Sources of Law and Administrative Regulations

Podcast

Play an AI-generated podcast conversation about this lesson

Questions and Answers

What is one primary reason society regulates medication?

To ensure public safety and efficacy (correct)

To promote competition among drug manufacturers

To limit access to necessary medications

To increase pharmaceutical profits

Which type of law is primarily established by legislative bodies?

Common law

Judicial law

Statutory law (correct)

Administrative law

What is a crucial element involved in the federal legislative process?

Public hearings by the Senate

Bipartisan approval in both chambers (correct)

Enforcement by the president

Judicial review of laws

What is primarily responsible for enforcing pharmacy laws?

Administrative agencies Signup and view all the answers

Which phase of the public policy life cycle involves the evaluation of policy effectiveness?

Policy evaluation Signup and view all the answers

What occurs during the problem identification phase of the public policy cycle?

Emergence of a problem needing public attention Signup and view all the answers

Who plays a role in setting the agenda for public policy?

Policy makers, elected officials, and citizens Signup and view all the answers

Which aspect is NOT part of the agenda-setting phase in public policy?

Finding a solution to the problem Signup and view all the answers

What is primarily achieved during the policy formulation/adoption phase?

Creation of alternatives to address an issue Signup and view all the answers

Which statement best describes the role of citizens in public policy?

Citizens can help set the agenda by identifying issues. Signup and view all the answers

What is the statute of limitations for most issues in Arizona?

2 years from when the issue is known or should have been known Signup and view all the answers

What are the typical steps involved in filing a civil suit?

Pay a fee, file a complaint, serve the complaint, discovery process, motions made Signup and view all the answers

Who primarily determines pharmacy law?

State legislators Signup and view all the answers

Which of the following is NOT a situation that prompted society to support laws regarding drug products?

High product sales Signup and view all the answers

What is a primary function of public policy?

To decide whether to act or not act to resolve a problem Signup and view all the answers

In the context of the trial process, who can determine the outcome in civil cases?

A jury or a judge Signup and view all the answers

Approximately what fraction of civil lawsuits are settled by a judge?

1/2 Signup and view all the answers

What is a common action that can be taken if a defendant wishes to contest an adjudication decision?

Appeal to a civil court Signup and view all the answers

What is the primary purpose of policy instruments?

To achieve behavior change within individuals Signup and view all the answers

Which policy instrument is defined by taking no action and allowing potential self-correction?

Doing Nothing Signup and view all the answers

Which policy instrument aims to influence individuals through knowledge transfer and communication?

Information-based Signup and view all the answers

What role does the regulation policy instrument primarily perform?

Commanding and prohibiting actions Signup and view all the answers

What is an example of an expenditure-based policy instrument?

Offering grants and contributions Signup and view all the answers

Which policy instrument involves directly providing a service to achieve a particular outcome?

Acting directly Signup and view all the answers

To which of the following classes does 'Information-based' policy instruments belong?

Least coercive Signup and view all the answers

Which of the following is not a role of policy instruments?

To enhance competition Signup and view all the answers

What is the primary purpose of enabling legislation?

To grant authority for law enforcement Signup and view all the answers

Where can you find final federal rules and regulations?

Code of Federal Regulation Signup and view all the answers

Which of the following is an example of state-level administrative law?

Arizona Medical Board regulations Signup and view all the answers

What enables the creation of administrative laws at the federal level?

Enabling legislation Signup and view all the answers

Which act is associated with the partial fills for controlled substances?

Comprehensive Addiction and Recovery Act Signup and view all the answers

What type of rulemaking is described by the Arizona Administrative Register?

State-level administrative rulemaking Signup and view all the answers

Which of the following is NOT a method of finding administrative laws?

City council meetings for federal regulations Signup and view all the answers

What is one example of a municipal rule at the city/county level?

Zoning rules Signup and view all the answers

What document would likely contain proposed federal rules?

Federal Register Signup and view all the answers

Which organization is responsible for implementing pharmacy regulations in Arizona?

Arizona Board of Pharmacy Signup and view all the answers

Which of the following refers to administrative laws at the city/county level?

Local zoning and tax rules Signup and view all the answers

Which document outlines final rules published by state agencies in Arizona?

Arizona Administrative Register Signup and view all the answers

What does the acronym CFR stand for?

Code of Federal Regulations Signup and view all the answers

How is administrative law primarily created at the state level?

Through enabling legislation Signup and view all the answers

Study Notes

Sources of Law

Enabling legislation is the legislation that gives government officials and/or agencies authority to implement or enforce the law.
This is determined by US or State statutes.
The FDA and Arizona State Board of Pharmacy were established by enabling legislation.

Finding Administrative Laws (Rules and Regulations)

Federal Rules and Regulations (final): Can be found at https://www.ecfr.gov/
State Rules and Regulations (final): Can be found at https://azsos.gov/rules/arizona-administrative-code
City/County Level: Can be found at https://library.municode.com

Creating Administrative Law (DEA & CARA examples)

The Comprehensive Addiction and Recovery Act (CARA) was passed by Congress and signed into law by the President.

Statute of limitations for civil law in Arizona:

Two years from the time the problem was known, or when it should have been known.

Filing a Civil Suit

Starts with paying a fee, filing a complaint in court, serving the complaint to the defendant, followed by a discovery process and motions.
Approximately half of all civil lawsuits are settled by a judge.

The Trial (criminal or civil)

The process can be decided by a jury or a judge.

Who Determines Pharmacy Law

Enabling legislation creates agencies like the FDA and state boards of pharmacy.
Federal agencies like the FDA make rules and regulations for drug products.
State Boards of Pharmacy make rules related to pharmacy practice in their specific state.
Courts enforce the laws.

Public Policy

Public policy is a decision made by the government to either act, or not act, to resolve a problem.
The goal of public policy is to correct issues related to misbranded products, adulterated products, and the absence of standards for products.

Phases of the Public Policy Life Cycle

The public policy life cycle involves various stages.
These stages include:
- Problem identification (idea): A problem emerges that requires attention from the public and decision-makers.
- Agenda Setting: Policy makers, elected officials, and citizens determine the government's agenda to find a solution for the problem.
- Policy Formulation/Adoption: Alternatives are formulated to address the problem.
- Implementation: Policies are put into action.
- Evaluation: The effectiveness of the policies are assessed and modifications are made if needed.

Types of Policy Instruments and their Purpose

Policy Instruments are used to realize social, political, or economic conditions and provide services to the public.
Policy Instruments: - Doing Nothing: No intervention is taken, allowing the problem to potentially resolve itself. - Information-based: Influences people through knowledge transfer, communication, and persuasion. - Expenditure-based: Money is directly used to achieve an outcome through grants, contributions, vouchers, etc. - Regulations: Government commands and prohibits actions, defining norms and acceptable behaviors. - Acting Directly: The government provides a direct service to achieve a result.

Studying That Suits You

Use AI to generate personalized quizzes and flashcards to suit your learning preferences.

Description

This quiz explores key concepts regarding sources of law, the role of enabling legislation, and the procedures for finding administrative laws. It also covers the creation of administrative law through examples like the Comprehensive Addiction and Recovery Act. Test your knowledge on these vital legal frameworks.