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