Sources Of Law

Question 1

What regulates non prescription drug advertising?

Answer 1

FTC

Federal Trade Commission

Question 2

What act established two drug classes?

Answer 2

Durham Humphrey Amendment of 1951

Question 3

What act provided for oral prescriptions and prescription refills?

Answer 3

Durham Humphrey amendment of 1951

Question 4

What was adopted in response to thalidomide?

Answer 4

Kefauver Harris amendment of 1962

Question 5

What required that all drugs marketed had to be not only safe, but effective?

Answer 5

Kefauver Harris amendment of 1962

Question 6

What prohibited foods and drugs that were distributed thru interstate commerce from being misbranded or adulterated?

Answer 6

Pure food and drug act of 1906

Question 7

What required for meds to be proven safe?

Answer 7

Food Drug and Cosmetic act of 1938

Question 8

The Food Drug and Cosmetic Act of 1938 also required what two other things?

Answer 8

Labels include adequate directions for use

Warnings about habit forming drugs

Question 9

What regulates prescription drug advertising?

Answer 9

FDA

Question 10

What drug application is filled out for generic products?

Answer 10

ANDA

Question 11

ANDAs require proof of what with its brand name counterpart?

Answer 11

Bioequivalence

Question 12

What placed more strict controls on distribution of prescriptions and samples?

Answer 12

Prescription Drug Marketing Act of 1987

Question 13

What are the three official compendia of the U.S.?

Answer 13

USP/NF
HPUS
Drugs@FDA

Question 14

What jurisdiction is the DEA under?

Answer 14

U.S. Department of Justice

Question 15

What department is the FDA under?

Answer 15

Department of Health and Human Services

DHHS

Question 16

What does FDCA stand for?

Answer 16

Food Drug and Cosmetic Act

Question 17

What act only prohibited adulteration and misbranding?

Answer 17

Pure Food and Drug Act

Question 18

What did sulfanilamide elixir lead to?

Answer 18

Food Drug and Cosmetic Act of 1938

Question 19

The Food Drug and Cosmetic Act said a drug cannot me marketed until it’s proven what?

Answer 19

Safe

Question 20

What established two classes of drugs?

Answer 20

Durham Humphrey amendment

Question 21

What gave authorization for oral prescriptions and prescription refills?

Answer 21

Durham Humphrey amendment

Question 22

What was made because of thalidomide?

Answer 22

Kefauver Harris amendment

Question 23

What amendment streamlined generic approval?

Answer 23

Wax man- Hatch Amendment

Question 24

What required informed decisions by patients?

Answer 24

Omnibus Budget Reconciliation Act

OBRA

Question 25

What said drugs had to be both safe and effective?

Answer 25

Kefauver Harris Amendment

Question 26

What act regulated certain health and disease prevention claims on nutritional products?

Answer 26

Nutrition Labeling Education Act (NLEA)

Question 27

A dietary supplement must include what statement?

Answer 27

This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.

Question 28

Who only can remove dietary supplements from the market?

Answer 28

FDA

Question 29

Why would the FDA remove a dietary supplement from the market?

Answer 29

Basis of public safety

Question 30

What act requires that prescription only drug products and CS can dispensed in child resistant packaging?

Answer 30

Poison prevention packaging Act of 1970

Question 31

What kind of packaging can be reused?

Answer 31

Glass bottles with plastic child resistant lids if replace the lids each time

Question 32

What dealt with the marketing and movement of sampling drugs?

Answer 32

Prescription drug marketing act of 1987

Question 33

The prescription drug marketing act (PDMA) stopped pharmacists from doing what?

Answer 33

Dispensing samples

Question 34

What class of medical devices have a low potential for causing harm?

Answer 34

Class 1

Question 35

Do class 1 medical devices have to get approval from FDA before marketing?

Answer 35

No only premarket notification

Question 36

What class of medical devices have specific performance standards that are fixed by panels of experts?

Answer 36

Class 2

Question 37

Do class 2 medical devices have to get FDA approval?

Answer 37

Yes and give pre-market notification

Question 38

What class of medical devices are usually used in serious life supporting situations?

Answer 38

Class 3

Question 39

Do class 3 medical devices have to have FDA approval?

Answer 39

Yes

Question 40

What medical devices have to have FDA approval?

Answer 40

Class 2 and 3

Question 41

When is a recall mandatory?

Answer 41

When it's a device

Question 42

Recalls of what two products are voluntary?

Answer 42

Drugs and cosmetics

Question 43

Which recall is the most serious?

Answer 43

1

Question 44

What made it required for a pharmacist to offer counseling at the point of purchase?

Answer 44

OBRA 90

Question 45

What law provided for oral prescriptions and prescription refills?

Answer 45

Durham Humphrey amendment

Question 46

What created GMP?

Answer 46

Kefauver Harris Amendment

Question 47

Who oversees Medicare and Medicaid?

Answer 47

CMS

Question 48

DEA is part of what department?

Answer 48

Department of Justice