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NYS MPJE 2024 > Federal Laws/Acts/Amendments > Flashcards

Federal Laws/Acts/Amendments Flashcards

1
Q

When was the Pure Food and Drug Act established?

A

1906

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2
Q

What did the Pure Food and Drug Act do? (2 major things)

A

-Prohibited food and drugs that were distributed through interstate commerce to be adulterated or misbranded
-Required a label to be placed on products

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3
Q

What did the Pure Food and Drug Act NOT do? (4 things)

A

Require manufacturers to list ingredients
Require manufacturers to label directions for use
Regulate cosmetic products
Regulate medical devices

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4
Q

When was the Food, Drug, and Cosmetic Act created?

A

1938

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5
Q

Why was the Food, Drug, and Cosmetic Act created?

A

In 1937, there were 107 deaths from antifreeze

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6
Q

Significance of the Food, Drug, and Cosmetic Act of 1938

A

It required any new drug wanting to be placed on the market to be tested for safety when used according to directions on the label

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7
Q

Requirements created from the Food, Drug, and Cosmetic Act

A

Adequate directions for use and required warnings about habit-forming drugs contained in the product

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8
Q

The Food, Drug, and Cosmetic Act was the first law that applied to what?

A

Cosmetic products and medical devices

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9
Q

What happened with drugs that were approved before the Food, Drug, and Cosmetic Act?

A

They were grandfathered into the system (Synthroid, digoxin, NTG, phenobarbital)

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10
Q

The Food, Drug, and Cosmetic Act also established what major government organization?

A

The FDA!

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11
Q

When was the Durham-Humphrey Amendment passed?

A

1951

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12
Q

What was the Durham-Humphrey Amendment added onto?

A

The Food, Drug, and Cosmetic Act (FDCA)

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13
Q

What did the Durham-Humphrey Amendment establish?

A

Legend and OTC drugs

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14
Q

What are legend drugs?

A

Drug that require medical supervision (so basically prescription drugs)

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15
Q

Legend drugs do not have to list what?

A

“Adequate directions for use”

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16
Q

Legend drugs require what on the label?

A

“Caution: federal law prohibits dispensing without a prescription”

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17
Q

What are OTC drugs

A

Drugs that don’t require medical supervision for use

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18
Q

What do OTC drugs require on the label?

A

“Adequate directions for use”

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19
Q

What did the Durham-Humphrey Amendment also provide?

A

Verbals and prescription refills

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20
Q

When was the Kefauver-Harris Amendment established?

A

1962

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21
Q

What was the Kefauver-Harris Amendment added onto?

A

The FDCA

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22
Q

Why was the Kefauver-Harris Amendment established?

A

Public concerns over the birth defects of thalidomide

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23
Q

What did the Kefauver-Harris Amendment put into law?

A

All new drugs marketed in the US had to be shown to be SAFE AND EFFECTIVE

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24
Q

What happened to the drugs that were approved before the Kefauver-Harris Amendment was passed?

A

All the drugs approved between 1938-1962 had to undergo re-testing

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25
Q

According to the K-H Amendment, who has the authority over prescription drug advertising?

A

The FDA

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26
Q

What do research subjects in clinical investigations have to do according to the K-H A?

A

Give informed consent

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27
Q

According to the K-H A, what is now required to report?

A

ADRs

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28
Q

What did the K-H A create?

A

Good Manufacturing Practices (GMP) requirements

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29
Q

What do GMPs do?

A

Define conditions for drug manufacture in the US

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30
Q

Exception to GMPs

A

Not required for compounding products or supplements

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31
Q

When was the Medical Device Amendment created?

A

1976

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32
Q

What is the Medical Device Amendment an amendment to?

A

The FDCA

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33
Q

What does the Medical Device Amendment do?

A

Provides for better classification of medical devices

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34
Q

According to the Medical Device Amendment, how do you classify a medical device?

A

According to specific function
Establishment of performance standards
Meets pre-market approval requirements
Conformance with GMP standards
Requirements for adherence to record and reporting requirements

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35
Q

When was the Orphan Drug Act created?

A

1983

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36
Q

What is an orphan drug?

A

A drug used to treat diseases that affect less than 200K people that has limited potential for profitability

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37
Q

What did the Orphan Drug Act provide?

A

Various tax and licensing incentives to manufacturers to make the development of orphan drugs more appealing

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38
Q

When was the Drug Price Competition and Patent-Term Restoration Act created?

A

1984

39
Q

Other name for the Drug Price Competition and Patent-Term Restoration Act

A

Waxman-Hatch Amendment

40
Q

What was the Waxman-Hatch Amendment an addition to?

A

The FDCA

41
Q

Why was the Waxman-Hatch Amendment created?

A

It attempted to resolve a dispute between generic drug and brand name manufacturers

42
Q

What did the Waxman-Hatch Amendment do?

A

Streamlined drug approval process for generic drugs- they needed to show bioequivalence

43
Q

What did the Waxman-Hatch Amendment provide?

A

Innovative drug manufacturers with incentives to develop new drug products

44
Q

When was the Prescription Drug Marketing Act created?

A

1987

45
Q

What did the Prescription Drug Marketing Act do?

A

Control distribution of prescription drug samples

46
Q

What did the Prescription Drug Marketing Act prevent?

A

They prevented hospitals and other healthcare entities from reselling pharmaceuticals to other businesses to prevent fraud/abuse

47
Q

When was the FDA Modernization Act created?

A

1997

48
Q

FDA Modernization Act: fast-track review

A

It allowed a fast-track review of New Drug Applications (NDAs) to expedite approval of new drugs for serious or life-threatening conditions (like AIDS)

49
Q

FDA Modernization Act: clarifications about compounding

A

Individual states need to regulate compounding

Pharmacies are exempt from the strict regulatory federal GMP standards and requirements for submission of NDAs

50
Q

FDA Modernization Act: change of prescription drug legend

A

Changed “Caution: federal law prohibits dispensing without a prescription” to “Rx only”

51
Q

FDA Modernization Act: provision that required certain substances to be labeled

A

“Warning- may be habit forming” was eliminated

52
Q

FDA Modernization Act: manufacturers and research

A

Encouraged manufacturers to conduct research for new uses of current drugs and submit supplemental NDAs for new uses

53
Q

What can manufacturers do about unapproved uses of an FDA-approved drug?

A

They can publicly disseminate limited information on such unapproved uses if a statement is included specifying that the use isn’t FDA-approved

54
Q

When was the Combat Methamphetamine Epidemic Act created?

A

2005

55
Q

Purpose of CMEA

A

Enacted to curb the illicit production of methamphetamine, so it regulates the sale of OTC meds containing PSE

56
Q

Daily sales limit on PSE

A

3.6 grams/day

57
Q

Monthly purchase limit on PSE

A

9g in a 30-day period

58
Q

Monthly purchase limit on PSE for mail-order/mobile retail

A

7.5g in a 30-day period

59
Q

When was the Affordable Care Act signed?

A

2010 (Obama Care)

60
Q

What did the ACA require of all individuals?

A

To have healthcare!

61
Q

How did the ACA allow people to get healthcare?

A

Health insurance exchanges were created, which allowed individuals and families to purchase health insurance with subsidies available based on their federal poverty level

Small businesses received tax credits if they provided healthcare coverage to employees

62
Q

What did the ACA do for transactions?

A

They required timely and transparent claims using standard electronic transactions

63
Q

What did the ACA stop?

A

Agreements between brand name and generic drug manufacturers that limit or delay competition from generic drugs

64
Q

What did the ACA start to phase out?

A

The donut hole (coverage gap) when patients have to cover the entire cost of their prescription meds themselves

I think as of 2024 that the donut hole closed

65
Q

When was the Inflation Reduction Act signed?

A

2022

66
Q

What did the Inflation Reduction Act require of the federal government?

A

Required the federal government to negotiate prices for some drugs covered under Medicare Part B and D with the highest total spending starting in 2026

67
Q

What did the Inflation Reduction Act require of drug companies?

A

Drug companies have to pay rebates to Medicare if prices rise faster than inflation for drugs used by Medicare beneficiaries starting in 2023

68
Q

What did the Inflation Reduction Act cap?

A

It capped OOP spending for Medicare Part D enrollees and made other Part D benefit design changes starting in 2024

69
Q

What did the Inflation Reduction Act do for the price of insulin?

A

Limited the monthly cost sharing for insulin to $35 for people with Medicare starting in 2023

70
Q

What did the Inflation Reduction Act do for vaccine costs?

A

Eliminated cost-sharing for adult vaccines covered under Part D and improved access to adult vaccines in Medicaid and CHIP starting in 2023

71
Q

What did the Inflation Reduction Act do for benefit eligibilities?

A

It expanded the eligibility for full benefits under the Part D Low-Income Subsidy Program starting in 2024

72
Q

What did the Inflation Reduction Act delay?

A

The Trump administration’s drug rebate rule starting in 2027

73
Q

When was the Drug Quality and Security Act signed?

A

2013

74
Q

What do the electronic tracing systems from the DQSA do?

A

They protect US consumers by readily identifying compromised prescription pharmaceutical products, including those that may be counterfeit, stolen, contaminated, dangerous, or harmful. Then it will be removed from the supply chain

74
Q

What requirements did the DQSA create?

A

It created requirements for trading partners regarding the tracing of prescription pharmaceutical products during distribution across the US

74
Q

Primary goal of HITECH

A

Promote the adoption and meaningful use of health information technology across the US healthcare system

75
Q

How did HITECH get people to adopt EHRs?

A

It provided HCPs, hospitals, and clinics incentives via Medicare and Medicaid to adopt EHRs

76
Q

How did HITECH allow people to get incentives?

A

They had “meaningful use” criteria people had to meet

77
Q

What happens to providers who don’t adopt EHRs?

A

They get penalized by getting reduced Medicare reimbursements

78
Q

HIPAA/HITECH Violation Tier 1

A

Person didn’t know that the person violated the provision (and the person wouldn’t have known)

79
Q

HIPAA/HITECH Violation Tier 2

A

Violation was due to reasonable cause and not willful neglect

80
Q

HIPAA/HITECH violation Tier 3

A

Violation was due to willful neglect that’s timely corrected

81
Q

HIPAA/HITECH violation Tier 4

A

Violation was due to willful neglect that isn’t timely corrected

82
Q

What did HITECH facilitate the creation of?

A

Health information exchanges (HIEs) that allow the secure exchange of health information between different healthcare organizations

83
Q

What is an adulterated drug according to NYS?

A

If a drug’s strength, purity, or quality differs from what it claims or if substances are mixed to reduce its quality

So basically: if the drug’s strength, purity, or quality falls below the standards in an official compendium

84
Q

What is a misbranded drug according to NYS?

A

Its labeling is false or misleading, lacks required information such as manufacturer details or content quantity, or fails to present necessary information conspicuously to be read under normal conditions

So basically: if the packaging is misleading, it imitates another drug, or is sold under another drug’s name

85
Q

Misbranded drugs: drugs that contain habit-forming substances have to have what?

A

A warning label

86
Q

Misbranded drugs: what should compounded drugs/drugs not recognized in an official compendium have?

A

Bear the common or usual name and active ingredients

87
Q

Misbranded drugs: what should labeling include?

A

Adequate usage directions and warnings, ensure that it meets compendium standards, and avoid imitating or misleading consumers about the drug’s identity or origin

88
Q

FDA Class I Recall definition

A

There is a reasonable probability that the use of, or exposure to a violative product, will cause serious adverse health consequences or death

89
Q

FDA Class II Recall definition

A

Use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

90
Q

FDA Class III Recall definition

A

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

91
Q

Market withdrawal definition

A

Occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation.

92
Q

Medical safety device alert definition

A

Issued in situations where a medical device may present an unreasonable risk of substantial harm. In some cases, it can be a recall

NYS MPJE 2024 (27 decks)

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