POP Law Quiz 1

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1

What event caused the FDCA to come about?

107 deaths from diethylene glycol (auto antifreeze) as a vehicle for sulfanilamide elixir

2

The FDCA said labels had to include what?

  • Adequate directions for use
  • Habit forming warnings
3

Which drugs were exempt to the FDCA?

Those marketed prior to 1938

4

Act prohibited foods and drugs distributed through interstate commerce from being adulterated or misbranded:

Pure Food and Drug Act of 1906

5

Any new drug had to be proven safe when used according to label directions corresponds to which law?

FDCA of 1938

6

Under Durham-Humphrey Nonprescription drugs were defined as:

  • products not requiring medical supervision for safe use
  • require “adequate directions for use” on the label from the manufacturer
7

Provided for better classification of medical devices according to their specific function

Medical Device Amendment of 1976

8

Who can sell, distribute, exchange or give to any person a hypodermic syringe or needle designed or marketed primarily for human use?

Only a pharmacist, intern, or extern

9

Which law was adopted as a result of public concern about thalidomide causing serious birth defects?

Kefauver-Harris Amendment of 1962

10

Over-the-counter, non-prescription drug products must:

  • Be safe for use without medical supervision
  • Be for conditions suitable for self-diagnosis
  • Have adequate written directions for self-use
11

True or False: By law, claims in advertisements, including OTC medicines, must be truthful and cannot be misleading or unfair.

True

12

Kefauver-Harris Amendment of 1962 is also known as what?

Drug Efficacy Amendment

13

Established performance standards and pre-market approval

Medical Device Amendment of 1976

14

Did not require manufacturers to list ingredients or directions for use corresponds to which law?

Pure Food and Drug Act of 1906

15

The FTC enforces OTC advertising by what 3 basic standards?

  • An advertiser needs to have prior substantiation that an objective claim in an ad is true before they run the advertisement.
  • Under its deception policy, the FTC looks to real life situations and how consumers would interpret an advertisement...if the overall ad seeks to mislead informed choice through misrepresentations or omissions, the FTC can act against the advertiser.
  • Under its unfairness policy, FTC may act against ads that cause substantial consumer harm that are not outweighed by a consumer or competitive benefit or where a consumer could not reasonably avoid the harm.
16

Did the Pure Food and Drug Act regulate cosmetics or medical devices?

No

17

In GA, where must syringes be kept in a pharmacy?

  • Behind prescription counter
  • In prescription department
18

Required all new drugs marketed in US to be shown as safe and effective:

Kefauver-Harris Amendment of 1962

19

Often contaminated, not consistent in strength, and poorly labeled relates to which law?

Pure Food and Drug Act of 1906

20

List some examples of Medical Devices:

  • tongue depressors
  • arm slings
  • physiologic monitors
  • pumps
  • X-ray systems
  • implants
21

Required devices be manufactured in accordance with GMP

Medical Device Amendment of 1976

22

Were drugs that were approved between 1938 and 1962 required to be tested and proven both safe and effective?

Yes

23

True or False: NO needle and/or syringe shall be sold if there is reasonable cause to believe that it will be used for an unlawful purpose.

True

24

Signed into FEDERAL law under the USA Patriot Act in 2006

Combat Methamphetamine Epidemic Act of 2005

25

Created Good Manufacturing Practice (GMP) requirements

Kefauver-Harris Amendment of 1962

26

Outlined record keeping and reporting requirements

Medical Device Amendment of 1976

27

The Combat Methamphetamine Epidemic Act limits purchasers to what amount of PSE products in 1 day?

No more than 3.6 grams

28

This was the first law that addressed safety and applied to cosmetics and medical devices in addition to foods and drugs:

FDCA of 1938

29

Provided for the regulation of prescription drug advertising by the FDA

Kefauver-Harris Amendment of 1962

30

Amendment to 1938 FDCA established two classes of drugs:

Durham-Humphrey Amendment of 1951

31

Prescription advertising is regulated by whom?

FDA

32

What were the 2 classes of drugs created by Durham-Humphrey?

  • Prescription or "Legend" drugs
  • Non-prescription or Over-the-counter drugs
33

Restricts the sale of psuedoephedrine and applies to all cough and cold products that contain ephedrine, pseudoephedrine (PSE), or phenylpropanolamine (PPA)

Combat Methamphetamine Epidemic Act of 2005

34

Non-prescription advertising is regulated by whom?

Federal Trade Commission (FTC)

35

Which law provided for oral prescriptions and prescription refills

Durham-Humphrey Amendment of 1951

36

Durham-Humphrey described prescription drugs as what?

  • requiring medical supervision for safe use
  • did not require “adequate directions for use” on the manufacturer’s label
37

Adequate directions for use was satisfied for legend drugs under Durham-Humphrey how?

By the pharmacist placing the prescribers directions on the label of the dispensed product

38

Durham-Humphrey required that legends drugs must have what on the manufacturer's label?

"Caution: Federal law prohibits dispensing without a prescription”

39

The Combat Methamphetamine Epidemic Act limits purchasers to what amount of PSE products in a 30 day period?

No more than 9 grams

40

The Combat Methamphetamine Epidemic Act limits purchasers to what amount of PSE products in a 30 day period for mail-order?

No more than 7.5 grams

41

Required informed consent for research subjects in clinical investigations and reporting of adverse reactions

Kefauver-Harris Amendment of 1962

42

Non-liquid forms of PSE must be sold in what?

Blister packs

43

What is the maximum amount of dosage units per pack for non-liquid forms of PSE?

No more than 2 dosage units per pack

44

In GA, PSE containing products must be kept where?

Behind the Pharmacy counter (in the pharmacy prescription department)

45

In GA, it is required that all PSE prescription sales are tracked prior to the sale using what?

Real-time electronic logging system

46

True or False: Pharmacists do not have to apply reasonable means to determine that the product being purchased is for a legitimate medical purpose

False; MUST

47

Who must approve all sales and transactions of PSE containing products?

Pharmacists

48

What is required for the approval of selling a PSE containing product in GA?

  • Legitimate purpose
  • Age verification (18 yo) with valid I.D.
49

True or False: After transactions have been approved, other pharmacy personnel may be directed by the pharmacist to complete the transaction

True