PCB Tutorial

Lesson 5 — Coding Drugs, Drug Products and Biologics

Antibiotics — Industry Code 56

Antibiotics are coded under Industry Code 56. This includes antibiotics for humans and animals. Examples of common antibiotics include, but are not limited to, natural or synthetic penicillin, tetracycline, neomycin, streptomycin, and erythromycin.

You will need to rely on the manufacturer's information when choosing the Product Class. Scientific and medical terms are used to describe the Product Classes. The Subclass categories are different for human and animal antibiotics. PICs are the same as those used for Human Drug products.

Code multi-ingredient products under the Product Class of the ingredient that is listed first in the product labeling active ingredient list. A list of active ingredients is required to be on the product label. Use the appropriate Subclass for multi-ingredient products based on whether the product is for humans or animals.

If the product contains a drug or antibiotic as well as dietary supplement ingredients, it should be coded as a drug or antibiotic, not a dietary supplement.

Glossary

Antibiotic Drug:A substance, such as penicillin or streptomycin, produced by or derived from certain fungi, bacteria, or other organisms that can destroy or inhibit the growth of other microorganisms. Antibiotics are widely used in the prevention and treatment of infectious diseases.

Rx: A prescription drug. Under Industry Code 56, this refers to a prescribed antibiotic.

Non-Rx: Under Industry Code 56, this refers to an antibiotic that can be obtained without a prescription.

Diagnostic In vitro: For diagnostic use outside of the body, not for therapeutic use.

The Antibiotic Product Classes

CLASS NAME PRODUCT EXAMPLES
A Penicillin Natural Penicillin G, Penicillin V, Penicillin, N.E.C.
B Synthetic Penicillin Amoxicillin, Ampicillin, Oxacillin Sodium, etc.
C Cephalosporin Cefazolin Sodium, Cefprozil, Ceftazidime, etc.
D Oligosaccharide Amikacin Sulfate, Gentamicin Sulfate, Streptomycin Sulfate, etc.
E Tetracycline Demeclocycline Hydrochloride, Doxycycline, Tetracycline Hydrochloride, etc.
F Peptide Bacitracin, Gramicidin, etc.
G Antifungal Amphotericin, Griseofulvin, Nystatin, etc.
H Antitumor Bieomycin Bleomycin Sulfate, Doxorubicin Hydrochloride, Mitomycin, etc.
I Macrolide Azithromycin, Erythromycin, etc.
J Lincomycin Clindamycin Hydrochloride, Lincomycin Hydrochloride, etc.
K Miscellaneous Certifiable Calcium Amphamcyin, Chloramphenicol, Rifampin, etc.
L Non-Certifiable Veterinary Antibiotic N.E.C. Carbamycin, Erythramycin Phosphate, Monensin, Tylosin, etc.
M BACTAM (B-Lactam Antibiotic) Aztreonam, Sulbactam Sodium/Ampicillin Sodium
N Streptogramins Quinupristin
O Fluoroquinolone Baytril, Danofloxacin Mesylate, Enrofloxacin, etc.
P Oxazolidinone Linezolid
X Diagnostic In vitro Antibiotics, N.E.C. Not Elsewhere Classified
Y Antibiotics, N.E.C. Not Elsewhere Classified

The Antibiotic Products Subclasses

The Subclasses for products under Industry Code 56 describe whether the product is intended for use in human or animals, and whether it contains a single ingredient or a combination of ingredients, and whether it is prescribed (Rx), is available without a prescription (OTC), or is intended for investigational use.

Refer to the manufacturer's information when selecting the Subclass.

SUBCLASS NAME PRODUCT USE EXAMPLES
A Human – Non-Rx Single Ingredient Bacitracin
B Human – Non-Rx Combination Ingredient Bacitracin and Neomycin
C Human – Rx Single Ingredient Penicillin G
D Human – Rx Combination Ingredient Penicillin G Benzathine and Penicillin G Procaine
I Human - Investigational Drug labeled with "Caution: New Drug Limited by Federal Law to Investigational Use." Example: Levofloxacin.
J Animal (Food Producing) – Non-Rx Single Ingredient Labeled for animal use. Example: "Oxytetracycline by or on the order of a licensed veterinarian."
K Animal (Food Producing) – Non-Rx Combination Ingredient Labeled for animal use. Example:“Procaine Penicillin by or on the order of a licensed veterinarian.”
L Animal (Food Producing) – Rx Single Ingredient Labeled for animal use. Example: "Ampicillin Sodium by or on the order of a licensed veterinarian."
M Animal (Food Producing) – Rx Combination Ingredient Labeled for animal use. Example: "Clindamycin and Clotrimazole 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: Piperacillin Sodium.
O Animal (Non-Food Producing) – Non-Rx Single Ingredient Labeled for animal use. Example: "Gentamycin by or on the order of a licensed veterinarian."
P Animal (Non-Food Producing) – Non-Rx Combination Ingredient Labeled for animal use. Example: "Piperacillin and Tazobactam by or on the order of a licensed veterinarian."
Q Animal (Non-Food Producing) – Rx Single Ingredient Labeled for animal use. Example: "Minocycline HCl by or on the order of a licensed veterinarian."
R Animal (Non-Food Producing) – Rx Combination Ingredient Labeled for animal use. Example: "Amoxicillin and Clavulanate Potassium 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: Oxytetracycline.
Y Not Elsewhere Classified (N.E.C.) Not Elsewhere Classified (N.E.C.)

The Antibiotic Process Indicator Codes (PIC)

The Antibiotic PICs are the same as those used for Human and Animal Drugs. 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: Erythromycin 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: Erythromycin Delayed-release Tablets.
D Transdermal Patches Medicated self-adhesive patches that deliver medication through the skin. Example: Bacitracin
E Prompt Release Hard Gelatin Capsules All hard-shell capsules for prompt or immediate release. Example: Erythromycin Capsules.
F Modified Release Hard Gelatin Capsules All hard-shell capsules for extended or delayed release. Example: Erythromycin Delayed-release Capsules.
G Semi-solid Oral All orally-administered ointments, creams, gels, or pastes. Example: Oleandomycin
H Soft Gelatin Capsules All soft-shell capsules.
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: Bacitracin Ointment.
K Sterile Liquids A sterile liquid is free from live bacteria or other microorganisms.
L Non-sterile Liquids Elixir, medicated shampoo, mouthwash, nasal spray, solution, spirit, tincture, syrup, suspension. Example: Erythromycin Topical Solution.
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: Clindamycin Phosphate Vaginal Suppositories.
N Large Volume Parenterals >=100 mL Liquid preparations of 100 mL or greater. 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: Sodium Chloride 0.9% IVPB.
O Sterile Ointments Sterile ointments are free from live bacteria or other microorganisms. Example: Gentamicin Sulfate 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: Streptomycin for Injection.
Q Aerosol Dispersed Medications Foam, powder, spray, nebulizers (excludes products packaged in non-metered mechanical dispensers such as nasal sprays).
R Non-sterile Powders Powder for reconstitution for oral or topical use (excludes aerosols and bulk pharmaceutical substances). Example: Amoxicillin for Oral Suspension.
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: Penicillin V 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: Minocycline HCl.
V Compressed Medical Gases Any gas for medicinal use.
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: Gentamycin Premix.
Y N.E.C. Not Elsewhere Classified.
Z Sterile Powders Sterile powders (excludes those used for small volume parenterals).

Check Your Knowledge

1. What subclass would you use for a product labeled as Ceftiofur, which is intended for use in both food and non-food producing animals?
2. The Process Indicator Codes provide what information for antibiotic products?
3. How can you determine if an antibiotic product contains a single or combination of ingredients?

Code the Products

Now you will have a chance to practice coding some antibiotic products. Below you will find five 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.

AMOXICILLIN PEDIATRIC DROPS (Amoxicillin Trihydrate, 50 mg/ml)

Antibiotics (Human/Animals)

Synthetic Penicillin

Human Use Single Ingredient Rx Use

Nonsterile Liquid

Amoxicillin Trihydrate (Penicillin Synthetically Produced)

ERYTHROMYCIN DELAYED CAPSULES, 250 mg

Antibiotics (Human/Animals)

Macrolide

Human Use Single Ingredient Rx Use

Modified Release Hard Gelatin Capsules

Erythromycin (macrolides)

STERILE OPHTHALMIC OINTMENT (Polymyxin B Sulfate & Bacitracin Zinc)

Antibiotics (Human/Animals)

Peptide

Human Use Combinations Ingredients Rx Use

Sterile Ointment

Polymyxin B Sulfate (Peptides)

PENICILLIN G INJECTION

Antibiotics (Human/Animals)

Penicillin Natural

Human Use Single Ingredient Rx Use

Small Volume Parenteral <100ml

Penicillin G, Natural

TETRACYCLINE HYDROCHLORIDE TABLETS, 250 MG

Antibiotics (Human/Animals)

Tetracycline

Human Use Single Ingredient Rx Use

Prompt Release Tablets

Tetracycline Hydrochloride (Tetracyclines)

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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