QUESTIONS WITH ANSWERS |\ |\
How long should RX be kept - CORRECT ANSWERS ✔✔5
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years FDA, 10 years MMA
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import information prescription label - CORRECT
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ANSWERS ✔✔pt name, rx serial number, drug name,
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strength, and directions |\ |\
A product is ________ if it does not have an expiration date
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- CORRECT ANSWERS ✔✔misbranded
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Who can provide a blanket waiver for non-child resistant
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container - CORRECT ANSWERS ✔✔patient (physician can
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only do it by RX)
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When are child resistant containers not used - CORRECT
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ANSWERS ✔✔hospital/healthcare settings |\ |\
A pharmacy dispensing to a LTCF requires what type of
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container - CORRECT ANSWERS ✔✔child resistant
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Policy for reversible closures - CORRECT ANSWERS
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✔✔discouraged by CPSC |\ |\
, products exempt from child closures - CORRECT ANSWERS
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✔✔sublingual nitro, sublingual/chewable isosorbide
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dinitrate, methylprednisone, betamethasone,
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Pharmaceutically equivalent - CORRECT ANSWERS |\ |\ |\ |\ |\
✔✔same ingredient, dosage form, route,
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strength/concentration
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therapeutically equivalent - CORRECT ANSWERS |\ |\ |\ |\ |\
✔✔pharma equiv and bioequivalent |\ |\ |\
bioequivalent - CORRECT ANSWERS ✔✔time to peak, peak
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concentration and AUC |\ |\
pharmaceutical alternative - CORRECT ANSWERS |\ |\ |\ |\ |\
✔✔different salt, ester, dosage form, strength
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therapeutic subsitution - CORRECT ANSWERS ✔✔limited to
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facilities that have a formulary
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the orange book - CORRECT ANSWERS ✔✔approved drug
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products with therapeutic equivalents
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NTI - CORRECT ANSWERS ✔✔less than 2 fold difference
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between LD50 and ED50|\ |\ |\
less than 2 fold difference between MTC and MEC
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