PTU Final Exam QUESTIONS WITH
ANSWERS
Food, Drug, and Cosmetic Act of 1938 - CORRECT ANSWERS
✔✔purity, strength, and safety
Pure Food and Drug Act of 1906 - CORRECT ANSWERS ✔✔forbade
the manufacture or transport or sale of mislabeled or adulterated
food or drugs and poisonous patent medicines.
Durham-Humphrey Amendment of 1951 - CORRECT ANSWERS
✔✔• Created a distinction between "OTC" and "Legend Drugs".
Patient Package Insert (PPI) - CORRECT ANSWERS
✔✔Manufacturer's patient product information included with the
product package.
Hatch-Waxman Act of 1984 - CORRECT ANSWERS ✔✔promoted
the manufacturing of generic drugs and new medications
,MedGuides - CORRECT ANSWERS ✔✔FDA-approved documents
created to educate patients about how to minimize harm from
potentially dangerous drugs
Class I recall - CORRECT ANSWERS ✔✔Serious adverse effects on
health or death
Class II recall - CORRECT ANSWERS ✔✔temporary or reversible
adverse effects
Class III recall - CORRECT ANSWERS ✔✔Unlikely to cause adverse
health consequences
Market Withdrawal - CORRECT ANSWERS ✔✔permanent removal
from the market, drug is harmful of unapproved
pharmacological alternative - CORRECT ANSWERS ✔✔same active
ingredient, different dosage form/strength
therapeutic alternative - CORRECT ANSWERS ✔✔different active
ingredient, same drug class
DAW 0 - CORRECT ANSWERS ✔✔no preference, OK to substitute
, DAW 1 - CORRECT ANSWERS ✔✔substitution not allowed by
prescriber
DAW 2 - CORRECT ANSWERS ✔✔substitution allowed, patient
requested specific product
DAW 7 - CORRECT ANSWERS ✔✔substitution not allowed; brand
mandated by law
DAW 8 - CORRECT ANSWERS ✔✔Substitution allowed; generic
drug not available in marketplace
DAW 3 - CORRECT ANSWERS ✔✔Substitution allowed;
pharmacist-selected product dispensed
DAW 4 - CORRECT ANSWERS ✔✔Substitution allowed - generic
drug not in stock
DAW 5 - CORRECT ANSWERS ✔✔Substitution allowed - brand
drug dispensed as generic
DAW 6 - CORRECT ANSWERS ✔✔override
ANSWERS
Food, Drug, and Cosmetic Act of 1938 - CORRECT ANSWERS
✔✔purity, strength, and safety
Pure Food and Drug Act of 1906 - CORRECT ANSWERS ✔✔forbade
the manufacture or transport or sale of mislabeled or adulterated
food or drugs and poisonous patent medicines.
Durham-Humphrey Amendment of 1951 - CORRECT ANSWERS
✔✔• Created a distinction between "OTC" and "Legend Drugs".
Patient Package Insert (PPI) - CORRECT ANSWERS
✔✔Manufacturer's patient product information included with the
product package.
Hatch-Waxman Act of 1984 - CORRECT ANSWERS ✔✔promoted
the manufacturing of generic drugs and new medications
,MedGuides - CORRECT ANSWERS ✔✔FDA-approved documents
created to educate patients about how to minimize harm from
potentially dangerous drugs
Class I recall - CORRECT ANSWERS ✔✔Serious adverse effects on
health or death
Class II recall - CORRECT ANSWERS ✔✔temporary or reversible
adverse effects
Class III recall - CORRECT ANSWERS ✔✔Unlikely to cause adverse
health consequences
Market Withdrawal - CORRECT ANSWERS ✔✔permanent removal
from the market, drug is harmful of unapproved
pharmacological alternative - CORRECT ANSWERS ✔✔same active
ingredient, different dosage form/strength
therapeutic alternative - CORRECT ANSWERS ✔✔different active
ingredient, same drug class
DAW 0 - CORRECT ANSWERS ✔✔no preference, OK to substitute
, DAW 1 - CORRECT ANSWERS ✔✔substitution not allowed by
prescriber
DAW 2 - CORRECT ANSWERS ✔✔substitution allowed, patient
requested specific product
DAW 7 - CORRECT ANSWERS ✔✔substitution not allowed; brand
mandated by law
DAW 8 - CORRECT ANSWERS ✔✔Substitution allowed; generic
drug not available in marketplace
DAW 3 - CORRECT ANSWERS ✔✔Substitution allowed;
pharmacist-selected product dispensed
DAW 4 - CORRECT ANSWERS ✔✔Substitution allowed - generic
drug not in stock
DAW 5 - CORRECT ANSWERS ✔✔Substitution allowed - brand
drug dispensed as generic
DAW 6 - CORRECT ANSWERS ✔✔override
