Major Federal Legislation

  1. Pure Food and Drug Act of 1906
    Prohibited adulterated and misbranded drugs from interstate commerce
  2. Food, Drug & Cosmetic Act of 1938
    • 1937 "elixir of Sulfanilamide" tragedy.
    • Required drugs to be tested for safety.
    • Labels had to include "adequate directions for use" and "warning: may be habit forming"
    • Placed drug advertising under the control of the FTC. Later changed to the FDA for Rx and FTC for OTC
  3. Durham-Humphrey Amendment 1951
    Distinguishes between "adequate directions for use" (intended for end user (OTC)) & "adequate information for use" (intended for prescribers and dispensers (Rx))
  4. Kefauver-Harris Amendments 1962
    • 1. Required drugs to be tested for efficacy (thalidomide)
    • 2. Standards for manufacturer registration¬†(inspections)
    • 3.Standards for good manufacturing practices (GMP)
    • 4.Procedures for New Drug Approval process
  5. Controlled Substance Act 1970
    • 1. Created the DEA
    • 2. Scheduling of drugs and other substances
  6. Poison Prevention Packaging ACT 1970
    • 1.All control substances and prescription drugs are subject to special packaging requirements.
    • 2.Child resistant containers
    • ¬† a.80% of kids can't open in 10 minutes
  7. Medical Device Act of 1976
    • 1.Classification of medical device according to their specific function
    • 2.Pre-market testing standards
  8. Orphan Drug Act of 1983
    Incentives for manufacturing of drugs intended for rare diseases (affects les than 200,000 individuals in the US)
  9. Drug Price Competition Act 1987
    • 1.Hatch-Waxman amendment
    • 2.Streamlined approval of generics (ANDA - abbreviated New Drug Application)
  10. Prescription Drug Marketing Act (PDMA) 1987
    • 1.Established Drug Pedigrees
    • 2.Ban re-importation of drugs made in US
    • 3.Samples -storage, handling and ban of selling
  11. Prescription Drug User Fee Act (PDUFA) 1992
    Provides annual fees on manufactures and their products (help FDA fund regulation process)
  12. Dietary Supplement and Health Education Act (DSHEA) 1994
    • remove dietary supplements¬†from food classification
    • 1.vitamin
    • 2.mineral
    • 3.herb
    • 4.amino acid
    • 5.supplement to increase total dietary intake
  13. Food and Drug Administration Modernization Act 1997
    • 1.overhaul the FDA for the 21st century
    • 2.promote efficiency in regulatory procedures
    • 3."Rx only" could replace the federal legend warning
  14. Best Pharmaceuticals for Children Act 2002
    Designed to stimulate additional research into pediatric data for pharmaceuticals
  15. Patient Protection and Affordable Care Act (PPRACA) 2010
Card Set
Major Federal Legislation
Major Federal Legislation