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Pharmacy Law and Regulations (Domain 2) > Pharmacy Law and Regulations (Domain 2) > Flashcards

Pharmacy Law and Regulations (Domain 2) Flashcards

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1
Q

What is the meaning of the acronym “DEA”?

A

drug enforcement administration

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2
Q

What is the meaning of the acronym “FDA”?

A

food and drug administration

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3
Q

How long is a Schedule III valid from the time it is written?

A

6 months

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4
Q

How many refills are permitted on an Accutane prescription?

A

0

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5
Q

How many Controlled Substance Schedules exist?

A

5

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6
Q

What is the meaning of “C II”?

A

schedule II medication

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7
Q

How many hours are considered readily retrievable?

A

72

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8
Q

What is the meaning of “CIII”?

A

schedule III medication

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9
Q

How many refills are permitted on a prescription for Accutane?

A

0

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10
Q

What is the meaning of “CIV”?

A

schedule IV medication

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11
Q

How many refills are permitted on Schedule II medications?

A

0

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12
Q

What is the meaning of “CV”?

A

schedule V medication

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13
Q

How many refills are permitted on Schedule III medications?

A

5

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14
Q

What is the maximum number of different CII medications that can be ordered on a DEA Form 222?

A

10

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15
Q

How often is a biennial inventory taken?

A

every 2 years

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16
Q

How often may one purchase an exempt narcotic?

A

every 48 hours

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17
Q

What government agency oversees controlled substances?

A

Drug Enforcement Administration (DEA)

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18
Q

How old must one be to purchase an exempt narcotic?

A

18 years old

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19
Q

Which government agency oversees safety in the workplace?

A

OSHA

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20
Q

What form is used to destroy controlled substances?

A

DEA Form 41

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21
Q

What organization oversees the practice of pharmacy within a state?

A

State Board of Pharmacy

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22
Q

What form is used to order Schedule II medications?

A

DEA Form 222

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23
Q

What is the maximum number of refills permitted on a Schedule III control Substance?

A

5

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24
Q

What form is used to report the theft of controlled substances?

A

DEA Form 106

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25
Q

What is the maximum number of refills permitted for a Schedule II medication?

A

0

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26
Q

What is the maximum number of different Schedule II medications that may be ordered at one time?

A

10

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27
Q

How long is a prescription with “prn” refills valid?

A

one year from the date it is written (12 months)

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28
Q

What letter must be stamped on an invoice or a prescription for a Schedule III medication?

A

a red C

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29
Q

How many times may a controlled substance be transferred from one pharmacy to another pharmacy?

A

one time

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30
Q

Who may counsel a patient?

A

a pharmacist

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31
Q

Within how many days must an Accutane prescription be filled?

A

7

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32
Q

What is the meaning of the acronym “HIPAA”?

A

Health Insurance Portability and Accountability Act

33
Q

What piece of legislation is known as the “prescription drug amendment”?

A

Durham-Humphrey Amendment

34
Q

Which law is being violated if a prescription is dispensed without a valid prescription?

A

Durham-Humphrey Amendment

35
Q

Which act introduced the terms “adulteration” and “misbranding”?

A

The Pure Drug Act

36
Q

What pharmacy law clearly DEFINED adulteration and misbranding?

A

the Food, Drug, and Cosmetic Act of 1938

37
Q

Which law mandated Drug Utilization be performed on every prescription?

A

OBRA ‘90

38
Q

Which law required that an offer to counsel must be made to every patent regarding his or her medication?

A

OBRA ‘90

39
Q

How much pseudoephedrine may be purchased at one time?

A

The Combat Methamphetamine Act allows an individual to purchase 3.6 g per day or a maximum of 9 g per month

40
Q

Which law requires that a pharmacy maintain accurate information on durable medical equipment?

A

FDA Safe Medical Device Act of 1990

41
Q

Which organization is responsible for overseeing the policies and procedures in handling hazardous substances in the pharmacy to protect the employee?

A

OSHA

42
Q

Which form is required to dispense controlled substances?

A

Form 224

43
Q

Which pharmacy law prohibits the sale or trading of drug samples or the distribution of samples to persons other than those licensed to prescribe them?

A

Prescription Drug Marketing Act of 1987

44
Q

Which law established standards of care for nursing homes?

A

OBRA ‘87

45
Q

Which government agency oversees OSHA?

A

Department of Labor

46
Q

Which drug law stated that all drugs must be pure, safe, and effective?

A

Kefauver-Harris Amendment

47
Q

What is an orphan drug used to treat?

A

rare diseases

48
Q

What term in civil law refers to personal injuries?

A

a tort

49
Q

What is negligence?

A

a type of tort in which the minimum standard of care was not met

50
Q

What is malpractice?

A

a form of negligence in which the standard of care was not met

51
Q

What is “standard of care”?

A

the expected level of care to be provided

52
Q

Which pharmacy law classified herbal products as dietary supplements rather than medications?

A

DSHEA 1994 (Dietary Supplement Health and Education Act)

53
Q

Which of the following drugs requires prescribers, pharmacists, and patients to register with the FDA iPledge program?

A

Isotretinoin

54
Q

Which piece of legislation requires a pharmacy to maintain a patient profile for each patient who has had a prescription filled?

A

OBRA ‘90

55
Q

What does OBRA stand for?

A

Omnibus Budget Reconciliation Act

56
Q

Which law is being violated if a pharmacist prepares a medication under unsanitary conditions?

A

FDCA of 1938

57
Q

How much time is considered “readily retrievable”?

A

72 hours

58
Q

What is the Federal Legend that must appear on all prescriptions?

A

“Caution: Federal law prohibits dispensing without a prescription”

59
Q

What law required that the Federal Legend (“Federal law prohibits the dispensing of this medication without a prescription”) appear on all prescription medication containers?

A

The Durham-Humphrey Amendment of 1951

60
Q

What law requires that the statement “Caution: Federal law prohibits the transfer of this prescription to anyone other than the intended” appear on all prescriptions of controlled substances?

A

Controlled Substance Act of 1970

61
Q

What statement is required on any OTC product that is not in a child-resistant package?

A

“Package Not Child Resistant”

62
Q

What law requires “Package Not Child Resistant” to be on any OTC product that is not in a child-resistant package?

A

Poison Control Act of 1970

63
Q

What act required the cautionary statement ““Warning—May be habit forming”?

A

Food, Drug and Cosmetic Act of 1938

64
Q

What is the maximum number of refills for a Schedule IV drug if authorized by the physician?

A

5

65
Q

Which pharmacy law prevents a prescription drug plan from requiring participants to use mail-order pharmacy only?

A

Prescription Drug Equity Act

66
Q

What is the purpose of the Any Willing Provider Law?

A

it allows any pharmacy to participate in an insurance plan as long as it is willing to meet the conditions of the contract

67
Q

What does the Freedom of Choice Law do?

A

allows participants to ask a pharmacy to participate in an insurance plan, but the pharmacy must agree to the conditions of the plan

68
Q

What do the Sherman Antitrust Laws promote?

A

free trade

69
Q

Whose regulations require that a long-term care facility must ensure that is free of significant medication error rates?

A

CMS

70
Q

What is included in protected patient information? (11)

A

Protected patient information includes the patient’s name, address info, phone numbers and emails; patient’s date of birth, sex, and race; National Health Service number; name of the residential or nursing home (if appropriate); doctor’s name; and details of dispensed medications,

71
Q

Which piece of legislation required that pharmaceutical manufacturers submit a New Drug Application with the FDA?

A

Food, Drug, and Cosmetic Act (FDCA)

72
Q

Which organization was responsible for the development of the Model State Pharmacy Practice Act (MSPPA)?

A

National Association of Boards of Pharmacy (NABP)

73
Q

Which piece of legislation distinguished the difference between prescription and over-the-counter medications?

A

Durham-Humphrey Ammendment

74
Q

A compounding pharmacy does not have a proper eyewash station on site. Which regulatory agency would cite the pharmacy with a violation?

A

OSHA

75
Q

Which piece of pharmacy legislation makes it illegal for anyone but the drug manufacturer to reimport a drug into the United States?

A

Prescription Drug Marketing Act of 1987

76
Q

Which pharmacy law addressed the treatment of patients in long-term facilities?

A

OBRA ‘87

77
Q

Which pharmacy law addressed adulteration and misbranding?

A

FDCA 1938

78
Q

Which pharmacy law addressed the portability of health insurance and patient confidentiality?

A

HIPAA

Pharmacy Law and Regulations (Domain 2) (1 decks)

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