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Pharmacy Law > Block 1 > Flashcards

Block 1 Flashcards

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1
Q

Where does policy come from?

A

Non-public source

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2
Q

Define Law

A

Body of principles that govern conduct and the observance of which can be enforced by the government, or that which must be obeyed and followed by citizens or be subject to legal sanctions or consequences.

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3
Q

Define Ethics

A

Standards of behavior enforced by professional organizations

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4
Q

Define Mores

A

Standards of behavior made by society and enforced by peer pressure

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5
Q

What are the two things John Locke made?

A

State of Nature and Social Contract

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6
Q

Define Police Power

A

Authority of government to make laws related to public health, safety, and welfare

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7
Q

What level of government does Police Power exist?

A

State

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8
Q

How can the Federal government obtain Police Power?

A

Commerce Clause

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9
Q

What branch of government makes laws, allocates money, and confirms presidential appointments?

A

Legislative Branch

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10
Q

What branch of government interprets the laws?

A

Judicial Branch

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11
Q

What branch of government enforces the laws?

A

Executive Branch

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12
Q

Define Employment at Will.

A

Employment at Will is when there is no contract between you and the employer.

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13
Q

What are the 4 types of law?

A

Constitution, Treaty, Statute, and Regulation

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14
Q

Out of the 4 types of law, which is the highest form and which is the lowest?

A

Constitution is the highest and Regulation is the lowest.

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15
Q

What convention did the US sign a treaty to make marijuana an illegal substance?

A

Single National Convention on Drugs in 1961

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16
Q

What is a law called that is enacted by the legislature (federal or state)?

A

Statute

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17
Q

What are 3 sources of Law?

A

Common Law, Judicial or Case Law, and Stare Decisis

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18
Q

Describe Common Law.

A

Body of legal principles that came over from England. It formed the bases of our legal system

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19
Q

Describe Judicial or Case Law.

A

Law that comes from judges deciding cases. This source of Law comes for the US.

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20
Q

Describe Stare Decisis.

A

Means the decision stands. Rule of Precedent. This is when a decision from a similar case will be the ruling of the new case.

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21
Q

How does Stare Decisis help lawyers?

A

It helps them give legal advice based off the prior case.

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22
Q

When did Equity start?

A

Equity started in England in the Middle Ages and was brought to the US.

23
Q

Define Equity.

A

Equity is a court where you can get something other than money if you were wronged.

24
Q

Injunction

A

Court order for someone to stop doing something

25
Q

UCC

A

Uniform Commercial Code

Model Statute taht deals with commercial issues

26
Q

Model Pharmacy Act

A

Model Statute

Only 3 states accepted it, but the wording from it is used by many states in their own versions of the statute

27
Q

Import Drug Act

A

1848

Prohibited importation of adulterated drugs

28
Q

Wiley-Heyburn Act

A

Federal Pure Food and Drug Act of 1906

Major advancement in prohibiting adulterated and misbranded drugs and foods

29
Q

Sulfanilamide Tragedy

A

1937
ethylene glycol was being used as a base for an elixir
Lead to the Federal Food, Drug, and Cosmetic Act of 1938

30
Q

Federal Food, Drug, and Cosmetic Act of 1938

A

Gave FDA primary enforcement authority
Prohibited interstate commerce from being adulterated or misbranded
Made it where only a pharmacist could dispense a drug with a written prescription and there were no refills allowed

31
Q

Durham-Humphrey Amendment

A

1952
Amendment to the Federal Food, Drug, and Cosmetic Act
Separated OTC from Rx drugs.
Allowed oral prescriptions and allowed refills if they were allowed on the original prescription, orally given to the pharmacist, or dispensed by the practitioner.
Also allowed the states to decide who can prescribe

32
Q

Thalidomide Tragedy

A

1961
Caused birth defects in infants
Lead to the Kefauver-Harris Amendment in 1963

33
Q

Kefauver-Harris Amendment

A

1963
Required the manufacturer to prove safety and efficacy of drugs to the FDA. This was for all drugs made after 1962 and for drugs between 1938 and 1962 for which NDAs had been approved.
It required the FDA to approve the drug instead of disapproving it.
Grandfather Clause exempted drugs made before 1938.

34
Q

Drug Price Competition and Patent Term Restoration Act of 1984

A

FDCA Amendment
Waxman-Hatch Act
Struck a balance between generic and brand name manufacturers
Made it where generic needed to prove bioequivalence

35
Q

Prescription Drug Marketing Act of 1987

A

FDCA Amendment

Reduced the public risk of having prescription drugs be advertised on commercial channels

36
Q

Food and Drug Administration Modernization Act of 1997

A

Major overhaul of FDCA
Clarified that compounding pharmaceuticals was regulated by states
Allowed some pharmacies to compound medication before they received that prescription for a specific patient
Banned advertising compounding services and soliciting prescriptions for compounding
Required that before dispensing the label of a prescription product contain “Rx only” (eliminated the Federal Legend”

37
Q

Drug Quality and Security Act of 2013

A

FDCA Amendment
Eliminated bans on solicitation and advertising from FDAMA of ‘97
Established “Outsourcing Facilities”
Established “Track and Trace”

38
Q

Poison Prevention Packaging Act of 1970

A

Allowed Consumer Product Safety Commission to establish standards for child-resistant caps

39
Q

Comprehensive Drug Abuse Prevention and Control Act of 1970

A

Principal law regulating drugs that are subject to or have potential for abuse or physical or psychological dependence
Enforced by the Drug Enforcement Administration

40
Q

Title 21-Food and Drugs, Chapter 1

A

Says FDA sets regulations for Food, Drug, and Cosmetic Act

41
Q

Title 21-Food and Drugs, Chapter 2

A

Says DEA sets regulations for Federal Controlled Substances Act

42
Q

OBRA ‘90

A

Omnibus Reconciliation Act of 1990
Stated, “In order to participated in Medicaid, states must have in place drug use review (DUR) programs, require pharmacists to offer counseling to Medicaid recipients, and require pharmacists to make reasonable efforts to obtain, record, and maintain patient medication records

43
Q

HIPAA

A

Health Insurance Portability and Accountability Act of 1996
Title 2-Administrative Simplification
Protects privacy and security
Creates a National Provider Identifiers
Required pharmacy to have backup system for records

44
Q

Electronic Signatures in Global and National Commerce Act

A

Allowed the use of electronic prescriptions

45
Q

Affordable care Act of 2010

A

Allowed pharmacists to provide MTM

46
Q

Kentucky Revised Statute (KRS 315) Chapter 315

A

1960

Established the Kentucky Board of Pharmacy

47
Q

KRS 218A

A 
Controlled Substances (1972)
Kentucky's "Controlled Substances Act"
48
Q

KRS 217

A

Foods, Drugs, and Poisons (1960)

Kentucky’s Food, Drug, and Cosmetic Act

49
Q

Kentucky Administrative Regulation Title 902 Chapter 55

A

Controlled Substances

50
Q

KAR 201.2

A

Board of Pharmacy

51
Q

USC

A

United States Code

Statutes made by Federal Government

52
Q

CFR

A

Code of Federal Regulations

53
Q

KRS

A

Kentucky Revised Statute

54
Q

KAR

A

Kentucky Administrative Regulations

Pharmacy Law (1 decks)

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