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Law > Sources Of Law > Flashcards

Sources Of Law Flashcards

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1
Q

What regulates non prescription drug advertising?

A

FTC

Federal Trade Commission

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2
Q

What act established two drug classes?

A

Durham Humphrey Amendment of 1951

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3
Q

What act provided for oral prescriptions and prescription refills?

A

Durham Humphrey amendment of 1951

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4
Q

What was adopted in response to thalidomide?

A

Kefauver Harris amendment of 1962

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5
Q

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

A

Kefauver Harris amendment of 1962

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6
Q

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

A

Pure food and drug act of 1906

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7
Q

What required for meds to be proven safe?

A

Food Drug and Cosmetic act of 1938

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8
Q

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

A

Labels include adequate directions for use

Warnings about habit forming drugs

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9
Q

What regulates prescription drug advertising?

A

FDA

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10
Q

What drug application is filled out for generic products?

A

ANDA

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11
Q

ANDAs require proof of what with its brand name counterpart?

A

Bioequivalence

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12
Q

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

A

Prescription Drug Marketing Act of 1987

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13
Q

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

A

USP/NF
HPUS
Drugs@FDA

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14
Q

What jurisdiction is the DEA under?

A

U.S. Department of Justice

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15
Q

What department is the FDA under?

A

Department of Health and Human Services

DHHS

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16
Q

What does FDCA stand for?

A

Food Drug and Cosmetic Act

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17
Q

What act only prohibited adulteration and misbranding?

A

Pure Food and Drug Act

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18
Q

What did sulfanilamide elixir lead to?

A

Food Drug and Cosmetic Act of 1938

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19
Q

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

A

Safe

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20
Q

What established two classes of drugs?

A

Durham Humphrey amendment

21
Q

What gave authorization for oral prescriptions and prescription refills?

A

Durham Humphrey amendment

22
Q

What was made because of thalidomide?

A

Kefauver Harris amendment

23
Q

What amendment streamlined generic approval?

A

Wax man- Hatch Amendment

24
Q

What required informed decisions by patients?

A

Omnibus Budget Reconciliation Act

OBRA

25
Q

What said drugs had to be both safe and effective?

A

Kefauver Harris Amendment

26
Q

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

A

Nutrition Labeling Education Act (NLEA)

27
Q

A dietary supplement must include what statement?

A

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

28
Q

Who only can remove dietary supplements from the market?

A

FDA

29
Q

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

A

Basis of public safety

30
Q

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

A

Poison prevention packaging Act of 1970

31
Q

What kind of packaging can be reused?

A

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

32
Q

What dealt with the marketing and movement of sampling drugs?

A

Prescription drug marketing act of 1987

33
Q

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

A

Dispensing samples

34
Q

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

A

Class 1

35
Q

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

A

No only premarket notification

36
Q

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

A

Class 2

37
Q

Do class 2 medical devices have to get FDA approval?

A

Yes and give pre-market notification

38
Q

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

A

Class 3

39
Q

Do class 3 medical devices have to have FDA approval?

A

Yes

40
Q

What medical devices have to have FDA approval?

A

Class 2 and 3

41
Q

When is a recall mandatory?

A

When it’s a device

42
Q

Recalls of what two products are voluntary?

A

Drugs and cosmetics

43
Q

Which recall is the most serious?

A

1

44
Q

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

A

OBRA 90

45
Q

What law provided for oral prescriptions and prescription refills?

A

Durham Humphrey amendment

46
Q

What created GMP?

A

Kefauver Harris Amendment

47
Q

Who oversees Medicare and Medicaid?

A

CMS

48
Q

DEA is part of what department?

A

Department of Justice

Law (11 decks)

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