BTEC 3317 Final UPDATED Exam
Questions and CORRECT Answers
Drug Quality and Security Act of 2013 - CORRECT ANSWER✔✔- - happened bc of fungal
meningitis outbreak from contaminated steroid for back pain
- use electronic system to track prescription drugs
- require companies to register
Dr. Harvey Wiley's "clinical trials" - CORRECT ANSWER✔✔- - no institutional review
board to oversee trial safety
- no informed consent forms were signed
- trial participants were volunteers
- no control group
Federal Anti-Tampering Act of 1982 - CORRECT ANSWER✔✔- - tamper-evident device
should be prominently displayed, identified on label, and have bright colors.
patent medicines - CORRECT ANSWER✔✔- - salesmen claim they cure crazy things
- they are not FDA approved drugs
Kefauver-Harris Amendments of 1962 - CORRECT ANSWER✔✔- - caused by thalidomide
crisis that caused birth defects
- first law to require to show safety and efficacy (using clinical trials) before drug marketing
approval
- require notifying before testing
Drugs definition - CORRECT ANSWER✔✔- - Non-prescription drugs are available over-
the-counter and can be procured without the need for medical supervision
- "Drugs are for use in the cure, mitigation, treatment, or prevention of disease in man"
- Prescription drugs are used under medical supervision of a healthcare practitioner.
- "Dietary supplements (herbs, vitamins) do not require FDA approval prior to marketing, as
they are GRAS "
, Hatch-Waxman Act of 1984 - CORRECT ANSWER✔✔- - encouraged making generic drugs
by extending patent term
and lowering clinical trials cost
Biologics Control Act of 1902 - CORRECT ANSWER✔✔- - children died bc of tetanus in
antitoxin from horse
- need pre-market approval
Federal Food Drugs and Cosmetic Act of 1938 - CORRECT ANSWER✔✔- - new drug
needs to be SAFE before marketing approval
- Safety tolerances for CHAMp "cocaine, heroine, alcohol and morphine in drugs"
- because of Toxic elixir formulation of a sulfanilamide antibiotic (had antifreeze)
- Need physician's prescription
Prescription Drug USERS FREE ACT of 1992 - CORRECT ANSWER✔✔- - passed to
Shorten the time for new drug review and marketing approval
Prescription Drug MARKETING ACT of 1987 - CORRECT ANSWER✔✔- - Intended to
reduce risks from misbranded or counterfeit drugs
- Arose from concerns about illegal sales of excess pharmacy inventories
- "required that prescription drugs manufactured in the US and exported, can no longer be
reimported into the US, except by the product's manufacturers."
Fair Packaging and Labeling Act of 1966 - CORRECT ANSWER✔✔- This law requires that
product labels identify the: address of manufacturer
identity of the product
name of manufacturing business
quantity of the product
all 3 preservatives that are still in use today - CORRECT ANSWER✔✔- Potassium nitrate -
meat
Questions and CORRECT Answers
Drug Quality and Security Act of 2013 - CORRECT ANSWER✔✔- - happened bc of fungal
meningitis outbreak from contaminated steroid for back pain
- use electronic system to track prescription drugs
- require companies to register
Dr. Harvey Wiley's "clinical trials" - CORRECT ANSWER✔✔- - no institutional review
board to oversee trial safety
- no informed consent forms were signed
- trial participants were volunteers
- no control group
Federal Anti-Tampering Act of 1982 - CORRECT ANSWER✔✔- - tamper-evident device
should be prominently displayed, identified on label, and have bright colors.
patent medicines - CORRECT ANSWER✔✔- - salesmen claim they cure crazy things
- they are not FDA approved drugs
Kefauver-Harris Amendments of 1962 - CORRECT ANSWER✔✔- - caused by thalidomide
crisis that caused birth defects
- first law to require to show safety and efficacy (using clinical trials) before drug marketing
approval
- require notifying before testing
Drugs definition - CORRECT ANSWER✔✔- - Non-prescription drugs are available over-
the-counter and can be procured without the need for medical supervision
- "Drugs are for use in the cure, mitigation, treatment, or prevention of disease in man"
- Prescription drugs are used under medical supervision of a healthcare practitioner.
- "Dietary supplements (herbs, vitamins) do not require FDA approval prior to marketing, as
they are GRAS "
, Hatch-Waxman Act of 1984 - CORRECT ANSWER✔✔- - encouraged making generic drugs
by extending patent term
and lowering clinical trials cost
Biologics Control Act of 1902 - CORRECT ANSWER✔✔- - children died bc of tetanus in
antitoxin from horse
- need pre-market approval
Federal Food Drugs and Cosmetic Act of 1938 - CORRECT ANSWER✔✔- - new drug
needs to be SAFE before marketing approval
- Safety tolerances for CHAMp "cocaine, heroine, alcohol and morphine in drugs"
- because of Toxic elixir formulation of a sulfanilamide antibiotic (had antifreeze)
- Need physician's prescription
Prescription Drug USERS FREE ACT of 1992 - CORRECT ANSWER✔✔- - passed to
Shorten the time for new drug review and marketing approval
Prescription Drug MARKETING ACT of 1987 - CORRECT ANSWER✔✔- - Intended to
reduce risks from misbranded or counterfeit drugs
- Arose from concerns about illegal sales of excess pharmacy inventories
- "required that prescription drugs manufactured in the US and exported, can no longer be
reimported into the US, except by the product's manufacturers."
Fair Packaging and Labeling Act of 1966 - CORRECT ANSWER✔✔- This law requires that
product labels identify the: address of manufacturer
identity of the product
name of manufacturing business
quantity of the product
all 3 preservatives that are still in use today - CORRECT ANSWER✔✔- Potassium nitrate -
meat
