Lesson 5 Coding Drugs, Drug Products and Biologics

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Pharmaceutical Necessities and Containers
Antibiotics (Human and Animal Use)
Biologics
Human Drugs

Pharmaceutical Necessities and Containers for Drugs and Biologics - Industry Code 55

Pharmaceutical Necessities and Containers for Drugs and Biologics Classes
Pharmaceutical Necessities and Containers for Drugs and Biologics Subclasses
Check Your Knowledge
Code the Products

Products that are considered Pharmaceutical Necessities or Containers for Drugs and Biologics are coded under Industry Code 55. There is a unique set of Subclass codes for these products. Although no Process Indicator Codes are used in this 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.

 

The Pharmaceutical Necessities or Containers for Drugs and Biologics Classes

The Class codes for Industry 55 are listed in the table below. A few sample products are also provided to further define the class code.

CLASS

NAME

PRODUCT EXAMPLES

A

Closure

Products in this Industry Class would be those that are N.E.C. (not elsewhere classified)

B

Coating (Closure/ Container)

Products in this Industry Class are coatings for closures and containers that are N.E.C. (not elsewhere classified)

C

Non-Metallic Container/ Material

Glass, acrylic, polyvinyl, etc.

D

Metallic Container/ Material

Steel, stainless steel, and metallic containers that are N.E.C. (not elsewhere classified)

E

Additive in Plastic

These are natural (rubber) or synthetics. Stabilizers, accelerators, anti-oxidant, colorant, etc.

P

Pharmaceutical Necessity (Mfr)

The number of products in this category is very large and is split into three parts – P, Q, and R

This Industry Class consists of chemicals, flavors, excipients, etc., used for making drugs.

Q

Pharmaceutical Necessity (Mfr)

Same as P

R

Pharmaceutical Necessity (Mfr)

Same as R

Y

Pharmaceutical Necessity (Mfr) & Container N.E.C.

This Industry Class is for products not elsewhere classified.

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The Pharmaceutical Necessities and Containers for Drugs and Biologic Products Subclasses

The Subclasses for products under Industry Code 55 describes the form of the product.

SUBCLASS

NAME

A

Closure Liners and Seals

B

Coatings for Closures

C

Coatings for Containers

F

Plastic – Natural (rubber)

G

Plastic - Synthetic

P

Pharmaceutic Necessity

Y

Not Elsewhere Classified (N.E.C.)

Back to Pharmaceutical Necessities and Containers Index

Check Your Knowledge

1. Which of the following would not be considered a Non-metallic container/material?


Answer  

2. Which class code would you find chemicals, flavors, excipients, etc?


Answer  

Back to Pharmaceutical Necessities and Containers Index

   Code the Products

Now you will have a chance to practice coding some Pharmaceutical Necessities and Containers for Drugs and Biologic Products. Below you will find three 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.

1. ACRYLIC PLASTIC CONTAINERS (reveal code)

2. CINNAMON OIL (reveal code)

3. POLYSORBATE 85 (reveal code)

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.

Back to Pharmaceutical Necessities and Containers Index

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Antibiotics - Industry Code 56

Glossary
Antibiotic Classes
Antibiotic Subclasses
Antibiotic Process Indicator Codes
Check Your Knowledge
Code the Products

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 differentiate between 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-ingredients based on whether the product is for humans or animals.

If the product contains a drug or antibiotics as well as dietary supplement ingredients they 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, bacterial, and 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 is a prescribed antibiotic.

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

Diagnostic Invitro: For diagnostic use outside the body, not for therapeutic use.

Back to Antibiotics Index

The Antibiotic Product Classes

CLASS

NAME

PRODUCT EXAMPLES

A

Penicillin Natural

Penicillin G, Penicillin V, Penicillin, N.E.C.

B

Synthetic Penicillin

Amoxicillin Trihydrate, Ampicillin, Hetacillin, Sodium, Oxacillin, etc.

C

Cephalosporin

Cefazolin Sodium, Cephaloridine, Cephradine, etc.

D

Oligosaccharide

Amilacin Sulfate, Gentamicin, Streptomycin, etc.

E

Tetracycline

Chlortetracycline, Doxcycyline, Methacycline, Tetracycline, etc.

F

Peptide

Bacitracin, Gramicidin, Peptides, N.E.C., etc.

G

Antifungal

Amphotericin, Candicidin, Nystatin, etc.

H

Antitumor

Bieomycin Sulfate, Doxorubicin, Mitomycin, etc.

I

Macrolide

Erythromycin, Troleandamycin, etc.

J

Lincomycin

Clindamycin, Lincamycin Hydrochloride Monohydrate, etc.

K

Miscellaneous Certifiable

Calcium Amphamcyin, Chlorampehnicol, Rifarpin, etc.

L

Non-Certifiable Veterinary Antibiotic N.E.C.

Carbamycin, Erythramycin Phosphate, Monensin, Tylosin, etc.

X

Diagnostic Invitro Antibiotics, N.E.C.

Not Elsewhere Classified

Y

Antibiotics, N.E.C.

Not Elsewhere Classified

Back to Antibiotics Index

Antibiotic Products Subclasses

The Subclasses for products under Industry Code 56 describes whether the product is intended for human or animals, and whether it is a single ingredient or a combination and whether it is prescribed or is investigational.

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

SUBCLASS

NAME

PRODUCT USE EXAMPLES

A

Human Use Single Ingredient Non Rx Use

Bacitracin

B

Human Use Combinations Ingredients Non Rx Use

Bacitracin and neomycin

C

Human Use Single Ingredient Rx Use

Penicillin G

D

Human Use Combinations Ingredients Rx Use

Penicillin G benzathine and Penicillin G procaine

I

Investigational Drug Use

Drug labeled with "Caution: New Drug Limited by Federal Law to Investigational Use" Such as levofloxacin

J

Animal Use – Single Ingredient Therapeutic

Labeled for animal use ("oxytetracycline by or on the order of a licensed veterinarian")

K

Animal Use – Combination Ingredients Therapeutic

Neomycin and Tylosin

X

Not Elsewhere Classified (N.E.C.) (Animal)

Not Elsewhere Classified (N.E.C.) (Animal)

Y

Not Elsewhere Classified (N.E.C.)

Not Elsewhere Classified (N.E.C.)

Back to Antibiotics Index

The Antibiotic Process Indicator Codes (PIC)

The Antibiotic PICs are the same as those used for Human 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. Such as erythromycin tablets.

 

B

Extended Release Tablets

All extended release tablets, coated or uncoated (active ingredient released over a prolonged period).

C

Delayed Release Tablets

All tablets with delayed release (not extended release, e.g., enteric coated tablets, active ingredient releases and is absorbed in the intestines). Such as erythromycin delayed-release tablets.

E

Prompt Release Hard Gelatin Capsules

All hard gelatin capsules for prompt release. Such as erythromycin capsules.

 

F

Modified Release Hard Gelatin Capsules

All hard gelatin capsules having extended or delayed release. Such as erythromycin delayed-release capsules.

 

H

Soft Gelatin Capsules

All soft gelatin capsules.

J

Non-Sterile Ointments

Any of various substances resembling cream that have a healing effect when applied. An ointment has an oil base whereas a cream is water-soluble. Includes non-sterile ointment, cream, paste, dressing, poultice, gel, jelly. Such as bacitracin ointment.

K

Sterile Liquid

A sterile liquid is free from live bacteria or other microorganisms. Such as erythromycin estolate liquid.

L

Non-sterile Liquid

Elixir, medicated shampoo, mouthwash, nasal spray solution, spirit, tincture, syrup suspension. Such as erythromycin oral 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 Parenteral >=100 ml

Single dose solutions, 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 by intravenous or intramuscular injection. Such as meropenem for intravenous use.

O

Sterile Ointment

Sterile ointments are free from live bacteria or other microorganisms. Such as gentamicin opthalmic ointment.

P

Small Volume Parenteral <100ml

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 by intravenous or intramuscular injection. Such as streptomycin sulfate injection.

Q

Aerosol Dispersed Medication

Foam, powder, spray, nebulizers (excludes products packaged in non-metered mechanical dispensers – e.g., nasal sprays).

R

Non-sterile Powder

Effervescent for reconstitution (oral use) Topical (excludes aerosols and bulk pharmaceutical chemicals). Such as amoxicillin powder.

S

Bulk Pharmaceutical

Such as Active Pharmaceutical Ingredient Penicillin V U.S.P.

V

Compressed Medical Gas

Any gas for medicinal use.

X

Block or Bolus Premix

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. Such as gentamycin premix.

Y

NEC

Not Elsewhere Classified. Such as cindamycin vaginal cream.

Z

Sterile Powder

Sterile powders (excludes those used for small volume parenterals). Such as sterile cefuroxime sodium powder.

Back to Antibiotics Index

Check Your Knowledge

1. What subclass would you use for a product labeled or invoiced as "Veterinary Sulfomyxin"?


Answer  

2. The Process Indicator Codes provide what information for antibiotic products?


Answer  

3. How can you determine if an antibiotic product contains a single or combination of ingredients?


Answer  

Back to Antibiotics Index

  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.

1. AMOXICILLIN PEDIATRIC DROPS (Amoxicillin Trihydrate, 50 mg/ml) (reveal code)

2. ERYTHROMYCIN DELAYED CAPSULES, 250 mg (reveal code)

3. STERILE OPHTHALMIC OINTMENT (Polymyxin B Sulfate & Bacitracin Zinc) (reveal code)

4. PENICILLIN G INJECTION (reveal code)

5. TETRACYCLINE HYDROCHLORIDE TABLETS, 250 MG (reveal code)

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.

Back to Antibiotics Index

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

Glossary
Biologic and Licensed In-Vivo and In-Vitro Diagnostic Classes
Biologic and Licensed In-Vivo and In-Vitro Diagnostic Subclasses
Check Your Knowledge
Code the Products

Biologics and licensed in-vivo and in-vitro diagnostic products are coded under Industry Code 57. A biologic is synthesized from living organisms or their products and used medically as a diagnostic, preventive, or therapeutic agent and includes both biological products, as defined in the PHS Act, and tissues. Biologics for animals are not regulated by FDA, but are regulated by USDA. Examples of common biologics for human use include, but are not limited to, human blood and blood products, vaccines, tissue products and licensed in-vitro diagnostic products.

There is a unique set of Subclass codes for biologics and licensed in-vivo and in-vitro diagnostic products, but Process Indicator Codes are not used. Although no Process Indicator Code is used in this 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.

 

Glossary

Biologic: A biologic is produced from living organisms or their products and used to diagnose, prevent or treat a medical condition.

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.

Back to Biologics Index

The Biologic and Licensed In-Vivo and In-Vitro Diagnostic Product Classes

CLASS

NAME

PRODUCT EXAMPLES

A

Antitoxin/Antivenins, Enzymes and Venoms

Diphtheria Antitoxin, Antivenin (Crotalidae), Cobra Venom Solution, Etc.

B

Immunization Toxoid/Toxin

Diphtheria Toxoid, Tetanus Toxoid, Etc.

C

Viral/Rickettsial Vaccine

Adenovirus Vaccine, Measles, Mumps, And Rubella Virus Vaccine (Live), Rabies Vaccine, Etc.

D

Blood & Derivatives

Anti-Inhibitor Coagulant Complex, Fibrinogen (Human), Normal Horse Serum, Single Donor Plasma (Human), Etc.

E

In-Vivo Diagnostic Products

Blastomycin, Histoplasmin, Mumps Skin Test Antigen, Trichinella Extract, Etc.

F

In-Vitro Diagnostic Products

Anti-Human Chorionic Gonadotropic Serum, Hepatitis B Surface Antigen, Hepatitis A Virus, Etc.

G

Allergenic Product

Allergenic Extracts, Poison Ivy Extract Poison Sumac Extract

H

Bacterial Antigen

Bacterial Antigens with "No U.S. Standard of Potency", Vaccines, i.e, Cholera, Pertussis, Typoid, etc., Therapeutic Immune Serums such as Anti-rabies Serum, Streptococcus Vaccine.

I

Multiple Antigen Preparations

Diptheria and Tetanus Toxoids, Staph Toxoid and Bacterial antigen made from Staph, etc.

J

Human Musculoskeletal Tissue

Bone, Cartilage, Ligaments, etc.

K

Human Reproductive Tissue

Embryo, Oocytes, Semen

L

Human Ocular Tissue

Cornea, Sclera

M

Human Tissue Hematopoietic Stem Cells

Peripheral Blood Stem Cells, Umbilical Cord Blood Stem Cells

N

Human Tissue Cellular Therapies

Somatic Cells

O

Other Human Tissues

Pericardium, Skin

P

Human Tissues, N.E.C.

Human Tissue Not Elsewhere Classified

Y

Biologics & Licensed In-Vivo and In-Vitro Diagnostic Products Not Elsewhere Classified

Not Elsewhere Classified

Back to Biologics Index

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 method of application, or the type of product. Be sure and note the restrictions as to the combinations of certain Product Class and Subclass codes.

SUBCLASS

NAME

PRODUCT USE EXAMPLES

THE FOLLOWING CAN BE USED WITH PRODUCT CLASS H ONLY

B

Bacterial Antigens

Bacterial Antigens with "No U.S. Standard of Potency", Pseudomonas Polysaccharide

C

Bacterial Vaccines

Anthrax Vaccine Adsorbed, BCG Vaccine, Cholera Vaccine

D

Modified Bacterial Vaccines

Polyvalent Modified Bacterial Antigens with "No U.S. Standard of Potency"

E

Sensitized Bacterial Vaccines

Currently no licensed products in this class

F

Therapeutic Immune Serums

Anti-Hemophilus Infolenae Type b Serum, Anti-rabies Serum, Streptococcus Vaccine.

THE FOLLOWING CAN BE USED WITH PRODUCT CLASSES A, B, C, D, E, F, G

G

Blood Grouping Serum

Anti-A1, Anti-M (Rabbit), Anti-P1 (Goat), Anti-Human Serum, Anti-C3d (Mouse Hybridoma)

THE FOLLOWING CAN BE USED WITH ALL PRODUCT CLASSES

H

Transfusion, Transplant, Implant, Clinical Research

 

I

For Further Manufacture In Device/Device Components

Example: bulk HIV antigen

J

For Non-Clinical Research Use

Not for use in treating patients or evaluating donors

K

For Educational Purposes

Products used solely is educational settings; not for use in treating patients or evaluating donors

THE FOLLOWING CAN BE USED WITH ALL PRODUCT CLASSES EXCEPT H

Y

Not Elsewhere Classified (N.E.C.)

 

Back to Biologics Index

Check Your Knowledge

1. Which of the following products would not be coded as a biologic?


Answer  

2. In order to be considered a biologic by FDA, a product must be used to treat or cure a disease or condition in humans.


Answer  

3. The Process Indicator Code for biologics provides the following information:


Answer  

Back to Biologics Index

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.

1. RED BLOOD CELLS (HUMAN) (reveal code)

2. INFLUENZA VIRUS VACCINE (reveal code)

3. ANTI-A BLOOD GROUPING SERUM (reveal code)

4. BOTULISM ANTITOXIN (reveal code)

5. BLOOD BAGS WITH ANTICOAGULANT (prior to use in blood collection) (reveal code)

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.

Back to Biologics Index

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Human Drugs - Industry Code 60-66

Glossary
Human Drug Classes
Human Drug Subclasses
Human Drug Process Indicator Codes
Check Your Knowledge
Code the Products

Human Drugs are coded under Industry Codes 60-66. Due to the large volume of drug products, numbers 60 through 66 are reserved for Human Drugs. Because of the large number of human drug products, you will need to rely on information from the manufacturer or the product label when you code human drug products. Some important points to keep in mind when coding Human 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 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 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 gelatin capsules, powders, etc. The label of a product usually provides the information necessary to determine the proper PIC.
  • You should note that the Human Drug product codes have not been updated for some time. 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 that a human drug product is Rx or non-Rx. The label for a prescription drug should bear the symbol "Rx only." The label may have more descriptive statements indicating that the Rx drug is limited to prescription only. Unapproved imported drugs may not have an equivalent statement, as there is no international agreement on what constitutes and Rx drug. It may be considered Rx 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. Filers and inspectors need to rely on the label when determining if a drug is Rx or non-Rx.

 

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 human drug product that can only be obtained with a prescription.

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

Back to Human Drugs Index

The Human Drug Products Classes

There are numerous Class codes associated with the seven Human Drug Industry Codes. The Industry Codes simply identify the product as a human drug. The Class code narrows the product down to a type of human 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 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 Drug Class Code.

Human Drug – 60  

Human Drug – 61  

Human Drug – 62  

Human Drug – 63  

Human Drug – 64  

Human Drug – 65  

Human Drug – 66  

Back to Human Drugs Index

Human Drug Products Subclasses

The Subclasses for products under Industry Codes 60-66 describes whether the product is a single ingredient or a combination and whether it is a prescription drug (Rx) or if it is an investigational drug.

SUBCLASS

NAME

PRODUCT USE EXAMPLES

A

Human Use Single Ingredient Non Rx Use

Bacitracin

B

Human Use Combinations Ingredients Non Rx Use

Bacitracin and neomycin

C

Human Use Single Ingredient Rx Use

Penicillin G

D

Human Use Combinations Ingredients Rx Use

Penicillin G benzathine and Penicillin G procaine

I

Investigational Drug Use

Drug labeled with "Caution: New Drug Limited by Federal Law to Investigational Use" Such as levofloxacin

J

Animal Use – Single Ingredient Therapeutic

Labeled for animal use ("oxytetracycline by or on the order of a licensed veterinarian")

K

Animal Use – Combination Ingredients Therapeutic

Neomycin and Tylosin

X

Not Elsewhere Classified (N.E.C.) (Animal)

Not Elsewhere Classified (N.E.C.) (Animal)

Y

Not Elsewhere Classified (N.E.C.)

Not Elsewhere Classified (N.E.C.)

Back to Human Drugs Index

The Human Drug Process Indication Codes (PIC)

The Human 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/ EXAMPLE

A

Prompt Release Tablets

All prompt release tablets, coated or uncoated. Active ingredient immediately released. Such as aspirin tablets.

 

B

Extended Release Tablets

All extended release tablets, coated or uncoated (active ingredient released over a prolonged period).

C

Delayed Release Tablets

All tablets with delayed release (not extended release, e.g., enteric coated tablets, active ingredient releases and is absorbed in the intestines). Such as aspirin delayed-release tablets.

E

Prompt Release Hard Gelatin Capsules

All hard gelatin capsules for prompt release. Such as aspirin capsules.

F

Modified Release Hard Gelatin Capsules

All hard gelatin capsules having extended or delayed release. Usually contain "seeds" or coated granules. Such as lansoprazole delayed-release capsules.

 

H

Soft Gelatin Capsules

All soft gelatin capsules. Usually contain encapsulated liquids. Such as ritonavir soft gelatin capsules.

J

Non-Sterile Ointments

A hydrophyllic semi-solid substance. An ointment has an oil base (whereas a cream is water-soluble). Includes non-sterile ointment, cream, paste, dressing, poultice, gel, jelly. Such as ichthammol ointment.

K

Sterile Liquid

A sterile liquid is free from live bacteria or other microorganisms. Such as hexylresorcinol solution.

L

Non-sterile Liquid

Elixir, medicated shampoo, mouthwash, nasal spray solution, spirit, tincture, syrup suspension. Such as pyrithione zinc dandruff shampoo.

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. Such as aspirin suppositories.

N

Large Volume Parenteral >=100 ml

Single dose solutions, 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 by intravenous injection. Includes dextrose and sodium chloride in water for injection.

O

Sterile Ointment

Sterile ointments are free from live bacteria or other microorganisms and labeled as such. Includes acyclovir ointment.

P

Small Volume Parenteral <100ml

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 by intramuscular injection. Includes phenytoin sodium injection.

Q

Aerosol Dispersed Medication

Foam, powder, spray, nebulizers (excludes products packaged in non-metered mechanical dispensers – e.g., nasal sprays). Such as sodium chloride inhalation solution.

R

Non-sterile Powder

Effervescent for reconstitution (oral use) Topical (excludes aerosols and bulk pharmaceutical chemicals). Such as calcium undecylenate powder

S

Bulk Pharmaceutical

Includes dacarbazine U.S.P.

V

Compressed Medical Gas

Any gas for medicinal use. Such as nitrious oxide U.S.P.

X

Block or Bolus Premix

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. Such as nicarbazin premix.

Y

NEC

Not Elsewhere Classified

Z

Sterile Powder

Sterile powders (excludes those used for small volume parenterals).

Back to Human Drugs Index

Check Your Knowledge

1. Which of the following products is not considered to be a drug product by the FDA?


Answer  

2. Which of the following products is not considered to be a drug product by the FDA?


Answer  

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.?


Answer  

Back to Human Drugs Index

   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.

1. LIDOCAINE OINTMENT, 2.5% (reveal code)

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

3. DIAZEPAM TABLETS, 2 mg (reveal code)

4. STANNOUS FLOURIDE TOOTHPASTE (reveal code)

5. WRINKLE REMOVING CREAM (reveal code)

6. AEROSOL ANTIPERSPIRANT CONTAINING ALUMINUM ACETATE (reveal code)

7. ENTERIC COATED ANTI-ARTHRITIC TABLES (containing aspirin) (reveal code)

8. LONG ACTING ALLERGY TABLETS (Chlorpheniramine maleate) (reveal code)

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.

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