The Law and Legal System Flashcards
What is the general Definition of Law?
- Requirement for human conduct applying to all persons within their jurisdiction
- Commanding what is right
- Prohibiting what is wrong
- Imposing penalties for violations
What are the important features pertaining to pharmacy practices?
- Assumes existence of a decision maker; legislative, administrative agency, or court providing definitive rulings
- Framework for practice situations
- Professional judgment
What is De Minimis Violations?
Falls under the limits of the law, minor violations (least serious)
What are De Minimis Violations?
- Occasional technical violation
- No impact on quality of drug therapy
- Professional judgment, ‘best interest’
- Frequency, repetition
What are Sources of Law?
- U.S. Constitution
- Legislatures
- Administrative Agencies
- Courts
What does CFR stand for?
Code of Federal Regulations
What is the Federal Register?
Daily publication of PROPOSED and FINAL regulations divided
What is the CFR?
Compilation of FINAL regulations divided and indexed by subject matter
What is the Legislative Function of administrative agencies?
Promulgate Regulations
What does it mean to Promulgate Regulations?
Regulations interpretation, define, and add detail to statues
What are the components of validity test of a regulation?
- Within scope of board’s authority
- Based on statutory authority
- Reasonable relationship to public health, safety, and welfare
What is the Judicial Function of administrative agencies?
Render decisions pursuant to ‘hearings’ resembling court proceedings
What are decisions subjected to judicial review?
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
What is Common Law?
Law made by courts, refers to Judicial Opinion
What are Judicial Opinions?
Decisions of Court
1. Enforceable as Law
2. Binding on lower courts in the same jurisdiction
3. Considered by courts outside the jurisdiction
What is Stare Decisis?
To abide by decided cases
What does Stare Decisis do to lower courts?
Opinions are binding on lower courts in the same jurisdiction and severe as a PRECEDENT
What are reasons for Deviating from precedent?
Factual Distinctions and Changing Times/Circumstances
What is a factual distinction?
Legal counsel may bring in precedent but the circumstances are different so it does not apply
Implication Outside Jurisdiction?
If something comes up in another state, it may not apply to yours right now but may in the future
In relation of Common Law and Statutory Law, what must the Courts do?
Courts often must interpret the meaning and application of statutes
What are the Principles of Interpretation?
- Determining legislative intent, if possible
- Ordinary meaning of words
- Due process rights of the individual
What is an Administrative Proceeding?
Agency vs. Private Party
Include warnings, fines, licensure revocation/suspension, and probation
What is a Civil Proceeding?
Private Party vs. Private Party
Based upon statue or common law
Compensation to injured party
What is a Criminal Proceeding?
Government vs. Private Party
Charged with a crime as prohibited by a statue
Deter, Punish, and Rehabilitate
What type of proceedings can happen in the world of pharmacy?
All three: administrative, civil, and criminal
What is a Plaintiff?
Person bringing the action
What is a Defendant?
Person action is brought against
Whose name appears first in the title of the case?
Plaintiff
How does the Plaintiff prove Standing?
The challenged conduct has caused the plaintiff injury and there is a legally protectable interest
What is the civil court procedure for Witnesses?
- May be subject to subpoena, an order to appear to court
- Failure to appear may result in contempt of court
What is the civil court procedure for an Expert Witnesses?
Called when the factual subject matter is beyond the scope of jurors
What is the criminal court procedure Burden of Proof?
Beyond a reasonable doubt, contrast to civil court trial, where “preponderance of evidence” is the standard
Pharmacy practice and drug distribution are subject to what?
Both Federal and State Regulation
Federal authority to regulate is based on what?
Interstate Commerce Clause of U.S. Constitution
State authority to regulate is based on what?
Tenth Amendment of the U.S. Constitution under inherent Police Powers
What law preempts the other?
Federal law preempts state law
What is the Supremacy Clause of the U.S. Constitution?
When federal and state law conflict, federal law will preempt state law
Preemption Doctrine
Can State pharmacy law/regulation be more than strict than Federal?
YES, not a conflict, there is conflict when state law is less strict than federal
