PTU FINAL EXAM
1. Food, Drug, and Cosmetic Act of 1938
Answer purity, strength, and safety
2. 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.
3. Durham-Humphrey Amendment of 1951
Answer • Created a distinction between "OTC" and "Legend Drugs".
4. Patient Package Insert (PPI)
Answer Manufacturer's patient product information included with the product package.
5. Hatch-Waxman Act of 1984
Answer promoted the manufacturing of generic drugs and new medications
6. MedGuides
Answer FDA-approved documents created to educate patients about how to minimize harm from poten- tially
dangerous drugs
,7. Class I recall
Answer Serious adverse ettects on health or death
8. Class II recall
Answer temporary or reversible adverse ettects
9. Class III recall
Answer Unlikely to cause adverse health consequences
10. Market Withdrawal
Answer permanent removal from the market, drug is harmful of unapproved
11. pharmacological alternative
Answer same active ingredient, ditterent dosage form/strength
12. therapeutic alternative
Answer ditterent active ingredient, same drug class
13. DAW 0
Answer no preference, OK to substitute
14. DAW 1
, Answer substitution not allowed by prescriber
15. DAW 2
Answer substitution allowed, patient requested specific product
16. DAW 7
Answer substitution not allowed; brand mandated by law
17. DAW 8
Answer Substitution allowed; generic drug not available in marketplace
18. DAW 3
Answer Substitution allowed; pharmacist-selected product dispensed
19. DAW 4
Answer Substitution allowed - generic drug not in stock
20. DAW 5
Answer Substitution allowed - brand drug dispensed as generic
21. DAW 6
Answer override
, 22. DAW 9
Answer Other. Reserved and currently not in use.
23. Fentanyl
Answer CII
duragesic, actiq, abstral, lazanda, fentora
24. Hydromorphone
Answer CII diludad
25. Hydrocodone
Answer CII
lortab, vicodin, norco, tussionex, vicoprofen
1. Food, Drug, and Cosmetic Act of 1938
Answer purity, strength, and safety
2. 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.
3. Durham-Humphrey Amendment of 1951
Answer • Created a distinction between "OTC" and "Legend Drugs".
4. Patient Package Insert (PPI)
Answer Manufacturer's patient product information included with the product package.
5. Hatch-Waxman Act of 1984
Answer promoted the manufacturing of generic drugs and new medications
6. MedGuides
Answer FDA-approved documents created to educate patients about how to minimize harm from poten- tially
dangerous drugs
,7. Class I recall
Answer Serious adverse ettects on health or death
8. Class II recall
Answer temporary or reversible adverse ettects
9. Class III recall
Answer Unlikely to cause adverse health consequences
10. Market Withdrawal
Answer permanent removal from the market, drug is harmful of unapproved
11. pharmacological alternative
Answer same active ingredient, ditterent dosage form/strength
12. therapeutic alternative
Answer ditterent active ingredient, same drug class
13. DAW 0
Answer no preference, OK to substitute
14. DAW 1
, Answer substitution not allowed by prescriber
15. DAW 2
Answer substitution allowed, patient requested specific product
16. DAW 7
Answer substitution not allowed; brand mandated by law
17. DAW 8
Answer Substitution allowed; generic drug not available in marketplace
18. DAW 3
Answer Substitution allowed; pharmacist-selected product dispensed
19. DAW 4
Answer Substitution allowed - generic drug not in stock
20. DAW 5
Answer Substitution allowed - brand drug dispensed as generic
21. DAW 6
Answer override
, 22. DAW 9
Answer Other. Reserved and currently not in use.
23. Fentanyl
Answer CII
duragesic, actiq, abstral, lazanda, fentora
24. Hydromorphone
Answer CII diludad
25. Hydrocodone
Answer CII
lortab, vicodin, norco, tussionex, vicoprofen
