pharmacy law

  1. what act protects public health?
    FDA- food, drug, and cosmetic act.
  2. what requires OTC products to have labels safe for consumer use?
  3. what prohibits the sale of "adulterated" or "misbranding" food and drugs?
  4. term for the presence of any decomposed substance, packaging under unsanitary coditions or if the product's strength or purity is different from what is indicated on the label?
  5. term for when label is false or misleading, or dosent have name and place of business of the manufacture, or fails to carry a "Warning- may be habit forming." if it is habit forming.
  6. when a drug is in the process of being made or discovered, this must be filled with the FDA to prove efficacy and safety before being commercially available.
    NDA - new drug application
  7. Seperates drugs into "legend and non-legend" (OTC)
    Durham-Humphrey Amendment
  8. also called "presciption drug amendment"
    Durham-Humphrey Amendment
  9. allows verbal new prescripton to be called in over the phone and allows refills okay to be done over teh phone.
    Durham-Humphrey Amendment
  10. requires presciption because drug requires supervision. "caution: federal law prohibits dispensing without a prescription."
    Durham-Humphrey Amendment
  11. label requirements for manufacturers and dispenser to the patients
    Kefauver-Harris Amendment
  12. regulates proper drug advertising and package inserts issued by the manufacturer
    Kefauver-Harris Amendment
  13. requires manufacturers to: 1) register annually
    2) be inspected every 2 years
    3) report any drug reactions
    Kefauver-Harris Amendment
  14. requires all medications on the US market to be pure, safe, and effective
    Kefauver-Harris Amendment
  15. Regualted by the FDA
    PPI'S patient package inserts
  16. must supply a PPI to patient receiving the following meds:
    oral contraceptives, estrogen, progestin, isotretinoin (Accutane), intrauterine devices, inhalers.
  17. whats on the information of a PPI. product description.
    • indications for use
    • contraindications (interactions)
    • warnings (extreme side effects)
    • precautions (less severe side effects)
    • dose (how much to take and how often)
  18. what ensures a safe and healthful workplace for employees by reducing hazards in the workplace. Audits show compliance.
    occupational and safety act of 1970
  19. this gave rise to occupational safety and health administration (OSHA)
    occupational and safety act of 1970
  20. the act of occupational and safety act of 1970 gave rise to this, which ensures job safety standards and an injury reporting system for job-related injuries or illnesses
    OSHA, occupational safety and health administration.
  21. according to what all pharmacies should:
    post the number of poison control
    have a reference guide for toxicities
    must have a Material Safety Data Sheet (MSDS) for any hazardous materials in pharmacy.
    occupational and safety act of 1970
  22. this act has an impact on pharmacy: air contaminants, flammable/combustible liuids, and eyes/skin protection
    occupational and safety act of 1970
  23. act enacted to reduce accidental poisonings in children
    Poison prevention packaging act
  24. requires pharmacies to use child resistant containers - defined as difficult for 80% of children under 5yrs to open and allows 90% of adults to open.
    poison prevention packaging act
  25. prohibits re-use of child resistant containers- because the wear and tear of normal use may decrease the effectiveness
    poison prevention packaging act
  26. exceptions to the legislation: medications used as medical emergencies such as nitroglycerin sublingual tablets for chest pain.
    -written requests from Drs or patients
    -OTC meds must labeled "package not child resistant" if not child resistant.
    -betamethasone, mebendazole, methylprednisolone, oral contraceptives, Panchrelipase, cholestyramine
    poison prevention packaging act
  27. poison log includes
    -date of sale -name and address of purchaser -name and quantitiy of poison dispensed -reason for purchase -full name of dispenser
  28. poison substances must be labeled with:
    • -complete name of poison
    • -the word "poison" boldly imprinted on label
    • - place of business of the seller
    • -proper directions of use.
  29. all pharmacies should be well stocked with "Syrup of Ipecac" and "Activated Charcoal" to:
    Activated charcoal works by absorbing the poison and eliminating it from the body. A person cannot take boh or the charcoal absorbs the Ipecac and will not work to either absorb the poison or make the person vomit.
  30. act regulates use and distributes drugs with high abuse potential and/or addiction into one of five schedules.
    Controlled Substance act or 1970 (CSA) the CSA is enforces and regulated by the DEA
  31. -act is directed toward the pharmacist but the pharmacist cannot do this without the help of technician.
    OBRA 90- omnibus reconciliation act of 1990
  32. improves quality care and reduces health care costs.
    OBRA 90- omnibus reconciliation act or 1990
  33. accordint to OBRA 90, counceling must include
    • name and description of med
    • dosage form, dose, route, and duration of therapy
    • special directions/ precautions
    • side effects and ways to prevent
    • techniques for self-monitoring
    • storage
    • refill info
    • action to take if missed a dose
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pharmacy law
Pharmacy tech: certified, supportive personnel, who aids in delivering quality pharmacy services under the supervision of a pharmacist