PTU Final Exam 165 Questions with Complete Solutions 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 DAW 2 - Correct Answer substitution allowed, patient requested specific product DAW 7 - Correct Answer substitution not allowed; brand mandated by law DAW 8 - Correct Answer Substitution allowed; generic drug not available in marketplace DAW 3 - Correct Answer Substitution allowed; pharmacist-selected product dispensed 1 / 2
DAW 4 - Correct Answer Substitution allowed - generic drug not in stock DAW 5 - Correct Answer Substitution allowed - brand drug dispensed as generic DAW 6 - Correct Answer override DAW 9 - Correct Answer Other. Reserved and currently not in use.Fentanyl - Correct Answer CII duragesic, actiq, abstral, lazanda, fentora Hydromorphone - Correct Answer CII diludad Hydrocodone - Correct Answer CII lortab, vicodin, norco, tussionex, vicoprofen Meperidine - Correct Answer CII demerol Oxycodone/APAP - Correct Answer CII perocet Metadone - Correct Answer CII dolophine Oxycodone - Correct Answer CII oxycontin Morphine Sulfate - Correct Answer CII MS contin, oramorph, kadian, avaniza Adderall - Correct Answer CII amphetamine stimulant Vyvanse - Correct Answer CII lisdexamfetamine stimulant Dexedrine - Correct Answer CII dextroamphetamine stimulant Methylphenidate - Correct Answer CII
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