Pharmacy Law

  1. Pure food and drug act of 1906
    • prohibited adulteration and misbranding of foods and drugs
    • didn't prevent false or misleading efficacy claims
  2. food, drug, and cosmetic act of 1938
    • prompted by sulfanilamide elixir tragedy
    • drugs can't be marketed until proven safe for use
    • expanded definitions of misbranding and adulteration
    • directions for use
    • warnings about habit forming properties of certain drugs
    • exempted drugs marketed before 1938
  3. durham-humphrey amendment of 1951
    • established Rx and OTC drugs
    • authorized oral rx's and refills
    • Rx doesn't have have to have adequate directions for use, if they have the legend
  4. Kefauver-harris amendment of 1962
    • prompted by thalidomide tragedy
    • safe and effective
    • ftc to fda
    • GMPs
    • informed consent of research subjects
    • reporting of AEs
  5. orphan drug act of 1938
    gave tax and exclusive licensing incentives for manufactueres that develop and market drugs for treatment of rare diseases and conditions ( < 200,000 ppl)
  6. Waxman-Hatch amendment
    • streamlined generic drug approval process
    • gave patent extensions to innovator drugs
  7. prescription drug marketing act of 1987
    • established sales restrictions and record keeping requirements for rx drug samples
    • prohibited hospitals from reselling pharmaceutical purchases to other businesses
    • state licensing of drug wholesalers
  8. prescription drug user fee act of 1992
    required manufacturers seeking NDAs to pay fees for applications and supplements when the FDA has to review clinical studies
  9. dietary supplement health and education actu of 1994
    • defined dietary supplements
    • permited manufactureres to make claims tht would have been illegal under the FDCA
    • dietary supplements more foods than drugs
  10. food and drug administration modernization act of 1997
    • made a more timely review of applications
    • created fast track approval process for drugs for serious or life threatening diseases
    • expanded FDA authority over OTCs
  11. Food and drug administration amendments act of 2007
    implement REMS
  12. FDA safety and innovation act of 2012
    reauthorized PDUFA
Card Set
Pharmacy Law