Florida Pharmacy Law & Ethics

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Questions and Answers

A pharmacist is asked to dispense a medication based on an order from an out-of-state practitioner. According to Florida law, which chapter primarily dictates whether this order is valid?

  • Chapter 499, which covers misbranding and adulteration of drugs.
  • Chapter 456, which establishes rules for all healthcare occupations.
  • Chapter 465, which contains statutes specific to the profession of pharmacy. (correct)
  • Chapter 893, which regulates controlled substances.

A new regulation regarding sterile compounding is being considered by the Florida Board of Pharmacy. Under which Florida Statute does the Board derive its authority to establish such rules?

  • Chapter 893.07, outlining penalties for controlled substance violations.
  • Chapter 499.05, concerning drug manufacturing standards.
  • Chapter 465.005, granting rule-making authority to implement Chapter 465. (correct)
  • Chapter 456.02, detailing healthcare professional qualifications.

Which action best exemplifies a situation where a pharmacist is primarily relying on ethical principles rather than legal requirements?

  • Providing a patient with detailed information about potential side effects, even if not legally required. (correct)
  • Checking the expiration date of medications before dispensing them.
  • Reporting suspected child abuse to the authorities.
  • Verifying the accuracy of a prescription before dispensing it.

Which scenario exemplifies the ethical principle of beneficence in pharmacy practice?

<p>A pharmacist provides a detailed consultation to ensure a patient understands how to take their medication correctly. (B)</p> Signup and view all the answers

Which scenario best demonstrates the application of utilitarian ethics in a pharmacy setting?

<p>A pharmacist decides to dispense a medication to a patient in severe pain, even though it is slightly past its expiration date, because no other alternative is immediately available. (A)</p> Signup and view all the answers

A pharmacist witnesses a colleague making a dispensing error that could harm a patient. Applying virtue ethics, what would be the most appropriate course of action?

<p>Address the error directly with the colleague, emphasizing the importance of patient safety and professional responsibility. (C)</p> Signup and view all the answers

A patient requests a prescription for a medication that the pharmacist believes is not in their best interest due to potential interactions. Applying the principle of autonomy, what action should the pharmacist take?

<p>Fill the prescription but counsel the patient about the potential risks and benefits, allowing them to make an informed decision. (C)</p> Signup and view all the answers

A pharmacist in a rural area is the only healthcare provider for miles. During a severe storm, the pharmacy's generator fails, and refrigerated medications risk spoilage. Applying the principle of non-maleficence, what should the pharmacist prioritize?

<p>Prioritizing the preservation of life-saving medications, even if it means some medications are lost. (A)</p> Signup and view all the answers

A pharmaceutical company offers a pharmacist a significant bonus for promoting their new medication to patients and physicians. Which ethical principle is most directly challenged by accepting this offer?

<p>Beneficence (C)</p> Signup and view all the answers

In a situation where there are not enough vaccines for everyone in a community, which ethical principle should guide the pharmacist's decision on how to distribute the vaccines?

<p>Justice, by ensuring a fair and equitable distribution of the vaccine. (C)</p> Signup and view all the answers

What is the primary function of the legislative branch at the federal level in the United States?

<p>Enacting statutes (C)</p> Signup and view all the answers

After a bill is sponsored in the U.S. Congress, what is the next step in the federal legislative process?

<p>Congressional committee review (C)</p> Signup and view all the answers

Why are committee hearings an important source for determining legislative intent?

<p>They provide a record of the debates and discussions that shaped the law, which can be used by courts to interpret the law. (D)</p> Signup and view all the answers

What role does the President of the United States play in the federal legislative process?

<p>Signing or vetoing bills passed by Congress (A)</p> Signup and view all the answers

How does the state-level legislative process typically differ from the federal process in the United States?

<p>State legislative history is often more difficult to access and use for determining legislative intent. (C)</p> Signup and view all the answers

What distinguishes a criminal case from a civil case?

<p>Criminal cases involve the government prosecuting an individual or entity for violating a statute, while civil cases involve disputes between private parties. (B)</p> Signup and view all the answers

In an administrative action against a pharmacist, what is the role of the Board of Pharmacy?

<p>To make a disciplinary determination, which may include actions like fines or license revocation. (B)</p> Signup and view all the answers

What is the primary role of the U.S. Supreme Court in the federal court system?

<p>To hear cases of original jurisdiction involving ambassadors or disputes between states. (A)</p> Signup and view all the answers

What is 'binding precedent' in the context of the U.S. legal system?

<p>A court ruling that must be followed by all lower courts within the same jurisdiction. (A)</p> Signup and view all the answers

In a civil lawsuit, what is meant by the term 'standing'?

<p>The plaintiff's ability to demonstrate they were injured and have a legally protectable interest in the case. (C)</p> Signup and view all the answers

What is the purpose of a 'statute of limitations'?

<p>To set a time limit within which a lawsuit must be filed. (A)</p> Signup and view all the answers

What is the role of a jury in a civil trial?

<p>To determine questions of fact. (B)</p> Signup and view all the answers

What is the standard of proof required in a criminal trial?

<p>Beyond a reasonable doubt (C)</p> Signup and view all the answers

Under the Supremacy Clause of the U.S. Constitution, what happens when federal and state laws conflict?

<p>Federal law always prevails. (C)</p> Signup and view all the answers

What is the primary purpose of government regulation of medicinal drugs?

<p>To protect people from harming themselves through risky choices and to correct market failures. (D)</p> Signup and view all the answers

What is a 'public good' in the context of drug regulation, and why does it require government intervention?

<p>A necessary and beneficial commodity that private entities will not supply because there is no sufficient incentive to provide them, like orphan drugs and vaccines. (A)</p> Signup and view all the answers

What is an 'externality' in the context of drug therapy, and how does it justify government regulation?

<p>A situation where the use of a good (like antibiotics) affects someone who does not fully consent to the effect (like antibiotic resistance). Government regulates to minimize these indirect costs. (A)</p> Signup and view all the answers

How does 'information asymmetry' lead to market failures in the context of drug use, and what is the government's role in addressing it?

<p>When the consumer is uniformed about the true value of a good. The government requires provision of information and input by educated professionals. (A)</p> Signup and view all the answers

What is the significance of the Federal Register and the Code of Federal Regulations (CFR) for pharmacists?

<p>They list proposed and final federal agency regulations, which affect pharmaceutical distribution and pharmacy practice. (C)</p> Signup and view all the answers

What is 'stare decisis', and why is it important in the U.S. legal system?

<p>Abiding by decided cases; this helps establish continuity of decisions and expedites judicial decision-making. (B)</p> Signup and view all the answers

How do common law and statutory law interact when courts interpret the meaning of statutes?

<p>Courts apply common law principles to interpret statutes, determining legislative intent and ensuring the law is applied reasonably. (C)</p> Signup and view all the answers

In Florida, what are the requirements for a pharmacist to serve as a member of the Board of Pharmacy?

<p>Must be a Florida resident, a licensed pharmacist with at least 4 years of practice in Florida, and meet other setting-specific criteria. (D)</p> Signup and view all the answers

Who appoints the members of the Florida Board of Pharmacy, and what other step is required for the appointment to be official?

<p>The Governor appoints members, and the Florida Senate confirms the appointments. (A)</p> Signup and view all the answers

According to Florida Statutes, what is the term length for a member of the Board of Pharmacy, and what happens when their term expires?

<p>4 years; they continue serving until their successors are appointed. (D)</p> Signup and view all the answers

If a provision of Chapter 456, Florida Statutes, relates to the activities of healthcare boards, how does it apply to the Board of Pharmacy?

<p>All provisions of Chapter 456 that relate to board activities automatically apply to the Board of Pharmacy. (B)</p> Signup and view all the answers

Under which Florida Statutes does the Board of Pharmacy derive its authority to adopt rules implementing the provisions of Chapter 465?

<p>Sections 120.536(1) and 120.54 (C)</p> Signup and view all the answers

According to Florida Statutes, what is the primary focus of Chapter 499 regarding pharmacy practice?

<p>Focusing on the misbranding and adulteration of drugs, as well as related criminal acts. (D)</p> Signup and view all the answers

Which Florida Statute chapter specifically addresses the rules applicable to all healthcare professions, including pharmacy?

<p>Chapter 456 (D)</p> Signup and view all the answers

What is the significance of Florida Code 64B16 in relation to Florida Statutes regarding pharmacy practice?

<p>It contains the regulations and rules that govern the day-to-day practice of pharmacy. (D)</p> Signup and view all the answers

In ethical decision-making, what does the word 'ought' generally signify?

<p>A moral imperative (A)</p> Signup and view all the answers

What is the primary focus of science as compared to ethics?

<p>Science focuses on explanation and prediction, while ethics focuses on justification. (B)</p> Signup and view all the answers

How do explanation and prediction relate to healthcare in the context of science?

<p>Explanation is equivalent to diagnosis, and prediction is equivalent to prognosis. (A)</p> Signup and view all the answers

What is the central focus of virtue ethics?

<p>The character and habits of the moral agent. (D)</p> Signup and view all the answers

According to deontological ethics, what is the primary consideration when determining the morality of an action?

<p>Whether the action aligns with a universal rational duty. (D)</p> Signup and view all the answers

In utilitarian ethics, what is the basis for determining whether an action is morally justifiable?

<p>Whether it results in the greatest good for the greatest number. (A)</p> Signup and view all the answers

What is the key question to consider in professional role-based ethics, such as pharmacy ethics?

<p>What values support the pharmacist-patient relationship? (C)</p> Signup and view all the answers

What does the bioethical principle of autonomy primarily emphasize?

<p>The individual's right to choose their treatment based on their own values. (B)</p> Signup and view all the answers

What is the primary meaning of the bioethical principle of non-maleficence?

<p>To do no harm or avoid causing harm. (C)</p> Signup and view all the answers

What is the primary focus of the bioethical principle of beneficence?

<p>Promoting the patient's best interest. (B)</p> Signup and view all the answers

In the context of healthcare ethics, what does the principle of 'justice' primarily refer to?

<p>Fair allocation of the benefits and burdens of medical treatment or research. (B)</p> Signup and view all the answers

Which ethical rule in healthcare emphasizes truthfulness and honesty in professional conduct?

<p>Veracity (A)</p> Signup and view all the answers

In the context of the relationship between law and ethics, how are they best described?

<p>Ethics is the larger set, and law is a subset within it. (D)</p> Signup and view all the answers

What is the significance of being aware of the law as a pharmacist?

<p>It is important to avoid trouble, but being a good pharmacist requires exceeding the minimum legal demands. (B)</p> Signup and view all the answers

What does the American Pharmacist Code of Ethics primarily aim to do?

<p>State the principles forming the basis of pharmacists' roles and responsibilities. (A)</p> Signup and view all the answers

According to the American Pharmacist Code of Ethics, what type of relationship exists between a pharmacist and a patient?

<p>A covenantal relationship (C)</p> Signup and view all the answers

In the U.S. federal legislative process, what is the role of congressional committees after a bill is sponsored?

<p>To conduct hearings, investigations, and potentially rewrite the bill. (B)</p> Signup and view all the answers

What role does a Conference Committee play in the federal legislative process?

<p>It reconciles differences between the House and Senate versions of a bill. (D)</p> Signup and view all the answers

What is the President's role in the federal legislative process after a bill has passed both the House and the Senate?

<p>To sign the bill into law or veto it. (C)</p> Signup and view all the answers

In a legal context, what is the key distinction between a criminal case and a civil case?

<p>Criminal cases are initiated by the government, while civil cases are initiated by private parties. (D)</p> Signup and view all the answers

In an administrative action against a pharmacist, what types of disciplinary actions can an administrative agency impose?

<p>Actions such as warnings, fines, license revocation, or required continuing education. (C)</p> Signup and view all the answers

What condition is required to get a case into Federal Court?

<p>There must be a federal law or U.S. Constitutional issue involved. (D)</p> Signup and view all the answers

What is meant by 'binding precedent' in the U.S. legal system?

<p>A ruling from a higher court that must be followed by lower courts in that jurisdiction. (A)</p> Signup and view all the answers

In a civil lawsuit, what does 'standing' refer to?

<p>Having a direct injury or risk of harm that grants the right to sue. (C)</p> Signup and view all the answers

What is the role of a 'summons' in a civil court procedure?

<p>To notify the defendant that they are being sued. (B)</p> Signup and view all the answers

What happens if a defendant fails to file an answer to a complaint in a civil lawsuit?

<p>The court issues a default judgment in favor of the plaintiff. (D)</p> Signup and view all the answers

What is the purpose of 'discovery' in a civil lawsuit?

<p>To gather all relevant facts and evidence for both sides. (C)</p> Signup and view all the answers

What is the main purpose of a deposition during the discovery phase in a civil case?

<p>To gather out-of-court testimony from witnesses under oath. (C)</p> Signup and view all the answers

What is the role of the jury during a trial?

<p>To determine questions of fact and come to a verdict. (B)</p> Signup and view all the answers

What standard of proof is required to convict a defendant in a criminal trial?

<p>Beyond a reasonable doubt (C)</p> Signup and view all the answers

Under the Supremacy Clause of the U.S. Constitution, what happens when a state law and a federal law conflict?

<p>The federal law always prevails. (B)</p> Signup and view all the answers

According to the readings, why does the government regulate medicinal drugs?

<p>Due to potential risks to the user and the existence of 'market failures'. (B)</p> Signup and view all the answers

What is a 'public good' in the context of drug regulation?

<p>A necessary commodity that private entities will not supply due to lack of incentive. (A)</p> Signup and view all the answers

What is an 'externality' in the context of drug therapy?

<p>The effect of a drug on someone who does not fully consent to the effect. (D)</p> Signup and view all the answers

What type of market failure is minimized with regulations requiring educated professionals' input into decisions about drug use?

<p>Information Asymmetry (B)</p> Signup and view all the answers

What is the significance of the Federal Register for pharmacists?

<p>It publishes proposed regulations, final regulations, and government notices. (A)</p> Signup and view all the answers

What does the legal doctrine of 'stare decisis' mean?

<p>To abide by decided cases. (D)</p> Signup and view all the answers

How do judges typically interpret statutes when applying them to specific court cases?

<p>By determining the legislative intent behind the statute. (B)</p> Signup and view all the answers

According to Florida Statute 465.004, how many members are on the Florida Board of Pharmacy?

<p>9 (B)</p> Signup and view all the answers

In order to be appointed as one of the licensed pharmacist members of the Florida Board of Pharmacy, how many years of practice in Florida must a pharmacist have?

<p>4 years (A)</p> Signup and view all the answers

According to Florida Statutes, what is the term length for a member of the Board of Pharmacy?

<p>4 years (C)</p> Signup and view all the answers

A pharmacist encounters a situation not explicitly covered by Florida Statutes or regulations. Which approach is MOST appropriate for determining the ethical course of action?

<p>Applying ethical principles and professional judgment, considering the values that support the pharmacist-patient relationship. (A)</p> Signup and view all the answers

In a scenario where a new drug is highly effective but very expensive and in limited supply, which ethical principle would MOST directly guide a pharmacist's decision on how to allocate the drug?

<p>Justice, focusing on fair distribution of resources. (B)</p> Signup and view all the answers

What is the MOST accurate comparison between science and ethics?

<p>Science focuses on facts and explanation, while ethics focuses on values and justification. (C)</p> Signup and view all the answers

A terminally ill patient asks a pharmacist for information on an experimental treatment not yet approved by the FDA. Applying the ethical principle of autonomy, what should the pharmacist do FIRST?

<p>Provide all available information about the treatment, including potential risks and benefits, so the patient can make an informed decision. (A)</p> Signup and view all the answers

Which ethical theory places the GREATEST emphasis on the consequences of an action when determining its morality?

<p>Utilitarian ethics (A)</p> Signup and view all the answers

How do explanation and prediction in science MOST closely relate to healthcare?

<p>Explanation is equivalent to diagnosis, and prediction is equivalent to prognosis. (B)</p> Signup and view all the answers

What is the PRIMARY focus of professional role-based ethics in healthcare?

<p>Identifying and upholding the values that support the healthcare professional-patient relationship. (C)</p> Signup and view all the answers

What does the bioethical principle of non-maleficence require of a pharmacist?

<p>To avoid causing harm to patients and to prevent harm whenever possible. (B)</p> Signup and view all the answers

In a situation where a pharmacist is unsure whether to dispense a prescription due to a potential drug interaction, what action would BEST reflect the principle of beneficence?

<p>Contact the prescribing physician to discuss the potential interaction and determine the best course of action for the patient. (D)</p> Signup and view all the answers

Which statement BEST describes the relationship between law and ethics?

<p>Ethics is a broader concept than law, and the law often reflects underlying ethical values. (A)</p> Signup and view all the answers

According to the American Pharmacist Code of Ethics, what is the fundamental basis of a pharmacist's roles and responsibilities?

<p>Moral or ethical obligations and virtues. (C)</p> Signup and view all the answers

After a bill is sponsored in the U.S. Congress, what is the NEXT critical step in the federal legislative process?

<p>The bill is sent to the appropriate congressional committee(s). (C)</p> Signup and view all the answers

Why are committee hearings considered an important source when determining legislative intent?

<p>They provide a record of the debates and discussions among legislators, experts, and stakeholders, revealing the purpose and scope of the law. (A)</p> Signup and view all the answers

In a civil lawsuit, what does the term 'standing' refer to?

<p>The plaintiff's right to bring a case, based on having suffered a direct injury or harm. (C)</p> Signup and view all the answers

Under the Supremacy Clause of the U.S. Constitution, how is a conflict between a federal law and a state law typically resolved?

<p>The federal law prevails if it is within the powers delegated to the federal government. (B)</p> Signup and view all the answers

Which scenario exemplifies a market failure that justifies government regulation of medicinal drugs?

<p>A new drug is effective but has rare side effects that are not immediately apparent to consumers or prescribers. (D)</p> Signup and view all the answers

What is the LEGAL significance of the Federal Register for pharmacists?

<p>It provides daily updates on proposed and final federal regulations, allowing pharmacists to stay informed and provide comments. (C)</p> Signup and view all the answers

According to Florida Statutes, what combination of requirements apply to licensed pharmacist members of the Florida Board of Pharmacy?

<p>Must be a Florida resident with at least 4 years of experience practicing pharmacy in Florida. (A)</p> Signup and view all the answers

Flashcards

Chapter 456

Establishes rules for all healthcare occupations in Florida.

Chapter 499

Florida Food, Drug and Cosmetic Act; covers misbranding and adulteration of drugs.

Chapter 893

Florida's version of the federal Controlled Substances Act; deals with controlled substances.

Chapter 465

Contains statutes specific to the profession of pharmacy in Florida.

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Florida Code 64B16

Florida regulations and rules that govern the day-to-day practice of pharmacy.

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Ethics

Reflection on and application of moral norms to human motivation and conduct.

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Virtue Ethics

Focuses on the person and their character; emphasizes virtues.

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Deontological Ethics

Focuses on whether an act conforms to a universal rational duty or rule.

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Utilitarian Ethics

Focuses on the consequences or outcomes of an action.

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Healthcare Ethics

Considered professional role-based ethics; supports the pharmacist-patient relationship.

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Autonomy

Individuals have the right to choose their treatment based on their own values.

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Non-maleficence

Do no harm, avoid harm, or prevent harm.

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Beneficence

Promote the patient's best interest.

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Justice

Fairly allocating the benefits and burdens of medical treatment or research.

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Bill Sponsorship

Individual Senators can introduce legislation.

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Committee hearings

Determine legislative intent by examining what was intended by the law.

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Presidential Action

Sign the bill or veto it.

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Legislatures

Enact statutes.

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Administrative agencies

Promulgate regulations.

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Cities or counties

Pass ordinances.

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Criminal Cases

Government v. a private party; involves penalties specified by statute.

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Civil Cases

One private party against another; based on statute or common law legal rights.

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Administrative Actions

Administrative agency versus a private party; agency makes a disciplinary determination.

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Federal court system

US Supreme Court.

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Standing

Requires you to be able to show that you were injured and you have a legally protectable interest to go to court.

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Filing a complaint and summons

Must contain all the material facts of the case and the remedy you are requesting.

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Discovery

Each side must give the other all the facts and evidence they know that they will bring up in court, so there should be no surprise witnesses or evidence.

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Depositions

Out-of-court testimony by witnesses under oath, subject to perjury if they lie.

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Jury Selection (Voir Dire)

Lawyers for both sides select from the jury pool.

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Witnesses and Subpoenas

A court order to appear in court; failure to appear can be contempt of court.

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Motions

A formal request made to a judge for an order or ruling.

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Appeals

You cannot appeal based on a claim that the jury believed the wrong witnesses or the jury's determination of facts.

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Case citations

The volume number of the reporter.

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Laws

Commands what is right, prohibits what is wrong, and imposes penalties for violations.

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Public Goods in drug industry

Necessary and beneficial commodities that private entities will not efficiently supply.

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Externalities

Exists when the production or consumption of a good affects someone who does not fully consent to the effect.

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Natural Monopolies

Occurs when the fixed costs of providing a good are high relative to the variable costs.

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Information Asymmetry

The consumer is uninformed about the true value of a good.

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U.S. government tripartite system

Each branch serves as a check on the power of the others, preventing any single branch from dominating.

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Legislature

An elected body primarily responsible for enacting laws called statutes.

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Administrative agencies legislative function

Perform their legislative function through the promulgation of regulations.

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Federal Register and Code of Federal Regulations

Congress mandates that federal agency regulations be recorded in a specific way for public notice.

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Stare Decisis

To abide by decided cases.

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Separation of Powers

Three branches of government.

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Board of Pharmacy appointment

Governor appoints, Senate confirms.

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Board of Pharmacy term length

4 years

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Board of Pharmacy Rule-Making Authority

The board can adopt rules under Sections 120.536(1) and 120.54.

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