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25 Cards in this Set
- Front
- Back
Define: "Orphan Drug"
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Drugs which are safe and effective to be marked but they possess a high cost and limited patient base making them not economically feasible to market.
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Define: "Constitutional Law"
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The supreme law of the country. Any federal or state statue which contradicts the constitution is deemed invalid
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Define: "Statutory Law"
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Created by a body of elected representatives who's primary job is to create said laws.
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What is the hierarchical order of statues?
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1) Federal statues
2) State constitutions 3) State legislation 4) Ordinances |
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Where are administrative agencies housed?
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In the executive branch of government... although they are created by the legislative branch
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How do administrative agencies enact laws?
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Usually through the enacting of regulations and to render decisions at hearings
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What are the three legal tests a regulation must pass in order to be valid?
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1) It must be within the scope of the agency which created it
2) It must be based on a legal statue which gives the agency authority to promote or put into action said regulation 3) It must bear a reasonable relationship to the public health, safety and welfare |
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What is The Federal Register?
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A daily publication outlining all proposed and final regulations as well as various government notices for review by the general public
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Where are federal agency regulations posted for public viewing?
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In the Federal Register and The Code of Federal Regulations
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What is The Code of Federal Regulations (CFR)
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An annual publication containing 50 titles of further indexed final regulations
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Define: "Common Law"
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Law which is developed from judicial opinions, typically used in the lower courts
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Define: "Stare Decisis"
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"to abide by decided cases" - Meaning that the decisions of the court follow that of previous experience in a set situation
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Why are laws sometimes intentionally written in general language?
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To impart flexibility in interpretations of laws. If a law is too specific, it is possible that the intent of the law may be lost.
Often when coming to a decision, one must consider what the frame of mind the creator of that law was, and use this to make a decision. |
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Define: "Judicial Law"
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Law created
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Describe the makeup of the legislative branch of government
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Composed of the Senate and House of Representatives
The Senate has 100 members The House has 435 members |
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What is the most important stage of a bill's life?
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The committee stage.
This is where public hearings are held, investigations are done and compromises are made to craft the bill before heading for further consideration. This, essentially, decides the life or death of the bill as it cannot go to a formal vote without passing the committee stage. |
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Describe the path of a bill to law
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1) Idea originated from a source
2) A sponsor, who is a member of the Senate or House, introduces it 3) The committee stage 4) Discussion of bill in both houses 4a) Has to pass one chamber before going to the next 5) If the Senate version is different from the House version, a conference committee is created to create an identical bill 6) Signed by the president of the Senate and Speaker of the House 7) Signed by the president, when it then becomes law |
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Define: "Criminal Law"
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Violation of a statue by an individual of a prohibited activity.
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Define: "Civil Law"
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A lawsuit in which one private party sues another private party alleging an injury.
Can be based on common law, statutory law or both, with the ultimate goal being financial compensation. A criminal law conviction is not required. |
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Define: "Administrative Law"
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Violation of a statute or regulation or has committed an act that warrants an investigation, typically called hearings.
Sanctions can follow are: 1) Warnings 2) Fines 3) License revocation 4) License suspension 5) Probation |
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What is the length of statue of limitations for a lawsuit pertaining to cases typically involving pharmacists?
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2 years
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Define: "Misdemeanor"
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Punishment of a criminal act considered less severe than a felony, usually considered that of low seriousness
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Define: "Felony"
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Punishment of a criminal act that is considered most severe
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In a case such as, United States v. Guardian Chemical Corporation, which entity is the plaintiff and which is the defendant?
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Plaintiff - United States
Defendant - Guardian Chemical Corporation The plaintiff is always the leading person/company |
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What is the purpose of the State Board of Pharmacy?
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It is a specialized regulatory body designed to create regulations as well as punish those who violate said regulations. The board, and others like that, are created by state governments to let those with more expertise dictate the regulations of their profession.
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