Pharmacy Law

  1. Food Drug and Cosmetic Act
    • 1938
    • Regulation of drug
    • Protects from misbranding
    • canNOT market unless proved safe & effective and approved by FDA
  2. Pure Food and Drug Act of 1906
    Prohibits adulteration and misbranding
  3. Pure Food and Drug Act of 1912
    • Became amendment after Johnson decision
    • Prohibits false and fraudulent claims
    • Further legislation in 1938
  4. FDCA 1941
    Required batch certification of safety and efficacy of insulin for uniform potency
  5. FDCA 1945
    Required batch certification of PENICILLIN
  6. FDCA
    Durham-Humphrey Amendment
    • 1951
    • aka Prescription Drug Amendment
    • OTC vs Rx
    • Legend drugs need not contain proper direction on mfg bottle
    • Dispensed by rxcist...THEN directions are req'd
    • also authorizes oral Rx and refills
  7. FDCA
    Food Additives Amendment of 1958
    any additives must have premarket approval before adding
  8. FDCA
    Color Additive Amendments of 1960
    Mfg must establish safety of food coloring before addition
  9. FDCA
    Kefauver-Harris Amendment of 1962
    • aka "Drug Efficacy Amendment"
    • Drug must not only be SAFE but also EFFECTIVE
    • established "Good Manufacturing Practice"
  10. FDCA
    Medica Device Amendment of 1976
    • Premarket approval
    • Classified devices based on their function
    • Establish performance standards
  11. FDCA
    Orphan Drug Act 1983
    Complaints of drug approval process being too long
  12. Drug Price Competition & Patent Term Restoration Act of 1984
    • aka "Waxma-Hatch Amendment"
    • Generic approval
    • Patent extensions
  13. FDCA
    Precription Drug Marketing Act of 1987
    Prevents hospitals and other health care entities from reselling
  14. FDCA
    Safe Medical Devices Act of 1990
    Expedited premarket device approval
  15. FDCA
    Generic Drug Enforcement Act of 1992
    • Came from a scandal
    • Ban from participation in drug approval if they're convicted
  16. FDCA 
    Prescription Drug User Fee Act of 1992
    Fee req'd from Mfg to for drug approval funding
  17. FDCA
    Nutrition Labeling and Education Act of 1990
    Must have labeling on nutritional foods
  18. FDCA
    Dietary Supplement Health and Education Act of 1994
    Regulates Dietary supplement as food
  19. FDCA
    Food and Drug Administration Modernization Act of 1997
    Regulation of Drugs and expanded to OTC
  20. FDCA
    Food and Drug Administration Amendments Act of 2007
  21. FDA National HQ Centers
    • CDER
    • CBER
    • Center for food safety and applied nutrition (CFSAN)
    • Center for Vet Medicine (CVM)
    • Center for devices and radiological health (CDRH)
  22. Definition:
    Articles used for food or drink for man or animals
  23. Definition:
    Special Dietary Food
    Dietary need because of physical, physiological, pathological, or other conditions
  24. Definition:
    Medical Foods
    • formulated for use under supervision of practitioner
    • contains no amino acids
  25. Definition:
    • Articles recognized by USP or NF
    • Articles intended for use in Dx or Tx or Prevention of Dz
  26. Definition:
    • Instrument, apparatus, machine, implant recognized by USP or NF
    • Intended for Dx
    • Intended to affection structure or fxn of Sphygmomanometer
Card Set
Pharmacy Law