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Compliance Policy Guides Index

Index

1000 ML WATER METHOD Vitamin B-15, Pangamic Acid - 457.100


Surgeon's Gloves & Patient Exam Gloves - 335.700 ACIDIFIED LOW-ACID CANNED FOODS
1989 GENERIC DRUG CASES High pH - 520.300
Orders for Post-Approval Record Reviews - 470.100 ACIDIFIERS
A CLINICAL REPERTORY TO THE DICTIONARY OF MATERIA MEDICA Sauerkraut - Definition - 585.750
Homeopathic Drugs - 400.400 Urinary Preparations - 430.400
ABBREVIATED ACTION LEVEL
Consistent Application of CGMP Determinations - 400.200 Action Levels for Aflatoxin in Animal Feeds - 683.100
Fraud, Untrue Statements of Material Facts, Bribery - 120.100 Aflatoxin in Peanuts and Peanut Products - 570.375
Marketed New Drugs Without Approved NDAs or ANDAs - 440.100 Ammoniated Cottonseed Meal - Interpretation of 21 CFR 573.14 - 670.500
Reconditioning New Drugs Lacking Approved NDA - 448.100 Apricot, Peach and Pear Nectars and Purees - Mold - 550.155
Salmonella Contamination of Dry Dog Food - 690.700 Dimethylnitrosamine (DMNA) in Barley Malt - 578.500
ABDOMINAL Diversion of Adulterated Food to Acceptable Animal Feed Use - 675.200
Definition of General Purpose Radiographic X-Ray System - 398.100 Food Storage & Warehousing, Adulteration, Filth - 580.100
Positive Beam Limitation (PBL) Requirements - 398.450 Pesticide Residues in Food and Feed - 575.100
Turtles - 170.100 Pottery (Ceramics) - Cadmium Contamination - 545.400
ABRADED Red Meat Adulterated with PCB's - 565.200
Karaya Gum Powder and Related Devices for Use by Ostomates - 325.100 Revocation of Tolerances for Cancelled Pesticides - 555.700
ABSOLUTE MINIMUM CRITERIA Streptomycin Residues in Cattle Tissues - 616.100
Assemblers Who Install Noncompliant Equipment - 398.325 Tree Nuts - Adulteration Involving Rejects - 570.425
ABUSE Volatile N-Nitrosamine in Rubber Baby Bottle Nipples - 500.450
Determination by Secretary that Product Fails to Comply - 390.200 ACUPUNCTURE
Obligations of Factory-based Manufacturers and Assemblers - 398.375 Devices & Accessories - 305.100
RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200 Lasers for Facelift, etc. - 393.200
ACCEPT/ REJECT ACUTE
Condoms; Defects - Criteria for Direct Reference Seizure - 345.100 OTC Ear Drops - 454.100
Retention of Microwave Oven Test Records - 394.100 Proper Drug Use & Residue Avoidance - 615.200
Surgeon's Gloves and Patient Examination Gloves - 335.700 Salt-Cured, Air-Dried, Uneviscerated Fish - 540.650
ACCEPTABLE QUALITY LEVEL (AQL) Sunlamp Performance Standard - 396.100
Condoms; Defects - Criteria for Direct Reference Seizure - 345.100 ADDITIVES
GWQAP Pre-Award Evaluation - 100.700 Additives - Labeling with Adequate Directions for Many Uses - 500.100
Surgeon's Gloves and Patient Examination Gloves - 335.700 Ammoniated Cottonseed Meal - Interpretation of 21 CFR 573.140 - 670.500
ACCESSORIES Approved by FDA - Labeling of a Food Additive - 500.300
Acupuncture Devices and Accessories - 305.100 Brandy Containing Methyl Alcohol - Food Additive - 510.200
Denture Cleaners, Adhesives, Cushions, & Repair Materials - 315.200 Caviar, Use of Term - Labeling - 540.150
ACCIDENTAL RADIATION OCCURRENCES Color Additives - 587.300
Electronic Products Subject to 21 CFR 1001.15(a) - 390.400 Color Additives in Paper and Paperboard for Use With Food - 500.425
ACCURACY Confectionery Decorations (Nutritive and Non-Nutritive) - 545.200
Clinical Thermometers - 370.200 Direct-Fed Microbial Products - 689.100
Compressed Medical Gases - Warning Letters - 435.100 FDA Jurisdiction Over Meat and Poultry Products - 565.100
Computerized Drug Processing - Input/Output - 425.400 Food Additives - Labeling Directions Necessary for SafeUse - 500.250
Cytotoxic Testing for Allergic Diseases - 370.100 Food and Drug Guaranty - Imports - 110.500
Fraud, Untrue Statements, Bribery - 120.100 Fraud, Untrue Statements of Material Facts, Bribery - 120.100
I.D. of "Persons" - 425.500 Imports - Identity of Ingredients - 560.250
Metric Declarations of Quantity of Contents - 140.500 Label Declaration of Artificial Color - 587.100
Process Validation Requirements for Drug Products - 490.100 Pesticide Residues in Food and Feed - 575.100
RIA Analysis of Hair - 370.200 Plastic Containers for Injectable Animal Drugs - 637.100
Source Plasma - Overbleeding - 252.100 Pottery (Ceramics) - Cadmium Contamination - 545.400
Temporal - Maximum Ultrasonic Power - 397.100 Pottery (Ceramics) - Lead Contamination - 545.450
ACCURATE Preservatives; Use in Nonstandardized Foods; Label Declaration - 562.600
Clinical Thermometer - Misbranding Defects - 335.800 Recycled Animal Waste - 685.100
Computerized Rx Records by Pharmacies - 460.400 Silage Ingredients - 687.500
Determination of Donor Suitability - 230.130 Silver-Plated Hollowware - Lead Contamination - 545.500
Foods - FPLA Compliance - 562.200 Starches--Common or Usual names - 578.100
Registration of Blood Banks & Other Firms - 230.110 Sweet Potatoes, Dyeing of Yellow and Red Varieties - 585.825
Source Plasma - Guidelines - 250.100 Teat Dips and Udder Washes for Dairy Cows and Goats - 654.200
ACETIC ACID Vitamins and Minerals in Feed - 670.200
Acetic Acid-Use in Foods-Labeling of Foods in Which Used - 562.100 ADEQUATE DIRECTIONS FOR USE
Sauerkraut - Definition; Adulteration by Thrips - 585.750 Acupuncture Devices and Accessories - 305.100
Vinegar, Definitions - Adulteration with Vinegar Eels - 525.825 Additives - Labeling with Adequate Directions for Many Uses - 500.100
ACID Adequate Directions for Use-Animal Drugs and Devices - 607.100
Acetic Acid - Use In Foods - 562.100 Adequate Directions for Use - Veterinary Devices - 655.200
Acidified Low-Acid Canned Foods - 520.300 Availability of Bulk Chemicals for Animal Drug Use - 625.200
Canned Pet Food - 690.300 Checklist Labeling for Custom Mixed Medicated Feeds - 665.200
Cumin Seed Adulteration - 525.325 Chloramphenicol - 654.300
Food Storage & Warehousing - 580.100 Compressed Medical Gases -- Warning Letters - 435.100
Imported Low-Acid Canned Foods - 560.450 Cytotoxic Testing for Allergic Diseases - 370.100
Jellies NonStandardized- 550.475 Diaphragms - Rx Devices - 345.200
Labeling of Seasonings - 525.650 Electrical Muscle Stimulators - 355.200
Large Volume Parenteral (LVP's) - 635.100 Homeopathic Drugs - 400.400
Nutritional Supplements for Pets - 690.100 Hypnotherapy Devices - Self Hypnotic Tape Recordings - 335.300
Potato Chips, Ingredients - 585.710 Illegal Sales of Veterinary Prescription Drugs - 608.500
Pottery - Cadmium Contamination - 545.400 Ineffective Devices - 502(f)(l) Labeling Requirements - 300.300
Prepared Mustard, Composition - 525.575 Inert Glandular Preparations - OTC - 455.100
Sauerkraut - Definition - 585.750 Large Volume Parenteral (LVP's) for Animal Use - 635.100
Silage Ingredients - 687.500 Over-The-Counter Sale of Injectable Animal Drugs - 608.200
Silver-Plated Hollowware - 545.500 RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200
Spices - Definitions - 525.750 Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100
Vinegar, Definitions - 525.825 Warning Label Required on Sunlamp Products - 396.400

395
Index Compliance Policy Guides
ADHESIVES Hops - Adulteration Involving Aphid Infestation - 525.425
Denture Cleaners, Repair Materials - 315.200 Hospital Pharmacies - 460.100
Tamper-Resistant Packaging Requirements - 450.500 Human-Labeled Drugs Distributed & Used in Animal Medicine - 608.100
ADMINISTRATIVE DETENTION Importation of Unlabeled Foods - *21 CFR 101.100(d)* - 560.100
Defective Suntanning Booths & Beds - 396.300 Imported Low-Acid Canned Foods - 560.450
ADRENAL Imports - Identity of Ingredients - 560.250
Grandular Preparations - 455.100 Interference with Compendial Tests - 420.500
ADULTERATED Jam, Black Currant - Adulteration with Mold - 550.450
Acupuncture Devices and Accessories - 305.100 Jams, Jellies and Related Products - Imports - 560.500
Adulterated Food Mixed with Good Food - 555.200 Lack of Expiration Date or Stability Data - 480.300
Adulteration of Drugs Under Sec. 501(b) and 501(c) - 420.100 Large volume parenteral (LVP's) for animal use - 635.100
Apple Butter - Adulteration with Mold; Rodent Filth, Insects - 550.100 Leafy Spices, Other than Bay Leaves - 525.500
Apricots - Canned - Adulteration with Insects - 550.150 Lingon Berries, Canned - Adulteration by Insects - 550.500
Apricot, Peach and Pear Nectars and Purees - mold - 550.155 Macaroni and Noodle Products - 505.500
Asparagus, Canned or Frozen - Adulteration with Insect Filth - 585.150 Mace-Insect Filth; Mold, Foreign Matter; Mammalian Excreta - 525.550
Availability of Bulk Chemicals for Animal Drug Use - 625.200 Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200
Bay (Laurel) Leaves - Insect Filth; Mold; etc. - 525.150 Marjoram - 525.900
Beets, Canned - Adulteration with Rot - 585.200 Medicated Feeds - Formula Information - 670.100
Black-Eyed Peas (Cow Peas, Field Peas); Dried - 585.225 Medicated Feeds - Combined Batches - 680.400
Broccoli, Frozen - Adulteration with Insects - 585.260 Milk and Milk Products Containing Penicillin - 527.450
Brussels Sprouts, Frozen - Adulteration by Insects - 585.275 Natural Bristle Brushes - Nit Contamination - 590.400
Butter - Adulteration Involving Low Fat - 527.100 Nutritional Supplements for Companion Animals - 690.100
Candy - Mixed with Trinkets and Sold in Vending Machines - 515.350 Olives - Adulteration Involving Pits; Rot; Insect Infestation - 550.600
Canned Salmon - Adulteration Involving Decomposition - 540.375 Oranges - Artificial Coloring - 550.625
Canned Foods - Seam Defects - 520.200 Oregano - 525.850
Capsicum Pods, etc. - Adulteration - 525.200 Pathogens in Dairy Products - 527.300
Cheese and Cheese Products - Adulteration with Filth - 527.200 Peanut Butter - Adulteration with Filth; Grit - 570.300
Cherries - 550.225 Peanuts, Shelled and Unshelled - Filth and Reject Nuts - 570.350
Cherry Jam - Adulteration with Mold - 550.235 Peas and Beans; Dried - Storage Insect Damage, Rocks - 585.575
Chloramphenicol - 654.300 Pesticide Residues in Food and Feed - 575.100
Chocolate & Chocolate Liquor - Adulteration - 515.700 Pineapple, Canned; Pineapple Juice-Adulterated with Mold - 550.680
Cinnamon-Flavored Toothpicks - 545.600 Plastic Containers for Injectable Animal Drugs - 637.100
Citrus Fruit Juices, Canned - Fly Filth and Mold - 550.250 Plums, Canned - Adulteration with Rot - 550.690
Class III Devices Subject to 5l5(b) Requirements - 300.750 Popcorn - Adulteration with Rodent Filth and Field Corn - 585.675
Clinical Thermometer - Adulteration; Misbranding Defects - 335.800 Potato Chips - Adulteration with Rot - 585.700
Cloudberries (Multer Berries), canned - Adulteration - 550.590 Pottery (Ceramics) - Cadmium Contamination - 545.400
Cloves - Adulteration with Stems - 525.250 Pottery (Ceramics) - Lead Contamination - 545.450
Cocoa Beans - Mold, Insect Infestation, and Mammalian Excreta - 515.750 Products Composed of Interstate Ingredients - 100.200
Coffee and Cocoa Bean Sweeps - 560.350 Proper Drug Use and Residue Avoidance - 615.200
Compendium Revisions and Deletions - 420.200 Radionuclides in Imported Foods - Levels of Concern - 560.750
Compressed Medical Gases - Warning Letters - 435.100 Raisins - Adulteration Involving Mold, Sand, Grit, and Insects - 550.750
Computerized Drug Processing - Vendor responsibility - 425.200 Reconditioners/Rebuilders of Medical Devices - 300.200
Computerized Drug Processing - Input/Output Checking - 425.400 Reconditioning of Foods Adulterated Under 402(a)(4) - 160.700
Condimental Seeds Other than Fennel Seeds and Sesame Seeds - 525.300 Reconditioning of Articles Found in Violation of GMP's - 160.750
Condoms; Defects - Criteria for Direct Reference Seizure - 345.100 Reconditioning of New Animal Drugs Seized Under Sec. 501(a)(5) - 625.400
Confectionery Decorations (Nutritive and Non-Nutritive) - 545.200 Red Meat Adulterated with PCB's - 565.200
Confectionery - Use of Non-Nutritive Substances as Ingredients. - 515.100 Rendered Animal Feed Ingredients - 675.400
Contamination of Devices Labeled as Sterile - 300.400 RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200
Corn Meal - Adulteration by Insect and Rodent Filth - 578.200 Rodent Contaminated Pet Foods - 690.600
Corn Husks (for Tamales) - Adulteration with Filth - 585.350 Sage - 525.950
Corn, Sweet; Canned - Adulteration - 585.300 Salmonella Contamination of Dry Dog Food - 690.700
Cowpeas (Black-Eyed Peas); Canned (Succulent Peas); Insects - 585.400 Salt-Cured, Air-Dried, Uneviscerated Fish - 540.650
Crabmeat Products, Labeling - 540.285 Seeds for Sprouting Prior to Food Use - 555.750
Crabmeat - Adulteration with Filth - Escherichia coli - 540.275 Sesame Seeds - Adulteration - 525.700
Cranberry Sauce - Adulteration with Mold - 550.260 Shrimp-Fresh or Frozen Raw Headless, Peeled or Breaded - 540.400
Cumin Seed - Adulteration with Sand and Grit - 525.325 Silage Ingredients - 687.500
Currants - Adulteration Involving Wormy Fruits - 550.270 Silver-Plated Hollowware - Lead Contamination - 545.500
Curry Powder - Adulteration by Insect and Rodent Filth - 525.330 Spinach, Canned or Frozen - Insects, Decomposition - 585.775
Cytotoxic Testing for Allergic Diseases - 370.100 Strawberries; Frozen, Whole, or Sliced - Sand, Mold - 550.850
Dates and Date Material; Imported and Domestic - 550.300 Streptomycin Residues in Cattle Tissues - 616.100
Decomp. & Histamine in Albacore, Skipjack & Yellowfin Tuna - 540.525 Surgeon's Gloves and Patient Examination Gloves - 335.700
Devices for Use in Animals - 655.100 Sweet Potatoes, Dyeing of Yellow and Red Varieties - 585.825
Dimethyl Sulfoxide (DMSO) for Animal Use - 654.100 Thyme - 525.925
Dimethylnitrosamine in Malt Beverages - 510.600 Tomato Products - Adulteration with Mold - 585.900
Direct Reference Authority for Class III Medical Devices - 300.700 Tomato Products - Drosophila Fly Eggs and Maggots - 585.890
Direct Reference Authority for Pseudomonas Contamination - 590.300 Treated Grain Seed - Mercury Residue - 578.400
Direct-Fed Microbial Products - 689.100 Tree Nuts - Adulteration Involving Rejects - 570.425
Diversion of Contaminated Food for Animal Use - 675.100 Tree Nuts - Escherichia coli - 570.450
Diversion of Adulterated Food to Acceptable Animal Feed Use - 675.200 Unapproved New Animal Drugs - Follow-up Action - 625.300
Dried Prunes, Dehydrated Low Moisture Prunes, and Pitted Prunes - 550.700 Uncertified or Delisted Colors - 587.200
Drupelet Berries (Blackberries, Raspberries, etc.) - 550.200 Uncooked Meat for Animal Food - 690.500
Eggnog; Eggnog Flavored Milk--Common Usual Names - 527.350 Unsafe Contamination of Animal Feed from Drug Carry-Over - 680.500
Eggs and Other Egg Products - Frozen - Decomposition - 537.100 Vinegar, Definitions - Adulteration with Vinegar Eels - 525.825
Enriched or Fortified Foods - Potency - 555.550 Water in Food Products (Ingredient or Adulterant) - 555.875
Ethylenediamine Dihydroiodide (EDDI) - 651.100 Water-Damaged Food Products - 555.850
Extra-Label Use of New Animal Drugs in Food-Producing Animals - 615.100 Water and Gravy in Pet Food - 690.400
Fennel Seed - Adulteration by Mammalian Excreta; Insects - 525.350 Wheat - Adulteration by Insect and Rodent Filth - 578.300
Figs; Fig Paste - Insect Infestation; Mold, Dirt - 550.350 Wheat Flour - 578.450
Fish - Fresh and Frozen-Adulteration Involving Decomp. - 540.575 Whole Cassia or Whole Cinnamon, Ground Cinnamon - 525.225
Fish - Fresh and Frozen, as Listed; Adulteration by Parasites - 540.590 Whole Ginger - Insect Filth; Mold; Mammalian Excreta - 525.375
Food Storage & Warehousing - Adulteration - Filth - 580.100 Whole and Ground Allspice Mold; Insect and Rodent Filth - 525.100
Food Additives -"GRAS" - 500.200 Whole and Ground Pepper - Adulteration - 525.625
Foods, Except Dairy Products - Adulteration with Salmonella - 555.300 Whole and Ground Nutmeg-Insect Filth; Mold; Rodent Filth - 525.600
Foods, Rail Car Sanitation - Adulteration - 545.300 ADULTERATION
Green Coffee Beans - Adulteration with Insects; Mold - 510.500 See Adulterated
Greens, Canned - Adulteration by Mildew - 585.450 ADVANCEMENT OF MEDICAL INSTRUMENTATION (AAMI)

396
Compliance Policy Guides Index
Sphygmomanometers - Accuracy - 310.210 Tree Nuts - Adulteration - 570.425
ADVERTISED ALTERNATE PROCEDURES AND PRECAUTIONS
Acupuncture Devices & Accessories - 305.100 Hazardous Diagnostic X-Ray Systems - 398.200
Commercial Distribution - 300.600 AMERICAN CITRON
ADVERTISING Candied Citron - Labeling - 515.600
Bulk Chemicals for Animal Drugs - 625.200 AMERICAN SPICE TRADE ASSOCIATION
Certification for Export - 110.100 Spices - Definitions - 525.750
Drug Product - 400.700 AMERICAN NATIONAL STANDARDS INSTITUTE
Health Fraud - 120.500 Sphygmomanometers - Accuracy - 310.210
Human-Labeled Drugs for Animals - 608.100 AMINE
Lasers for Facelift - 393.200 Barley Malt - 578.500
Literature for Mercury Vapor Lamps - 391.100 AMINO ACID
Mercury Vapor Lamps - 391.200 LVP's for Animals - 635.100
NADA Approval - 605.100 AMMONIATED
Promotion by Pharmacies - 460.200 Cottonseed Meal - 670.500
ADVISABILITY Medicated Feeds - 670.100
Sphygmomanometers - Rx Legend - 310.200 AMMONIUM CHLORIDE
ADVISORY OPINION Urinary Preparations - 430.400
Color Additives in Paperboard for Use with Foods - 500.425 AMPROLIUM
Commercial Distribution - 300.600 Medicated Feeds - 670.100
Drug Product Entries in Periodic Publications - 400.700 AMPLITUDE-MODULATED (PULSED)
Fortification of Standardized Juices - 510.700 Temporal-Maximum Ultrasonic Power - 397.100
Labeling: "Chocolate" or "Chocolate Flavored" - 515.800 AMYGDALIN
Microfiche and/or Microfilm - Records Retention - 130.400 Articles of Foreign Origin Not Intended for Entry - 110.700
Override of Positive Beam Limitation - 398.425 ANALGESICS
Plastic Containers for Injectable Animal Drugs - 637.100 Human Labeled Drugs for Animals - 608.100
Seeds for Sprouting Prior to Food Use - 555.750 Urinary Preparations - 430.400
AEROBIC PLATE COUNTS ANALYTICAL
Raw Breaded Shrimp - Microbiological - 540.420 Action Levels for Aflatoxin in Animal Feeds - 683.100
AEROSOL PRODUCTS Adulteration of Drugs under Sec. 501(b) and 501(c) - 420.100
Tamper-Resistant Packaging Requirements - 450.500 Aflatoxin in Peanuts and Peanut Products - 570.375
AFFIRMATION Analytical Methodology Used by FDA - Drugs - 150.500
Importation - TV Receivers & Microwave Ovens - 394.500 Apple Butter - Adulteration with Mold; Rodent Filth, Insects - 550.100
AFLATOXIN Apricots - Canned - Adulteration with Insects - 550.150
Action Levels for Aflatoxin in Animal Feeds - 683.100 Apricot, Peach and Pear Nectars and Purees - Mold - 550.155
Ammoniated Cottonseed Meal - 670.500 Black-Eyed Peas (Cow Peas, Field Peas); Dried - 585.225
in Foods - 555.400 Brazil Nuts - Adulteration with Aflatoxin - 570.200
in Pistachio Nuts - 570.500 Brussels Sprouts, Frozen - Adulteration by Insects - 585.275
in Peanut Products - 570.375 Canned Green Beans & Canned Wax Beans - Standards - 585.475
in Brazil Nuts - 570.200 Cherries, Canned-Misbranding Involving Food Standards - 550.230
Milk - 527.400 Chubs, Hot Process Smoked with Added Nitrite - 540.200
Moisture Damaged Grain - 675.300 Clams, Mussels, Oysters - Paralytic Shellfish Poison - 540.250
AIR-DRIED, AIR-DRYING Compendium Revisions and Deletions - 420.200
Uneviscerated Fish - 540.650 Compressed Medical Gases -- Warning Letters - 435.100
AIR-LIQUEFACTION Corn, Sweet; Canned - Adulteration - 585.300
Compressed Medical Gases - Warning Letters - 435.100 Cowpeas (Black-Eyed Peas); Canned (Succulent Peas)-Insects - 585.400
ALBACORE Decomp. & Histamine in Canned Albacore, Skipjack & Yellowfin Tuna - 540.525
Decomposition & Histamine - 540.525 Dimethylnitrosamine in Malt Beverages - 510.600
ALBUMEN Direct Reference Authority for Pseudomonas Contamination - 590.300
Confectionery Decorations - 545.200 Diversion of Adulterated Food to Acceptable Animal Feed Use - 675.200
ALBUMIN Dried Prunes, Dehydrated Low Moisture Prunes, and Pitted Prunes - 550.700
Registration of Blood Bands & Other Firms - 230.110 Drupelet Berries (Blackberries, Raspberries, etc.) - 550.200
Standards & Minimum Requirements for Biologic Products - 205.100 Eggs and Other Egg Products - Frozen - Decomposition - 537.100
ALBUTEROL SULFATE Figs; Fig Paste - Insect Infestation; Mold, Dirt - 550.350
Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200 Fish-Fresh and Frozen, as Listed-Adulteration by Parasites - 540.590
ALCOHOL Fish, Shellfish, Crustaceans, etc. - Methyl Mercury - 540.600
Acetic Acid Use in Foods - 562.100 Fish-Fresh and Frozen-Adulteration Involving Decomposition - 540.575
Brandy - 510.200 Foods, Except Dairy Products - Adulteration with Salmonella - 555.300
Confectionery - 515.100 Foods, Adulteration with Aflatoxin - 555.400
Labeling Wines and Cider - 510.450 Imported Frozen Products of Multiple Sizes - 560.700
Large Volume Parenteral (LVP's) - 635.100 Lingon Berries, Canned - Adulteration by Insects - 550.500
Use in Foods - 555.100 Milk and Milk Products Containing Penicillin - 527.450
Vinegar, Definitions - 525.825 Oleomargarine - Misbranding Due to Low Fat - 535.100
Wine and Malt Beverages - 510.400 Olives - Adulteration Involving Pits; Rot; Insect
ALDEHYDE Infestation - 550.600
Spices - Definitions - 525.750 Pathogens in Dairy Products - 527.300
ALFALFA SEEDS Peaches, Canned-Misbranding Involving Food Standards - 550.655
Seeds For Sprouting - 555.750 Peanut Butter - Adulteration with Filth; Grit - 570.300
ALGAL "BLOOMS" Peanuts, Shelled and Unshelled - Filth and Reject Nuts - 570.350
Paralytic Shellfish - 540.250 Peas and Beans; Dried - Storage Insect Damage, Rocks - 585.575
ALLERGENIC PRODUCTS Pesticide Residues in Food and Feed - 575.100
Standards & Minimum Requirements for Biologic Products - 205.100 Pistachio Nuts - Aflatoxin Adulteration - 570.500
ALLERGIC DISEASES Plastic Containers for Injectable Animal Drugs - 637.100
Cytotoxic Testing - 370.100 Plums, Canned - Adulteration with Rot - 550.690
ALLERGIES Pottery (Ceramics) - Lead Contamination - 545.450
Hypnotherapy Devices - 335.300 Raisins-Adulteration involving Mold, Sand, Grit, & Insects - 550.750
Immune Milk - 275.100 Repacking of Drug Products -- CGMP's - 430.200
ALLERGY CLINICS RIA Analysis of Hair to Detect the Presence of Drugs Abuse - 370.200
Cytotoxin Testing - 370.100 Salmonella Contamination of Dry Dog Food - 690.700
ALLSPICE Shrimp-Fresh/Frozen Raw Headless, Peeled or Breaded - 540.400
Spices - Definitions - 525.750 Shrimp - Frozen, Raw, Breaded or Lightly Breaded - 540.410
Whole and Ground - 525.100 Spinach, Canned or Frozen - Insects, Decomposition - 585.775
ALMONDS Standardized Canned Fruit - Packing Medium - 550.800
Confectionery Decorations - 545.200 Strawberries; Frozen, Whole, or Sliced - Sand, Mold - 550.850
Jordan Almonds - Common or Usual Name - 570.100 Tomato Products - Drosophila Fly Eggs and Maggots - 585.890
Maraschino Cherries - 550.550 Tomato Products - Adulteration with Mold - 585.900

397
Index Compliance Policy Guides
Tomatoes-Canned-Misbranding Involving Food Standards (Peel) - 585.875 Export of Uncertified Antibiotics - 405.200
Tree Nuts - Adulteration Involving Rejects - 570.425 Marketed New Drugs w/o Approved NDAs or ANDAs - 440.100
Tuna, Sable, Salmon, Shad-Smoked, Cured-Sodium Nitrite - 540.500 Prescriptions Prepared from Certified Antibiotics - 405.100
Unsafe Contamination of Animal Feed from Drug Carry-Over - 680.500 Regulatory Action Regarding ANDAs - 446.100
Vitamin B-15, Pangamic Acid and Pangamic Acid Products - 457.100 Returned Antibiotics Exported Under 801 (d) of The Act - 405.210
Whole Milk, Low Fat Milk, Skim Milk - Aflatoxin M1 - 527.400 Unit Dose Labels for Solid & Liquid Oral Dose Form - 430.100
ANEROID Use of Antibiotic Drug Residue - 682.200
Sphygmomanometers - Accuracy - 310.210 ANTIBODY
ANESTHETICS Registration of Blood Banks & Other Firms - 230.110
Human-Labeled Drugs for Pet Medicine - 608.100 Standards & Minimum Requirements for Biologic Products - 205.100
ANETHOLE ANTICOAGULANT
Spices Definitions - 525.750 Source Plasma - Overbleeding - 252.100
ANIMAL FEED ANTIGEN
Ammoniated Cottonseed Meal - 670.500 Immune Milk - 275.100
Common Names for Animal Feed - 665.100 Source Plasma Guidelines Informed Consent Form - 250.100
Direct-Fed Microbial Products - 689.100 Standards & Minimum Requirements for Biologic Products - 205.100
Diversion/Food to Pet Feed Use - 675.200 ANTIPASTO
Diversion of Food for Pets - 675.100 Common or Usual Name - 567.100
Ethylenediamine Dihydroiodide - 651.100 Foreign Language Declarations - 562.400
Imported Milk and Cream - 560.400 ANTIVENIN
Medicated Feeds Information - 670.100 Standards & Minimum Requirements for Biologic Products - 205.100
Moisture Damaged Grain - 675.300 AOAC
Pesticide Residues in Food - 575.100 Apricot, Peach & Pear Nectars & Purees - Mold - 550.155
Radionuclides in Foods - 560.750 Capsicum Products, etc. - Adulteration - 525.200
Reconditioning Foods for Pets - 555.650 Figs; Fig Paste - Insect Infestation; Mold, Dirt - 550.350
Recycled Animal Waste - 685.100 Raw Breaded Shrimp - Microbiological - 540.420
Rendered Pet Feed Ingredients - 675.400 Whole Milk, Low Fat Milk, Skim Milk - Aflatoxin M1 - 527.400
Sequencing in Production - 680.600 APHID
Tracers in Animal Feed - 680.100 Hops - Adulteration - 525.425
Unsafe Contamination from Drug - 680.500 APLASTIC ANEMIA
Use of Drug-Contaminated Products - 682.100 Chloramphenicol - 654.300
Use of Antibiotic Drug - 682.200 APPEARANCE
Use of Type A Medicated Article Brand Names - 665.300 Cherries - Canned - Misbranding Involving Food Standard - 550.500
Vitamins and Minerals in Feed - 670.200 Cytotoxic Testing for Allergic Diseases - 370.100
ANIMAL DRUGS - SEE ATTACHED LIST Health Fraud - 120.500
Adequate Directions for Use - Veterinary Devices - 655.200 Imports - Identity of Ingredients - 560.250
Adequate Directions for Use - Animal Drugs and Devices - 607.100 Jellies - Nonstandardized - 550.475
Animal Drugs for Euthanasia - 650.100 Oriental Noddles - 505.400
Availability of Bulk Chemicals for Animal Drug Use - 625.200 Payment of Expert Witnesses - 160.600
Biological Drugs for Animal Use - 645.100 Snapper - Labeling - 540.475
Certification for Exports - 110.100 Spices - Definitions - 525.750
Chloramphenicol - 654.300 Squash Seeds - Labeling as Pumpkin Seeds - 585.800
Direct-Fed Microbial Products - 689.100 APPLE BUTTER
Drugs for Odor Control in Animals - 642.100 Adulteration with Mold; Filth - 550.100
Ethylenediamine Dihydroiodide (EDDI) - 651.100 APPLE VINEGAR
Extra-Label Use of New Animal Drugs in Food-Producing Animals - 615.100 Vinegar Definitions - Adulteration with Vinegar Eels - 525.825
Human-Labeled Drugs Distributed & Used in Animal Medicine - 608.100 APPLESAUCE
Imported Products - Labeling - 110.900 Silver-Plated Hollowware - 545.500
Large Volume Parenteral (LVP's) for Animal Use - 635.100 APPLICATION TO RELABEL OR PERFORM
Medicated Feeds -- Formula Information - 670.100 Returned Antibiotics Exported Under 801(d) of the Act - 405.210
Nutritional Supplements for Companion Animals - 690.100 APRICOT
Oral Iron Products for Baby Pigs - 643.100 Contamination with Mold - 550.155
Over-The-Counter Sale of Injectable Animal Drugs - 608.200 Apricots - Canned - Adulteration with Insects - 550.150
Plastic Containers for Injectable Animal Drugs - 637.100 ARIZONA
Proper Drug Use and Residue Avoidance - 615.200 Turtles - 170.100
Reconditioning of New Animal Drugs Seized Under Sec. 501(a)(5) - 625.400 ARTICHOKE
Reconditioning of Articles Found in Violation of GMP's - 160.750 Common or Usual Name - 585.100
Sequencing in Medicated Feed Production - 680.600 ARTIFICIAL TEETH
Teat Dips and Udder Washes for Dairy Cows and Goats - 654.200 Dentures - Sale by Persons Not Licensed - 315.100
Unapproved New Animal Drugs - Follow-up Action - 625.300 ASEPTIC PROCESSING
ANIMAL MEDICINE Process Validation Requirements for Drug Products - 490.100
Bulk Chemicals - 625.200 ASIAGO
Human-Labeled Drugs Distributed and Used in Animal Medicine - 608.100 Cheese Moisture and Fat - 527.225
ANISE ASPARAGUS
Spices Definitions - 525.750 Canned or Frozen Adultration With Filth - 585.150
ANTI-INFLAMMATORY ASPERGILLUS
Human-Labeled Drugs for Animals - 608.100 Moisture Damaged Grain - 675.300
ANNUAL REPORTS AQUEOUS SOLUTIONS
Electronic Products Subject to 21 CFR 1001.15(a) - 390.400 LVP's for Animals - 635.100
ANTHRAX ASSEMBLAGE OF COMPONENTS
Communicable Disease Hazards - 100.300 Certification and Identification of X-Ray Components - 398.600
Standards & Minimum Requirements for Biologic Products - 205.100 ASSEMBLER CERTIFICATION
ANTHRAX VACCINE ADSORBED Registration of Assemblers of Diagnostic X-Ray Systems - 398.300
Standards and Minimum Requirements for Biologic Products - 205.100 ASSEMBLERS OF X-RAY EQUIPMENT
ANTI-RABIES SERUM Assemblers Who Install Noncompliant Equipment - 398.325
Standards & Minimum Requirements for Biologic Products - 205.100 Assessment of Civil Penalties - 390.300
ANTIBIOTIC CERTIFICATION Certification & Identification of X-ray Components - 398.600
Hospital Pharmacies -460.100 Obligations of Factory-Based Manufacturers & Assemblers - 398.375
ANTIBIOTIC DRUG Reconditioners/Rebuilders of Medical Devices - 300.200
Chloramphenicol - 654.300 Registration of Assemblers of Diagnostic X-ray Systems - 398.300
Export of Uncertified Antibiotics - 405.200 Regulatory Actions Against Assemblers of X-ray Equip.- 398.350
Use Antibiotic Drug Residues By Products in Animal Feed - 2.200 Reloaders of X-Ray Tube Housing Assemblies - 398.700
ANTIBIOTICS ASSEMBLERS
Analytical Methodology Used by FDA - Drugs - 150.500 Assemblers Who Install Noncompliant Equipment - 398.325
Drugs for Odor Control in Animals - 642.100 Assessment of Civil Penalties - 390.300
Expiration Dating of Unit Dose Repackaged Drugs - 480.200 Certification and Identification of X-Ray Components - 398.600

398
Compliance Policy Guides Index
Laser Light Shows, etc. - 393.100 Malted Milk - 527.500
Obligations of Factory-Based Manufacturers and Assemblers - 398.375 Vinegar, Definitions; Adulteration - 525.825
Reconditioners/Rebuilders of Medical Devices - 300.200 BARRIER
Registration of Assemblers of Diagnostic X-Ray Systems - 398.300 Assemblers Who Install Noncompliant Equipment - 398.325
Regulatory Actions Against Assemblers of X-ray Equipment - 398.350 Surgeons' Gloves & Patient Examination Gloves - 335.700
Reloaders of X-Ray Tube Housing Assemblies - 398.700 Tamper-Resistant Packaging Requirements - 450.500
ASSEMBLY BARYTES
Assemblers Who Install Noncompliant Equipment - 398.325 Confectionery - 515.100
Certification and Identification of X-Ray Components - 398.600 BAY LEAVES
Definition of "Commerce" - 21 CFR 1000.3(g) - 390.100 Filth, Mold - 525.150
Definition of "High-Voltage Vacuum Switch - 390.500 Leafy Spices - 525.500
Laser Light Shows, etc. - 393.100 Spices - Definitions - 525.750
Obligations of Factory-Based Manufacturers and Assemblers - 398.375 BAY OF FUNDY
Registration of Assemblers of Diagnostic X-Ray Systems - 398.300 Clams, Mussels, Oysters - Paralytic Shellfish Poison - 540.250
Regulatory Actions Against Assemblers of X-Ray Equipment - 398.350 BCG VACCINE
Reloaders of X-Ray Tube Housing Assemblies - 398.700 Standards & Minimum Requirements for Biologic Products - 205.100
ASSESSMENT BEAM LIMITING DEVICE
Assemblers Who Install Noncompliant Equipment - 398.325 Automatic Adjustment of the X-ray Field Size - 398.400
Assessment of Civil Penalties - 390.300 BEANS
Consistent Application of CGMP Determinations - 400.200 Bean Products - Labeling - 567.200
Diversion of Adulterated Food to Acceptable Animal Feed Use - 675.200 Canned Green and Wax Beans - 585.475
Fraud, Untrue Statements of Material Facts, Bribery - 120.100 Cocoa Beans- Mold, Filth - 515.750
GWQAP Pre-Award Evaluation - 100.700 Coffee and Coca Bean Sweeps - 560.350
Pesticide Residues in Food and Feed - 575.100 Green Coffee Beans - Adulteration - 510.500
Reloaders of X-Ray Tube Housing Assemblies - 398.700 Labeling "Chocolate Flavored" - 515.800
ASSOCIATION OF OFFICIAL ANALYTICAL CHEMISTS Pesticide Residues in Food - 575.100
Action Levels for Aflatoxin in Animal Feeds - 683.100 Proper Drug Use and Residue - 615.200
Aflatoxin in peanuts and peanut products - 570.375 Reconditioning of Coffee - 560.300
Brazil nuts - Adulteration with Aflatoxin - 570.200 Seeds for Sprouting - 550.750
Clams, Mussels, Oysters - Paralytic Shellfish Poison - 540.250 BEEF
Decomp. & Histamine in Albacore, Skipjack & Yellowfin Tuna - 540.525 Aflatoxin in Animal Feeds - 683.100
Fish, Shellfish, Crustaceans, etc. - Methyl Mercury - 540.600 Ethylenediamine Dihydroiodide - 651.100
Foods, Adulteration with Aflatoxin - 555.400 BEEF AND GRAVY WITH RICE
Pesticide Residues in Food and Feed - 575.100 FDA Meat & Poultry Products - 565.100
Pistachio Nuts - Aflatoxin Adulteration - 570.500 BEEF STEW
Pottery (Ceramics) - Lead Contamination - 545.450 FDA Meat & Poultry Products - 565.100
Shrimp - Fresh or Frozen Raw Headless, Peeled or Breaded- 540.400 BEETS, CANNED
ASSURANCE Beets, Canned - Adulteration with Rot - 585.200
Access to Results of Quality Assurance Audits - 130.300 BEHAVIOR MODIFICATION
Compendial Requirements - 420.400 Hypnotherapy Devices-Self-Hypnotic Tape Recordings - 335.300
Computerized Drug Processing -- I.D. of "Persons" - 425.500 BENTONITE
Consistent Application of CGMP Determinations - 400.200 Medicated Feeds - 670.100
Direct Reference Authority for Class III Medical Devices - 300.700 BENZYL ALCOHOL
Diversion of Adulterated Food to Acceptable Animal Feed Use - 675.200 LVP's for Animals - 635.100
Expiration Dating and Stability Testing - 480.100 BENZOCAINE
Expiration Dating of Unit Dose Repackaged Drugs - 480.200 OTC Anti-Obesity Preparations - 456.100
Fraud, Untrue Statements of Material Facts, Bribery - 120.100 BERRIES
GWQAP Pre-Award Evaluation - 100.700 Cloudberries, Canned Filth Adulteration - 550.590
Lack of Expiration Date or Stability Data - 480.300 Drupelet Berries - 550.200
Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200 Lingon Berries, Canned Filth - 550.500
Medicated Feeds -- Combined Batches - 680.400 Pesticide Residues - 575.100
Process Validation Requirements for Drug Products - 490.100 Spices - Definitions - 525.750
Regulatory Action Regarding Approved New Drugs - 446.100 Strawberries; Sand, Mold - 550.850
Regulatory Actions and Small Business - 160.100 Whole and Ground Allspice - Mold Filth - 525.100
Return of Unused Rx Drugs to Pharmacy Stock - 460.300 BEVERAGE
Tracers in Animal Feed - 680.100 Beverage Bases - 510.100
ATROPHY THERAPY Dealcoholized Wine, Malt Beverages - 510.400
Electrical Muscle Stimulators - 355.200 Malted Milk - 527.500
ATTEMPTED REPAIRS Use of Synthetic Alcohol - 555.100
Obligations of Factory-based Manufacturers & Assemblers - 398.375 Vending Machine Food - Labeling - 562.800
AURICULAR STIMULATION THERAPY BIENNIAL INSPECTION
Lasers for Facelift, Wrinkle Removal, Acupuncture, etc - 393.200 Contract Sterilizers - 100.550
AUTOCLAVING Reconditioners/Rebuilders of Medical Devices - 300.200
Validation Requirements for Drugs - 490.100 Reloaders of X-ray Tube Housing Assemblies - 398.700
AUTOIMMUNE BIO-PROBLEM DRUGS
Blood & Blood Products - Definitions - 230.100 Marketed New Drugs without NDAs or ANDAs Approval - 440.100
AUTOLOGOUS COLLECTIONS BIO-RELATED DRUGS
Registration of Blood Banks & Other Firms - 230.110 Marketed New Drugs Wthout Approved NDAs or ANDAs - 440.100
AUTOSOMAL RECESSIVE TRAIT BIOEQUIVALENCE
Fructose-Containing Drugs - 400.335 Fraud, Untrue Statements of Material Facts, Bribery - 120.100
BACTERIAL Marketed New Drugs without Approved NDAs or ANDAs - 440.100
Immune Milk - 275.100 BIOLOGICAL INDICATORS
Imported Milk and Cream - 560.400 Parametric Release of Terminally Heat-Sterilized Drugs - 460.800
Plastic Containers for Injectable Animal Drugs - 637.100 BIOLOGICS
Standards for Biologic Products - 205.100 48-hour Period Between Plasmapheresis Procedures - 256.100
BACTERIAL VACCINES Allergenic Extracts Containing Glycerin - 270.100
Standards & Minimum Requirements for Biologic Products - 205.100 Biological Drugs for Animal Use - 645.100
BAKERY PRODUCTS Blood and Blood Products - Definitions - 230.100
Bakery products, Candy "Shotgun" Ingredients Declaration - 505.100 Certification for Exports - 110.100
Honey Bread, Honey Buns - 505.350 Communicable Disease Hazards - 100.300
BARBECUE SEASONING Contract Sterilizers - 100.550
Labeling of Seasonings - 525.650 Human Blood and Blood Products as Drugs - 230.120
BARE QUARTZ Immune Milk - 275.100
Sunlamp Performance Standard - 396.100 Importation of Licensed Biologic Products for Human Use - 210.150
BARLEY MALT IND Filings - 215.100
Dimethylnitrosamine (DMNA) in Barley Malt - 578.500 Licensing - Changes to be Reported - 210.100

399
Index Compliance Policy Guides
Medical Emergencies - 220.100 Fish Fresh and Frozen - 540.590
Plasma Brokers - Registration and Compliance - 250.500 BLUE CRAB
Plastic Containers for Injectable Animal Drugs - 637.100 Crabmeat - 540.300
Platelets, Pooled - 231.110 BODY FLUIDS
Quality Control Testing - 231.110 Pacemaker Reuse - 310.100
QuantitativeTesting for Serum Proteins in Plasmapheresis Donors - 255.100 BODY SHAPING AND CONTOURING
Registration of Blood Banks and Other Firms - 230.110 Electrical Muscle Stimulators - 355.200
Source Plasma - Syphilis - 254.100 BODY SLIMMING AND TRIMMING
Source Plasma - Overbleeding - 252.100 Electrical Muscle Stimulators - 355.200
Standards and Minimum Requirements for Biologic Products - 205.100 BOND
Storage of Platelets - 231.130 Export From U.S. Foreign Trade Zones - 110.200
Time Period for Separation of Platelets - 231.120 Foreign Trade Zones, Bonded Warehouses or Carriers - 110.600
Use of Units Which Have Been Thawed - 253.100 Importation of TV Receivers & Microwave Ovens - 394.500
BIOSTIMULATION Imports - Post Detention Sampling - 110.800
Lasers for Facelift, Wrinkle Removal, Acupuncture etc - 393.200 Tamper-Resistant Packaging Requirements - 450.500
BIPIN FLUORESCENT BONDED
Sunlamp Performance Standard - 396.100 Diversion of Adulterated Food to Acceptable Animal Feed Use - 675.200
BIRD, BIRD CONTAMINATION, BIRD EXCRETA Foreign Trade Zones, Bonded Warehouses or Carriers - 110.600
Food Storage & Warehousing - 580.100 Olives Stuffed w/Minced Pimentos - Labeling - 550.605
BIRTH CONTROL BOOKS
Hypnotherapy Devices-Self-Hypnotic Tape Recordings - 335.300 Hollandaise Sauce - Common or Usual Name - 525.400
BITTER ALMONDS Seizure of Books That Constitute Misleading Labeling - 140.100
Maraschino Cherries - 550.550 BOTTLE CONTAINER CAPS
BIVALVE Tamper-Resistant Packaging Requirements - 450.500
Clams, Mussels & Oysters - 540.250 BOUILLON
BLACK CURRANT Bouillon Cubes, Granulated Bouillon - 567.300
Grenadine - 550.400 BOYSENBERRIES
Jam, Black Currant - Adulteration - 550.450 Drupelet, Raspberries - 550.200
Jellies, Nonstandardized - 550.475 BRAIN
BLACK-EYED PEAS Inert Glandular Preparations - OTC - 455.100
Cow Peas, Field Peas); Dried - 585.225 BRAND NAMES
BLACKBERRIES Use of Type A Medicated Article Brand Names in Feed Labels - 665.300
Drupelet Berries - 550.200 Identical or Similar Product Names - 400.500
BLADDER BRANDY
Definition of General Purpose Radiographic X-Ray System- 398.100 Containing Methyl Alcohol - 510.200
BLEMISH BRASSICA HIRTA, B. NIGRA, B. JUNCEA
Canned Green and Wax Beans - 585.475 Prepared Mustard, Composition - 525.575
Cherries, Canned Misbranding - 550.230 Spices - Definitions - 525.750
Pineapple, Canned; Food - 550.685 BRAZIL NUTS
BLISTER Adulteration with Aflatoxin - 570.200
Tamper-Resistant Packaging Requirements - 450.500 BREADED
BLOOD Imitation Breaded Shrimp - 540.450
Blood and Blood Products - Definitions - 230.100 Processed, Blended Seafood Products - 540.700
Electrical Muscle Stimulators - 355.200 Raw Breaded Shrimp - Microbiological - 540.420
Human Blood and Blood Products as Drugs - 230.120 Shrimp Frozen, Raw, Breaded - 540.410
Hypnotherapy Devices - Self Hypnotic Tape Recordings - 335.300 BRIBERY
IND Filings - 215.100 Fraud, Untrue Statements of Material Facts, Bribery - 120.100
Oral Iron Products for Baby Pigs - 643.100 BRICK
Plasma Brokers - Registration and Compliance - 250.500 Cheese Moisture and Fat - 527.225
Platelets, Pooled - 231.100 BRINE
Processed and/or Blended Seafood Products - 540.700 Salted Dried, Uneviscerated Fish - 540.650
Quality Control Testing - 231.110 BRIX
Registration of Blood Banks and Other Firms - 230.110 Canned Fruit Packing Medium - 550.800
Source Plasma - Overbleeding - 252.100 Pineapple, Canned; Food Standards - 550.685
Source Plasma - Guidelines for Informed Consent Forms - 250.100 Sweet Potatoes - Sirup Pack - 585.850
Sphygmomanometers - Rx Legend - 310.200 BROCCOLI
Sphygmomanometers - Accuracy - 310.210 Adulteration with Insect - 585.260
Standards and Minimum Requirements for Biologic Products - 205.100 BROCHURE
Storage of Platelets - 231.130 Additives-Labeling/Adequate Directions for Many Uses - 500.100
Surgeons' Gloves and Patient Examination Gloves - 335.700 Mercury Vapor Lamps That Aren't Self-Extinguishing - 391.200
Time Period for Separation of Platelets - 231.120 BROKEN
Use of Units Which Have Been Thawed - 253.100 Canned Green & Wax Beans - Standards - 585.475
BLOOD BANKS Coffee & Cocoa Bean Sweeps - 560.350
Plasma Brokers - Registration & Compliance - 255.500 Contamination of Devices Labeled as Sterile - 300.400
Platelets, Pooled - 231.100 Denture Cleaners & Repair Materials - 315.2300
Registration of Blood Banks & Other Firms - 230.110 Mercury Vapor Lamps-Not Self-Extinguishing - 391.200
Storage of Platelets - 231.130 Olives-Adulteration Involving Insect Infestation - 550.600
Time Period for Separation of Platelets - 231.120 Retention of Microwave Oven Test Records - 394.100
Use of Units Which Have Been Thawed - 253.100 Spices - Definitions - 525.750
BLOOD CELLS Tamper-Resistant Packaging Requirements - 450.500
Registration of Blood Banks & Other Firms - 230.110 BRUSSELS SPROUTS
Source Plasma-Guidelines for Informed Consent Form - 250.100 Adulteration w/Insects - 585.275
Standards & Minimum Requirements for Biologic Products - 205.100 Pesticide Residues - 575.100
BLOOD GROUPING SUBSTANCES BUBBLE PACKS
Standards & Min.Requirements - Biologic Products - 205.100 Tamper-Resistant Packaging Requirements - 450.500
BLOOD PRESSURE BUCKLING
Hypnotherapy Devices-Self-Hypnotic Tape Recordings - 335.300 Kipper and Kipper Unsplit - 540.550
Source Plasma - Overbleeding - 252.100 BULK BUTTER
Sphygmomanometers - Accuracy - 310.210 Butter Involving Low Fat - 527.100
Sphygmomanometers - Rx Legend - 310.200 BULK DRUG
BLOOD PRODUCTS Availability of Bulk Chemical for Animal Drug Use - 625.200
Blood & Blood Products - 230.100 Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200
Human Blood & Blood Products as Drugs - 230.120 Extra Label Use-New Drugs in Food-Producing Animals - 615.100
Plasma Brokers - Registration & Compliance - 250.500 BULK OXYGEN
Registration of Blood Banks & Other Firms - 230.110 Compressed Medical Gases- Warning Letters - 435.100
BLUE FIN BULK PHARMACEUTICAL CHEMICALS (BPC)

400
Compliance Policy Guides Index
Process Validation Requirements for Drug Products - 450.500 Shotgun Ingredients Declaration - 505.100
BURDEN OF PROOF CANDY PILLS
Determination by Secretary that Product Fails to Comply - 390.200 Candy "Pills" - 400.325
Unsafe Contamination of Animal Feed from Drug Carry-Over - 680.500 CANE SUGAR
BURGUNDY Labeling of Seasonings - 525.700
Dealcoholized Wine & Malt Beverages-Labeling - 510.400 CANNED
BUSINESS Acidified Low-Acid Canned Foods - High pH - 520.300
Collection and Charitable Distribution of Drugs - 400.800 Apple Butter - Adulteration with Mold; Rodent Filth, Insects - 550.100
Common Carrier as a Relabeler, Repacker, Reprocessor, etc. - 100.500 Apricots - Canned - Adulteration with Insects - 550.150
Definition of "Commerce" - 21 CFR 1000.3(g) - 390.100 Artichoke; Jerusalem Artichoke - Common or Usual Name - 585.100
Guaranties Over Printed Signatures - 100.800 Asparagus, Canned or Frozen - Adulteration with Insect Filth - 585.150
Homeopathic Drugs - 400.400 Beets, Canned - Adulteration with Rot - 585.200
Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200 Canned Peas - Label Designation of Sizes - 585.625
Menstrual Sponges - 345.300 Canned Green Beans and Canned Wax Beans-Standards - 585.475
Reconditioners/Rebuilders of Medical Devices - 300.200 Canned Pimentos & Red Sweet Peppers-Seeds Should be Removed - 585.650
Refusal to Permit Inspection. - 130.100 Canned Foods - Seam Defects - 520.200
Regulatory Actions and Small Business - 160.100 Canned Salmon - Adulteration Involving Decomposition - 540.375
Turtles - 170.100 Canned Foods, Use of the Term "Solid Pack" - 520.100
Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100 Canned Pet Food - 690.300
BUST DEVELOPMENT Canned Shrimp: Size Designations and Corresponding Counts - 540.390
Electrical Muscle Stimulators - 355.200 Cherries - 550.225
BUTTER Cherries, Canned - Misbranding Involving Food Standards - 550.230
Apple Butter - with Mold; Rodent Filth - 550.100 Citrus Fruit Juices, Canned - Fly Filth and Mold - 550.250
Butter-Nut Bread - 505.300 Cloudberries (Multer Berries), Canned - Adulteration - 550.590
Butter Featured in Product Name - 505.200 Corn, Sweet; Canned - Adulteration - 585.300
Butter Involving Low Fat - 527.100 Corn on the Cob, Canned - Quantity of Contents Declaration - 585.325
Declaration of Artificial Color - 587.100 Cowpeas (Black-Eyed Peas); Canned (Succulent Peas) - Insects - 585.400
Hollandaise Sauce Common or Usual - 525.400 Decomposition & Histamine in Albacore, Skipjack & Yellowfin Tuna - 540.525
Jams, Jellies and Related Products - 560.500 Drupelet Berries (Blackberries, Raspberries, etc.) - 550.200
Peanut Butter Filth; Grit - 570.300 Greens, Canned - Adulteration by Mildew - 585.450
Peas and Carrots, Labeling of Mixture - 585.600 Identity of Foods--Terms such as Fresh, Frozen, Dried, Canned - 562.450
BUTTER COOKIES Imported Low-Acid Canned Foods - 560.450
Butter Featured in Product Name - 505.200 Lingon Berries, Canned - Adulteration by Insects - 550.500
BUTTER SHORTBREAD Maraschino Cherries - 550.550
Butter Featured in Product Name - 505.200 Mushrooms, Canned or Dried (Freeze-Dried or Dehydrated) - 585.500
BUTTER-NUT BREAD Peaches, Canned, Frozen-Adulteration Due to Insects and Mold - 550.650
Butter-Nut Bread - 505.300 Peaches, Canned - Misbranding Involving Food Standards - 550.655 Peas and
BUTTON Carrots, Labeling of Canned Mixture - 585.600
Automatic Adjustment of X-Ray Field Size - 398.400 Pineapple, Canned; Imported and Domestic - Food Standards - 550.685
BUTYLATED HYDROXYANIXOLE Pineapple, Canned; Pineapple Juice - Adulteration with Mold - 550.680
Labeling of Seasonings - 525.650 Plums, Canned - Adulteration with Rot - 550.690
BY-PRODUCTS Pork and Beans and Similar Bean Products--Labeling - 567.200
Aflatoxin in Pet Feeds - 683.100 Processing - Use of Term in Section 405 of the FD&C Act - 562.650
Antibiotic Drug Residue in Pet Feed - 682.200 Pumpkin - Articles Made from Certain Varieties of Squash - 585.725
Milk, Aflatoxin - 527.400 Spinach, Canned or Frozen - Insects, Decomposition - 585.775
C. BOTULINUM Squash Seeds - Labeling as Pumpkin Seeds - 585.800
Salted, Dried Uneviscerated Fish - 540.650 Standardized Canned Fruit - Packing Medium - 550.800
CACAO BEANS Sweet Potatoes - Sirup Pack - 585.850
Chocolate or Chocolate Flavored - 515.800 Tomato Products - Drosophila Fly Eggs and Maggots - 585.890
CACHEXIA Tomato Products - Adulteration with Mold - 585.900
Fructose-Containing Drugs - 400.335 Tomatoes-Canned-Misbranding Involving Food Standards (Peel) - 585.875
CADMIUM Water in Food Products (Ingredient or Adulterant) - 555.875
Pottery (Ceramics) - 545.400 CANS
CAKE DECORATIONS Canned Foods - Seam Defects - 520.200
Confectionery Decorations - 545.200 Canned Salmon - Adulteration Involving Decomposition - 540.375
CALCIUM GLUCONATE Cheese and Cheese Products - Adulteration with Filth - 527.200
Vitamin B-15, Pangamic Acid - 457.100 Cherries, Canned - Misbranding Involving Food Standards - 550.230
CALCIUM PANGAMATE Corn, Sweet; Canned - Adulteration - 585.300
Vitamin B-15, Pangamic Acid & Products - 457.100 Decomp. & Histamine in Albacore, Skipjack & Yellowfin Tuna - 540.525
CALCIUM SOLUTIONS Eggs and Other Egg Products - Frozen - Decomposition - 537.100
LVP for Animal Use - 635.100 Identity of Foods--Terms such as Fresh, Frozen, Dried, Canned - 562.450
CALCULATED VALUE Imported Milk and Cream. Import Milk Act - 560.400
Temporal-Maximum Ultrasonic Power - 397.100 Peaches, Canned, Frozen -- Adulteration Due to Insects and Mold - 550.650
CALF MUSCLES Peaches, Canned - Misbranding Involving Food Standards - 550.655 Pineapple,
Electrical Muscle Stimulators - 355.200 Canned; Imported and Domestic - Food Standards - 550.685
CALIFORNIA CHAMPAGNE Proper Drug Use and Residue Avoidance - 615.200
Unfermented Beverages - 510.300 Tamper-Resistant Packaging Requirements - 450.500
CALLINECTES SAPIDUS Tomatoes - Canned - Misbranding Involving Food Standards (Peel) - 585.875
Crabmeat - Product Name - 540.300 CAPELIN
CAMPYLOBACTER JEJUNI Prohibited From Being Labeled as Smelt - 540.100
Pathogens in Dairy Products - 527.300 CAPS
CAMPYLOBACTER COLI Tamper-Resistant Packaging Requirements - 450.500
Pathogens in Dairy Products - 527.300 CAPSICUM
CANADA Capsicum Pods, etc. - Adulteration - 525.200
Aflatoxin in Peanuts - 570.375 Spices - Definitions - 525.750
CANDIED CITRON Unfermented Beverages, "Champagne" - 510.300
Candied Citron - Labeling - 515.600 CAPSULE
CANDLEHOLDERS Content Uniformity Testing of Tabs & Capsules - 460.600
Confectionery Decorations - 545.200 Controlled-Release Dosage Form Drugs - 430.100
CANDY Nutritional Supplements for Companion Animals - 690.100
Barley Sugar and Barley Sugar Candy - 515.500 Tamper-Resistant Packaging Requirements - 450.500
Candy Pills - 400.325 Unit Dose Labeling for Solid & Liquid Oral Dosage Forms - 430.100
Confectionery - 515.100 CAPTURED KEY SWITCHES
Jordan Almonds - Common or Usual Name - 570.100 Override of Positive Beam Limitation - 398.425
Labeling "Chocolate Flavored - 515.800 CARAWAY SEED
Mixed with Trinkets, in Machines - 515.350 Spices - Definitions - 525.750

401
Index Compliance Policy Guides
CARBADOX Uncertified or Delisted Colors - 587.200
Animal Feeds - 680.500 CERTIFICATE
CARCINOGENIC Aflatoxin in Peanuts & Peanut Products - 570.375
CGMP'S for Medicated Feeds - 680.200 Compressed Medical Gases -Warning Letters - 435.100
Contamination of Animal Feed - 680.500 CERTIFICATE OF ANALYSIS (COA)
Moisture Damaged Grain - 675.300 Compressed Medical Gases -Warning Letters - 435.100
CARDAMOM CERTIFIED ANTIBIOTICS
Spices - Definitions - 525.750 Prescriptions from Certified Antibiotics - 405.100
CARDIAC PACERS CERTIFIED COLOR
Pacemaker Reuse - 310.100 Labeling of Seasonings - 525.650
CARDIOVASCULAR DEVICES CERVIMUNDA JOHN
Sphygmomanometers - Accuracy - 310.210 Names for Crustaceans - 540.350
CARRIER CGMP REGULATIONS
Common Carrier as Relabeler,Repacker,Reprocess,etc - 100.500 CGMP Applicability to Hardware and Software - 425.100
Direct-Fed Microbial Products - 689.100 CGMP Enforcement Policy - OTC vs Rx Drugs - 450.100
Foods; Railcar Sanitation - Adulteration - 545.300 CGMP's for Medicated Feeds - Daily Inventory Requirements - 680.200
Foreign Trade Zones, Bonded Warehouses or Carriers - 110.600 Color Additives in Paper and Paperboard for Use With Food - 500.425
Parametric Release of Terminally Heat Sterilized Drugs - 460.800 Compendial Requirements - 420.400
CARTONS Consistent Application of CGMP Determinations - 400.200
FDA Jurisdiction over Meat & Poultry Products - 565.100 Contract Sterilizers - 100.550
Labeling-Food Bearing Residues of Pesticides Chemicals - 562.700 Control/Accountability of TRP Materials - 450.550
Shrimp-Fresh/Frozen Raw Headless, Peeled,or Breaded - 540.400 Expiration Dating of Unit Dose Repackaged Drugs - 480.200
Water-Damaged Food Products - 555.850 Finished Dosage Form Drugs in Bulk Containers - 410.100
CASHEWS Hospital Pharmacies - 460.100
Cashews, Insect Infested - Reconditioning - 570.250 Lack of Expiration Date or Stability Data - 480.300
Tree Nuts - Adulteration Involving Rejects - 570.425 Process Validation Requirements for Drug Products - 490.100
CASSETTE HOLDER Repacking of Drug Products -- CGMP's - 430.200
Definition of General Purpose Radiographic X-Ray System - 398.100 Returned Antibiotics Exported Under 801(d) of the Act - 405.210
CASSETTE TRAY OR BUCKY Sequencing in Medicated Feed Production - 680.600
Definition of General Purpose Radiographic X-Ray System - 398.100 CHAMPAGNE
CASSETTE TUNNEL Unfermented Beverages - 510.300
Definition of General Purpose Radiographic X-Ray System - 398.100 CHARACTERISTICS
CASSIA Bouillon, Bouillon Cubes, Granulated Bouillon - 567.300
Spices - Definitions - 525.750 Adulteration of Drugs under Sec. 501(b) and 501(c) - 420.100
Whole Cassia or Whole & Ground Cinnamon - 525.225 Confectionery - Use of Nonnutritive Substances as Ingredients. - 515.100
CATALOG Jellies, Nonstandardized - 550.475
Certification & Identification of X-Ray Components - 398.600 Jordan Almonds - Common or Usual Name - 570.100
Mercury Vapor Lamps -Not Self-Extinguishing - 391.200 Parametric Release of Terminally Heat Sterilized Drugs - 460.800
CATALOG NUMBERS Regulatory Action and Small Business - 160.100
Certification & Identification of -X-Ray Components - 398.600 Reuse of Medical Disposable Devices - 300.500
CATEGORIES Salmonella Contamination of Dry Dog Food - 690.700
Class III Devices Subject to 5l5(b) Requirements - 300.750 Sequencing in Medicated Feed Production - 680.600
Control/Accountability of TRP Materials - 450.550 Spices - Definitions - 525.750
Foods, Except Dairy Products - Adulteration with Salmonella - 555.300 Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100 CHEAT
Marketed New Drugs Without Approved NDAs or ANDAs - 440.100 Health Fraud - 120.500
OTC Drugs - Combination Products - 450.300 CHEDDAR
Pottery (Ceramics) - Cadmium Contamination - 545.400 Cheese Moisture and Fat - 527.225
Radionuclides in Imported Foods - Levels of Concern - 560.750 Labeling of Seasonings - 525.650
Retention of Microwave Oven Test Records - 394.100 CHEESE
Silage Ingredients - 687.500 Cheese Moisture and Fat - 527.225
"CATCH ALL" OR "SHOTGUN" INGREDIENTS Cheese and Cheese Products - 527.200
Bakery Products, Candy "Shotgun" Ingredients Declaration - 505.100 Misbranding Involving Net Contents - 527.250
CATHETERS Pathogens in Dairy Products - 527.300
Reuse of Medical Disposable Devices - 300.500 CHEESE PRODUCTS
CAUTIONARY INFORMATION Cheese and Cheese Products - 527.200
NADA Labeling - 605.100 Misbranding Involving Net Contents - 527.250
CAVIAR Pathogens in Dairy Products - 527.300
Use of Term - Labeling - 540.150 CHELATED
CAYENNE PEPPER Supplements for Pets - 690.100
Tomato Sauce or Tomato Hot Sauce Labeling - 525.800 CHEMICAL PRESERVATIVES
CELERY SEED "Chocolate" or Chocolate Flavored" - 515.800
Spices - Definitions - 525.750 Preservatives; Use in Foods; Label - 562.600
CELLULITE REMOVAL CHERRIES
Electrical Muscle Stimulators - 355.200 Cherries Brined, Fresh, Canned and Frozen - 550.225
CELLULITIS Cherries, Canned-Misbranding - 550.230
Cellutron Machine - 355.100 Maraschino Cherries - 550.550
CELLUTRON MACHINE CHERRY JAM
Cellutron Machine - 355.100 Adulteration with Mold - 550.235
CEPHALOMETRIC X-RAY SYSTEM CHERVIL
Definition of General Purpose Radiographic X-ray System - 398.100 Spices - Definitions - 525.750
CERAMICS CHEST OR SPINAL RADIOGRAPHY
Pottery (Ceramics) - Cadmium Contamination - 545.400 Definition of General Purpose Radiographic X-Ray
Pottery (Ceramics) - Lead Contamination - 545.450 System - 398.100
CERTIFICATION CHESTNUTS
Access to Results of Quality Assurance Audits - 130.300 Tree Nuts-Involving Rejects - 570.425
Assessment of Civil Penalties - 390.300 CHEWABLE
Certification for Exports - 110.100 Unit Dose Labeling for Solid & Liquid Oral Dose Forms - 430.100
Certification and Identification of X-Ray Components - 398.600 CHINESE NOODLES
Color Additives in Paper and Paperboard for Use with Food - 500.425 Chow Mein and Other Oriental Noodles - 505.400
Definition of "Commerce" - 21 CFR 1000.3(g) - 390.100 CHIROPRACTORS
Hospital Pharmacies - 460.100 Lasers for Facelift, Wrinkle Removal, Acupuncture, etc. - 393.200
Importation of Television Receivers and Microwave Ovens - 394.500 CHLORAMPHENICOL
Prescriptions Prepared from Certified Antibiotics - 405.100 Chloramphenicol - 654.300
Registration of Blood Banks and Other Firms - 230.110 Extra-Label Use of Animal Drugs - 615.100
Registration of Assemblers of Diagnostic X-Ray Systems - 398.300 CHLORMADINONE ACETATE
Returned Antibiotics Exported Under 801(d) of the Act - 405.210 Contamination of Pet Feed - 680.500

402
Compliance Policy Guides Index
CHLOROPHYII Use - 210.150
Odor Control in Animals - 642.100 Pottery (Ceramics) - Lead Contamination - 545.450
CHLORTETRACYCLINE Pottery (Ceramics) - Cadmium Contamination - 545.400
Odor Control in Animals - 642.100 Vitamin B-15, Pangamic Acid & Products - 457.100
CHOCOLATE CLENBUTEROL
Chocolate and Chocolate Liquor - 515.700 Extra-Label Use in Producing Animals - 615.100
Labeling - 515.800 CLINGSTONE PEACHES
Malted Milk - 527.500 Peaches, Canned - 550.655
CHOCOLATE-FLAVORED CLINICAL INVESTIGATOR
Labeling Chocolate Flavored - 515.800 IND Filings - 215.100
Malted Milk - 527.500 CLINICAL LABORATORIES
CHOCOLATE LIQUOR Registration of Blood Banks & Other Firms - 230.110
Chocolate and Chocolate Liquor - 515.700 CLINICAL STUDIES
CHOCOLATE MANUFACTURERS ASSOCIATION Direct Reference Authority for Class III Medical Devices - 300.700
Labeling: "Chocolate" or "Chocolate Flavored" - 515.800 IND Filings - 215.100
CHOCOLATE PUDDING CLINICAL THERMOMETER
Labeling: "Chocolate" or "Chocolate Flavored" - 515.800 Adulteration; Misbranding Defects - 335.800
CHOLERA VACCINE CLOUDBERRIES
Standards & Minimum Requirements for Biologic Cloudberries Adulteration - 550.590
Products - 205.100 CLOVER HONEY
CHROME YELLOW Source Declaration - 515.300
Confectionery - 515.100 CLOVES
CHRONIC EXPOSURE Adulteration with Stems - 525.250
Lasers for Facelift, Wrinkle Removal, Acupuncture, etc. - 393.200 Spices - Definitions - 525.750
CHUBS COCOA BEANS
Adulteration by Parasites - 540.590 Coffee & Cocoa Bean Sweeps - 560.350
Hot Smoked with Nitrite - 540.200 Mold, Insect Infestation & Mammalian Excretion - 515.750
CHURN MARK Pesticide Residues in Food & Feed - 575.100
Butter-Adulteration Involving Low Fat - 527.100 COCOA POWDER
CIDER Press Cake - Insect & Rodent Filth - 515.775
Unfermented Beverages - 510.300 COD
Vinegar, Adulteration with Vinegar Eels - 525.825 Crab & Crabmeat Product.s w/Other Seafood Labeling - 540.285
Wines and Cider Less Than 7% Alcohol - 510.450 Pet Food Labeling - 690.200
CIMETADINE HC1 COFFEE BEANS
Unit Dose Labeling for Solid & Liquid Oral Dose Forms - 430.100 Adulteration with Insects; Mold - 510.500
CINEOLE Coffee and Cocoa Bean Sweeps - 560.350
Spices-Definitions - 525.750 Proper Drug Use and Residue Avoidance - 615.200
CINNAMALDEHYDE Reconditioning of Imported Coffee Beans - 560.300
Cinnamon-Flavored Toothpicks - 545.600 COLBY
Spices-Definitions - 525.750 Cheese - Misbranding Due to Moisture & Fat - 527.225
CINNAMON COLLIMATION PROBLEMS IN RADIOGRAPHIC
Cinnamon-Flavored Toothpicks - 545.600 Assemblers Who Install Noncompliant Equipment - 398.325
Spices-Definitions - 525.750 COLLIMATOR LIGHT BULBS
Whole and Ground Cinnamon - 525.225 Assemblers Who Install Noncompliant Equipment - 398.325
CINNAMON BARK COLOR ADDITIVES
Whole Cassia or Whole & Ground Cinnamon - 525.225 Color Additives - 587.300
CISCOES Confectionery - 515.100
Fish-Fresh-Frozen - 540.590 In Paper and Paperboard - 500.425
CITRIC ACID Unapproved Additives for Exported Grains - 578.600
Jellies, Nonstandardized - 550.475 COLORANTS
Labeling of Seasonings - 525.650 In Paper and Paperboard - 500.425
CITRUS FRUIT JUICES COLORINGS
Fly Filth and Mold - 550.250 Bakery Products, Candy - 505.100
CITRUS FRUIT MARMALADE Labeling Chocolate/Chocolate Flavored - 515.800
Marmalade - 550.575 COLOSSAL
CITRUS MEDICA L., VARIETY GENUINA Canned Shrimp; Size Designation - 540.390
Candied Citron - Labeling - 515.600 COMMERCE
CITRUS MELON Compressed Medical Gases -- Warning Letters - 435.100
Candied Citron - Labeling - 515.600 Definition of "Commerce" - 21 CFR 1000.3(g) - 390.100
CIVIL PENALTIES Dentures -- Sale by Persons not Licensed to Practice - 315.100
Assemblers Who Install Noncompliant Equipment - 398.325 Products Composed of Interstate Ingredients - 100.200
Assessment of Civil Penalties - 390.300 COMMERCIAL
Importation of TV Receivers & Microwave Ovens - 394.500 Chloramphenicol - 654.300
CLAIMS Coffee and Cocoa Bean Sweeps - 560.350
Dealcoholized Wine and Malt Beverages - Labeling - 510.400 Commercial Distribution -- Premarket Notification - 300.600
Fortification of Standardized Juices - 510.700 Compendial Requirements - 420.400
CLAMS Cytotoxic Testing for Allergic Diseases - 370.100
Paralytic Shellfish Poison - 540.250 Definition of "Commerce" - 21 CFR 1000.3(g) - 390.100
CLARET Direct Reference Authority for Pseudomonas Contamination - 590.300
Dealcoholized Wine & Malt Beverages - 510.400 Direct Reference Authority for Class III Medical Devices - 300.700
CLASS A NONCOMPLIANCE Fish - Fresh and Frozen, as Listed - Adulteration by Parasites - 540.590
Hazardous Diagnostic X-Ray Systems - 398.200 Hospital Pharmacies - 460.100
CLASS I RECALLS Importation of Television Receivers and Microwave Ovens - 394.500
Class I Recalls of Prescription Drugs - 400.900 Inert Glandular Preparations - OTC - 455.100
CLASS III Lasers for Facelift, Wrinkle Removal, Acupuncture, etc. - 393.200
Canned Salmon-Adulteration Involving Decomposition - 540.375 Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200
Direct Reference Authority for Class III Medical New Drugs - Export - 442.100
Devices - 300.700 Oral Iron Products for Baby Pigs - 643.100
Lasers for Facelift, Wrinkle Removal, Acupuncture, etc. - 393.200 RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200
Reconditioners/Rebuilders of Medical Devices - 300.200 Salt-Cured, Air-Dried, Uneviscerated Fish - 540.650
CLEANERS Sugar - Water Damaged - Reconditioning - 515.425
Denture Cleaners, Adhesives, & Repair Materials - 315.200 Turtles - 170.100
CLEARANCE Water and Gravy in Pet Food - 690.400
Devices for Use in Animals - 655.100 COMMERCIAL DISTRIBUTION
Hospital Pharmacies - 460.100 Commercial Distribution-Premarket Notification - 300.600
Importation of Licensed Biological Products for Human Cytotoxic Testing for Allergic Diseases - 370.100

403
Index Compliance Policy Guides
Direct Reference Authority for Class III Medical Devices - 300.700 COMPLETE SYSTEM
Importation of TV Receivers & Microwave Ovens - 394.500 Certification and Identification of X-Ray Components - 398.600
Lasers for Facelift, Wrinkle Removal, Acupuncture, etc - 393.200 Exemption for Certain Sunlamp Product Purchaser Records - 396.300
New Drugs - Export - 442.100 Metric Declarations of Quantity of Contents - 140.500
RIA Analysis of Hair to Detect Presence of Drugs - 370.200 Sequencing in Medicated Feed Production - 680.600
Salt-Cured, Air-Dried, Uneviscerated Fish - 540.650 COMPLIANCE POLICY GUIDES
Turtles - 170.100 CPG # Sec. #
COMMISSION CPG 7101.01 510.100
Communicable Disease Hazards - 100.300 CPG 7101.02 Deleted
Cytotoxic Testing for Allergic Diseases - 370.100 CPG 7101.03 510.300
Health Fraud - 120.500 CPG 7101.04 510.400
Responsibility for Illegal Drug Residues in Meat & Milk - 615.300 CPG 7101.05 510.450 Revised
COMMON CPG 7101.06 510.500 Revised
Anthelmintics - 640.100 CPG 7101.07 510.600 Revised
Antipasto, Common or Usual Name - 567.100 CPG 7101.08 510.700 Revised
Artichoke; Jerusalem Artichoke - Common or Usual Name - 585.100 CPG 7102.01 505.100 Revised
Assemblers Who Install Noncompliant Equipment - 398.325 CPG 7102.02 505.400 Revised
Bakery Products, Candy "Shotgun" Ingredients CPG 7102.03 505.350
Declaration - 505.100 CPG 7102.04 505.300
Beverage Bases - 510.100 CPG 7102.05 505.200
Bouillon, Bouillon Cubes, Granulated Bouillon - 567.300 CPG 7102.06 505.500 Revised
Canned Foods, Use of the Term "Solid Pack" - 520.100 CPG 7103.01 580.100 Revised
Caviar, Use of Term - Labeling - 540.150 CPG 7104.01 578.100
Checklist Labeling for Custom Mixed Medicated Feeds - 665.200 CPG 7104.02 578.200
Common Carrier as a Relabeler, Repacker, Reprocessor, etc. - 100.500 CPG 7104.03 578.300
Common or Usual Names for Crustaceans - 540.350 CPG 7104.04 578.350
Compressed Medical Gases -- Warning Letters - 435.100 CPG 7104.05 578.400
Crab and Crabmeat Products with Other Seafood - Labeling - 540.285 CPG 7104.06 578.450
Crabmeat - Product Name - 540.300 CPG 7104.07 578.500
Drupelet Berries (Blackberries, Raspberries, etc.) - 550.200 CPG 7104.08 578.600
Eggnog; Eggnog Flavored Milk-Common Usual Names - 527.350 CPG 7105.01 515.100
Foreign Language Declarations on Food Labels - 562.400 CPG 7105.02 515.200 Revised
Fortification of Standardized Juices - 510.700 CPG 7105.03 515.300
Hollandaise Sauce - Common or Usual Name - 525.400 CPG 7105.04 515.350
Homeopathic Drugs - 400.400 CPG 7105.05 515.400
Human-Labeled Drugs Distributed & Used in Animal Medicine - 608.100 CPG 7105.06 Deleted
Identity of Foods--Terms Such as Fresh, Frozen, Dried, Canned - 562.450 CPG 7105.07 515.500
Jellies, Nonstandardized - 550.475 CPG 7105.08 Deleted
Jordan Almonds - Common or Usual Name - 570.100 CPG 7105.09 515.600
Label Declaration of Artificial Color - 587.100 CPG 7105.10 Deleted
Labeling of Food Bearing Residues of Pesticide Chemicals - 562.700 CPG 7105.11 515.700 Revised
Labeling of Seasonings - 525.650 CPG 7105.12 515.750 Revised
Malted Milk - 527.500 CPG 7105.13 515.775 Revised
Maraschino Cherries - 550.550 CPG 7105.14 515.425
Marmalade - 550.575 CPG 7105.15 515.800
Oral Iron Products for Baby Pigs - 643.100 CPG 7106.01 527.500 Revised
Oranges - Artificial Coloring - 550.625 CPG 7106.02 527.350
Pet Food Labeling - 690.200 CPG 7106.03 527.450
Polysorbate 20, 40, 60, 65, 80, 85 - Common or Usual Names - 555.800 CPG 7106.04 527.600 Revised
Pork and Beans and Similar Bean Products--Labeling - 567.200 CPG 7106.05 527.100 Revised
Potato Chips, Ingredients - Labeling - 585.710 CPG 7106.06 527.225 Revised
Preservatives; Use in Nonstandardized Foods; Label Declaration - 562.600 CPG 7106.07 527.200 Revised
Processed and/or Blended Seafood Products - 540.700 CPG 7106.08 527.300 Revised
Pumpkin - Articles Made from Certain Varieties of Squash.- 585.725 CPG 7106.09 527.250
Recycled Animal Waste - 685.100 CPG 7106.10 527.400 Revised
Regulatory Action Regarding Approved New Drugs - 446.100 CPG 7107.02 537.100 Revised
Rendered Animal Feed Ingredients - 675.400 CPG 7108.01 540.150
Sauerkraut - Definition; Adulteration by Thrips - 585.750 CPG 7108.02 540.275
Source Plasma - Guidelines for Informed Consent Forms - 250.100 CPG 7108.03 540.285
Spices - Definitions - 525.750 CPG 7108.04 540.300
Starches--Common or Usual Names - 578.100 CPG 7108.05 540.575
Sweet Potatoes - Sirup Pack - 585.850 CPG 7108.06 540.590
Unsafe Contamination of Animal Feed from Drug Carry-over - 680.500 CPG 7108.07 540.600
Vitamins and Minerals in Feed - 670.200 CPG 7108.08 540.550
Water and Gravy in Pet Food - 690.400 CPG 7108.10 540.375
Whole Milk, Low Fat Milk, Skim Milk - Aflatoxin M1 - 527.400 CPG 7108.11 540.400
COMPATIBILITY TESTING CPG 7108.12 540.410
Registration of Blood Banks & Other Firms - 230.110 CPG 7108.13 540.390
COMPENDIAL PRODUCTS CPG 7108.14 540.450
Compendial Requirements - 420.400 CPG 7108.15 540.200
COMPENDIAL TESTS CPG 7108.16 540.700
Adulteration of Drugs Under 501(b) & (c) - 420.100 CPG 7108.17 540.650
Interference with Compendial Tests - 420.500 CPG 7108.18 540.500
COMPENDIUM CPG 7108.19 Deleted
Adulteration of Drugs Under 501(b) & (c) - 420.100 CPG 7108.20 540.250
Changes-Compendial Specifications & NDA Supplements - 420.300 CPG 7108.21 540.475
Homeopathic Drugs - 400.400 CPG 7108.22 540.100
Interference with Compendial Tests - 420.500 CPG 7108.23 540.350
Lack of Expiration Date of Stability Data - 480.300 CPG 7108.24 540.525 Revised 7/26/95
Revisions & Deletions - 420.200 CPG 7108.25 540.420
Unit Dose Labeling for Solid & Liquid Oral Dose Forms - 430.100 CPG 7109.01 525.100
COMPENDIUM OF HOMEOTHERAPEUTICS CPG 7109.02 525.150
Homeopathic Drugs - 400.400 CPG 7109.03 525.200
COMPLAINT FILES CPG 7109.04 525.225
GWQAP Pre-Award Evaluation - 100.700 CPG 7109.05 525.250
Reloaders of X-Ray Tube Housing Assemblies - 398.700 CPG 7109.06 525.300

404
Compliance Policy Guides Index
CPG 7109.07 525.325 CPG 7114.22 585.725
CPG 7109.08 525.330 CPG 7114.23 585.750
CPG 7109.09 525.350 CPG 7114.24 585.775
CPG 7109.10 525.375 CPG 7114.25 585.800
CPG 7109.11 525.400 CPG 7114.26 585.825
CPG 7109.12 525.425 CPG 7114.27 585.850
CPG 7109.13 525.500 CPG 7114.28 585.875
CPG 7109.14 525.550 CPG 7114.29 585.890
CPG 7109.15 525.575 CPG 7114.30 585.900 Revised
CPG 7109.16 525.600 CPG 7116.01 567.100
CPG 7109.17 525.625 CPG 7116.02 567.200
CPG 7109.18 525.650 CPG 7116.03 567.300
CPG 7109.19 525.700 CPG 7117.01 500.100
CPG 7109.20 525.750 CPG 7117.02 500.400
CPG 7109.21 525.800 CPG 7117.03 545.200
CPG 7109.22 525.825 CPG 7117.04 Deleted
CPG 7109.23 525.850 CPG 7117.05 545.500
CPG 7109.24 525.900 CPG 7117.06 545.400 Revised 12/12/95
CPG 7109.25 525.925 CPG 7117.07 545.450 Revised12/12/95
CPG 7109.26 525.950 CPG 7117.08 500.300
CPG 7110.01 550.100 CPG 7117.09 500.300 Revised
CPG 7110.02 550.150 CPG 7117.10 500.425
CPG 7110.03 550.200 CPG 7117.11 500.450
CPG 7110.04 550.225 CPG 7117.12 500.200 Revised
CPG 7110.05 550.230 CPG 7117.13 500.250 Revised
CPG 7110.06 550.250 CPG 7118.01 Deleted
CPG 7110.07 550.260 CPG 7119.01 560.100
CPG 7110.08 550.270 CPG 7119.02 560.200
CPG 7110.09 550.300 CPG 7119.03 560.250
CPG 7110.10 550.350 CPG 7119.04 560.300
CPG 7110.11 550.400 CPG 7119.05 560.400
CPG 7110.12 550.235 CPG 7119.06 560.450
CPG 7110.13 550.450 CPG 7119.08 560.350
CPG 7110.14 550.475 CPG 7119.09 510.200
CPG 7110.15 550.500 CPG 7119.10 560.700 Revised
CPG 7110.16 550.550 CPG 7119.11 560.500
CPG 7110.17 550.575 CPG 7119.12 560.600
CPG 7110.18 550.590 CPG 7119.13 560.650 Deleted
CPG 7110.19 550.600 CPG 7119.14 562.750
CPG 7110.20 550.605 CPG 7120.01 562.400
CPG 7110.21 550.625 CPG 7120.02 555.450
CPG 7110.22 550.650 CPG 7120.03 562.650
CPG 7110.23 550.655 CPG 7120.04 562.750
CPG 7110.24 550.680 CPG 7120.05 520.100
CPG 7110.25 550.685 CPG 7120.06 562.450
CPG 7110.26 550.690 CPG 7120.07 555.875
CPG 7110.27 550.700 CPG 7120.08 562.550
CPG 7110.28 550.750 CPG 7120.09 555.800
CPG 7110.29 550.800 CPG 7120.10 555.100
CPG 7110.30 550.850 CPG 7120.11 562.100
CPG 7110.31 550.155 CPG 7120.12 562.200
CPG 7111.01 565.100 Revised CPG 7120.13 562.600
CPG 7111.03 565.200 CPG 7120.14 555.200
CPG 7112.01 570.100 CPG 7120.15 562.800
CPG 7112.02 570.375 CPG 7120.16 520.200
CPG 7112.03 570.300 CPG 7120.17 555.850
CPG 7112.04 570.350 CPG 7120.18 555.600
CPG 7112.05 570.425 CPG 7120.19 562.300
CPG 7112.06 570.700 CPG 7120.20 555.300
CPG 7112.07 570.200 CPG 7120.21 555.650
CPG 7112.08 570.500 CPG 7120.22 555.550
CPG 7112.09 570.550 CPG 7120.24 555.500
CPG 7112.10 570.250 CPG 7120.25 520.300
CPG 7112.11 570.450 CPG 7120.26 555.400
CPG 7113.01 535.100 Revised CPG 7120.27 562.700
CPG 7114.01 585.100 CPG 7120.28 550.750
CPG 7114.02 585.150 CPG 7120.29 550.700
CPG 7114.03 585.475 CPG 7121.01 457.100
CPG 7114.04 585.200 CPG 7121.02 530.400
CPG 7114.05 585.225 CPG 7121.03 530.500
CPG 7114.06 585.260 CPG 7122.01 405.100
CPG 7114.07 585.275 CPG 7122.02 405.200
CPG 7114.08 585.300 CPG 7122.03 405.210
CPG 7114.09 585.325 CPG 7124.01 300.400
CPG 7114.10 585.350 CPG 7124.02 355.300
CPG 7114.11 585.400 CPG 7124.03 355.100
CPG 7114.12 585.450 CPG 7124.04 335.500
CPG 7114.13 585.500 CPG 7124.05 315.300
CPG 7114.14 585.525 CPG 7124.06 370.200
CPG 7114.15 585.575 CPG 7124.07 315.100 Revised
CPG 7114.16 585.600 CPG 7124.08 300.300
CPG 7114.17 585.625 CPG 7124.09 345.200
CPG 7114.18 585.650 CPG 7124.11 305.100
CPG 7114.19 585.675 Revised CPG 7124.12 310.100
CPG 7114.20 585.700 CPG 7124.13 320.100
CPG 7114.21 585.710 CPG 7124.14 398.300

405
Index Compliance Policy Guides
CPG 7124.15 300.100 CPG 7126.27 681.100
CPG 7124.16 300.500 CPG 7126.28 682.100
CPG 7124.17 325.100 CPG 7126.29 680.500
CPG 7124.18 300.350 CPG 7126.30 Deleted
CPG 7124.19 300.600 CPG 7126.31 682.200
CPG 7124.20 335.800 CPG 7126.32 Deleted
CPG 7124.21 345.100 CPG 7126.33 683.100
CPG 7124.22 310.200 CPG 7126.34 685.100
CPG 7124.23 310.210 CPG 7126.35 680.600
CPG 7124.24 345.300 CPG 7126.36 666.100
CPG 7124.25 335.300 CPG 7126.37 680.400
CPG 7124.26 355.200 CPG 7126.38 690.600 Revised
CPG 7124.27 355.200 CPG 7126.39 Deleted
CPG 7124.28 300.200 CPG 7126.40 688.100
CPG 7124.29 350.100 CPG 7126.41 689.100
CPG 7124.30 300.700 CPG 7127.01 587.100
CPG 7124.31 335.700 CPG 7127.02 587.200
CPG 7125.01 605.100 CPG 7127.03 587.300
CPG 7125.02 Deleted CPG 7128.01 Deleted
CPG 7125.03 Deleted CPG 7128.02 545.600
CPG 7125.04 Deleted CPG 7128.03 590.300 Revised
CPG 7125.05 615.300 CPG 7128.04 590.400 Revised
CPG 7125.06 615.100 CPG 7128.05 590.600
CPG 7125.07 Deleted CPG 7128.06 590.500
CPG 7125.08 Deleted CPG 7129.01 170.100
CPG 7125.09 608.200 CPG 7132.01 400.900
CPG 7125.10 Deleted CPG 7132.02 420.200
CPG 7125.11 642.100 CPG 7132.03 400.600
CPG 7125.12 640.100 CPG 7132.04 400.325
CPG 7125.14 645.100 CPG 7132.05 420.400
CPG 7125.15 Deleted CPG 7132.06 460.100
CPG 7125.16 643.100 CPG 7132.07 400.100
CPG 7125.17 650.100 CPG 7132.08 400.800
CPG 7125.18 651.100 CPG 7132.09 460.300
CPG 7125.19 625.400 CPG 7132.10 450.100
CPG 7125.20 625.200 CPG 7132.11 460.500
CPG 7125.21 653.100 CPG 7132.12 400.200
CPG 7125.22 616.100 CPG 7132.13 430.200
CPG 7125.23 654.100 CPG 7132.14 450.550
CPG 7125.24 607.100 CPG 7132.15 400.400
CPG 7125.25 625.500 CPG 7132.16 460.200
CPG 7125.26 608.300 CPG 7132a.01 420.500
CPG 7125.27 Deleted CPG 7132a.02 460.700
CPG 7125.28 641.100 CPG 7132a.03 420.100
CPG 7125.29 608.500 CPG 7132a.04 480.100
CPG 7125.30 654.200 CPG 7132a.06 410.100
CPG 7125.31 635.100 CPG 7132a.07 425.400
CPG 7125.32 637.100 CPG 7132a.08 425.500
CPG 7125.33 654.300 Revised CPG 7132a.10 480.300
CPG 7125.34 625.600 CPG 7132a.11 425.100
CPG 7125.35 608.100 CPG 7132a.12 425.200
CPG 7125.36 625.300 CPG 7132a.13 460.800
CPG 7125.37 615.200 CPG 7132a.14 460.600
CPG 7125.38 638.100 CPG 7132a.15 425.300
CPG 7125.39 634.100 CPG 7132a.16 435.100
CPG 7125.40 608.400 New CPG 7132a.17 450.500
CPG 7125a.01 655.100 CPG 7132b.01 454.100
CPG 7125a.02 655.300 CPG 7132b.02 400.335
CPG 7125a.03 655.400 CPG 7132b.03 Deleted
CPG 7125a.04 655.200 CPG 7132b.04 430.400
CPG 7126.01 680.100 CPG 7132b.05 456.100
CPG 7126.02 Deleted CPG 7132b.06 450.400
CPG 7126.03 660.100 CPG 7132b.07 460.450
CPG 7126.04 690.100 CPG 7132b.08 460.425
CPG 7126.05 675.100 CPG 7132b.09 460.400
CPG 7126.06 Deleted CPG 7132b.10 430.100
CPG 7126.07 Deleted CPG 7132b.11 480.200
CPG 7126.08 665.100 CPG 7132b.12 455.100
CPG 7126.09 690.200 CPG 7132b.13 430.300
CPG 7126.10 675.300 CPG 7132b.14 400.500
CPG 7126.11 670.200 CPG 7132b.15 450.200
CPG 7126.12 665.300 CPG 7132b.16 450.300
CPG 7126.13 Deleted CPG 7132b.17 400.700
CPG 7126.14 Deleted CPG 7132c.01 442.100
CPG 7126.15 Deleted CPG 7132c.02 440.100
CPG 7126.16 670.100 CPG 7132c.03 448.100
CPG 7126.17 690.700 CPG 7132c.04 420.300
CPG 7126.18 690.300 CPG 7132c.05 444.100
CPG 7126.19 680.200 CPG 7132c.06 446.100
CPG 7126.20 675.200 CPG 7132c.07 470.100
CPG 7126.21 687.500 CPG 7132c.08 490.100
CPG 7126.22 690.400 CPG 7133.01 390.400
CPG 7126.23 690.500 CPG 7133.02 390.100
CPG 7126.24 675.400 CPG 7133.03 398.600
CPG 7126.25 670.500 CPG 7133.04 390.500
CPG 7126.26 665.200 CPG 7133.05 390.200

406
Compliance Policy Guides Index
CPG 7133.06 390.225 Compressed Medical Gases -- Warning Letters - 435.100
CPG 7133.07 390.425 Definition of "High-Voltage Vacuum Switch" - 390.500
CPG 7133.08 398.425 Direct-Fed Microbial Products - 689.100
CPG 7133.09 398.400 Homeopathic Drugs - 400.400
CPG 7133.10 393.100 Milk and Milk Products Containing Penicillin - 527.450
CPG 7133.11 398.100 Obligations of Factory-based Manufacturers and Assemblers - 398.375
CPG 7133.12 398.325 Processed and/or Blended Seafood Products - 540.700
CPG 7133.13 391.100 Registration of Blood Banks and Other Firms - 230.110
CPG 7133.14 397.100 Repacking of Drug Products -- CGMP's - 430.200
CPG 7133.15 391.200 Safety and Labeling of Waxed (Coated) Fruits and Vegetables - 562.550
CPG 7133.16 396.100 Tracers in Animal Feed - 680.100
CPG 7133.17 398.475 COMPOSITE-MOLDED
CPG 7133.18 396.300 Processed and/or Blended Seafood Products - 540.700
CPG 7133.19 394.100 COMPOSITION
CPG 7133.20 398.700 Bouillon, Bouillon Cubes, Granulated Bouillon - 567.300
CPG 7133.21 393.200 Chow Mein Noodles, Chinese Noodles and Other Oriental Noodles - 505.400
CPG 7133.22 394.500 Cloudberries (Multer Berries), Canned - Adulteration - 550.590
CPG 7133.23 390.300 Crab and Crabmeat Products with Other Seafood - Labeling - 540.285
CPG 7133.24 396.300 Homeopathic Drugs - 400.400
CPG 7133.25 398.200 Identical or Similar Product Names - 400.500
CPG 7133.26 398.450 Imports - Identity of Ingredients - 560.250
CPG 7133.27 398.375 Marmalade - 550.575
CPG 7133.28 398.350 Medicated Feeds - Formula Information - 670.100
CPG 7133.29 396.400 Pork and Beans and Similar Bean Products-Labeling - 567.200
CPG 7134.01 230.110 Potato Chips, Ingredients - Labeling - 585.710
CPG 7134.02 230.120 Prepared Mustard, Composition - 525.575
CPG 7134.03 205.100 Processed and/or Blended Seafood Products - 540.700
CPG 7134.04 275.100 Quantitative Testing for Serum Proteins in Plasmapheresis Donors - 255.100
CPG 7134.05 210.100 Source Plasma - Overbleeding - 252.100
CPG 7134.06 270.100 COMPOUNDED DRUGS
CPG 7134.07 215.100 Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200
CPG 7134.08 250.100 COMPRESSED MEDICAL GASES
CPG 7134.09 210.150 Warning Letters - 435.100
CPG 7134.10 255.100 COMPUTER FILES
CPG 7134.11 220.100 Regulatory Actions Against Assemblers of X-Ray Equipment - 398.350
CPG 7134.12 230.100 COMPUTERIZED DRUG PROCESSING
CPG 7134.13 231.100 CGMP Applicability to Hardware & Software - 425.100
CPG 7134.14 252.100 I.D. of "Persons" - 425.500
CPG 7134.15 254.100 Input/Output Checking - 425.400
CPG 7134.16 231.110 Source Code for Process Control Application Programs - 425.300
CPG 7134.17 230.130 Vendor Responsibility - 425.200
CPG 7134.18 251.100 CONCENTRATIONS
CPG 7134.19 253.100 Blood Definitions - 230.100
CPG 7134.20 231.120 Drugs and Residue Avoidance - 615.200
CPG 7134.21 231.130 Vitamins in Feed - 670.200
CPG 7134.22 250.500 CONDIMENTAL SEEDS
CPG 7134.23 256.100 Other than Fennel & Sesame Seeds - 525.300
CPG 7141.01 575.100 CONDIMENTS
CPG 7150.01 110.100 Prepared Mustard, Composition - 525.575
CPG 7150.02 100.600 CONDOMS
CPG 7150.03 100.500 Condoms;Defects-Criteria for Direct Reference Seizure - 345.100
CPG 7150.04 110.800 CONFECTIONERY
CPG 7150.05 100.100 Candy-Mixed w/Trinkets & Sold in Vending Machines - 515.350
CPG 7150.06 100.350 Confectionery Decorations (Nutritive & Non-Nutritive) - 545.200
CPG 7150.07 100.700 Use of Nonnutritive Substances as Ingredients - 515.100
CPG 7150.08 100.300 CONFECTIONERY DECORATIONS
CPG 7150.09 120.100 Nutritive & Non-Nutritive - 545.200
CPG 7150.10 120.500 CONFUSION
CPG 7150.11 110.200 Artichoke; Jerusalem Artichoke - Common or Usual Name - 585.100
CPG 7150.12 100.800 Blood and Blood Products - Definitions - 230.100
CPG 7150.13 130.400 CGMP's for Medicated Feeds - Daily Inventory Requirements - 680.200
CPG 7150.14 110.600 Content Uniformity Testing of Tablets and Capsules - 460.600
CPG 7150.15 110.900 Revised Crabmeat - Product Name - 540.300
CPG 7150.16 100.550 Drupelet Berries (Blackberries, Raspberries, etc.) - 550.200
CPG 7150.17 140.500 Fortification of Standardized Juices - 510.700
CPG 7150.18 150.100 Identical or Similar Product Names - 400.500
CPG 7150.19 100.900 New Inspection of Firms when Legal Action is Pending - 130.200
CPG 7151.01 130.100 Karaya Gum Powder and Related Devices for Ose by Sstomates- 325.100
CPG 7151.02 130.300 Revised1/3/96 Schedule of Physical Examination- 251.100
CPG 7152.01 150.500 Source Plasma - Syphilis - 254.100
CPG 7153.01 130.200 Squash Seeds - Labeling as Pumpkin Seeds - 585.800
CPG 7153.02 160.300 Sweet Potatoes - Sirup Pack - 585.850
CPG 7153.03 160.400 Temporal-Maximum Ultrasonic Power - 397.100
CPG 7153.04 160.700 CONSIGNEES
CPG 7153.05 160.500 Revised Acupuncture Devices & Accessories - 305.100
CPG 7153.07 160.600 Class I Recalls of Rx Drugs - 400.900
CPG 7153.08 110.700 Communicable Disease Hazards - 100.300
CPG 7153.09 160.200 Failure to Register - 625.500
CPG 7153.10 110.500 Plasma Brokers - Registration & Compliance - 250.500
CPG 7153.11 100.200 Reconditioning New Drugs Lacking Approved NDA - 448.100
CPG 7153.12 160.100 CONSPICUOUS
CPG 7153.13 140.100 Antipasto, Common or Usual Name - 567.100
CPG 7153.14 160.750 Revised Beverage Bases - 510.100
COMPONENT Certification & Identification of X-Ray Components - 398.600
Assemblers Who Install Noncompliant Equipment - 398.325 Statements Regarding NDA Approved-Labeling & Advertising - 605.100
Certification and Identification of X-Ray Components - 398.600 CONSTITUENTS

407
Index Compliance Policy Guides
LVP's for Animals - 635.100 Importation of TV Receivers & Microwave Ovens - 394.500
Malt Products - 515.200 Registration of Blood Banks & Other Firms - 230.110
CONSTRUCTION BY THE FACTORY-BASED MANUFACTURER CONVENTIONAL RS (REFLECTOR SPOT)
Obligations-Factory-Based Manufacturers & Assemblers - 398.375 Sunlamp Performance Standard - 396.100
CONTACT LENS COOK CHEESE
Packaging - Contact Lens Solutions & Tablets - 350.100 Cheese - Misbranding Due to Moisture and Fat - 527.225
Tamper-Resistant Packaging Requirements - 450.500 COOPERATIVE OR CONTRACTUAL ARRANGEMENTS
CONTACT LENS SOLUTIONS Records and Reports - Applicability - 21 CFR 1002.1 - 390.425
Packaging - Contact Lens Solutions & Tablets - 350.100 CORDIAL
Tamper-Resistant Packaging Requirements - 450.500 Maraschino Cherries - 550.550
CONTAINER, SCREW-TOP, CRIMPED-CAP CORIANDER
Water-Damaged Food Products - 555.850 Labeling of Seasonings - 525.650
CONTAMINATION CORN
Aflatoxin in Peanuts and Peanut Products - 570.375 Aflatoxin in Animal Feeds - 683.100
Calcium Chloride - 500.400 Corn, Sweet; Canned - 585.300
Canned Foods - Seam Defects - 520.200 Corn Husks Filth - 585.350
Clams, Mussels, Oysters - Bacteriological Contamination - 560.600 Corn Meal - Adulteration by Filth - 578.200
Classification of Establishments - 555.500 Foods, Adulteration with Aflatoxin - 555.400
Communicable Disease Hazards - 100.300 Malt Products - 515.200
Contamination of Devices Labeled as Sterile - 300.400 On The Cob, Canned Contents Declaration - 585.325
Dimethylnitrosamine (DMNA) in Barley Malt - 578.500 Pesticide Residues - 575.100
Direct Reference Authority for Pseudomonas Contamination - 590.300 Popcorn - Adulteration with Filth - 585.675
Diversion of Adulterated Food to Acceptable Animal Feed Use - 675.200 Potato Chips, Ingredients - Labeling - 585.710
Food Storage & Warehousing - Adulteration - Filth - 580.100 Seeds for Sprouting Prior to Food Use - 555.750
Foods - Adulteration Involving Infestation and 1080 Rodenticide - 555.450 Silage Ingredients - 687.500
Foods, Rail Car Sanitation - Adulteration - 545.300 Starches--Common or Usual Names - 578.100
Interpretation of Insect Filth in Foods - 555.600 Whole, Low Fat and Skim Milk - 527.400
Large Volume Parenteral (LVP's) for Animal Use - 635.100 CORN MEAL
Natural Bristle Brushes - Nit Contamination - 590.400 Cornmeal-Adulteration by Insect & Rodent Filth - 578.200
Parametric Release of Terminally Heat Sterilized Drugs - 460.800 Foods, Adulteration w/ Aflatoxin - 555.400
Pesticide Residues in Food and Feed - 575.100 Pesticide Residues in Food & Feed - 575.100
Plastic Containers for Injectable Animal Drugs - 637.100 CORRECTIVE ACTION
Pottery (Ceramics) - Cadmium Contamination - 545.400 Access to Results of Quality Assurance Audits - 130.300
Pottery (Ceramics) - Lead Contamination - 545.450 Assessment of Civil Penalties - 390.300
Radionuclides in Imported Foods - Levels of Concern - 562.750 Communicable Disease Hazards - 100.300
Raw Breaded Shrimp - Microbiological - 540.420 Early Correction of Defects or Noncompliance - 390.225
Reconditioning of Foods Adulterated Under 402(a)(4) - 160.700 Fraud, Untrue Statements of Material Facts, Bribery - 120.100
Recycled Animal Waste - 685.100 Health Fraud- 120.500
Return of Unused Rx Drugs to Pharmacy Stock - 460.300 Obligations of Factory-Based Manufacturers and Assemblers - 398.375
Revocation of Tolerances for Cancelled Pesticides - 555.700 Section 305 Meeting - 160.400
Rodent Contaminated Pet Foods - 690.600 Storage of Platelets - 231.130
Salmonella Contamination of Dry Dog Food - 690.700 COSMETICS
Sequencing in Medicated Feed Production - 680.600 Animal Grooming Aids - 653.100
Silver-Plated Hollowware - Lead Contamination - 545.500 Denture Cleaners, Adhesives, Cushions, and Repair Materials- 315.200
Unsafe Contamination of Animal Feed from Drug Carryover - 680.500 Direct Reference Authority for Pseudomonas Contamination - 590.300
Volatile N-Nitrosamine in Rubber Baby Bottle Nipples - 500.450 Drugs for Odor Control in Animals - 642.100
Whole Milk, Low Fat Milk, Skim Milk - Aflatoxin M1 - 527.400 Health Fraud - 120.500
CONTENT Imported Products - Lack of English Labeling - 110.900
Adulteration of Drugs Under Sec. 501(b) and 501(c) - 420.100 Metric Declarations of Quantity of Contents - 140.500
Brazil Nuts - Adulteration with Aflatoxin - 570.200 Tamper-Resistant Packaging - 450.500
Chow Mein Noodles, Chinese Noodles and Other Oriental Noodles - 505.400 Wigs - 590.600
Compendial Requirements - 420.400 COW PEAS
Content Uniformity Testing of Tablets and Capsules - 460.600 Black-Eyed Peas (Cow Peas, Field Peas); Dried - 585.225
Dealcoholized Wine and Malt Beverages - Labeling - 510.400 CRAB AND COD CAKES
Decomposition & Histamine in Albacore, Skipjack & Yellowfin Tuna - 540.525 Crab Products with Other Seafood - 540.285
Dimethylnitrosamine (DMNA) in Barley Malt - 578.500 CRAB CAKES
Direct-Fed Microbial Products - 689.100 Crab Products with Other Seafood - 540.285
Homeopathic Drugs - 400.400 CRAB NEWBURG
Imitation Breaded Shrimp - 540.450 Crab Products with Other Seafood - 540.285
Inert Glandular Preparations - OTC - 455.100 CRABMEAT
Jellies, Nonstandardized - 550.475 Crabmeat - Product Name - 540.300
Labeling - Diluted Wines and Cider with Less Than 7% Alcohol - 510.450 Filth E. Coli - 540.275
Nutritional Supplements for Companion Animals - 690.100 Pesticide Residues - 575.100
Oleomargarine - Misbranding Due to Low Fat - 535.100 Processed Blended Seafood Products - 540.700
Oral Iron Products for Baby Pigs - 643.100 With Other Seafood -- Labeling - 540.285
Pesticide Residues in Food and Feed - 575.100 CRABMEAT COCKTAIL
Rendered Animal Feed Ingredients - 675.400 Crab Products with Other Seafood - 540.285
Spices - Definitions - 525.750 CRANBERRY SAUCE
Tomato Products - Adulteration with Mold - 585.900 Adulteration - 550.260
Vitamins and Minerals in Feed - 670.200 CRAWFISH
Water in Food Products (Ingredient or Adulterant) - 555.875 Common or Usual Names for Crustaceans - 540.350
CONTRACT CRAYFISH
Blood & Blood Products - Definitions - 230.100 Common or Usual Names for Crustaceans - 540.350
Commercial Distribution-Premarket Notification - 300.600 CRUSTACEANS
Consistent Application of CGMP Determinations - 400.200 Methyl Mercury - 540.600
Contract Sterilizers - 100.550 Common or Usual Names for Crustaceans - 540.350
GWQAP Pre-Award Evaluation - 100.700 CRYOGENIC CONTAINER
Marketed New Drugs w/o Approved NDAs or ANDAs - 440.100 Compressed Medical Gases - Warning Letters - 435.100
Records & Reports -Applicability-21 CFR 1002.1 - 390.425 CRYOPRECIPITATED ANTIHEMOPHILIC FACTOR
CONTRACT OF SALE Quality Control Testing - 231.110
Commercial Distribution -- Premarket Notification - 300.600 Standards & Min. Requirements for Biologic Products - 205.100
CONTRAINDICATED CRYOPROTECTANTS
Karaya Gum Powder & Devices for Use by Ostomates - 325.100 Processed, Blended Seafood Products - 540.700
CONTROL OF ALLERGIES CULTURES
Hypnotherapy Devices - Self Hypnotic Tape Recordings - 335.300 Intermediate or End Products of Sample Analysis - 150.100
CONTROLLED CONDITIONS CUMIN SEED

408
Compliance Policy Guides Index
Adulteration with Sand and Grit - 525.325 Drug Product Entries in Periodic Publications - 400.700
Spices - Definitions - 525.750 Drugs for Odor Control in Animals - 642.100
CURCUMIN Ear Piercing Devices - 320.100
Spices - Definitions - 525.750 Electrical Muscle Stimulators- 355.200
CURE OF DISEASE Ethylenediamine Dihydroiodide (EDDI) - 651.100
Direct-Fed Microbial Products - 689.100 Products for Control of Fleas and Ticks - 641.100
Homeopathic Drugs - 400.400 Fraud, Untrue Statements of Material Facts, Bribery - 120.100
Human Blood and Blood Products as Drugs - 230.120 Health Fraud - 120.500
Hypnotherapy Devices - Self Hypnotic Tape Recordings - 335.300 Human-Labeled Drugs Distributed & Used in Animal Medicine - 608.100
Razor Blades, Manicuring Instruments - 335.500 IND Filings - 215.100
Vitamin B-15, Pangamic Acid and Pangamic Acid Products - 457.100 Lack of Expiration Date or Stability Data - 480.300
CURING Large Volume Parenterals (LVP's) for Animal Use - 635.100
"Processing"-Use of Term - 562.650 Macaroni and Noodle Products - 505.500
Salt-Cured, Air-Dried, Uneviscerated Fish - 540.650 OTC Drugs - Combination Products - 450.300
CURRANTS Plastic Containers for Injectable Animal Drugs - 637.100
Adulteration - 550.270 Process Validation Requirements for Drug Products - 490.100
Jellies, Nonstandardized - 550.475 Reuse of Medical Disposable Devices - 300.500
Pesticide Residues in Food and Feed - 575.100 Shrimp - Frozen, Raw, Breaded or Lightly Breaded, - 540.410
CURRICULUM VITAE Silage Ingredients - 687.500
Licensing - Changes to be Reported - 210.100 Source Code for Process Control Application Programs - 425.300
CURRY POWDER Storage of Platelets - 231.130
Adulteration by Insect & Rodent Filth - 525.330 Streptomycin Residues in Cattle Tissues - 616.100
CUSHIONS Sweet Potatoes - Sirup Pack - 585.850
Denture Cleaners, Cushions, & Repair Materials - 315.200 Tuna, Sable, Salmon, Shad - Smoked, Cured - Sodium Nitrite - 540.500
CUSTOMS Unsafe Contamination of Animal Feed from Drug Carry-over - 680.500
Articles of Foreign Origin Not Intended for Entry - 110.700 Use of DDVP (Vapona) Strips in Milkhouses and Milkrooms - 527.600
Coffee & Cocoa Bean Sweeps - 560.350 Vitamins and Minerals in Feed - 670.200
Country of Origin Labeling - 560.200 Volatile N-Nitrosamine in Rubber Baby Bottle Nipples - 500.450
Exports from U.S. Foreign Trade Zones - 110.200 DATES
Foreign Trade Zones Bonded Warehouses or Carriers - 110.600 Dates and Date Material - 550.300
Importation of TV Receivers & Microwave Ovens - 394.500 DDVP
Imports - Post Detention Sampling - 110.800 Use of (Vapona) Strips in Milkhouses & Milkrooms - 527.600
Returned Antibiotics Exported Under 801(d) of the Act - 405.210 DEALCOHOLIZED WINE
CYLINDER PLATE METHOD Dealcoholized Wine and Malt Beverages - 510.400
Milk & Milk Products Containing Penicillin - 527.450 DEBILITATED
CYSTOGRAPHIC Contamination of Devices Labeled as Sterile - 300.400
Definition-General Purpose Radiographic X-Ray System - 398.100 DEBRIS
CYSTS Intermediate or End Products of Sample Analysis - 150.100
Fish Adulteration by Parasite - 540.590 DECLARATION
CYTOTOXIC Bakery Products, Candy "Shotgun" Ingredients Declaration - 505.100
Allergic Diseases - 370.100 Caviar, Use of Term - Labeling - 540.150
CYTOTOXIC TESTING Corn on the Cob, Canned - Quantity of Contents Declaration - 585.325
Allergic Diseases - 370.100 Drugs - Metric and Apothecary System Declarations - 400.600
D-CARVONE Foods - FPLA Compliance - 562.200
Spices - Definitions - 525.750 Fortification of Standardized Juices - 510.700
DACUS Hollandaise Sauce - Common or Usual Name - 525.400
Olives - 550.600 Homeopathic Drugs - 400.400
DAIRY Honey - Source Declaration - 515.300
Extra-Label Use of New Animal Drugs - 615.100 Importation of Television Receivers and Microwave Ovens - 394.500
Ethylenediamine Dihydroiodide - 651.100 Label Declaration of Artificial Color - 587.100
DAIRY INDUSTRY Labeling of Food Bearing Residues of Pesticide Chemicals - 562.700
Imported Milk & Cream - 560.400 Labeling: "Chocolate" or "Chocolate Flavored" - 515.800
DAIRY PRODUCTS Malted Milk - 527.500
Foods, Adulteration with Salmonella - 555.300 Maraschino Cherries - 550.550
Imported Milk and Cream. Import Milk Act - 560.400 Marmalade - 550.575
Pathogens in Dairy Products - 527.300 Metric Declarations of Quantity of Contents - 140.500
Teat Dips and Udder Washes - 654.200 Mixed Nuts - Misbranding Involving Food Standards - 570.700
Whole Low Fat, Skim Milk - 527.400 Nutritional Supplements for Companion Animals - 690.100
DAMAGE Pineapple, Canned; Imported and Domestic - Food
Black-Eyed Peas (Cow Peas, Field Peas); Dried - 585.225 Standards - 550.685
Canned Green Beans and Canned Wax Beans - Polysorbate 20, 40, 60, 65, 80, 85 - Common or Usual Names - 555.800
Standards - 585.475 Preservatives; Use in Nonstandardized Foods; Label Declaration - 562.600
Corn Husks (for Tamales) - Adulteration with Filth - 585.350 Safety and Labeling of Waxed (Coated) Fruits and Vegetables - 562.550
Determination by Secretary that Product Fails to Comply - 390.200 Sauerkraut - Definition; Adulteration by Thrips - 585.750
Fructose-Containing Drugs - 400.335 Standardized Canned Fruit - Packing Medium - 550.800
Green Coffee Beans - Adulteration with Insects; Mold - 510.500 Sweet Potatoes - Sirup pack - 585.850
Olives - Adulteration Involving Pits; Rot; Insect Infestation - 550.600 Tomato Sauce or Tomato Hot Sauce Labeling - 525.800
Peas and Beans; Dried - Storage Insect Damage, Rocks - 585.575 Tracers in Animal Feed - 680.100
Preservatives; Use in Nonstandardized Foods; Label Declaration - 562.600 Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100
Returned Antibiotics Exported Under 801(d) of the Act - 405.210 Water in Food Products (Ingredient or Adulterant) - 555.875
Sweet Potatoes, Dyeing of Yellow and Red Varieties - 585.825 DECLARATION OF NET QUANTITY OF CONTENTS
Tamper-Resistant Packaging Requirements - 450.500 Homeopathic Drugs - 400.400
Water-Damaged Food Products - 555.850 Metric Declarations of Quantity of Contents - 140.500
Whole Milk, Low Fat Milk, Skim Milk - Aflatoxin M1 - 527.400 DECOMPOSED
DATA Apple Butter - Adulteration with Mold; Rodent Filth, Insects - 550.100
Acupuncture Devices and Accessories - 305.100 Apricot, Peach and Pear Nectars and Purees - Mold - 550.155
Analytical Methodology Used by FDA - Drugs - 150.500 Bay (Laurel) Leaves - Insect Filth; Mold; Mammalian Excreta - 525.150
Animal Drugs for Euthanasia - 650.100 Beets, Canned - Adulteration with Rot - 585.200
Chubs, Hot Process Smoked with Added Nitrite - 540.200 Canned Salmon - Adulteration Involving Decomposition - 540.375
Computerized Rx Recordkeeping by Pharmacies - 460.400 Canned Foods - Seam Defects - 520.200
Consistent Application of CGMP Determinations - 400.200 Canned Pet Food - 690.300
Crab and Crabmeat Products with Other Seafood - Labeling - 540.285 Capsicum Pods, etc. - Adulteration - 525.200
Decomposition & Histamine in Albacore, Skipjack & Yellowfin Tuna - 540.525 Cherries - 550.225
Dimethylnitrosamine (DMNA) in Barley Malt - 578.500 Cherry Jam - Adulteration with Mold - 550.235
Direct Reference Authority for Class III Medical Devices - 300.700 Citrus Fruit Juices, Canned - Fly Filth and Mold - 550.250
Diversion of Adulterated Food to Acceptable Animal Feed Use - 675.200 Cocoa Beans - Mold, Insect Infestation, and Mammalian Excreta - 515.750

409
Index Compliance Policy Guides
Corn Husks (for Tamales) - Adulteration with Filth - 585.350 DENTURE
Cranberry Sauce - Adulteration with Mold - 550.260 Denture Cleaners, Adhesives, & Repair Materials - 315.200
Dates and Date Material; Imported and Domestic - 550.300 Dentures-Sale by Persons Not Licensed in Dentistry - 315.100
Dried Prunes, Dehydrated Low Moisture Prunes, and Pitted Prunes - 550.700 DEPARTMENT OF JUSTICE
Drupelet Berries (Blackberries, Raspberries, etc.) - 550.200
Eggs and Other Egg Products - Frozen - Decomposition - 537.100 Answering Inquiries on Status of Criminal Referrals - 160.500
Figs; Fig Paste - Insect Infestation; Mold, Dirt - 550.350 Dentures -- Sale by Persons Not Licensed to Practice Dentistry - 315.100
Fish-Fresh and Frozen-Adulteration Involving Decomposition - 540.575 Failure to Register - 625.500
Green Coffee Beans - Adulteration with Insects; Mold - 510.500 Imported Milk and Cream. Import Milk Act - 560.400
Greens, Canned - Adulteration by Mildew - 585.450 Payment of Expert Witness - 160.600
Jam, Black Currant - Adulteration with Mold - 550.450 DEPARTMENT OF TRANSPORTATION
Leafy Spices, Other than Bay Leaves - 525.500 Foods, Rail Car Sanitation - Adulteration - 545.300
Mace-Insect Filth; Mold, Foreign Matter; Mammalian Excreta - 525.550 DEPENDABLE
Marjoram - 525.900 Clinical Thermometer-Adulteration ; Misbranding Defects - 335.800
Mushrooms, Canned or Dried (Freeze-Dried or Dehydrated) - 585.500 DEPLETION DATA
Olives - Adulteration Involving Pits; Rot; Insect Infestation - 550.600 Human-Labeled Drugs Used in Pet Medicine - 608.100
Oregano - 525.850 DERMATOLOGICS
Peanuts, Shelled and Unshelled - Filth and Reject Nuts - 570.350 Tamper-Resistant Packaging Requirements - 450.500
Pineapple, Canned; Pineapple Juice - Adulteration with Mold - 550.680 DESI
Pistachio Nuts - Aflatoxin Adulteration - 570.500 Marketed New Drugs w/o Approved NDAs or ANDAs - 440.100
Plums, Canned - Adulteration with Rot - 550.690 Reconditioning New Drugs Lacking Approved NDA - 448.100
Potato Chips - Adulteration with Rot - 585.700 DETAINED
Raisins - Adulteration Involving Mold, Sand, Grit, & Insects - 550.750 Aflatoxin in Peanuts and Peanut Products - 570.375
Sage - 525.950 Dates and Date Material; Imported and Domestic - 550.300
Sesame Seeds - Adulteration - 525.700 Diversion of Adulterated Food to Acceptable Animal Feed Use - 675.200
Shrimp - Fresh or Frozen Raw Headless, Peeled or Breaded - 540.400 Foods, Adulteration with Aflatoxin - 555.400
Spinach, Canned or Frozen - Insects, Decomposition - 585.775 Importation of Television Receivers and Microwave Ovens - 394.500
Strawberries; Frozen, Whole, or Sliced - Sand, Mold - 550.850 Imported Products - Lack of English Labeling - 110.900
Thyme - 525.925 Imported Frozen Products of Multiple Sizes or Codes - 560.700
Tomato Products - Adulteration with Mold - 585.900 Imported Low-Acid Canned Foods - 560.450
Tree Nuts - Adulteration Involving Rejects - 570.425 Imports -- Post Detention Sampling - 110.800
Whole Ginger - Insect Filth; Mold; Mammalian Excreta - 525.375 Jams, Jellies and Related Products - Imports - 560.500
Whole Cassia or Whole Cinnamon, Ground Cinnamon - 525.225 Pistachio Nuts - Aflatoxin Adulteration - 570.500
Whole and Ground Pepper - Adulteration - 525.625 Pottery (Ceramics) - Lead Contamination - 545.450
Whole and Ground Nutmeg - Insect Filth; Mold; Rodent Filth - 525.600 Pottery (Ceramics) - Cadmium Contamination - 545.400
Whole and Ground Allspice - Mold; Insect and Rodent Filth - 525.100 Reconditioning of Imported Coffee Beans - 560.300
DECOMPOSITION (see Decomposed) Returned Antibiotics Exported Under 801(d) of the Act - 405.210
DECORATIVE CAKE LETTERS Silver-Plated Hollowware - Lead Contamination - 545.500
Confectionery Decorations - 545.200 Sphygmomanometers - Rx Legend - 310.200
DEEP SEA LOBSTER DETENTION
Usual Names for Crustaceans - 540.350 Dates and Date Material; Imported and Domestic - 550.300
DEFECT ACTION LEVELS Defective Suntanning Booths and Beds - 396.300
Diversion of Food to Pet Feed - 675.200 Diversion of Adulterated Food to Acceptable Animal Feed Use - 675.200
Interpretation of Insect Filth in Foods - 555.600 Food Storage & Warehousing - Adulteration - Filth - 580.100
Macaroni and Noodle Products - 505.500 Hazardous Diagnostic X-Ray Systems - 398.200
DEFECTIVE PACKAGING Importation of Television Receivers and Microwave Ovens - 394.500
Contamination of Devices Labeled as Sterile - 300.400 Imported Products - Lack of English Labeling - 110.900
DEFECTS Imported Low-Acid Canned Foods - 560.450
Canned Foods - Seam defects - 520.200 Imports -- Post Detention Sampling - 110.800
Clinical Thermometer - Adulteration; Misbranding Defects - 335.800 Jams, Jellies and Related Products - Imports - 560.500
Condoms; Defects - Criteria for Direct Reference Seizure - 345.100 Pesticide Residues in Food and Feed - 575.100
Contamination of Devices Labeled as Sterile - 300.400 Pineapple, Canned; Imported and Domestic - Food Standards - 550.685
Determination by Secretary that Product Fails to Comply - 390.200 Pistachio Nuts - Aflatoxin Adulteration - 570.500
Early Correction of Defects or Noncompliance - 390.225 Pottery (Ceramics) - Lead Contamination - 545.450
Hazardous Diagnostic X-Ray Systems - 398.200 Pottery (Ceramics) - Cadmium Contamination - 545.400
Marjoram - 525.900 Radionuclides in Imported Foods - Levels of Concern - 560.750
Obligations of Factory-based Manufacturers and Assemblers - 398.375 Silver-Plated Hollowware - Lead Contamination - 545.500
Oregano - 525.850 DETERIORATE
Reconditioning of Articles Found in Violation of GMP's - 160.750 Reloaders of X-Ray Tube Housing Assemblies - 398.700
Sage - 525.950 DETOXIFICATION
Surgeons' Gloves and Patient Examination Gloves - 335.700 Ammoniated, Cottonseed Meal - 670.500
Thyme - 525.925 DEVICE COMPONENTS
Whole Cassia or Whole Cinnamon, Ground Cinnamon - 525.225 Inspection of Manufacturers of Device Components - 300.100
Whole and Ground Nutmeg - Insect Filth; Mold; Rodent Filth - 525.600 DEVICES
Whole and Ground Allspice - Mold; Insect and Rodent Filth- 525.100 Access to Results of Quality Assurance Audits - 130.300
DEHYDRATED Acupuncture Devices and Accessories - 305.100
Dried, Dehydrated Low Moisture & Pitted Prunes - 550.700 Adequate Directions for Use - Animal Drugs and Devices - 607.100 Adequate
Identity-Foods-Terms Such Fresh,Frozen,Dried - 562.450 Directions for Use - Veterinary Devices - 655.200
Imported Milk & Cream. Import Milk Act - 560.400 Assemblers Who Install Noncompliant Equipment - 398.325
Labeling of Seasonings - 525.650 Automatic Adjustment of the X-Ray Field Size - 398.400
Mushrooms, Canned or Dried - 585.500 CGMP Applicability to Hardware and Software - 425.100
Potato Chips, Ingredients - Labeling - 585.710 Class III Devices Subject to 5l5(b) Requirements - 300.750
Spices - Definitions - 525.750 Computerized Drug Processing -- Vendor Responsibility - 425.200
DELIVERY Condoms; Defects - Criteria for Direct Reference Seizure - 345.100
Adulteration of Drugs Under Sec.501(b) & (c) - 420.100 Contamination of Devices Labeled as Sterile - 300.400
Commercial Distribution -Premarket Notification - 300.600 Contract Sterilizers - 100.550
Common Carrier as Relabelers, Repacker,Reprocessor, etc - 100.500 Cytotoxic Testing for Allergic Diseases - 370.100
Compressed Medical Gases -Warning Letters - 435.100 Defective Suntanning Booths and Beds - 396.300
Hazardous Diagnostic X-Ray Systems - 398.200 Definition of General Purpose Radiographic X-Ray System - 398.100
Hospital Pharmacies - 460.100 Definition of "High-Voltage Vacuum Switch" - 390.500
Registration of Blood Banks & Other Firms - 230.110 Dentures -- Sale by Persons not Licensed to Practice Dentistry - 315.100
Sequencing in Medicated Feed Production - 680.600 Denture Cleaners, Adhesives, Cushions, and Repair Materials - 315.200
Unit Dose Labeling for Solid & Liquid Oral Dose Forms - 430.100 Devices for Use in Animals - 655.100
DENTAL X-RAY SYSTEM Diaphragms - Rx Devices - 345.200
Definition of General Purpose Radiographic X-Ray System - 398.100 Direct Reference Authority for Class III Medical Devices - 300.700
DENTIFRICES Ear Piercing Devices - 320.100
Tamper-Resistant Packaging Requirements - 450.500 Electrical Muscle Stimulators - 355.200

410
Compliance Policy Guides Index
Failure to Register - 400.100 DIMETHYLNITROSAMINE (DMNA)
Health Fraud - 120.500 In Malt Beverages - 510.600
Hypnotherapy Devices - Self Hypnotic Tape Recordings - 335.300 In Barley Malt - 578.500
Imported Products - Lack of English Labeling - 110.900 DIMETRIDAZOLE
Ineffective Devices - 502(f)(l) Labeling Requirements - 300.300 Extra-Label Use of New Animal Drugs - 615.100
Inspection of Manufacturers of Device Components - 300.100 Unsafe Contamination of Animal Feed - 680.500
Ion Generating Devices - 355.300 DINNERWARE
Karaya Gum Powder and Related Devices for Use by Ostomates - 325.100 Pottery Cadmium - 545.400
Laser Light Shows, etc. - 393.100 Pottery Lead - 545.450
Lasers for Facelift, Wrinkle Removal, Acupuncture, etc. - 393.200 DINOFLAGELLATA
Menstrual Sponges - 345.300 Clams, Mussels, Oysters - 540.250
Metric Declarations of Quantity of Contents - 140.500 DIPHTHERIA ANTITOXIN
Microfiche and/or Microfilm for Records Retention - 130.400 Standards & Min.Requirements - Biologic Products - 205.100
OTC Drugs in Vending Machines - 450.400 DIPHTHERIA TOXIN
Pacemaker Reuse - 310.100 Standards & Min.Requirements - Biologic Products - 205.100
Products Composed of Interstate Ingredients - 100.200 DIPHTHERIA TOXOID
Razor Blades, Manicuring Instruments - 335.500 Standards & Min.Requirements - Biologic Products - 205.100
Reconditioners/Rebuilders of Medical Devices - 300.200 DIRECT REFERENCE AUTHORITY
Regulatory Actions and Small Business - 160.100 Direct Reference Authority for Pseudomonas Contamination - 590.300
Regulatory Actions Against Assemblers of X-Ray Equipment - 398.350 For Class III Medical Devices - 300.700
Reloaders of X-Ray Tube Housing Assemblies - 398.700 Illegal Sales of Veterinary Prescriptions - 608.500
Reuse of Medical Disposable Devices - 300.500 DIRECT REFERENCE SEIZURE
RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200 Adulteration of Drugs Under Sec. 501(b) and 501(c) - 420.100
Sphygmomanometers - Rx Legend - 310.200 Direct Reference Authority for Pseudomonas Contamination - 590.300
Sphygmomanometers - Accuracy - 310.210 Direct Reference Authority for Class III Medical Devices - 300.700 DIRECTED
Sunlamp Performance Standard - 396.100 Access to Results of Quality Assurance Audits - 130.300
Surgeons' Gloves and Patient Examination Gloves - 335.700 Aflatoxin in Peanuts and Peanut Products - 570.375
Temporal-Maximum Ultrasonic Power - 397.100 Animal Drugs for Euthanasia - 650.100
The Status of Syringes and Needles for Animal Use - 655.400 Determination by Secretary that Product Fails to Comply - 390.200
Warning Label Required on Sunlamp Products - 396.400 Ethylenediamine Dihydroiodide (EDDI) - 651.100
X-Ray Field Size for Spot-Film - 398.475 Health Fraud - 120.500
DEVILED CRAB Jams, Jellies and Related Products - Imports - 560.500
Crab & Crabmeat Products w/Other Seafood-Labeling - 540.285 Lasers for Facelift, Wrinkle Removal, Acupuncture, etc. - 393.200
DEWBERRIES Marketed New Drugs Without Approved NDAs or ANDAs - 440.100
Drupelet Berries - 550.200 OTC Drugs - Combination Products - 450.300
DEXTRANS OTC Anti-Obesity Preparations - 456.100
LVP's for Animal Use - 635.100 Regulatory Actions and Small Business - 160.100
DEXTROSE Sequencing in Medicated Feed Production - 680.600
Fructose-Containing Drugs - 420.200 Statements Regarding NADA Approval in Labeling and Advertising - 605.100 Urinary Preparati
LVP's for Animal Use - 635.100 DIRECTIONS FOR USE
Marmalade - 550.575 Acupuncture Devices and Accessories - 305.100
Potato Chips, Ingredients Labeling - 585.710 Additives - Labeling with Adequate Directions for Many Uses - 500.100
Prepared Mustard, Composition - 525.575 Adequate Directions for Use - Animal Drugs and Devices - 607.100
Sweet Potato Sirup Pack - 585.850 Adequate Directions for Use - Veterinary Devices - 655.200
DIAGNOSTIC X-RAY EQUIPMENT Alternate Feeding of Different Medicated Feeds - 666.100
Assemblers Who Install Noncompliant Equipment - 398.325 Availability of Bulk Chemicals for Animal Drug Use - 625.200
Assessment of Civil Penalties - 390.300 Cellutron Machine - 355.100
Certification & Identification of X-Ray Components - 398.600 Checklist Labeling for Custom Mixed Medicated Feeds - 665.200
Obligations of Factory-Based Manufactures & Assemblers - 398.375 Chloramphenicol - 654.300
Regulatory Actions Against Assemblers of X-Ray Equipment - 398.350 Compressed Medical Gases -- Warning Letters - 435.100
DIAGNOSTIC X-RAY SYSTEMS Cytotoxic Testing for Allergic Diseases - 355.200
Hazardous Diagnostic X-Ray Systems - 398.200 Diaphragms - Rx Devices - 345.200
Obligation of Factory-Based Manufactures & Assemblers - 398.375 Direct-Fed Microbial Products - 689.100
Reconditioners/Rebuilders of Medical Devices - 300.200 Electrical Muscle Stimulators - 355.200
Registration of Assemblers of Diagnostic X-Ray Systems - 398.300 Extra-Label Use of New Animal Drugs in Food-Producing Animals - 615.100
Regulatory Actions Against Assemblers of X-Ray Equipment - 398.350 Food Additives - Labeling Directions Necessary for Safe Use - 500.250
DATE MATERIAL Homeopathic Drugs - 400.400
Dates and Date Material - 550.300 Human-Labeled Drugs Distributed & Used in Animal Medicine - 608.100
DATES PERTAINING TO DRUGS Hypnotherapy Devices - Self Hypnotic Tape Recordings - 335.300
Expiration Dating of Unit Dose Drugs - 480.200 Illegal Sales of Veterinary Prescription Drugs - 608.500
Labeling for Oral Dosages - 430.100 Ineffective Devices - 502(f)(l) Labeling Requirements - 300.300
Manufacture, Distribution, Promotion - 460.200 Inert Glandular Preparations - OTC - 455.100
Repacking of Drug Products - 430.200 Over-The-Counter Sale of Injectable Animal Drugs - 608.200
DAIRY INDUSTRY Repacking of Drug Products -- CGMP's - 430.200
Imported Milk & Cream - 560.400 RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200
DIAPHRAGMS Seizure of Books that Constitute Misleading Labeling - 140.100
Rx Devices - 345.200 Teat Dips and Udder Washes for Dairy Cows and Goats - 654.200
DICTIONARY OF PRACTICAL MATERIAL MEDICA Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100
Homeopathic Drugs - 400.400 Warning Label Required on Sunlamp Products - 396.400
DIETARY SUPPLEMENTS DISCLOSURE AND CLAIMS
Nutritional Supplements - 690.100 Inert Glandular Preparations - OTC - 455.100
DIETHYLSTILBESTROL (DES) Unit Dose Labeling for Solid & Liquid Oral Dose Forms - 430.100
Extra-Label Use of Drugs in Animals - 615.100 Urinary Preparations-Lack of Rx Legend Claims - 430.400
Unsafe Contamination of Pet Feed/Carryover - 680.500 DISPLAY
DIFFERENT COMPOSITION Commercial Distribution -- Premarket Notification - 300.600
Identical or Similar Product Names - 400.500 Dealcoholized Wine and Malt Beverages - Labeling - 510.400
DIHYDROSTREPTOMYCIN Foods - FPLA Compliance - 562.200
Streptomycin Residues in Cattle Tissues - 616.100 Homeopathic Drugs - 400.400
DILL SEED Identity of Foods--Terms Such as Fresh, Frozen, Dried, Canned - 562.450
Spices - Definitions - 525.750 Labeling of Food Articles Distributed Solely in Puerto Rico - 562.750
DILUTED WINES Laser Light Shows, etc. - 393.100
Labeling - 510.450 Mercury Vapor Lamps That are Not Self-Extinguishing - 391.200
DIMETHYL GLYCENE Metric Declarations of Quantity of Contents - 140.500
Pangamic Acid - 457.100 Pottery (Ceramics) - Lead Contamination - 545.450
DIMETHYL SULFOXIDE (DMSO) Pottery (Ceramics) - Cadmium Contamination - 545.400
For Animal Use - 654.100 Processed and/or Blended Seafood Products - 540.700

411
Index Compliance Policy Guides
Safety and Labeling of Waxed (Coated) Fruits and Vegetables - 562.550 DRIED MALT
Silver-Plated Hollowware - Lead Contamination - 545.500 Malt Products - 515.200
Tamper-Resistant Packaging Requirements - 450.500 DRIED MUNG BEANS
DISPLAYED Seeds for Sprouting Prior to Food Use - 555.750
Distribution - Premarket Notification - 300.600 DROSOPHILA
Identity of Foods-Terms Like Fresh, Frozen, Dried - 562.450 Citrus Fruit Juices, Canned-Fly Filth & Mold - 550.250
Labeling-Food w/ Residues of Pesticide Chemicals - 562.700 Raisins-Adulteration Involving Mold, & Insect Filth - 550.750
Oranges - Artificial Coloring - 550.625 Tomato Products-Drosophila Fly Eggs & Maggots - 585.890
OTC Drugs in Vending Machines - 450.400 DRUG CONTAMINATION
Safety & Labeling of Waxed (Coated) Fruits & Vegetables - 562.550 Sequencing in Medicated Feed - 680.600
Seizure of Books That Constitute Misleading Labeling - 140.100 DRUG DISTRIBUTION
Tamper-Resistant Packaging Requirements - 450.500 Expiration Dating of Unit Dose Repackaged Drugs - 480.200
Vending Machine Food - Labeling - 562.800 DRUG INTERACTIONS
Warning Label required on Sunlamp Products - 396.400 Extra-Label Use of New Pet Drugs - 615.100
DISPOSABLE GUIDEWIRES DRUG MARKETING APPLICATIONS
Reuse of Medical Disposable Devices - 300.500 Consistent Application of CGMP Determinations - 400.200
DISTILLED VINEGAR DRUGS
Acetic Acid Use in Foods-Labeling - 562.100 Adequate Directions for Use - Animal Drugs and Devices - 607.100
Vinegar, Adulteration with Vinegar Eels - 525.825 Adequate Directions for Use - Veterinary Devices - 655.200
DISUSE Adulterated Food Mixed with Good Food - 555.200
Electrical Muscle Stimulators - 355.200 Adulteration of Drugs under Sec. 501(b) and 501(c) - 420.100
DIURETICS Alcohol; Use of Synthetic Alcohol in Foods - 555.100
Urinary Preparations-Lack of Rx Legend Claims - 430.400 Alternate Feeding of Different Medicated Feeds - 666.100
DOCUMENTED EVIDENCE Analytical Methodology Used by FDA - Drugs - 150.500
Decomposition & Histamine in Albacore,Skipjack, Tuna - 540.525 Animal Drugs for Euthanasia - 650.100
Karaya Gum Powder & Devices for Use by Ostomates - 325.100 Animal Grooming Aids - 653.100
Obligations of Factory-Based Manufactures & Assemblers - 398.375 Availability of Bulk Chemicals for Animal Drug Use - 625.200
DONOR Biological Drugs for Animal Use - 645.100
Blood & Blood Products - Definitions - 230.100 Blood and Blood Products - Definitions - 230.100
Quantitative Testing for Serum Proteins-Plasmapheresis - 255.100 Candy "Pills" - 400.325
Registration of Blood Banks & Other Firms - 230.110 Certification for Exports - 110.100
Source Plasma Guideline for Informed Consent CGMP Applicability to Hardware and Software - 425.100
Form - 250.100 CGMP Enforcement Policy - OTC vs Rx Drugs - 450.100
Standards & Min. Requirements - Biologic Products - 205.100 CGMP's for Medicated Feeds - Daily Inventory Requirements -680.200
DONOR SUITABILITY Changes in Compendial Specifications and NDA Supplements - 420.300
Determination of Donor Suitability - 230.130 Checklist Labeling for Custom Mixed Medicated Feeds - 665.200
DOSAGE Chloramphenicol - 654.300
Adulteration of Drugs under Sec. 501(b) and 501(c) - 420.100 Class I Recalls of Rx Drugs - 400.900
Chloramphenicol - 654.300 Collection and Charitable Distribution of Drugs - 400.800
Compendium Revisions and Deletions - 420.200 Color Additives - 587.300
Content Uniformity Testing of Tablets and Capsules - 460.600 Compendial Requirements - 420.400
Controlled-Release Dosage Form Drugs - 460.700 Compendium Revisions and Deletions - 420.200
Expiration Dating of Unit Dose Repackaged Drugs - 480.200 Compressed Medical Gases -- Warning Letters - 435.100
Expiration Dating and Stability Testing - 480.100 Computerized Rx Recordkeeping by Pharmacies - 460.400
Extra-Label Use of New Animal Drugs in Food-Producing Animals - 615.100 Computerized Drug Processing -- Vendor Responsibility - 425.200
Finished Dosage Form Drugs in Bulk Containers - 410.100 Fructose-Containing Computerized Drug Processing -- Input/Output Checking - 425.400
Drugs - 400.335 Computerized Drug Processing -- I.D. of "Persons" - 425.500
Homeopathic Drugs - 400.400 Confectionery - Use of Nonnutritive Substances as Ingredients - 515.100
Hospital Pharmacies - 460.100 Consistent Application of CGMP Determinations - 400.200
Identical or Similar Product Names - 400.500 Content Uniformity Testing of Tablets and Capsules - 460.600
Interference with Compendial Tests - 420.500 Contract Sterilizers - 100.550
Lack of Expiration Date or Stability Data - 480.300 Control/Accountability of TRP Materials - 450.550
Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200 Controlled-release dosage form drugs - 460.700
Marketed New Drugs Without Approved NDAs - 440.100 Dimethyl Sulfoxide (DMSO) for Animal Use - 654.100
Oral Iron Products for Baby Pigs - 643.100 Direct-Fed Microbial Products - 689.100
Process Validation Requirements for Drug Products - 490.100 Drug Product Entries in Periodic Publications - 400.700
Proper Drug Use and Residue Avoidance - 615.200 Drugs for Odor Control in Animals - 642.100
Regulatory Action Regarding Approved New Drugs - 446.100 Ethylenediamine Dihydroiodide (EDDI) - 651.100
Repacking of Drug Products -- CGMP's - 430.200 Expiration Dating of Unit Dose Repackaged Drugs - 480.200
Returned Antibiotics Exported under 801(d) of the Act - 405.210 Expiration Dating and Stability Testing - 480.100
Tamper-Resistant Packaging Requirements - 450.500 Export of Uncertified Antibiotics - 405.200
Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100 Extra-Label Use of New Animal Drugs in Food-Producing Animals - 615.100
DOSAGE FORM (See Dosage above) Failure to Register - 400.100
DRIED Failure to Register - 625.500
Black-Eyed Peas (Cow Peas, Field Peas); Dried - 585.225 Finished Dosage Form Drugs in Bulk Containers - 410.100
Canned Green Beans and Canned Wax Beans-Standards - 585.475 Flea and Tick Products Containing a Pesticide - 641.100
Communicable Disease Hazards - 100.300 Fraud, Untrue Statements of Material Facts, Bribery - 120.100
Dried Prunes, Dehydrated Low Moisture Prunes, and Pitted Prunes - 550.700 Fructose-Containing
FDA Jurisdiction OverDrugs
Meat -and
400.335
Poultry Products - 565.100
Identity of Foods--Terms Such as Fresh, Frozen, Dried, Canned - 562.450 Health Fraud - 120.500
Imported Milk and Cream. Import Milk Act - 560.400 Homeopathic Drugs - 400.400
Labeling of Seasonings - 525.650 Hospital Pharmacies - 460.100
Malt Products - 515.200 Human Blood and Blood Products as Drugs - 230.120
Mushrooms, Canned or Dried (Freeze-Dried or Dehydrated) - 585.500 Human-Labeled Drugs Distributed & Used in Animal Medicine - 608.100
Pathogens in Dairy Products - 527.300 Identical or Similar Product Names - 400.500
Peas and Beans; Dried - Storage Insect Damage, Rocks - 585.575 Illegal Sales of Veterinary Prescription Drugs - 608.500
Pork and Beans and Similar Bean Products--Labeling - 567.200 Imported Products - Lack of English Labeling - 110.900
Potato Chips, Ingredients - Labeling - 585.710 Inert Glandular Preparations - OTC - 455.100
Processing - Use of Term in Section 405 of the FD&C Act - 562.650 Interference with Compendial Tests - 420.500
Salmonella Contamination of Dry Dog Food - 690.700 Labeling of Shipping Containers for Drugs - 430.300
Salt-Cured, Air-Dried, Uneviscerated Fish - 540.650 Lack of Expiration Date or Stability Data - 480.300
Seeds for Sprouting Prior to Food Use - 555.750 Large Volume Parenteral (LVP's) for Animal Use - 635.100
Spices - Definitions - 525.750 Lay Use of Veterinary Prescription Drugs - 608.300
Tomato Products - Adulteration with Mold - 585.900 Mail-Order Filling of Prescriptions - 460.450
Tree Nuts - Adulteration Involving Rejects - 570.425 Malted Milk - 527.500
Vinegar, Definitions - Adulteration with Vinegar Eels - 525.825 Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200
Water in Food Products (Ingredient or Adulterant) - 555.875 Maraschino Cherries - 550.550

412
Compliance Policy Guides Index
Marketed New Drugs Without Approved NDAs - 440.100 Streptomycin Residues in Cattle - 616.100
Marmalade - 550.575 EFFECTIVENESS
Medicated Feeds -- Formula Information - 670.100 Adequate Directions for Use - Animal Drugs and Devices - 607.100
Metric Declarations of Quantity of Contents - 140.500 Alternate Feeding of Different Medicated Feeds - 666.100
Microfiche and/or Microfilm for Records Retention - 130.400 Cytotoxic Testing for Allergic Diseases - 370.100
New Drugs - Export - 442.100 Direct Reference Authority for Class III Medical Devices - 300.700
Nutritional Supplements for Companion Animals - 690.100 Expiration Dating and Stability Testing - 480.100
Oral Iron Products for Baby Pigs - 643.100 Fraud, Untrue Statements of Material Facts, Bribery - 120.100
Orders for Post-Approval Record Reviews - 470.100 Health Fraud - 120.500
OTC Drugs in Vending Machines - 450.400 Lasers for Facelift, Wrinkle Removal, Acupuncture, Etc. - 393.200
OTC Anti-Obesity Preparations - 456.100 Marketed New Drugs Without Approved NDAs - 440.100
OTC Drugs - Recognition as Safe and Effective - 450.200 Orders for Post-Approval Record Reviews - 470.100
OTC Drugs - Combination Products - 450.300 Process Validation Requirements for Drug Products - 490.100
OTC Ear Drops - 454.100 Regulatory Action Regarding Approved New Drugs - 446.100
Over-The-Counter Sale of Injectable Animal Drugs - 608.200 Reuse of Medical Disposable Devices - 300.500
Parametric Release of Terminally Heat Sterilized Drugs - 460.800 RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200
Plasma Brokers - Registration and Compliance - 250.500 Surgeons' Gloves and Patient Examination Gloves - 335.700
Plastic Containers for Injectable Animal Drugs - 637.100 EFFERVESCENT
Prepared Mustard, Composition - 525.575 Unfermented Beverages, Use of Word "Champagne" - 510.300
Prescription Status - Telephone Answering Machine - 460.425 EGG
Process Validation Requirements for Drug Products - 490.100 Chow Mein, Chinese Noodle - 505.400
Products Composed of Interstate Ingredients - 100.200 Eggnog, Eggnog Flavored Milk - 527.350
Proper Drug Use and Residue Avoidance - 615.200 Eggs and Other Egg Products - 537.100
Reconditioning of New Animal Drugs Seized Under Sec. 501(a)(5) - 625.400 Hollandaise Sauce - 525.400
Reconditioning New Drugs Lacking Approved NDA - 448.100 Processed Blended Seafood Products - 540.700
Reconditioning of Articles Found in Violation of GMP's - 160.750 Processing Use of Term - 562.650
Recovery of IND's from Clinical Investigators - 444.100 Vitamins and Minerals in Feed - 670.200
Recycled Animal Waste - 685.100 EGG CONTENT
Registration of Blood Banks and Other Firms - 230.110 Oriental Noodles - 505.400
Regulatory Action Regarding Approved New Drugs - 446.100 EGG YOLK
Repacking of Drug Products -- CGMP's - 430.200 Eggnog Flavored Milk - 527.350
Responsibility for Illegal Drug Residues in Meat, Milk and Eggs -615.300 Hollandaise Sauce - 525.400
Return of Unused Rx Drugs to Pharmacy Stock - 460.300 EGGNOG FLAVORED MILK
RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200 Imported Milk & Cream - 560.400
Rx Drugs for Ships' Medicine Chests - 460.500 ELECTROLYTE SOLUTION
Sequencing in Medicated Feed Production - 680.600 LVP's for Animal Use - 635.100
Source Code for Process Control Application Programs - 425.300 ELECTRONIC
Spices - Definitions - 525.750 Assessment of Civil Penalties - 390.300
Statements Regarding NADA Approval in Labeling and advertising - 605.100 Certification for Exports - 110.100
Sweet Potatoes, Dyeing of Yellow and Red Varieties - 585.825 Computerized Drug Processing -- Input/Output Checking - 425.400
Tamper-Resistant Packaging Requirements - 450.500 Defective Suntanning Booths and Beds - 396.300
Teat Dips and Udder Washes for Dairy Cows and Goats - 654.200 Definition of "Commerce" - 21 CFR 1000.3(g) - 390.100
The Use of Antibiotic Drug Residue By-Products in Animal Feed - 682.200 Determination by Secretary that Product Fails to Comply - 390.200
The Status of Syringes and Needles for Animal Use - 655.400 Electronic Products Subject to 21 CFR 1001.15(a) - 390.400
Unapproved New Animal Drugs - Follow-up Action - 625.300 Exemption for Certain Sunlamp Product Purchaser Records - 396.200
Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100 Hazardous Diagnostic X-Ray Systems - 398.200
Unsafe Contamination of Animal Feed from Drug Carry over -680.500 Importation of Television Receivers and Microwave Ovens - 394.500
Urinary Preparations - Lack of Rx Legend - Claims - 430.400 Peanuts, Shelled and Unshelled - Filth and Reject Nuts - 570.350
Vinegar, Definitions - Adulteration with Vinegar Eels - 525.825 Records and Reports - Applicability - 21 CFR 1002.1 - 390.425
DRUGS OF ABUSE Retention of Microwave Oven Test Records - 394.100
RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200 Sphygmomanometers - Accuracy - 310.210
DRUPELET BERRIES Tree Nuts - Adulteration Involving Rejects - 570.425
(Blackberries, Raspberries, etc...) - 550.200 Warning Label Required on Sunlamp Products - 396.400
DRYING ELECTRONIC PRODUCTS
Calcium Chloride - 500.400 Assessment of Civil Penalties - 390.300
Dimethylnitrosamine in Malt Beverages - 510.600 Defective Suntanning Booths & Beds - 396.300
DMNA in Barley Malt - 578.500 Determination by Secretary: Product Fails to Comply - 390.200
Salt-Cured, Air-Dried, Uneviscerated Fish - 540.650 Electronic Products Subject to 21 CFR 1001.15(a) - 390.400
Tomato Products - Adulteration w/ Mold - 585.900 Hazardous Diagnostic X-Ray Systems - 398.200
DRYING AGENT Importation of TV Receivers & Microwave Ovens - 394.500
Calcium Chloride - 500.400 Warning Label Required on Sunlamp Products - 396.400
DUODENUM ELECTROPHORETIC
Inert Glandular Preparations - OTC - 455.100 Quantitative Testing for Serum Proteins-Plasmapheresis - 255.100
DURUM FLOUR ELIXIRS
Macaroni & Noodle Products - 505.500 Unit Dose Labeling for Solid & Liquid Oral Dose Forms - 430.100
E. COLI EMBRYO
Clams, Muscles, Oysters-Bacterial Contamination - 560.600 Aflatoxin in Peanuts & Peanut Products - 570.375
Pathogens in Dairy Products - 527.300 Inert Glandular Preparations - OTC - 455.100
Reconditioning Tree Nuts Contaminated w/ E.coli - 570.550 EMERGENCY
EAR DROP PREPARATIONS Class I Recalls of Rx Drugs - 400.900
OTC Eardrops - 454.100 Licensing - Changes to be Reported - 210.100
EARLOBE Medical Emergencies - 220.100
Ear Piercing Devices - 320.100 Pesticide Residues in Food and Feed - 575.100
EARLY CORRECTION OF DEFECTS Radionuclides in Imported Foods - Levels of Concern - 560.750
Early Correction of Defects or Noncompliance - 390.225 Registration of Blood Banks and Other Firms - 230.110
EASY READING EMOTIONAL HEALTH
Clinical Thermometer-Adulteration;Misbranding Defects - 335.800 Hypnotherapy Devices-Self Hypnotic Tape Recordings - 335.300
ECONOMIC EMULSIFYING
Health Fraud - 120.500 Hollandaise Sauce - 525.400
Human Labeled Drugs Distributed & Used-Animal Medicine - 608.100 ENDURANCE TESTING
Regulatory Actions & Small Business - 160.100 Retention of Microwave Oven Test Records - 394.100
EDAM ENFORCEMENT ACTIONS
Cheese - Misbranding Due to Moisture & Fat - 527.225 Action Levels for Aflatoxin in Animal Feeds - 683.100
EDIBLE TISSUE CGMP Enforcement Policy - OTC vs Rx Drugs - 450.100
Action Levels for Aflatoxin in Pet Feeds - 683.100 Defective Suntanning Booths and Beds - 396.300
Proper Drug Use and Residue Avoidance - 615.200 Direct-Fed Microbial Products - 689.100

413
Index Compliance Policy Guides
Human-Labeled Drugs Distributed & Used in Animal Karaya Gum Powder & Devices for Use by Ostomates - 325.100
Medicine - 608.100 ESTABLISHMENT, CLASSIFICATION OF
Laser Light Shows, etc. - 393.100 Classification of establishment - 555.500
Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200 ESTRUS
Marketed New Drugs Without Approved NDAs - 440.100 Drugs for Odor Control in Pet - 642.100
Pesticide Residues in Food and Feed - 575.100 ETHER EXTRACT
Process Validation Requirements for Drug Products - 490.100 Spices- Definitions - 525.750
Proper Drug Use and Residue Avoidance - 615.200 ETHYLENE OXIDE
Red Meat Adulterated with PCB's - 565.200 Karaya Gum Powder & Devices for Use by Ostomates - 325.100
Regulatory Action Regarding Approved New Drugs - 446.100 Parametric Release of Terminally Heat Sterilized Drugs - 460.800
Safety and Labeling of Waxed (Coated) Fruits and Vegetables - 562.550 ETIOLOGIC AGENTS
Sunlamp Performance Standard - 396.100 Blood & Blood Products - Definitions - 230.100
ENGAGED IN THE BUSINESS EUROPEAN LOBSTER
Definition of "Commerce" - 21 CFR 1000.3(g) - 390.100 Common or Usual Names for Crustaceans - 540.350
ENRICHED EUTHANASIA
Enriched or Fortified Foods - 555.550 Animal Drugs for Euthanasia - 650.100
Fortification of Standardized Juices - 510.700 Lay Use of Veterinary Prescription Drugs - 608.300
ENSURE EXCESSIVE HARDNESS
Consistent Application of CGMP Determinations - 400.200 Peaches, Canned Misbranding Standards - 550.655
Dealcoholized Wine *and Malt Beverages* - Labeling - 510.400 EXCORIATED
Dimethylnitrosamine (DMNA) in Barley Malt - 578.500 Karaya Gum Powder & Devices for Use by Ostomates - 325.100
Direct Reference Authority for Class III Medical Devices - 300.700 EXEMPTION FROM REGISTRATION
Expiration Dating of Unit Dose Repackaged Drugs - 480.200 Inspection of Manufacturers of Device Components - 300.100
Fraud, Untrue Statements of Material Facts, Bribery - 120.100 Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200
Human-Labeled Drugs Distributed & Used in Animal Medicine - 608.100 Pesticide Residues in Food and Feed - 575.100
Process Validation Requirements for Drug Products - 490.100 Registration of Blood Banks and Other Firms - 230.110
Proper Drug Use and Residue Avoidance - 615.200 EXEMPTS THEM FROM INSPECTION
Recycled Animal Waste - 685.100 Inspection of Manufacturers of Device Components - 300.100
Regulatory Actions and Small Business - 160.100 Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200
Regulatory Action Regarding Approved New Drugs - 446.100 EXHAUST RATE
Rendered Animal Feed Ingredients - 675.400 Sphygmomanometers - Accuracy - 310.210
Salt-Cured, Air-Dried, Uneviscerated Fish - 540.650 EXHIBITS
ENTERIC COATED Peas & Beans, Dried-Storage Insect Damage, Rocks - 585.575
Unit Dose Labeling for Solid & Liquid Oral Dose Forms - 430.100 Contamination of Devices Labeled as Sterile - 300.400
ENTRANCE EXPOSURE RATES Foods, Rail Car Sanitation - Adulteration - 545.300
Assemblers Who Install Noncompliant Equipment - 398.325 EXPERT
ENURESIS Decomposition & Histamine in Albacore, Skipjack, Tuna - 540.525
Hypnotherapy Devices-Self Hypnotic Tape Recordings - 335.300 Drugs for Odor Control in Animals - 642.100
ENVIRONMENT SENSITIVITY TO LOAD PLACEMENT CAVITY Payment of Expert Witness - 160.600
Retention of Microwave Oven Test Records - 394.100 Squash Seeds - Labeling as Pumpkin Seeds - 585.800
EPIDURAL EXPIRATION DATE
OTC Sale of Injectable Pet Drugs - 608.200 Expiration Dating & Stability Testing - 480.100
EQUIVALENT Lack of Expiration Date or Stability Data - 480.300
Apple Butter - Adulteration with Mold; Rodent Filth, Insects - 550.100 Parametric Release of Terminally Heat Sterilized Drugs - 460.800
Asparagus, Canned or Frozen - Adulteration with Insect Filth - 585.150 EXPIRATION DATING
Canned Salmon - Adulteration Involving Decomposition - 540.375 Expiration Dating & Stability Testing - 480.100
Class III Devices Subject to 5l5(b) Requirements - 300.750 Expiration Dating of Unit Dose Repackaged Drugs - 480.200
Commercial Distribution -- Premarket Notification - 300.600 Homeopathic Drugs - 400.400
Compressed Medical Gases -- Warning Letters - 435.100 Regulatory Action Regarding Approved New Drugs - 7132c.16
Computerized Drug Processing -- I.D. of "Persons" - 425.500 Unit Dose Labeling for Solid&Liquid Oral Dose Forms - 430.100
Consistent Application of CGMP Determinations - 400.200 EXPORT
Corn Meal - Adulteration by Insect and Rodent Filth - 578.200 Exports from U.S. Foreign Trade Zones - 110.200
Corn, Sweet; Canned - Adulteration - 585.300 EXPORTATION
Cowpeas (Black-Eyed Peas); Canned (Succulent Peas) - Insects - 585.400 Articles of Foreign Origin Not Intended for Entry - 110.700
Dates and Date Material; Imported and Domestic - 550.300 Class III Devices Subject to 515 (b) Requirements - 300.750
Dealcoholized Wine *and Malt Beverages* - Labeling - 510.400 Coffee & Cocoa Bean Sweeps - 560.350
Dimethylnitrosamine (DMNA) in Barley Malt - 578.500 Foreign Traded Zones,Bonded Warehouses or Carriers - 110.600
Direct Reference Authority for Class III Medical Devices - 300.700 Importation of TV Receivers & Microwave Ovens - 394.500
Drupelet Berries (Blackberries, Raspberries, etc.) - 550.200 Imported Frozen Products of Multiple Sizes or Codes - 560.700
Expiration Dating of Unit Dose Repackaged Drugs - 480.200 Imports - Post Detention Sampling - 110.800
Foreign Language Declarations on Food Labels - 562.400 New Drugs - Export - 442.100
Fraud, Untrue Statements of Material Facts, Bribery - 120.100 Unapproved Additives For Exported Grains - 578.600
Green Coffee Beans - Adulteration with Insects; Mold - 510.500 EXPORTER
Health Fraud - 120.500 Class III Devices Subject To 515 (b) Requirements - 300.750
Human-Labeled Drugs Distributed & Used in Animal Medicine - 608.100 Returned Antibiotics Exported Under 801(d)of The Act - 405.210
Peaches, Canned, Frozen -- Adulteration Due to Insects and Mold - 550.650 Unapproved Additives for Exported Grains - 578.600
Peanuts, Shelled and Unshelled - Filth and Reject Nuts - 570.350 EXPOSURE
Process Validation Requirements for Drug Products - 490.100 Action Levels for Aflatoxin in Animal Feeds - 683.100
Proper Drug Use and Residue Avoidance - 615.200 Assemblers Who Install Noncompliant Equipment - 398.325
Raisins - Adulteration Involving Mold, Sand, Grit, & Insects - 550.750 Assessment of Civil Penalties - 390.300
Recycled Animal Waste - 685.100 Automatic Adjustment of the X-Ray Field Size - 398.400
Regulatory Actions and Small Business - 160.100 Blood and Blood Products - Definitions - 230.100
Regulatory Action Regarding Approved New Drugs - 446.100 Dimethylnitrosamine in Malt Beverages - 510.600
Rendered Animal Feed Ingredients - 675.400 Hazardous Diagnostic X-Ray Systems - 398.200
Responsibility for Reporting Violations - 100.100 Lasers for Facelift, Wrinkle Removal, Acupuncture, etc. - 393.200
RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200 Preservatives; Use in Nonstandardized Foods; Label Declaration - 562.600
Salt-Cured, Air-Dried, Uneviscerated Fish - 540.650 Salmonella Contamination of Dry Dog Food - 690.700
Tomato Products - Drosophila Fly Eggs and Maggots - 585.890 Sunlamp Performance Standard - 396.100
Vitamin B-15, Pangamic Acid and Pangamic Acid Products - 457.100 Use of DDVP (Vapona) Strips in Milkhouses and Milkrooms - 527.600
ERYTHEMA Volatile N-Nitrosamine in Rubber Baby Bottle Nipples - 500.450
Sunlamp Performance Standard - 396.100 Whole Milk, Low Fat Milk, Skim Milk - Aflatoxin M1 - 527.400
ESCHERICHIA COLI EXPOSURE RATE
Crabmeat - Adulteration with Filth - Escherichia Coli - 540.275 Assemblers Who Install Nocompliant Equipment - 398.325
Raw Breaded Shrimp - Microbiological - 540.420 EXTEMPORANEOUSLY COMPOUNDED OTC PRODUCTS
Tree Nuts - Escherichia Coli - 570.450 Homeopathic Drugs - 400.400
ESSENTIAL ACCESSORY EXTERIOR SURFACE

414
Compliance Policy Guides Index
Warning Label Required on Sunlamp Products - 396.400 Silage Ingredients - 687.500
EXTRACTED FOOD ANTIGENS The Use of Antibiotic Drug Residue By-Products - 682.200
Cytotoxic Testing For Allergic Diseases - 370.100 Unfermented Beverages "Champagne" - 510.300
EXTRACTS Vinegar, Definitions with Vinegar Eels - 525.825
Allergenic Extracts Containing Glycerin - 270.100 FIELD LIMITATION AND ALIGNMENT
Bouillon, Bouillon Cubes, Granulated Bouillon - 567.300 Automatic Adjustment of the X-Ray Field Size - 398.400
Dealcoholized\Wine Malt Beverages - Labeling - 510.400 FIELD PEAS
Inert Glandular Preparations - OTC - 455.100 Black-Eyed Peas - 585.225
Intermediate or End Products of Sample Analysis - 150.100 FIELD SURVEILLANCE ACTIVITIES
Lack of Expiration Date or Stability Data - 480.300 Defective Suntanning Booths & Beds - 396.300
Malt Products - 515.200 FIELD TESTING
EXTRA-LABEL Assemblers Who Install Noncompliant Equipment - 398.325
Extra Label Use of New Pet Drugs - 615.100 FIG PASTE
Proper Drug Use Residue Avoidance - 615.200 Insect Infestation - 550.350
Unapproved New Animal Drugs - 625.300 FIGS
EXTREMITIES Insect Infestation - 550.350
Positive Beam Limitation (PBL) Requirements - 398.450 Pesticide Residues - 575.100
EXTRAORAL IMAGE RECEPTORS FILBERTS
Definition of General Purpose Radiographic X-Ray Tree Nuts-Adulteration for Rejects - 570.425
System - 398.100 FILLETS
EYE INFLAMMATION Fish-Adulteration Decomposition - 540.575
Mercury Vapor Lamps--Not Self-Extinguishing - 391.200 Fish by Parasites - 540.590
FAA ACT Identity of Foods - 562.450
Labeling-Diluted Wines & Cider w/ < 7%Alcohol - 510.450 FILM WRAPPERS
FACIAL Tamper-Resistant Packaging Requirements - 450.500
Facial Tissue, Paper Napkins, Paper Towels, etc. - 100.600 FILTH- See attached list
Lasers for Facelift, Wrinkle Removal, Acupuncture, etc - 393.200 Apple Butter - Adulteration with Mold; Rodent Filth, Insects - 550.100
FACIAL CARE ESTABLISHMENTS Apricot, Peach and Pear Nectars and Purees - Mold - 550.155
Lasers for Facelift, Wrinkle Removal, Acupuncture, etc. - 393.200 Articles of Foreign Origin Not Intended for Entry - 110.700
FACSIMILE Asparagus, Canned or Frozen - Adulteration with Insect Filth - 585.150
Canned Peas - Label Designation of Sizes - 585.625 Bay (Laurel) Leaves - Insect Filth; Mold; Mammalian etc - 525.150
Food Storage & Warehousing -Adulteration-Filth - 580.100 Capsicum Pods, Etc. - Adulteration - 525.200
Guaranties Over Printed Signatures - 100.800 Cheese and Cheese Products - Adulteration with Filth - 527.200
Tamper-Resistant Packaging Requirements - 450.500 Chocolate & Chocolate Liquor - Adulteration - 515.700
FACTORY-BASED MANUFACTURERS AND ASSEMBLERS Citrus Fruit Juices, Canned - Fly Filth and Mold - 550.250
Obligations of Factory-Based Manufacturers & Assemblers - 398.375 Cocoa Powder, Press Cake - Insect and Rodent Filth and Shell - 515.775
FAILURE ANALYSIS RECORDS Coffee and Cocoa Bean Sweeps - 560.350
Reloaders of X-ray Tube Housing Assemblies - 398.700 Corn Husks (for Tamales) - Adulteration with Filth - 585.350
FAIR PACKAGING AND LABELING ACT Corn Meal - Adulteration by Insect and Rodent Filth - 578.200
Antipasto, Common or Usual Name - 567.100 Crabmeat - Adulteration with Filth - Escherichia coli - 540.275
Beverage Bases - 510.100 Curry Powder - Adulteration by Insect and Rodent Filth - 525.330
Confectionery Decorations - 545.200 Diversion of Adulterated Food to Acceptable Animal Feed Use - 675.200
Food Distributed in Puerto Rico - 562.750 Dried Prunes, Dehydrated Low Moisture Prunes, and Pitted Prunes - 550.700
Labeling Diluted Wines and Cider - 510.450 Food Storage & Warehousing - Adulteration-Filth - 580.100
Pumpkin Articles from Squash - 585.725 Foods - Adulteration Involving Infestation and 1080 Rodenticide - 555.450
Starches-Common or Usual Names - 578.100 Foods, Rail Car Sanitation - Adulteration - 545.300
FAST TURNAROUND TIME Green Coffee Beans - Adulteration with Insects; Mold - 510.500
Reloaders of X-Ray Tube Housing Assemblies - 398.700 Intermediate or End Products of Sample Analysis - 150.100
FAT Interpretation of Insect Filth in Foods - 555.600
Butter Adulteration - 527.100 Leafy Spices, Other Than Bay Leaves - 525.500
Cheese Misbranding - 527.225 Macaroni and Noodle Products - 505.500
Hollandaise Sauce - 525.400 Mace - Insect Filth; Mold, Foreign Matter; Mammalian Excreta - 525.550
Nutritional Supplements for Animals - 690.100 Marjoram - 525.900
Oleomargarine-Misbranding - 535.100 Oregano - 525.850
Pesticide Residues in Food and Feed - 575.100 Peanut Butter - Adulteration with Filth; Grit - 570.300
Potato Chips, Ingredients-Labeling - 585.710 Peanuts, Shelled and Unshelled - Filth and Reject Nuts - 570.350
Prepared Mustard, Composition - 525.575 Popcorn - Adulteration with Rodent Filth and Field Corn - 585.675
Red Meat with PCB's - 565.200 Proper Drug Use and Residue Avoidance - 615.200
Rendered Animal Feed Ingredients - 675.400 Raw Sugar - 515.400
Seafood Products - 540.700 Reconditioning of Foods Adulterated Under 402(a)(4) - 160.700
Whole Low and Skim Milk - 527.400 Reconditioning - Tree Nuts Contaminated with E. coli - 570.550
FATTY ACID Rodent Contaminated Pet Foods - 690.600
Nutritional Supplements for Pets - 690.100 Sage - 525.950
FD&C ACT Sesame Seeds - Adulteration - 525.700
Origin of Country Labeling - 560.200 Thyme - 525.925
FDA JURISDICTION Tree Nuts - Escherichia coli - 570.450
Certificate for Exports - 110.100 Water-Damaged Food Products - 555.850
Condoms; Defects-Criteria for Direct Reference Seizure - 345.100 Wheat - Adulteration by Insect and Rodent Filth - 578.300
Country of Origin Labeling - 560.200 Whole and Ground Pepper - Adulteration - 525.625
On Indian Reservations - 100.350 Whole Ginger - Insect Filth; Mold; Mammalian Excreta - 525.375
Over Meat & Poultry Products - 565.100 Whole Cassia or Whole Cinnamon, Ground Cinnamon - 525.225
Products Composed of Interstate Ingredients - 100.200 Whole and Ground Nutmeg - Insect Filth; Mold; Rodent Filth - 525.600
Recondition-New Animal Drugs Seized Under 501(a)(5) - 625.400 Whole and Ground Allspice - Mold; Insect and Rodent Filth - 525.100
FEDERAL TRADE COMMISSION (FTC) FILTRATION
Cytotoxic Testing For Allergic Diseases - 370.100 Parametric Release of Terminally Heat Sterilized Drugs - 460.800
Health Fraud - 120.500 Vinegar, Definitions-Adulteration w/ Vinegar Eels - 525.825
FENNEL SEED FINAL CLASSIFICATION
Spices - Definition - 525.750 Class III Devices Subject to 515 (b) Requirements - 300.750
FENUGREEK FINAL COMPLIANCE TEST
Spices - Definition - 525.750 Retention of Microwave Oven Test Records - 394.100
FERMENTATION FINISHED UNITS
Alcohol Use of Synthetic Alcohol in Foods - 555.100 Records & Reports-Applicability-21 CFR 1002.1 - 390.425
Dealcoholized Wine Labeling - 510.400 FISH - FRESH AND FROZEN
Direct-Fed Microbial Products - 689.100 Fish-Fresh and Frozen-Adulteration Involving Decomposition - 540.575
Maraschino Cherries - 550.550 Fish - Fresh and Frozen, as Listed - Adulteration by Parasites - 540.590
Sauerkraut-Adulteration by Thrips - 585.750 FISH FLAKES

415
Index Compliance Policy Guides
Crabmeat Product Labeling - 540.285 Pistachio Nuts - Aflatoxin Adulteration - 570.500
FIXED SID FOODS
Definition of General Purpose Radiographic X-Ray System - 398.100 FPLA Compliance - 562.200
X-Ray Field Size for Spot-Film - 398.475 FOODS - NET WEIGHT
FLATWARE Cheese & Cheese Products - Misbranding Involving Net Contents - 527.250
Pottery Cadmium Contamination - 545.400 Corn on the Cob, Canned - Quantity of Contents Declaration - 585.325
Pottery Lead Contamination - 545.450 Foods - Net Weight - 562.300
FLAVORING AGENTS Lingon Berries, Canned - Adulteration by Insects - 550.500
Denture Cleaners, Adhesives, & Repair Materials - 315.200 Metric Declarations of Quantity of Contents - 140.500
FLAVORINGS Mixed Nuts - Misbranding Involving Food Standards - 570.700
Bakery Products - 505.100 Mixed Nuts - Misbranding Involving Food Standards - 570.700
Labeling of Seasonings - 525.650 FOODS-PRODUCING ANIMALS
Spices - Definitions - 525.750 Alternate Feeding of Medicated Feeds - 666.100
FLEXIBILITY Extra-Label Use of Pet Drugs in Pets - 615.100
Automatic Adjustment of X-Ray Field Size - 398.400 Human-Labeled Drugs in Pet Medicine - 608.100
Computerized Drug Processing-Input/Output Checking - 425.400 Illegal Sales of Veterinary Prescription Drugs - 608.500
Regulatory Actions & Small Business - 160.100 Proper Drug Use and Residue Avoidance - 615.200
FLOUNDER Use of Antibiotic Drug Residue - 682.200
Crabmeat Products Labeling - 540.285 Unsafe Contamination of Pet Feed Carryover - 680.500
FLUID-BORNE INFECTIOUS AGENTS FOODS - STANDARDIZED
Surgeons' Gloves and Patient Examination Gloves - 335.700 Enriched or Fortified Foods - 555.550
FLUOROSCOPIC Fortification of Juices - 510.700
Assemblers Who Install Noncompliant Equipment - 398.325 Honey Bread, Honey Buns - 505.350
Automatic Adjustment of X-Ray Field Size - 398.400 Malted Milk - 527.500
X-Ray Field Size for Spot-Film - 398.475 FOOT ROT
FLUOROSCOPIST Ethylenediamine Dihydroiodide - 651.100
Automatic Adjustment of X-Ray Field Size - 398.400 FOREIGN
FLY FILTH Acupuncture Devices and Accessories - 305.100
In Citrus Fruit Juices - 550.250 Articles of Foreign Origin Not Intended for Entry - 110.700
FOOD ADDITIVE Bouillon, Bouillon Cubes, Granulated Bouillon - 567.300
Ammoniated Cottonseed Meal - 670.500 Brandy Containing Methyl Alcohol - Food Additive - 510.200
Approved by FDA - 510.200 Certificate for Exports - 110.100
Brandy Containing Methyl Alcohol - 510.200 Exports from U.S. Foreign Trade Zones - 110.200
Confectionery Decorations - 545.200 Food and Drug Guaranty - Imports - 110.500
Direct-Fed Microbial Products - 689.100 Foreign Language Declarations on Food Labels - 562.400
Fraud, Untrue Statements, Facts, Bribery - 120.100 Foreign Trade Zones, Bonded Warehouses or Carriers - 110.600
Imports Identity of Ingredients - 560.250 Homeopathic Drugs - 400.400
Labeling with Directions for Use - 500.100 Importation of Unlabeled Foods -- *21 CFR 101.100(d)* - 560.100
Labeling Directions Necessary - 500.250 Importation of Licensed Biologic Products for Human Use - 210.150
Meat and Poultry - 565.100 Imported Products - Lack of English Labeling - 110.900
Pesticide Residues - 575.100 Imported Milk and Cream. Import Milk Act - 560.400
Pottery Cadmium Contamination - 545.400 Imported Low-Acid Canned Foods - 560.450
Pottery Lead Contamination - 545.450 Mace - Insect Filth; Mold, Foreign Matter; Mammalian Excreta - 525.550
Preservatives; In Nonstandard Foods - 562.600 Metric Declarations of Quantity of Contents - 140.500
Recycled Animal Waste - 685.100 New Drugs - Export - 442.100
Silage Ingredients - 687.500 Olives Stuffed with Minced Pimentos - Labeling - 550.605
Silver-Plated Hollowware Lead - 545.500 Pacemaker Reuse - 310.100
Teat Dips and Udder Washes - 654.200 Pesticide Residues in Food and Feed - 575.100
Vitamin B-15, Pangamic Acid - 457.100 Returned Antibiotics Exported Under 801(d) of the Act - 405.210
Vitamins and Minerals in Feed - 670.200 Sesame Seeds - Adulteration - 525.700
FOOD ADDITIVES - GRAS Surgeons' Gloves and Patient Examination Gloves - 335.700
Food Additives -"GRAS" - 500.200 Unapproved Additives for Exported Grains - 578.600
Safety and Labeling of Waxed (Coated) Fruits and Vegetables - 562.550 Uncertified or Delisted Colors - 587.200
FOOD ADDITIVES - LABELING DIRECTIONS Whole and Ground Pepper - Adulteration - 525.625
Additives Labeling Directions - 500.100 FOREIGN MATTER
Approved by FDA - 500.300 Mace Filth; Mold, Mammalian Excreta - 525.550
Food Additives Labeling Directions - 500.250 Sesame Seeds - 525.700
FOOD, ADULTERATED - MIXED WITH GOOD FOOD Whole and Ground Pepper - 525.625
Adulterated Food Mixed w/ Good Food - 555.200 FOREIGN NAMES
Diversion-Adulterated Food to Acceptable Animal Feed Use - 675.200 Foreign Language of Food Labels - 562.400
Proper Drug Use & Residue Avoidance - 615.200 FOREIGN PROTEIN MATTER
Seeds for Sprouting Prior to Food Use - 555.750 Pacemaker Reuse - 310.100
FOOD LABELS - FOREIGN LANGUAGE DECLARATION FORMULATION
Foreign Language Declarations - 562.400 Certificate for Exports - 110.100
FOOD STORAGE - WAREHOUSING Large Volume Parenteral (LVPs) for Animal Use - 635.100
Adulteration Filth - 580.100 Marketed New Drugs w/oApprovd NDAs - 440.100
Cocoa Beans Mold Filth - 515.750 Nutritional Supplements for Companion Animals - 690.100
Coffee and Cocoa Bean Sweeps - 560.350 OTC Anti-Obesity Preparations - 456.100
Green Coffee Beans - 510.500 Processed and/or Blended Seafood Products - 540.700
Interpretation of Filth in Foods - 555.600 Source Code for Process Control Application Programs - 425.300
Rodent Contaminated Pet Foods - 690.600 Urinary Preparations-Lack of Rx Legend-Claims - 430.400
FOOD, WATER DAMAGED FORTIFIED
Water Damaged Food Products - 555.850 Enriched or Fortified Foods-Potency - 555.550
FOODS Fortification of Juices - 510.700
Action Levels for Aflatoxin in Pet Feeds - 683.100 Imported Milk and Cream - 560.400
Enriched of Fortified Foods - 555.550 FRACTIONATION
Foods, Adulteration with Aflatoxin - 555.400 Blood & Blood Products - Definitions - 230.100
Foods Adulteration with Salmonella - 555.300 Registration of Blood Banks & Other Firms - 230.110
Moisture Damaged Grain - 675.300 Source Plasma - Syphilis - 254.100
Salmonella Contamination of Dry Dog Food - 690.700 FRAUD
FOODS - ADULTERATION INVOLVING MISBRANDING Articles of Foreign Origin Not Intended for Entry - 110.700
Enriched or Fortified Foods - Potency - 555.550 Electrical Muscle Stimulators - 355.200
FOODS - ADULTERATION WITH AFLATOXIN Fraud, Untrue Statements of Material Facts, Bribery - 120.100
Action Levels for Aflatoxin in Animal Feeds - 683.100 Health Fraud - 120.500
Brazil Nuts - Adulteration with Aflatoxin - 570.200 Homeopathic Drugs - 400.400
Foods, Adulteration with Aflatoxin - 555.400 Hypnotherapy Devices - Self Hypnotic Tape Recordings - 335.300

416
Compliance Policy Guides Index
Ineffective Devices - 502(f)(l) Labeling Requirements - 300.300 Standardized Canned Fruit - Packing Medium - 550.800
Ion Generating Devices - 355.300 FRUIT PEEL
Orders for Post-Approval Record Reviews - 470.100 Marmalade - 550.575
FREE FULL RESPONSIBILITY
Foods - FPLA Compliance - 562.200 Reuse of Medical Disposable Devices - 300.500
Identity of Foods - 562.450 FULLY ASSEMBLED UNIT
Metric Declarations of Contents - 140.500 Retention of Microwave Oven Test Records - 394.100
Water in Food Products - 555.875 FURAZOLIDONE
FREEDOM FROM HAZARD Extra-Label use of New Pet Drugs - 615.100
Sunlamp Performance Standard - 396.100 Unsafe Contamination of Pet Feed Carryover - 680.500
FREEDOM OF INFORMATION (FOI) GAS CHROMATOGRAPH
Regulatory Actions and Small Business - 160.100 RIA Analysis of Hair to Detect Presence-Drugs of Abuse - 370.200
Statements Regarding NADA Approval - 605.100 GASTROENTERITIS
FREESTONE PEACHES Immune Milk - 275.100
Canned Misbranding Food Products - 550.655 GELATIN
FREEZE DRIED Silver Plated Hollowware - 545.500
FDA Over Meat & Poultry Products - 565.100 Tamper Resistant Packaging - 450.500
Mushrooms, Canned or Dried - 585.500 GELATIN CAPSULE PRODUCTS
FRESH Tamper-Resistant Packaging Requirements - 450.500
Cherries - 550.225 GENERAL COUNSEL
Classification of Establishments - 555.500 Ammoniated Cottonseed Meal - Interpretation of 21 CFR 573.140 - 670.500
Crabmeat Filth Coli - 540.275 Answering Inquiries on Status of Criminal Referrals - 160.500
Fish Adulteration by Parasites - 540.590 Chloramphenicol - 654.300
Fish Decomposition - 540.300 Cocoa Beans - Mold, Insect Infestation, and Mammalian Excreta - 515.750
Identify of Foods - 562.450 Dentures -- Sale by Persons Not Licensed to Practice dentistry - 315.100
Peas and Carrots Labeling - 585.600 Direct Reference Authority for Pseudomonas Contamination - 590.300
Pesticide Residues in Food Feed - 575.100 FDA Jurisdiction Over Meat and Poultry Products - 565.100
Shrimp - 540.400 Food Storage & Warehousing - Adulteration - Filth - 580.100
Sugar Water Damaged - 515.425 Foods, Rail Car Sanitation - Adulteration - 545.300
Time Period Separation of Platelets - 231.120 Imported Products - Lack of English Labeling - 110.900
Use of Units Which Have Been Thawed - 253.100 Natural Bristle Brushes -- Nit Contamination - 590.400
FRESHENING THE MOUTH Popcorn - Adulteration with Rodent Filth and Field Corn - 585.675
Denture Cleaners, Adhesives, Cushions, and Repair Materials Rodent Contaminated Pet Foods - 690.600
- 315.200 Tomato Products - Adulteration with Mold - 585.900
FROZEN GENERAL LABELING REQUIREMENTS
Asparagus, Canned Frozen Filth - 585.150 Homeopathic Drugs - 400.400
Broccoli, Adulteration with Insects - 585.260 GENERAL PUBLIC
Brussels Sprouts, Insects - 585.275 Class I Recalls of Rx Drugs - 400.900
Canned and Cooked Shrimp - 560.650 Electrical Muscle Stimulators - 355.200
Cherries - 550.225 Mail-Order Filing of Prescriptions - 460.450
Crabmeat Filth E. coli - 540.275 Mercury Vapor Lamps--Not Self-Extinguishing - 391.200
Drupelet Berries - 550.200 Unit Dose Labeling for Solid & Liquid Oral Dose Forms - 430.100
Eggs and Egg Products Decomposition - 537.100 GENERAL PURPOSE RADIOGRAPHIC X-RAY SYSTEM
Fish Adulteration/Decomposition - 540.575 Definition - 398.100
Fish Adulteration by Parasites - 540.590 GENERAL TESTS
Identity of Foods - 562.450 Expiration Dating of Unit Dose Repackaged Drugs - 480.200
Imitation Breaded Shrimp - 540.450 Unit Dose Labeling for Solid & Liquid Oral Dose Forms - 430.100
Immune Milk - 275.100 GENERALLY RECOGNIZED AS SAFE (GRAS)
Imported Milk and Cream - 560.400 Ethylenediamine Dihydroiodide (EDDI) - 651.100
Imported Frozen Products - 560.700 Food Additives-"GRAS" - 500.200
Metric Declarations of Contents - 140.500 Recycled Animal Waste - 685.100
Peaches, Canned, Frozen Insects - 550.650 Silage Ingredients - 687.500
Peas and Carrots, Labeling - 585.600 Spices Definitions - 525.750
Pesticide Residues in Food and Feed - 575.100 Teat Dips and Udder Washes - 654.200
Pet Food Labeling - 690.200 Vitamins and Minerals in Feed - 670.200
Raw Breaded Shrimp-Microbiological - 540.420 Waxed Fruits - 562.550
Seafood Products - 540.700 GENERIC
Shrimp- Raw, Breaded - 540.410 Crab & Crabmeat Products w/Other Seafood-Labeling - 540.285
Shrimp-Fresh Frozen - 540.400 Fraud, Untrue Statements of Material Facts, Bribery - 120.100
Spinach Insects, Decomposition - 585.775 Manufacturer, Distribution, Promotion of Drugs by Pharmacies - 460.200
Strawberries Sand, Mold - 550.850 Orders for Post-Approved Record Reviews - 470.100
Time Period Separation of Platelets - 231.120 Water & Gravy in Pet Food - 690.400
Uncooked Meat for Animal Food - 690.500 GENTIAN VIOLET
Use of Units Thawed - 253.100 Unapproved Additives - 578.600
FRUCTOSE GEOGRAPHICAL ORIGIN OF A FOOD
Fructose-Containing Drugs - 400.335 Country of Origin Labeling - 560.200
Jerusalem Artichoke-Common or Usual Name - 585.100 GINGER
FRUIT Spices-Definition - 525.750
Alcohol; Use of Synthetic Alcohol in Foods - 555.100 Whole Ginger- Filth - 525.375
Apricot, Peach and Pear Nectars and Purees - Mold - 550.155 GLANDULAR PREPARATION
Apricots - Canned - Adulteration with Insects - 550.150 Inert Glandular Preparations - OTC - 455.100
Bakery Products, Candy "Shotgun" Ingredients Declaration - 505.100 GLUCOSE VINEGAR
Candied Citron - Labeling - 515.600 Vinegar, Definitions Vinegar Eels - 525.825
Citrus Fruit Juices, Canned - Fly Filth and Mold - 550.250 GLYCERIN
Dealcoholized Wine *and Malt Beverages* - Labeling - 510.400 Allergenic Extracts Containing Glycerin - 270.100
Drupelet Berries (Blackberries, Raspberries, Etc.) - 550.200 Malt Products - 515.200
Figs; Fig Paste - Insect Infestation; Mold, Dirt - 550.350 GLYCOSIDE SINIGRIN
Grenadine - 550.400 Spices - Definitions - 525.750
Jams, Jellies and Related Products - Imports - 560.500 GOLDEN BLEACHED RAISINS
Jellies, Nonstandardized - 550.475 Raisins-Adulteration with Filth - 550.750
Marmalade - 550.575 GOOD MANUFACTURING PRACTICE REGULATIONS
Olives - Adulteration Involving Pits; Rot; Insect Infestation - 550.600 CGMP Applicability to Hardware and Software - 425.100
Peaches, Canned, Frozen--Adulteration Due to Insects and Mold - 550.650 Compressed Medical Gases -- Warning Letters - 435.100
Pineapple, Canned; Imported and Domestic - Food Standards - 550.685 Computerized Drug Processing -- Input/Output Checking - 425.400
Pottery (Ceramics) - Lead Contamination - 545.450 Computerized Drug Processing -- I.D. of "Persons" - 425.500
Spices - Definitions - 525.750 Content Uniformity Testing of Tablets and Capsules - 460.600

417
Index Compliance Policy Guides
Control/Accountability of TRP Materials - 450.550 HAIR SAMPLE
Expiration Dating of Unit Dose Repackaged Drugs - 480.200 RIA Analysis-Hair to Detect Presence of Drugs of Abuse - 370.200
Finished Dosage Form Drugs in Bulk Containers - 410.100 HALVED
Lack of Expiration Date or Stability Data - 480.300 Olives-Adulteration Involving Pits; Rot; Insect infestation - 550.600
Orders for Post-Approval Record Reviews - 470.100 HARDENER
Raw Breaded Shrimp - Microbiological - 540.420 Denture Cleaners, Adhesives, & Repair Materials - 315.200
Reconditioning of Articles Found in Violation of GMP's - 160.750 HAZARD
Source Code for Process Control Application Programs - 425.300 Adulteration of Drugs under Sec. 501(b) and 501(c) - 420.100
Unsafe Contamination of Animal Feed from Drug Carryover - 680.500 Articles of Foreign Origin Not Intended for Entry - 110.700
GOUDA Canned Pet Food - 690.300
Cheese Misbranded Due to Moisture & Fat - 527.225 CGMP Enforcement Policy - OTC vs Rx Drugs - 450.100
GOVERNMENT WIDE QUALITY ASSURANCE PROGRAM Clams, Mussels, Oysters - Paralytic Shellfish Poison - 540.250
Compendial Requirements - 420.400 Communicable Disease Hazards - 100.300
GWQAP Pre-Award Evaluation - 100.700 Contamination of Devices Labeled as Sterile - 300.400
GOVERNMENT-WIDE Defective Suntanning Booths and Beds - 396.300
Consistent Application of CGMP Determinations - 400.200 Hazardous Diagnostic X-Ray Systems - 398.200
GWQAP Pre-Award Evaluation - 100.700 Health Fraud - 120.500
Compendial Requirements - 420.400 Identical or Similar Product Names - 400.500
GOVERNMENTS Importation of Television Receivers and Microwave Ovens - 394.500
Certification for Exports - 110.100 Karaya Gum Powder and Related Devices for Use by Ostomates - 325.100
Common or Usual Names for Animal Feed Ingredients - 665.100 Lasers for Facelift, Wrinkle Removal, Acupuncture, Etc. - 393.200
Imitation Breaded Shrimp - 540.450 Nutritional Supplements for Companion Animals - 690.100
Imported Milk and Cream Import Milk Act - 560.400 OTC Drugs - Combination Products - 450.300
Lay Use of Veterinary Prescription Drugs - 608.300 OTC Drugs - Recognition as Safe and Effective - 450.200
Responsibility for Reporting Violations - 100.100 Pottery (Ceramics) - Cadmium Contamination- 545.400
Water-Damaged Food Products - 555.850 Pottery (Ceramics) - Lead Contamination - 545.450
GRADE 'A' PASTEURIZED MILK ORDINANCE Recycled Animal Waste - 685.100
Acetic Acid-Use in Foods - 562.100 Rendered Animal Feed Ingredients - 675.400
Antibiotic Drug Residue by Products - 682.200 Responsibility for Illegal Drug Residues in Meat, Milk and Eggs - 615.300
Canned Peas-Label Designation of Sizes - 585.625 Responsibility for Reporting Violations - 100.100
Dimethyl Sulfoxide for Animal Use - 654.100 Salmonella Contamination of Dry Dog Food - 690.700
Eggnog; Eggnog Flavored Milk - 527.350 Salt-Cured, Air-Dried, Uneviscerated Fish - 540.650
Food Additives "GRAS" - 500.200 Sequencing in Medicated Feed Production - 680.600
Food Additives Labeling Directions - 500.250 Silver-Plated Hollowware - Lead Contamination - 545.500
Green Coffee Beans, Mold - 510.500 Source Plasma - Overbleeding - 398.450
Imported Milk and Cream - 560.400 Sphygmomanometers - Rx Legend - 310.200
Peas and Beans; Dried Rocks - 585.575 Sunlamp Performance Standard - 396.100
Preservatives; Label Declaration - 562.600 Uncooked Meat for Animal Food - 690.500
Responsibility for Reporting Violations - 100.100 Unsafe Contamination of Animal Feed from Drug Carryover - 680.500 Vitamins
Teat Dips and Udder Washes - 654.200 and Minerals in Feed - 670.200
GRAIN VINEGAR Whole Milk, Low Fat Milk, Skim Milk - Aflatoxin M1 - 527.400
Vinegar, Definitions - 525.825 Wigs - 590.600
GRANULAR HAZARDOUS UNITS
Bouillon, Bouillon Cubes - 567.300 Defective Suntanning Booths & Beds - 396.300
Cheese - 527.225 HBSAG TEST KITS
GLUCOSE Blood & Blood Products - Definitions - 230.100
Fructose-Containing Drugs - 400.335 HEAD AND NECK
LVP's for Animal Use - 635.100 Definition-General Purpose Radiographic X-Ray System - 398.100
Malt Products - 515.200 Positive Beam Limitation (PBC) Requirements - 398.450
Vinegar, Definitions with Vinegar Eels - 525.825 HEALTH
GRAPE JUICE Action Levels for Aflatoxins in Animal Feeds - 683.100
Unfermented Beverages - 510.300 Acupuncture Devices and Accessories - 305.100
GRAPE VINEGAR Adulteration of Drugs under Sec. 501(b) and 501(c) - 420.100
Vinegar, Definitions - 525.825 Articles of Foreign Origin Not Intended for Entry - 110.700
GRATUITIES Assemblers Who Install Noncompliant Equipment - 398.325
Fraud, Untrue Statements of Material Fact, Bribery - 120.100 Assessment of Civil Penalties - 390.300
GREEN BEANS, CANNED Automatic Adjustment of the X-Ray Field Size - 398.400
Canned Wax Beans - 585.475 Barking Dog Collars - 655.300
GREEN COFFEE BEANS Biological Drugs for Animal Use - 645.100
Adulteration with Filth - 510.500 Blood and Blood Products - Definitions - 230.100
Reconditioning - 560.300 Candy - Mixed with Trinkets and Sold in Vending Machines - 515.350
GREENS, CANNED Canned Pet Food - 690.300
Adulteration by Mildew - 585.450 Certification for Export - 110.100
GRIT Certification and Identification of X-Ray Components - 398.600
Cumin Seed Adulteration - 525.325 Clams, Mussels, Oysters - Paralytic Shellfish Poison - 540.250
Menstrual Sponges - 345.300 Class III Devices Subject to 5l5(b) Requirements - 750.350
Peanut Butter Adulteration - 570.300 Collection and Charitable Distribution of Drugs - 400.800
Raisins Adulteration - 550.750 Communicable Disease Hazards - 100.300
GROSS NEGLIGENCE Confectionery - Use of Nonnutritive Substances as Ingredients - 515.100
Assemblers Who Install Noncompliant Equipment - 398.325 Contamination of Devices Labeled as Sterile - 300.400
GROUND CAPSICUMS Cytotoxic Testing for Allergic Diseases - 370.100
Capsicum Pods- Adulteration - 525.200 Decomp. & Histamine in Albacore, Skipjack & Yellowfin Tuna - 540.525
GROUND OREGANO Defective Suntanning Booths and Beds - 396.300
Labeling of Seasonings - 525.650 Definition of "Commerce" - 21 CFR 1000.3(g) - 390.100
Oregano - 525.850 Definition of General Purpose Radiographic X-Ray System - 398.100
GROUND PAPRIKA Definition of "High-Voltage Vacuum Switch - 390.500
Capsicum Pods - Adulteration - 525.200 Dentures -- Sale by Persons Not Licensed to Practice Dentistry - 315.100
GRUYERE Determination by Secretary that Product Fails to Comply - 390.200
Cheese - 527.225 Direct Reference Authority for Class III Medical Devices - 300.700
GUARANTY Diversion of Contaminated Food for Animal Use - 675.100
Food & Drug Guaranty - Imports - 110.500 Drug Product Entries in Periodic Publications - 400.700
Guaranties Over Printed Signatures - 100.800 Early Correction of Defects or Noncompliance - 390.225
HABIT CORRECTION Eggnog; Eggnog Flavored Milk--Common Usual Names - 527.350
Hypnotherapy Devices-Self-Hypnotic Tape Recordings - 335.300 Electrical Muscle Stimulators - 355.200
HAIR LOSS Electronic Products Subject to 21 CFR 1001.15(a) - 390.400
Hypnotherapy Devices-Self-Hypnotic Tape Recordings - 335.300 Exemption for Certain Sunlamp Product Purchaser Records -396.300

418
Compliance Policy Guides Index
Expiration Dating of Unit Dose Repackaged Drugs - 480.200 Surgeon's Gloves & Patient Examination Gloves - 335.700
Extra-Label Use of New Animal Drugs in Food-Producing Animals - 615.100 HEALTH CENTERS
FDA Jurisdiction Over Meat and Poultry Products - 565.100 Cytotoxic Testing For Allergic Diseases - 370.100
Foods, Except Dairy Products - Adulteration with Salmonella - 555.300 HEALTH FRAUD
Fortification of Standardized Juices - 510.700 Electrical Muscle Stimulators - 355.200
Fraud, Untrue Statements of Material Facts, - 120.100, Health Fraud - 120.500
Hazardous Diagnostic X-Ray Systems - 398.200 Homeopathic Drugs - 400.400
Health Fraud - 120.500 Hypnotherapy Devices-Self-Hypnotic Tape Recordings - 335.300
Homeopathic Drugs - 400.400 Ineffective Devices-502(f)(l) Labeling Requiremts - 300.300
Human-Labeled Drugs Distributed & Used in Animal Medicine - 608.100 Ion Generating Devices - 355.300
Human Blood and Blood Products as Drugs - 230.120 HEALTH HAZARD
Hypnotherapy Devices - Self Hypnotic Tape Recordings - 335.300 Adulteration of Drugs under Sec. 501(b) and 501(c) - 420.100
Identical or Similar Product Names - 400.500 Articles of Foreign Origin not Intended for Entry - 110.700
Illegal Sales of Veterinary Prescription Drugs - 608.500 Clams, Mussels, Oysters - Paralytic Shellfish Poison - 540.250
Immune Milk - 275.100 Communicable Disease Hazards - 100.300
Importation of Television Receivers and Microwave Ovens - 394.500 Contamination of Devices Labeled as Sterile - 300.400
Imported Low-Acid Canned Foods - 560.450 Defective Suntanning Booths and Beds - 396.300
Imported Milk and Cream Import Milk Act - 560.400 Hazardous Diagnostic X-Ray Systems - 398.200
Ineffective Devices - 502(f)(l) Labeling Requirements - 300.300 Health Fraud - 120.500
Inspection of Manufacturers of Device Components - 300.100 Identical or Similar Product Names - 400.500
Intermediate or End Products of Sample Analysis - 150.100 Importation of Television Receivers and Microwave Ovens - 394.500
Ion Generating Devices - 355.100 Lasers for Facelift, Wrinkle Removal, Acupuncture, Etc. - 393.200
Jams, Jellies and Related Products - Imports - 560.500 Nutritional Supplements for Companion Animals - 690.100
Karaya Gum Powder and Related Devices for Use by Ostomates - 325.100 OTC Drugs - Combination Products - 450.300
Laser Light Shows, etc. - 393.100 OTC Drugs - Recognition as Safe and Effective - 450.200
Lasers for Facelift, Wrinkle Removal, Acupuncture, Etc. - 393.200 Recycled Animal Waste - 685.100
Literature for High-Intensity Mercury Vapor Lamps - 391.100 Rendered Animal Feed Ingredients - 675.400
Manufacture, Distribution, Promotion of Drugs by Pharmacies -460.200 Responsibility for Reporting Violations - 100.100
Marketed New Drugs Without Approved NDAs - 440.100 Responsibility for Illegal Drug Residues in Meat, Milk and Eggs - 615.300
Medical Emergencies - 220.100 Salt-Cured, Air-Dried, Uneviscerated Fish - 540.650
Menstrual Sponges - 345.300 Sequencing in Medicated Feed Production - 680.600
Mercury Vapor Lamps that are Not Self-Extinguishing - 391.200 Source Plasma - Overbleeding - 252.100
Milk and Milk Products Containing Penicillin - 527.450 Sphygmomanometers - Rx Legend - 310.200
Nutritional Supplements for Companion Animals - 655.300 Uncooked Meat for Animal Food - 690.500
Obligations of Factory-Based Manufacturers and Assemblers - 398.375 Unsafe Contamination of Animal Feed from Drug Carry-Over - 680.500
OTC Drugs - Combination Products - 450.300 Vitamins and Minerals in Feed - 670.200
OTC Anti-Obesity Preparations - 456.100 Whole Milk, Low Fat Milk, Skim Milk - Aflatoxin M1 - 527.400
OTC Drugs - Recognition as Safe and Effective - 450.200 HEALTH PROFESSIONALS
Override of Positive Beam Limitation - 398.425 Acupuncture Devices & Accessories - 305.100
Pathogens in Dairy Products - 527.300 Drug Product Entries in Periodic Publications - 400.700
Positive Beam Limitation (PBL) Requirements - 398.450 Laser for Facelift, Wrinkle Removal, Acupuncture, etc - 393.200
Pottery (Ceramics) - Lead Contamination - 545.450 Surgeon's Gloves & Patient Examination Gloves - 355.700
Process Validation Requirements for Drug Products - 490.100 HEALTH SPA OWNER OPERATOR
Proper Drug Use and Residue Avoidance - 615.200 Defective Suntanning Booths & Beds - 396.300
Radionuclides in Imported Foods - Levels of Concern - 562.750 HEALTH SPAS
Reconditioning New Drugs Lacking Approved NDA - 448.100 Defective Suntanning Booths & Beds - 396.300
Records and Reports - Applicability - 21 CFR 1002.1 - 390.425 HEARING LOSS
Recycled Animal Waste - 685.100 Hynotherapy Devices-Self-Hypnotic Tape Recordings - 335.300
Red Meat Adulterated with PCB's - 565.200 HEART
Registration of Blood Banks and Other Firms - 230.110 Inert Glandular Preparations - OTC - 455.100
Registration of Assemblers of Diagnostic X-Ray systems - 398.300 HEAT SHRINK BANDS
Regulatory Action Regarding Approved New Drugs - 446.100 Tamper-Resistant Packaging Requirements - 450.500
Regulatory Actions Against Assemblers of X-Ray Equipment - 398.350 HEAT STERILIZED
Reloaders of X-Ray Tube Housing Assemblies - 398.700 Parametric Release of Terminally Heat Sterilized Drugs - 460.800
Rendered Animal Feed Ingredients - 675.400 HEATING VENTILATION AIR CONDITIONING (HVAC)
Responsibility for Illegal Drug Residues in Meat, Milk and Eggs - 615.300 Process Validation Requirements for Drug Products - 490.100
Responsibility for Reporting Violations - 100.100 HEMATOCRIT
Retention of Microwave Oven Test Records - 394.100 Source Plasma - Overbleeding - 252.100
Return of Unused Rx Drugs to Pharmacy Stock - 460.300 HEMOGLOBIN
Reuse of Medical Disposable Devices - 300.500 Oral Iron Products for Baby Pigs - 643.100
Revocation of Tolerances for Cancelled Pesticides - 550.700 Source Plasma -Guidelines for Informed Consent Forms - 250.100
RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 315.100 HEMOLYTIC TRANSFUSION REACTION
Salmonella Contamination of Dry Dog Food - 690.700 Source Plasma Guidelines for Informed Consent Forms - 250.100
Salt-Cured, Air-Dried, Uneviscerated Fish - 540.650 HEMOPHILUS INFLUENZA TYPING SERUM
Sequencing in Medicated Feed Production - 680.600 Standards & Min. Requirements for Biologic Products - 205.100
Source Plasma - Overbleeding - 252.100 HEPARIN SOLUTION
Sphygmomanometers - Rx Legend - 310.200 Source Plasma - Overbleeding - 252.100
Standards and Minimum Requirements for Biologic Products - 205.100 HEPATITIS
Sunlamp Performance Standard - 396.100 Communicable Disease Hazards - 100.300
Surgeons' Gloves and Patient Examination Gloves - 335.700 Registration of Blood Banks & Other Firms - 230.110
Teat Dips and Udder Washes for Dairy Cows and Goats - 654.200 Source Plasma Guidelines for Informed Consent Forms - 250.100
Temporal-Maximum Ultrasonic Power - 397.100 Standards & Minimum Requiremets for Biologic Products - 205.100
Turtles- 170.100 HEPATITIS B
Unapproved Additives for Exported Grains - 578.600 Communicable Disease Hazards - 100.300
Uncooked Meat for Animal Food - 690.500 Standards & Min. Requiremts for Biologic Products - 205.100
Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100 Unsafe HEPATITIS B SURFACE ANTIGEN
Contamination of Animal Feed from Drug Carry-Over - 680.500 Standards & Min.Requiremts for Biologic Products - 205.100
Urinary Preparations - Lack of Rx Legend - Claims - 430.400 HERRING
Vitamins and Minerals in Feed - 670.200 Fish - Adulteration by Parasite - 540.590
Warning Label Required on Sunlamp Products - 396.400 Kipper & Kipper Unsplit - 540.550
Whole Milk, Low Fat Milk, Skim Milk - Aflatoxin M1 - 527.400 HIGH BLOOD PRESSURE
X-Ray Field Size for Spot-Film - 398.475 Hypnotherapy Devices-Self-Hypnotic Tape Recordings - 335.300
HEALTH CARE FINANCING ADMINISTRATION (HCFA) HIGH EFFICIENCY PARTICULATE AIR (HEPA)
Cytotoxic Testing for Allergic Diseases - 370.100 Process Validation Requirements - Drug Products - 490.100
Registration of Blood Banks & Other Firms - 230.110 HIGH-INTENSITY MERCURY VAPOR LAMPS
HEALTH CARE WORKERS Literature for High-Intensity Mercury Vapor Lamps - 391.100

419
Index Compliance Policy Guides
HIGH PRESSURE CYLINDERS Food--Terms Such as Fresh, Frozen, Dried, Canned - 562.450
Compressed Medical Gases -Warning Letters - 435.100 Hollandaise Sauce- Usual Name - 525.400
HIGH VOLTAGE VACUUM SWITCH Homeopathic Drugs - 400.400
Definition - 390.500 Imports - 560.250
HISTAMINE Malted Milk - 527.500
In Albacore, Skipjack & Yellowfin - 540.525 Marmalade - 550.575
HIV Peas and Carrots, Labeling Mixture - 585.600
Surgeon's Gloves & Patient Examination Gloves - 335.700 Prepared Mustard, Composition - 525.575
HOLES Regulatory Action Regarding Approved Drugs - 446.100
Condoms; Defects - 345.100 Repacking of Drug Products -- CGMP's - 430.200
Contamination of Devices Labeled as Sterile - 300.400 Tomato Sauce or Tomato Hot Sauce Labeling - 525.800
Pottery (Ceramics) - Cadmium Contamination - 545.400 IDIOPATHIC THROMBOCYTOPENIC
Pottery (Ceramics) - Lead Contamination - 545.450 Blood & Blood Products - Definitions - 230.100
Silver-Plated Holloware - Lead Contamination - 545.500 ILLEGAL RESIDUES
Surgeon's Gloves & Patient Examination Gloves - 335.700 Alternate Feeding of Medicated Feeds - 666.100
HOLLANDAISE SAUCE Diversion of Adulterated Food in Pet Feed - 675.200
Common or Usual Name - 525.400 Extra-Label Use of New Pet Drug - 615.100
HOLLOWWARE Human-Labeled Drugs Used in Pet Medicine - 608.100
Pottery Cadmium Contamination - 545.400 Proper Drug Use and Residue Avoidance - 615.200
Pottery Lead Contamination - 545.450 Recycled Animal Waste - 685.100
Silver-Plated Lead Contamination - 545.500 Responsibility for Illegal Drug in Meat, Milk - 615.300
HOMARUS AMERICANUS/HOMARUS VULGARIS Sequencing in Medication Feed Production - 680.600
Usual Names for Crustaceans - 540.350 ILLUMINANCE
HOME REMEDY KITS Assemblers Who Install Noncompliant Equipment - 398.325
Homeopathic Drugs - 400.400 INAD
HOME RESPIRATORY CARE COMPANIES (HRC) Availability of Bulk Chemicals for Pet Drug - 625.200
Compressed Medical Gases - Warning Letters - 435.100 Recovery of IND's from Clinical Investigators - 444.100
HOMEOPATHIC DRUGS INJECTABLE
Definition - 400.400 Oral Iron Products for Baby Pigs - 643.100
Lack of Expiration Date or Stability Data - 480.300 OTC Sale of Injectable Animal Drugs - 608.200
HOMEOPATHIC PHARMACOPEIA OF THE UNITED STATES IMAGE-INTENSIFIED FLUOROSCOPY
Homeopathic Drugs - 400.400 X-Ray Field Size for Spot-Film - 398.475
HOMEOTHERAPEUTICS IMITATION
Homeopathic Drugs - 400.400 Imitation Breaded Shrimp - 540.450
HONEY Seafood Products - 540.700
Honey Bread, Honey Buns - 505.350 Maraschino Cherries -550.550
Honey - Source Declaration - 515.300 IMMUNE GLOBULINS
Pesticide Residues - 575.100 Blood & Blood Products - Definitions - 230.100
HOPS IMMUNE SERUM GLOBULIN (HUMAN)
Adulteration with Aphid Infestation - 525.425 Standards & Minimum Requirements for Biologic Products - 205.100
Pesticide Residues in Food and Feed - 575.100 IMMUNIZATION
HORSERADISH Source Plasma -Guidelines for Informed Consent Form - 250.100
Pesticide Residues in Food and Feed - 575.100 Schedule of Physical Examination - 251.100
Spices - 525.750 IMMUNIZATION INJECTIONS
HOSPITAL Schedule of Physical Examination - 251.100
Class I Recalls of Rx Drugs - 400.900 IMMUNODIFFUSION
Expiration Dating of Unit Dose Repackaged Drugs - 480.200 QuantitatveTesting for Serum Proteins - 255.100
Hospital Pharmacies - 460.100 IMPAIRMENT OF HUMAN HEALTH
Manfacture, Distrbution, Promotion Of Drugs by Pharmacies - 460.200 Direct Reference Authority for Class III Medical Devices - 300.700
Registration of Blood Banks & Other Firms - 230.110 IMPORT
Unit Dose Labeling for Solid & Liquid Oral Dose Forms - 430.100 Action Levels for Aflatoxins in Animal Feeds - 683.100
Volatile N-Nitrosamines in Rubber Baby Bottle Nipples - 500.450 Bay (Laurel) Leaves - Insect Filth; Mold; Mammalian Excreta - 525.150
HOWARD MOLD COUNT Brandy Containing Methyl Alcohol - Food Additive - 510.200
Apricot, Peach, Pear, Nectars and Purees - 550.155 Capsicum Pods, Etc. - Adulteration - 525.200
Cherry Jam - 550.235 Cloves - Adulteration with Stems - 525.250
Cranberry Sauce - 550.260 Coffee and Cocoa Bean Sweeps - 560.350
Jam, Black Currant - 550.450 Condimental Seeds Other Than Fennel Seeds and Sesame Seeds - 525.300
Pineapple, Canned; Pineapple Juice - 550.680 Cumin Seed - Adulteration with Sand and Grit - 525.325
HUMAN IMMUNODEFICIENCY VIRUS Curry Powder - Adulteration by Insect and Rodent Filth - 525.330
Surgeon's Gloves and Patient Examination Gloves - 335.700 Fennel Seed - Adulteration by Mammalian Excreta; Insects - 525.350
HUMAN-LABELED DRUG PRODUCTS Food Storage & Warehousing - Adulteration - Filth - 580.100
Distributed & Used in Pet Medicine - 608.100 Foreign Trade Zones, Bonded Warehouses or Carriers - 110.600
HYDROCHLORIC ACID Hops - Adulteration Involving Aphid Infestation - 525.425
Prepared Mustard, Compositions - 525.575 Importation of Licensed Biologic Products for Human Use - 210.150
HYDROLYZED YEAST Importation of Television Receivers and Microwave Ovens - 394.500
Labeling of Seasonings - 525.650 Imported Milk and Cream. Import Milk Act - 560.400
HYDROPHONE Imported Products - Lack of English Labeling - 110.900
Temporal-Maximun Ultrasonic Power - 397.100 Interpretation of Insect Filth in Foods - 555.600
HYGIENIC SPONGES Jams, Jellies and Related Products - Imports - 560.500
Menstrual Sponges - 345.300 Leafy Spices, Other Than Bay Leaves - 525.500
HYPERACTIVE CHILDREN Mace - Insect Filth; Mold, Foreign Matter; Mammalian Excreta - 525.550
Hypnotherapy Devices-Self-Hypnotic Tape Recordings - 335.300 Marjoram - 525.900
HYPNOTHERAPY DEVICES Oregano - 525.850
Hypnotherapy Devices-Self-Hypnotic Tape Recordings - 335.300 Pesticide Residues in Food and Feed - 575.100
HYPOGLYCEMIA Pistachio Nuts - Aflatoxin Adulteration - 570.500
Fructose-Containing Drugs - 400.335 Pottery (Ceramics) - Cadmium Contamination - 545.500
IBACUS CILIATUS Pottery (Ceramics) - Lead Contamination - 545.450
Common or Usual Names for Crustaceans - 540.350 Radionuclides in Imported Foods - Levels of Concern - 560.750
IDENTITY OF FOODS - USE OF TERMS AS FRESH, FROZEN, Returned Antibiotics Exported Under 801(d) of the Act - 405.210
Identity of Foods--Terms Such as Fresh, Frozen, Dried, Canned - 562.450 Sage - 525.950
IDENTITY OF INGREDIENTS Sesame Seeds - Adulteration - 525.700
Bakery Products Candy Ingredients - 505.100 Silver-Plated Hollowware - Lead Contamination - 545.500
Canned Pimentos and Red Sweet Peppers - 585.650 Thyme - 525.925
Caviar, Use of Term-Labeling - 540.150 Vitamin B-15, Pangamic Acid and Pangamic Acid Products - 457.100
Chocolate or Chocolate Flavored - 515.800 Whole and Ground Allspice - Mold; Insect and Rodent Filth - 525.100
Compressed Medical Gases--Warning Letters - 435.100 Whole Cassia or Whole Cinnamon, Ground Cinnamon - 525.225

420
Compliance Policy Guides Index
Whole and Ground Pepper - Adulteration - 525.625 IMPROPER MAINTENANCE
Whole Ginger - Insect Filth; Mold; Nammalian Excreta - 525.375 Assemblers Who Install Noncompliant Equipment - 398.325
Whole and Ground Nutmeg - Insect Filth; Mold; Rodent Filth - 525.600 Obligations of Factory-Based Manufacturers & Assemblers - 398.375
IMPORT DETENTION STATUS IMPROVING VISION
Importation of Television Receivers and Microwave Ovens - 394.500 Hypnotherapy Devices-Self-Hypnotic Tape Recordings - 335.300
IMPORT FOODS Extra Lable Use of New Animal Drugs - 615.100
Food Storage and Warehousing Filth - 580.100 IMVIC
IMPORT FOODS - LABELING Crabmeat - Adulteration w/ Filth - E. coli - 540.275
Lack of English Labeling - 110.900 Tree Nuts - E. coli - 570.450
IMPORT MILK ACT INCH-POUND
Imported Milk & Cream - 560.400 Metric Declarations of Quantity of Contents - 140.500
IMPORTED INCONNUS
Acidified Low-Acid Canned Foods - High pH - 520.300 Fish Fresh & Frozen - 540.590
Acupuncture Devices and Accessories - 305.100 INDIAN
Availability of Bulk Chemicals for Animal Drug Use - 625.200 FDA Jurisdiction on Indian Reservations - 100.350
Bay (Laurel) Leaves - Insect Filth; Mold; Mammalian Excreta - 525.150 INDICATIONS FOR USE
Biological Drugs for Animal Use - 645.100 Expiration Dating & Stability Testing - 480.100
Brazil Nuts - Adulteration with Aflatoxin - 570.200 Homeopathic Drugs - 400.400
Canned and Cooked/Frozen Shrimp - Decomposition - 540.375 Large Volume Parenterals (LVPs) for Animal Use - 635.100
Capsicum Pods, Etc. - Adulteration - 525.200 Reconditioning-Tree Nuts Contaminated w/ E.coli - 570.550
Caviar, Use of Term - Labeling - 540.150 Source Plasma - Overbleeding - 252.100
Class III Devices Subject to 5l5(b) Requirements - 300.750 Temporal-Maximum Ultra-Sonic Power - 397.100
Cloves - Adulteration with Stems - 525.250 INDISCRIMINATE USE
Condimental Seeds Other Than Fennel Seeds and Sesame Seeds - 525.300 Ear Piercing Devices - 320.100
Country of Origin Labeling - 560.200 INDOLE
Crabmeat - Product Name - 540.300 Shrimp - 540.400
Cumin Seed - Adulteration with Sand and Grit - 525.325 Canned & Cooked Frozen Shrimp - 540.390
Curry Powder - Adulteration by Insect and Rodent Filth - 525.330 INEFFECTIVE DEVICES
Dates and Date Material; Imported and Domestic - 550.300 502(f)(l) Labeling Requirements - 300.300
Fennel Seed - Adulteration by Mammalian Rct; Insects - 525.350 INEFFECTIVE DRUGS
Foreign Trade Zones, Bonded Warehouses or Carriers - 110.600 Marketed New Drugs w/o Approved NDAs - 440.100
Hops - Adulteration Involving Aphid Infestation - 525.425 INFESTATION
Importation of Television Receivers and Microwave Ovens - 394.500 Cashews, Reconditioning - 570.250
Importation of Unlabeled Foods -- *21 CFR 101.100(d)* - 560.100 Cocoa Beans - 515.750
Imported Products - Lack of English Labeling - 110.900 Dates and Date Material - 550.300
Imported Low-Acid Canned Foods - 560.450 Figs, Fig Paste - 550.350
Imported Frozen Products of Multiple Sizes - 560.700 Food Storage & Warehousing - 580.100
Imported Milk and Cream. Import Milk Act - 560.400 Foods Infestation - 555.450
Imports -- Post Detention Sampling - 110.800 Green Coffee Beans Mold - 510.500
Jams, Jellies and Related Products - Imports - 560.500 Hops - 525.425
Leafy Spices, Other Than Bay Leaves - 525.500 Olives - Adulteration - 550.600
Mace - Insect Filth; Mold, Foreign Matter; Mammalian Excreta - 525.550 Pistachio Nuts - Aflatoxin - 570.500
Marjoram - 525.900 Reconditioning of Foods Under 402(a)(4) - 160.700
Olives - Adulteration Involving Pits; Rot; Insect Infestation - 550.600 Reconditioning Coffee Beans - 560.300
Oregano - 525.850 Tree Nuts - 570.425
Pesticide Residues in Food and Feed - 575.100 INFLUENZA VIRUS VACCINE
Pineapple, Canned; Imported and Domestic - Food Standards - 550.685 Standards & Minimum Requirements for Biologic Products - 205.100
Pistachio Nuts - Aflatoxin Adulteration - 570.500 INFORMED CONSENT
Pottery (Ceramics) - Cadmium Contamination - 545.400 Schedule of Physical Examination - 251.100
Pottery (Ceramics) - Lead Contamination - 545.450 Source Plasma-Guidelines for Infomed Consent Form - 250.100
Radionuclides in Imported Foods - Levels of Concern - 560.750 INFORMED DECISION
Reconditioning of Imported Coffee Beans - 560.300 Warning Label Required on Sunlamp Products - 396.400
Sage - 525.950 INHALATION THERAPY DRUGS
Sesame Seeds - Adulteration - 525.700 Manufacture, Distribution, Promotion of Drugs by Pharmcies - 460.200
Silver-Plated Hollowware - Lead Contamination - 545.500 INITIAL DISTRIBUTOR
Sphygmomanometers - Rx Legend - 310.200 Class III Devices Subject to 515 (b) Requiremts - 300.750
Surgeon's Gloves and Patient Examination Gloves - 335.700 INITIAL IMPLANTATION
Thyme - 525.925 Pacemaker Reuse - 310.100
Unapproved Additives for Exported Grains - 578.600 INITIAL REPORTS
Warning Label Required on Sunlamp Products - 396.400 Certification & Identification of X-Ray Components - 398.600
Whole and Ground Allspice - Mold; Insect and Rodent Filth - 525.100 Electronic Products Subject to 21 CFR 1001.15(a) - 390.400
Whole Cassia or Whole Cinnamon, Ground Cinnamon - 525.225 INJECTABLE
Whole Ginger - Insect Filth; Mold; Mammalian Excreta - 525.375 Oral Iron Products for Baby Pigs - 643.100
Whole and Ground Nutmeg - Insect Filth; Mold; Rodent Filth - 525.600 OTC Sale of Injectable Pet Drugs - 608.200
Whole and Ground Pepper - Adulteration- 525.625 Plastic Containers for Injectable Pet Drugs - 637.100
IMPORTER Status of Syringes, Needles for Pet Drugs - 655.400
See Imported Above INJUNCTION
IMPORTERS ENTRY NOTICE Animal Drugs for Euthanasia - 650.100
Importation of TV Receivers & Microwave Ovens - 394.500 Blood and Blood Products - Definitions - 230.100
IMPORTS Schedule of Physical Examination - 251.100
See Imported Above INJURY
IMPRESSION Acupuncture Devices and Accessories - 305.100
Canned Peas - Label Designation of Sizes - 585.625 Assessment of Civil Penalties - 390.300
Dentures - Sale by Persons Not Licensed - 315.100 Candy - Mixed with Trinkets and Sold in Vending Machines - 515.350
IMPRISONED Cherries, Canned - Misbranding Involving Food Standards - 550.230
Dentures - Sale by Persons Not Licensed - 315.100 Cinnamon-Flavored Toothpicks - 545.600
IMPROPER Diaphragms - Rx Devices - 345.200
Assemblers Who Install Noncompliant Equipment - 398.325 Direct Reference Authority for Class III Medical Devices - 300.700
Determination by Secretary: Product Fails to Comply - 390.200 Health Fraud - 120.500
FDA Jurisdiction Over Meat & Poultry Products - 565.100 Illegal Sales of Veterinary Prescription Drugs - 608.500
Lasers for Facelift, Wrinkle Removal, Acupuncture, Etc - 393.200 Lasers for Facelift, Wrinkle Removal, Acupuncture, etc. - 393.200
Obligations of Factory-Based Manfacturers & Assemblers - 398.375 Proper Drug Use and Residue Avoidance - 615.200
Pineapple,Canned;Imported & Domestic-Food Standards - 550.685 Reloaders of X-Ray Tube Housing Assemblies - 398.700
Proper Drug Use & Residue Avoidance - 615.200 Sequencing in Medicated Feed Production - 680.600
Rx Drugs for Ships' Medicine Chests - 460.500 Sphygmomanometers - Rx Legend - 310.200
Standardized Canned Fruit - Packing Medium - 550.800 INJURY REPORTS

421
Index Compliance Policy Guides
Reloaders of X-ray Tube Housing Assemblies - 398.700 Classification of Establishments - 555.500
INNOVATIVE PHARMACY CARE Compressed Medical Gases -- Warning Letters - 435.100
Computerized Rx Record Keeping by Pharmacies - 460.400 Condoms; Defects - Criteria for Direct Reference Seizure - 345.100
INCREASING RANGE OF MOTION Consistent Application of CGMP Determinations - 400.200
Electrical Muscle Stimulators - 355.200 Contamination of Devices Labeled as Sterile - 300.400
INSECT CONTAMINATION Contract Sterilizers - 100.550
Food Storage & Warehousing - 580.100 Failure to Register - 400.100
Interpretation of Insect Filth - 555.600 Failure to Register - 625.500
INSECT FRAGMENTS FDA Jurisdiction Over Meat and Poultry Products - 565.100
Apricots - Canned - Adulteration with Insects - 550.150 Finished Dosage Form Drugs in Bulk Containers - 410.100
Asparagus, Canned or Frozen - Adulteration with Insect Filth - 585.150 Food Storage & Warehousing - Adulteration - Filth - 580.100
Bay (Laurel) Leaves - Insect Filth; Mold; Mammalian Excreta - 525.150 Foods, Rail Car Sanitation - Adulteration - 545.300
Capsicum Pods, Etc. - Adulteration - 525.200 Foods - Adulteration Involving Infestation and 1080 Rodenticide - 555.450
Cheese and Cheese Products - Adulteration with Filth - 527.200 GWQAP Pre-Award Evaluation - 100.700
Chocolate & Chocolate Liquor - Adulteration - 515.700 Importation of Unlabeled Foods-*21 CFR 101.100(d)* - 560.100
Cocoa Beans - Mold, Insect Infestation, and Mammalian Excreta - 515.750 Imported Milk and Cream Import Milk Act - 560.400
Cocoa Powder, Press Cake - Insect and Rodent Filth and Shell - 515.775 Imported Products - Lack of English Labeling - 110.900
Corn Meal - Adulteration by Insect and Rodent Filth - 578.200 Inspection of Manufacturers of Device Components - 300.100
Corn, Sweet; Canned - Adulteration - 585.300 Malted Milk - 527.500
Curry Powder - Adulteration by Insect and Rodent Filth - 525.330 Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200
Dates and Date Material; Imported and Domestic - 550.300 Maraschino Cherries - 550.550
Green Coffee Beans - Adulteration with Insects; Mold - 510.500 Medicated Feeds -- Formula Information - 670.100
Interpretation of Insect Filth in Foods - 555.600 Menstrual Sponges - 345.300
Macaroni and Noodle Products - 505.500 Pathogens in Dairy Products - 527.300
Marjoram - 525.900 Pesticide Residues in Food and Feed - 575.100
Oregano - 525.850 Plasma Brokers - Registration and Compliance - 250.500
Peanut Butter - Adulteration with Filth; Grit - 570.300 Prepared Mustard, Composition - 525.575
Sage - 525.950 Process Validation Requirements for Drug Products - 490.100
Thyme - 525.925 Proper Drug Use and Residue Avoidance - 615.200
Wheat Flour - 578.450 Radionuclides in Imported Foods - Levels of Concern - 560.750
Wheat - Adulteration by Insect and Rodent Filth - 578.300 Raw Breaded Shrimp - Microbiological - 540.420
Whole and Ground Nutmeg - Insect Filth; Mold; Rodent Filth - 525.600 Reconditioners/Rebuilders of Medical Devices - 300.200
Whole and Ground Allspice - Mold; Insect and Rodent Filth - 525.100 Reconditioning of Imported Coffee Beans - 560.300
Whole Cassia or Whole Cinnamon, Ground Cinnamon - 525.225 Red Meat Adulterated with PCB's - 565.200
Whole and Ground Pepper - Adulteration - 525.625 Refusal to Permit Inspection - 130.100
INSECT FILTH Registration of Blood Banks and Other Firms - 230.110
Asparagus, Canned or Frozen - 585.150 Regulatory Actions Against Assemblers of X-Ray Equipment - 398.350
Bay (Laurel) Leaves - 525.150 Regulatory Action Regarding Approved New Drugs - 446.100
Chocolate & Chocolate Liqour - 515.700 Reloaders of X-Ray Tube Housing Assemblies - 398.700
Cocoa Powder, Press Cake - 515.775 Salmonella Contamination of Dry Dog Food - 690.700
Coffee and Coca Bean Sweeps - 560.350 Salt-Cured, Air-Dried, Uneviscerated Fish - 540.650
Curry Powder Filth - 525.330 Sauerkraut - Definition; Adulteration by Thrips - 585.750
Food Storage & Warehousing - 580.100 Spices - Definitions - 525.750
Green Coffee Beans Filth - 510.500 Surgeon's Gloves and Patient Examination Gloves - 335.700
Interpretation of Insect Filth in Foods - 555.600 Turtles - 170.100
Leafy Spices, Other Than Bay Leaves - 525.500 Unapproved Additives for Exported Grains - 578.600
Mace - 525.550 INSPECTION BY ATTRIBUTES
Marjoram - 525.900 Condoms; Defects - Criteria for Direct Reference Seizure - 345.100
Oregano - 525.850 Surgeon's Gloves and Patient Examination Gloves - 335.700
Sage - 525.950 INSPECTION REPORTS
Sesame Seeds - 525.700 Contamination of Devices - Labeled as Sterile - 300.400
Thyme - 525.925 Pesticide Residues in Food & Feed - 575.100
Wheat - 578.300 INSPECTOR OPERATIONS MANUAL
Whole Cinnamon, Ground Cinnamon - 525.225 Dates & Date Material; Imported & Domestic - 550.300
Whole Ginger - 525.375 Foods, Except Dairy Products - Adulteration w/ Salmonella - 555.300
Whole and Ground Pepper-Adulteration - 525.625 INSTALL NONCOMPLIANT EQUIPMENT
Whole and Ground Nutmeg - 525.600 Assemblers Who Install Noncompliant Equipment - 398.325
INSECT INFESTED INSTALLATION
Apricots - Canned - Adulteration with Insects - 550.150 Assemblers Who Install Noncompliant Equipment - 398.325
Capsicum Pods, Etc. - Adulteration - 525.200 Determinatin by Secretary: Product Fails to Comply - 390.200
Cashews, Insect Infested - Reconditioning - 570.250 Obligations of Factory-Based Manufacturers & Assemblers - 398.375
Corn Husks (for Tamales) - Adulteration with Filth - 585.350 INSTITUTIONAL REVIEW BOARD (IRB)
Dried Prunes, Dehydrated Low Moisture Prunes, and Pitted Prunes - 550.700 Acupuncture Devices & Accessories - 305.100
Figs; Fig Paste - Insect Infestation; Mold, Dirt - 550.350 Lasers for Facelift, Wrinkle Removal, Acupuncture, etc. - 393.200
Peanuts, Shelled and Unshelled - Filth and Reject Nuts - 570.350 INSULIN
Peas and Beans; Dried - Storage Insect Damage, Rocks - 585.575 Certification for Exports - 110.100
Tree Nuts - Adulteration Involving Rejects - 570.425 Human-Labeled Drugs in Pet Medicine - 608.100
INSECT WEBBING (See Insect References Above) Tamper-Resistant Packing Requirements - 450.500
INSECTS - (See Insect References Above) INTRAARTICULAR
INSOLUBLE ASH OTC Sale of Injectable Pet Drugs - 608.200
Cumin Seed Adulteration - 525.325 INTRAPERITIONEAL
Dates & Date Material - 550.300 LVP's for Animal Use - 635.100
Foods Adulteration with Salmonella - 555.300 INTRAVENOUS
Spices Definition - 525.750 LVP's for Animal Use - 635.100
INSOMNIA OTC Sale of Injectable Pet Drugs - 608.200
Hypnotherapy Devices-Self-Hypnotic Tape Recordings - 335.300 INTENDED PURPOSE
INSPECTION Commercial Distribution-Premarket Notification - 300.600
Access to Results of Quality Assurance Audits - 130.300 Fortification of Standardized Juices - 510.700
Acetic Acid - Use in Foods - Labeling of Foods in Which Used - 562.100 IneffectiveDevices-502(f)(l) Labeling Requirements - 300.300
Assessment of Civil Penalties - 390.300 Karaya Gum Powder & Devices for Use by Ostmates - 325.100
Biological Drugs for Animal Use - 645.100 INTERIM MARKETING
Bouillon, Bouillon Cubes, Granulated Bouillon - 567.300 OTC Drugs - Combination Products - 450.300
Canned Peas - Label Designation of Sizes - 585.625 INTERLOCK MISSASSEMBLIES
Canned Pet Food - 690.300 Assemblers Who Install Noncompliant Equipment - 398.325
Canned Shrimp: Size Designations and Corresponding Counts - 540.390 INTERLOCK OPERATING
Cheese and Cheese Products - Adulteration with Filth - 527.200 Retention of Microwave Oven Test Records - 394.100

422
Compliance Policy Guides Index
INTERLOCKS Common or Usual Name - 570.100
Retention of Microwave Oven Test Records - 394.100 JUNIPER
INTERNAL Labeling of Seasonings - 525.650
Alcohol; Use of Synthetic Alcohol in Foods - 555.100 KAPCHUNKA
Brandy Containing Methyl Alcohol - Food Additive - 510.200 Salted Dried, Uneviserated Fish - 540.650
Cashews, Insect Infested - Reconditioning - 570.250 KARAYA GUM POWDER
Fraud, Untrue Statements of Material Facts, Bribery - 120.100 Related Devices for Use by Ostomates - 325.100
Lack of Expiration Date or Stability Data - 480.300 KEGANI CRABMEAT
Medicated Feeds -- Combined Batches - 680.400 Crabmeat - Product Name - 540.300
Oral Iron Products for Baby Pigs - 643.100 KERNELS
Pottery (Ceramics) - Cadmium Contamination - 545.400 Jordan Almonds Usual Name - 570.100
Pottery (Ceramics) - Lead Contamination - 545.450 Peanuts, Shelled and Unshelled - 570.350
Use of Income Tax Information from IRS - 160.200 Pistachio Nuts - 570.500
INTERVAL Popcorn - 585.675
Controlled-Release Dosage Form Drugs - 460.700 Spices-Definitions - 525.750
Sunlamp Performance Standard - 396.100 Treated Grain Seed-Mecury Residue - 578.400
INTERVENTION Wheat for Human Consumption - 578.350
Hazardous Diagnostic X-Ray Systems - 398.200 Wheat-Adulteration by Insect Rodent Filth - 578.300
INTOLERANCE TO FOOD KETCHUP
Cytotoxic Testing for Allergic Diseases - 370.100 Silver-Plated Holloware - Lead Contamination - 545.500
Fructose-Containing Drugs - 400.335 KETOSIS
INTRAORAL Human-Labeled Drugs in Pet Medicine - 608.100
Defnition of General Purpose Radiographc X-Ray System - 398.100 KIDNEY
INVALID Blood & Blood Products - Definitions - 230.100
Acupuncture Devices & Accessories - 305.100 Defniton of General Purpose Radiographic X-Ray System - 398.100
INVERT SUGAR Inert Glandular Preparations - OTC - 455.100
Fructose-Containing Drugs - 400.335 Pork & Beans & Similar Bean Products -Labeling - 567.200
INVESTIGATION EXEMPTION Streptomycin Residues in Cattle Tissues - 616.100
Hospital Pharmacies - 460.100 KIDNEY DISEASE
INVESTIGATIONAL ANIMAL DRUG Blood & Blood Products - Definitions - 230.100
Reconditioning of New Pet Drugs - 625.400 KING CRABMEAT
INVESTIGATIONAL DEVICE EXEMPTION Crabmeat-Product Name - 540.300
Acupuncture Devices & Accessories - 305.100 KIPPER
Class III Devices Subject to 515 (b) Requirements - 300.750 Kipper and Kipper Unsplit Definitions - 540.550
Cytotoxic Testing for Allergic Diseases - 370.100 LABELING - FOREIGN LANGUAGE DECLARATIONS
Direct Reference Authority for Class III Medical Devices - 300.700 Food Labels - 562.400
Lasers for Facelift, Wrinkle Removal, Acupuncture, etc - 393.200 Homeopathic Drugs - 400.400
Menstrual Sponges - 345.300 Quanity of Contents - 140.500
RIA Anlysis:Hair to Detect Presence of Drugs of Abuse - 370.200 LABELING-NET WEIGHT
INVESTIGATIONAL DRUGS Cheese and Cheese Products - 527.250
Collection of Charitable Distribution of Drugs - 400.800 Corn on the Cob, Canned - 585.325
Hospital Pharmacies - 460.100 Foods-Net Weight - 562.300
Recovery of INDs from Clinical Investigators - 444.100 Lingon Berries, Canned - 550.500
INVESTIGATIONAL NEW DRUGS Metric Declaration - 140.500
Recovery of INDs from Clinical Investigators - 444.100 Mixed Nuts - 570.700
INVESTIGATIONAL USE LABELING REQUIREMENTS
Commercial Distribution-Premarket Notification - 300.600 Additives - Labeling with Adequate Directions for Many Uses - 500.100
Food Additives - "GRAS" - 500.200 Adequate Directions for Use - Animal Drugs and Devices - 607.100
New Drugs - Export - 442.100 Bakery Products, Candy "Shotgun" Ingredients Declaration - 505.100
IONIZATION Biological Drugs for Animal Use - 645.100
Action Levels for Aflatoxins in Pet Feeds - 683.100 Certification for Exports - 110.100
Foods, Adulteration with Aflatoxin - 555.400 Compressed Medical Gases -- Warning Letters - 435.100
IPRONIDAZOLE Country of Origin Labeling - 560.200
Extra-Label Use of New Pet Drug - 615.100 Drug Product Entries in Periodic Publications - 400.700
Unsafe Cont. of Pet Drug/Carryover - 680.500 Food Additives - Labeling Directions Necessary for Safe Use - 500.250
IRIS FAMILY Homeopathic Drugs - 400.400
Spices - Definitions - 525.750 Illegal Sales of Veterinary Prescription Drugs - 608.500
IRRADIATION Importation of Unlabeled Foods-*21 CFR 101.100(d)* - 560.100
Karaya Gum Powder & Devices - Use by Ostomates - 325.100 Ineffective Devices - 502(f)(l) Labeling Requirements - 300.300
Sunlamp Performance Standard - 396.100 Labeling - Diluted Wines and Cider with Less than 7% Alcohol - 510.450
IRRITATION Labeling of Food Articles Distributed Solely in Puerto Rico - 562.750
Denture Cleaners,Adhesives, & Repair Materials - 315.200 Labeling of Food Bearing Residues of Pesticide Chemicals - 562.700
IRON DEFICIENCY ANEMIA Metric Declarations of Quantity of Contents - 140.500
Oral Iron Products for Baby Pigs - 643.100 Platelets, Pooled - 231.100
ISOEUGENOL Preservatives; Use in Nonstandardized Foods; Label Declaration - 562.600
Labeling of Seasonings - 525.650 Processing" - Use of Term in Section 405 of the FD&C Act - 562.650
ISOLATES Reconditioners/Rebuilders of Medical Devices - 300.200
Direct Refrence Authority for Pseudnomas Contamintion - 590.300 Regulatory Action Regarding Approved New Drugs - 446.100
Intermediate or End Products of Sample Analysis - 150.100 Repacking of Drug Products -- CGMP's - 430.200
Labeling of Seasonings - 525.650 Tamper-Resistant Packaging Requirements - 450.500
JAM Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100
Jams, Jellies & Related Products - 560.500 LABELING - SPANISH ONLY
JAPANESE NOODLES Foods Distributed in Puerto Rico - 562.750
Chow Mein Noodles - 505.400 Imported Products - 110.900
JAUNDICE LABORATORY
Fructose-Containing Drugs - 400.335 Access to Results of Quality Assurance Audits - 130.300
JASUS LALUNDI Acetic Acid - Use in Foods - Labeling of Foods in Which Used - 562.100
Common or Usual Names for Crustaceans - 540.350 Action Levels for Aflatoxins in Animal Feeds - 683.100
JELLIES Adulteration of Drugs under Sec. 501(b) and 501(c) - 420.100
Jams, Jellies and Related Products - 560.500 Analytical Methodology Used by FDA - Drugs - 150.500
Jellies, Nonstandardized - 550.475 CGMP Applicability to Hardware and Software - 425.100
JERUSALEM ARTICHOKE Cheese and Cheese Products - Adulteration with Filth - 527.200
Artichoke - Common or Usual Name - 585.100 Compressed Medical Gases -- Warning Letters - 435.100
JOINT COUNCIL OF ALLERGY AND IMMUNOLOGY Dimethylnitrosamine in Malt Beverages - 510.600
Cytotoxic Testing for Allergic Diseases - 370.100 Direct-Fed Microbial Products - 689.100
JORDAN ALMONDS Homeopathic Drugs - 400.400

423
Index Compliance Policy Guides
Imported Frozen Products of Multiple Sizes or Codes - 560.700 Decomposition & Histamine in Albacore, Skipjack & Yellowfin Tuna -540.525
Menstrual Sponges - 345.300 Dimethylnitrosamine in Malt Beverages - 510.600
Microfiche and/or Microfilm for Records Retention - 130.400 Dimethylnitrosamine (DMNA) in Barley Malt - 578.500
Milk and Milk Products Containing Penicillin - 527.450 Electrical Muscle Stimulators - 355.200
Pineapple, Canned; Imported and Domestic - Food Standards - 550.685 Failure to Register - 625.500
Pottery (Ceramics) - Cadmium Contamination - 545.400 Fish, Shellfish, Crustaceans, etc. - Methyl Mercury - 540.600
Pottery (Ceramics) - Lead Contamination - 545.450 Foods - FPLA Compliance - 562.200
Quantitative Testing for Serum Proteins in Plasmapheresis Donors - 255.100 Foods, Adulteration with Aflatoxin - 555.400
Reconditioning New Drugs Lacking Approved NDA - 448.100 Foods - Net Weight - 562.300
Registration of Blood Banks and Other Firms - 230.110 Foods, Rail Car Sanitation - Adulteration - 545.300
Repacking of Drug Products -- CGMP's - 430.200 Foreign Trade Zones, Bonded Warehouses or Carriers - 110.600
Rodent Contaminated Pet Foods - 690.600 Health Fraud - 120.500
Shrimp - Fresh or Frozen Raw Headless, Peeled or Breaded - 540.400 Identical or Similar Product Names - 400.500
Silver-Plated Hollowware - Lead Contamination - 545.500 Imitation Breaded Shrimp - 540.450
Source Plasma - Overbleeding - 252.100 Ineffective Devices - 502(f)(l) Labeling Requirements - 300.300
Unapproved Additives for Exported Grains - 578.600 Inert Glandular Preparations - OTC - 455.100
LACTIC ACID Interference with Compendial Tests - 420.500
Jellies, Nonstandardized - 550.475 Mail-Order Filling of Prescriptions - 460.450
Labeling of Seasonings - 525.650 Marjoram - 525.900
Sauerkraut-Definition; Adulteration - 585.750 Marketed New Drugs without Approved NDAs or ANDAs - 440.100
LAMP VOLTAGE Metric Declarations of Quantity of Contents - 140.500
Assemblers Who Install Noncompliant Equipment - 398.325 Mixed Nuts - Misbranding Involving Food Standards - 570.700
LANGOSTINOS Mushrooms, Canned or Dried (Freeze-Dried or Dehydrated) - 585.500
Usual Names for Crustaeans - 540.350 Oral Iron Products for Baby Pigs - 643.100
LANGUAGE Orders for Post-Approval Record Reviews - 470.100
Foreign Language Declarations of Food Labels - 562.400 Oregano - 525.850
Homeopathic Drugs - 400.400 OTC Ear Drops - 454.100
Imported Products - Lack of English Labeling - 110.900 Pathogens in Dairy Products - 527.300
Labeling-Food Articals Distributed Soley in Puerto Rico - 562.750 Peaches, Canned, Frozen -- Adulteration Due to Insects and Mold - 550.650
Metric Declaration of Quantity of Contents - 140.500 Peas and Beans; Dried - Storage Insect Damage, Rocks - 585.575
Source Code for Process Control Application Programs - 425.300 Pistachio Nuts - Aflatoxin Adulteration - 570.500
Source Plasma Guidelines for Informed Consent Form - 250.100 Pottery (Ceramics) - Cadmium Contamination - 545.400
LAUREL LEAVES Pottery (Ceramics) - Lead Contamination - 545.450
Bay (Laurel) Leaves Filth - 525.150 Raisins - Adulteration Involving Mold, Sand, Grit, & Insects - 550.750
LAWFUL INVESTIGATION Raw Sugar - 515.400
Acupuncture Devices & Accessories - 305.100 Raw Breaded Shrimp - Microbiological - 540.420
LAXTES CONDOM Sage - 525.950
Condoms; Defects-Crteria for Direct Refrence Seizure - 345.100 Sauerkraut - Definition; Adulteration by Thrips - 585.750
LAYMAN Shrimp - Fresh or Frozen Raw Headless, Peeled or Breaded - 540.400
Extra Label Use-new Animal Drug-Food-Producing Animals - 615.100 Shrimp - Frozen, Raw, Breaded or Lightly Breaded, - 540.410
LEACHABLE LEAD Silage Ingredients - 687.500
Silver-Plated Holloware - 545.500 Silver-Plated Hollowware - Lead Contamination - 545.500
LEAD Source Plasma Guidelines for Informed Consent Forms - 250.100
Canned Foods-Seam Defects - 520.200 Sphygmomanometers - Accuracy - 310.210
Caviar, Use of Term - 540.150 Streptomycin Residues in Cattle Tissues - 616.100
Fortification of Standard Juices - 510.700 Thyme - 525.925
Pottery-Lead Contamination - 545.450 Tomato Products - Adulteration with Mold - 585.900
Silver-Plated Holloware-Lead Contamination - 545.500 Tree Nuts - Escherichia coli - 570.450
Squash Seeds-Labeling as Pumpkin Seeds - 585.800 Tuna, Sable, Salmon, Shad - Smoked, Cured - Sodium Nitrite - 540.500
Vitamin B-15, Pangamic Acid and Products - 457.100 Turtles - 170.100
Water in Food Products - 555.875 Uncertified or Delisted Colors - 587.200
LEAFY SPICES Vitamin Products for Human Use - Low Potency - 530.400
Majoram - 525.900 Vitamin B-15, Pangamic Acid and Pangamic Acid Products - 457.100
Oregano - 525.850 Volatile N-Nitrosamines in Rubber Baby Bottle Nipples - 500.450
Other than Bay Leaves - 525.500 Wheat Germ Containing Nonwheat Germ Tissue - 530.500
Sage - 525.950 Whole and Ground Pepper - Adulteration - 525.625
Thyme - 525.925 Whole and Ground Nutmeg - Insect Filth; Mold; Rodent Filth - 525.600
LEAKAGE Whole Cassia or Whole Cinnamon, Ground Cinnamon - 525.225
Canned Foods - Seam Defects - 520.200 Whole and Ground Allspice - Mold; Insect and Rodent Filth - 525.100
Calcium Chloride - 500.400 Whole Milk, Low Fat Milk, Skim Milk - Aflatoxin M1 - 527.400
Comdoms; Defects-Criteria for Direct Reference Seizure - 345.100 LEGAL ACTION (see legal above)
Determination by Secretary: Product Fails to Comply - 390.200 LEGIBLE AND ACCESSIBLE TO VIEW
Reloaders of X-Ray Tube Housing Assemblies - 396.400 Certification and Identification of X-Ray Components - 398.600
Retention of Microwave Oven Test Records - 394.100 Warning Label Required on Sunlamp Products - 396.400
Surgeons' Gloves & Patient Examination Gloves - 335.700 LEMON
LEARNING TECHNIQUES Candied Citron-Labeling - 515.600
Hypnotherapy Devices-Self-Hypnotic Tape Recordings - 335.300 Citrus Fruit Juices, Canned - 550.250
LEGAL Hollandaise Sauce-Common or Usual Name - 525.400
Acidified Low-Acid Canned Foods - High pH - 520.300 Jellies, Nonstandardized - 550.475
Aflatoxin in Peanuts and Peanut Products - 570.375 Marmalade - 550.575
Apricot, Peach and Pear Nectars and Purees - Mold - 550.155 LEMON JUICE
Assemblers Who Install Noncompliant Equipment - 398.325 Hollandaise Sauce-Common or Usual Name - 525.400
Brazil Nuts - Adulteration with Aflatoxin - 570.200 Jellies, Nonstandardized - 550.475
Canned Salmon - Adulteration Involving Decomposition - 540.375 LESS-THAN-EFFECTIVE PRESCRIPTION DRUGS
Canned Foods - Seam Defects - 520.200 Marketed New Drugs Without Approved NDAs or ANDAs - 440.100
Cheese & Cheese Products - Misbranding Involving Net Contents - 527.250 LEUKOCYTE TEST
Chloramphenicol - 654.300 Cytotoxic Testing for Allergic Diseases - 370.100
Chubs, Hot Process Smoked with Added Nitrite - 540.200 LEUKOCYTE TYPING SERUM
Clams, Mussels, Oysters - Paralytic Shellfish Poison - 540.250 Standards & Min. Requiremts for Biologic Products - 205.100
Cocoa Powder, Press Cake - Insect and Rodent Filth and Shell - 515.775 LEUKOCYTES
Cocoa Beans - Mold, Insect Infestation, and Mammalian ect -515.750 Cytotoxic Testing for Allergic Diseases - 370.100
Collection and Charitable Distribution of Drugs - 400.800 Registration of Blood Banks & Other Firms - 230.110
Color Additives - 587.300 LEUKOCYTIC FOOD ALLERGY TEST
Common or Usual Names for Animal Feed Ingredients - 665.100 Cytotoxic Testing for Allergic Diseases - 370.100
Controlled-Release Dosage Form Drugs - 460.700 LEUKOCYTOTOXICITY TEST
Crabmeat - Adulteration with Filth - Escherichia coli - 540.275 Cytotoxic Testing for Allergic Diseases - 370.100

424
Compliance Policy Guides Index
LEVULOSE Whole Milk, Low Fat Milk, Skim Milk-Aflatoxin MI - 527.400
Fructose-Containing Drugs - 400.335 LOBSTER
LICENSE Processed Seafood Products - 540.700
Acupuncture Devices and Accessories - 305.100 Usual Names for Crustaceans - 540.350
Allergenic Extracts Containing Glycerin - 270.100 LOCAL BLOOD CIRCULATION
Biological Drugs for Animal Use - 645.100 Electrical Muscle Stimulators - 355.200
Blood and Blood Products - Definitions - 230.100 LOGANBERRIES
IND Filings - 215.100 Drupelet Berries - 550.200
Licensing - Changes to be Reported - 210.100 LONG-TERM LIFE
Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200 Retention of Microwave Oven Test Records - 394.100
Medical Emergencies - 220.100 LONGER WAVELENGTH UVA RADIATION
Source Plasma - Overbleeding - 252.100 Sunlamp Performance Standard - 396.100
Storage of Platelet Concentrate - 231.130 LOOSE FIT
LICENSED Denture Cleaners, Adhesives, & Repair Materials - 315.200
Acupuncture Devices and Accessories - 305.100 LOW ACID CANNED FOODS
Allergenic Extracts Containing Glycerin - 270.100 Acidifred Low-Acid Canned Foods High ph - 520.300
Biological Drugs for Animal Use - 645.100 Imported - 560.450
Blood and Blood Products - Definitions - 230.100 LOW FAT
Certification for Exports - 110.100 Imported Milk and Cream - 560.400
CGMP Enforcement Policy - OTC vs Rx Drugs - 450.100 LOW POWER LASERS
Chloramphenicol - 654.300 Lasers for Facelift, Wrinkle Removal, Acupuncture, etc. - 393.200
Collection and Charitable Distribution of Drugs - 400.800 LOWFAT MILK
Contract Sterilizers - 100.550 Imported Milk/Cream. Import Milk Act - 560.400
Dentures -- Sale by Persons Not Licensed to Practice Dentistry - 315.100 Pathogens in Dairy Products - 527.300
Ear Piercing Devices - 320.100 LOZENGES
Electrical Muscle Stimulators - 355.200 Tamper-Resistant Packaging Requirements - 450.500
Extra-Label Use of New Animal Drugs in Food-Producing Animals - 615.100 LUMPY JAW
Homeopathic Drugs - 400.400 Ethylenediamine Dihydrolodide - 651.100
Hospital Pharmacies - 460.100 LUTJANIDAE
Human-Labeled Drugs Distributed & Used in Animal Medicine - 608.100 Snapper - Labeling - 540.475
Illegal Sales of Veterinary Prescription Drugs - 608.500 LUTJANUS CAMPECHANUS
Importation of Licensed Biologic Products for Human Use - 210.150 Snapper - Labeling - 540.475
Ineffective Devices - 502(f)(l) Labeling Requirements - 300.300 LYGUS BUG DAMAGE
Licensing - Changes to be Reported - 210.100 Black-Eyed Peas - 585.225
Mail-Order Filling of Prescriptions - 460.450 LYMPH
Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200 Inert Glandular Preparations - OTC - 455.100
Over-The-Counter Sale of Injectable Animal Drugs - 608.200 MACARONI
Platelets, Pooled, - 231.100 Macaroni & Noodle Products - 505.500
Proper Drug Use and Residue Avoidance - 615.200 MACROANALYTICAL PROCEDURES MANUAL
Registration of Blood Banks and Other Firms - 230.110 Black-Eyed Peas; Dried - 585.225
Regulatory Action Regarding Approved New Drugs - 446.100 Dates and Date Material - 550.300
Source Plasma - Guidelines for Informed Consent Forms - 250.100 Marjoram - 525.900
Standards and Minimum Requirements for Biologic Products - 205.100 Peanuts, Shelled and Unshelled - 570.350
LICENSED BLOOD BANK REAGENTS Sage - 525.950
Blood & Blood Products - Definitions - 230.100 Thyme - 525.925
LICENSED PRACTITIONERS Tree Nuts - Audlteration - 570.425
Acupuncture Devices & Accessories - 305.100 Whole and Ground Allspice - 525.100
Homeopathic Drugs - 400.400 MAINTENANCE
Manfacture, Distribution, Promotion of Drugs by Pharmacies - 460.200 Assemblers Who Install Noncompliant Equipment - 398.325
LICENSING (See Licensed Above) Compressed Medical Gases -Warning Letters - 435.100
LICHEE NUTS Computerized Drug Processing-Vender Responsbilty - 425.200
Tree Nuts Involving Rejects - 570.425 Exemption for Certain Sunlamp Prod. Purchase Records - 396.2300
LICORICE-LIKE- Hospital Pharmacies - 460.100
Spices - 525.750 Microfiche and/or Microfilm for Records Retention - 130.400
LIME JUICE Obligations-Factory-Based Manufacturers & Assemblers - 398.375
Citrus Fruit Juices, Canned - 550.250 MALIC ACID
Jellies, Nonstandardized - 550.475 Jellies, Nonstandardized - 550.475
LIMITATIONS MALLOTUS VILLOSUS
Alcohol; Use of Synthetic Alcohol in Foods - 555.100 Capelin - 540.100
Color Additives in Paper & Paperboard for Use w/Food - 500.425 MALT
Commercial Distribution -Premarket Notification - 300.600 Confectionery - 515.100
Food Additives-Labeling Directions Necessary for Safe Use - 500.250 Dimethylnitrosamine (DMNA) in Barley Malt - 578.500
Manfacture, Distribution, Promotion of Drugs by Pharmcies - 460.200 Dimethylnitrosamine - 510.600
Medicated Feeds - Formula Info - 670.100 Malt Products - 515.200
Over-The-Counter Sale of Injectable Animal Drugs - 608.200 Malted Milk - 527.500
LINGON BERRIES Vinegar, Definitions - 525.825
Adulteration by insects - 550.500 Wine and Malt Beverages - 510.400
LIQUEUR MALT BEVERAGES
Maraschino Cherries - 550.550 Dealcoholized Wine and Malt Beverages - 510.400
LIQUID AND GASEOUS OXYGEN Dimethylnitrosamine in Malt Beverages - 510.600
Compressed Medical Gases-Warning Letters - 435.100 Dimryhylnitrosamine (DMNA) in Barley Malt - 578.500
LIQUID MALT MALT EXTRACT
Malt Products - 515.200 Malt Products - 515.200
LIQUID OXYGEN (LOX) Malted Milk - 527.500
Compressed Medical Gases -Warning Letters - 435.100 MALT SYRUP
LIQUIDATION Malt Products - 515.200
Importation of TV Receivers & Microwave Ovens - 394.500 MALT VINEGAR
LISTED ELECTRONIC PRODUCT Vinegar Definitions - 525.825
Electronic Products Subject to 21 CFR 1001.15(a) - 390.400 MALTED CEREAL SYRUP
LISTERIA MONOCYTOGENES Malt Products - 515.200
Pathogens in Dairy Products - 527.300 MAMMALIAN EXCRETA
LISTERIOSIS Bay (Laurel) Leaves - Insect Filth; Mold; Mammalian ect. - 525.150
Pathogens in Dairy Products - 527.300 Capsicum Pods, etc. - Adulteration - 525.200
LIVER Cocoa Beans - Mold, Insect Infestation, and Mammalian Excreta - 515.750
Fructose-Containing Drugs - 400.335 Condimental Seeds Other Than Fennel Seeds and Sesame Seeds - 525.300
Inert Glandular Preparations - OTC - 455.100 Fennel Seed - Adulteration by Mammalian Excreta; Insects - 525.350

425
Index Compliance Policy Guides
Leafy Spices, Other Than Bay Leaves - 525.500 MARGARINE
Mace - Insect Filth; Mold, Foreign Matter; Mammalian Excreta - 525.550 Hollandaise Sauce 525.- 400
Marjoram - 525.900 MARINE CRAYFISH
Oregano - 525.850 Common or Usual Names for Curstaceans - 540.350
Sage - 525.950 MARJORAM
Sesame Seeds - Adulteration - 525.700 Leafy Spices, Other Than Bay Leaves - 525.500
Thyme - 525.925 Marjoram - 525.900
Whole Cassia or Whole Cinnamon, Ground Cinnamon - 525.225 Spices-Definitions - 525.750
Whole and Ground Pepper - Adulteration - 525.625 MASTITIS
Whole Ginger - Insect Filth; Mold; Mammalian Excreta - 525.375 Teat Dips & Washes for Cows & Goats - 654.200
MAMMARY MEAT
Inert Glandular Preparations - OTC - 455.100 Aflatoxins in Animal Feeds - 683.100
MAMMOGRAPHY X-RAY SYSTEM Bouillon, Bouillon Cubes, Granulated - 567.300
Definition: General Purpose Radiographc X-Ray System - 398.100 Canned Pet Food - 690.300
MANDATORY RECALL Clams, Mussels, Oysters - 540.250
Assessment of Civil Penalties - 390.300 Diversion of Adulterated Food - 675.200
MANICURING INSTRUMENTS Drug Use and Residue Avoidance - 615.200
Razor Blades, Manicuring Instruments - 335.500 Extra-Label Use of New Animal Drugs - 615.100
MANUAL COLLIMATION FDA Jurisdiction - 565.100
Positive Beam Limitation (PBL) Requirements - 398.450 Foreign Language Declarations - 562.400
MANUFACTURERS Human-Labeled Drugs - 608.100
Acupuncture Devices and Accessories - 305.100 Illegal Drug Residues - 615.300
Allergenic Extracts Containing Glycerin - 270.100 Processed Seafood Products - 540.700
Anthelmintics - 640.100 Radionuclides - 560.750
Assessment of Civil Penalties - 390.300 Red Meat with PCB's - 565.200
Automatic Adjustment of the X-Ray Field Size - 398.400 Rendered Animal Feed Ingredients - 675.400
Biological Drugs for Animal Use - 645.100 Uncooked Meat for Animal Food - 690.500
Blood and Blood Products - Definitions - 230.100 Unsafe Contamination of Animal Feed - 680.500
Brandy Containing Methyl Alcohol - Food Additive - 510.200 Usual Names for Crustaceans - 540.350
Certification and Identification of X-Ray Components - 398.600 MEDICATED FEED
CGMP's for Medicated Feeds - Daily Inventory Requirements - 680.200 Adequate Use Drugs and Devices - 607.100
Compendial Requirements - 420.400 Alternate Feeding of Medicated Feeds - 666.100
Condoms; Defects - Criteria for Direct Reference Seizure - 345.100 CGMP's for Medicated Feeds - 680.200
Consistent Application of CGMP Determinations - 400.200 Checklist Labeling for Medicated Feeds - 665.200
Crab and Crabmeat Products with Other Seafood - Labeling - 540.285 Medicated Feeds --Formula Information - 670.100
Electrical Muscle Stimulators - 355.200 Medicated Feeds--Combined Batches - 680.400
Exemption for Certain Sunlamp Product Purchaser Records - 396.200 Sequencing in Medicated Feed Production - 680.600
Expiration Dating of Unit Dose Repackaged Drugs - 480.200 Type A Medicated Article in Feed Labels - 665.300
Extra-Label Use of New Animal Drugs in Food - Producing Animals - 615.100 Unsafe Contamination of Pet Feed - 680.500
Fortification of Standardized Juices - 510.700 Use of Drug Contaminated Products - 682.100
Fraud, Untrue Statements of Material Facts, Bribery - 120.100 Vitamins and Minerals in Feed - 670.200
Homeopathic Drugs - 400.400 MENADIONE DIMETHYLPYRIMIDINOL BISULFITE
Hospital Pharmacies - 460.100 Medicated Feeds Formulation - 670.100
Human-Labeled Drugs Distributed & Used in Animal Medicine - 608.100 MERCURY RESIDUE
Hypnotherapy Devices - Self Hypnotic Tape Recordings - 335.300 Treated Grain Seed - 578.400
Importation of Licensed Biologic Products for Human Use - 210.150 METHYLENE CHLORIDE
Importation of Television Receivers and Microwave Ovens - 394.500 Spices Definitions - 525.750
Inspection of Manufacturers of Device Components - 300.100 MEASLES IMMUNE GLOBULIN
Karaya Gum Powder and Related Devices for Use by Ostomates - 325.100 Standards & Min. Requirements for Biologic Products - 205.100
Label Declaration of Artificial Color - 587.100 MEASLES VIRUS VACCINE, INACTIVATED
Labeling: "Chocolate" or "Chocolate Flavored" - 515.800 Standards & Min. Requirements for Biologic Products - 205.100
Laser Light Shows, etc. - 393.100 MEASLES VIRUS VACCINE, LIVE, ATTENUATED
Licensing - Changes to be Reported - 210.100 Standards & Min. Requirements for Biologic Products - 205.100
Literature for High-Intensity Mercury Vapor Lamps - 31.100 MEASURED VALUE
Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200 Temporal-Maximum Ultrasonic Power - 397.100
Marketed New Drugs without Approved NDAs or ANDAs - 440.100 MEASUREMENT DEVICES
Medicated Feeds -- Formula Information - 670.100 Sphygmomanometers - Accuracy - 310.210
Medicated Feeds -- Combined Batches - 680.400 MEASUREMENTS
Mercury Vapor Lamps that are not Self-Extinguishing - 391.200 Metric Declarations of Quantity of Contents - 140.500
Metric Declarations of Quantity of Contents - 140.500 Sweet Potatoes - Sirup Pack - 585.850
Obligations of Factory-Based Manufacturers and Assemblers - 398.375 Temporal-Maximum Ultrasonic Power - 397.100
Orders for Post-Approval Record Reviews - 470.100 MEDICAL CLAIMS
Override of Positive Beam Limitation - 398.425 Hypnotherapy Devices-Self-Hypnotic Tape Recordings - 335.300
Pet Food Labeling - 690.200 Ion Generating Devices - 355.300
Positive Beam Limitation (PBL) Requirements - 398.450 Lasers for Facelift, Wrinkle Removal, Acupuncture, etc - 393.200
Potato Chips, Ingredients - Labeling - 585.710 MEDICAL DEVICE REPORTING (MDR)
Records and Reports - Applicability - 21 CFR 1002.1 - 390.425 Reconditioners/Rebuilders of Medical Devices - 300.200
Registration of Blood Banks and Other Firms - 230.110 MEDICAL DISPOSABLE DEVICES
Regulatory Actions and Small Business - 160.100 Reuse of Medical Disposable Devices - 300.500
Reloaders of X-Ray Tube Housing Assemblies - 398.700 MEDICAL GAS DRUG
Repacking of Drug Products -- CGMP's - 430.200 Compressed Medical Gases -Warning Letters - 435.100
Retention of Microwave Oven Test Records - 394.100 MEDICAL LASERS DEVICES
Salmonella Contamination of Dry Dog Food - 690.700 Lasers for Facelift, Wrinkle Removal, Acupuncture, - 393.200
Standards and Minimum Requirements for Biologic Products - 205.100 MEDICAL MODALITY
Sunlamp Performance Standard - 396.100 Hypnotherapy Devices-Self-Hypnotic Tape Recordings - 335.300
Surgeon's Gloves and Patient Examination Gloves - 335.700 MEDICAL PROCEDURE
Tamper-Resistant Packaging Requirements - 450.500 Blood & Blood Products - Definitions - 230.100
Teat Dips and Udder Washes for Dairy Cows and Goats - 654.200 Ear-Piercing Devices - 320.100
Temporal-Maximum Ultrasonic Power - 397.100 MEDICARE
Uncooked Meat for Animal Food - 690.500 Registration of Blood Banks & Other Firms - 230.110
Vitamin B-15, Pangamic Acid and Pangamic Acid Products - 457.100 MENSTRUAL CONTROL
Volatile N-Nitrosamines in Rubber Baby Bottle Nipples - 500.450 Hypnotherapy Devices-Self-Hypnotic Tape Recordings - 335.300
Water in Food Products (Ingredient or Adulterant) - 555.875 Menstral Sponges - 345.300
Water and Gravy in Pet Food - 690.400 MENSTRUAL TAMPONS
MARANTA ARUNDICACEA L (arrow root). Menstrual Sponges - 345.300
Starches--Common or Usual Names - 578.100 MERCURY

426
Compliance Policy Guides Index
Adulterated Food Mixed w/ Good Food - 555.200 Rodent Contaminated Pet Foods - 690.600
Clincal Thermometer-Adulteration - 335.800 MICROWAVE OVENS
Literature for High-Intensity Mercury Vapor Lamps - 391.100 Certification for Exports - 110.100
Mercury Vapor Lamps--Not Self-Extinguishing - 391.200 Importation of TV Receivers & Microwave Ovens - 394.500
Seeds for Sprouting Prior to Food Use - 555.750 Retention of Microwave Oven Test Records - 394.100
Sphygmomanometers - Accuracy - 310.210 MIGRAINE HEADACHES
Treated Grain Seed - Mercury Residue - 578.400 Hypnotherapy Devices-Self-Hypnotic Tape Recordings - 335.300
MERCURY-IN-GLASS MIL-STD-105D
Clinical Thermometer-Adultration - 335.800 Condoms; Defects-Criteria - Direct Reference Seizure - 345.100
MERCURY RESIDUE MILDEW
Treated Grain Seed - Mercury Residue - 578.400 Greens, Canned - 585.450
METHOD Spinach, Canned or Frozen - 585.775
Adulteration of Drugs under Sec. 501(b) and 501(c) - 420.100 MILK
Alcohol; Use of Synthetic Alcohol in Foods - 555.100 Aflatoxin M1 - 527.400
Ammoniated Cottonseed Meal - Interpretation of 21 CFR 573.140 - 670.500 Butter-Adulteration - 527.100
Analytical Methodology Used by FDA - Drugs - 150.500 Cheese and Cheese Products - 527.200
Apricot, Peach and Pear Nectars and Purees - Mold - 550.155 Cheese-Misbranding - 527.225
Capsicum Pods, etc. - Adulteration - 525.200 Chocolate or Chocolate Flavored - 515.800
Caviar, Use of Term - Labeling - 540.150 Containing Penicillin - 527.450
Changes in Compendial Specifications and NDA - 420.300 Contaminated Products in Pet Food - 682.100
Cherries, Canned - Misbranding Involving Food Standards - 550.230 DDVP (Vapona) Strips in Milkhouses - 527.600
Chloramphenicol - 654.300 Drug Use and Residue Avoidance - 615.200
Compendial Requirements - 420.400 Eggnog; Eggnog Flavored Milk - 527.350
Compressed Medical Gases -- Warning Letters - 435.100 Extra-Label Use of New Pet Drugs - 615.100
Controlled-Release Dosage Form Drugs - 460.700 Human-Labeled Drugs in Pet Medicine - 608.100
Cytotoxic Testing for Allergic Diseases - 370.100 Illegal Drug Residues - 615.300
Decomposition & Histamine in Albacore, Skipjack and Yellowfin Tuna - 540.525 Immune Milk - 275.100
Direct-Fed Microbial Products - 689.100 Imported Milk and Cream - 560.400
Direct Reference Authority for Pseudomonas Contamination - 590.300 Iron Products for Baby Pigs - 643.100
Dried Prunes, Dehydrated Low Moisture Prunes, and Pitted Prunes - 550.700 Malted Milk - 527.500
Illegal Sales of Veterinary Prescription Drugs - 608.500 N-Nitrosamines in Rubber Baby Bottle Nipples - 500.450
Metric Declarations of Quantity of Contents - 140.500 Pathogens in Dairy Products - 527.300
Microfiche and/or Microfilm for Records Retention - 130.400 Pesticide Residues - 575.100
Milk and Milk Products Containing Penicillin - 527.450 Radionuclides - 560.750
Oleomargarine - Misbranding Due to Low Fat - 535.100 Rendered Animal Feed Ingredients - 675.400
Over-The-Counter Sale of Injectable Animal Drugs - 608.200 Teat Dips and Udder Washes - 654.200
Pathogens in Dairy Products - 527.300 Unsafe Contamination of Pet Feed - 680.500
Peaches, Canned - Misbranding Involving Food Standards - 550.655 Vitamins and Minerals Infeed - 670.200
Pesticide Residues in Food and Feed - 575.100 MILKHOUSES
Pistachio Nuts - Aflatoxin Adulteration - 570.500 Use of DDVP (Vapona) Strips-Milk Houses & Rooms - 527.600
Pottery (Ceramics) - Cadmium Contamination - 545.400 MILKROOMS
Pottery (Ceramics) - Lead Contamination - 545.450 Use of DDVP (Vapona) Strips-Milk Houses & Rooms - 527.600
Raw Breaded Shrimp - Microbiological - 540.420 MINCED PIMENTO
Reconditioning - Tree Nuts Contaminated with E. coli - 570.550 Olives - 550.605
RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200 MINOR VIOLATION
Sequencing in Medicated Feed Production - 680.600 Assessment of Civil Penalites - 390.300
Silver-Plated Hollowware - Lead Contamination - 545.500 MISBRANDED-See Attached List
Sugar - Water Damaged - Reconditioning - 515.425 Acupuncture Devices and Accessories - 305.100
Surgeon's Gloves and Patient Examination Gloves -335.700 Canned Green Beans and Canned Wax Beans - Standards - 585.475
Tracers in Animal Feed - 680.100 Capelin; Prohibited from Being Labeled as Smelt - 540.100
Turtles - 170.100 Cheese - Misbranding Due to Moisture and Fat - 527.225
Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100 Use of Cherries, Canned - Misbranding Involving Food Standards - 550.230
DDVP (Vapona) Strips in Milkhouses and Milkrooms - 527.600 Clinical Thermometer - Adulteration; Misbranding Defects - 335.800
Vitamin B-15, Pangamic Acid and Pangamic Acid Products - 457.100 Compressed Medical Gases -- Warning Letters - 435.100
Volatile N-Nitrosamines in Rubber Baby Bottle Nipples - 500.450 Computerized Drug Processing -- Input/Output Checking - 425.400
Water-Damaged Food Products - 555.850 Computerized Drug Processing -- Vendor Responsibility - 425.200
Whole Milk, Low Fat Milk, Skim Milk - Aflatoxin M1 - 527.400 Condoms; Defects - Criteria for Direct Reference Seizure - 345.100
METHYL MERCURY Contamination of Devices Labeled as Sterile - 300.400
Fish, Shellfish, Crustaceans, etc - Methyl Mercury - 540.600 Country of Origin Labeling - 560.200
METHYLCELLULOSE Crab and Crabmeat Products with Other Seafood - Labeling - 540.285
OTC Anti-Obesity Preparations - 456.100 Crabmeat - Product Name - 540.300
METHYLENE CHLORIDE Cytotoxic Testing for Allergic Diseases - 370.100
Spices - Definitions - 525.750 Defective Suntanning Booths and Beds. - 396.300
METRIC Devices for Use in Animals - 655.100
Metric Declarations of Quantity of Contents - 140.500 Diaphragms - Rx Devices - 345.200
MICROBIAL BIOBURDEN Direct-Fed Microbial Products - 689.100
Parametric Release of Terminally Heat Sterilized Drug Products - 460.800 Direct Reference Authority for Class III Medical Devices - 300.700
MICROBIOLOGICAL Dried Prunes, Dehydrated Low Moisture Prunes, and Pitted Prunes - 550.700
Diversion of Adultrated Food to Accetable Animal Feed Eggnog; Eggnog Flavored Milk--Common Usual Names - 527.350
Use - 675.200 Electrical Muscle Stimulators - 355.200
Intermediate or End Products of Sample Analysis - 150.100 Enriched or Fortified Foods - Potency - 555.550
Karaya Gum Powder & Devices for Use by Ostomates - 325.100 Ethylenediamine Dihydroiodide (EDDI) - 651.100
Raw Breaded Shrimp - Microbiological - 540.420 Failure to Register - 625.500
Rodent Contaminated Pet Foods - 690.600 Food Additives - Labeling Directions Necessary for Safe Use - 500.250
MICROBIOLOGICAL ATTRIBUTES Foods, Rail Car Sanitation - Adulteration - 545.300
Karaya Gum Powder & Devices - Use by Ostomates - 325.100 Hazardous Diagnostic X-Ray Systems - 398.200
MICROBIOLOGICAL CRITERIA Homeopathic Drugs - 400.400
Raw Breaded Shrimp - Microbiological - 540.420 Human-Labeled Drugs Distributed & Used in Animal Medicine - 608.100
MICROFICHE Hypnotherapy Devices - Self Hypnotic Tape Recordings - 335.300
Microfiche and/or Microfilm - Records Retention - 130.400 Identical or Similar Product Names - 400.500
MICROFILM Illegal Sales of Veterinary Prescription Drugs - 608.500
Microfiche and/or Microfilm Records Retention - 130.400 Importation of Unlabeled Foods - 21 CFR 101.100(d) - 560.100
MICROOGANISM Imported Products - Lack of English Labeling - 110.900
Direct-Fed Microbial Products - 689.100 Imports - Identity of Ingredients - 560.250
Foods, Except Dairy Products - 555.300 Ineffective Devices - 502(f)(l) Labeling Requirements - 300.300
Pathogens in Dairy Products - 527.300 Ion Generating Devices - 355.300

427
Index Compliance Policy Guides
Jams, Jellies and Related Products - Imports - 560.500 Figs; Fig Paste - Insect Infestation; Mold, Dirt - 550.350
Lack of Expiration Date or Stability Data - 480.300 Green Coffee Beans - Adulteration with Insects; Mold - 510.500
Malt Products - 515.200 Jam, Black Currant - Adulteration with Mold - 550.450
Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200 Leafy Spices, Other Than Bay Leaves - 525.500
Medicated Feeds -- Formula Information - 670.1001 Mace - Insect Filth; Mold, Foreign Matter; Mammalian Excreta - 525.550
Nutritional Supplements for Companion Animals - 690.100 Marjoram - 525.900
Oleomargarine - Misbranding Due to Low Fat - 535.100 Menstrual Sponges - 345.300
Olives - Adulteration Involving Pits; Rot; Insect Infestation - 550.600 Moisture Damaged Grain - 675.300
OTC Drugs - Combination Products - 450.300 Olives - Adulteration Involving Pits; Rot; Insect Infestation - 550.600
OTC Drugs - Recognition as Safe and Effective - 450.200 Oregano - 525.850
Peaches, Canned - Misbranding Involving Food Standards - 550.655 Peaches, Canned, Frozen -- Adulteration Due to Insects and Mold - 550.650
Pet Food Labeling - 690.200 Pineapple, Canned; Pineapple Juice - Adulteration with Mold - 550.680
Prescription Status - Telephone Answering Machine - 460.425 Plums, Canned - Adulteration with Rot - 550.690
Products Composed of Interstate Ingredients - 100.200 Preservatives; Use in Nonstandardized Foods; Label Declaration - 562.600
Reconditioners/Rebuilders of Medical Devices - 300.200 Raisins - Adulteration Involving Mold, Sand, Grit, & Insects - 550.750
Returned Antibiotics Exported Under 801(d) of the Act - 405.210 Sage - 525.950
RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200 Strawberries; Frozen, Whole, or Sliced - Sand, Mold - 550.850
Safety and Labeling of Waxed (Coated) Fruits and Vegetables - 562.550 The Use of Antibiotic Drug Residue By-Products in Animal Feed - 682.200
Silage Ingredients - 687.500 Thyme - 525.925
Standardized Canned Fruit - Packing Medium - 550.800 Tomato Products - Adulteration with Mold - 585.900
Tomatoes - Canned - Misbranding Involving Food Standards (Peel) - 585.875 Whole Milk, Low Fat Milk, Skim Milk - Aflatoxin M1 - 527.400
Uncertified or Delisted Colors - 587.200 Whole and Ground Nutmeg - Insect Filth; Mold; Rodent Filth - 525.600
Unfermented Beverages, Use of Word "Champagne" - 510.300 Whole and Ground Pepper - Adulteration - 525.625
Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100 Vitamins Whole Ginger - Insect Filth; Mold; Mammalian Excreta - 525.375
and Minerals in Feed - 670.200 Whole Cassia or Whole Cinnamon, Ground Cinnamon - 525.225
Warning Label Required on Sunlamp Products - 396.400 Whole and Ground Allspice - Mold; Insect and Rodent Filth - 525.100
Water in Food Products (Ingredient or Adulterant) - 555.875 MONENSIN
Water and Gravy in Pet Food - 690.400 Sequencing in Medicated Feed - 680.600
MISCALIBRATION MONITOR CIRCUIT
Assemblers Who Install Noncompliant Equipment - 398.325 Retention of Microwave Oven Test Recordes - 394.100
MISUSE MONOGRAPHS
Acupuncture Devices & Accessories - 305.100 Adulteration of Drugs Under 501(b) & (c) - 420.100
Determination by Secretary: Product Fails to Comply - 390.200 Compendium Revisions & Deletions - 420.200
Extra-Label Use-New Animal Drugs-Food-Producing Animals - 615.100 Health Fraud - 120.500
Illegal Sales of Veterinary Prescription Drugs - 608.500 Homeopathic Drugs - 400.400
Proper Drug Use & Residue Avoidance - 615.200 OTC Drugs - Recognition as Safe & Effective - 450.200
Seizure of Books That Constitute Misleading Labeling - 140.100 MONOSODIUM GLUTAMATE
MITES Labeling of Seasoning - 525.650
Apple Butter-Adulteration - 550.100 MONTEREY, MOZZARELLA, MUENSTER
Broccoli, Frozen Adulteration - 585.260 Cheese - 527.225
Drupelet Berries - 550.200 MOST RESPONSIBLE OWNER OPERATOR
Food Storage & Warehousing - 580.100 Defective Suntanning Booth & Beds - 396.300
Interpretation of Insect Filth in Foods - 555.600 MOUTH TISSUES
Mushrooms, Canned or Dried - 585.500 Denture Cleaners, Adhesives, & Repair Materials - 315.230
Spinach, Canned or Frozen - 585.775 MULTER BERRIES
MITIGATION Cloudberries - 550.590
Direct-Fed Microbial Products - 689.100 MULTIPLE BATCH PROCESS VALIDATION
Homeopathic Drugs - 400.400 Process Validation Requiremts - Drug Products - 490.100
Human Blood & Blood Products as Drugs - 230.120 MULTIPLE SAMPLING
Hypnotherapy Devices-Self-Hypnotic Tape Recordings - 335.300 Condoms; Defects-Criteria-Direct Reference Seizure - 345.100
Razor Blades, Manicuring Instruments - 335.500 Surgeons' Gloves & Patient Examination Gloves - 335.700
Vitamin B-5, Pangamic Acid & P.A. Products - 457.100 MULTIPLE SCLEROSIS
MIXED NUTS Immune Milk - 275.100
Mixed Nuts-Misbranding Involving Food Standards - 570.700 MUMPS VIRUS VACCINE, LIVE
Tree Nuts -Adulteration Involving Rejects - 570.425 Standards & Min. Requirements - Biologic Products - 205.100
MODEL CHANGE REPORTS MUNG BEANS
Electronic Products Subject to 21 CFR 1001.15(a) - 390.400 Sprouting Prior to Food Use - 555.750
MODEL DESIGNATION MUSCLE
Certification & Identification of X-Ray Components - 398.600 Chubs, Hot Process Smoked w/ Added Nitrite - 540.200
MODES OF OPERATION Electrical Muscle Stimulators - 355.200
Automatic Adjustment of the X-Ray Field Size - 398.400 MUSHROOM MYCELIUM
X-Ray Field Size for Spot-Film - 398.475 Fitness for Food - 585.525
MOISTURE MUSHROOMS
Calcium Chloride - 500.400 Canned or Dried - 585.500
Cheese - Misbranding Due to Moisture and Fat - 527.225 Fitness for Food; Labeling - 585.525
Collection and Charitable Distribution of Drugs - 400.800 Pesticide Residues - 575.100
Dimethylnitrosamine (DMNA) in Barley Malt - 578.500 MUSSELS
Dried Prunes, Dehydrated Low Moisture Prunes, and Pitted Prunes - 550.700 Bacteriological Contamination - 560.600
Malted Milk - 527.500 Paralytic Shellfish Poison - 540.250
Moisture Damaged Grain - 675.300 MUSTARD
Spices - Definitions - 525.750 Composition - 525.575
Tomato Products - Adulteration with Mold - 585.900 Spices-Definitions - 525.750
Water in Food Products (Ingredient or Adulterant) - 555.875 MUSTARD CAKE
MOLD- See Attached List Prepared Mustard, Composition - 525.575
Action Levels for Aflatoxins in Animal Feeds - 683.100 MUSTARD FLOUR
Apple Butter - Adulteration with Mold; Rodent Filth, Insects - 550.100 Prepared Mustard, Composition - 525.575
Apricot, Peach and Pear Nectars and Purees - Mold - 550.155 Spices - Definitions - 525.750
Bay (Laurel) Leaves - Insect Filth; Mold; Mammalian Etc. - 525.150 MUSTARD OIL
Capsicum Pods, etc. - Adulteration - 525.200 Prepared Mustard - 525.575
Cherry Jam - Adulteration with Mold - 550.235 Spices-Definitions - 525.750
Citrus Fruit Juices, Canned - Fly Filth and Mold - 550.250 MYCELIA
Cocoa Beans - Mold, Insect Infestation, and Mammalian Eexcreta - 515.750 Use of Antibiotic Drug Residue - 682.200
Coffee and Cocoa Bean Sweeps - 560.350 NADA
Cranberry Sauce - Adulteration with Mold - 550.260 Animal Drugs for Euthanasia - 608.300
Dates and Date Material; Imported and Domestic - 550.300 Availability of Bulk Chemicals - 625.200
Drupelet Berries (Blackberries, Raspberries, etc.) - 550.200 Chloramphenicol - 654.300

428
Compliance Policy Guides Index
Dimethyl Sulfoxide for Animal Use - 654.100 Controlled-Release Dosage Form Drugs - 460.700
Direct-Fed Microbial Products - 689.100 Export of Uncertified Antibiotics - 405.200
LVP's for Animal Use - 635.100 Fraud, Untrue Statements of Material Facts, Bribery - 120.100
Oral Iron Products for Baby Pigs - 643.100 Hospital Pharmacies - 460.100
Proper Drug Use and Residue Avoidance - 615.200 Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200
Reconditioning of New Pet Drugs - 625.400 Marketed New Drugs without Approved NDAs or ANDAs - 440.100
Silage Ingredients - 687.500 New Drugs - Export - 442.100
Statements Regarding NADA - 605.100 Orders for Post-Approval Record Reviews - 470.100
Teat Dips and Udder Washes Cows/Goats - 654.200 OTC Drugs - Recognition as Safe and Effective - 450.200
Tracers in Pet Feed - 680.100 OTC Drugs - Combination Products - 450.300
NANOMETERS Parametric Release of Terminally Heat Sterilized Drugs - 460.800
Sunlamp Performance Standard - 396.100 Reconditioning New Drugs Lacking Approved NDA - 448.100
NAPKINS Recovery of IND's from Clinical Investigators - 444.100
Facial Tissue, Paper Napkins & Towels, etc. - 100.600 Regulatory Action Regarding Approved New Drugs - 446.100
NARCOTICS Unit Dose Labeling for Solid and Liquid Oral Dosage
Articles not Intended for Entry - 110.700 Forms - 430.100
Confectionery - 515.100 Vitamin B-15, Pangamic Acid and Pangamic Acid Products - 457.100
NATIONAL ASSOCIATION OF BOARDS OF PHARMACY (NABP) NEW DRUG APPLICATIONS
Computerized Rx Recordkeeping by Pharmacies - 460.400 Analytical Methodology Used by FDA - Drugs - 150.500
NATIONAL CANNERS ASSOCIATION Changes in Compendial Specifications and NDA - 420.300
Corn on the Cob, Canned - 585.325 Compendial Requirements - 420.400
Sweet Potatoes-Sirup Pack - 585.850 Content Uniformity Testing of Tablets and Capsules - 460.600
NATIONAL DRUG CODE Export of Uncertified Antibiotics - 405.200
Unit Dose Labeling Solid & Liquid Oral Dose Forms - 430.100 Hospital Pharmacies - 460.100
NATIONAL FORMULARY XIV Jellies, Nonstandardized - 550.475
Homeopathic Drugs - 400.400 Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200
Malt Products - 515.200 Marketed New Drugs without Approved NDAs or ANDAs - 440.100
Spices-Definitions - 525.750 OTC Drugs - Combination Products - 450.300
NATIONAL MARINE FISHERIES SERVICE Reconditioning New Drugs Lacking Approved NDA - 448.100
Fish-Involving Decomposition - 540.575 Regulatory Action Regarding Approved New Drugs - 446.100
Processed Seafood Products - 540.700 Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100
NATURAL CHOCOLATE FLAVORED Vitamin B-15, Pangamic Acid and Pangamic Acid Products - 457.100
Labeling: "Chocolate" or "Chocolate Flavored" - 515.800 NEW YORK GREEN COFFEE ASSOCIATION
NATURAL FERMENTATION Green Coffee Beans-Adulteration w/ Insects; Mold - 510.500
Unfermented Beverages, "Champagne" - 510.300 NIHYDRAZONE
Dealcoholized Wine, Malt Beverages - 510.400 Unsafe Contamination of Pet Feed - 680.500
Alcohol; Use of Synthetic in Foods - 555.100 NITROFURAZONE
NATURAL SEA SPONGES Extra-Label Use of New Pet Drug - 615.100
Menstrual Sponges - 345.300 Unsafe Contamination of Pet Feed - 680.500
NEEDLES NITROIMIDAZOLES
Regulatory Action Approved New Drugs - 446.100 Extra-Label Use of New Pet Drug - 615.100
Status of Syringes & Needles - 655.400 N-NITROSAMINES
NEGATIVE In Rubber Baby Bottles - 500.450
Adulteration of Drugs Under 501(b) & (c) - 420.100 NITRITE
Food,Except Dairy Products-Adulteration w/ Salmonella - 555.300 Clubs - 540.200
Foods, Adulteration w/ Aflatoxin - 555.400 Tuna, Sable, Salmon Shad - 540.500
Ion Generating Devices - 355.300 NITROGEN OXICES (NOX)
Milk & Milk Products Containing Penicillin - 527.450 DMNA in Barley Malt - 578.500
NEPHROPS NORWEGICUS NITROGLYCERIN
Common or Usual Names for Crustaceans - 540.350 Expiration Dating of Unit Dose Repackaged Drugs - 480.200
NET WEIGHT/NET CONTENTS Unit Dose Labeling - Solid & Liquid Oral Dose Forms - 430.100
Corn on the Cob, Canned - 585.325 NITROSATING AGENT
Foods-Net Weight - 562.300 Dimethylnitrosamme in Barley Malt - 578.500
Lingon Berries, Canned - 550.500 NON-AUTOMATE
Metric Declarations - 140.500 Sphygmomanometers - Accuracy - 310.210
Mixed Nuts - 570.700 NON-HEALTH PROFESSIONALS
NEW ANIMAL DRUG Lasers for Facelift, Wrinkle Removal, Acupuncture, etc. - 393.200
Adequate Directions for Drugs/Devices - 607.100 NON-STERILE PHARMACEUTICAL PRODUCTS
Animal Grooming Aids - 653.100 Karaya Gum Powder and Related Devices for Use by Ostomates - 325.100
Anthelmintics - 640.100 NONCOMPLIANCE
Availability/Bulk Chemicals for Pet Drugs - 625.200 Assemblers Who Install Noncompliant Equipment - 398.325
Chloramphenicol - 654.300 Assessment of Civil Penalties - 390.300
Dimethyl Sulfoxide for Pet Use - 654.100 Blood and Blood Products - Definitions - 230.100
Direct-Fed Microbial Products - 689.100 Contract Sterilizers - 100.550
Drugs for Odor Control in Pets - 642.100 Determination by Secretary that Product Fails to Comply - 390.200
Ethylenediamine Dihydroiodide (EDDI) - 651.100 Early Correction of Defects or Noncompliance - 390.225
Extra-Label Use of New Pet Drugs - 615.100 Fraud, Untrue Statements of Material Facts, Bribery - 120.100
Fraud, Untrue Statements of Material - 120.100 Hazardous Diagnostic X-Ray Systems - 398.200
Human-Labeled Drugs Used in Pet Medicine - 608.100 Obligations of Factory-Based Manufacturers and Assemblers - 398.375
Milk Products Containing Penicillin - 527.450 Orders for Post-Approval Record Reviews - 470.100
Orders for Post-Approval Record Reviews - 470.100 Shrimp - Frozen, Raw, Breaded or Lightly Breaded - 540.410
Proper Drug Use and Residue Avoidance - 615.200 NONFAT DRY
Reconditioning of New Pet Drugs Seized - 625.400 Imported Milk and Cream. Import Milk Act - 560.400
Silage Ingredients - 687.500 Pathogens in Dairy Products - 527.300
Statements Regarding NADA Approval - 605.100 Use of Drug-Contaminated Products in Animal Feed - 682.100
Tracers in Animal Feed - 680.100 NONNUTRITIVE SWEETENERS
Unapproved New Animal Drugs - 625.300 Confectionery - 515.100
Unsafe Contamination of Pet Feed - 680.500 NONREACTIVE
NEW DRUG Source Plasma - Syphilis - 254.100
Adequate Directions for Use - Animal Drugs and Devices - 607.100 NONSIGNIFICANT RISK DEVICES
Adulteration of Drugs under Sec. 501(b) and 501(c) - 420.100 Acupuncture Devices and Accessories - 305.100
Analytical Methodology Used by FDA - Drugs - 150.500 NONSTERILE
Compendial Requirements - 420.400 Contamination of Devices Labeled as Sterile - 300.400
Compressed Medical Gases -- Warning Letters - 435.100 Karaya Gum Powder and Related Devices for Use by Ostomates - 325.100
Consistent Application of CGMP Determinations - 400.200 NONSTERILITY
Content Uniformity Testing of Tablets and Capsules - 460.600 Contamination of Devices Labeled as Sterile - 300.400

429
Index Compliance Policy Guides
NONSURGICAL PROCEDURES Labeling of Seasonings - 525.650
Lasers for Facelift, Wrinkle Removal, Acupuncture, etc. - 393.200 Spices - Definitions - 525.750
NOODLE PRODUCTS OIL OF JUNIPER
Macaroni and Noodle Products - 505.500 Labeling of Seasonings - 525.650
Water in Food Products (Ingredient or Adulterant) - 555.875 OLALLIE BLACKBERRIES
NORMAL INSPECTION Drupelet Berries (Blackberries, Raspberries, etc.) - 550.200
Condoms; Defects - Criteria for Direct Reference Seizure - 345.100 OLEOMARGARINE
NORMAL SERUM ALBUMIN Oleomargarine - Misbranding Due to Low Fat - 535.100
Standards and Minimum Requirements for Biologic Products - 205.100 Products Composed of Interstate Ingredients - 100.200
NORMAL WEAR OLEORESIN CELERY
Assemblers Who Install Noncompliant Equipment - 398.325 Labeling of Seasonings - 525.650
Determination by Secretary that Product Fails to Comply - 390.200 OLEORESIN SWEET BASIL
NORTH ATLANTIC LOBSTER/NORWEGIAN LOBSTER Labeling of Seasonings - 525.650
Common or Usual Names for Crustaceans - 540.350 OLIVES
NOTICE Olives - Adulteration Involving Pits; Rot; Insect Infestation - 550.600
Acupuncture Devices and Accessories - 305.100 OLIVES STUFFED WITH MINCED PIMENTOS
Assemblers Who Install Noncompliant Equipment - 398.325 Olives Stuffed with Minced Pimentos - Labeling - 550.605
Assessment of Civil Penalties - 390.300 OMISSION
Class III Devices Subject to 5l5(b) Requirements - 300.750 Assessment of Civil Penalties - 390.300
Confectionery - Use of Nonnutritive Substances as Ingredients - 515.100 Country of Origin Labeling - 560.200
Crabmeat - Adulteration with Filth - Escherichia coli - 540.275 Determination by Secretary that Product Fails to Comply - 390.200
Cytotoxic Testing for Allergic Diseases - 370.100 Responsibility for Illegal Drug Residues in Meat, Milk and Eggs - 615.300
Direct Reference Authority for Class III Medical ONE-FOR-ONE EXCHANGE
Devices - 300.700 Compressed Medical Gases -- Warning Letters - 435.100
Failure to Register - 625.500 Reloaders of X-Ray Tube Housing Assemblies - 398.700
Fish-Fresh and Frozen-Adulteration Involving Decomposition - 640.575 ONION POWDER
Health Fraud - 120.500 Labeling of Seasonings - 525.650
Homeopathic Drugs - 400.400 ONION RINGS MADE FROM DICED ONIONS
Hospital Pharmacies - 460.100 Olives Stuffed with Minced Pimentos - Labeling - 550.605
Importation of Television Receivers and Microwave Ovens - 394.500 OPINION
Imported Milk and Cream. Import Milk Act - 560.400 Adulterated Food Mixed with Good Food - 555.200
Imported Products - Lack of English Labeling - 110.900 Alcohol; Use of Synthetic Alcohol in Foods - 555.100
Large Volume Parenterals (LVP's) for Animal Use - 635.100 Canned Peas - Label Designation of Sizes - 585.625
Marketed New Drugs without Approved NDAs or ANDAs - 440.100 Caviar, Use of Term - Labeling - 540.150
Menstrual Sponges - 345.300 Collection and Charitable Distribution of Drugs - 400.800
OTC Drugs - Combination Products - 450.300 Color Additives in Paper and Paperboard for Use with Food - 500.425
Refusal to Permit Inspection - 130.100 Commercial Distribution -- Premarket Notification - 300.600
Regulatory Actions Against Assemblers of X-Ray Equipment - 398.350 Crab and Crabmeat Products with Other Seafood - Labeling - 540.285
Revocation of Tolerances for Cancelled Pesticides - 550.700 Cytotoxic Testing for Allergic Diseases - 370.100
Section 305 Meeting - 160.400 Drug Product Entries in Periodic Publications - 400.700
Shrimp - Fresh or Frozen Raw Headless, Peeled or Breaded - 540.400 Drupelet Berries (Blackberries, Raspberries, etc.) - 550.200
Water and Gravy in Pet Food - 690.40022 Ear Piercing Devices - 320.100
NOTICE OF ADVERSE FINDINGS Electrical Muscle Stimulators - 355.200
Failure to Register - 625.500 FDA Jurisdiction Over Meat and Poultry Products - 565.100
Health Fraud - 120.500 Foods, Rail Car Sanitation - Adulteration - 545.300
Homeopathic Drugs - 400.400 Fortification of Standardized Juices - 510.700
Large Volume Parenterals (LVP's) for Animal Use - 635.100 Hollandaise Sauce - Common or Usual Name - 525.400
Menstrual Sponges - 345.300 Hospital Pharmacies - 460.100
Regulatory Actions Against Assemblers of X-Ray Equipment - 398.350 Importation of Television Receivers and Microwave Ovens - 394.500
NUMBERS Imported Milk and Cream. Import Milk Act - 560.400
Blood and Blood Products - Definitions - 230.100 Jordan Almonds - Common or Usual Name - 570.100
Certification and Identification of X-Ray Components - 398.600 Karaya Gum Powder and Related Devices for Use by Ostomates - 325.100
Cheese - Misbranding Due to Moisture and Fat - 527.225 Labeling: "Chocolate" or "Chocolate Flavored" - 515.800
Clams, Mussels, Oysters - Bacteriological Contamination - 560.600 Malt Products - 515.200
Common or Usual Names for Animal Feed Ingredients - 665.100 Marmalade - 550.575
Contamination of Devices Labeled as Sterile - 300.400 Microfiche and/or Microfilm for Records Retention - 130.400
Diversion of Adulterated Food to Acceptable Animal Feed Use - 675.200 Override of Positive Beam Limitation - 398.425
Metric Declarations of Quantity of Contents - 140.500 Peas and Carrots, Labeling of Canned Mixture - 585.600
Olives Stuffed with Minced Pimentos - Labeling - 550.605 Pet Food Labeling - 690.200
Pathogens in Dairy Products - 527.300 Plastic Containers for Injectable Animal Drugs - 637.100
Platelets, Pooled - 231.100 RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200
NUT Seeds for Sprouting Prior to Food Use - 555.750
Bakery Products, Candy "Shotgun" - 505.100 Sphygmomanometers - Rx Legend - 310.200
Butter Nut Bread - 505.300 Unfermented Beverages, Use of Word "Champagne" - 510.300
Mixed Nuts-Misbranding - 570.700 Use of DDVP (Vapona) Strips in Milkhouses and Milkrooms - 527.600
Names for Crustaceans - 540.350 OPPORTUNISTIC PATHOGENS
Reconditioning Tree Nuts - 570.550 Karaya Gum Powder and Related Devices for Use by Ostomates -325.100
Tree Nuts-Escherichia coli - 570.450 ORAL HYGIENE PRODUCTS
NUTMEG Tamper-Resistant Packaging Requirements - 450.500
Spices-Definitions - 525.750 ORAL PRESCRIPTION
Whole and Ground Filth; Mold - 525.600 Prescription Status - Telephone Answering Machine - 460.425
OBJECTIONABLE PRACTICE ORANGE BLOSSOM HONEY
Pacemaker Reuse - 310.100 Honey - Source Declaration - 515.300
OBLIGATIONS ORANGE MARMALADE
Responsibility for Reporting Violations - 100.100 Marmalade - 550.575
Inspection of Firms When Legal Action is Pending - 130.200 ORANGES
OCEAN PERCH Marmalade - 550.575
Fish - Adulteration by Parasite - 540.590 Oranges - Artificial Coloring - 550.625
OFFICE OF GENERAL COUNSEL Pesticide Residues in Food and Feed - 575.100
Ammoniated Cottonseed Meal - Interpretation of 21 CFR 573.140 - 670.500 ORCHIC
Answering Inquiries on Status of Criminal Referrals - 160.500 Inert Glandular Preparations - OTC - 455.100
Chloramphenicol - 654.300 OREGANO
Dentures -- Sale by Persons not Licensed to Practice Dentistry - 315.100 Labeling of Seasonings - 525.650
OIL OF BITTER ALMONDS Leafy Spices, Other Than Bay Leaves - 525.500
Maraschino Cherries - 550.550 Oregano - 525.850
OIL OF CORIANDER Spices - Definitions - 525.750

430
Compliance Policy Guides Index
ORGANOLEPTIC ANALYSIS Dealcoholized Wine and Malt Beverages - Labeling - 510.400
Canned Salmon - Adulteration Involving Decomposition - 540.375 Foods - FPLA Compliance - 562.200
Shrimp - Fresh or Frozen Raw Headless, Peeled or Breaded - 540.400 Homeopathic Drugs - 400.400
ORGANOLEPTIC CHARACTERISTICS Identity of Foods--Terms such as Fresh, Frozen, Dried, Canned - 562.450
Jellies, Nonstandardized - 550.475 Labeling of Food Articles Distributed Solely in Puerto Rico - 562.750
ORIENTAL NOODLES Metric Declarations of Quantity of Contents - 140.500
Chow Mein Noodles, Chinese Noodles and Other Oriental Noodles - 505.400 OTC Drugs - Combination Products - 450.300
OSTOMATES Processed and/or Blended Seafood Products - 540.700
Karaya Gum Powder and Related Devices for Use by Ostomates - 325.100 Statements Regarding NADA Approval in Labeling and Advertising - 605.100
OSTOMY APPLIANCES Time Period for Separation of Platelets - 231.120
Karaya Gum Powder and Related Devices for Use by Ostomates - 325.100 Warning Label Required on Sunlamp Products - 396.400
OTC PANULIRUS ARGUS, RISSONII, ORNATUS
CGMP Enforcement Policy - OTC vs Rx Drugs - 450.100 Common or Usual Names for Crustaceans - 540.350
Control/Accountability of TRP Materials - 450.550 PAPER
Health Fraud - 120.500 Approved by FDA" - Labeling of a Food Additive -500.300
Homeopathic Drugs - 400.400 Color Additives in Paper and Paperboard for Use with Food -500.425
Inert Glandular Preparations - OTC - 455.100 Dimethyl Sulfoxide (DMSO) for Animal Use - 654.100
Lack of Expiration Date or Stability Data - 480.300 Facial Tissues, Paper Napkins, Paper Towels, etc. - 100.600
Marketed New Drugs without Approved NDAs or ANDAs - 440.100 Food Storage & Warehousing - Adulteration - Filth - 580.100
Nutritional Supplements for Companion Animals - 690.100 Tamper-Resistant Packaging Requirements - 450.500
OTC Drugs - Combination Products - 450.300 PAPERBOARD
OTC Anti-Obesity Preparations - 456.100 Color Additives in Paper and Paperboard for Use with Food - 500.425
OTC Drugs - Recognition as Safe and Effective - 450.200 Tamper-Resistant Packaging Requirements - 450.500
OTC Drugs in Vending Machines - 450.400 PAPRIKA
OTC Ear Drops - 454.100 Capsicum Pods, etc. - Adulteration - 525.200
Packaging -- Contact Lens Solutions and Tablets - 350.100 Labeling of Seasonings - 525.650
Tamper-Resistant Packaging Requirements - 450.500 Pesticide Residues in Food and Feed - 575.100
OTC DRUG MONOGRAPH IMPLEMENTATION Spices - Definitions - 525.750
OTC Drugs - Recognition as Safe and Effective - 450.200 PARAGRAPH XIV PRESCRIPTION DRUGS
OTHER IDENTICAL DESI-EFFECTIVE PRESCRIPTION DRUGS Marketed New Drugs without Approved NDAs or ANDAs - 440.100
Marketed New Drugs without Approved NDAs or ANDAs - 440.100 PARALYTIC SHELLFISH POISON
OTHER SAUCES Clams, Mussels, Oysters - Paralytic Shellfish Poison - 540.250
Tomato Products - Drosophila Fly Eggs and Maggots - 585.890 PARAMETRIC RELEASE
OUTER ENVELOPE Parametric Release of Terminally Heat Sterilized Drugs - 460.800
Mercury Vapor Lamps that are Not Self-Extinguishing - 391.200 PARAPROTEINEMIC
OUTPUT WAVEFORM Blood and Blood Products - Definitions - 230.100
Temporal-Maximum Ultrasonic Power - 397.100 PARASITES
OVARY Fish - Fresh and Frozen, as listed - Adulteration by Parasites - 540.590
Inert Glandular Preparations - OTC - 455.100 Flea and Tick Collars Containing a Pesticide - 641.100
OVEN PARATHYROID
Retention of Microwave Oven Test Records - 394.100 Inert Glandular Preparations - OTC - 455.100
Importation of Television Receivers and Microwave Ovens - 394.500 PARENTERAL DRUGS
OVER-THE-COUNTER Fructose-Containing Drugs - 400.335
Acupuncture Devices and Accessories - 305.100 PARENTERAL USE
Control/Accountability of TRP Materials - 450.550 Inert Glandular Preparations - OTC - 455.100
Extra-Label Use of New Animal Drugs in Food-Producing Animals -615.100 PAROTID
Homeopathic Drugs - 400.400 Inert Glandular Preparations - OTC - 455.100
Metric Declarations of Quantity of Contents - 140.500 PARSLEY
Nutritional Supplements for Companion Animals - 690.100 Spices - Definitions - 525.750
OTC Ear Drops - 454.100 PART NUMBERS
OTC Drugs in Vending Machines - 450.400 Certification and Identification of X-Ray Components - 398.600
Over-The-Counter Sale of Injectable Animal Drugs - 608.200 PASTEURIZATION
Packaging -- Contact Lens Solutions and Tablets - 350.100 Processing" - Use of Term in Section 405 of the FD&C Act - 562.650
Tamper-Resistant Packaging Requirements - 450.500 Immune Milk - 275.100
Tamper-Resistant Packaging - 590.500 PASTEURIZED BLENDED (CHEESE)
The Status of Syringes and Needles for Animal Use - 655.400 Cheese - Misbranding Due to Moisture and Fat - 527.225
Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100 PASTEURIZED PROCESS
OVERBLEEDING Cheese - Misbranding Due to Moisture and Fat - 527.225
Source Plasma - Overbleeding - 252.100 PATHOGENS
OVERRIDE Immune Milk - 275.100
Override of Positive Beam Limitation - 398.425 Karaya Gum Powder and Related Devices for Use by Ostomates - 325.100
OXYGEN ANALYZER Pathogens in Dairy Products - 527.300
Compressed Medical Gases -- Warning Letters - 435.100 PATIENT EXAMINATION GLOVES
OYSTERS Surgeon's Gloves and Patient Examination Gloves - 335.700
Clams, Mussels, Oysters - Paralytic Shellfish Poison - 540.250 PATIENT POPULATION
Clams, Mussels, Oysters - Bacteriological Contamination - 560.600 Marketed New Drugs without Approved NDAs or ANDAs - 440.100
Water in Food Products (Ingredient or Adulterant) - 555.875 PBL LOGIC SYSTEM
OZONE Override of Positive Beam Limitation - 398.425
Ion Generating Devices - 355.300 PDP
PACKAGE INSERTS Class III Devices Subject to 5l5(b) Requirements - 300.750
Tamper-Resistant Packaging Requirements - 450.500 Metric Declarations of Quantity of Contents - 140.500
PACKING MEDIUM PEACH
Canned Foods, Use of the Term "Solid Pack" - 520.100 Peaches, Canned - Misbranding Involving Food Standards - 550.655 Apricot,
Corn on the Cob, Canned - Quantity of Contents Declaration - 585.325 Peach and Pear Nectars and Purees - Mold - 550.155
Maraschino Cherries - 550.550 PEANUT
Pineapple, Canned; Imported and Domestic - Food Standards - 550.685 Action Levels for Aflatoxins in Animal Feeds - 683.100
Pork and Beans and Similar Bean Products--Labeling - 567.200 Aflatoxin in Peanuts and Peanut Products - 570.375
Processing" - Use of Term in Section 405 of the FD&C Act - 562.650 Foods, Adulteration with Aflatoxin - 555.400
Standardized Canned Fruit - Packing Medium - 550.800 Peanut Butter - Adulteration with Filth; Grit - 570.300
Sweet Potatoes - Sirup Pack - 585.850 Peanuts, Shelled and Unshelled - Filth and Reject Nuts - 570.350
Tomato Products - Adulteration with Mold - 585.900 Pesticide Residues in Food and Feed - 575.100
PAIN CONTROL PEANUT BUTTER
Hypnotherapy Devices - Self Hypnotic Tape Recordings - 335.300 Peanut Butter - Adulteration with Filth; Grit - 570.300
PANEL PEANUT PRODUCTS
Bakery Products, Candy "Shotgun" Ingredients Declaration -505.100 Action Levels for Aflatoxins in Animal Feeds - 683.100
Certification and Identification of X-Ray Components - 398.600 Aflatoxin in Peanuts and Peanut Products - 570.375

431
Index Compliance Policy Guides
Foods, Adulteration with Aflatoxin - 555.400 Fraud, Untrue Statements of Material Facts, Bribery - 120.100
PEAR NECTARS Silage Ingredients - 687.500
Apricot, Peach and Pear Nectars and Purees - Mold - 550.155 PH
PEAR PUREES Acidified Low-Acid Canned Foods - High pH - 520.300
Apricot, Peach and Pear Nectars and Purees - Mold - 550.155 Immune Milk - 275.100
PEAS AND CARROTS Large Volume Parenterals (LVP's) for Animal Use - 635.100
Peas and Carrots, Labeling of Canned Mixture - 585.600 PHARMACEUTICALS
Pesticide Residues in Food and Feed - 575.100 Adulteration of Drugs under Sec. 501(b) and 501(c) - 420.100
PECANS Compendium Revisions and Deletions - 420.200
Pesticide Residues in Food and Fruit - 575.100 Karaya Gum Powder and Related Devices for Use by Ostomates - 325.100
Tree Nuts - Adulteration Involving Rejects - 570.425 Process Validation Requirements for Drug Products - 490.100
PECTIN Regulatory Action Regarding Approved New Drugs - 446.100
Confectionery - Use of Nonnutritive Substances as Ingredients. - 515.100 Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100
Jellies, Nonstandardized - 550.475 PHARMACOLOGY
PENDENCY Extra-Label Use of New Animal Drugs - 615.100
Commercial Distribution -- Premarket Notification - 300.600 PHENAZOPYRIDINE
PENICILLIN Urinary Preparations - Lack of Rx Legend - Clains - 430.400
Milk and Milk Products Containing Penicillin - 527.450 PHENOL
Repacking of Drug Products -- CGMP's - 430.200 Immune Milk - 275.100
Use of Drug-Contaminated Products in Animal Feed - 682.100 Pathogens in Dairy Products - 527.300
PEPPER PHOSPHATASE
Capsicum Pods, etc. - Adulteration - 525.200 Pathogens in Dairy Products - 527.300
Spices - Definitions - 525.750 PHYSICAL
PEPPER, RED Blood and Blood Products - Definitions - 230.100
Capsicum Pods, etc. - Adulteration - 525.200 Canned Green Beans and Canned Wax Beans - Standards - 585.475
Spices - Definitions - 525.750 CGMP Applicability to Hardware and Software - 425.100
PERCH Confectionery - Use of Nonnutritive Substances as Ingredients - 515.100
Fish - Fresh and Frozen, as listed - Adulteration by Parasites - 540.590 Diversion of Adulterated Food to Acceptable Animal Feed Use - 675.200
PERFORMANCE STANDARD Failure to Register - 625.500
Assemblers who Install Noncompliant Equipment - 398.325 Food Additives -"GRAS" - 500.200
Assessment of Civil Penalties - 390.300 Identity of Foods--Terms Such as Fresh, Frozen, Dried, Canned - 562.450
Certification and Identification of X-Ray Components - 398.600 Imports -- Post Detention Sampling - 100.800
Defective Suntanning Booths and Beds - 396.300 Jordan Almonds - Common or Unual Name - 570.100
Definition of General Purpose Radiographic X-Ray System - 398.100 Plastic Containers for Injectable Animal Drugs - 637.100
Determination by Secretary that Product Fails to Comply - 390.200 Registration of Blood Banks and Other Firms - 230.110
Early Correction of Defects or Noncompliance - 390.225 Reuse of Medical Disposable Devices - 300.500
Exemption for Certain Sunlamp Product Purchaser Records - 396.230 Schedule of Physical Examination - 251.100
Importation of Television Receivers and Microwave Ovens - 394.500 Sequencing in Medicated Feed Production - 680.600
Laser Light Shows, etc. - 393.100 Use of Income Tax Information from IRS - 160.200
Lasers for Facelift, Wrinkle Removal, Acupuncture, etc. - 393.200 PHYSICAL EXAMINATION
Literature for High-Intensity Mercury Vapor Lamps - 391.100 Schedule of Physical Examination - 251.100
Obligations of Factory-Based Manufacturers and Assemblers - 398.375 PILFERAGE
Sunlamp Performance Standard - 396.100 Labeling of Shipping Containers for Drugs - 430.300
Temporal-Maximum Ultrasonic Power - 397.100 PILI NUTS
Warning Label Required on Sunlamp Products - 396.400 Adulteration Involving Rejects - 570.425
PERSON PIMENTA
Acupuncture Devices and Accessories - 305.100 Spices - 525.750
Answering Inquiries on Status of Criminal Referrals - 160.500 PIMPINELLA ANISUM
Assessment of Civil Penalties - 390.300 Spices-Definitions - 525.750
Blood and Blood Products - Definitions - 230.100 PINEAL
Computerized Drug Processing -- I.D. of "Persons" - 425.500 Inert Glandular Preparations OTC - 455.100
Confectionery - Use of Nonnutritive Substances as Ingredients - 515.100 PINEAPPLE
Contamination of Devices Labeled as Sterile - 300.400 Pesticide Residues in Food and Feed - 575.100
Definition of "Commerce" - 21 CFR 1000.3(g) - 390.100 Pineapple, Canned; Imported and Domestic - Food Standards - 550.685
Dentures -- Sale by Persons not licensed to Practice Dentistry - 315.100 Pineapple, Canned; Pineapple Juice - Adulteration with Mold - 550.680
Ear Piercing Devices - 320.100 PIPERINE
Extra-Label Use of New Animal Drugs in Food-Producing Animals - 615.100 Spices - 525.750
Food and Drug Guaranty - Imports - 110.500 PISTACHIO NUTS
Fraud, Untrue Statements of Material Facts, Bribery - 120.100 Aflatoxin and Adulteration - 570.500
Guaranties Over Printed Signatures - 100.800 PIT
Health Fraud - 120.500 Cherries, Canned - 550.230
Hospital Pharmacies - 460.100 Dates and Date Material - 550.300
Illegal Sales of Veterinary Prescription Drugs - 608.500 Dried Prunes - 550.700
Importation of Unlabeled Foods -- *21 CFR 101.100(d) - 560.100 Olives - Pits; Rot; Insect Infestation - 550.600
Intermediate or End Products of Sample Analysis - 150.100 PIT FRAGMENTS (see pits)
Lasers for Facelift, Wrinkle Removal, Acupuncture, etc. - 393.200 PITTED DATES
Obligations of Factory-Based Manufacturers and Assemblers - 398.375 Dates and Date Material - 550.300
Reconditioners/Rebuilders of Medical Devices - 300.200 PITTED SALAD OLIVES
Refusal to Permit Inspection. - 130.100 Olives - 550.600
Registration of Blood Banks and Other Firms - 230.110 PITUITARY
Requests for Records under Section 703 - 160.300 Inert Glandular Preperations OTC - 455.100
RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200 PIZZA
Section 305 Meeting - 160.400 Labeling of Seasonings - 525.650
Turtles - 170.100 Tomato Products - Drosophila Fly Eggs and Maggots - 585.890
PERTUSSIS VACCINE Tomato Products - Adulteration with Mold - 585.900
Standards and Minimum Requirements for Biologic Products - 205.100 PIZZA SEASONING (see pizza)
PESTICIDE CHEMICALS PLACENTA
Flea and Tick Collars Containing a Pesticide - 641.100 Inert Glandular Preperation OTC - 455.100
Foods, Rail Car Sanitation - Adulteration - 545.300 PLASMA
Labeling of Food Bearing Residues of Pesticide Chemicals - 562.700 Blood and Blood Products - Definitions - 230.100
PESTICIDE RESIDUES IN FOOD - 575.100 Communicable Disease Hazard - 100.300
PESTICIDES, CANCELLED Large Volume Parenterals (LVP's) for Animal Use - 635.100
Revocation of Tolerances for Cancelled Pesticides - 555.700 Plasma Brokers - Registration and Compliance - 250.500
PETITION Quantitative Testing for Serum Proteins in Plasmapheresis Donors - 255.100
Approved by FDA" - Labeling of a Food Additive - 510.300 Registration of Blood Banks and Other Firms - 230.110
Confectionery - Use of Nonnutritive Substances as Ingredients. - 515.100 Source Plasma - Overbleeding - 252.100

432
Compliance Policy Guides Index
Source Plasma - Guidelines for Informed Consent Forms - 250.100 Ingredients - Labeling - 585.710
Source Plasma - Syphilis - 254.100 POTATO STARCH
Standards and Minimum Requirements for Biologic Products - 205.100 Starches, Common and Usual Names - 578.100
Time Period for Separation of Platelets - 231.120 POTENCY
Use of Units which have been Thawed - 253.100 Adulteration of Drugs under Sec. 501(b) and 501(c) - 420.100
PLASMA BROKERS Biological Drugs for Animal Use - 645.100
Plasma Brokers - Registration and Compliance - 255.500 Blood and Blood Products - Definitions - 230.100
Registration of Blood Banks and Other Firms - 230.110 Compendial Requirements - 420.400
PLASMAPHERESIS Enriched or Fortified Foods - Potency - 555.550
48-hour Period between Plasmapheresis Procedures - 256.100 Extra-Label Use of New Animal Drugs in Food-Producing Animals - 615.100
Blood and Blood Products - Definitions - 230.100 Homeopathic Drugs - 400.400
Quantitative Testing for Serum Proteins in Plasmapheresis Donors - 255.100 Lack of Expiration Date or Stability Data - 480.300
Registration of Blood Banks and Other Firms - 230.110 Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200
Schedule of Physical Examination - 251.100 Medicated Feeds -- Combined Batches - 680.400
Source Plasma - Guidelines for Informed Consent Forms - 250.100 Reconditioning New Drugs Lacking Approved NDA - 448.100
Source Plasma - Syphilis - 254.100 Repacking of Drug Products -- CGMP's - 430.200
Source Plasma - Overbleeding - 252.100 Standards and Minimum Requirements for Biologic Products - 205.100
PLASMAPROTEIN FRACTION Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100 Vitamin
Standards and Minimum Requirements for Biologic Products - 205.100 Products for human use - low potency - 530.400
PLASTICS POTENTIAL
Denture Cleanres, Adhesives, Cushions, & Repair Materials - 315.200 Alternate Feeding of Different Medicated Feeds - 666.100
PLATELET CONCENTRATE Answering Inquiries on Status of Criminal Referrals - 160.500
Platelets, Pooled - 231.100 CGMP Enforcement Policy - OTC vs Rx Drugs - 450.100
Standards & Minimum Requirements for Biological Products - 205.100 CGmp's for Medicated Feeds - Daily Inventory Requirements - 680.200
Storage of Platelet Concentrate - 231.130 Clams, Mussels, Oysters - Paralytic Shellfish Poison - 540.250
Time Period of Seperation of Platlets - 231.120 Communicable Disease Hazards - 100.300
PLEURONCODES MONODON Direct Reference Authority for Class III Medical Devices - 300.700
Common or Usual Names for Crustaceans - 540.350 Human-Labeled Drugs Distributed & Used in Animal Medicine - 608.100
PLUGGING Identical or Similar Product Names - 400.500
Wheat Filth - 578.300 Illegal Sales of Veterinary Prescription Drugs - 608.500
PLUMS, CANNED Imitation Breaded Shrimp - 540.450
Adulteration with Rot - 550.690 Karaya Gum Powder and Related Devices for Use by Ostomates - 325.100
Pesticide Residues - 575.100 Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200
PMA Marketed New Drugs without Approved NDAs or ANDAs - 440.100
Class III Devices Subject to 515(b) Requirements - 300.350 Mercury Vapor Lamps that are not Self-Extinguishing - 391.200
Direct Reference Authority for Class III Medical Devices - 300.700 OTC Drugs - Combination Products - 450.300
RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200 OTC Drugs - Recognition as Safe and Effective - 450.200
POLIOMYELITIS VACCINE Pottery (Ceramics) - Cadmium Contamination - 545.400
Standards & Minimum Requirements for Biological Products - 205.100 Pottery (Ceramics) - Lead Contamination - 545.450
POLIOVIRUS VACCINE, LIVE, ORAL Radionuclides in Imported Foods - Levels of Concern - 562.750
Standards & Minimum Requirements for Biological Products - 205.100 Raw Breaded Shrimp - Microbiological - 540.420
POLLOCK Responsibility for Reporting Violations - 100.100
Crab and Other Seafood Products - Labeling - 540.285 Sequencing in Medicated Feed Production - 680.600
Petfood Labeling - 690.200 Silver-Plated Hollowware - Lead Contamination - 545.500
Processed Seafood Products - 540.700 Surgeon's Gloves and Patient Examination Gloves - 335.700
Red Meat - 565.200 Teat Dips and Udder Washes for Dairy Cows and Goats - 654.200
POLYVALENT ANTIGENS Uncooked Meat for Animal Food - 690.500
Immune Milk - 275.100 Whole Milk, Low Fat Milk, Skim Milk - Aflatoxin M1 - 527.400
POOR DESIGN POTENTIAL HAZARDS
Obligations of Factory Based Manufacturers & Assemblers - 398.375 Karaya Gum Powder and Related Devices for Use by Ostomates - 325.100
POPCORN POTTERY
Filth - 585.675 Cadmium Contamination - 545.400
Pesticide Residues and Feed - 575.100 Lead Contamination - 545.450
POPPY SEEDS POUCHES
Spices - 525.750 Tamper Resistant Packaging Requirements - 450.500
PORK AND BEANS POULTRY
Similar Bean Products - 567.200 Action Levels for Aflatoxins in Animal Feeds - 683.100
PORTABLE HOME SUNLAMP PRODUCTS AND Canned Pet Food - 690.300
ULTRAVIOLET LAMPS Common or Usual Names for Animal Feed Ingredients - 665.100
Exemptions for Certain Sunlamp Product Purchaser Records - 396.200 Diversion of Adulterated Food to Acceptable Animal Feed Use - 675.200
Sunlamp Performance Standard - 396.100 FDA Jurisdiction Over Meat and Poultry Products - 565.100
POSITIVE BEAM LIMITATION (PBL) Human-Labeled Drugs Distributed & Used in Animal Medicine - 608.100
Override of Positive Beam Limitation - 398.425 Nutritional Supplements for Companion Animals - 690.100
Positive Beam Limitation (PBL) Requirements - 398.450 Proper Drug Use and Residue Avoidance - 615.200
POSTAL Radionuclides in Imported Foods - Levels of Concern - 560.750
Health Fraud - 120.500 Recycled Animal Waste - Alternate Feeding of Different Medicated
POSTAMENDMENT DEVICES Feeds - 666.100
Class III Devices Subject to 515(b) Requirements - 300.350 Red Meat Adulterated with PCB's - 565.200
POSTIVE Rendered Animal Feed Ingredients - 675.400
Adulteration of Drugs under Sec. 501(b) and 501(c) - 420.100 Responsibility for Illegal Drug Residues in Meat, Milk and Eggs - 615.300
Direct Reference Authority for Pseudomonas Contamination - 590.300 Revocation of Tolerances for Cancelled Pesticides - 555.700
Food Storage & Warehousing - Adulteration - Filth - 580.100 Vitamins and Minerals in Feed - 670.200
Foods, Except Dairy Products - Adulteration with Salmonella - 555.300 PRE-AMENDMENTS DEVICE
Fraud, Untrue Statements of Material Facts, Bribery -120.100 Commercial Distribution - 300.600
Ion Generating Devices - 355.300 PREMARKET
Milk and Milk Products Containing Penicillin - 527.450 Certification for Exports - 110.100
Override of Positive Beam Limitation - 398.425 Class III Devices Subject to 5l5(b) Requirements - 300.350
Pathogens in Dairy Products - 527.300 Commercial Distribution -- Premarket Notification - 300.600
Positive Beam Limitation (PBL) Requirements - 398.450 Cytotoxic Testing for Allergic Diseases - 370.100
Salmonella Contamination of Dry Dog Food - 690.700 Direct Reference Authority for Class III Medical Devices - 300.700
Source Plasma - Syphilis - 254.100 Fraud, Untrue Statements of Material Facts, Bribery - 120.100
POSTSURGICAL STIMULATION Menstrual Sponges - 345.300
Electrical Muscle Stimulators - 355.200 Reconditioners/Rebuilders of Medical Devices - 300.200
POTATO CHIPS Regulatory Action Regarding Approved New Drugs - 446.100
Use of Calcium Cholride as Drying Agent - 500.400 RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200
Adulteration with Rot - 585.700 PREMARKET APPROVAL

433
Index Compliance Policy Guides
Class III Devices Subject to 5l5(b) Requirements - 300.750 Canned Foods - Seam Defects - 520.200
Cytotoxic Testing for Allergic Diseases - 370.100 CGMP Applicability to Hardware and Software - 425.100
Direct Reference Authority for Class III Medical Devices - 300.700 Cherries, Canned - Misbranding Involving Food Standards - 550.230
Fraud, Untrue Statements of Material Facts, Bribery - 120.100 Coffee and Cocoa Bean Sweeps - 560.350
Menstrual Sponges - 345.300 Compressed Medical Gases -- Warning Letters - 435.100
Regulatory Action Regarding Approved New Drugs - 446.100 Computerized Drug Processing -- Input/Output Checking - 425.200
RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200 Computerized Drug Processing -- i.d. of "Persons" - 425.500
PREMARKET NOTIFICATION Computerized Drug Processing -- Vendor Responsibility - 460.800
Class III Devices Subject to 5l5(b) Requirements - 300.750 Dates and Date Material; Imported and Domestic - 550.300
Commercial Distribution -- Premarket Notification - 300.600 Decomp. & Histamine in Albacore, Skipjack and Yellowfin Tuna - 540.525
Direct Reference Authority for Class III Medical Devices - 300.700 Failure to Register - 625.500
Fraud, Untrue Statements of Material Facts, Bribery - 120.100 Finished Dosage Form Drugs in Bulk Containers - 410.100
Reconditioners/Rebuilders of Medical Devices - 300.200 Food Storage & Warehousing - Adulteration - Filth - 580.100
PREPACKAGED DRUGS Hospital Pharmacies - 460.100
Hospital Pharmacies - 460.100 Identity of Foods--Terms such as Fresh, Frozen, Dried, Canned - 562.450
PREPACKAGING (see prepackaged drugs) Importation of Licensed Biologic Products for Human Use - 210.150
PRESCRIPTION DEVICES Inspection of Manufacturers of Device Components - 300.100
Diaphragms - Rx Devices - 345.200 Lack of Expiration Date or Stability Data - 480.300
Ear Piercing Devices - 320.100 Laser Light Shows, etc. - 393.100
Electrical Muscle Stimulators - 355.200 Leafy Spices, other than Bay Leaves - 525.500
Hypnotherapy Devices - Self Hypnotic Tape Recordings - 335.300 Oranges - Artificial Coloring - 550.625
Reconditioners/Rebuilders of Medical Devices - 300.200 Pesticide Residues in Food and Feed - 575.100
RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200 Plasma Brokers - Registration and Compliance - 250.500
Sphygmomanometers - Rx Legend - 310.200 Platelets, Pooled - 231.100
PRESCRIPTION DISPENSING Process Validation Requirements for Drug Products - 490.100
Ear Piercing Devices - 320.100 Processing" - Use of Term in Section 405 of the FD&C Act - 562.650
PRESCRIPTION DRUGS Raw Breaded Shrimp - Microbiological - 540.420
Class I Recalls of Rx Drugs - 400.900 Reconditioning -Tree Nuts Contaminated with E. coli - 570.550
Collection and Charitable Distribution of Drugs - 400.800 Reconditioning of Imported Coffee Beans - 560.300
Compressed Medical Gases -- Warning Letters - 435.100 Registration of Blood Banks and other Firms - 230.110
Failure to Register - 625.500 Regulatory Action Regarding Approved New Drugs - 446.100
Homeopathic Drugs - 400.400 Rendered Animal Feed Ingredients - 675.400
Illegal Sales of Veterinary Prescription Drugs - 608.500 Salt-Cured, Air-Dried, Uneviscerated Fish - 540.650
Lay Use of Veterinary Prescription Drugs - 608.300 Source Code for Process Control Application Programs - 425.300
Marketed New Drugs without Approved NDAs or ANDAs - 440.100 Tomato Products - Adulteration with Mold - 585.900
OTC Ear Drops - 454.100 Tracers in Animal Feed - 680.100
Proper Drug Use and Residue Avoidance - 615.200 Uncertified or Delisted Colors - 587.200
Return of Unused Rx Drugs to Pharmacy Stock - 460.300 Uncooked Meat for Animal Food - 690.500
Rx Drugs for Ships' Medicine Chests - 460.500 Use of DDVP (Vapona) Strips in Milkhouses and Milkrooms - 527.600
Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100 Water in Food Products (Ingredient or Adulterant) - 555.875
PRESCRIPTION HOMEOPATHIC DRUGS Water and Gravy in Pet Food - 690.400
Homeopathic Drugs - 400.400 PRODUCT DESIGN
PRESERVATIVES Retention of Microwave Oven Test Records - 394.100
Chocklet or Chocklet Flavored - 515.800 PRODUCT DEVELOPMENT PROTOCOL
Potato Chips - Ingredients Labeling - 585.710 Class III Device Subject to 515(b) Requirements - 300.350
Use in Nonstandard Foods- 562.600 PRODUCT SAFETY
PRESS CAKE Compendial Requirements - 420.400
Filth - 515.750 Communicable Disease Hazards - 100.300
PRICE SCHEDULES Retention of Microwave Oven Records - 394.100
Mercury Vapor Lamps that are Not Self Extinguishing - 391.200 PRODUCTION PERIOD
PRIMARY BARRIER Retention of Microwave Oven Test Records - 394.100
Assemblers who Install Noncompliant Equipment - 398.325 PROGRAM
PRINCIPAL DISPLAY PANEL Access to Results of Quality Assurance Audits - 130.300
Dealcoholized Wine and Malt Beverages - Labeling - 510.400 Aflatoxin in Peanuts and Peanut Products - 570.375
Foods - FPLA Compliance - 562.200 Assemblers who install Noncompliant Equipment - 398.325
Homeopathic Drugs - 400.400 Assessment of Civil Penalties - 390.300
Identity of Foods--Terms such as Fresh, Frozen, Dried, Canned - 562.450 Brazil Nuts - Adulteration with Aflatoxin - 570.200
Metric Declarations of Quantity of Contents - 140.500 Canned Pet Food - 690.300
Processed and/or Blended Seafood Products - 540.700 Compendial Requirements - 420.400
PRINTED Compressed Medical Gases -- Warning Letters - 435.100
Communicable Disease Hazards - 100.300 Computerized Drug Processing - I.D. of "Persons" - 425.500
Foods - FPLA Compliance - 562.200 Consistent Application of CGMP Determinations - 400.200
Guaranties Over Printed Signatures - 100.800 Expiration Dating and Stability Testing - 480.100
Labeling of Food Articles Distributed Solely in Puerto Rico - 562.750 Literature Fraud, Untrue Statements of Material Facts, Bribery - 120.100
for High-Intensity Mercury Vapor Lamps - 391.100 GWQAP Pre-Award Evaluation - 100.700
Metric Declarations of Quantity of Contents - 140.500 Human-Labeled Drugs Distributed & Used in Animal Medicine - 608.100
Seizure of Books that Constitute Misleading Labeling - 140.100 Illegal Sales of Veterinary Prescription Drugs - 608.500
PROCEED Jams, Jellies and Related Products - Imports - 560.500
Direct-Fed Microbial Products - 689.100 Lack of Expiration Date or Stability Data - 480.300
Fraud, Untrue Statements of Material Facts, Bribery - 120.100 Marketed New Drugs without Approved NDAs or ANDAs - 440.100
Imported Products - Lack of English Labeling - 110.900 OTC Drugs - Combination Products - 450.300
Marketed New Drugs without approved NDAs or ANDAs - 440.100 OTC Drugs - Recognition as Safe and Effective - 450.200
Milk and Milk Products Containing Penicillin - 527.450 Pistachio Nuts - Aflatoxin Adulteration - 570.500
Pathogens in Dairy Products - 527.300 Process Validation Requirements for Drug Products - 490.100
Pineapple, Canned; Imported and Domestic - Food Standards - 550.685 Proper Drug Use and Residue Avoidance - 615.200
PROCESS VALIDATION Quantitative Testing for Serum Proteins in Plasmapheresis Donors - 255.100
Compendial Requirement - 420.400 Radionuclides in Imported Foods - Levels of Concern - 560.750
Contract Sterilizer - 100.550 Reconditioning New Drugs Lacking Approved NDA - 448.100
Process Validation Requirements for Drug Products - 490.100 Registration of Blood Banks and other Firms - 230.110
PROCESSED GRAIN Regulatory Actions and Small Business - 160.100
Pesticide Residues - 575.100 Salmonella Contamination of Dry Dog Food - 690.700
PROCESSING - USE OF THE TERM Schedule of Physical Examination - 251.100
Aflatoxin in Peanuts and Peanut Products - 570.375 Source Code for Process Control Application Programs - 425.300
Answering Inquiries on Status of Criminal Referrals - 160.500 Source Plasma - Guidelines for Informed Consent Forms - 250.100
Bay (Laurel) Leaves - Insect Filth; Mold; Mammalian Excreta - 525.150 Use of DDVP (Vapona) Strips in Milkhouses and Milkrooms - 527.600
Canned and Cooked/Frozen Shrimp - Decomposition - 540.400 Vitamins and Minerals in Feed - 670.200

434
Compliance Policy Guides Index
Whole Milk, Low Fat Milk, Skim Milk - Aflatoxin M1 - 527.400 Labeling of Food Articles Distributed soley in Puerto Rico - 562.750
PROMINENT PART Imported Milk & Cream. Import Milk Act - 560.400
Warning Label Required on Sunlamp Products - 396.400 Imported Products Lack of English Labeling - 110.900
PROMISED FUTURE DATE PULSED OR CONTINOUS MODE
Commercial Distribution Premarket Notification - 300.600 Temporal Maximum Ultrasonic Power - 397.100
PROMOTIONAL ACTIVITIES PUMPKIN
Commercial Distribution Premarket Notification - 300.600 Action Levels for Aflatoxin - 683.100
Manufacture Distribution Promotion of Drugs by Pharmacies - 460.200 Adulteration with Aflatoxin - 555.400
PROPHYLACTICS Articles from Certain Varieties of Squash - 585.725
Condoms, Defects Criteria for Direct Reference Seizure - 345.100 Squash Seeds Labeling as Pumpkin Seeds - 585.800
PROPYLENE GLYCOL PUNCTURED OUTER WRAP
Labeling of Seasonings - 525.650 Contamination of Devices Labeled as Sterile - 300.400
PROSTATE PUNGENCY RATING
Inert Glandular Preparations - 455.100 Spices - Definitions - 525.750
PROSTHETIC DENTAL APPLIANCE PURCHASER RECORDS
Dentures Sale by Persons not licensed to Practice Dentistry - 315.100 Exemption for Certain Sunlamp Porduct Purchaser Records - 396.200
PROTECTIVE EYEWEAR PURCHASERS
Defective Suntanning Booths and Beds - 396.300 Assessment of Civil Penalties - 390.300
PROTEIN Calcium Chloride - 500.400
Ammoniated Cottonseed Meal - Interpretation of 21 CFR 573.140 - 670.500 Canned Shrimp: Size Designations and Corresponding Counts - 540.390
Blood and Blood Products - Definitions - 230.100 Commercial Distribution -- Premarket Notification - 300.600
Bouillon, Bouillon Cubes, Granulated Bouillon - 567.300 Exemption for Certain Sunlamp Product Purchaser Records - 396.200
Canned Pet Food - 690.300 Mercury Vapor Lamps that are not Self-Extinguishing - 391.200
Large Volume Parenterals (LVP's) for Animal Use - 635.100 Safety and Labeling of Waxed (Coated) Fruits and Vegetables - 562.550
Nutritional Supplements for Companion Animals - 690.100 Unfermented Beverages, Use of word "Champagne" - 510.300
Pacemaker Reuse - 310.100 PURITY
Pineapple, Canned; Imported and Domestic - Food Acetic Acid - Use in Foods - Labeling of Foods in which Used - 562.100
Standards - 550.685 Adulteration of Drugs under Sec. 501(b) and 501(c) - 420.100
Quantitative Testing for Serum Proteins in Plasmapheresis Donors - 255.100 Biological Drugs for Animal Use - 645.100
Recycled Animal Waste - 685.100 Blood and Blood Products - Definitions - 230.100
Registration of Blood Banks and Other Firms - 230.110 Compendial Requirements - 420.400
Rendered Animal Feed Ingredients - 675.400 Compendium Revisions and Deletions - 420.200
Source Plasma Guidelines for Informed Consent Forms - 250.100 Compressed Medical Gases -- Warning Letters - 435.100
Source Plasma - Overbleeding - 252.100 Contamination of Devices Labeled as Sterile - 300.400
Standards and Minimum Requirements for Biologic Products - 205.100 Homeopathic Drugs - 400.400
PROTEIN SOLUTIONS Interference with Compendial Tests - 420.500
LVP's for Animal Use - 635.100 Lack of Expiration Date or Stability Data - 480.300
PROTOTYPES Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200
Records and Reports Applicability 21CFR 1002.1 - 390.425 Plastic Containers for Injectable Animal Drugs - 637.100
PRUNES, DEHYDRATED Preservatives; Use in Nonstandardized Foods; Label Declaration - 562.600
Dried Prunes, Dehydrated Low Moisture Prunes & Pitted Prunes - 550.700 Reconditioning New Drugs Lacking Approved NDA - 448.100
PSOCIDS Regulatory Action Regarding Approved New Drugs - 446.100
Food Storage & Warehousing - 580.100 Repacking of Drug Products -- CGMP's - 430.200
In Green Coffee Beans - 510.500 Return of Unused Rx Drugs to Pharmacy Stock - 460.300
PSYCHIC HEALING Starches--Common or Usual Names - 578.100
Hypnotherapy Devices Self Hypnotic Tape Recordings - 335.300 Tracers in Animal Feed - 680.100
PUBLIC HEALTH PURPURA
Action Levels for Aflatoxins in Animal Feeds - 683.100 Blood and Blood Products Definitions - 230.100
Biological Drugs for Animal Use - 645.100 PYROLIGNEOUS ACID
Blood and Blood Products - Definitions - 230.100 Labeling of Seasoning - 525.650
Class III Devices Subject to 5l5(b) Requirements - 300.350 QUACKERY
Communicable Disease Hazards - 100.300 Health Fraud - 120.500
Determination by Secretary that Product Fails to Comply - 390.200 QUALITY
Eggnog; Eggnog Flavored Milk--Common Usual Names - 527.350 Access to Results of Quality Assurance Audits - 130.300
Hazardous Diagnostic X-Ray Systems - 398.200 Adulteration of Drugs under Sec. 501(b) and 501(c) - 420.100
Health Fraud - 120.500 Analytical Methodology Used by FDA - Drugs - 150.500
Human Blood and Blood Products as Drugs - 230.120 Canned Peas - Label Designation of Sizes - 585.625
Human-Labeled Drugs Distributed & Used in Animal Medicine - 608.100 Canned and Cooked/Frozen Shrimp - Decomposition - 540.400
Illegal Sales of Veterinary Prescription Drugs - 608.500 Canned Foods - Seam Defects - 520.200
Immune Milk - 275.100 Canned Green Beans and Canned Wax Beans - Standards - 585.475
Importation of Television Receivers and Microwave Ovens - 394.500 Cheese and Cheese Products - Adulteration with Filth - 527.200
Imported Low-Acid Canned Foods - 560.450 Cherries, Canned - Misbranding Involving Food Standards - 550.230
Imported Milk and Cream. Import Milk Act - 560.400 Clinical Thermometer - Adulteration; Misbranding Defects - 335.800
Intermediate or End Products of Sample Analysis - 150.100 Collection and Charitable Distribution of Drugs - 400.800
Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200 Compendial Requirements - 420.400
Marketed New Drugs Without Approved NDAs or ANDAs - 440.100 Compendium Revisions and Deletions - 420.200
Medical Emergencies - 220.100 Compressed Medical Gases -- Warning Letters - 435.100
Process Validation Requirements for Drug Products - 490.100 Computerized Drug Processing -- input/output Checking - 425.400
Proper Drug Use and Residue Avoidance - 615.200 Condoms; Defects - Criteria for Direct Reference Seizure - 345.100
Radionuclides in Imported Foods - Levels of Concern - 562.750 Consistent Application of CGMP Determinations - 400.200
Reconditioning New Drugs Lacking approved NDA - 448.100 Contamination of Devices Labeled as Sterile - 300.400
Red Meat Adulterated with PCB's - 565.200 Content Uniformity Testing of Tablets and Capsules - 460.600
Regulatory Action Regarding Approved New Drugs - 446.100 Electronic Products Subject to 21 CFR 1001.15(a) - 390.400
Responsibility for Reporting Violations - 100.100 Food additives -"GRAS" - 500.200
Retention of Microwave Oven Test Records - 394.100 Fraud, Untrue Statements of Material Facts, Bribery - 120.100
Return of Unused Rx Drugs to Pharmacy Stock - 460.300 GWQAP Pre-Award Evaluation - 100.700
Reuse of Medical Disposable Devices - 300.500 Homeopathic Drugs - 400.400
Revocation of Tolerances for Cancelled Pesticides - 555.700 Interference with Compendial Tests - 420.500
Surgeon's Gloves and Patient Examination Gloves - 335.700 Lack of Expiration Date or Stability Data - 480.300
Teat Dips and Udder Washes for Dairy cows and Goats - 654.200 Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200
Turtles - 170.100 Medicated Feeds -- Combined Batches - 680.400
Unapproved Additives for Exported Grains - 578.600 Microfiche and/or Microfilm for Records Retention - 130.400
Whole Milk, Low Fat Milk, Skim Milk - Aflatoxin M1 - 527.400 Peaches, Canned - Misbranding Involving Food Standards - 550.655
PUDDINGS Pineapple, Canned; Imported and Domestic - Food Standards - 550.685
Silver Plated Holloware - 545.500 Process Validation Requirements for Drug Products - 490.100
PUERTO Quality Control Testing - 231.110

435
Index Compliance Policy Guides
Records and Reports - Applicability - 21 CFR 1002.1 - 390.425 Early Correction of Defects or Noncompliance - 390.225
Regulatory Action Regarding Approved New Drugs - 446.100 Obligations of Factory Based Manufacturers & Assemblers - 398.375
Repacking of Drug Products -- CGMP's - 430.200 RADIATION SHIELDED SHOCK PROOF HOUSING
Return of Unused Rx Drugs to Pharmacy Stock - 460.300 Reloders of X-Ray Tube Housing Assemblies - 398.700
Reuse of Medical Disposable Devices - 300.500 RADIATION-EMITTING
Salt-Cured, Air-Dried, Uneviscerated Fish - 540.650 Reconditioners/Rebuilders of Medical Devices - 300.200
Source Code for Process Control Application Programs - 425.300 RADIOGRAPHIC EXAMINATION
Spices - Definitions - 525.750 Definition of General Purpose Radiographic X-Ray System - 398.100
Storage of Platelet Concentrate - 231.130 RADIOGRAPHIC TIMER NONTERMINATION
Streptomycin Residues in Cattle Tissues - 616.100 Hazardous Diagnostic X-Ray System - 398.200
Surgeon's Gloves and Patient Examination Gloves - 335.700 RADIOIMMUNOASSAY
Time Period for Separation of Platelets - 231.120 RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200
Tomatoes - Canned - Misbranding Involving Food standards (Peel) - 585.875 RADIONUCLIDES
Tracers in Animal Feed - 680.100 In Imported Foods - 562.750
Unfermented Beverages, Use of word "Champagne" - 510.300 RAIL CAR SANITATION
Water in Food Products (Ingredient or Adulterant) - 555.875 Foods in - 545.300
QUALITY CONTROL RAISINS
Access to Results of Quality Assurance Audits - 130.300 Adulteration with Mold, Filth - 550.750
Compendial Requirements - 420.400 RASPBERRIES
Electronic Products Subject to 21 CFR 1001.15(a) - 390.400 Drupelet Berries - 550.200
Medicated Feeds -- Combined Batches - 680.400 RAZOR BLADES
Microfiche and/or Microfilm for Records Retention - 130.400 Razer Blades, Manicuring Instruments - 335.500
Quality Control Testing - 231.110 REACTIVE
Records and Reports - Applicability - 21 CFR 1002.1 - 390.425 Plastic Containers for Injectable Animal Drugs - 637.100
Salt-Cured, Air-Dried, Uneviscerated Fish - 540.650 Source Plasma Syphilis - 254.100
Storage of Platelet Concentrate - 231.130 READY-TO-EAT
QUARANTINE Salt, Dried Unevicerated Fish - 540.650
Diversion of Adulterated Food to Acceptable Animal Feed USA - 675.200 REAGENT RED BLOOD CELLS
Proper Drug Use & Residue Avoidance - 615.200 Standards & Minimum Requirements for Biologic Products - 205.100
QUARTERED, SLICED AND CHIPPED OR MINCED REAGENTS
Olives - Adulteration Involving Pits; Rat, Insect Infestation - 550.600 Blood & Blood Product Definition - 230.100
QUESTIONABLE CLAIMS Registration of Blood Banks and other Firms - 230.110
Lasers for Facelift, Wrinkle Removal, Acupuncture etc. - 393.200 RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200
Silage Ingredients - 687.500 REBUILDERS
QUESTIONS Reconditioners/Rebuilders of Medical Devices - 300.200
Alcohol; Use of Synthetic Alcohol in Foods - 555.100 RECALL
Artichoke; Jerusalem Artichoke - Common or Usual Name - 585.100 Adulteration of Drugs under Sec. 501(b) and 501(c) - 420.100
Availability of Bulk Chemicals for Animal Drug Use - 625.200 Assessment of Civil Penalties - 390.300
CGMP Applicability to Hardware and Software - 425.100 Clams, Mussels, Oysters - Paralytic Shellfish Poison - 540.250
Checklist Labeling for Custom Mixed Medicated Feeds - 665.200 Class I Recalls of Rx Drugs - 400.900
Collection and Charitable Distribution of Drugs - 400.800 Color Additives - 587.300
Color Additives in Paper and Paperboard for Use with Food -500.425 Contamination of Devices Labeled as Sterile - 300.400
Commercial Distribution -- Premarket Notification - 300.600 Direct Reference Authority for Class III Medical Devices - 300.700
Common or Usual Names for Animal Feed Ingredients - 665.100 Diversion of Adulterated Food to Acceptable Animal Feed Use - 675.200
Computerized Drug Processing -- Vendor Tesponsibility - 425.200 Exemption for Certain Sunlamp Product Purchaser Records - 396.200
Computerized Drug Processing -- input/output Checking - 425.400 Fraud, Untrue Statements of Material Facts, Bribery - 120.100
Computerized Drug Processing -- i.d. of "Persons" - 425.500 Identical or Similar Product Names - 400.500
Contamination of Devices Labeled as Sterile - 300.400 Jordan Almonds - Common or Usual Name - 570.100
Contract Sterilizers - 100.550 Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200
Control/Accountability of TRP Materials - 450.550 OTC Drugs - Combination Products - 450.300
Dealcoholized Wine *and Malt Beverages* - Labeling - 510.400 Reconditioning New Drugs Lacking Approved NDA - 448.100
Definition of General Purpose Radiographic X-Ray System - 398.100 Definition Recovery of IND's from Clinical Investigators - 444.100
of "Commerce" - 21 CFR 1000.3(g) - 390.100 Salmonella Contamination of Dry Dog Food - 690.700
Determination of Donor Suitability - 230.130 RECALLED DRUG
Direct-Fed Microbial Products - 689.100 Class I Recalls of Rx Drugs - 400.900
Expiration Dating of Unit Dose Repackaged Drugs - 480.200 RECLASSIFICATION
Export of Uncertified Antibiotics - 405.200 Direct reference Authority for Class III Medical Devices - 300.700
Finished Dosage Form Drugs in Bulk Containers - 410.100 RECONDITIONERS
Foreign Trade Zones, Bonded Warehouses or Carriers - 110.600 Reconditioner/Rebuilders of Medical Devices - 300.200
Fraud, Untrue Statements of Material Facts, Bribery - 120.100 RECONDITIONING
Human Blood and Blood Products as Drugs - 230.120 Ammoniated Cottonsseed Meal - 670.500
Imported Low-Acid Canned Foods - 560.450 Articles - 160.750
Jams, Jellies and Related Products - Imports - 560.500 Brazil Nuts with Aflatoxin - 570.200
Label Declaration of Artificial Color - 587.100 Builders of Medicdal Devices - 300.200
Labeling - Diluted Wines and Cider with Less than 7% Alcohol -510.450 By Diversion for Animal Feed - 555.650
Labeling of Shipping Containers for Drugs - 430.300 Cashews, Insect Infested - 570.250
Marketed New Drugs Without Approved NDAs or NDAs - 440.100 Diversion to - 675.200
Microfiche and/or Microfilm for Records Retention - 130.400 Foods Adulterated under 402(a)(4) - 160.500
Orders for Post-Approval Record Reviews - 470.100 Imported Coffee Beans - 560.300
Override of Positive Beam Limitation - 398.425 Imports - Post Detention Sampling - 100.800
Prescription Status - Telephone Answering Machine - 460.425 Milk and Milk Products - 527.450
Reconditioning Foods by Diversion for Animal Feed - 555.650 New Drugs Lacking Aproved NDA - 448.100
Reconditioning of Foods Adulterated under 402(a)(4) - 160.700 New Animal Drugs Seized - 625.400
Refusal to Permit Inspection - 130.100 Reconditioning - 578.350
Registration of Assemblers of Diagnostic X-Ray systems - 398.300 Sugar - Water Damaged - 515.425
Regulatory Action Regarding Approved New Drugs - 446.100 Tree Nuts with E. Coli - 570.550
Repacking of Drug Products -- CGMP's - 430.200 Water Damaged Food Products - 555.850
Responsibility for Reporting Violations - 100.100 RECORD PRESERVATION GUIDANCE
Source Plasma - Guidelines for Informed Consent Forms - 250.100 Retention of Microwave Oven Test Records - 394.100
Spices -Definitions - 525.750 RECORDS
Time Period for Separation of Platelets - 231.120 Access to Results of Quality Assurance Audits - 130.300
RABIES VACCINE Assemblers who install Noncompliant Equipment - 398.325
Standards & Minimum Requirements for Biologic Products - 205.100 Assessment of Civil Penalties - 390.300
RADIATION FORCE TECHNIQUES Blood and Blood Products - Definitions - 230.100
Temporal Maximum Ultrasonic Power - 394.100 CGMP Applicability to Hardware and Software - 425.100
RADIATION SAFETY DEFECTS AND NONCOMPLIANCES CGmp's for Medicated Feeds - Daily Inventory Requirements -680.200

436
Compliance Policy Guides Index
Chloramphenicol - 654.300 Teat Dips and Udder Washes for Dairy Cows and Goats - 654.200
Class I Recalls of Rx Drugs - 400.900 Use of DDVP (Vapona) Strips in Milkhouses and Milkrooms - 527.600
Compressed Medical Gases -- Warning Letters - 435.100 REGULATORY FOLLOWUP
Computerized Drug Processing -- Input/Output Checking - 425.400 Reconditioners/Rebuilders of Medical Devices - 300.200
Computerized Rx Recordkeeping by Pharmacies - 460.400 REGULATORY LETTER
Computerized Drug Processing -- I.D. of "Persons" - 425.500 Assessment of Civil Penalties - 390.300
Contract Sterilizers - 100.550 Consistent Application of CGMP Determinations - 400.200
Cytotoxic Testing for Allergic Diseases - 370.100 Direct-Fed Microbial Products - 689.100
Exemption for Certain Sunlamp Product Purchaser Records - 396.200 Direct Reference Authority for Class III Medical Devices - 300.700
Guaranties Over Printed Signatures - 100.800 Expiration Dating and Stability Testing - 480.100
GWQAP Pre-Award Evaluation - 100.700 Failure to Register - 625.500
Hospital Pharmacies - 460.100 Failure to Register - 400.100
Large volume parenterals (LVP's) for animal use - 635.100 Health Fraud - 120.500
Marketed New Drugs Without Approved NDAs or ANDAs - 440.100 Homeopathic Drugs - 400.400
Medicated Feeds -- Formula Information - 670.100 Identical or Similar Product Names - 400.500
Medicated Feeds -- Combined Batches - 680.400 Illegal Sales of Veterinary Prescription Drugs - 608.500
Microfiche and/or Microfilm for Records Retention - 130.400 Lack of Expiration Date or Stability Data - 480.300
Orders for Post-Approval Record Reviews - 470.100 Large Volume Parenterals (LVP's) for Animal Use - 635.100
Pineapple, Canned; Imported and Domestic - Food Standards -550.685 Lasers for Facelift, Wrinkle Removal, Acupuncture, etc. - 393.200
Plasma Brokers - Registration and Compliance - 250.500 Manufacture, Distribution, Promotion of Drugs by Pharmacies -460.200
Proper Drug Use and Residue Avoidance - 615.200 Nutritional Supplements for Companion Animals - 690.100
Reconditioning New Drugs Lacking Approved NDA - 448.100 Oral Iron Products for Baby Pigs - 643.100
Records and Reports - Applicability - 21 CFR 1002.1 - 390.425 Plasma Brokers - Registration and Compliance - 250.500
Regulatory Actions Against Assemblers of X-Ray Equipment - 398.350 Proper Drug Use and Residue Avoidance - 615.200
Reloaders of X-Ray Tube Housing Assemblies - 398.700 Reconditioning New Drugs Lacking Approved NDA - 448.100
Requests for Records Under Section 703 - 160.300 Registration of Blood Banks and other Firms - 230.110
Retention of Microwave Oven Test Records - 394.100 Regulatory Actions Against Assemblers of X-Ray Equipment - 398.350
Returned Antibiotics Exported under 801(d) of the Act - 405.210 Regulatory Actions and Small Business - 160.100
RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200 Turtles - 170.100
Source Code for Process Control Application Programs - 425.300 Unapproved New Animal Drugs - Follow-up Action - 625.300
Source Plasma - Syphilis - 254.100 REJECT
Uncertified or Delisted Colors - 587.200 Cheese and Cheese Products - 527.200
RECOVERED HUMAN PLASMA Cocoa Beans - 515.750
Blood and Blood Products Definition - 230.100 Condoms; Defects - 345.100
Use of Units Which Have Been Thawed - 253.100 Dates and Date Material - 550.300
RECOVERED PLASMA Peanuts Filth - 570.350
Registration of Blood Banks and other Firms - 230.110 Pineapple, Canned - 550.685
Source plasma Guidelines for Informed Consent Form - 250.100 Pistachio Nuts - 570.500
Standards and Minimum Requirements for Biologic Products - 205.100 Retention of Microwave - 394.100
RED BLOOD CELLS (See recovered plasma) Shirmp - 540.400
RED FISH Surgeon's and Patient Examination Gloves - 335.700
Adulteration by Parasites - 540.590 Tree Nuts - 570.425
RED MEAT REJECT NUTS
Adulterated with PCBs - 565.200 Peanuts Filth - 570.350
RED SNAPPER REJECTION see reject
Labeling - 540.475 RELAXACISOR
RED SWEET PEPPERS Cellutron Machine - 355.100
Canned Pimentos, Red Sweet Peppers - 585.650 RELEASE
REDDENED Articles of Foreign Origin not intended for Entry - 110.700
Karaya Gum Powder & Related Devices for Use by Ostomates - 325.100 Brazil Nuts - Adulteration with Aflatoxin - 570.200
REDELIVERY Compendial Requirements - 420.400
Imports-Post Detention Sampleing - 100.800 Compressed Medical Gases -- Warning Letters - 435.100
REEDUCATION Controlled-Release Dosage Form Drugs - 460.700
Electrical Muscle Stimulators - 355.200 Diversion of Adulterated Food to Acceptable Animal Feed Use -675.200
REFRACTOMETER Homeopathic Drugs - 400.400
Marmalade - 550.575 Imported Frozen Products of Multiple Sizes or Codes - 560.700
Source Plasma Overbleeding - 252.100 Marketed New Drugs without approved NDAs or ANDAs - 440.100
REFURBISHES Natural Bristle Brushes -- Nit Contamination - 590.400
Reconditioners/Rebuilders of Medical Devices - 300.200 Nutritional Supplements for Companion Animals - 690.100
REFUND Parametric Release of Terminally Heat Sterilized Drugs - 460.800
Determination by Secretary that Product Fails to Comply - 390.200 Pottery (Ceramics) - Cadmium Contamination - 545.400
Early Correction of Defects or Noncompliance - 390.225 Pottery (Ceramics) - Lead Contamination - 545.450
REFUSAL Radionuclides in Imported Foods - Levels of Concern - 560.750
Assessment of Civil Penalties - 390.300 Reconditioning New Drugs Lacking Approved NDA - 448.100
Importation of Unlabeled Foods *21CFR 101.100(d)* - 560.100 Repacking of Drug Products -- CGMP's - 430.200
Imports - Identity of Ingredients - 560.250 Silver-Plated Hollowware - Lead Contamination - 545.500
Radionuclitides in Imported Foods - Levels of Concern - 560.750 Source Plasma - Guidelines for Informed Consent Forms - 250.100
Refusal to Permit Inspection - 130.100 Turtles - 170.100
REGISTRATION Unit Dose Labeling for Solid and Liquid Oral Dosage forms - 430.100
Biological Drugs for Animal Use - 645.100 RELIEF OF MUSCLE SPASM
Blood and Blood Products - Definitions - 230.100 Electrical Muscle Stimulators - 355.200
Contract Sterilizers - 100.550 Retention of Microwave Oven Test Records - 394.100
Failure to Register - 625.500 RELOADERS
Flea and Tick Collars Containing a Pesticide - 641.100 Reconditioners/Rebuilders of Medical Devices - 300.200
Hospital Pharmacies - 460.100 Reloders of X-Ray Tube Housing Assemblies - 398.700
Imported Low-Acid Canned Foods - 560.450 RELOADING (see Reloaders)
Inspection of Manufacturers of Device Components - 300.100 RELOADING STATIONS (see Reloaders)
Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200 RELOCATE
Pesticide Residues in Food and Feed - 575.100 Certification & Identification of X-Ray Components - 398.600
Plasma Brokers - Registration and Compliance - 250.500 RENAL IMPAIRMENT
Reconditioners/Rebuilders of Medical Devices - 300.200 Fructose Containing Drugs - 400.335
Registration of Assemblers of Diagnostic X-Ray Systems - 398.300 REPACKAGING
Registration of Blood Banks and Other Firms - 230.110 Expiration Dating of Unit Dose Repackaged Drugs - 480.200
Regulatory Actions and Small Business - 160.100 Failure to Register - 625.500
Reloaders of X-Ray Tube Housing Assemblies - 398.700 Regulatory Action Regarding Approved New Drugs - 446.100
Revocation of Tolerances for Cancelled Pesticides - 555.700 Unit Dose Labeling for Solid & Liquid Oral Dosage Forms - 430.100

437
Index Compliance Policy Guides
REPACKAGING REQUIREMENTS Tamper Resistant Packaging Requirements - 450.500
Expiration Dating of Unit Dose Repackaged Drugs - 480.200 RESPONSIBLE HEAD
Unit Dose Labeling of Solid & Liquid Oral Dosage Forms - 430.100 Compressed Medical Gases - Warning Letters - 435.100
REPACKERS Licensing Changes to be Reported - 210.100
Country of Origin Labeling - 560.200 RESTORES
Repacking of Durg Products - CGMPs - 430.200 Reconditioner/Rebuilders of Medicdal Devices - 300.200
Vitamin B-15, Pargamic Acid & Pargamic Acid Products - 457.100 RESTRICTED
REPACKING Blood and Blood Products - Definitions - 230.100
Collection and Charitable Distribution of Drugs - 400.800 Color Additives in Paper and Paperboard for Use with Food - 500.425
Condoms; Defects - Criteria for Direct Reference Seizure - 345.100 Ear Piercing Devices - 320.100
Country of Origin Labeling - 560.200 Labeling of Food Articles Distributed Solely in Puerto Rico - 562.750 The
Finished Dosage Form Drugs in Bulk Containers - 410.100 Status of Syringes and Needles for Animal Use - 655.400
Hospital Pharmacies - 460.100 RETAIL ESTABLISHMENTS
Regulatory Action Regarding Approved New Drugs - 446.100 Menstral Sponges - 345.300
Repacking of Drug Products -- CGMP's - 430.200 Safety & Labeing of Waxed (Coated) Fruits and Vegtables - 562.550
Sauerkraut - Definition; Adulteration by Thrips - 585.750 REUSE
Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100 Reuse of Disposable Medical Devices - 300.500
REPAIR REVENUE
Assemblers who Install Noncompliant Equipment - 398.325 Alcohol Use of Synthetic Alcohol in Foods - 555.100
Compressed Medical Gases -- Warning Letters - 435.100 Brandy Containing Methyl Alcohol - Food Additive - 510.200
Denture Cleaners, Adhesives, Cushions, and Repair Materials - 315.300 Use of Incom Tax Information from IRS - 160.200
Determination by Secretary that Product Fails to Comply - 390.200 REVOCATION
Early Correction of Defects or Noncompliance - 390.225 Licensing Changes to be Reported - 210.100
Obligations of Factory-Based Manufacturers and Assemblers -398.375 Recycled Animal Waste - 685.100
Override of Positive Beam Limitation - 398.425 Revocation of Tolerance for Cancelled Pesticides - 555.700
Reloaders of X-Ray Tube Housing Assemblies - 398.700 RHEUMATOID ARTHRITIS
REPAIR MATERIALS Immune Milk - 275.100
Denture Cleaners Adhesives, Cushions, & Repair Materials - 315.200 RICO
REPLACE Imported Milk & Cream ; Imported Milk Act - 560.400
Assessment of Civil Penalties - 390.300 Imported Products Lack of English Labeling - 110.900
Determination by Secretary that Product Fails to Comply - 390.200 Labeling of Food Articles Distributed Solely in Puerto Rico - 562.750
Early Correction of Defects or Noncompliance - 390.225 RIFAMPIN
Fraud, Untrue Statements of Material Facts, Bribery - 120.100 Unit Dose Labeling for Solid & Liquid Oral Dose Forms - 430.100
REPLACED ROCK LOBSTER
Blood and Blood Products - Definitions - 230.100 Common or Usual Names for Crustaceans - 540.350
Jellies, Nonstandardized - 550.475 ROCKY MOUNTAIN SPOTTED FEVER VACCINE
Preservatives; Use in Nonstandardized Foods; Label Declaration - 562.600 Standards & Minimum Requirements for Biologic Products - 205.100
Reloaders of X-Ray Tube Housing Assemblies - 398.700 RODENT URINE, RODENT EXCRETA PELLETS, RODENT HAIRS
Revocation of Tolerances for Cancelled Pesticides - 555.700 Food Storage & Warehouseing - 580.100
Tamper-Resistant Packaging Requirements - 450.500 Rodent Contamination Pet Foods - 690.600
REPLACEMENT PARTS RODENTICIDE
Determination by the Secretary that Product Fails to Comply - 390.200 Foods - Adulteration Involving Infestation and 1080 Rodent - 555.450
REPORTING REQUIREMENTS Pesticide Residues in Food and Feed - 575.100
Dates and Date Material; Imported & Domestic - 550.300 Revocation of Tolerance for Canceled Pesticides - 555.700
Electronic Products Subject to 21 CFR 1001.15(a) - 390.400 Silage Ingredients - 687.500
Obligations of Factory Based Manufacturers & Assemblers - 398.375 ROSE FISH
Regulatory Actions & Small Business - 160.100 Adulteration by Parasitse - 540.590
RESEARCH ROSEMARY
48-hour Period Between Plasmapheresis Procedures - 256.100 Spices - Definition - 525.750
Adulteration of drugs under Sec. 501(b) and 501(c) - 420.100 ROSTOV
Allergenic Extracts Containing Glycerin - 270.100 Salt Curred Air Dried Uneviscerated Fish - 540.650
Availability of Bulk Chemicals for Animal Drug Use - 625.200 ROT
Commercial Distribution -- Premarket Notification - 300.600 Beets, Canned - Adulteration with Rot - 585.200
Common or Usual Names for Animal Feed Ingredients - 665.100 Cherries - 550.225
Communicable Disease Hazards - 100.300 Drupelet Berries - 550.200
Compressed Medical Gases -- Warning Letters - 435.100 Ethylenediamine Dihydroiodide (EDDI) - 651.100
Ethylenediamine Dihydroiodide (EDDI) - 651.100 Olives - 550.600
Flea and Tick Collars Containing a Pesticide - 641.100 Plums, Canned - Adulteration with Rot - 550.690
Fraud, Untrue Statements of Material Facts, Bribery - 120.100 Potato Chips - Adulteration with Rot - 585.700
Homeopathic Drugs - 400.400 RUBBER BABY BOTTLE NIPPLES
Immune Milk - 275.100 Volatile N-Nitrosamines - 500.450
Importation of Licensed Biologic Products for Human Use - 210.150 RUBBER CONTRACEPTIVES
Importation of Television Receivers and Microwave Ovens - 394.500 Condoms; Defects - Criteria for Direct Reference Seizure - 345.100
IND Filings - 215.100 RUBELLA VIRUS VACCINE, LIVE
Jordan Almonds - Common or Usual Name - 570.100 Standards & Minimum Requirements for Biologic Products - 205.100
Licensing - Changes to be Reported - 210.100 RX DRUGS
Microfiche and/or Microfilm for Records Retention - 130.400 CGMP Enforcement Policy - OTC vs Rx Drugs - 450.100
Nutritional Supplements for Companion Animals - 690.100 Class I Recalls of Rx Drugs - 400.900
Platelets, Pooled - 231.100 Illegal Sales of Veterinary Prescription Drugs - 608.500
Process Validation Requirements for Drug Products - 490.100 OTC Anti-Obesity Preparations - 456.100
Quality Control Testing - 231.110 Return of Unused Rx Drugs to Pharmacy Stock - 460.300
Quantitative Testing for Serum Proteins in Plasmapheresis Donors - 255.100 Rx Drugs for Ships' Medicine Chests - 460.500
Registration of Blood Banks and other Firms - 230.110 RYBETZ
RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200 Salt-Cured, Air-Dried, Uneviscerated Fish - 540.650
Source Plasma - Overbleeding - 252.100 SABLE
Standards and Minimum Requirements for Biologic Products -205.100 Smoked, Cured - 540.500
Storage of Platelet Concentrate - 231.130 SACCHARINE
Time Period for Separation of Platelets - 231.120 Jellies, Nonstandardized - 550.475
Unapproved Additives for Exported Grains - 578.600 SAFETY AND EFFECTIVENESS
Use of Units Which Have Been Thawed - 253.100 Alternate Feeding of Different Medicated Feeds - 666.100
Vitamins and Minerals in Feed - 670.200 Direct Reference Authority for Class III Medical Devices - 300.700
RESERVATIONS Fraud, Untrue Statements of Material Facts, Bribery - 120.100
FDA Jurisdiction on Indian Reservations - 100.350 Health Fraud - 120.500
RESISTANCE Lasers for Facelift, Wrinkle Removal, Acupuncture, etc. - 393.200
Contamination of Devices Labeled as Sterile - 300.400 Marketed New Drugs without approved NDAs or ANDAs - 440.100
Parametric Release of Terminally Heat Sterlized Drugs - 460.800 Orders for Post-Approval Record Reviews - 470.100

438
Compliance Policy Guides Index
Regulatory Action Regarding Approved New Drugs - 446.100 Shrimp - Fresh or Frozen Raw Headless, Peeled or Breaded - 540.400
Reuse of Medical Disposable Devices - 300.500 SEDATION
RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200 Human Labeled Drugs Distributed & Used in Animal Medicine - 608.100
SAFFRON SEGREGATION
Spices Definition - 525.750 Cashews Reconditioning - 570.250
SAGE Drug Use & Residue Avoidance - 615.200
Leafy Spices other than Bay Leaves - 525.500 Medicated Feeds Combined Batches - 680.400
Spices - Definition - 525.750 SEIZURE RECOMMENDATION
SALMON Compressed Medical Gases -- Warning Letters - 435.100
Canned Decomposition - 540.375 Direct Reference Authority for Class III Medical Devices - 300.700
Sodium Nitrite - 540.500 Diversion of Adulterated Food to Acceptable Animal Feed Use - 675.200
SALMONELLA Unapproved New Animal Drugs - Follow-up Action - 625.300
Diversion of Contaminated Food for Animal Use - 675.100 SELECTED FORMAT
Foods, Except Dairy Products - Adulteration with Salmonella - 555.300 Automatic Adjustment of the X-Ray Field Size - 398.400
Pathogens in Dairy Products - 527.300 SELF HYPNOTIC TAPE RECORDINGS
Recycled Animal Waste - 685.100 Hypnotherapy Devices - 335.300
Salmonella Contamination of Dry Dog Food - 690.700 SELF-EXTINGUISHING LAMPS
Turtles - 170.100 Literature for High Intensity Mercury Vapor Lamps - 391.100
Wheat for Human Consumption - Reconditioning - 578.350 SELF-IMPROVEMENT
SALMONELLA, ADULTERATION OF FOODS (See Salmonella) Hypnotherapy Devices Self Hypnotic Tape Recordings - 335.300
SALMONELLOSIS (See Salmonella) SEMOLINA
SALONS Macaroni and Noodle Products - 505.500
Electrical Muscle Stimulators - 355.200 SENSING MECHANISM
SALT CURED Override of Positive Beam Limitation - 398.425
Salt-Cured, Air-Dried, Uneviscerated Fish - 540.650 SEPTRA/BACTRIM
Olives - Adulteration Involving Pits; Rot; Insect Infestation - 550.600 Unit Dose Labeling for Solid & Liquid Oral Dosage Form - 430.100
SALT CURED OLIVES (see salt cured above) SERIOUS ADVERSE HEALTH CONSEQUENCES
SALVAGED HUMAN PLASMA Assessment of Civil Penalties - 390.300
Blood & Blood Products Definitions - 230.100 SERIOUS DEFICIENCES
SAMSOE Assessment of Civil Penalties - 390.300
Cheese - 527.200 SERIOUS RADIATION HAZARD
SAND Hazardous Diagnostic X-Ray Systems - 398.200
Cumin Seeds - 525.325 SEROLOGIC TEST FOR SYPHILIS (STS)
Mace - 525.550 Source Plasma Syphilis - 254.100
Menstral sponges - 345.300 SERUM
Raisins - 550.750 Biological Drugs for Animal Use - 645.100
Sesame Seeds - 525.700 SERUM PROTEIN
Strawberries - 550.850 Quantative Testing for Serium Protein in Plasmapheresis - 255.100
Whole and Ground Pepper - 525.625 Registration of Blood Banks and Other Firms - 230.110
SANITARY SPONGES Standards and Minimum Requirements for Biologic Products - 205.100
Menstral Sponges - 345.300 SERVICE
SAP SAGO CHEESE Alcohol; use of Synthetic Alcohol in Foods - 555.100
Cheese - Misbranding Due to Moisture and Fat - 527.225 Articles of Foreign Origin not intended for Entry - 110.700
SATELLITE PACKS Biological Drugs for Animal Use - 645.100
Storage of Platelet Concentrate - 231.130 Blood and Blood Products - Definitions - 230.100
SATISFACTION Brandy Containing Methyl Alcohol - Food Additive - 510.200
Action Levels for Aflatoxins in Animal Feeds - 683.100 Canned Shrimp: Size Designations and Corresponding Counts -540.390
Commercial Distribution Premarket Notification - 300.600 Caviar, use of Term - Labeling - 540.150
SAVORY Communicable Disease Hazards - 100.300
Spices Definition - 525.750 Contract Sterilizers - 100.550
SCALE INSECTS Country of Origin Labeling - 560.200
Apple Butter - Filth - 550.100 Defective Suntanning Booths and Beds - 396.300
Olives...Pits, Rot & Infestation - 550.600 Determination by Secretary that Product Fails to Comply - 390.200
SCALLOPS Eggnog; Eggnog Flavored Milk--Common Usual Names - 527.350
Processed Seafood Products - 540.700 Expiration Dating of Unit Dose Repackaged Drugs - 480.200
Water in Food Products - 555.875 Exports from U. S. Foreign Trade Zones - 110.200
SCIENTIFIC REVIEW FDA Jurisdiction Over Meat and Poultry Products - 565.100
Direct Reference Authority for Class III Medical Devices - 300.700 Fish-Fresh and Frozen-Adulteration Involving Decomposition -540.300
Fraud, Untrue Statements of Material Facts, Bribery - 120.100 Foreign Trade Zones, Bonded Warehouses or Carriers - 110.600
Orders for Post-Approval Record Reviews - 470.100 Hazardous Diagnostic X-Ray Systems - 398.200
SCOVILLE UNITS Health Fraud - 120.500
Spices Definition - 525.750 Human Blood and Blood Products as Drugs - 230.120
SEAFOOD COCKTAIL Immune Milk - 275.100
Crab & other Seafood Products - Labeling - 540.285 Importation of Television Receivers and Microwave Ovens - 394.500
SEALS Malted Milk - 527.500
Control/Accountability of TRP Materials - 450.550 Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200
Tamper Resistant Packaging Requirements - 450.500 Medical Emergencies - 220.100
SEAMS Override of Positive Beam Limitation - 398.425
Canned Foods - Seam Defects - 520.200 Pottery (Ceramics) - Cadmium Contamination - 545.400
Contamination of Devices Labeled as Sterile - 300.400 Pottery (Ceramics) - Lead Contamination - 545.450
Tamper Resistant Packaging Requirements - 450.500 Prepared Mustard, Composition - 525.575
SEASONINGS Processed and/or Blended Seafood Products - 540.700
Labeling of Seasonings - 525.650 Proper Drug Use and Residue Avoidance - 615.200
Potato Chips, Ingredients, Labeling - 585.710 Radionuclides in Imported Foods - Levels of Concern - 562.750
Sweet Potatoes Sirup Packed - 585.850 Red Meat Adulterated with PCB's - 565.200
Tomato Sauce or Tomato Hot Sauce Labeling - 585.850 Registration of Blood Banks and Other Firms - 230.110
SEBASTES Revocation of Tolerances for Cancelled Pesticides - 550.700
Snapper Labeling - 540.475 Sauerkraut - Definition; Adulteration by Thrips - 585.750
SECOND RECIPIENT - Silver-Plated Hollowware - Lead Contamination - 545.500
Pacemaker Reuse - 310.100 Spices - Definitions - 525.750
SECTION 305 Streptomycin Residues in Cattle Tissues -616.100
Answering Inquiries on Status of Criminal Referrals - 160.500 Teat Dips and Udder Washes for Dairy Cows and Goats - 654.200
Canned Salmon - Adulteration Involving Decomposition - 540.375 Turtles - 170.100
Crabmeat - Adulteration with Filth - Escherichia coli - 540.275 Unapproved Additives for Exported Grains - 578.600
Fish-Fresh and Frozen-Adulteration Involving Decomposition -540.300 Use of DDVP (Vapona) Strips in Milkhouses and Milkrooms - 527.600
Section 305 Meeting - 160.400 Use of Income Tax Information from IRS - 160.200

439
Index Compliance Policy Guides
SERVOMEX OXYGEN ANALYZER SKIN BURNS
Compressed Medicdal Gases Warning Letters - 435.100 Mercury Vaper Lamps that aren't Self Extinguishing - 391.200
SEVERE SUNBURN SKIN PROBLEMS
Sunlamp Performance Standards - 396.100 Hypnotherapy Devices Self Hypnotic Tape Recordings - 335.300
SHAD SKIN TANNING
Smoked Cured - 540.500 Sunlamp Performance Standards - 396.100
SHELLFISH Warning label Required on Sumlamp Products - 396.400
Methyl Mercury - 540.600 SKIPJACK
Paralytic Shellfish Poisioning - 540.250 Decomposition & Histamine - 540.525
Pesticide Residues - 575.100 SLIPPER LOBSTERS
Processed and/or Blended - 540.700 Common or Usual Names for Crustaceans - 540.350
SHIELDING SMALL
Mercury Vapor Lamps that are not Self Extinguishing - 391.200 Canned Shrimp: Size Designations and Corresponding Counts - 540.390
SHIPPING CARTON Canned Peas - Label Designation of Sizes - 585.625
Importation of Television Receivers and Microwave Ovens - 394.500 Compressed Medical Gases -- Warning Letters - 435.100
Labeling of Shipping Containers for Drugs - 430.300 Confectionery decorations (nutritive and non-nutritive) - 545.200
SHIPS' MEDICINE CHESTS Drugs for Odor Control in Animals - 642.100
Rx Drugs for Ships Medicine Chests - 460.500 Failure to Register - 625.500
SHORT GWQAP Pre-Award Evaluation - 100.700
Blood and Blood Products - Definitions -230.100 Homeopathic Drugs - 400.400
Cheese & Cheese Products - Misbranding Involving Net Contents - 527.250 Importation of Television Receivers and Microwave Ovens - 394.500
Controlled-Release Dosage Form Drugs - 460.700 Labeling of Seasonings - 525.650
Failure to Register - 625.500 Large Volume Parenterals (LVP's) for Animal Use - 635.100
Foods - Net Weight - 562.300 Malt Products - 515.200
Importation of Licensed Biologic Products for Human Use - 210.150 Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200
Radionuclides in Imported Foods - Levels of Concern - 560.750 Maraschino Cherries - 550.550
Retention of Microwave Oven Test Records - 394.100 Menstrual Sponges - 345.300
Spices - Definitions - 525.750 Over-The-Counter Sale of Injectable Animal Drugs - 608.200
SHORT SUPPLY Pesticide Residues in Food and Feed - 575.100
Blood and Blood Products - 230.100 Pottery (Ceramics) - Cadmium Contamination - 545.400
Failure to Register - 625.500 Pottery (Ceramics) - Lead Contamination - 545.450
Importation of Licensed Biologic Products for Human Use - 210.150 Registration of Blood Banks and other Firms - 230.110
SHORT WEIGHT Regulatory Actions and Small Business - 160.100
Cheese Misbranding - 527.250 Regulatory Action Regarding Approved New Drugs - 446.100
Foods Net Weight - 562.300 Reloaders of S-Ray Tube Housing Assemblies - 398.700
SHORTWAVE ULTRAVIOLET RADIATION RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200
Mercury Vapor Lamps that are not Self Extinguishing - 391.200 Seizure of Books that Constitute Misleading Labeling - 140.100
SHUTTER SYSTEM Spices - Definitions - 525.750
Electronic Products Subject to 21 CFR 1001.15(a) - 390.400 The use of Antibiotic Drug Residue by-products in Animal Feed -682.200
SID SENSING MECHANISM Tomato Products - Adulteration with Mold - 585.900
Override of Positive Limitation - 398.425 Turtles - 170.100
SIDE EFFECTS OF TRANSPORATION Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100
Retention of Microwave Oven Test Records - 394.100 SMALLPOX VACCINE
SILAGE Standards and Minimum Requirements for Biologic Products - 205.100
Direct Fed Microbial Products - 689.100 SMELT
Silage Ingrediesnts - 687.500 Capelin - 540.100
SIGNATURE SMOKE FLAVOR
Compressed Medical Gases -- Warning Letters - 435.100 Labeling of Seasonings - 525.650
Orders for Post-Approval Record Reviews - 470.100 SMOKED
SILVER DRAGEES Chubs Hot Process Smoked w/Added Nitrite - 540.200
Confectionery - 515.100 Classification of Establishments - 555.500
SILVER-PLATED HOLLOWWARE Kipper & Kipper Unsplit Definitions - 540.550
Lead Contamination - 545.500 Salt-Cured, Air Dried Unevicerated Fish - 540.650
SIMPLE RELAXATION Tuna Sable, Salmon, Shad, Smoked Cured Sodium Nitrite - 540.500
Hyonotherapy Devices Self Hypnotic Tape Records - 335.300 SMOKED CURED
SIMPLIFIED AND EXPEDITED VARIANCE PROCEDURE Sodium Nitrite - 540.500
Laser Light Shows etc. - 393.100 SNAPPER
SINGLE DONOR PLASMA Labeling - 540.475
Blood & Blood Products - 230.100 SNOW CRABMEAT
Standards & Minimum Requirements for Biologic Products - 205.100 Crab Meat - Product Name - 540.300
SINGLE SAMPLING SODA WATER
Condoms Defects - Criteria for Direct Reference Seizure - 345.100 Unfermented Beverages - 510.300
Surgeons Gloves, Patient Examination Gloves - 335.700 SODIUM BICARBONATE
SINGLE UNIT CONTAINERS LVP's for Animal Use - 635.100
Time Period for Separation of Platelets - 231.120 Malted Milk - 527.500
Use of Units which have been Thawed - 253.100 SODIUM BIPHSOPHATE
SIRUP Urinary Preparations lack of Rx Legend Claims - 430.400
Malt Products - 505.200 SODIUM CHLORIDE
Marachinio Cherries - 550.550 LVP's for Animal Use - 635.100
Sugar - Water Damaged - 515.425 Malted Milk - 527.500
Sweet Potatoes, Sirup Packed - 585.850 SODIUM NITRITE
Vinegar Definitions - 515.825 Tuna, Sable, Salmon, Shad - 540.500
SKIM MILK SODIUM PENTOBARBITAL
Aflatoxin M1 - 527.400 Animak Drugs for Euthanasia - 650.100
Importated Milk Act - 560.400 SODIUM PHOSPHAGE
SKIN Labeling of Seasonings - 525.650
Corn, Sweet; Canned - Adulteration - 585.300 Potato Chips Labeling - 585.710
Dimethyl Sulfoxide (DMSO) for Animal Use - 654.100 SOFT WHEAT FLOUR
Hypnotherapy Devices - Self Hypnotic Tape Recordings - 625.300 Macaroni and Noodle Products - 505.500
Karaya Gum Powder and Related Devices for Use by Ostomates - 325.100 SOLID AND LIQUID ORAL DOSAGE FORMS
Mercury Vapor Lamps that are not Self-Extinguishing - 391.200 Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100
Oranges - Artificial Coloring - 550.625 Regulatory Action Regarding Approved New Drugs - 446.100
Pet Food Labeling - 690.200 SOLID-PACK
Sunlamp Performance Standard - 396.100 Canned Foods - 520.100
Sweet Potatoes, Dyeing of Yellow and Red Varieties - 585.825 Pinapple Food Standards - 550.685
Warning Label Required on Sunlamp Products - 396.400 Sweet Potatoes - 585.850

440
Compliance Policy Guides Index
SOLUTION Imported Milk - 560.400
Chloramphenicol - 654.300 Preservatives - 562.600
Imported Products - Lack of English Labeling - 110.900 Salt cured, Uneviscerated Fish - 540.350
Large Volume Parenterals (LVP's) for Animal Use - 635.100 SPONSOR
Malt Products - 515.200 Access to Results of Quality Assurance Audits - 130.300
Pottery (Ceramics) - Cadmium Contamination - 545.400 Acupuncture Devicses and Accessories - 305.100
Pottery (Ceramics) - Lead Contamination - 545.450 Hospital Pharmacies - 275.100
Silver-Plated Hollowware - Lead Contamination - 545.500 Illegal Sales of Veterinary Prescription Drugs - 608.500
Source Plasma - Overbleeding - 252.100 IND Findings - 215.100
Teat Dips and Udder Washes for Dairy Cows and Goats - 654.200 Menstral Sponges - 345.300
Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100 Vinegar, Recovery of IND's from Clinical Investigators - 444.100
Definitions - Adulteration with Vinegar Eels - 525.825 SPONSOR-INVESTIGATORS
Volatile N-Nitrosamines in Rubber Baby Bottle Nipples - 500.450 Acupuncture Devices and Accessories - 305.100
SOURCE PLASMA SPOT FILM MODES
Blood and Blood Products Definitions - 230.100 Assemblers who installed Noncompliant Equipment - 398.325
Registration of Blood Banks and other Firms - 230.110 X-Ray Field Size for Spot Film - 398.475
Source Plasma Syphilis - 254.100 SQUASH
Source Plasma Overbleeding - 252.100 Labeling as Pumpkin Seeds - 585.800
Source Plasma Guidelines for Informed Consent Form - 250.100 SQUASH SEEDS
Standards & Minimum Requirements for Biologic Products - 205.100 Pesticide Residues - 575.100
SPARKLING WINE Pumpkin - 585.725
Unfermented Beverages, Use of Word "champagne" - 510.300 Squash Seeds Labeling - 585.800
SPECIFIC ANATOMICAL REGIONS STABILITY TESTING
Definition of General Purpose Radiographic X-Ray Expiration Dating and Stability Testing - 480.100
System - 398.100 Lack of Expiration Date or Stability Data - 480.300
SPECIFICATION SHEET Repacking of Drug Products - CGMPs - 430.200
Mercury Vaper Lamps that are Not Self Extinguishing - 391.200 STABILIZERS
SPECIMEN CHARGES Interference w/Compendial Tests - 420.500
Canned Salmon - Adulteration Involving Decomposition - 540.375 STANDARD OF IDENTITY
Canned Green Beans and Canned Wax Beans-Standards - 585.475 Artichoke; Jerusalem Artichoke - Common or Usual
Cherries, Canned - Misbranding Involving Food Standards - 550.230 Name - 585.100
Clinical Thermometer - Adulteration; Misbranding Defects - 335.800 Bakery Products, Candy "Shotgun" Ingredients Declaration -505.100
Condoms; Defects - Criteria for Direct Reference Seizure - 345.100 Canned Pimentos & Red Sweet Peppers - Seeds should be Removed -585.650
Dates and Date Material; Imported and Domestic - 550.300 Canned Peas - Label Designation of Sizes - 585.625
Direct Reference Authority for Class III Medical Devices - 300.700 Canned Foods, Use of the Term "Solid Pack" - 520.100
Dried Prunes, Dehydrated Low Moisture Prunes, and Pitted Prunes - 550.700 Caviar, Use of Term - Labeling - 540.150
Drupelet Berries (Blackberries, Raspberries, etc.) - 550.200 Cheese - Misbranding Due to Moisture and Fat - 527.225
Fish-Fresh and Frozen-Adulteration Involving Decomposition - 540.300 Chow mein Noodles, Chinese Noodles and Other Oriental Noodles - 505.400
Marjoram - 525.900 Compendium Revisions and Deletions - 420.200
Olives - Adulteration involving Pits; Rot; Insect Infestation - 550.600 Dealcoholized Wine *and Malt Beverages* - Labeling - 510.400
Oregano - 525.850 Drupelet Berries (Blackberries, Raspberries, etc.) - 550.200
Peaches, Canned - Misbranding Involving Food Eggnog; Eggnog Flavored Milk--Common Usual Names - 527.350
Standards - 550.655 Enriched or Fortified Foods - Potency - 555.550
Peanut Butter - Adulteration with Filth; Grit - 570.300 Foreign Language Declarations on Food Labels - 562.400
Pesticide Residues in Food and Feed - 575.100 Fortification of Standardized Juices - 510.700
Raisins - Adulteration Involving Mold, Sand, Grit, & Insects -550.750 Hollandaise Sauce - Common or Usual Name - 525.400
Sage - 525.950 Honey Bread, Honey Buns - 505.350
Standardized Canned Fruit - Packing Medium - 550.800 Imitation Breaded Shrimp* - 540.450
Surgeon's Gloves and Patient Examination Gloves - 335.700 Jellies, Nonstandardized - 550.475
Thyme - 525.925 Malted Milk - 527.500
Tree Nuts - Adulteration Involving Rejects - 570.425 Maraschino Cherries - 550.550
Tree Nuts - Escherichia coli - 570.450 Marmalade - 550.575
Vitamin B-15, Pangamic Acid and Pangamic Acid Products - 457.100 Oleomargarine - Misbranding Due to Low Fat - 535.100
SPEECH Peas and Carrots, Labeling of Canned Mixture - 585.600
Seizusre of Books that Constitute Misleading Labeling - 140.100 Prepared Mustard, Composition - 525.575
SPHYGMOMANOMETERS Sauerkraut - Definition; Adulteration by Thrips - 585.750
Rx Legend - 310.200 Standardized Canned Fruit - Packing Medium - 550.800
Accuracy - 310.210 Starches--Common or Usual Names - 587.100
SPICE Sweet Potatoes - Sirup Pack - 585.850
Grenadine - 550.100 Tomato Sauce or Tomato Hot Sauce Labeling - 525.800
Labeling of Seasonings - 525.650 Water in Food Products (Ingredient or Adulterant) - 555.875
Leafy Spices - 525.500 STAPHYLOCOCCUS AUREUS
Mace - 525.550 Menstrual Sponges - 345.300
Marjoram - 525.900 Raw Breaded Shrimp - 540.420
Oregano - 525.850 STAR ANISEED
Spices - Definitions - 525.750 Spices - 525.750
Thyme - 525.925 STARCHES
Tomatoe Sauce or Tomatoe Hot Sauce Labeling - 525.800 Common or usual name - 578.100
Whole Ground Cinnamon - 525.200 STATE AUTHORITY
SPINACH, CANNED OR FROZEN Action Levels for Aflatoxins in Animal Feeds - 683.100
Decomposition - 585.775 Acupuncture Devices & Accessories - 305.100
Pesticide Residues - 575.100 STATE INTERVENTION
SPINACH WORMS Hazardous Diagnostic X-Ray Systems - 398.200
Spinach, Canned or Frozen Insects, Decomposition - 585.775 STATE LICENSING
SPINY LOBSTER Acupuncture Devices and Accessories - 305.100
Common or Usual Names - 540.350 Ear Piercing Devices - 320.100
SPIRIT VINEGAR Electrical Muscle Stimulators - 355.200
Adulteration with Vinegar Eels - 525.825 Lasers for Facelift, Wrinkle Removal, Acupuncture, etc. - 393.200
SPIRITUOUS LIQUOR STATE LICENSING BOARDS
Confectionery - 515.100 Lasers for Facelift, Wrinkle Removal, Acupuncture, etc - 393.200
SPIROCHETES STATEMENT OF IDENTITY
Source Plasma Syphilis - 254.100 Bakery Products, Candy "Shotgun" Ingredients Declaration - 505.100
SPLEEN Canned Foods, Use of the Term "Solid Pack" - 520.100
Inert Glandular Preparations - OTC - 455.100 Caviar, use of term - labeling - 540.150
SPOILAGE Compressed Medical Gases -- Warning Letters - 435.100
Identity of Foods - 562.450 Dealcoholized Wine *and Malt Beverages* - Labeling - 510.400

441
Index Compliance Policy Guides
Homeopathic Drugs - 400.400 Regulatory Action Regarding Approved New Drugs - 446.100
Identity of Foods--Terms such as Fresh, Frozen, Dried, Canned - 562.450 Similar Bean Products - 567.200
Malted Milk - 527.500 Source Plasma Guidelines for Informed Consent Form - 250.100
Peas and Carrots, Labeling of Canned Mixture - 585.600 STERILITY RELEASE
Processed and/or Blended Seafood Products - 540.700 Parametric Release of Terminally Heat Sterilized Drugs - 460.800
STATUS STERILITY TESTING
Access to Results of Quality Assurance Audits - 130.300 Contamination of Devices Labeled as Stesrile - 300.400
Action Levels for Aflatoxins in Animal Feeds - 683.100 Parametric Release of Terminally Heat Sterilized Drugs - 460.800
Animal grooming aids - 653.100 Regulatory Action Regarding Approved New Drugs - 446.100
Answering Inquiries on Status of Criminal Referrals -160.500 STERILIZATION
Anthelmintics -640.100 Contract Sterilizers - 100.550
Certification for Export -110.100 Karaya Gum Powder and Related Devices for Use by Ostomates - 325.100
Checklist Labeling for Custom Mixed Medicated Feeds - 665.200 Parametric Release of Terminally Heat Sterilized Drugs - 460.800
Classification of Establishments - 555.500 Process Validation Requirements for Drug Products - 490.100
Coffee and Cocoa Bean Sweeps - 560.350 Regulatory Action Regarding Approved New Drugs - 446.100
Contract Sterilizers - 100.500 Volatile N-Nitrosamines in Rubber Baby Bottle Nipples - 500.450
Crab and Crabmeat Products withOther Seafood -- Labeling - 540.285 STERILIZER (see sterilization above)
Denture Cleaners, Adhesives, Cushions, and Repair Materials - 315.200 STOCK
Dimethyl Sulfoxide (DMSO) for Animal Use - 654.100 Bouillon, Bouillon Cubes, Granulated Bouillon - 567.300
Direct-Fed Microbial Products - 689.100 Condoms; Defects - Criteria for Direct Reference Seizure - 345.100
Facial Tissues, Paper Napkins, Paper Towels, etc. - 100.600 Homeopathic Drugs - 400.400
Foreign Trade Zones, Bonded Warehouses or Carriers - 110.600 Hospital Pharmacies - 460.100
Homeopathic Drugs - 400.400 Raw Breaded Shrimp - Microbiological - 540.420
Hospital Pharmacies - 460.100 Reconditioning of Foods Adulterated Under 402(a)(4) - 160.700
Importation of Television Receivers and Microwave Ovens - 394.500 Recovery of IND's from Clinical Investigators - 444.100
Imported Products - Lack of English Labeling - 110.900 Reloaders of X-Ray Tube Housing Assemblies - 398.700
Imported Low-Acid Canned Foods - 560.450 Return of Unused Rx Drugs to Pharmacy Stock - 460.300
Interference with Compendial Tests - 420.500 Uncertified or Delisted Colors - 587.200
Jams, Jellies and Related Products - Imports - 560.500 Vinegar, Definitions - Adulteration with Vinegar Eels - 525.825
Labeling of Seasonings - 525.650 STOCK RECOVERY
Lasers for Facelift, Wrinkle Removal, Acupuncture, etc. - 393.200 Recovery of INDs from Clinical Investigators - 444.100
Mail-Order Filling of Prescriptions - 460.450 STOMACH
Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200 Inert Glandular Preparations - 455.100
Marketed New Drugs Without Approved NDAs or ANDAs - 440.100 STORAGE CONDITIONS
Nutritional Supplements for Companion Animals - 690.100 Collection & Charitable Distribution of Drugs - 400.800
OTC Drugs - Recognition as Safe and Effective - 450.200 Expiration Dating & Stability Testing - 480.100
Pistachio Nuts - Aflatoxin Adulteration - 570.500 Food Storage and Warehousing - Adulteration Filth - 580.100
Prescription Status - Telephone Answering Machine - 460.425 Interpretation of Insect Filth in Foods - 555.600
Returned Antibiotics Exported Under 801(d) of the Act - 405.210 Lack of Expiration Date or Stability Data - 480.300
RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 310.200 Parametric Release of Terminally Heat Sterilized Drugs - 460.800
Safety and Labeling of Waxed (Coated) Fruits and Vegetables - 562.550 Plasma Brokers - Registration and Compliance - 250.500
Silage Ingredients - 687.500 Unit Dose Labeling for Solid & Liquid Oral Dosage Forms - 430.100
Sphygmomanometers - Rx Legend - 310.200 STRAWBERRIES
Teat Dips and Udder Washes for Dairy Cows and Goats - 654.200 Sand or Mold - 550.850
The Status of Syringes and Needles for Animal Use - 655.400 STREPTOMYCES
Uncertified or Delisted Colors - 587.200 Use of Antibiotic Drug Residue by-Products in Animal Feed - 682.200
Vitamins and Minerals in Feed - 665.300 STREPTOMYCIN
Water-Damaged Food Products - 555.850 Residues in Cattle Tissue - 616.100
STEAM STERILIZATION STREPTOKINASE-STREPTODORNASE
Process Validation Requirements for Drug Products - 490.100 Standards and Minimum Requirements for Biologic Products -205.100
STEMS STRIP PACKS
Cloves - 525.250 Tamper Resistant Packaging Requirements - 450.500
Radionuclides in Imported Foods - 560.750 STYLE NUMBERS
Spices - 525.750 Certification & Identification of X-Ray Components - 398.600
STEPLESS ADJUSTMENT SUBCONJUNCTIVAL
X-Ray Field Size for Spot Film - 398.475 OTC Sale Injectable Animal Drugs - 608.200
STERILE SUBCUTANEOUS
Adulteration of Drugs Under Sec. 501(b) and 501(c) - 420.100 LVPs for Animal Use - 635.100
Compressed Medical Gases -- Warning Letters - 435.100 SUBLINGUAL
Contamination of Devices Labeled as Sterile - 300.400 Cytotoxic Testing for Allergic Diseases - 370.100
Expiration Dating and Stability Testing - 480.100 Expiration Dasting of Unit Dose Repackaged Drugs - 480.200
Finished Dosage Form Drugs in Bulk Containers - 410.100 Unit Dose Labeling for Solid & Liquid Oral Dosage Form - 430.100
Karaya Gum Powder and Related Devices for Use by SUBSTANTIALLY
Ostomates - 325.100 Caviar, Use of Term - Labeling - 540.150
Large Volume Parenterals (LVP's) for Animal Use - 635.100 Class III Devices Subject to 5l5(b) Requirements - 300.750
Parametric Release of Terminally Heat Sterilized Drugs - 460.800 Commercial Distribution -- Premarket Notification - 300.600
Process Validation Requirements for Drug Products - 490.100 Dimethylnitrosamine in Malt Beverages - 510.600
Regulatory Action Regarding Approved New Drugs - 446.100 Imitation Breaded Shrimp - 540.450
Reuse of Medical Disposable Devices - 300.500 RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200
STERILE DRUG PRODUCTS Salt-Cured, Air-Dried, Uneviscerated Fish - 540.650
Process Validation Requirements for Drug Products - 490.100 Unfermented Beverages, Use of Word "Champagne" - 510.300
Regulatory Action Regarding Approved New Drugs - 446.100 SUBSTANTIALLY EQUIVALENT
STERILE PRODUCTS Class III Devices Subject to 515(b) Requirements - 300.750
Adulteration of Drugs Under Section 501(b) & 501(c) - 420.100 Commercial Distribution - Premarket Notification - 300.600
Contamination of Devices Labeled as Sterile - 300.400 RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200
STERILITY SUBSYSTEM
Cadmium Contamination - 545.400 Assemblers Who Install Noncompliant Equipment - 398.325
Compendial Requirements - 390.200 SUGAR VINEGAR
Contamination of Devices Labeled as Stesrile - 300.400 Adulteration with Vinegar Eels - 525.825
Contract Sterilizers - 100.550 SUGAR
Lead Contamination - 545.450 Barley Sugar - Definition, and Barley Sugar Candy - 515.500
Parametric Release of Terminally Heat Sterilized Drugs - 410.100 Beverage Bases - 510.100
Pesticide Residues and Feed - 575.100 Confectionery Decorations (Nutritive and Non-Nutritive) - 545.200
Petfood Labeling - 690.200 Fructose-Containing Drugs - 400.335
Process Validation Requirements for Drug Products - 490.100 Grenadine - 550.400
Processed Seafood Products - 540.700 Jellies, Nonstandardized - 550.475

442
Compliance Policy Guides Index
Jordan Almonds - Common or Usual Name - 570.100 Hazardous Diagnostic X-Ray Systems - 398.200
Labeling of Seasonings - 525.650 Metric Declarations of Quantity of Contents - 140.500
Large Volume Parenterals (LVP's) for Animal Use - 635.100 Microfiche and/or Microfilm for Records Retention - 130.400
Maraschino Cherries - 550.550 Obligations of Factory-Based Manufacturers and Assemblers - 398.375
Marmalade - 550.575 Override of Positive Beam Limitation - 398.425
Pesticide Residues in Food and Feed - 575.100 Parametric Release of Terminally Heat Sterilized Drugs - 460.800
Prepared Mustard, Composition - 525.575 Plastic Containers for Injectable Animal Drugs -637.100
Processed and/or Blended Seafood Products - 540.700 Positive Beam Limitation (PBL) Requirements - 398.450
Raw Sugar - 515.400 Proper Drug Use and Residue Avoidance - 615.200
Silver-Plated Hollowware - Lead Contamination - 545.500 Radionuclides in Imported Foods - Levels of Concern - 562.750
Spices - Definitions - 525.750 Repacking of Drug Products -- CGMP's - 430.200
Sugar - Water Damaged - Reconditioning - 515.425 Sequencing in Medicated Feed Production - 680.600
Sweet Potatoes - Sirup Pack - 585.850 Source Code for Process Control Application Programs - 425.300
Vinegar, Definitions - Adulteration with Vinegar Eels - 525.825 Sphygmomanometers - Accuracy - 310.210
SULFAETHOXY-PYRIDAZINE Tamper-Resistant Packaging Requirements - 450.500
Extra Label Use of New Animal Drugs in Food Producing Animals - 615.100 Uncertified or Delisted Colors - 587.200
SULFAMETHOXAZOLE Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100
Unit Dose Labeling for Solid & Liquid Oral Dosage Forms - 430.100 Vinegar, Definitions - Adulteration with Vinegar Eels - 525.825
SULFONAMIDE SYSTEM FAILURE
Extra Label Use of New Animal Drugs in Food Producing Animals - 615.100 Override of Positive Beam Limitations - 398.425
SULFUR TABLETOP
Dimethylnitrosamine in Malt Beverages - 510.600 Definition of General Purpose Radiographic X-Ray System - 398.100
DMNA in Barley Malt - 578.500 TABLETS
SUN BEDS Content Uniformity Testing of Tablets and Capsules - 460.600
Exemption for Certain Sunlamp Product Purchaser Records - 396.200 Expiration Dating of Unit Dose Repackaged Drugs - 480.200
SUNLAMP PERFORMANCE STANDARD Finished Dosage Form Drugs in Bulk Containers - 410.100
Defective Suntanning Booths & Beds - 396.300 Oral Iron Products for Baby Pigs - 643.100
Exemption for Certain Sunlamp Product Purchaser Records - 396.200 Packaging -- Contact Lens Solutions and Tablets - 350.100
SUNTANNING BOOTHS (see performance standard above) Products Composed of Interstate Ingredients - 100.200
SURGEON'S GLOVES Regulatory Action Regarding Approved New Drugs - 446.100
And Patients Examination Gloves - 335.700 Tamper-Resistant Packaging Requirements - 450.500
SURIMI Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100
Processed and/or Blended Seafood Products - 540.700 TALC
SURIMI-BASED Confectionery - 515.100
Processed Seafood Products - 540.700 TAMALES
SUSPENSION Adulteration with Filth - 585.350
Blood and Blood Products - Definitions - 230.100 Foreign Language Declarations - 562.400
Licensing - Changes to be Reported - 210.100 TAMPER-RESISTANT PACKAGING
Source Plasma - Overbleeding - 252.100 Control/Accountability of TRP Materials - 450.550
Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100 Packaging-Contact Lens Solutions & Tablets - 350.100
SUSTAINED Tamper Resistant Packaging Requirements - 450.500
Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100 SWEET TAPIOCA STARCH
BASIL Starches Common or Usual Name - 578.100
Labeling of Seasonings - 525.650 TARRAGON
Spices Definitions - 525.750 Spices Definitions - 525.750
SWEET CIDER TARTARIC ACID
Unfermented Beverages - 510.300 Jellies Nonstandardized - 550.475
SWEET ORANGES TAX
Marmalade - 550.575 Alcohol; Use of Synthetic Alcohol in Foods - 555.100
SWEET POTATOES Brandy Containing Methyl Alcohol -Food Additive - 510.200
Dyeing - 585.825 Exports from U.S. Foreign Trade Zones - 110.200
Pesticide Residues - 575.100 Foreign Trade Zones, Bonded Warehouses or Carriers - 110.600
Sirup Packed - 585.850 Use of Income Tax Information from IRS - 160.200
Water in Food Products - 555.875 TECHNICALLY TRAINED INDIVIDUALS
SWISS Importation of Television Receivers & Microwave Ovens - 394.500
Cheese - Misbranding Due to Moisture and Fat - 527.225 TELEVISION RECEIVERS
SWITCH Importation of Television Receivers & Microwave Ovens - 394.500
Automatic Adjustment of the X-Ray Field Size - 398.400 TEMPERATURE
Definition of "High-Voltage Vacuum Switch" - 390.500 Collection and Charitable Distribution of Drugs - 400.800
Override of Positive Beam Limitation - 398.425 Expiration Dating and Stability Testing - 480.100
SWITCHGEAR Imported Milk and Cream. Import Milk Act - 560.400
Definition of "High-Voltage Vacuum Switch" - 390.500 Malt Products - 515.200
SYNTHETIC ALCOHOL Metric Declarations of Quantity of Contents - 140.500
Use of Alcohol in Foods - 555.100 Parametric Release of Terminally Heat Sterilized Drugs - 460.800
SYPHILIS Pottery (Ceramics) - Lead Contamination - 545.450
Registration of Blood Banks and Other Firms - 230.110 Retention of Microwave Oven Test Records - 394.100
Source Plasma - Syphilis - 254.100 Salt-Cured, Air-Dried, Uneviscerated Fish - 540.650
SYRUP Source Plasma - Overbleeding - 252.100
Grenadine - 550.400 Sphygmomanometers - Accuracy - 310.210
Malt Products - 515.200 Sugar - Water Damaged - Reconditioning - 515.425
Standardized Canned Fruit Packing Medium - 550.800 Tamper-Resistant Packaging Requirements - 450.500
SYSTEM Time Period for Separation of Platelets - 231.120
Assemblers Who Install Noncompliant Equipment - 398.325 TEMPORARY IMPORT BOND (TIB)
Assessment of Civil Penalties - 390.300 Importation of TV Receivers and Microwave Ovens - 394.500
Automatic Adjustment of the X-Ray Field Size - 398.400 TEREBINTHIC
Certification and Identification of X-Ray Components - 398.600 Spices Definitions - 525.750
CGMP Applicability to Hardware and Software - 425.100 TERMINAL LEADS
Computerized Drug Processing -- I.D. of "Persons" - 425.500 Pacemaker Reuse - 310.100
Computerized Drug Processing -- Input/Output Checking - 425.400 TERMINALLY
Computerized Drug Processing -- Vendor Responsibility - 425.200 Parametric Release of Terminally Heat Sterilized Drugs - 460.800
Computerized Rx Recordkeeping by Pharmacies - 460.400 TERMINOLOGY
Control/Accountability of TRP Materials - 450.550 Anthelmintics - 640.100
Definition of General Purpose Radiographic X-Ray System - 398.100 Electronic Blood & Blood Products Definitions - 230.100
Products Subject to 21 CFR 1001.15(a) - 390.400 Certification & Identification of X-Ray Components - 398.600
Exemption for Certain Sunlamp Product Purchaser Records - 396.200 CGMPs for Medicated Feed Daily Inventory
Expiration Dating of Unit Dose Repackaged Drugs - 480.200 Requirements - 680.200

443
Index Compliance Policy Guides
Fraud, Untrue Statements of Material Facts, Bribery - 120.100 TOMOGRAPHY (see tomographic above)
TERRA ALBA TOP 200 PRESCRIPTION DRUGS
Confectionery - 515.100 Marketed New drugs without Approved NDAs or
TERRITORY ANDAs - 440.100
Dentures -Sale by Persons Not Licensed to Practice Dentistry - 315.100 TOPICAL OINTMENTS/CREAMS OPHTHALMIC
Imported Products - Lack of English Labeling - 110.900 Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100
Labeling of Food Articles Dstributed Slely in Puerto Rico - 562.750 TORN
TESTING EVALUATION RECEIVER Coffee & Cocoa Bean Sweeps - 560.350
Importation of TV Receivers and Microwave Ovens - 394.500 Contamination of Devices Labeled as Sterile - 300.400
TETANUS ANTITOXIN Tamper Resistant Packaging Requirements - 450.500
Standards and Minimum Requirements for Biologic Products - 205.100 TOTAL AND ACID INSOLUBLE ASH
TETANUS TOXOID Cumin Seed - 525.325
Standards and Minimum Requirements for Biologic Products - 205.100 Spices - 525.750
THERAPEUTIC CLAIMS TOTAL PROTEIN
Animal Grooming Aids - 653.100 Quantitative Testing for Serum Proteins in
Ethylenediamine Dihydroiodide (EDDI) - 651.100 plasmapheresis - 255.100
Health Fraud - 120.500 Source Plasma Overbleeding - 252.100
Reconditioning of New Animal Drugs - 625.400 TOWELS
Silage Ingredients - 687.500 Facial Tissues, Paper Napkins, Paper Towels etc - 100.600
Vitamin B-15, Pangamic Acid and Pangamic Acid Products - 457.100 TOXIC SHOCK SYNDROME
Vitamins and Minerals in Feed - 670.200 Menstral Sponges - 345.300
THERAPEUTIC EXCHANGE PLASMA TOXICITY
Blood and Blood Products Definitions - 230.100 Decomposition & Histamine in Albacore, Skipjack and Yellowfin Tuna - 540.525
THERAPEUTIC PLASMAPHERESIS Illegal Sales of Veterinary Prescription Drugs - 608.500
Blood and Blood Products Definitions - 230.100 Over The Counter Sale of Injectable Animal Drugs - 608.200
THERAPEUTIC USE Sequencing in Medicated Feed Production - 680.600
Acupuncture Devices and Accessories - 305.100 TRACING
Hypnotherapy Devices - Self Hypnotic Tape Recordings - 335.300 Exemption for Certain Sunlamp Product Purchaser Records - 396.200
THEUS ORIENTALIS TRADE
Common or Usual Names for Crustaceans - 540.350 Artichoke; Jerusalem Artichoke - Common or Usual Name - 585.100
THORACIC Availability of Bulk Chemicals for Animal Drug Use - 625.200
Definition of General Purpose Radiographic X-Ray System - 398.100 Bouillon, Bouillon Cubes, Granulated Bouillon - 567.300
Positive Beam Limitation (PBL) Requirements - 398.450 Candied Citron - Labeling - 515.600
THRIPS Canned Foods, Use of the Term "Solid Pack" - 520.100
Apple Butter - 550.100 Cytotoxic Testing for Allergic Diseases - 370.100
Asparagus, Canned or Frozen - 585.150 Exports from U. S. Foreign Trade Zones - 110.200
Broccoli, Frozen - 585.260 Food Additives -"GRAS" - 500.200
Brussel Sprouts, Frozen - 585.275 Foreign Trade Zones, Bonded Warehouses or Carriers - 110.600
Cloudberries (Multer Berries) Canned - 550.590 Foreign Language Declarations on Food Labels - 562.400
Drupelet Berries - 550.200 Health Fraud - 120.500
Food Storage and Warehousing - 580.100 Jordan Almonds - Common or Usual Name - 570.100
Interpretation of Insect Filth in Foods - 555.600 Kipper and Kipper Unsplit - Definitions - 540.550
Sauerkraut-Definition - 585.750 Labeling of Food Bearing Residues of Pesticide Chemicals - 562.700
Spinach, Canned or Frozen - 585.775 Malt Products - 515.200
THROAT LOZENGES Malted Milk - 527.500
Tamper Resistant Packaging Requirements - 450.500 Maraschino Cherries - 550.550
THYME Medicated Feeds -- Formula Information - 670.100
Leafy Spices - 525.500 New Drugs - Export - 442.100
Spices - 525.750 Peas and Carrots, Labeling of Canned Mixture - 585.600
THYMOL Pesticide Residues in Food and Feed - 575.100
Spices - 525.750 Pork and Beans and Similar Bean Products--Labeling - 567.200
THYMUS Potato Chips, Ingredients - Labeling - 585.710
Inert Glandular Preparations - OTC - 455.100 Processed and/or Blended Seafood Products - 540.700
Spices - 525.750 Processing" - Use of Term in Section 405 of the FD&C
THYROID Act - 562.650
Inert Glandular Preparations - OTC - 455.100 Reconditioning New Drugs Lacking Approved NDA - 448.100
Radionuclides in Imported Foods -Levels of Concern - 560.750 Reconditioning of Articles Found in Violation of GMP's - 160.750
TISSUES Spices - Definitions - 525.750
TOLERANCE Use of Type A Medicated Article Brand Names in Feed Labels - 665.300
Adulteration of Drugs - 420.100 TRADE CORRESPONDENCE
Alternate Feeding of Medicated Feeds - 666.100 Artichoke; Jerusalem Artichoke -585.100
Brushes -- Nit Contamination - 590.400 Bouillon, Bouillon Cubes - 567.300
CGMPs for Medicated Feeds - 680.200 Canned Foods, Use of "Solid Pack" - 520.100
Chubs, Smoked with Added Nitrite - 540.200 Malt Products - 515.200
Diversion of Adulterated Food - 675.200 Malted Milk - 527.500
Pesticide Residues - 575.100 Peas and Carrots, Labeling of Mixture - 585.600
Red Meat with PCBs - 565.200 TRANSFILLING
Sequencing in Medicated Feed Production - 680.600 Compressed Medical Gases Warning Letters - 435.100
Sodium Nitrite - 540.500 TRANSFORMER NUMBERS
Streptomycin in Cattle Tissues - 616.100 Certification & Identification of X-Ray Components - 398.600
Treated Grain Seed -Mercury Residue - 578.400 TRANSFUSION
Use of DDVP (Vapona) Strips - 527.600 Registration of Blood Banks & Other Firms - 230.110
TOMATO PRODUCTS Source Plasma Guidelines for Informed Consent Forms - 250.100
Tomato Products - Adulteration w/Mold - 585.900 Use of Units Which Have Been Thawed - 253.100
Tomato Products Drosophila Fly Eggs and Maggots - 585.890 TRANSFUSION SERVICE
Tomato Sauce or Tomato Hot Sauce Labeling - 525.800 Registration of Blood Banks & Other Firms - 230.110
TOMATO PUREE - (see tomato products) TRANSMISSION
TOMATO SAUCE Rendered Animal Feed Ingredients - 675.400
Filth - 585.890 Source Plasma Guidelines for Informed Consent Forms - 250.100
Labeling - 525.800 Surgeon's Gloves & Patient Examination Gloves - 335.700
Mold - 585.900 TREASURY DEPT.
TOMATOES, CANNED Labeling - Diluted Wines & Cider w/Less Than 7% Alcohol - 510.450
Misbranding - 585.875 TREATED GRAIN SEED
Mold - 585.900 Mercury Residue - 578.400
TOMOGRAPHIC X-RAY SYSTEM TREATMENT
Definition of General Purpose Radiographic X-Ray System - 398.100 Adequate Directions for Use - Animal Drugs and Devices - 607.100

444
Compliance Policy Guides Index
Biological Drugs for Animal Use - 645.100 Determination by Secretary that Product Fails to Comply - 390.200
Cellutron Machine - 355.100 UNIFORMITY
Chloramphenicol - 654.300 Adulteration of Drugs Under Sec. 501(b) and 501(c) - 420.100
Direct-Fed Microbial Products - 689.100 Common or Usual Names for Animal Feed Ingredients - 665.100
Diversion of Contaminated Food for Animal Use - 675.100 Compendial Requirements - 420.400
Diversion of Adulterated Food to Acceptable Animal Feed Use - 675.200 Content Uniformity Testing of Tablets and Capsules - 460.600
Ethylenediamine Dihydroiodide (EDDI) - 651.100 Process Validation Requirements for Drug Products - 490.100
Extra-Label Use of New Animal Drugs in Food-Producing Animals - 615.100 Recycled Animal Waste - 685.100
Health Fraud - 120.500 Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100
Homeopathic Drugs - 400.400 UNIT DOSE
Human Blood and Blood Products as Drugs - 230.120 Expiration Dating of Unit Dose Repackaged Drugs - 430.100
Human-Labeled Drugs Distributed & Used in Animal Medicine - 608.100 Regulatory Action Regarding Approved New Drugs - 446.100
Hypnotherapy Devices - Self Hypnotic Tape Recordings - 335.300 Unit Dose Labeling for Solid & Liquid Oral Dose Forms - 480.200
Ion Generating Devices - 355.300 UNIT DOSE CONTAINERS FOR CAPSULES AND TABLETS
Lasers for Facelift, Wrinkle Removal, Acupuncture, etc. - 393.200 Expiration Dating of Unit Dose Repackaged Drugs - 480.200
Marketed New Drugs Without Approved NDAs or ANDAs - 440.100 Unit Dose Labeling for Solid & Liquid Oral Dose Forms - 430.100
Oral Iron Products for Baby Pigs - 643.100 UNIT DOSE PACKAGING
OTC Drugs - Recognition as Safe and Effective - 450.200 Expiration Dating of Unit Dose Repackaged Drugs - 480.200
OTC Drugs - Combination Products - 450.300 Unit Dose Labeling for Solid & Liquid Oral Dose Forms - 430.100
Proper Drug Use and Residue Avoidance - 615.200 UNIT DOSE PACKAGING SYSTEMS (see unit dose packaging)
Razor Blades, Manicuring Instruments - 335.500 UNIT DOSE REPACKAGED DRUGS
Reconditioning Foods by Diversion for Animal Feed - 555.650 Expiration Dating of Unit Dose Repackaged Drugs - 480.200
Source Plasma - Syphilis - 254.100 UNITED STATES BREWERS ASSOCIATION (USBA)
Sugar - Water Damaged - Reconditioning - 515.425 Dimethylnitrosamine in Malt Beverages - 510.600
Vitamin B-15, Pangamic Acid and Pangamic Acid Products - 457.100 UNITED STATES PHARMACOPEIA
TREE NUTS Adulteration of Drugs Under Sec. 501(b) and 501(c) - 420.100
Adulteration Involving Rejects - 570.425 Alcohol; Use of Synthetic Alcohol in Foods - 555.100
Pistachio Nuts - 570.500 Compressed Medical Gases -- Warning Letters - 435.100
Reconditioning - 570.550 Content Uniformity Testing of Tablets and Capsules - 460.600
TRICALCIUM PHOSPHATE Expiration Dating of Unit Dose Repackaged Drugs - 480.200
Labeling of Seasonings - 525.650 Homeopathic Drugs - 400.400
TRIMETHOPRIM Human Blood and Blood Products as Drugs - 230.120
Unit Dose Labeling for Solid & Liquid Oral Dosage Forms - 430.100 Karaya Gum Powder and Related Devices for Use by Ostomates - 325.100
TRINKETS Starches--Common or Usual Names - 578.100
Candy Mixed With Trinkets - 515.350 Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100
TRIVALENT ORGANIC ARSENICALS UNITS
Standards & Minimum Requirements for Biologic Products - 205.100 Blood and Blood Products - Definitions - 230.100
TSS Butter - Adulteration Involving Low Fat - 527.100
Menstrual Sponges - 345.300 Canned Green Beans and Canned Wax Beans - Standards - 585.475
TUBE HOUSING ASSEMBLY Commercial Distribution -- Premarket Notification - 300.600
Certification & Identification of X-Ray Components - 398.600 Compressed Medical Gases -- Warning Letters - 435.100
Reloaders of X-Ray Tube Housing Assemblies - 398.700 Contamination of Devices Labeled as Sterile - 300.400
TUBERCULIN Defective Suntanning Booths and Beds - 396.300
Imported Milk & Cream. Import Milk Act - 560.400 Direct-Fed Microbial Products - 689.100
Standards & Minimum Requirements for Biologic Foods, Except Dairy Products - Adulteration with Salmonella - 555.300
Products - 205.100 Foods - Net Weight - 562.300
TUBES Health Fraud - 120.500
Tamper Resistant Packaging Requirements - 450.500 Importation of Television Receivers and Microwave Ovens - 394.500
TULLIBEES Manufacture, Distribution, Promotion of Drugs by Pharmacies - 460.200
Fish, Adulteration by Parasites - 540.590 Metric Declarations of Quantity of Contents - 140.500
TUNA Parametric Release of Terminally Heat Sterilized Drugs - 460.800
Decomposition and Histamine - 540.525 Pathogens in Dairy Products - 527.300
Smoked Cured - 540.500 Peaches, Canned - Misbranding Involving Food Standards - 550.655 Plasma
TYPHOID VACCINE Brokers - Registration and Compliance - 255.500
Standards & Minimum Requirements for Biologic Products - 205.100 Platelets, Pooled - 231.100
U.S. STANDARD OF POTENCY Pottery (Ceramics) - Cadmium Contamination - 545.400
Lack of Expiration Date or Stability Data - 480.300 Pottery (Ceramics) - Lead Contamination - 545.450
Standards and Minimum Requirements for Biologic Products - 205.100 Quality Control Testing - 231.110
ULTRA HIGH TEMPERATURE PROCESSED MILK Raw Breaded Shrimp - Microbiological - 540.420
Imported Milk and Cream - 560.400 Records and Reports - Applicability - 21 CFR 1002.1 - 390.425
ULTRAVIOLET LAMP Retention of Microwave Oven Test Records - 394.100
Exemption for Certain Sunlamp Product Purchaser Records - 396.200 Silver-Plated Hollowware - Lead Contamination - 545.500
Sunlamp Performance Standard - 396.100 Source Plasma - Overbleeding - 252.100
ULTRAVIOLET RADIATION Source Plasma - Syphilis - 254.100
Mercury Vapor Lamps That are Not Self Extinguishing - 391.200 Spices - Definitions - 525.750
Sunlamp Performance Standards - 396.100 Storage of Platelet Concentrate - 231.130
UNACCEPTABLE RATE OF FAILURE Surgeon's Gloves and Patient Examination Gloves - 335.700
Assemblers Who Install Noncompliant Equipment - 398.325 Tamper-Resistant Packaging Requirements - 450.500
UNAPPROVED ADDITIVES Temporal-Maximum Ultrasonic Power - 397.100
Exported Grains - 578.600 Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100
UNAPPROVED INTENDED Use of Units Which Have Been Thawed - 253.100
Direct Reference Authority for Class III Medical Devices - 300.700 Vitamin B-15, Pangamic Acid and Pangamic Acid Products - 457.100
UNAPPROVED NEW DRUGS Whole Milk, Low Fat Milk, Skim Milk - Aflatoxin M1 - 527.400
Inert Glandular Preparations-OTC - 455.100 UNLICENSED PERSON
Manufacture Distribution Promotion of Drugs by Pharmacies - 460.200 Ear Piercing Devices - 320.100
Reconditioning of New Animal Drugs Seized Under Sec. 501(a) - 625.400 UNLOCK
Reconditioning of New Drugs Lacking Approved NDA - 448.100 Certification & Identification of X-Ray Components - 398.600
UNBOLT UNREASONABLE RISK
Certification & Identification of X-Ray Components - 398.600 Class III Devices Subject to 5l5(b) Requirements - 300.750
UNCERTIFIED TELEVISION RECEIVERS Direct Reference Authority for Class III Medical Devices - 300.700
Importation of TV Receivers and Microwave Ovens - 394.500 UNUSED PRESCRIPTION DRUGS
UNEVICERATED FISH Return of Unused Rx Drugs to Pharmacy Stock - 460.300
Salt Cured, Air Dried - 540.650 UNWARRANTED USER ABUSE
UNFERMENTED BEVERAGES Obligation of Factory Based Manufacturers & Assemblers - 398.375
Use of Word "Champagne" - 510.300 URINARY ANALGESICS
UNFORESEEABLE ABUSE Urinary Preparations - Lack of Rx Legend - Claims - 430.400

445
Index Compliance Policy Guides
URINARY ANTISEPTICS VOLATILE N-NITROSAMINES
Definition of General Purpose Radiographic X-Ray System - 398.100 In Rubber Baby Bottle Nipples - 500.450
Immune Milk - 275.100 VOLATILE OIL
Urinary Preparations - Lack of Rx Legend Claims - 430.400 Spices Definitions - 525.750
URINARY PREPARATIONS VOLUNTARY BASIS
Urinary Preparations - Lack of Rx Legend - Claims - 430.400 Defective Sun Tanning Booths & Beds - 396.300
URINARY TRACT Failure to Register - 400.100
Definition of General Purpose Radiographic X-Ray System - 398.100 Pistachio Nuts - Aflatoxin Adulteration - 570.500
Immune Milk - 275.100 VOLUNTARY STANDARDS
UROLOGIC Sphygomanometers - Accuracy - 310.210
Definition of General Purpose Radiographic X-Ray System - 398.100 VOMITING
US CUSTOMS SERVICE Fructose Containing Drugs - 400.335
Articles of Foreign Origin not Intended for Entry - 110.700 WALLBUCKY STAND
Country of Origin Labeling - 560.200 Definition of General Purpose Radiographic X-Ray System - 398.100
Exports from U.S. Foreign Trade Zones - 110.200 WALNUTS
Foreign Trade Zones Bonded Warehouses or Carriers - 110.600 Tree Nuts - Adulteration Involving Rejects - 570.425
Importation of TV Receivers & Microwave Ovens - 394.500 WAREHOUSE
USDA ANIMAL AND PLANT HEALTH INSPECTION SERVICE Canned Foods - Seam Defects - 520.200
FDA Jurisdiction Over Meat & Poultry Products - 565.100 Coffee & Coco Bean Sweeps - 560.350
USDA FEDERAL GRAIN INSPECTION SERVICE Food Storage & Warehousing Adulteration Filth - 580.100
Unapproved Additives for Exported Grains - 578.600 Foreign Trade Zones, Bonded Warehouses or Carriers - 110.600
USP TESTS WARNING LABEL
Contamination of Devices Labeled as Sterile - 300.400 Certification & Identification of X-Ray Components - 398.600
VACUMM BOTTLE SWITCH ASSEMBLY Warning Label Required on Sunlamp Products - 396.400
Definition of "High-Voltage Vacum Switch" - 390.500 WARNING STATEMENTS
VAGINAL PRODUCTS Literature for High-Intensity Mercury Vaper Lamps - 391.100
Tamper Resistant Packaging Requirements - 450.500 WARRANT
VALID SCIENTIFIC STUDIES Access to Results of Quality Assurance Audits - 130.300
Acupuncture Devices & Accessories - 305.100 Action Levels for Aflatoxins in Animal Feeds - 683.100
Ion Generating Devices - 355.300 Assessment of Civil Penalties - 390.300
VALIDATION Bouillon, Bouillon Cubes, Granulated Bouillon - 567.300
Analytical Methodology Used by FDA - Drugs - 150.500 Color Additives - 587.300
Compendial Requirements - 420.400 Dimethylnitrosamine (DMNA) in Barley Malt - 578.500
Computerized Drug Processing -- Vendor Responsibility - 425.200 Food Storage & Warehousing - Adulteration - Filth - 580.100
Computerized Drug Processing -- I.D. of "Persons" 425.500 Intermediate or End Products of Sample Analysis - 150.100
Parametric Release of Terminally Heat Sterilized Drugs - 460.800 Macaroni and Noodle Products - 505.500
Process Validation Requirements for Drug Products - 490.100 Malted Milk - 527.500
Registration of Bblood Banks and Other Firms - 230.110 Marketed New Drugs without Approved NDAs or ANDAs - 440.100
Regulatory Action Regarding Approved New Drugs -446.100 Medicated Feeds -- Formula Information - 670.100
VALIDITY Orders for Post-Approval Record Reviews - 470.100
Analytical Methodology Used by FDA - Drugs - 150.500 OTC Anti-Obesity Preparations - 456.100
Cytotoxic Testing for Allergic Diseases - 370.100 Pesticide Residues in Food and Feed - 575.100
Fraud, Untrue Statements of Material Facts, Bribery - 120.100 Refusal to Permit Inspection - 130.100
Process Validation Requirements for Drug Products - 490.100 Seeds for Sprouting Prior to Food Use - 555.750
Refusal to Permit Inspection - 130.100 Starches--Common or Usual Names - 578.100
Reuse of Medical Disposable Devices - 300.500 Treated Grain Seed - Mercury Residue - 578.400
RIA Analysis of Hair to Detect the Presence of Drugs of Abuse - 370.200 Unit Dose Labeling for Solid and Liquid Oral Dosage Forms - 430.100
VAPONA STRIPS Urinary Preparations - Lack of Rx Legend - Claims - 430.400
In Milkhouses - 527.600 Use of Units Which Have Been Thawed - 253.100
VENDING MACHINE FOOD Water in Food Products (Ingredient or Adulterant) - 555.875
Candy - 515.350 Wheat - Adulteration by Insect and Rodent Filth - 578.300
Labeling - 562.800 Wheat Germ Containing Non Wheat Germ Tissue - 530.500
OTC Drugs in Vending Machine - 450.400 Wheat Flour - 578.450
VENOUS THROMBOSIS Wheat for Human Consumption - Reconditioning - 578.350
Electrical Muscle Stimulators - 355.200 WART REMOVAL
VERIFICATION Hypnotherapy Devices - Self Hypnotic Tape Recordings - 335.300
Fraud, Untrue Statements of Material Facts, Bribery - 120.100 WASHED CURD
Ion Generating Devices - 355.300 Cheese - 527.225
VERMIFUGE WATER IN FOOD PRODUCTS
Anthelmintics - 640.100 Ingredient or Adulteration - 555.875
VETERINARY DEVICE WAVELENGTH
Adequate Directions- Animal Drugs & Devices - 607.100 Sunlamp Performance Standard - 396.100
Barking Dog Collars - 655.300 WAX BEENS, CANNED
VETERINARY LABELED Canned Green Beans & Canned Wax Beans Standing - 585.475
Human Labeled Drugs Distributed & Used in Animal Medicine - 608.100 WEIGHT LOSS
VIABLE ORGANISMS Electric Muscle Stimulators - 355.200
Contamination of Devices Labeled as Sterile - 300.400 WHEAT
VIBRATION Bouillon, Bouillon Cubes, Granulated Bouillon - 567.300
Barking Dog Collars - 655.300 Dimethylnitrosamine (DMNA) in Barley Malt - 578.500
Reloaders of X-Ray Tube Housing Assemblies - 398.700 Macaroni and Noodle Products - 505.500
Retention of Microwave Oven Tests Records - 394.100 Malted Milk - 527.500
VIGNETTES Pesticide Residues in Food and Feed - 575.100
Bakery Products - 505.100 Seeds for Sprouting Prior to Food Use - 555.750
VINEGAR EELS Starches--Common or Usual Names - 578.100
Definition - Adulteration with Vinegar Eels - 525.825 Treated Grain Seed - Mercury Residue - 578.400
VISCERA Water in Food Products (Ingredient or Adulterant) - 555.875
Salt Cured, Air Dried Uneviscerated Fish - 540.650 Wheat for Human Consumption - Reconditioning - 578.350
VITAMIN B-15 Wheat - Adulteration by Insect and Rodent Filth - 578.300
Pangamic Acid & Pangamic Acid Products - 457.100 Wheat Flour - 578.450
VITAMIN Wheat Germ Containing Non Wheat Germ Tissue - 530.500
For Human Use - Low Potency - 530.400 WHEAT CARLOAD SAMPLING
Identical or Similar Product Names - 400.500 Dimethylnitrosamine (DMSO) in Barley Malt - 578.500
Imported Milk and Cream - 560.400 WHEAT GERM
In Feed - 670.200 Wheat Germ ContainingNnon Wheat Germ Tissue - 530.500
Inert Glandular Preparations - OTC - 455.100 WHEAT STARCH
Vitamin B-15, Pangmic Acid and Pangamic Acid Products - 457.100 Starches Common or Usual Names - 578.100

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Compliance Policy Guides Index
WHITE BREAD
Butter Nut Bread - 505.300
WHITE FISH
Fish Adulteratsion by Parasites - 540.590
Processed Seafood Products - 540.700
WHITE MUSTARD
Prepared Mustard Composition - 525.575
Spices Definitions - 525.750
WHITE POTATOES
Sweet Potatoes, Dying Yellow - 585.825
WHOLE BLOOD
Blood and Blood Products - Definitions - 230.100
Registration of Blood Banks and Other Firms - 230.110
Source Plasma - Overbleeding - 252.100
Standards and Minimum Requirements for Biologic Products - 205.100
Time Period for Separation of Platelets - 231.120
WHOLE MILK
Malt Milk - 527.500
Pathogens in Dairy Products - 527.300
Whole Milk Aflatoxin M1 - 527.400
WILLFUL
Assembler who Install Noncompliant Equipment - 398.325
WINE
Dealcoholized Wine - 510.400
Labeling diluted Wines - 510.450
Unfermented Beverages - 510.300
Vinegar - 525.825
WITNESS
Payment of Expert Witness - 160.600
WOOD DISTILLATES
Labeling of Seasonings - 525.650
WORLD HEALTH ORGANIZATION
Standards & Minimum Requirements for Biologic Products - 205.100
WORMY FRUITS
Currants Adulteration Involving Wormy Fruits - 550.270
WRAPPER
Bakery Products - 505.100
Butter Nut Bread - 505.300
WRAPPERS
Tamper Resistant Packaging Requirements - 450.500
WRINKLE
Electrical Muscle Stimulators - 355.200
Lasers for Face Lift, Wrinkle Removal, Acupuncture etc. - 393.200
Reloaders of X-Ray Tube Housing Assemblers - 398.700
WRINKLE REMOVAL (See wrinkle above)
WRITTEN DECLARATION
Importation of TV Receivers & Microwave Ovens - 394.500
WRITTEN NOTICE
Direct Reference Authority for Class III Medical Devices - 300.700
YEAST
Direct Fed Microbial Products - 689.100
Labeling of Seasonings - 525.650
Menstral Sponges - 345.300
YELLOW FEVER VACCINE
Standards & Minimum Requirements for Biologic Products - 205.100
YELLOWFIN TUNA
Decomposition and Histamine in Albacore - 540.525
YERSINIA ENTEROCOLITICA
Pathogens in Dairy Products - 527.300
YOUNGBERRIES
Drupelet Berries - 550.200
ZEA MAYS, LINNE
Starches - Common or Usual Names - 578.100
ZINGIBERENE(EMS)
Spices - 525.750
ZONE
Exports from U.S. Foreign Trade Zones - 110.200

447