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PTU FINAL EXAM STUDY GUIDE

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PTU FINAL EXAM STUDY GUIDE

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  • August 8, 2024
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PTU FINAL EXAM STUDY GUIDE
Food, 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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