PCB Tutorial

Lesson 5 — Coding Drugs, Drug Products and Biologics

Biological Products and Licensed In-Vivo and In-Vitro Diagnostic Products - Industry Code 57

Products regulated by FDA’s Center for Biologics Evaluation and Research (CBER) are coded under Industry Code 57. This includes licensed biological products, human cells, tissues, and cellular tissue-based products (HCT/Ps), and related drugs and medical devices that are regulated under sections 351 and 361 of the Public Health Services Act and various provisions of the Federal Food, Drug, and Cosmetic Act. Examples of common biological products for human use include, but are not limited to, human blood and blood products, vaccines, cell and gene therapy products, and in-vitro diagnostic products used to screen blood or to diagnose certain diseases. CBER also regulates human tissue for transplantation. Biologics for animals are not regulated by FDA but are regulated by USDA.

NOTE: If you are importing biological specimens (e.g., blood, tissue, DNA) that are intended for testing in a clinical laboratory or for basic scientific research, these are not considered to be biological products subject to licensure by FDA and do not appear to be regulated by FDA as a drug, device, or tissue product and these should be disclaimed.

There is a unique set of Subclass codes for biological products and licensed in-vivo and in-vitro diagnostic products but Process Indicator Codes (PIC) are not used. Although no Process Indicator Code is used in this industry, filers must transmit a dash "-" on the PIC field. The Product Code Builder Application will return a dash automatically.

Glossary

Biological Products:For the FDA Product Code Builder, biological products include licensed biological products, human cells, tissues, and cellular tissue-based products (HCT/Ps), and related drugs and medical devices regulated by the FDA Center for Biologics Evaluation and Research.

Licensed In-Vitro Diagnostic Product: A licensed in-vitro diagnostic product (1) is used for in the treatment, cure or prevention of a disease or condition in man; (2) is used outside the body on specimens taken from the body; and (3) is subject to licensure under the Public Health Service Act.

Licensed In-Vivo Diagnostic Product: A licensed in-vivo diagnostic product is (1) is used for in the treatment, cure or prevention of a disease or condition in man; (2) is used inside the body; and (3) is subject to licensure under the Public Health Service Act.

The Biological Products and Licensed In-Vivo and In-Vitro Diagnostic Product Classes

CLASS NAME PRODUCT EXAMPLES
A Antitoxins and Antivenins Botulism Antitoxin, Antivenins (Snake, Spider)
B Immunization Toxoids Diphtheria Toxoid, Tetanus Toxoid
C Viral Vaccines Rabies, Yellow Fever, Hepatitis, Small Pox, Influenza Vaccines
D Blood and Blood Components, single donor & pheresis Whole Blood (Human), Red Blood Cells, Plasma
E In-Vivo Diagnostic Products Tuberculin, Purified Protein Derivative (PPD) (skin test)
G Allergenic Products Allergen Patch Tests, Animal Allergens, Venom Proteins (Bee, Wasp, Hornet)
H Bacterial Vaccines/Antigens Pneumococcal Vaccine, Meningococcal Vaccine
I Multiple Vaccine/Multiple Antigen Preparations Measles, Mumps, Rubella Vaccine, Diphtheria, Tetanus, and Pertussis Vaccine (DTaP)
J Human Musculoskeletal Tissue Bone, Connective Tissue
K Human Reproductive Tissue Embryo, Oocytes, Semen
L Human Ocular Tissue Eye Tissue (Cornea, Sclera), Amniotic Membrane for Eye Repair
M Human Hematopoietic Cells Peripheral Blood Stem Cells, Umbilical Cord Blood Stem Cells, Lymphocytes
N Human Cell and Gene Therapies Cell Therapies, Gene Therapies (vectors, genetically modified cells)
P Human Tissues, N.E.C. Human Tissue,Not Elsewhere Classified
Q Human Skin Skin
R Human Vascular Tissues Veins, Arteries
S Human Cardiac Tissue Heart Tissue
T Human Dura Mater Dura Mater
U Blood Derivatives Albumin, Immune Globulin, Varicella-Zoster Immune Globulin.
V In-Vitro Diagnostic Products Blood Grouping Reagents, Reagent Red Blood Cells, Hepatitis C Virus Encoded Antigen.
W Immunomodulators Hookworms, Whipworms, Tapeworms (eggs and larvae)
Y In-Vivo and In-Vitro Diagnostic Products Not Elsewhere Classified (NEC) Blood and Blood Products For Reprocessing, Blood bags with Anti-Coagulant Prior to Use, Plasma Volume Expanders

The Biologic and Licensed In-Vivo and In-Vitro Diagnostic Products Subclasses

The Subclasses for products under Industry Code 57 describe how the products are to be used.

THE FOLLOWING CAN BE USED WITH ALL PRODUCT CLASSES
SUBCLASS NAME PRODUCT USE EXAMPLES
H Final product; Ready For Use Product is in finished form and ready for use in humans (e.g., ready for injection, transfusion, transplant, implant, ingestion), for diagnostic testing of humans, or for clinical studies.
I For Further Manufacture Requires further manufacture before use as finished product. Examples are: bulk HIV antigen, fraction II paste, bulk vaccine, and unprocessed human tissue.
L Product sample for testing or lot release Sample of product to be used for product testing/assessment or to be submitted to FDA/CBER for lot release.

Check Your Knowledge

1. Which of the following products would not be coded as a biologic?
2. The Subclass Code for biologics provides the following information:
3. Which Subclass Code would you use for a product labeled or invoiced as “bulk for further manufacturing use”?
4. True or False - Biological specimens (e.g., blood, tissue, DNA) that are intended for use only for testing in a clinical laboratory or for basic scientific research are products regulated by FDA and when importing these products you must select the appropriate FDA product code.

Code the Products

Now you will have a chance to practice coding some Biologics and Licensed In-Vivo and In-Vitro Diagnostic 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.

PERIPHERAl BLOOD STEM CELLS FOR TRANSFUSION

Biologics and Licensed In-Vivo and In-Vitro Diagnostic Products

Human Hematopoietic Cells

Final product; Ready For Use

Not Used

Peripheral Blood Stem Cells

MEASELES, MUMPS, RUBELLA VIRUS VACCINE FOR INJECTION

Biologics and Licensed In-Vivo and In-Vitro Diagnostic Products

Multiple Vaccine/Multiple Antigen Preparations

Final product; Ready For Use

Not Used

Measles, Mumps, Rubella Virus Vaccine

BULK HEPATITIS B VIRUS FOR FURTHER MANUFACTURE

Biologics and Licensed In-Vivo and In-Vitro Diagnostic Products

In-Vitro Diagnostic Products

For Further Manufacture

Not Used

Hepatitis B Virus

IMMUNE GLOBULIN INTRAVENEOUS FOR LOT RELEASE TESTING

Biologics and Licensed In-Vivo and In-Vitro Diagnostic Products

Blood Derivatives

Product sample for testing or lot release

Not Used

Immune Globulin Intravenous

TETANUS TOXOID FOR FURTHER MANUFACTURE

Biologics and Licensed In-Vivo and In-Vitro Diagnostic Products

Immunization Toxoids

For Further Manufacture

Not Used

Tetanus Toxoid

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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