Regulatory Definitions

Question 1

Drug

Answer 1

1. Recognized or contained by USP, Homeopathic Pharmacopeia, or National Formulary.
2. Substances intended for diagnosis, cure, prevention, or treatment of diseases.
3. Substances intended to affect any structure or function of the body.

Question 2

New Drug

Answer 2

Composition is not generally recognized as safe and effective

Question 3

Device

Answer 3

Instrument which is:

1. Recognized in the official NF or USP
2. Intended to diagnose, treat, cure, or prevent disease
3. Intended to affect the structure or function of the body

Question 4

Prescription Drug

Answer 4

1. Habit-forming
2. Not safe except under supervision of a doctor
3. Limited by approved application

Question 5

Over-the-counter (OTC) Drug

Answer 5

1. Recognized by experts to be safe and effective for use

2. Must contain adequate directions for use

Question 6

New Drug Application

Answer 6

Procedure for obtaining pre-marketing approval for a drug

Question 7

ANDA

Answer 7

Abbreviated New Drug Application

Procedure for obtaining pre-marketing approval for a generic

Question 8

Approved Prescription Drug Product List

Answer 8

Listing of all FDA approved drugs, Orange Book (must be bookmarked at your pharmacy)

Question 9

OTC Monograph

Answer 9

Regulation specifying dosages and indications for which an OTC product can be formulated without FDA approval

Question 10

Adulterated Drugs

Answer 10

1. Prepared in unsanitary conditions
2. Don’t conform with GMP
3. Container made of poisonous or deleterious materials
4. Contains unsafe color additive
5. Varies from official compendia
6. Not in tamper-resistant packaging
7. Sex out of marriage

Question 11

Class I Medical Device

Answer 11

Relatively low potential for harm (scissors, forceps, needles)

Question 12

Class II Medical Device

Answer 12

Safety and effectiveness must be evaluated by a panel of experts (hearing aids, sunlamps, tampons, thermometers)

Question 13

Class III Medical Device

Answer 13

Devices are usually life supporting systems.
Failure could lead to injury and/or death
(Catheters, pace makers)

Question 14

Misbranded Drugs

Answer 14

1. Label is false or misleading, inaccurate, difficult to read, or excluding info
2. Generic name cannot be less than 1/2 the font size of the brand
3. Drug is misleading in the way it is filled or formed (imitates another drug)
4. Endangering is used in the manner suggested by the labeling

Question 15

Label v. Labeling

Answer 15

Label- printed on the container, adequate directions for use

Labeling- printed material that accompanies the drug,
adequate information for use

Question 16

National Drug Code

Answer 16

1st section- manufacturer, 4-5 characters
2nd section- product, 3-4 characters
3rd section- packaging, 1-2 characters

Question 17

Class I Recall

Answer 17

Reasonable probability use will cause serious adverse health consequences or death!

Question 18

Class II Recall

Answer 18

May cause temporary or medically reversible health consequences

Question 19

Class III Recall

Answer 19

Not likely to cause serious adverse health consequences

Question 20

Market Withdrawal

Answer 20

Minor violation that would not be subject to FDA legal action.
Voluntary by the manufacturer

Question 21

Phase I study

Answer 21

Safety testing
Small n
Normal pts

Question 22

Phase II study

Answer 22

Efficacy in indicated puts

Additional PK in animals

Question 23

Phase III

Answer 23

Safety and efficacy
Larger study
Often multi enter

Question 24

Phase I study

Answer 24

Safety testing
Small n
Normal pts

Question 25

Phase II study

Answer 25

Efficacy in indicated puts

Additional PK in animals

Question 26

Phase III

Answer 26

Safety and efficacy
Larger study
Often multi enter