PCB Tutorial
Lesson 5 — Coding Drugs, Drug Products and Biologics
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Human and Animal Therapeutic Biologic and Biosimilar Drugs – Industry Code 58
Human and Animal Therapeutic Biologic and Biosimilar Drugs are coded under Industry Code 58. The products in this industry code are regulated by the Center for Drug Evaluation and Research (CDER) and thus are distinguished from Biologics in Industry Code 57, which are regulated by the Center for Biologics Evaluation and Research (CBER). These products are also differentiated from drugs in Industry Codes 56 and 60-66 because they are biological products. Therapeutic Biologic and Biosimilar Drugs are generally large, complex molecules, and these products may be produced through biotechnology in a living system, such as a microorganism, plant cell, or animal cell. The Therapeutic Biologic and Biosimilar Drugs in Industry Code 58 are approved in the U.S. through the Biologics License Application (BLA) regulatory pathway, whereas drugs in Industry Codes 56 and 60-66 are approved through the New Drug Application (NDA) pathway, or they may be over-the-counter (OTC) drugs evaluated under FDA's OTC Drug Review. Additionally, the Therapeutic Biologic and Biosimilar Drugs in Industry Code 58 are approved in the U.S. under section 351 of the Public Health Service Act, while drugs in the Industry Codes 56 and 60-66 are approved under section 505 of the Federal Food, Drug, and Cosmetic Act. For animal therapeutic biologic and biosimilar drugs, regulation is through the Center for Veterinary Medicine (CVM) under a New Animal Drug Application (NADA).
Some important points to keep in mind when coding Human and Animal Therapeutic Biologic and Biosimilar 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 it is not a food and its intended use is to affect the structure or function of the body.
- Product codes for therapeutic biologic and biosimilar 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 therapeutic biologic and biosimilar 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 therapeutic biologic and biosimilar drugs 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, Unconventional Dietary Specialty products, and Drugs found in Industry Codes 56 and 60-66. PICs are the same as those used for Drugs found in Industry Codes 56 and 60-66 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.
- There may not be a specific Human and Animal Drug product code for every drug or drug product. Each of the drug classes has "N.E.C. 99" (not elsewhere classified) that can be selected when the specific drug or drug product name is not in the database.
- It may not always be obvious if a human and animal therapeutic biologic or biosimilar drug product requires a prescription (Rx) for sale in the U.S. or if it may be sold without a prescription (non-Rx or OTC). 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 human and animal therapeutic biologics and biosimilar drugs (no associated BLA) 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 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
Drugs: An article is considered to be a drug if it meets any one of the following definitions:
- Articles recognized in the United States Pharmacopoeia, Homeopathic Pharmacopoeia, or 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 animals.
- Articles intended for use as a component of any drug as described above.
Rx: A drug product that can only be obtained with a prescription.
Non-Rx: A drug product that can be obtained without a prescription.
Therapeutic Biologic and Biosimilar Drugs: Origin is living systems and the drug may contain organic molecules. These drugs are approved through the BLA regulatory pathway for human use, and they are regulated by CDER. If intended for animal use, they are regulated by CVM through the NADA regulatory pathway. Broadly, this drug category includes monoclonal antibodies, cytokines, growth factors, enzymes, immunomodulators, thrombolytics, proteins, and other non-vaccine therapeutic immunotherapies.
The Human and Animal Therapeutic Biologic and Biosimilar Drug Product Classes
Included below is a drop down list with the Class Codes associated with the Human and Animal Therapeutic Biologic and Biosimilar Drug Industry Code. This will give you an idea of the range of drug types that can be coded.
| A | Anti-Asthmatic |
| C | Antimigraine |
| D | Antineoplastic |
| E | Antiviral |
| F | Cardiovascular Agent |
| G | Diagnostic Agent |
| H | Endocrine-Metabolic Agent |
| I | Enzyme |
| J | Gonad-Stimulating Principle |
| K | Growth Factor |
| L | Hematological Agent |
| M | Immunological Agent |
| N | Lung Surfactant |
| O | Monoclonal Antibody |
| P | Neuromuscular Blocker |
| Q | Ophthalmologic Agent |
| S | Tumor Necrosis Factor (TNF) Inhibitor |
Human and Animal Therapeutic Biologic and Biosimilar Drug Subclasses
The Subclasses for products under Industry Code 58 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 |
|---|---|
| A | Human — Non-Rx Single Ingredient |
| B | Human — Non-Rx Combination Ingredient |
| C | Human — Rx Single Ingredient |
| D | Human — Rx Combination Ingredient |
| I | Human — Investigational |
| J | Animal (Food Producing) — Non-Rx Single Ingredient |
| K | Animal (Food Producing) — Non-Rx Combination Ingredient |
| L | Animal (Food Producing) — Rx Single Ingredient |
| M | Animal (Food Producing) — Rx Combination Ingredient |
| N | Animal (Food Producing) — Investigational |
| O | Animal (Non-Food Producing) — Non-Rx Single Ingredient |
| P | Animal (Non-Food Producing) — Non-Rx Combination Ingredient |
| Q | Animal (Non-Food Producing) — Rx Single Ingredient |
| R | Animal (Non-Food Producing) — Rx Combination Ingredient |
| S | Animal (Non-Food Producing) — Investigational |
| Y | Not Elsewhere Classified (N.E.C.) |
Human and Animal Therapeutic Biologic and Biosimilar Drug Process Indicator Codes (PIC)
The Human and Animal Therapeutic Biologic and Biosimilar Drug PICs are the same as those used for Drugs in Industry Codes 56 and 60-66. 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). |
| 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). |
| D | Transdermal Patches | Medicated self-adhesive patches that deliver medication through the skin. |
| 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. |
| G | Semi-solid Oral | All orally-administered ointments, creams, gels, or pastes. |
| H | Soft Gelatin Capsules | All soft-shell capsules. Usually contain encapsulated liquids. |
| I | Premix/Topdress | Premix/Topdress includes non-sterile pellets, powders, and/or granules that are intended to be added to an individual animal's food ration in dry form. These products are not reconstituted before use. |
| 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. |
| 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. |
| 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. |
| 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. |
| O | Sterile Ointments | Sterile ointments are free from live bacteria or other microorganisms and labeled as such. |
| 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. |
| 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). |
| 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. |
| T | Active Pharmaceutical Ingredients — Chemicals for Rx Compounding | Substance for use in pharmaceutical compounding that becomes a finished dosage form product. It is also referred to as "bulk drug substance." |
| U | Block | A medicated block is a dosage form of compressed material containing a drug intended for administration to a group of animals. |
| V | Compressed Medical Gases | Any gas for medicinal use. |
| Y | N.E.C | Not Elsewhere Classified. |
| Z | Sterile Powders | Sterile powders (excludes those used for small volume parenterals). |
Check Your Knowledge
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.
INCRELEX (MECASERMIN RECOMBINANT) STERILE SOLUTION, 40 mg/4 mL
Human and Animal Therapeutic Biologic and Biosimilar Drugs
Endocrine-Metabolic Agent
Human - Rx/Single Ingredient
Small Volume Parenteral < 100ml
Mecasermin Recombinant
ENTYVIO (VEDOLIZUMAB) INJECTION, 300 mg in a 20 mL vial
Human and Animal Therapeutic Biologic and Biosimilar Drugs
Immunological Agent
Human - Rx/Single Ingredient
Small Volume Parenteral < 100ml
Vedolizumab
IPRIVASK (DESIRUDIN), 15 mg/vial
Human and Animal Therapeutic Biologic and Biosimilar Drugs
Hematological Agent
Human - Rx/Single Ingredient
Small Volume Parenteral < 100ml
Desirudin
GRANIX (TBO-FILGRASTIM) INJECTION, 480 mcg/0.8 mL
Human and Animal Therapeutic Biologic and Biosimilar Drugs
Hematological Agent
Human - Rx/Single Ingredient
Small Volume Parenteral < 100ml
Tbo-Filgrastim
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.