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7365 Pharm Prac Law > Chapter A > Flashcards

Chapter A Flashcards

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1
Q

Which act is designed to protect the public health by requiring the only safe, effective, and properly labeled drugs and devices be introduced into interstate commerce and to assure that food and cosmetics are safe and properly labeled?

A

Federal Food Drug and Cosmetic Act (FDCA) - 1938

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2
Q

Which act was passed in response to the Elixir Sulfanilamide tragedy?

A

Federal Food Drug and Cosmetic Act (FDCA) - 1938

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3
Q

Which act created the FDA as we know it today?

A

Federal Food Drug and Cosmetic Act (FDCA) - 1938

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4
Q

Which act requires that drugs which cannot be used safely without medical supervision must be dispensed only pursuant to a prescription?

A

Durham-Humphrey Amendments - 1951

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5
Q

Which act essentially created the OTC and prescription drug categories?

A

Durham-Humphrey Amendments - 1951

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6
Q

Which act was created in response to the discovery of birth defects caused by the drug thalidomide?

A

Kefauver-Harris Amendments - 1962

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7
Q

Which act required new drug products to be proven safe and effective?

A

Kefauver-Harris Amendments - 1962

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8
Q

Which act amended the FDCA to provide incentives for manufacturers to deliver and market drugs intended for. rare disease or medical condition?

A

Orphan Drug Act - 1983

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9
Q

What was the purpose of the 1984 Drug Price Competition and Patent Restoration Act (Hatch-Waxman Act)?

A

reduce healthcare costs

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10
Q

Which act codified the FDA’s authority to accept abbreviated NDAs for generic versions of “pioneer” drugs products first approved after 1962?

A

Drug Product Competition and Patent Restoration Act (Hatch-Waxman Act) - 1984

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11
Q

The Drug Product Competition and Patent Restoration Act (Hatch-Waxman Act) provides a __ day market exclusivity period for the first marketed generic.

A

180

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12
Q

The Drug Product Competition and Patent Restoration Act (Hatch-Waxman Act) gives brand name pharmaceutical companies a __ year exclusivity period.

A

5

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13
Q

Which act bans the reimportation of Rx human drugs produced in the US?

A

Prescription Drug Marketing Act of 1987 (PDMA)

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14
Q

Which act requires that all requests for drug samples be made in writing by licensed practitioners?

A

Prescription Drug Marketing Act of 1987 (PDMA)

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15
Q

Which act authorized the FDA to assess fees on manufacturers seeking approval of drugs or biologicals?

A

Prescription Drug User Fee Act (PDUFA) - 1992

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16
Q

Which act replaces “Caution: Federal law prohibits dispensing without a prescription” with “Rx only”?

A

FDA Modernization Act (FDAMA) - 1997

reauthorized user fees

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17
Q

Which act established the Reagan-Udall Foundation?

A

Food and Drug Administration Amendments Act (FDAAA) - 2007

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18
Q

Which act established the Risk Evaluation and Management Strategies (REMs) for certain drugs and biologics?

A

Food and Drug Administration Amendments Act (FDAAA) - 2007

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19
Q

Which act requires a toll-free number with new and refilled prescription drugs for reporting adverse drug effects?

A

Food and Drug Administration Amendments Act (FDAAA) - 2007

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20
Q

Which act creates an abbreviated approval pathway for biological products that are shown to be biosimilar?

A

Biologics Price Competition and Innovation Act - 2009

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21
Q

What book has FDA’s list of biosimilars?

A

The Purple Book

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22
Q

What act is title I of The Drug Quality and Security Act ?

A

Compounding Quality Act

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23
Q

What act was passed in response to an outbreak of fungal meningitis in fall 2012?

A

Compounding Quality Act

title I of The Drug Quality and Security Act

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24
Q

How long is the comment period for compound only drugs from bulk ingredients published in the Federal Register?

A

60 days

outsourcing facilities

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25
How often do outsourcing facilities report to the Secretary of HHS?
upon registering and every 6 months thereafter
26
Outsourcing facilities must report serious AEs within ___ days?
15
27
What is title II of the FDA Safety and Innovation Act of 2012?
Drug Supply Chain Security Act (Track and Trace)
28
The Drug Supply Chain Security Act (Track and Trace) mandates the transaction record must be available within ___ business days during suspect product investigations.
two
29
If a product is illegitimate, pharmacies should notify the FDA using what form?
FDA 3911 within 24 hours Title II - Drug Supply Chain Security Act (Track and Trace)
30
___ are articles intended to be rubbed, poured, etc into or on the body for the purpose of cleansing, beautifying, or altering the appearance of the body.
cosmetics
31
Which organization administers the Federal Controlled Substances Act?
DEA
32
What section defines prohibited Acts per the FDCA?
section 301
33
The OTC drug review was established to evaluate the safety and effectiveness of OTC drug produces marketed in the US before what date?
May 11, 1972 3 phases
34
Which phase of the OTC drug review was accomplished by advisory review panels?
phase 1
35
Which phase of the OTC drug review was the agency's review of ingredients?
phase 2
36
What category of OTC drug is generally recognized as safe and effective?
category I
37
What OTC category is not generally recognized as safe and effective?
category II
38
What OTC category has insufficient data available to permit final classification?
category III
39
Which phase of the OTC drug review was the creation of drug monographs?
phase 3
40
OTC monographs can be found in what section and chapter of the Code of Federal Regulations?
section 300 chapter 21
41
The FDA requires content labeling for OTC drugs containing levels of what 4 electrolytes that might be harmful to persons with certain underlying medical conditions?
- calcium - magnesium - sodium - potassium
42
OTC drugs containing __mg or more sodium in a single dose must state exact amount of a particular ingredient
5
43
OTC drugs containing __ mg or more calcium in a single dose must state exact amount of a particular ingredient.
20
44
OTC drugs containing __ mg or more magnesium in a single dose must state exact amount of a particular ingredient.
8
45
OTC drugs containing ___ mg or more potassium in a single dose must state exact amount of a particular ingredient.
5
46
Customers on restricted diets should consult with their physician before using oral OTC products the contain more than ___ mg of sodium
140
47
Customers on restricted diets should consult with their physician before using oral OTC products the contain more than ___ mg of calcium
3.2
48
Customers on restricted diets should consult with their physician before using oral OTC products the contain more than ___ mg of magnesium
600
49
Customers on restricted diets should consult with their physician before using oral OTC products the contain more than ___ mg of potassium.
975
50
Sodium phosphates are limited to ___ mL per OTC container.
90
51
Ipecac syrup may only be sold in ___ ounce containers.
1 30mL
52
Ipecac fluid extract is ___ times as potent as the syrup.
14
53
Phenacetin (acetophenetidin) must contain warnings about possible ___ damage when taken in large amounts or for a long period of time.
kidney
54
Retail containers of ___ grain (pediatric) aspirin tablets cannot be distributed in retail containers containing more than ___ tablets.
1.25, 36
55
Internal analgesics and antipyretics are required to have a warning for persons consuming ___ or more alcoholic beverages per day.
3
56
NSAID product labeling must contain a "stomach bleeding warning" which highlights the potential for stomach bleeding in persons over ___ years of age.
60
57
If an OTC drug is filled as an Rx it is deemed a prescription drug. a. true b. false
a. true
58
What class recall exists where there is a reasonable possibility that the use of or exposure to a violative product will cause serious AEs on health or death?
class I
59
What class recall exists where the use of or exposure to a violative product may cause temporary or medically reversible AEs on health or where the probability to cause adverse health consequences?
class II
60
What class recall exists where the use of or exposure to a violative product is not likely to cause adverse health consequences?
class III
61
The FDA has the authority to order a recall of what items?
- controlled substances - devices - biological products - tobacco products - foods (including dietary supplements)
62
Who regulates prescription drug advertising?
FDA
63
Who regulates OTC advertising?
FTC
64
the FDA requires pharmacists provide patient package inserts (PPIs) with what two type of products?
- oral contraceptives | - estrogen containing products
65
6 components of a risk evaluation and mitigation strategy (REMS)
- medication guide - patient package insert - communication plan - elements to assure safe use - implementation system - timetable
66
What is the name of the Accutane (isotretinoin) REMS program?
iPLEDGE
67
The Accutane (isotretinoin) REMS program states that prescriptions must be picked up within ____ days of a pregnancy test
7 30 day maximum supply may be dispensed
68
What is required to be affixed to all Lotronex prescriptions?
Prescribing Program Sticker
69
What act allows manufacturers to distribute literature containing unlabeled (off-label) use under certain conditions?
1997 FDA Modernization Act
70
What new drug classification type appears to represent an advance over available therapy?
type P
71
What new drug classification type appears to have therapeutic qualities similar to those of an already marketed drug?
type S
72
What new drug classification type treats a rare disease affecting fewer than 200,000 Americans?
type O
73
How many digits are in an National drug Code (NDC) number?
10 first segment identifies manufacturer second segment identifies strength, dosage form formulation third segment identifies package size/type
74
The NDC is required to be on the manufacturer's label. a. true b. false
b. false
75
What blood has information on therapeutic equivalent drugs?
FDA Orange Book
76
What category (Orange Book) indicates drug products that the FDA considers pharmaceutically equivalent?
A
77
What category (Orange Book) indicates drug products that the FDA considers NOT pharmaceutically equivalent?
B
78
An ___ biological product is biosimilar to an FDA approved reference product and meets additional standards.
interchangeable
79
What act makes dietary supplement manufacturers responsible for determining that the dietary supplements they manufacture or distribute are safe?
Dietary Supplement and Health Education Act of 1994 (DSHEA)
80
3 type of claims allowed for dietary supplements per the DSHEA?
- health claims - structure/function claims - nutrient content claims
81
What act requires dietary supplement manufacturers, packers, or distributors to report serious AEs to the FDA?
Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006
82
Serious dietary supplement adverse events must be submitted to the FDA on what form?
MedWatch Form 3500A
83
Serious dietary supplement AEs must be submitted to the FDA no later than __ business days after the report is received by the responsible person.
15
84
Needles, scissors, stethoscopes, toothbrushes, tongue depressors, ice bag, and eye pads are what class medical devices?
class I
85
Insulin syringes, thermometers, diagnostic reagents, tampons, BP gauges, and electric heating pads are what class medical devices?
class II
86
Pacemakers, intraocular lenses, replacement heart valves, insulin pumps, and breast implants are what class medical devices?
class III
87
What act created the 3 class, risk based classification system for all medical devices?
Medical Device Amendments of 1976
88
What act authorized the FDA to ban devices?
Medical Device Amendments of 1976
89
What act required a "device user facility" to report to the FDA when aware a device caused facilty's patient death?
Safe Medical Device Act of 1990
90
Which act created the Humanitarian Use Device (HUD)/Humanitarian Device Exemption (HDE) programs to encourage development of devices targeting rare diseases?
Safe Medical Device Act of 1990
91
What act required device distributors to maintain records and provide info to help the FDA locate a pt in the event of a device recall?
Medical Device Amendments of 1992
92
What act established the De Novo program through which novel low to moderate risk devices could be classified into Class I or II instead of automatically classifying them into Class III?
Food and Drug Administration Modernization Act of 1997 (FDAMA)
93
What act granted the FDA authority to collect user fees for select medical device pre-market submissions to help the FDA improve efficiency, quality, and predictability of medical device submission reviews?
Medical Device User Fee and Modernization Act of 2002
94
What act required the FDA establish a unique device identification system for medical devices?
Food and Drug Administration Amendments Act of 2007
95
What act mandated the creation or revision of policies and processes intended to speed patient access to new medical devices?
21st century Cures Act of 2016
96
What act required the FDA to conduct at least one pilot project to explore how real-world evidence can improve post market surveillance?
Food and Drug Administration Reauthorization Act of 2017
97
Who enforces the Federal Hazardous Substances Act of 1966?
Consumer Product Safety Commission (CPSC)
98
A ___ substance is a substance or mixture of substances that can cause injury or illness through handling and that can cause potential danger, especially to children if misused?
hazardous
99
A ___ substance is any substance which has the capacity to produce personal injury or illness to a human though ingestion, inhalation, or absorption through any bodily surface?
toxic
100
A highly toxic oral dose of __ mg or less per Kg of body weight would kill half or more of the white rats to which it is fed?
50

7365 Pharm Prac Law (3 decks)

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