Block 1

Question 1

Where does policy come from?

Answer 1

Non-public source

Question 2

Define Law

Answer 2

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.

Question 3

Define Ethics

Answer 3

Standards of behavior enforced by professional organizations

Question 4

Define Mores

Answer 4

Standards of behavior made by society and enforced by peer pressure

Question 5

What are the two things John Locke made?

Answer 5

State of Nature and Social Contract

Question 6

Define Police Power

Answer 6

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

Question 7

What level of government does Police Power exist?

Answer 7

State

Question 8

How can the Federal government obtain Police Power?

Answer 8

Commerce Clause

Question 9

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

Answer 9

Legislative Branch

Question 10

What branch of government interprets the laws?

Answer 10

Judicial Branch

Question 11

What branch of government enforces the laws?

Answer 11

Executive Branch

Question 12

Define Employment at Will.

Answer 12

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

Question 13

What are the 4 types of law?

Answer 13

Constitution, Treaty, Statute, and Regulation

Question 14

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

Answer 14

Constitution is the highest and Regulation is the lowest.

Question 15

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

Answer 15

Single National Convention on Drugs in 1961

Question 16

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

Answer 16

Statute

Question 17

What are 3 sources of Law?

Answer 17

Common Law, Judicial or Case Law, and Stare Decisis

Question 18

Describe Common Law.

Answer 18

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

Question 19

Describe Judicial or Case Law.

Answer 19

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

Question 20

Describe Stare Decisis.

Answer 20

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

Question 21

How does Stare Decisis help lawyers?

Answer 21

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

Question 22

When did Equity start?

Answer 22

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

Question 23

Define Equity.

Answer 23

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

Question 24

Injunction

Answer 24

Court order for someone to stop doing something

Question 25

UCC

Answer 25

Uniform Commercial Code | Model Statute taht deals with commercial issues

Question 26

Model Pharmacy Act

Answer 26

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

Question 27

Import Drug Act

Answer 27

1848 | Prohibited importation of adulterated drugs

Question 28

Wiley-Heyburn Act

Answer 28

Federal Pure Food and Drug Act of 1906 | Major advancement in prohibiting adulterated and misbranded drugs and foods

Question 29

Sulfanilamide Tragedy

Answer 29

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

Question 30

Federal Food, Drug, and Cosmetic Act of 1938

Answer 30

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

Question 31

Durham-Humphrey Amendment

Answer 31

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

Question 32

Thalidomide Tragedy

Answer 32

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

Question 33

Kefauver-Harris Amendment

Answer 33

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.

Question 34

Drug Price Competition and Patent Term Restoration Act of 1984

Answer 34

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

Question 35

Prescription Drug Marketing Act of 1987

Answer 35

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

Question 36

Food and Drug Administration Modernization Act of 1997

Answer 36

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"

Question 37

Drug Quality and Security Act of 2013

Answer 37

FDCA Amendment Eliminated bans on solicitation and advertising from FDAMA of '97 Established "Outsourcing Facilities" Established "Track and Trace"

Question 38

Poison Prevention Packaging Act of 1970

Answer 38

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

Question 39

Comprehensive Drug Abuse Prevention and Control Act of 1970

Answer 39

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

Question 40

Title 21-Food and Drugs, Chapter 1

Answer 40

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

Question 41

Title 21-Food and Drugs, Chapter 2

Answer 41

Says DEA sets regulations for Federal Controlled Substances Act

Question 42

OBRA '90

Answer 42

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

Question 43

HIPAA

Answer 43

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

Question 44

Electronic Signatures in Global and National Commerce Act

Answer 44

Allowed the use of electronic prescriptions

Question 45

Affordable care Act of 2010

Answer 45

Allowed pharmacists to provide MTM

Question 46

Kentucky Revised Statute (KRS 315) Chapter 315

Answer 46

1960 | Established the Kentucky Board of Pharmacy

Question 47

KRS 218A

Answer 47

``` Controlled Substances (1972) Kentucky's "Controlled Substances Act" ```

Question 48

KRS 217

Answer 48

Foods, Drugs, and Poisons (1960) | Kentucky's Food, Drug, and Cosmetic Act

Question 49

Kentucky Administrative Regulation Title 902 Chapter 55

Answer 49

Controlled Substances

Question 50

KAR 201.2

Answer 50

Board of Pharmacy

Question 51

USC

Answer 51

United States Code | Statutes made by Federal Government

Question 52

CFR

Answer 52

Code of Federal Regulations

Question 53

KRS

Answer 53

Kentucky Revised Statute

Question 54

KAR

Answer 54

Kentucky Administrative Regulations