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Flashcards in Sources Of Law Deck (48):
1

What regulates non prescription drug advertising?

FTC
Federal Trade Commission

2

What act established two drug classes?

Durham Humphrey Amendment of 1951

3

What act provided for oral prescriptions and prescription refills?

Durham Humphrey amendment of 1951

4

What was adopted in response to thalidomide?

Kefauver Harris amendment of 1962

5

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

Kefauver Harris amendment of 1962

6

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

Pure food and drug act of 1906

7

What required for meds to be proven safe?

Food Drug and Cosmetic act of 1938

8

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

Labels include adequate directions for use

Warnings about habit forming drugs

9

What regulates prescription drug advertising?

FDA

10

What drug application is filled out for generic products?

ANDA

11

ANDAs require proof of what with its brand name counterpart?

Bioequivalence

12

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

Prescription Drug Marketing Act of 1987

13

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

USP/NF
HPUS
Drugs@FDA

14

What jurisdiction is the DEA under?

U.S. Department of Justice

15

What department is the FDA under?

Department of Health and Human Services

DHHS

16

What does FDCA stand for?

Food Drug and Cosmetic Act

17

What act only prohibited adulteration and misbranding?

Pure Food and Drug Act

18

What did sulfanilamide elixir lead to?

Food Drug and Cosmetic Act of 1938

19

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

Safe

20

What established two classes of drugs?

Durham Humphrey amendment

21

What gave authorization for oral prescriptions and prescription refills?

Durham Humphrey amendment

22

What was made because of thalidomide?

Kefauver Harris amendment

23

What amendment streamlined generic approval?

Wax man- Hatch Amendment

24

What required informed decisions by patients?

Omnibus Budget Reconciliation Act

OBRA

25

What said drugs had to be both safe and effective?

Kefauver Harris Amendment

26

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

Nutrition Labeling Education Act (NLEA)

27

A dietary supplement must include what statement?

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

28

Who only can remove dietary supplements from the market?

FDA

29

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

Basis of public safety

30

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

Poison prevention packaging Act of 1970

31

What kind of packaging can be reused?

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

32

What dealt with the marketing and movement of sampling drugs?

Prescription drug marketing act of 1987

33

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

Dispensing samples

34

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

Class 1

35

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

No only premarket notification

36

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

Class 2

37

Do class 2 medical devices have to get FDA approval?

Yes and give pre-market notification

38

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

Class 3

39

Do class 3 medical devices have to have FDA approval?

Yes

40

What medical devices have to have FDA approval?

Class 2 and 3

41

When is a recall mandatory?

When it's a device

42

Recalls of what two products are voluntary?

Drugs and cosmetics

43

Which recall is the most serious?

1

44

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

OBRA 90

45

What law provided for oral prescriptions and prescription refills?

Durham Humphrey amendment

46

What created GMP?

Kefauver Harris Amendment

47

Who oversees Medicare and Medicaid?

CMS

48

DEA is part of what department?

Department of Justice