PTU Final Exam Guide Questions and CORRECT Answers
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Course
PTU
Institution
PTU
PTU Final Exam Guide Questions and
CORRECT Answers
Food, Drug, and Cosmetic Act of 1938 - Correct Answer- purity, strength, and safety
Pure Food and Drug Act of 1906 - Correct Answer- forbade the manufacture or transport or
sale of mislabeled or adulterated food or drugs and poisonous patent ...
PTU Final Exam Guide Questions and
CORRECT Answers
Food, Drug, and Cosmetic Act of 1938 - Correct Answer- purity, strength, and safety
Pure Food and Drug Act of 1906 - Correct Answer- forbade the manufacture or transport or
sale of mislabeled or adulterated food or drugs and poisonous patent medicines.
Durham-Humphrey Amendment of 1951 - Correct Answer- • Created a distinction between
"OTC" and "Legend Drugs".
Patient Package Insert (PPI) - Correct Answer- Manufacturer's patient product information
included with the product package.
Hatch-Waxman Act of 1984 - Correct Answer- promoted the manufacturing of generic drugs
and new medications
MedGuides - Correct Answer- FDA-approved documents created to educate patients about
how to minimize harm from potentially dangerous drugs
Class I recall - Correct Answer- Serious adverse effects on health or death
Class II recall - Correct Answer- temporary or reversible adverse effects
Class III recall - Correct Answer- Unlikely to cause adverse health consequences
Market Withdrawal - Correct Answer- permanent removal from the market, drug is harmful
of unapproved
pharmacological alternative - Correct Answer- same active ingredient, different dosage
form/strength
therapeutic alternative - Correct Answer- different active ingredient, same drug class
,DAW 0 - Correct Answer- no preference, OK to substitute
DAW 1 - Correct Answer- substitution not allowed by prescriber
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