PHRD5045 Pharmacy Law - Exam 1 (Campanella)

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  1. a court’s establishment of a certain rule of law based on a particular set of facts becomes a precedent that all lower courts in that jurisdiction must follow
    stare decisis
  2. order of court power
    Supreme Court > appellate > district
  3. 4 factors courts commonly apply in reaching decisions
    • 1) fundamental notions of fairness
    • 2) custom/history involved
    • 3) command of a political entity
    • 4) best balance between conflicting societal interests
  4. role of law in pharmacy practice
    create parameters/general guidelines for professionals to work in to keep patients safe
  5. NOT the role of law to dictate:
    • practice strategy
    • professional judgement
  6. limits of the law
    • certain human relationships
    • de minimis violations with overly harsh punishments
  7. violations having no real impact on the quality of drug therapy
    de minimis violation
  8. branches of the tripartite system
    legislative, executive, judicial
  9. supreme law of US
  10. gives Congress the power to make all laws "necessary and proper" for carrying out its responsibilities
    article 1, section 8 of the Constitution
  11. allows states to legislate in all areas except those prohibited or given to Congress by the US Constitution
    10th Amendment
  12. - states that State Legislatures have extremely broad "police" powers to pass laws to protect the "health, safety, and welfare" of the public
    - the State can make federal laws more stringent, as long as constitutional rights are not impinged upon
    10th Amendment
  13. an elected body of persons with the primary responsibility to enact laws, also called statutes
  14. hierarchical order of statutes
    federal laws > state constitutions > state legislation > political subdivisions (ordinances)
  15. "4th branch" of government
    administrative agencies
  16. 2 ways admin agencies create "law"
    • 1) enacting policies, rules, procedures, and regulations
    • 2) rendering decisions at hearings
  17. implement desired changes in policies, and administer a body of substantive law
    administrative agencies
  18. This process ensures that constituents
    whose interests are affected by the actions of the agency receive notice of any proposed regulation. Constituents then have an opportunity to comment on the proposed
    regulation. The agency considers all comments and may incorporate them into the regulation before its final promulgation.
    notice-and-comment rulemaking
  19. interpret, define, and add detail to statutes
  20. how regulations are enacted
    via notice-and-comment rulemaking
  21. legislative function
    promulgate regulations
  22. 3 validity tests of a regulation
    • 1) within the scope of the agency's authority
    • 2) based upon statutory authority
    • 3) reasonable relationship to public health, safety, & welfare
  23. laws made by administrative agencies
  24. Are regulations considered statutory law?
    NO, they just have the effect of law
  25. daily publication of proposed and final regulations and notices
    Federal Register (Fed. Reg)
  26. compilation of final regulations divided and indexed by subject matter
    Code of Federal Regulations (CFR)
  27. where to find proposed/final regulations that affect the Pharmacy Practice
    • 1) Fed Reg
    • 2) CFR
    • 3) Board website
  28. law developed from judicial opinions
    common law
  29. - analogous to administrative law, but not created by an administrative agency
    - enforceable
    judicial opinion
  30. opinions are binding on lower courts in the same jurisdiction and serve as precedent
    stare decisis
  31. reasons for deviating from stare decisis
    • factual distinctions
    • changing times/circumstances
  32. principles of interpretation
    • 1) legislative intent ("what is the law attempting to accomplish?")
    • 2) give the ordinary meaning of the words
    • 3) support the best fit with current social policy
    • 4) heed is an individual’s constitutional due process rights
  33. 3 types of action that can be imposed on an offender
    • 1) criminal
    • 2) civil
    • 3) administrative
  34. government vs. private party
    criminal action
  35. objectives of this action: deter, punish, rehabilitate
    criminal action
  36. private party vs private party
    civil action
  37. objective of this action: compensation to injured party
    civil action
  38. agency vs private party
    administrative action
  39. action that may be based on statute or common law
    civil action
  40. charged with a crime as prohibited by a statute and subject to fines/prison specified by statute
    criminal action
  41. disciplinary determination which may include warning, fines, licensure revocation/suspension/probation
    administrative action
  42. like criminal action, but can't impose jail time/revocation of civil liberties
    administrative action
  43. part of the Federal court system
    created by Congress via Article III
    12 judicial circuits and courts
    primarily hears appeals
    Court of Appeals
  44. If an act requires legal authority and it is done withOUT such authority
    ultra vires
  45. Federal Court System order of power
    Supreme Court > Court of Appeals > District Courts > Specialty Courts
  46. composed of: tax courts, customs & patent courts, court of claims
    specialty courts
  47. the court where you sue the U.S.
    court of claims
  48. person bringing the action
  49. person action is brought against
  50. plaintiff must prove "standing"
    the challenged conduct has caused the plaintiff actual injury and there is a legally protectable interest
  51. Civil Court Procedure
    • 1) complaint
    • 2) summons
    • 3) answer
  52. "complaint" in civil court
    all material facts of case and remedy requested
  53. "summons" of civil court
    issued by court notifying defendant of suit and commanding defendant to file an answer
  54. "answer" of civil court
    admitting to or denying ALL allegations in the complaint
  55. if answer not filed in civil court
    default judgement
  56. civil court discovery
    • 1) pretrial
    • 2) deposition
    • 3) interrogatory
  57. civil court procedure where each side must give the other side all the facts, evidence, and names of witnesses upon which it will rely to present its case (evidence discovery)
  58. civil court procedure involving out of court testimony by a witness under oath
  59. civil court procedure consisting of a list of written questions that witness must respond to under oath
  60. the questioning by each side of the potential jurors
    voir dire examination
  61. whose role is it to determine questions of fact?
  62. whose role is it to determine questions of law?
  63. level of legal proof required
    burden of proof
  64. % needed to be considered "probable cause"
  65. % needed to be considered "reasonable doubt"
  66. level of proof criminal cases require
    reasonable doubt
  67. level of proof civil cases require
    probable cause
  68. states that federal law always prevails over state law
    Supremacy Clause
  69. authorizes Federal law to regulate drugs
    Interstate Commerce Clause (of US Constitution)
  70. authorizes State law to regulate drugs
    10th Amendment
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PHRD5045 Pharmacy Law - Exam 1 (Campanella)
2013-09-13 02:29:22
pharmacy law

pharmacy law
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