Reading 1 & 2 - Definitions

Question 1

What is the 4 part definition of a drug?

Answer 1

• approved by official compendium
• intented to treat, prevent, or cure a disease in man or animal
• intenteded to affect the body of man or animal by chemical action
• intended for use as a component of any article specified

Question 2

What is included as “official compendium”?

Answer 2

United States Pharmacopeia - National Formulary (USP-NF)
Homeopathic Pharmacopeia of the United States (HPUS)

Question 3

What is the definition of prescription drug?

Answer 3

Drug intented for man which because of harmful effects is not safe unless under supervision of a licensed practitioner OR limited by an approved application under section 355 (new drug)

Question 4

The definition of over the counter drug?

Answer 4

Drug safe and effective for use without a prescriber’s supervision for certain conditions

Question 5

Which of the following are included as dietary supplements:
- Amino acids
- Herbs
- Tobacco
- Vitamins

Answer 5

All but TOBACCO!!!!!!

Question 6

What is GRAS and GRAE?

Answer 6

Generally Recognized as Safe
Generally Recognized as Effective

Question 7

What application is needed to get approval by the FDA after clinical trials?

Answer 7

New Drug Application

Question 8

What application is needed to be reviewed by FDA before conducting clinical trials on a drug?

Answer 8

Investigation New Drug Application (IND)

Question 9

The definition of orphan drug

Answer 9

drugs used for a condition affecting less than 200,000 people in the US, OR there is no reasonable cost benefit when it affects more than 200,000 people

Question 10

Definition of Estabilished Name

Answer 10

Generic Name of a drug products

Question 11

What is responsible for the established name of a drug?

Answer 11

United States Adopted Names (USAN)

Question 12

Label vs Labeling

Answer 12

Label is what is printed on the actual product
Labeling is anything added to the container or included with the product

Question 13

What is the PPPA?

Answer 13

Poison Prevention Packaging Act
Requires special packaging on drug products to inhibit children under 5 from opening products within a reseasonable amount of time

Question 14

What is a DESI drug?

Answer 14

Drugs marketed between 1938 - 1962 that has been deemed SAFE, but needed to prove their efficacy

Question 15

What is the application to FDA to show proof of bioequivalence?

Answer 15

Abbreviated New Drug Application

Question 16

Out of the 3 drug applications (NDA, IND, ANDA), which one do you not need to prove safety and efficacy?

Answer 16

ANDA

Question 17

What drugs never had official clinical trials but have been deemed safe and effective due to their time on the market?

Answer 17

Pre-‘38 Drugs / Grandfathered Drugs

EX: Digoxin

Question 18

What do two Pharmaceutical Equivalent drugs have in common? What can they differ in?

Answer 18

Dosage Form
Active Ingredient
Strength

Differing in look, release mechanism, expiration, labeling

Question 19

What is the definition of Therapeutic Equivalent?

Answer 19

Two Pharmacetical Equivalent drugs that have the same clinical safety profile

Question 20

What is the definition of “state”?

Answer 20

All 50 US state plus any territory of the US
EX: Puerto Rico, Guam, District of Columbia, Republic of Marshall Islands

Question 21

What are the 3 required components of a device?

Answer 21

-Recognized by USP-NF
- Intented for use in diagnosis, cure, or prevention of a disease in man or animals
- They afffect the structure of body NOT through chemical action (no metaboliam, they stay intact)

***there is no such thing as “homeopathic devices”

Question 22

Definition of Biological Product:

Answer 22

“a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, allergenic, protein, arsphenamine, or analogous product used to prevent, treat, or cure a disease for human beings”

NOT for animals…

Question 23

What is USC? Used for rules or statutes?

Answer 23

United States Code
Laws or Statues coming from a body of elected officials

Question 24

What is CFR? Used for rules or statutes?

Answer 24

Code of Federal Regulations
Regulations issued by an administrative agency

Question 25

What is the IC?

Answer 25

Indiana Code
Laws established by a body of electived officials

Question 26

The Indiana BoP develops laws or regulations?

Answer 26

Regulations === they are NOT elected officials

Question 27

Laws or Rules that need to go through public commenting before finalized?

Answer 27

Rules and Regulations!!!

Question 28

What organizations develop rules and regulations?

Answer 28

FDA
DEA
Indiana BoP

Question 29

T or F: A new drug that requires regular lab tests to monitor for adverse events at normal doses
would likely be approved as an over-the-counter-drug.

Answer 29

FALSE

Question 30

T or F: Although used in animals, prescription drugs are only approved for use in humans.