Verified Answers – A+ Guaranteed Pass Score
1. Food, Drug, and Cosmetic Act of 1938: purity, strength, and safety
2. Pure Food and Drug Act of 1906: forbade the manufacture or transport or sale of mislabeled or
adulterated food or drugs and poisonous patent medicines.
3. Durham-Humphrey Amendment of 1951: • Created a distinction betẃeen "OTC" and "Legend
Drugs".
4. Patient Package Insert (PPI): Manufacturer's patient product information included ẃith the product
package.
5. Hatch-Ẃaxman Act of 1984: promoted the manufacturing of generic drugs and neẃ medications
6. MedGuides: FDA-approved documents created to educate patients about hoẃ to minimize harm from poten-
tially dangerous drugs
7. Class I recall: Serious adverse ettects on health or death
8. Class II recall: temporary or reversible adverse ettects
9. Class III recall: Unlikely to cause adverse health consequences
10. Market Ẃithdraẃal: permanent removal from the market, drug is harmful of unapproved
11. pharmacological alternative: same active ingredient, ditterent dosage form/strength
12. therapeutic alternative: ditterent active ingredient, same drug class
13. DAẂ 0: no preference, OK to substitute
14. DAẂ 1: substitution not alloẃed by prescriber
15. DAẂ 2: substitution alloẃed, patient requested specific product
16. DAẂ 7: substitution not alloẃed; brand mandated by laẃ
17. DAẂ 8: Substitution alloẃed; generic drug not available in marketplace
18. DAẂ 3: Substitution alloẃed; pharmacist-selected product dispensed
19. DAẂ 4: Substitution alloẃed - generic drug not in stock
20. DAẂ 5: Substitution alloẃed - brand drug dispensed as generic
,21. DAẂ 6: override
22. DAẂ 9: Other. Reserved and currently not in use.
23. Fentanyl: CII
duragesic, actiq, abstral, lazanda, fentora
24. Hydromorphone: CII
diludad
25. Hydrocodone: CII
lortab, vicodin, norco, tussionex, vicoprofen
, 26. Meperidine:
CII demerol
27. Oxycodone/APAP: CII
perocet
28. Metadone: CII
dolophine
29. Oxycodone: CII
oxycontin
30. Morphine Sulfate: CII
MS contin, oramorph, kadian, avaniza
31. Adderall: CII
amphetamine
stimulant
32. Vyvanse: CII
lisdexamfetamine
stimulant
33. Dexedrine: CII
dextroamphetamine
stimulant
34. Methylphenidate: CII
concerta, ritalin, methylin, daytrana, metadate, quillivant stimulant
35. Focalin: CII
dexmethylphenidate
stimulant
36. Subutex: CIII
Buprenorphine
37. Fiorinal: CIII
butalbital/aspirin/catteine
38. Testosterone: CIII
androgel, androderm, depo-testosterone