PTU Final Exam QUESTIONS WITH ANSWERS

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