PCB Tutorial

Lesson 5 — Coding Drugs, Drug Products and Biologics

Human and Animal Drugs — Industry Code 60 – 66

Human and Animal Drugs are coded under Industry Codes 60-66. Due to the large volume of drug products, numbers 60 through 66 are reserved for Human and Animal Drugs. Because of the large number of human and animal drug products, you will need to rely on information from the manufacturer or the product label when you code human and animal drug products. Some important points to keep in mind when coding Human and Animal Drugs are listed below.

  • The intended use of a product, which is frequently conveyed by the product label, is a very significant factor in determining if a product is a drug. A product is considered to be a drug if the label contains claims that it will prevent or treat a disease or that it is other than a food that will affect the structure or function of the body. For example, wrinkle-removing cream might typically be thought of as a cosmetic (Industry code 53). However, if the label contains anti-aging claims, then the product is coded as a drug because its intended use is to affect the structure or function of the body.
  • Product codes for drug products are determined on the basis of the "active" ingredients in the product. An "active" ingredient is the one that causes the product to have the effect that the label claims. If a drug product has multiple active ingredients, its product code is determined on the basis of the first active ingredient listed.
  • Normally, your first step in coding human and animal drug products would be to search for the name of the active ingredient. In many cases, this method will give you the Industry Code, Product Class and Product Code, leaving the Subclass and PIC codes for you to select. The Subclass categories are similar to those for Vitamins, Minerals, Proteins, and Unconventional Dietary Specialty products and Antibiotic products. PICs are the same as those used for Antibiotic products and provide information about the dosage form of the drug product, (e.g., prompt release tablets, extended-release tablets, prompt release hard-shell capsules, powders, etc.). The label of a product usually provides the information necessary to determine the proper PIC.
  • You should note that there may not be a specific Human and Animal Drug product code for every drug or drug product. Use Product Code 66 Y [ ] [ ] 99, for both prescription (Rx) and non-prescription (non-Rx) products that cannot be coded elsewhere. The Product Class code "Y" stands for Exhibit, Other Drug Related Item and can be used for miscellaneous products that you cannot code elsewhere.
  • It may not always be obvious if a human and animal drug product requires a prescription for sale in the U.S (Rx) or may be sold without a prescription (non-Rx). The label for a prescription drug should bear the symbol "Rx only." The label may have more descriptive statements indicating that the drug is limited to sale by prescription only. Unapproved new drugs imported into the U.S. may not have an equivalent statement, as there is no international agreement on what constitutes a prescription drug. A drug may be considered prescription only in the U.S. but Over-the-Counter (OTC) in another country. The strength of the drug also may determine if it is Rx or non-Rx. OTC drug products sold in the U.S. are required to bear a “Drug Facts” label. The label helps determine if a drug is sold by prescription or OTC.

Glossary

Drug Products: A product is considered to be a drug if it meets any one of the following definitions:

  • Articles recognized in the United States Pharmacopoeia, Homeopathic Pharmacopoeia and the National Formulary.
  • Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.
  • Articles (other than food) intended to affect the structure or any function of the body of man or other animal.
  • Articles used as a component of any such product.

Rx: A drug product that can only be obtained with a prescription.

Non-Rx: A drug product that can be obtained without a prescription.

The Human and Animal Drug Products Classes

There are numerous Class codes associated with the seven Human and Animal Drug Industry Codes. The Industry Codes simply identify the product as a drug. The Class code narrows the product down to a type of drug, such as an antacid, anti-depressant, anti-hypertensive, a laxative and so on.

Included below is a drop down list with the Class Codes associated with each of the Human and Animal Drug Industry Codes. This will give you an idea of the range of drug types that can be coded. Remember, the product label or other information from the manufacturer is your best resource for determining the Human and Animal Drug Class Code

X A-Adrenergic
A Abrasive
B Acidifier
C Adrenergic
D Adrenocortical Steroid
E Adrenocortical Suppress
F Adsorbant
O Agonist
G Alcohol Deterrent
H Aldosterone Antagon
I Alkalizer
J Ammonia Detox
K Anabolic
L Analgesic
M Analgesic (Narc)
N Androgen
Q Anesthetic
P Anesthesia Adjunct
R Anorexic
S Antacid
T Antagonist
U Anter Pituit Activ
V Anter Pituit Suppress
W Anthelmintic
Z Antiparasitic
Y Inhibitor (Growth Factor)
A A-Amebic
B A-Androgen
C A-Anemic
D A-Anginal
E A-Asthmatic
I A-Bacterial Enzyme
F A-Bacterial Pt. I (Not Antibiotic)
G A-Bacterial Pt. II (Not Antibiotic)
H A-Bacterial Pt. III (Not Antibiotic)
J A-Cholesteremic
K A-Cholinergic
L A-Coagulant
M A-Convulsant
N A-Depressant
P A-Diabetic
Q A-Diuretic
S A-Eczematic
T A-Emetic/Nauseant
U A-Estrogen
V A-Flatulent
W A-Fungal
X A-Histaminic
Z A-Platelet
R Antidote
Y TNF Inhibitors
A A-Hypercalcemic
B A-Hyperlipidemic
C A-Hypertensive
D A-Hypocalcemic
E A-Hypotensive
F A-Infective, Topical
G A-Inflammatory
H A-Microbial
I A-Neoplastic
J A-Parkinsonian
K A-Peristaltic
L A-Protozoal, A-Leishmanial, A-Malarial
M A-Pruritic
N A-Psoriatic
P A-Pyretic
Q A-Rheumatic
R A-Schistosomal
S A-Seborrheic
T A-Secretory
U A-Tussive/Cold
V A-Viral
O Anti-Hypertensive Part II
Y Anti-Inflammatory Part II
Z Anti-neoplastic Part II
W Astring/A-Perspirant
O Antimigraine Agent
A Bone Calcium Reg
B Bronchodilator
C Carbon Dioxide Absorb
D Carbonic Anhydrase Inhib
E Cardiac Depress
F Cardiotonic
G Catecholamine Potentiator
H Cathartic
I Caustic
J Chelating Agent
K Chemotic
M Choleretic
N Cholinergic
P Cholinesterase React
R Dental Caries Prophyl
S Dental Protect
T Dental Restor Agent
U Dentin Desensitizer
V Depigmentor
W Detergent
X Diag Aid (Drugs)
L Phosphate Binder
Y Biologic Response Modifiers
A Disinfect
B Diuretic
C Emetic
D Emollient/Lubricant
E Enzyme
F Enzyme Inhib
G Estrogen
H Expectorant
I Fibrinolytic
K Gas, Diluent
J Gas, Medicinal
L Glucocorticoid
M Gonad-Stim Princ
N Hematinic
P Hemostatic
Q Histidine Decarboxylase Inhib
R Hormone
S Hypnotic
T Immunosuppress
U Inhibitor
V Ion-Exchange Resin
W Irrigation Sol
X Keratolytic
O Monoclonal Antibodies
Z Peritoneal Dialysis Solution
A Memory Adjuvant
B Mucolytic
C Nutrient/Tonic
D Oxytocic
E Pediculicide
G Pigmentation Agent
H Plasma Vol Extend
I Plasminogen Activator
Z Positron Emission Tomography Radioactive Agent
J Progestin
K Prostaglandin
L Protectant
M Prothyrotropin
N Radioactive Agent
O Radioactive Agent Part II
P Regulator
Q Relaxant
R Replenisher
S Rubefacient
T Scabicide
U Sclerosing Agent
V Sedative
W Serotonin Inhib
Z Smoking Cessation
X Spermaticide
F Water (Pharm Aid)
Y Exhibit Other Drug Related Item
O Hematopoietic Agents
W Immunomodulator
U Nat Body Part (Invivo Only)
V Patent Medicines, Etc
A Spreading Agent
B Stimulant
C Stool Soften
D Sulfide, Source
E Suppl Iodine
F Suppressant
G Surg/Prosth Aid
H Sweetener
I Synergist
J Thyroid Hormone
K Thyroid Inhib
L Thyromimetic
M Tranquilizer
N Tranquilizer (Anti-Psychotic) Part II
P Ultraviolet Screen/Sunscreen
Q Uricosuric
R Vasoconstrictor
S Vasodilator
T Xanthine Oxidase Inhib

The Human and Animal Drug Products Subclasses

The Subclasses for products under Industry Codes 60-66 describe whether the product contains a single ingredient or a combination of ingredients, is for human or animal use, and whether it is prescribed (Rx), is available without a prescription (OTC), or if it is intended for investigational use.

SUBCLASS NAME PRODUCT USE EXAMPLES
A Human – Non-Rx Single Ingredient Acetaminophen
B Human – Non-Rx Combination Ingredient Acetaminophen, Aspirin, and Caffeine
C Human – Rx Single Ingredient Codeine Sulfate
D Human – Rx Combination Ingredient Acetaminophen and Codeine Phosphate
I Human - Investigational Drug labeled with "Caution: New Drug Limited by Federal Law to Investigational Use." Example: Venlafaxine Hydrochloride
J Animal (Food Producing) – Non-Rx Single Ingredient Labeled for animal use. Example: "Albendazole by or on the order of a licensed veterinarian"
K Animal (Food Producing) – Non-Rx Combination Ingredient Labeled for animal use. Example: “Acetylsalicylic Acid and Methylprednisolone by or on the order of a licensed veterinarian.”
L Animal (Food Producing) – Rx Single Ingredient Labeled for animal use. Example: "Trilostane by or on the order of a licensed veterinarian"
M Animal (Food Producing) – Rx Combination Ingredient Labeled for animal use. Example: "Cotrimazine and Sulfadiazine by or on the order of a licensed veterinarian"
N Animal (Food Producing) – Investigational Drug labeled with "Caution: New Drug Limited by Federal Law to Investigational Use." Example: Treprostinil
O Animal (Non-Food Producing) – Non-Rx Single Ingredient Labeled for animal use. Example: "Nandrolone Cyclotate by or on the order of a licensed veterinarian"
P Animal (Non-Food Producing) – Non-Rx Combination Ingredient Labeled for animal use. Example: "Moxidectin and Praziquantel by or on the order of a licensed veterinarian"
Q Animal (Non-Food Producing) – Rx Single Ingredient Labeled for animal use. Example: "Butorphanol Tartrate by or on the order of a licensed veterinarian"
R Animal (Non-Food Producing) – Rx Combination Ingredient Labeled for animal use. Example: "Emodepside and Praziquantel by or on the order of a licensed veterinarian"
S Animal (Non-Food Producing) – Investigational Drug labeled with "Caution: New Drug Limited by Federal Law to Investigational Use." Example: Tetrahyrdrozoline HCl
Y Not Elsewhere Classified (N.E.C.) Not Elsewhere Classified (N.E.C.)

The Human and Animal Drug Process Indicator Codes (PIC)

The Human and Animal Drug PICs are the same as those used for Antibiotics. The PIC is used to describe the form of the product. Below is a brief definition of the PIC codes currently in use.

PROCESS INDICATOR CODE NAME PROCESS/FORM/DOSAGE
A Prompt Release Tablets All prompt release tablets, coated or uncoated (active ingredient immediately released). Example: Aspirin Tablets.
B Extended Release Tablets All extended-release tablets, coated or uncoated (active ingredient released over an extended period of time).
C Delayed Release Tablets All tablets with delayed release (not extended-release, e.g., enteric coated tablets in which the active ingredient releases and is absorbed in the intestines). Example: Aspirin Delayed-release Tablets.
D Transdermal Patches Medicated self-adhesive patches that deliver medication through the skin. Example: Lidocaine
E Prompt Release Hard Gelatin Capsules All hard-shell capsules for prompt or immediate release. Example: Lithium Carbonate Capsules.
F Modified Release Hard Gelatin Capsules All hard-shell capsules for extended or delayed release. Example: Lansoprazole Delayed-release Capsules.
G Semi-solid Oral All orally-administered ointments, creams, gels, or pastes. Example: Lamotrigine.
H Soft Gelatin Capsules All soft-shell capsules. Usually contain encapsulated liquids. Example: Ritonavir Soft Gelatin Capsules.
I Premix
J Non-Sterile Ointments Semisolid preparations generally intended for external application to the skin or mucous membranes. An ointment has an oil base (whereas a cream is water-soluble). Includes non-sterile ointment, cream, paste, dressing, poultice, gel, jelly. Example: Acyclovir Ointment.
K Sterile Liquids A sterile liquid is free from live bacteria or other microorganisms. Example: Hexylresorcinol Solution.
L Non-sterile Liquids Elixir, medicated shampoo, mouthwash, nasal spray, solution, spirit, tincture, syrup, suspension. Example: Dexamethasone Elixir.
M Suppositories A small plug of medication designed to melt at body temperature within a body cavity other than the mouth, especially the rectum or vagina. Example: Aspirin Suppositories.
N Large Volume Parenterals >=100 mL Liquid preparations of 100 mL or greater. Parenteral means the product is injected into the body or administered in a manner other than through the digestive tract, such as intravenously or intramuscularly. Example: Dextrose and Sodium Chloride Injection.
O Sterile Ointments Sterile ointments are free from live bacteria or other microorganisms and labeled as such. Example: Ciprofloxacin Ophthalmic Ointment.
P Small Volume Parenterals <100 mL Liquid preparations of less than 100 mL. Includes emulsion solutions, repository suspensions, dry solid, and sterile bulk powders for solution or suspension. Parenteral means the product is taken into the body or administered in a manner other than through the digestive tract, such as intravenously or intramuscularly. Example: Phenytoin Sodium Injection.
Q Aerosol Dispersed Medications Foam, powder, spray, nebulizers (excludes products packaged in non-metered mechanical dispensers such as nasal sprays). Example: Tolnaftate Topical Aerosol.
R Non-sterile Powders Powder for reconstitution for oral or topical use (excludes aerosols and bulk pharmaceutical substances). Example: Tolnaftate Topical Powder.
S Active Pharmaceutical Ingredients – Chemicals for Further Manufacturing Substance for use in a drug that when used in the manufacturing of a drug becomes an active pharmaceutical ingredient or finished dosage form of the drug. Example: Dacarbazine U.S.P.
T Active Pharmaceutical Ingredients – Chemicals for Rx Compounding Substance for use in pharmacy compounding that becomes an active pharmaceutical ingredient or finished dosage form in the product. Example: Phenylephrine HCl.
U Block
V Compressed Medical Gases Any gas for medicinal use. Example: Nitrous Oxide U.S.P.
W Bolus
X Block or Bolus Premixes Premix, dry; Premix, liquid; mineral or salt mixture block
Bolus: enteric coated: immediate action, sustained action
Bolus: uncoated or plain coated: immediate action, sustained action. Bolus is a large pill; used especially in veterinary medicine. Example: Nicarbazin Roxarsone Premix.
Y N.E.C Not Elsewhere Classified.
Z Sterile Powders Sterile powders (excludes those used for small volume parenterals).

Check Your Knowledge

1. Which of the following products is not considered to be a drug product by the FDA?
2. Which of the following products is generally not considered to be a drug product by the FDA?
3. On what ingredient would you determine the product code for a cold & allergy product labeled to contain the following active ingredients: Chlorpheniramine maleate, 4 mg.; Pseudoephedrine HCl, 60 mg.?

Code the Products

Now you will have a chance to practice coding some Human Drug Products. Below you will find eight 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.

LIDOCAINE OINTMENT, 2.5%

Human Drugs

Anesthetic

Human Use Single Ingredient Non Rx Use

Nonsterile Ointment

Lidocaine (Anesthetic)

OR

Human Drugs

Anesthetic

Human Use Single Ingredient Non Rx Use

Nonsterile Ointment

Lidocaine

ALLERGY – SINUS CONGESTION TABLETS (Chlorpheniramine maleate, 4 mg; Pseudoephedrine sulfate, 60 mg)

Human Drugs

A-Histaminic

Human Use Combination Ingredient Non Rx Use

Prompt Release Tablets

Chlorphenira-mine Maleate (Anti-Histaminic)

DIAZEPAM TABLETS, 2 mg

Human Drugs

Sedative

Human Use Single Ingredient Rx Use

Prompt Release Tablets

Diazepam (Sedative)

STANNOUS FLOURIDE TOOTHPASTE

Human Drugs

Dental Caries Prophylactic

Human Use Single Ingredient Non-Rx Use

Semi-solid Oral

Stannous Fluoride

WRINKLE REMOVING CREAM

Human Drugs

Miscellaneous Patent Medicines, etc.

Human Use Combination Ingredients Non-Rx Use

Nonsterile Ointment

Miscellaneous Patent Medicines

AEROSOL ANTIPERSPIRANT CONTAINING ALUMINUM ACETATE

Human Drugs

Astringent/ A-Perspirant

Human Use Single Ingredient Non-Rx Use

Aerosol Dispersed Medication

Aluminum Acetate (Sol) (Astringent/Anti-Perspirant)

ENTERIC COATED ANTI-ARTHRITIC TABLES (containing aspirin)

Human Drugs

Analgesic

Human Use Single Ingredient Non-Rx Use

Delayed Release Tablets

Aspirin (Analgesic)

LONG ACTING ALLERGY TABLETS (Chlorpheniramine maleate)

Human Drugs

A-Histaminic

Human Use Single Ingredient Non-Rx Use

Extended Release Tablets

Chlorphenira-mine Maleate (Anti-Histaminic)

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 to the Product Code Builder application and try again.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
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