2025 NAPSRX CNPR
QUESTIONS WITH DETAILED VERIFIED ANSWERS
(REVISED 18TH EDITION) 2025–2026
1. what does a STAT order mean? - CORRECT ANSWER >> -a drug needed immediately and
given only once
2. what information does the overdosage section of the labeling provide? - CORRECT
ANSWER >> -signs, symptoms and treatment of acute overdoses
3. types of drug-drug interactions: - CORRECT ANSWER >> -duplication, opposition
(antagonism) and alteration (p.51)
4. tolerance vs resistance - CORRECT ANSWER >> -tolerance is the diminished response to
a drug; resistance is the cells ability to resist the effects of the drug on them.
5. abbreviated new drug application (ANDA) - CORRECT ANSWER >> -the process by
which applicants must scientifically demonstrate to the FDA that their generic product
is bioequivalent to or performs in the same way as the innovator drug, no duplicate
testing (p. 75)
6. the Hatch-Waxman Act of 1984 - CORRECT ANSWER >> --A.K.A. Drug Price Competition
and Patent Restoration Act
-made it easier to bring generic drugs to the market by requiring the FDA to only look at
bioavailability studies in order to approve an ANDA.
https://www.stuvia.com/en-us/user/MBoffin
, -gave protection to the research based manufacturers by providing a 30-month automatic
cooling off period once an ANDA is challenged for patent infringement (p. 75)
https://www.stuvia.com/en-us/user/MBoffin
QUESTIONS WITH DETAILED VERIFIED ANSWERS
(REVISED 18TH EDITION) 2025–2026
1. what does a STAT order mean? - CORRECT ANSWER >> -a drug needed immediately and
given only once
2. what information does the overdosage section of the labeling provide? - CORRECT
ANSWER >> -signs, symptoms and treatment of acute overdoses
3. types of drug-drug interactions: - CORRECT ANSWER >> -duplication, opposition
(antagonism) and alteration (p.51)
4. tolerance vs resistance - CORRECT ANSWER >> -tolerance is the diminished response to
a drug; resistance is the cells ability to resist the effects of the drug on them.
5. abbreviated new drug application (ANDA) - CORRECT ANSWER >> -the process by
which applicants must scientifically demonstrate to the FDA that their generic product
is bioequivalent to or performs in the same way as the innovator drug, no duplicate
testing (p. 75)
6. the Hatch-Waxman Act of 1984 - CORRECT ANSWER >> --A.K.A. Drug Price Competition
and Patent Restoration Act
-made it easier to bring generic drugs to the market by requiring the FDA to only look at
bioavailability studies in order to approve an ANDA.
https://www.stuvia.com/en-us/user/MBoffin
, -gave protection to the research based manufacturers by providing a 30-month automatic
cooling off period once an ANDA is challenged for patent infringement (p. 75)
https://www.stuvia.com/en-us/user/MBoffin
