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PTU FINAL EXAM STUDY GUIDE
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PTU FINAL EXAM STUDY GUIDE
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PTU FINAL EXAM STUDY GUIDEFood, Drug, and Cosmetic Act of 1938 - answer- purity, strength, and safety
Pure Food and Drug Act of 1906 - answer- forbade the manufacture or transport or sale
of mislabeled or adulterated food or drugs and poisonous patent medicines.
Durham-Humphrey Amendment of 1951 - answer- • Created a distinction between
"OTC" and "Legend Drugs".
Patient Package Insert (PPI) - answer- Manufacturer's patient product information
included with the product package.
Hatch-Waxman Act of 1984 - answer- promoted the manufacturing of generic drugs and
new medications
MedGuides - answer- FDA-approved documents created to educate patients about how
to minimize harm from potentially dangerous drugs
Class I recall - answer- Serious adverse effects on health or death
Class II recall - answer- temporary or reversible adverse effects
Class III recall - answer- Unlikely to cause adverse health consequences
Market Withdrawal - answer- permanent removal from the market, drug is harmful of
unapproved
pharmacological alternative - answer- same active ingredient, different dosage
form/strength
therapeutic alternative - answer- different active ingredient, same drug class
DAW 0 - answer- no preference, OK to substitute
DAW 1 - answer- substitution not allowed by prescriber
DAW 2 - answer- substitution allowed, patient requested specific product
DAW 7 - answer- substitution not allowed; brand mandated by law
DAW 8 - answer- Substitution allowed; generic drug not available in marketplace
DAW 3 - answer- Substitution allowed; pharmacist-selected product dispensed
DAW 4 - answer- Substitution allowed - generic drug not in stock
, DAW 5 - answer- Substitution allowed - brand drug dispensed as generic
DAW 6 - answer- override
DAW 9 - answer- Other. Reserved and currently not in use.
Fentanyl - answer- CII
duragesic, actiq, abstral, lazanda, fentora
Hydromorphone - answer- CII
diludad
Hydrocodone - answer- CII
lortab, vicodin, norco, tussionex, vicoprofen
Meperidine - answer- CII
demerol
Oxycodone/APAP - answer- CII
perocet
Metadone - answer- CII
dolophine
Oxycodone - answer- CII
oxycontin
Morphine Sulfate - answer- CII
MS contin, oramorph, kadian, avaniza
Adderall - answer- CII
amphetamine
stimulant
Vyvanse - answer- CII
lisdexamfetamine
stimulant
Dexedrine - answer- CII
dextroamphetamine
stimulant
Methylphenidate - answer- CII
concerta, ritalin, methylin, daytrana, metadate, quillivant
stimulant
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