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
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
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
concerta, ritalin, methylin, daytrana, metadate, quillivant
stimulant