PHRD5045 Pharmacy Law - Exam 1 (Moore)

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  1. act that prohibited adulteration and misbranding of foods & drugs
    Pure Food & Drug Act
  2. FDCA
    Federal Food, Drug, and Cosmetic Act
  3. prompted by deaths from sulfanilamide elixer
  4. states that new drugs must be proven to be SAFE
  5. established Rx and OTC drug classes
    Durham-Humphrey Amendments
  6. authorized verbal/call-in prescriptions & refills
    Durham-Humphrey Amendments
  7. prompted by thalidomide disaster
    Kefauver-Harris Amendments
  8. stated that drugs must be proven to be EFFECTIVE
    Kefauver-Harris Amendments
  9. established Good Manufacturing Practices (GMP)
    Kefauver-Harris Amendments
  10. required informed consent of research subjects in investigational drug trials
    Kefauver-Harris Amendments
  11. created incentives for pharma companies to create drugs for rare conditions
    Orphan Drug Act
  12. stated that prescription labels must contain "Rx only"
    FDA Modernization Act
  13. establishes the offenses of "adulteration" and "misbranding"
  14. 3 functions of the FDA
    • 1) rulemaking
    • 2) issue guidance documents
    • 3) incorporate advice from standing advisory committees of outside experts
  15. FDCA prohibited acts (3)
    • 1) receipt & delivery of adulterated/misbranded drugs
    • 2) counterfeiting dugs
    • 3) altering labeling
  16. FDA enforcement of the FDCA (4)
    • 1) injunction
    • 2) criminal proceedings
    • 3) drug seizure
    • 4) warning letter
  17. general penalties of FDCA offenses
    fines ($1000-$1M), prison
  18. what does the FDCA *NOT* require on Rx label?
    drug name
  19. document required to be issued to patient every time they fill for certain high risk drugs
  20. required in labeling when use of a drug may lead to death or serious injury
    black box warning
  21. Pregnancy Warning: X
    DO NOT TAKE if pregnant
  22. Pregnancy Warning: C
    inadequate info to prove unsafe/contraindicated during pregnancy
  23. Phase I of NDA Process
    detect adverse effects
  24. Phase II of NDA process
    determine efficacy
  25. Phase III of NDA process
    determine safety & efficacy on large scale
  26. which phases are informed consents required?
    all 3
  27. gives FDA authority to require procedures ranging from MedGuides to limiting the drug to specified settings for dispensing
    Risk Evaluation & Mitigation Strategy (REMS)
  28. designed to detect early signs of a drug's risk
    • Sentinel Initiative
    • established by FDA Amendments Act
  29. 3 requirements generic manufacturers must demonstrate under the DPC and PTRA
    • 1) same active generic ingredient
    • 2) bioequivalence
    • 3) acceptable manufacturing & control
  30. review process that approves drugs on the basis therapeutic category and conformance to a monograph
    OTC drug review
  31. review process that approves drugs o a drug by drug basis
    prescription drug review
  32. products derived from living organisms
  33. Class I drug
    causes serious adverse effects or death
  34. Class II drug
    product causes temporary adverse effects on health
  35. Class III drug
    product not likely to cause adverse effects on health
  36. OTC insulin
    • 1) Novolin
    • 2) Humilin
  37. Rx insulin
    anything that is NOT Novolin or Humulin
  38. Def'n of a drug (3)
    • 1) recognized in the U.S. Pharmacopeia, Homeopathic Pharmacopeia, or National Formulary
    • 2) intended for diagnosis, treatment, or prevention of disease
    • 3) articles other than food intended to affect structure/fcn
  39. evidence a product is a drug (3)
    • 1) labeling
    • 2) advertising
    • 3) nature of product
  40. Special Food Categories (2)
    • 1) legal
    • 2) publicly conceived
  41. legal (special food) categories (2)
    • 1) special dietary foods (ex: gluten free)
    • 2) medical foods (ex: infant formulas)
  42. Dietary Supplement Health and Education Act (DSHEA)
    • -DS more food than drug
    • -DS does not req premarket approval
    • -only safety tested (NOT effectiveness)
  43. DSHEA only permits DS manufacturers to make health claims if.. (2)
    • 1) FDA approves claim
    • 2) by significant scientific agreement test
  44. may be made when claim does not meet the "significant scientific agreement test"
    qualified health claim
  45. by FDCA definition, excludes articles that achieve their purpose through chemical action and metabolism
    • device
    • ex: IUD, drug eluting stent
  46. Does a DS firm have to provide the FDA with safety and efficacy info prior to product marketing?
  47. FD&C Act defines a drug by its
    intended use
  48. primary purpose of DSHEA
    product safety
  49. 2 major government agencies regulating drug advertising and promotion
    • 1) FDA
    • 2) Federal Trade Commission (FTC)
  50. type of advertising the FDA regulates
    Rx drugs
  51. type of advertising the FTC regulates
    OTC drugs
  52. reminder advertising
    • brand/drug labeled materials (pens, clocks, etc)
    • exempt from FDCA required labeling
  53. requirements of a "true statement" (3)
    • 1) not misleading
    • 2) presents fair balance
    • 3) reveals material facts
  54. brochures, booklets, mailings, bulletins, calendars, etc dist'd to health care professionals by a manufacturer
  55. PhRMA Code on Interactions with Healthcare Professionals
    • bans entertainment & recreational activities separate from or in conjunction with educational programming
    • companies should not provide meals
    • items that do not advance education should be be provided
  56. regulates deceptive ads
    FTC under FTC Act
  57. Durham-Humphrey Amendments (3)
    • 1) distinguishes Rx from OTC
    • 2) allows verbal Rx & refills
    • 3) specifies min info Rx label must contain
  58. beyond-use date
    expiration date that is 1 year from dispensing (even if original packing exp date is later)
  59. 3 methods to switch Rx drug to OTC
    • 1) Supplemental New Drug Application (SNDA)
    • 2) petition
    • 3) adding/amending OTC drug monograph (affects all products in class)
  60. who has the authority to determine who may prescribe independently or in collaborative practice?
    the state
  61. whether a pharmacist has a right to refuse to dispense prescriptions s/he has a moral or religious objection towards
    conscientious objection
  62. products contain same active ingredients and are identical in strength/dosage form
    pharmaceutical equivalence
  63. under the FDCA, is off-label prescribing and dispensing legal?
  64. less than a 2-fold difference between median lethal dose and median effective dose
    narrow therapeutic index (NTI)
  65. Prescription Drug Marketing Act
    • requires state licensing of wholesalers
    • regulates how drugs are marketed/distributed by wholesalers
    • **prohibits community pharmacies from receiving samples**
    • prevents hospitals from reselling drugs to community pharmacies
    • requires pedigree
  66. prohibits community pharmacies from receiving samples
    Prescription Drug Marketing Act
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PHRD5045 Pharmacy Law - Exam 1 (Moore)
pharmacy law
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