment - 398.325

UNAPPROVED ADDITIVESExported Grains - 578.600

UNAPPROVED INTENDEDDirect Reference Authority for Class III Medical Devices - 300.700

UNAPPROVED NEW DRUGSInert Glandular Preparations-OTC - 455.100Manufacture Distribution Promotion of Drugs by Pharmacies - 460.200Reconditioning of New Animal Drugs Seized Under Sec. 501(a) - 625.400Reconditioning of New Drugs Lacking Approved NDA - 448.100

UNBOLTCertification & Identification of X-Ray Components - 398.600

UNCERTIFIED TELEVISION RECEIVERSImportation of TV Receivers and Microwave Ovens - 394.500

UNEVICERATED FISHSalt Cured, Air Dried - 540.650

UNFERMENTED BEVERAGESUse of Word "Champagne" - 510.300

UNFORESEEABLE ABUSE

Determination by Secretary that Product Fails to Comply - 390.200UNIFORMITY

Adulteration of Drugs Under Sec. 501(b) and 501(c) - 420.100Common or Usual Names for Animal Feed Ingredients - 665.100Compendial Requirements - 420.400Content Uniformity Testing of Tablets and Capsules - 460.600Process Validation Requirements for Drug Products - 490.100Recycled Animal Waste - 685.100Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100

UNIT DOSEExpiration Dating of Unit Dose Repackaged Drugs - 430.100Regulatory Action Regarding Approved New Drugs - 446.100Unit Dose Labeling for Solid & Liquid Oral Dose Forms - 480.200

UNIT DOSE CONTAINERS FOR CAPSULES AND TABLETSExpiration Dating of Unit Dose Repackaged Drugs - 480.200Unit Dose Labeling for Solid & Liquid Oral Dose Forms - 430.100

UNIT DOSE PACKAGINGExpiration Dating of Unit Dose Repackaged Drugs - 480.200Unit Dose Labeling for Solid & Liquid Oral Dose Forms - 430.100

UNIT DOSE PACKAGING SYSTEMS (see unit dose packaging)UNIT DOSE REPACKAGED DRUGS

Expiration Dating of Unit Dose Repackaged Drugs - 480.200UNITED STATES BREWERS ASSOCIATION (USBA)

Dimethylnitrosamine in Malt Beverages - 510.600UNITED STATES PHARMACOPEIA

Adulteration of Drugs Under Sec. 501(b) and 501(c) - 420.100Alcohol; Use of Synthetic Alcohol in Foods - 555.100Compressed Medical Gases -- Warning Letters - 435.100Content Uniformity Testing of Tablets and Capsules - 460.600Expiration Dating of Unit Dose Repackaged Drugs - 480.200Homeopathic Drugs - 400.400Human Blood and Blood Products as Drugs - 230.120Karaya Gum Powder and Related Devices for Use by Ostomates - 325.100Starches--Common or Usual Names - 578.100Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100

UNITSBlood and Blood Products - Definitions - 230.100Butter - Adulteration Involving Low Fat - 527.100Canned Green Beans and Canned Wax Beans - Standards - 585.475Commercial Distribution -- Premarket Notification - 300.600Compressed Medical Gases -- Warning Letters - 435.100Contamination of Devices Labeled as Sterile - 300.400Defective Suntanning Booths and Beds - 396.300Direct-Fed Microbial Products - 689.100Foods, Except Dairy Products - Adulteration with Salmonella - 555.300Foods - Net Weight - 562.300Health Fraud - 120.500Importation of Television Receivers and Microwave Ovens - 394.500Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200Metric Declarations of Quantity of Contents - 140.500Parametric Release of Terminally Heat Sterilized Drugs - 460.800Pathogens in Dairy Products - 527.300Peaches, Canned - Misbranding Involving Food Standards - 550.655 Plasma

Brokers - Registration and Compliance - 255.500Platelets, Pooled - 231.100Pottery (Ceramics) - Cadmium Contamination - 545.400Pottery (Ceramics) - Lead Contamination - 545.450Quality Control Testing - 231.110Raw Breaded Shrimp - Microbiological - 540.420Records and Reports - Applicability - 21 CFR 1002.1 - 390.425Retention of Microwave Oven Test Records - 394.100Silver-Plated Hollowware - Lead Contamination - 545.500Source Plasma - Overbleeding - 252.100Source Plasma - Syphilis - 254.100Spices - Definitions - 525.750Storage of Platelet Concentrate - 231.130Surgeon's Gloves and Patient Examination Gloves - 335.700Tamper-Resistant Packaging Requirements - 450.500Temporal-Maximum Ultrasonic Power - 397.100Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100Use of Units Which Have Been Thawed - 253.100Vitamin B-15, Pangamic Acid and Pangamic Acid Products - 457.100Whole Milk, Low Fat Milk, Skim Milk - Aflatoxin M1 - 527.400

UNLICENSED PERSONEar Piercing Devices - 320.100

UNLOCKCertification & Identification of X-Ray Components - 398.600

UNREASONABLE RISKClass III Devices Subject to 5l5(b) Requirements - 300.750Direct Reference Authority for Class III Medical Devices - 300.700

UNUSED PRESCRIPTION DRUGSReturn of Unused Rx Drugs to Pharmacy Stock - 460.300

UNWARRANTED USER ABUSEObligation of Factory Based Manufacturers & Assemblers - 398.375

URINARY ANALGESICSUrinary Preparations - Lack of Rx Legend - Claims - 430.400


446446

URINARY ANTISEPTICSDefinition of General Purpose Radiographic X-Ray System - 398.100Immune Milk - 275.100Urinary Preparations - Lack of Rx Legend Claims - 430.400

URINARY PREPARATIONSUrinary Preparations - Lack of Rx Legend - Claims - 430.400

URINARY TRACTDefinition of General Purpose Radiographic X-Ray System - 398.100Immune Milk - 275.100

UROLOGICDefinition of General Purpose Radiographic X-Ray System - 398.100

US CUSTOMS SERVICEArticles of Foreign Origin not Intended for Entry - 110.700Country of Origin Labeling - 560.200Exports from U.S. Foreign Trade Zones - 110.200Foreign Trade Zones Bonded Warehouses or Carriers - 110.600Importation of TV Receivers & Microwave Ovens - 394.500

USDA ANIMAL AND PLANT HEALTH INSPECTION SERVICEFDA Jurisdiction Over Meat & Poultry Products - 565.100

USDA FEDERAL GRAIN INSPECTION SERVICEUnapproved Additives for Exported Grains - 578.600

USP TESTSContamination of Devices Labeled as Sterile - 300.400

VACUMM BOTTLE SWITCH ASSEMBLYDefinition of "High-Voltage Vacum Switch" - 390.500

VAGINAL PRODUCTSTamper Resistant Packaging Requirements - 450.500

VALID SCIENTIFIC STUDIESAcupuncture Devices & Accessories - 305.100Ion Generating Devices - 355.300

VALIDATIONAnalytical Methodology Used by FDA - Drugs - 150.500Compendial Requirements - 420.400Computerized Drug Processing -- Vendor Responsibility - 425.200Computerized Drug Processing -- I.D. of "Persons" 425.500Parametric Release of Terminally Heat Sterilized Drugs - 460.800Process Validation Requirements for Drug Products - 490.100Registration of Bblood Banks and Other Firms - 230.110Regulatory Action Regarding Approved New Drugs -446.100

VALIDITYAnalytical Methodology Used by FDA - Drugs - 150.500Cytotoxic Testing for Allergic Diseases - 370.100Fraud, Untrue Statements of Material Facts, Bribery - 120.100 Process Validation Requirements for Drug Products - 490.100Refusal to Permit Inspection - 130.100Reuse of Medical Disposable Devices - 300.500RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200

VAPONA STRIPSIn Milkhouses - 527.600

VENDING MACHINE FOODCandy - 515.350Labeling - 562.800OTC Drugs in Vending Machine - 450.400

VENOUS THROMBOSISElectrical Muscle Stimulators - 355.200

VERIFICATIONFraud, Untrue Statements of Material Facts, Bribery - 120.100Ion Generating Devices - 355.300

VERMIFUGEAnthelmintics - 640.100

VETERINARY DEVICEAdequate Directions- Animal Drugs & Devices - 607.100Barking Dog Collars - 655.300

VETERINARY LABELEDHuman Labeled Drugs Distributed & Used in Animal Medicine - 608.100

VIABLE ORGANISMSContamination of Devices Labeled as Sterile - 300.400

VIBRATIONBarking Dog Collars - 655.300Reloaders of X-Ray Tube Housing Assemblies - 398.700Retention of Microwave Oven Tests Records - 394.100

VIGNETTESBakery Products - 505.100

VINEGAR EELSDefinition - Adulteration with Vinegar Eels - 525.825

VISCERASalt Cured, Air Dried Uneviscerated Fish - 540.650

VITAMIN B-15Pangamic Acid & Pangamic Acid Products - 457.100

VITAMINFor Human Use - Low Potency - 530.400Identical or Similar Product Names - 400.500Imported Milk and Cream - 560.400In Feed - 670.200Inert Glandular Preparations - OTC - 455.100Vitamin B-15, Pangmic Acid and Pangamic Acid Products - 457.100

VOLATILE N-NITROSAMINESIn Rubber Baby Bottle Nipples - 500.450

VOLATILE OILSpices Definitions - 525.750

VOLUNTARY BASISDefective Sun Tanning Booths & Beds - 396.300Failure to Register - 400.100Pistachio Nuts - Aflatoxin Adulteration - 570.500

VOLUNTARY STANDARDSSphygomanometers - Accuracy - 310.210

VOMITINGFructose Containing Drugs - 400.335

WALLBUCKY STANDDefinition of General Purpose Radiographic X-Ray System - 398.100

WALNUTSTree Nuts - Adulteration Involving Rejects - 570.425

WAREHOUSECanned Foods - Seam Defects - 520.200Coffee & Coco Bean Sweeps - 560.350Food Storage & Warehousing Adulteration Filth - 580.100Foreign Trade Zones, Bonded Warehouses or Carriers - 110.600

WARNING LABELCertification & Identification of X-Ray Components - 398.600Warning Label Required on Sunlamp Products - 396.400

WARNING STATEMENTSLiterature for High-Intensity Mercury Vaper Lamps - 391.100

WARRANTAccess to Results of Quality Assurance Audits - 130.300Action Levels for Aflatoxins in Animal Feeds - 683.100Assessment of Civil Penalties - 390.300Bouillon, Bouillon Cubes, Granulated Bouillon - 567.300Color Additives - 587.300Dimethylnitrosamine (DMNA) in Barley Malt - 578.500Food Storage & Warehousing - Adulteration - Filth - 580.100Intermediate or End Products of Sample Analysis - 150.100Macaroni and Noodle Products - 505.500Malted Milk - 527.500Marketed New Drugs without Approved NDAs or ANDAs - 440.100Medicated Feeds -- Formula Information - 670.100Orders for Post-Approval Record Reviews - 470.100OTC Anti-Obesity Preparations - 456.100Pesticide Residues in Food and Feed - 575.100Refusal to Permit Inspection - 130.100 Seeds for Sprouting Prior to Food Use - 555.750Starches--Common or Usual Names - 578.100Treated Grain Seed - Mercury Residue - 578.400Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100

Urinary Preparations - Lack of Rx Legend - Claims - 430.400Use of Units Which Have Been Thawed - 253.100Water in Food Products (Ingredient or Adulterant) - 555.875Wheat - Adulteration by Insect and Rodent Filth - 578.300Wheat Germ Containing Non Wheat Germ Tissue - 530.500Wheat Flour - 578.450Wheat for Human Consumption - Reconditioning - 578.350

WART REMOVALHypnotherapy Devices - Self Hypnotic Tape Recordings - 335.300

WASHED CURDCheese - 527.225

WATER IN FOOD PRODUCTSIngredient or Adulteration - 555.875

WAVELENGTHSunlamp Performance Standard - 396.100

WAX BEENS, CANNEDCanned Green Beans & Canned Wax Beans Standing - 585.475

WEIGHT LOSSElectric Muscle Stimulators - 355.200

WHEATBouillon, Bouillon Cubes, Granulated Bouillon - 567.300Dimethylnitrosamine (DMNA) in Barley Malt - 578.500Macaroni and Noodle Products - 505.500Malted Milk - 527.500Pesticide Residues in Food and Feed - 575.100Seeds for Sprouting Prior to Food Use - 555.750Starches--Common or Usual Names - 578.100Treated Grain Seed - Mercury Residue - 578.400Water in Food Products (Ingredient or Adulterant) - 555.875Wheat for Human Consumption - Reconditioning - 578.350Wheat - Adulteration by Insect and Rodent Filth - 578.300Wheat Flour - 578.450Wheat Germ Containing Non Wheat Germ Tissue - 530.500

WHEAT CARLOAD SAMPLINGDimethylnitrosamine (DMSO) in Barley Malt - 578.500

WHEAT GERMWheat Germ ContainingNnon Wheat Germ Tissue - 530.500

WHEAT STARCHStarches Common or Usual Names - 578.100


447447

WHITE BREADButter Nut Bread - 505.300

WHITE FISHFish Adulteratsion by Parasites - 540.590Processed Seafood Products - 540.700

WHITE MUSTARDPrepared Mustard Composition - 525.575Spices Definitions - 525.750

WHITE POTATOESSweet Potatoes, Dying Yellow - 585.825

WHOLE BLOODBlood and Blood Products - Definitions - 230.100Registration of Blood Banks and Other Firms - 230.110Source Plasma - Overbleeding - 252.100Standards and Minimum Requirements for Biologic Products - 205.100Time Period for Separation of Platelets - 231.120

WHOLE MILKMalt Milk - 527.500Pathogens in Dairy Products - 527.300Whole Milk Aflatoxin M1 - 527.400

WILLFULAssembler who Install Noncompliant Equipment - 398.325

WINEDealcoholized Wine - 510.400Labeling diluted Wines - 510.450Unfermented Beverages - 510.300Vinegar - 525.825

WITNESSPayment of Expert Witness - 160.600

WOOD DISTILLATESLabeling of Seasonings - 525.650

WORLD HEALTH ORGANIZATIONStandards & Minimum Requirements for Biologic Products - 205.100

WORMY FRUITSCurrants Adulteration Involving Wormy Fruits - 550.270

WRAPPERBakery Products - 505.100Butter Nut Bread - 505.300

WRAPPERSTamper Resistant Packaging Requirements - 450.500

WRINKLEElectrical Muscle Stimulators - 355.200Lasers for Face Lift, Wrinkle Removal, Acupuncture etc. - 393.200Reloaders of X-Ray Tube Housing Assemblers - 398.700

WRINKLE REMOVAL (See wrinkle above)WRITTEN DECLARATION

Importation of TV Receivers & Microwave Ovens - 394.500WRITTEN NOTICE

Direct Reference Authority for Class III Medical Devices - 300.700 YEAST

Direct Fed Microbial Products - 689.100Labeling of Seasonings - 525.650Menstral Sponges - 345.300

YELLOW FEVER VACCINEStandards & Minimum Requirements for Biologic Products - 205.100

YELLOWFIN TUNADecomposition and Histamine in Albacore - 540.525

YERSINIA ENTEROCOLITICAPathogens in Dairy Products - 527.300

YOUNGBERRIESDrupelet Berries - 550.200

ZEA MAYS, LINNEStarches - Common or Usual Names - 578.100

ZINGIBERENE(EMS)Spices - 525.750

ZONEExports from U.S. Foreign Trade Zones - 110.200

UCM142644

Documents