Reading 1

Question 1

Law

Answer 1

The body of principles that govern conduct and the observance of which can be enforced in courts

Question 2

T/F: The law reflects whether something is morally or ethically right or wrong

Answer 2

False

Question 3

T/F: Following the law may not allow a pharmacist to provide the best care to their patient

Answer 3

True

Question 4

Statute

Answer 4

A written law enacted by the legislature

Question 5

Who reviews the laws?

Answer 5

Congress or the state legislature

Question 6

Who signs the laws?

Answer 6

President or state governor

Question 7

T/F: Laws go through a public comment and revision process

Answer 7

False

Question 8

Where are federal laws listed?

Answer 8

United States Code (USC)

Question 9

Where are Indiana laws listed?

Answer 9

Indiana Code (IC)

Question 10

Regulation (rule)

Answer 10

A rule having the force of law issued by an administrative agency (often provide detailed information on how to follow a particular law)

Question 11

Administrative agency

Answer 11

Groups of non-elected, although sometimes appointed, officials with expertise in the area of interest that are authorized to issue regulations within the law itself

Question 12

Administrative agencies that establish federal regulations for pharmacy

Answer 12

Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA)

Question 13

Promulgation process for regulations

Answer 13

Publication and comment process that a regulation must go through before it is final (if it does not go through this process, it can be challenged in court for failing to follow proper procedures)

Question 14

Where are federal regulations listed?

Answer 14

Code of Federal Regulations (CFR)

Question 15

Where are Indiana regulations listed?

Answer 15

Indiana Administrative Code (IAC)

Question 16

US Code citation

Answer 16

Title USC § section(subsections)

Question 17

Code of Federal Regulations citation

Answer 17

Title CFR §section(subsection)

Question 18

Location of most citations for pharmacy or drug-related topics in USC and CFR

Answer 18

Title 21 - Food and Drugs

Question 19

Indiana Code citation

Answer 19

IC title-article-chapter-sections

Question 20

Indiana Administrative Code citation

Answer 20

Title IAC article-chapter (also called rules in IAC)-section

Question 21

Legal actions for pharmacists who do not follow the law

Answer 21

Criminal, civil, and administrative actions

Question 22

Criminal action

Answer 22

When you break the law and face punishment from the state or federal government related to the breach

Question 23

Examples of criminal penalties

Answer 23

Fines and jail time

Question 24

Civil actions

Answer 24

Occur when one private party sues another because they believe they have been harmed by the other person’s conduct

Question 25

Result of civil action

Answer 25

Compensate the injured party for the damage caused by the wrongdoer

Question 26

Example of civil action

Answer 26

Getting sued/ going to court

Question 27

Causes of civil action

Answer 27

Liability, negligence, and malpractice

Question 28

Administrative action

Answer 28

Occurs when a professional violates a law or regulation, or when an administrative agency believes an activity warrants investigation (may result in a hearing to review the evidence related to the issue -> vote on whether a violation occurred and the sanction)

Question 29

Examples of sanctions (result of administrative action)

Answer 29

Warnings, fines, probation, license suspension, and license revocation