PCB Tutorial
Lesson 6 — Coding Animal Use Products
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Glossary
The following terms are used when coding products under Industry Codes 67 and 69.
Drug Categories (these are the Class Categories for Ind. Code 67 and 69)
Category I: drugs require no withdrawal period at the lowest use level in each species for which they are approved.
Category II: drugs require a withdrawal period at the lowest use level for at least one species for which they are approved or are regulated on a "no-residue" basis or with a "zero" tolerance because of a carcinogenic concern regardless of whether a withdrawal period is required.
Combo Category I & II: Products containing both category I & II animal drugs.
Types of Medicated Products
Type A medicated article: (previously called Premix) is intended solely for use in the manufacture of another Type A medicated article or a Type B or Type C medicated feed. It consists of a new animal drug (s) with or without a carrier (e.g., calcium carbonate, rice hull, corn, gluten) with or without inactive ingredients.
Type B medicated feed: (previously called Concentrate) is intended solely for the manufacture of other medicated feeds (Type B or Type C). It contains a substantial quantity of nutrients including vitamins and/or minerals and/or other nutritional ingredients in an amount not less than 25 percent of the weight. It is manufactured by diluting a Type A medicated article or another Type medicated feed.
Type C medicated feed: is intended as the complete feed for the animal or may be fed "top dressed" (added on top of usual ration) on or offered "free-choice" (e.g., supplement) in conjunction with other animal feed. It contains a substantial quantity of nutrients including vitamins, minerals, and/or other nutritional ingredients. It is manufactured by diluting a Type A medicated article or a Type B medicated feed. A Type C medicated feed may be further diluted to produce another Type C medicated feed.
Retorted: Process of distilling, sublimating or decomposing by heat. This term is used with the Process Indicator Codes for Industry Codes 71, By Products for Animals and 72, Pet and Laboratory Animal Foods.
Animal Use Products — Industry Codes 54, 56, 67-72
Animal Use Products cover several industries. Animal uses of Vitamins — Industry Code 54 and Antibiotics — Industry Code 56 are included in the Lessons on those products. Click on the hyperlinks to go to Vitamins or Antibiotics.
The remaining Animal Use Products are under Industry Codes 67-72. These include:
67 — Type A Medicated Articles
68 — Animal Devices and Diagnostic Products
69 — Medicated Animal Feeds
70 — Animal Food (Non-Medicated Feed and Feed Ingreds)
71 — Byproducts for Animal Foods
72 — Pet and Laboratory Animal Foods
Class Codes, Subclasses and PICs depend on the Industry Code selected.
The Animal Use Products Classes
| CLASS | NAME | PRODUCT EXAMPLES |
|---|---|---|
| A | Category I | Aklomide Category I, Type A Medicated Article |
| B | Category II | Pyrantel Tartrate Category II, Type A Medicated Article |
| C | Combination of Category I and II Drugs | Example Apramycin Combo Category I & II, Type A Medicated Article |
| CLASS | NAME | PRODUCT EXAMPLES |
|---|---|---|
| L | Disposables/single use devices-Nonhuman | Blood collection bags, tubing and accessories (Nonhuman), Needles for injection (Nonhuman) |
| M | Large hospital/clinic equipment-Nonhuman | Autoclave (Nonhuman), Radiograph (X-ray) machine (Nonhuman) |
| N | Small hospital/clinic equipment-Nonhuman | Blood Pressure Monitoring Equipment (Nonhuman), Endoscope (Nonhuman) |
| O | Anesthesia-Nonhuman | Anesthesia machines (Nonhuman), Endotracheal tubes (Nonhuman) |
| P | Orthopedic-Nonhuman | Bone Plates (Nonhuman), Orthopedic Screws (Nonhuman) |
| Q | Ophthalmic-Nonhuman | Eye Speculum (Nonhuman), Ophthalmoscopes (Nonhuman) |
| R | Dental-Nonhuman | Forceps (Nonhuman), Hand Scalers (Nonhuman) |
| S | Diagnostics (in vivo, in vitro and NEC)-Nonhuman | In Vitro Test Kits, Individual (Nonhuman), Parasite Egg Flotation Solution (Nonhuman) |
| Z | Animal Medical Devices, NEC | Animal Medical Devices, NEC |
| CLASS | NAME | PRODUCT EXAMPLES |
|---|---|---|
| A | Category I | Lasalocid Category I, Medicated Animal Feed |
| B | Category II | Florfenicol Category II, Medicated Animal Feed |
| C | Combination of Category I and II Drugs |
| CLASS | NAME | PRODUCT EXAMPLES |
|---|---|---|
| A | Ground Grains Animal | Includes barley, corn, oats, rice, rye, etc. |
| B | Hay | Includes, alfalfa, clover hay, grass hay, grain straw, peanut forage, soybean forage, etc. |
| C | Silage | Silage is fodder prepared by storing and fermenting green forage plants in a silo. Includes field corn silage, grass silage, sorghum silage, etc. |
| D | Whole Grains Animal | Barley, Whole Grains |
| E | Additives | Lignin Sulfonatess |
| F | Edible Seeds-Oilseed | Flax seed, Pumpkin seed |
| G | Edible Seeds-Legumes | Lentils, Peas |
| H | Vegetables-Fresh (incl. tubers & root vegetables) | Sweet Potato |
| I | Vegetables-Dried (incl. tubers & root vegetables) | Sweet Potato Products Dried |
| M | Mixed Feed Rations | Cattle Mixed Feed Ration |
| N | Algae and Seaweed | Brown Seaweed, Algae (Fresh Chlorella) |
| Y | Animal Feeds, N.E.C. | Not Elsewhere Classified |
| CLASS | NAME | PRODUCT EXAMPLES |
|---|---|---|
| A | Slaughtered Mammal Byproducts | Includes: animal fats, blood, bone meal, meat scraps, meat or tankage, etc. |
| B | Poultry | Includes: blood, feathers, feather meal, poultry byproduct meal, etc. |
| C | Dairy | Includes: dried buttermilk, dried whey, liquid buttermilk, etc. |
| D | Fish/Marine | Includes: condensed fish solubles, crab meal, fish meal, oyster shell, crushed shrimp, etc. |
| E | Animal Waste Feed Products | Poultry waste meal, beef or dairy cattle waste meal, horse waste meal, etc. |
| F | Brewery and Distillery Byproducts | This includes: Malt barley spent, Spent mash, etc. |
| G | Corn Products/Byproducts | Examples are: Corn cobs, corn gluten, corn hominy. |
| H | Flour Mill Byproducts | Includes: bran, middlings, shorts, flour mill |
| I | Rice Mill Byproducts | Includes: rice hulls, rice meal. |
| J | Fruit | Apple pomace, citrus meal, citrus molasses, etc. |
| K | Vegetable Byproducts | Beet pulp, molasses-cane, pea vine silage, sweet corn silage, etc. |
| L | Oilseed Byproducts | Coconut meal, copra meal peanut meal, soybean meal, etc. |
| M | Wheat and Wheat Byproducts | Wheat Gluten |
| N | Human Food Byproducts | Bakery Byproducts, Meat Scraps Waste |
| Y | Byproducts for Animal, N.E.C. | Not Elsewhere Classified |
| CLASS | NAME | PRODUCT EXAMPLES |
|---|---|---|
| A | Pet Cat Food | Poultry product cat food, fish-seafood product pet cat food |
| B | Pet Dog Food | Includes red meat products, poultry products, cereal and vegetable products |
| C | Pet Bird Food | Pellets, mash, grain and seed, etc. |
| D | Pet Fish Food | Meats, grains, vegetables, etc. |
| E | Other Pet Food, N.E.C. | |
| F | Pet Chews (Non-Nutritive) | Pork ears, beef bone, bully stick |
| G | Pet Treats | Poultry treat, fish-seafood treat |
| L | Lab Animal Food | For Dog, rat, monkey, etc. |
| Y | Pet and Lab Animal Food N.E.C. | Not Elsewhere Classified |
The Animal Use Products Subclasses
The Subclasses for Animal Use Products varies depending on the specific Industry Code. If a subclass is not used in a specific industry, filers must transmit a dash "-". The Product Code Builder Application will return a dash automatically. See the table below for Subclass information.
| SUBCLASS | NAME |
|---|---|
| E | Animal (Food Producing), RX |
| F | Animal (Food Producing), non-RX |
| G | Animal (Non-Food Producing), RX |
| H | Animal (Non-Food Producing), non-Rx |
| I | Investigational Drug Use |
| J | Animal (Food and Non-Food Producing), Rx |
| K | Animal (Food and Non-Food Producing), non-Rx |
| Y | Not Elsewhere Classified (N.E.C.) |
| SUBCLASS | NAME |
|---|---|
| A | Type B Feed made from Type A Medicated Article |
| B | Type C Feed made from Type A Medicated Article |
| C | Type B Feed made from Type B Feed |
| D | Type C Feed made from Type B or C Feed |
The Animal Use Products Process Indicator Codes (PIC)
Similar to the Subclass codes, the PICs vary depending on the specific Animal Use Industry Code. Remember, when there is no Process Indicator Code used in an Industry by FDA OASIS and FACTS users, filers must transmit a dash "-" on the PIC field. The Product Code Builder Application will return a dash automatically.
| PROCESS INDICATOR CODE | NAME |
|---|---|
| D | Sterile |
| G | Non-Sterile |
| PROCESS INDICATOR CODE | NAME |
|---|---|
| B | Raw, Fresh, Ambient |
| C | Raw, Fresh, Refrigerated |
| D | Raw, Fresh, Frozen, Natural State |
| E | Commercially Sterile |
| F | Aseptic Pack-Commercially Sterile |
| H | Ntrl/Artfcl Dried |
| I | Acidified |
| N | Heat Treated |
| O | Pasteurized |
| P | Cultured/Cured |
| R | Irradiated |
| S | Ultrapasteurized |
| T | Packaged Food (Not Commercially Sterile) |
| U | Aseptic Lab Analysis Only-Not For Use as Food |
| W | LACF Lab Analysis Only-Not For Use as Food |
| X | Acidified Lab Analysis Only-Not For Use as Food |
| Y | NEC |
Check Your Knowledge
Code the Products
Now you will have a chance to practice coding some Animal Use Products. Below you will find six product descriptions. Read the descriptions and then click on the PCB Application button below. This will take you to the Product Code Builder application.
Have notepaper and a pen or pencil handy. As you code each product, jot down the product code result. When you're ready to check your answers, click the Tutorial button on the Taskbar. The Taskbar is located at the bottom of the screen. This will bring you back here. Caution: Don't click the Tutorial button in the Product Code Builder application, it will take you to the beginning of the Tutorial.
OATS
Animal Feed (non-medicated)
Whole Grain Oats
Not elsewhere classified (N.E.C.)
Not used
Oats whole grains animal
BONE MEAL
Byproducts for Animal Foods
Slaughtered Mammal Byproducts
Not Elsewhere Classified (N.E.C.)
Heated, Pasteurized, Cooked or Retorted
Bone Meal Slaughtered Mammal Byproduct
BAGGED DRY DOG FOOD (BEEF-FLAVORED)
Pet/Laboratory Animal Food
Pet Dog Food
Paper
Not Elsewhere Classified (N.E.C.)
Cereal/Veg Product Pet Dog Food
WOUND DRESSING (EQUINE) (several ingredients)
Animal Drugs, Devices and Diagnostics
Wound Dressing
Combination Ingredients, Non-Rx Drug
Nonsterile Ointment
Horses Wound Dressing
MEDICATED PREMIX CONTAINING MONENSIN
Type A Medicated Articles
Category I
Not used
Not used
Monensin, Category I, Type A Medicated Article
MEDICATED FEED FOR FURTHER MANUFACTURING CONTAINING MONENSIN (manufactured from a medicated premix)
Medicated Animal Feeds
Category I
Type C Feed made from a Type A Medicated Article
Not used
Monensin, Category I, Medicated Animal Feed
Check your answers — Click on reveal code for each product description to reveal the correct product code. Compare it with the one you got. Did you get the correct code? If not, determine which element was incorrect. You can go back the Product Code Builder application and try again.