Law Chapter 2 Part 2

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  1. Adulteration laws
    • ensure that drugs are mfg under conditions that are not putrid, filthy or impure
    • mostly applies to mfg
  2. A pharmacy may be deemed a mfg if it
    repackages or compounds medications for sale
  3. A pure drug may be considered adulterated due to
    • preparation
    • packing
    • storage
    • contamination
    • mfg under non-GMP conditions
  4. Product tampering
    violation may be deemed adulteration and/or misbranding
  5. misbranded drugs
    consideres whenter the label or labeling of a drug is false or misleading
  6. drug packages must contain
    • information on manufacturer, packer or distributor
    • all statemtns required by FDA
    • name and ingredient prominently displayed
    • cannot be immitation of another drug
  7. Drugs may be considered to be misbranded if
    • info reguarding dosage is dangerous
    • no info for use in children
    • no special pkg to prevent deterioration if needed
    • does not contain adequate directions for use
  8. All medications must meed conditions of the
    poison prevention packaging act
  9. Rx vs OTC labeling
    • Rx on all medications
    • must contain info on type of container used to dispense
    • OTC must have specific info related to warnings and when to stop use
  10. Mandatory Label Contents
    • name & address of mfg
    • est. drug name & ingredients (generic and brand)
    • inactive ingredients if not PO
    • quantity and strength
    • RX only FDA prohibits dispensing...
    • Lot # & exp date
    • statement about container to use
  11. FDA law requires leaflets to be included with certain medications including
    • estrogens
    • DES
    • oral contraceptives
    • IUDs
  12. Patient Package Inserts
    • mfg must notify pharmacist to insert leaflet in each rx
    • provide general risk info
    • community and institutional pharmacy
    • provided once every 30 days in institutions
  13. Medication guides are required for products if FDA finds
    • pt labeling could help prevent serious ADEs
    • product has serious risks
    • pt adherence is crucial to efficacy
  14. Side effects statement for RX drugs
    • pharmacies must include side effects statement with all dispensed Rx
    • must say "call PCP for medical advise about side effects. You may report side effects to 800-FDA-1088"
  15. Pharmacies may provide side effect information in the following ways:
    • sticker on the vial
    • pre printed vial cap
    • medication leaflet
    • FDA approved med guide
  16. An approved drug can become a new drug if
    • addition of a new substance
    • new combination of approved drugs
    • change in proportion of ingredients
    • new intended use
    • dose, method, duration of admin is changed
  17. INDA
    • investigational new drug application
    • must have approved notice of claimed investigational exemption for a new drug in order to ship drug interstate to conduct phase 1, 2 and 3 trials
    • FDA may terminate at any time
  18. FDAAA requires NDA sponsors to publish
    summary info reguarding phase 1 trials on a public registry
  19. Informed consent
    • required in all 3 phases
    • subjects required to know risks, benefits and alternatives of treatment
  20. Drug rating and classification system
    • rates new drug by chemical type and therapeutic potential
    • determines how quickly drug will move through IND/NDA process
    • six designations for chemical type
    • 2 designations for therapeutic potential (S&P)
  21. SNDA required when
    mfg makes any change in an approved drug or in its production
  22. Three categories of SNDAs
    • production
    • labeling
    • editorial
  23. Postmarketing surveillance
    • required of mfg after NDA approval
    • must submit results to FDA
  24. Postmarket labeling
    FDA has authority to require mfg to add safety info or warnings to labeling postmarket
  25. If generic is created by the brand mfg
    no approval is necessary
  26. If brand drug is approved for certain indications
    other mfg can creat a generic that is for those same indications and does not have to complete testing for those indications
  27. Reasons for unapproved drugs on the market
    • pre-1938 drugs
    • FDA has yet to remove drugs lacking efficacy
    • Lax generic approval prior to 1984
    • unscrupulous mfg
  28. If a mfg obtains NDA for an unapproved marketed drug
    all marketed drugs in the class must obtain NDA approval within 1 year
  29. Biologics
    • products derived from living organisms
    • lcensure by PHSA
    • subject to FDCA and FDA requirements
    • congress is considering allowing generics
  30. Medwatch
    • voluntary reporting system
    • report ADRs, use errors or quality issues
    • Medwatch # must be supplied to patients at the pharmacy
  31. Regulation of Rx drug advertising
    FDA regulates
  32. Regulation of OTC drug advertising
    FTC regulates
  33. First amendment restricts
    governement regulation of commercial advertising
  34. Rx drug advertising from MFG to HCPs
    • law requires true statement and brief summary
    • must present fair balance and reveal material facts
  35. Brochures, booklets, mailings, bulletins, calendars and other information distributed to HCPs by MFG is considered
  36. Direct to consumer advertising for Rx drugs
    • no specific laws and regulations
    • present key risk info in user friendly ways is encouraged
    • FDA has authority to pre-review ads
  37. Off label use
    • physician can prescribe off label
    • mfg can provide scientific studies to HCPs
    • mfg cannot advertise for unapproved indications
  38. Non-Rx drug advertising
    • regulated by FTC
    • claims must have reasonable basis
    • FTC can say customers are likely to be mislead
    • FTC has authority to require corrective advertising
Card Set
Law Chapter 2 Part 2
Law Chapter 2 Part 2
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