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Therapeutics V Spring 2019 (P3 Spring) > Law - Exam 1 > Flashcards

Law - Exam 1 Flashcards

1
Q

Class 1, 2, or 3 devices are most dangerous

A

3

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2
Q

T or F: Class 1, 2 and 3 devices require pre-market approval

A 
false!! only class 3
Class 2 "require special controls" but do not need pre approval
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3
Q

what is the only banned device in the US

A

prosthetic hair fibers

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4
Q

Example of Class 1, 2, or 3 Device?

tampons

A

2

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5
Q

Example of Class 1, 2, or 3 Device?

stethoscope

A

1

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6
Q

Example of Class 1, 2, or 3 Device?

condoms

A

2

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7
Q

Drug recalls are ________

Device recalls are ________

A

drug: voluntary
device: mandatory

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8
Q

Example of Class 1, 2, or 3 Device?

syringes

A

2

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9
Q

Example of Class 1, 2, or 3 Device?

Ventilator tubing

A

1

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10
Q

Example of Class 1, 2, or 3 Device?

pacemakers

A

3

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11
Q

Example of Class 1, 2, or 3 Device?

replacement heart valves

A

3

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12
Q

Example of Class 1, 2, or 3 Device?

soft contact lenses

A

3

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13
Q

T or F: FDA can request, but NOT order manufacturers to recall a drug

A

true

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14
Q

if FDA requests for a drug recall and manufacturer refuses – the FDA has to file a lawsuit called ____________

A

libel for information and condemnation

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15
Q

Class 1, 2 or 3 recalls are worse?

A

1

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16
Q

Class 1, 2 or 3 recalls?

  • Exposure to or use of product may cause temporary or medically reversible adverse health consequences
  • Chance of severe consequences is remote
A

2

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17
Q

Class 1, 2 or 3 recalls?

Use of or exposure to product may cause serious consequences or death

A

1

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18
Q

Class 1, 2 or 3 recalls?

Use of or exposure to product is not likely to cause adverse health consequences

A

3

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19
Q

what is the Durham-Humphrey Amendment?

A
  • Passed in 1951
  • Gave us information for what drugs required prescriptions!!
  • Allowed refills on prescriptions for the first time
  • Previously one and done
  • Allowed written or oral (telephone) prescriptions
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20
Q

what four practitioners are recognized as prescribers in all states? The big four

A

Physicians (MD/DO)
Dentists (DDS/DMD)
Podiatrists (DPM)
Veterinarians (DVM)

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21
Q

Physicians: scope of practice?

A

whole body practice

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22
Q

Dentists: scope of practice?

A

Mouth, oral cavity, maxillary area

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23
Q

Podiatrists: scope of practice?

A

Feet, ankles, and associated structures
(*May include hands in some states
**^Only a few states, not Indiana)

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24
Q

Veterinarians: scope of practice?

A
  • Responsible for animals
  • No restriction on the type of animal they can prescribe for (small, large, exotic)
  • Can prescribe animal drugs or human drugs for conditions in animals
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25
Q

who is responsible for PPPA

A

pharmacist and manufacturer

manufacturer is hen 30 or 90 unit dose containers

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26
Q

what pregnancy info is needed in the package insert now (as of 6/30/15)

A
  • Pregnancy
  • Lactation
  • Females and males of reproductive potential
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27
Q

Lactation Section of Package Insert:

If the drug is absorbed systemically must include information on the drug in human milk and its effects of ___________

A

effects of the drug on the child/milk production

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28
Q

Generic name = _________ name

A

established

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29
Q

Statute vs Regulation:

A

Statute: written law enacted by legislature
Regulation: rule having the force of law issued by an administrative agency

30
Q

Statute vs. Regulation:

T or F: both are enacted by elected officials

A

FALSE
only statute is elected officials

regulation: is non-elected officials (ex: board of pharmacy, FDA, DEA)

31
Q

The following is a definition for ________:
article recognized in the official compendium or any supplement of the official compendium
AND
article is intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animal
AND
an article (other than food) intended to affect the structure or any function of the body in man or other animal
(AND steps 1 - 3 above…)

A

Drug

32
Q

what are examples of official compendiums

A

USP
NF
HPUS

33
Q

USP stands for?

A

united states pharmacopeia

34
Q

NF stands for?

A

national formulary

35
Q

HPUS stands for?

A

homeopathic pharmacopeia of the U.S

36
Q

The following is a definition for ________
Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance AND articles that intended for use as a component of any article
(but not soap…)

A

Cosmetics

37
Q

other names for prescription drugs?

A

Rx-Only
or
Legend Drug

38
Q

The following are definitions for _______:
Drugs used by humans
Require supervision for safe/effective use
Are unavoidably unsafe but not unreasonably dangerous

A

Prescription drug/ Rx-Only/ Legend Drug

39
Q

The following is a definition of _______:

Drugs that are safe and effective for use without a prescribers supervision

A

OTC Drug

40
Q

The following is a definition of _________:
An unofficial class of drugs
State or proposal specific
certain drugs sold only by a pharmacist - but not needing a prescription

A

behind the counter drugs (BTC)

41
Q

The following is a definition for _______:

A drug that has a dependence liability and/or potential for abuse

A

controlled substance

42
Q

The following is a definition for _______:
used for a condition that affects less than 200,000 persons in the US
OR
affects more than 200,000 in the US but the cost of developing and making the drug will not be recovered from sales in the US

A

orphan drug (sometimes called Drugs for Rare Diseases)

43
Q

T or F:

If an orphan drug later gains another use after first approved it does not lose its orphan drug status

A

TRUE

44
Q

The following is a definition for _______:
A product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:
- vitamin
- mineral
- herb/other botanical
- an amino acid
- dietary substance for use by man to supplement the diet by increasing total dietary intake
OR
- concentrate/metabolite, constituent, extract or combo of any ingredient described above

A

Dietary supplement

45
Q

GRAE and GRAS stand for?

A

GRAE: generally recognized as effective
GRAS: generally recognized as safe

46
Q

T or F:

To be FDA approved you only need one (GRAE or GRAS) *don’t need both

A

FALSE:

need to be GRAE AND GRAS to get FDA approval

47
Q

The following is a definition for _______:
Not generally recognized as GRAE or GRAS
For a new condition or in a new dosage form
Has not been used in the condition/dosage form long enough
Must go through New drug application for FDA approval

A

New Drug

48
Q

what does DESI stand for

A

drug efficacy study implementation

49
Q

The following is a definition for _______:
drugs introduced onto the market between 1938 and 1962
(known to be safe but not proved to be effective)
thus they had to prove efficacy or pull drug from market

A

DESI Drugs

50
Q 
NDA stands for?
vs
IND stands for?
vs
ANDA stands for?
A

NDA: new drug application
IND: Investigational new drug application
ANDA: Abbreviated New Drug Application

51
Q

The following is a definition for _______:
Application sent to FDA once all clinical trials and ata have been collected on a new drug in order to have the drug approved for marketing

A

NDA: new drug application

52
Q

The following is a definition for _______:
Application sent to FDA asking them for exemption to the NDA requirements in order to investigate and conduct clinical trials on the new drug

A

IND: Investigational New Drug application

53
Q

The following is a definition for _______:
Application used by generic manufacturers to show proof of bioequivalence and proof of acceptable manufacturing practices and controls

A

ANDA: Abbrev. New Drug Application

54
Q

The following is a definition for _______:
Official name
or
Official title thereof in the official compendium
or
common or usual name

A

Established Name

55
Q

The following is a definition for _______:

display of written, printed, or graphic matter upon the immediate container or any article

A

Label

56
Q

The following is a definition for _______:
All labels and other written, printed, graphic matter:
[- Upon any article or any of its containers or wrappers
OR
-Accompanying such article (papers assoc. with paper]

A

Labeling

57
Q

T or F:

Label is part of labeling (but not the other way around)

A

True

58
Q

The following is a definition for _______:
-Significantly difficult for kids under 5 years of age to…
open or obtain a toxic/harmful amount of substance contained therein, within a reasonable amount of time, and not difficult for NORMAL ADULTS to use properly BUT does not mean packaging cannot be opened by kids in a reasonable time completely

A

special packaging

59
Q 
Special packaging:
deterring kids of ages \_\_\_\_\_\_:
A) 4 and Under
B) 5 and under
C) 0 - 5
A

A

age five cannot be included!!

60
Q

The following is a definition for _______:
Products with the same active ingredient, same dosage form, same strength
may differ in look, release mechanism, expiration times, and have minor variations in labeling

A

Pharmaceutical Equivalent

Ex: ProAir vs Ventolin

61
Q

The following is a definition for _______:

Pharmaceutical equivalents that are likely to have the same clinical and safety profiles

A

Therapeutic Equivalents

62
Q

Pharmaceutical or Therapeutic Equivalents are substitutable?

A

Therapeutic

63
Q

The following is a definition for _______:
An instrument or related article which is recognized in USP, NF, or any supplement
AND
Intended for use in the diagnosis of disease or other condition, or in the cure, mitigation, treatment, or prevention of disease in man or other animal
AND
intended to affect the structure or any function of the body in man or other animal, which does not achieve its primary intended purposes through chemical action and which is not dependent upon being metabolized for the achievement of its primary intended purpose

A

Device

64
Q

The following is a definition for _______:

can mean individual, partnership, corporation, and association

A

Person

plural in law is persons

65
Q

3 recognized classes of devices?

A

Class 1, 2, or 3

66
Q

what are the other types of devices? (outside of 1,2 or 3)

A

Restricted
Custom
Banned

67
Q

T or F:

FDA can order/require manufacturers to recall a drug

A

false!!

they can request, not order

68
Q

what did the Durham-Humphrey Amendment do?

A
  • gave us info on what drugs needed an rx
  • allowed refills on prescriptions for the first time
  • allowed written/telephone rxs
69
Q

Federal government or States decide who has authority to prescribe?

A

states

70
Q

Federal Requirements for a Label:

A

slide 81

Therapeutics V Spring 2019 (P3 Spring) (27 decks)

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