The Law and Legal System

Question 1

What is the general Definition of Law?

Answer 1

1. Requirement for human conduct applying to all persons within their jurisdiction
2. Commanding what is right
3. Prohibiting what is wrong
4. Imposing penalties for violations

Question 2

What are the important features pertaining to pharmacy practices?

Answer 2

1. Assumes existence of a decision maker; legislative, administrative agency, or court providing definitive rulings
2. Framework for practice situations
3. Professional judgment

Question 3

What is De Minimis Violations?

Answer 3

Falls under the limits of the law, minor violations (least serious)

Question 4

What are De Minimis Violations?

Answer 4

1. Occasional technical violation
2. No impact on quality of drug therapy
3. Professional judgment, ‘best interest’
4. Frequency, repetition

Question 5

What are Sources of Law?

Answer 5

1. U.S. Constitution
2. Legislatures
3. Administrative Agencies
4. Courts

Question 6

What does CFR stand for?

Answer 6

Code of Federal Regulations

Question 7

What is the Federal Register?

Answer 7

Daily publication of PROPOSED and FINAL regulations divided

Question 8

What is the CFR?

Answer 8

Compilation of FINAL regulations divided and indexed by subject matter

Question 9

What is the Legislative Function of administrative agencies?

Answer 9

Promulgate Regulations

Question 10

What does it mean to Promulgate Regulations?

Answer 10

Regulations interpretation, define, and add detail to statues

Question 11

What are the components of validity test of a regulation?

Answer 11

1. Within scope of board’s authority
2. Based on statutory authority
3. Reasonable relationship to public health, safety, and welfare

Question 12

What is the Judicial Function of administrative agencies?

Answer 12

Render decisions pursuant to ‘hearings’ resembling court proceedings

Question 13

What are decisions subjected to judicial review?

Answer 13

Review the record to determine if the decision was based on substantial review, and if substantial evidence is lacking the court will conduct an entirely new trial

Question 14

What is Common Law?

Answer 14

Law made by courts, refers to Judicial Opinion

Question 15

What are Judicial Opinions?

Answer 15

Decisions of Court
1. Enforceable as Law
2. Binding on lower courts in the same jurisdiction
3. Considered by courts outside the jurisdiction

Question 16

What is Stare Decisis?

Answer 16

To abide by decided cases

Question 17

What does Stare Decisis do to lower courts?

Answer 17

Opinions are binding on lower courts in the same jurisdiction and severe as a PRECEDENT

Question 18

What are reasons for Deviating from precedent?

Answer 18

Factual Distinctions and Changing Times/Circumstances

Question 19

What is a factual distinction?

Answer 19

Legal counsel may bring in precedent but the circumstances are different so it does not apply

Question 20

Implication Outside Jurisdiction?

Answer 20

If something comes up in another state, it may not apply to yours right now but may in the future

Question 21

In relation of Common Law and Statutory Law, what must the Courts do?

Answer 21

Courts often must interpret the meaning and application of statutes

Question 22

What are the Principles of Interpretation?

Answer 22

1. Determining legislative intent, if possible
2. Ordinary meaning of words
3. Due process rights of the individual

Question 23

What is an Administrative Proceeding?

Answer 23

Agency vs. Private Party
Include warnings, fines, licensure revocation/suspension, and probation

Question 24

What is a Civil Proceeding?

Answer 24

Private Party vs. Private Party
Based upon statue or common law
Compensation to injured party

Question 25

What is a Criminal Proceeding?

Answer 25

Government vs. Private Party
Charged with a crime as prohibited by a statue
Deter, Punish, and Rehabilitate

Question 26

What type of proceedings can happen in the world of pharmacy?

Answer 26

All three: administrative, civil, and criminal

Question 27

What is a Plaintiff?

Answer 27

Person bringing the action

Question 28

What is a Defendant?

Answer 28

Person action is brought against

Question 29

Whose name appears first in the title of the case?

Answer 29

Plaintiff

Question 30

How does the Plaintiff prove Standing?

Answer 30

The challenged conduct has caused the plaintiff injury and there is a legally protectable interest

Question 31

What is the civil court procedure for Witnesses?

Answer 31

1. May be subject to subpoena, an order to appear to court
2. Failure to appear may result in contempt of court

Question 32

What is the civil court procedure for an Expert Witnesses?

Answer 32

Called when the factual subject matter is beyond the scope of jurors

Question 33

What is the criminal court procedure Burden of Proof?

Answer 33

Beyond a reasonable doubt, contrast to civil court trial, where “preponderance of evidence” is the standard

Question 34

Pharmacy practice and drug distribution are subject to what?

Answer 34

Both Federal and State Regulation

Question 35

Federal authority to regulate is based on what?

Answer 35

Interstate Commerce Clause of U.S. Constitution

Question 36

State authority to regulate is based on what?

Answer 36

Tenth Amendment of the U.S. Constitution under inherent Police Powers

Question 37

What law preempts the other?

Answer 37

Federal law preempts state law

Question 38

What is the Supremacy Clause of the U.S. Constitution?

Answer 38

When federal and state law conflict, federal law will preempt state law
Preemption Doctrine

Question 39

Can State pharmacy law/regulation be more than strict than Federal?

Answer 39

YES, not a conflict, there is conflict when state law is less strict than federal