NAPSRx CNPR Exam (Revised 18th Edition) Questions and Answers
|Fall 2025/2026 Update | 100% Correct Latest
QUESTION 1:
Which federal agency is primarily responsible for approving new prescription drugs for
marketing in the United States?
A. Centers for Disease Control and Prevention (CDC)
B. U.S. Food and Drug Administration (FDA)
C. Drug Enforcement Administration (DEA)
D. Department of Health and Human Services (HHS)
CORRECT ANSWER: B. U.S. Food and Drug Administration (FDA)
RATIONALE: The FDA reviews clinical data and ensures the safety, efficacy, and quality of
pharmaceutical products before market approval.
QUESTION 2:
The Controlled Substances Act (CSA) is enforced by which agency?
A. Federal Trade Commission (FTC)
B. Drug Enforcement Administration (DEA)
C. Centers for Medicare and Medicaid Services (CMS)
D. Environmental Protection Agency (EPA)
CORRECT ANSWER: B. Drug Enforcement Administration (DEA)
RATIONALE: The DEA regulates manufacturing, distribution, and dispensing of controlled
substances within U.S. laws.
QUESTION 3:
Phase III clinical trials typically involve:
A. Animal testing
B. Healthy volunteer testing only
C. Large-scale patient population testing for efficacy and safety
D. Post-marketing surveillance
CORRECT ANSWER: C. Large-scale patient population testing for efficacy and safety
,RATIONALE: Phase III evaluates drug effectiveness and monitors adverse reactions in extensive
human patient populations.
QUESTION 4:
Which of the following terms describes the process of a drug moving from the bloodstream into
tissues?
A. Absorption
B. Distribution
C. Metabolism
D. Excretion
CORRECT ANSWER: B. Distribution
RATIONALE: Distribution describes the reversible transfer of a drug from circulation to tissue
compartments.
QUESTION 5:
The study of drug actions and mechanisms is known as:
A. Pharmacokinetics
B. Pharmacodynamics
C. Toxicology
D. Pharmacovigilance
CORRECT ANSWER: B. Pharmacodynamics
RATIONALE: Pharmacodynamics concerns how drugs interact with receptors and produce
physiological effects.
QUESTION 6:
The term “bioavailability” refers to:
A. The rate of drug absorption in animals
B. The fraction of administered dose reaching systemic circulation unchanged
C. The volume of drug excreted after metabolism
D. The potency of a drug in the liver
,CORRECT ANSWER: B. The fraction of administered dose reaching systemic circulation
unchanged
RATIONALE: Bioavailability determines how much active drug enters circulation to exert a
therapeutic effect.
QUESTION 7:
Which of the following is a Schedule II controlled substance?
A. Diazepam
B. Morphine
C. Cough syrup with codeine
D. Lorazepam
CORRECT ANSWER: B. Morphine
RATIONALE: Schedule II drugs have high abuse potential but accepted medical uses; morphine is
a prototypical example.
QUESTION 8:
The abbreviation “QD” on a prescription means:
A. Take twice daily
B. Take three times daily
C. Take once daily
D. Take as needed
CORRECT ANSWER: C. Take once daily
RATIONALE: “QD” stands for “quaque die” (Latin), meaning once per day.
QUESTION 9:
A pharmaceutical sales representative’s primary ethical obligation is to:
A. Meet quarterly sales quotas only
B. Provide accurate, balanced, and fair information about approved drugs
C. Promote competitive off-label uses
D. Avoid interactions with healthcare professionals
, CORRECT ANSWER: B. Provide accurate, balanced, and fair information about approved
drugs
RATIONALE: CNPR standards emphasize truthfulness, compliance, and adherence to FDA-
approved labeling.
QUESTION 10:
Drugs that require a prescription and monitoring by a licensed healthcare provider are termed:
A. Over-the-counter medications
B. Controlled substances
C. Legend drugs
D. Placebos
CORRECT ANSWER: C. Legend drugs
RATIONALE: “Legend drugs” carry the federal legend: “Caution: Federal law prohibits dispensing
without prescription.”
QUESTION 11:
What term describes the process of transforming a drug into one or more metabolites?
A. Excretion
B. Absorption
C. Metabolism
D. Compartmentalization
CORRECT ANSWER: C. Metabolism
RATIONALE: Metabolism, primarily hepatic, chemically alters drugs to facilitate elimination.
QUESTION 12:
Which act requires pharmaceutical manufacturers to prove safety before marketing drugs?
A. Pure Food and Drug Act of 1906
B. Food, Drug, and Cosmetic Act of 1938
C. Kefauver-Harris Amendment of 1962
D. Hatch-Waxman Act of 1984
|Fall 2025/2026 Update | 100% Correct Latest
QUESTION 1:
Which federal agency is primarily responsible for approving new prescription drugs for
marketing in the United States?
A. Centers for Disease Control and Prevention (CDC)
B. U.S. Food and Drug Administration (FDA)
C. Drug Enforcement Administration (DEA)
D. Department of Health and Human Services (HHS)
CORRECT ANSWER: B. U.S. Food and Drug Administration (FDA)
RATIONALE: The FDA reviews clinical data and ensures the safety, efficacy, and quality of
pharmaceutical products before market approval.
QUESTION 2:
The Controlled Substances Act (CSA) is enforced by which agency?
A. Federal Trade Commission (FTC)
B. Drug Enforcement Administration (DEA)
C. Centers for Medicare and Medicaid Services (CMS)
D. Environmental Protection Agency (EPA)
CORRECT ANSWER: B. Drug Enforcement Administration (DEA)
RATIONALE: The DEA regulates manufacturing, distribution, and dispensing of controlled
substances within U.S. laws.
QUESTION 3:
Phase III clinical trials typically involve:
A. Animal testing
B. Healthy volunteer testing only
C. Large-scale patient population testing for efficacy and safety
D. Post-marketing surveillance
CORRECT ANSWER: C. Large-scale patient population testing for efficacy and safety
,RATIONALE: Phase III evaluates drug effectiveness and monitors adverse reactions in extensive
human patient populations.
QUESTION 4:
Which of the following terms describes the process of a drug moving from the bloodstream into
tissues?
A. Absorption
B. Distribution
C. Metabolism
D. Excretion
CORRECT ANSWER: B. Distribution
RATIONALE: Distribution describes the reversible transfer of a drug from circulation to tissue
compartments.
QUESTION 5:
The study of drug actions and mechanisms is known as:
A. Pharmacokinetics
B. Pharmacodynamics
C. Toxicology
D. Pharmacovigilance
CORRECT ANSWER: B. Pharmacodynamics
RATIONALE: Pharmacodynamics concerns how drugs interact with receptors and produce
physiological effects.
QUESTION 6:
The term “bioavailability” refers to:
A. The rate of drug absorption in animals
B. The fraction of administered dose reaching systemic circulation unchanged
C. The volume of drug excreted after metabolism
D. The potency of a drug in the liver
,CORRECT ANSWER: B. The fraction of administered dose reaching systemic circulation
unchanged
RATIONALE: Bioavailability determines how much active drug enters circulation to exert a
therapeutic effect.
QUESTION 7:
Which of the following is a Schedule II controlled substance?
A. Diazepam
B. Morphine
C. Cough syrup with codeine
D. Lorazepam
CORRECT ANSWER: B. Morphine
RATIONALE: Schedule II drugs have high abuse potential but accepted medical uses; morphine is
a prototypical example.
QUESTION 8:
The abbreviation “QD” on a prescription means:
A. Take twice daily
B. Take three times daily
C. Take once daily
D. Take as needed
CORRECT ANSWER: C. Take once daily
RATIONALE: “QD” stands for “quaque die” (Latin), meaning once per day.
QUESTION 9:
A pharmaceutical sales representative’s primary ethical obligation is to:
A. Meet quarterly sales quotas only
B. Provide accurate, balanced, and fair information about approved drugs
C. Promote competitive off-label uses
D. Avoid interactions with healthcare professionals
, CORRECT ANSWER: B. Provide accurate, balanced, and fair information about approved
drugs
RATIONALE: CNPR standards emphasize truthfulness, compliance, and adherence to FDA-
approved labeling.
QUESTION 10:
Drugs that require a prescription and monitoring by a licensed healthcare provider are termed:
A. Over-the-counter medications
B. Controlled substances
C. Legend drugs
D. Placebos
CORRECT ANSWER: C. Legend drugs
RATIONALE: “Legend drugs” carry the federal legend: “Caution: Federal law prohibits dispensing
without prescription.”
QUESTION 11:
What term describes the process of transforming a drug into one or more metabolites?
A. Excretion
B. Absorption
C. Metabolism
D. Compartmentalization
CORRECT ANSWER: C. Metabolism
RATIONALE: Metabolism, primarily hepatic, chemically alters drugs to facilitate elimination.
QUESTION 12:
Which act requires pharmaceutical manufacturers to prove safety before marketing drugs?
A. Pure Food and Drug Act of 1906
B. Food, Drug, and Cosmetic Act of 1938
C. Kefauver-Harris Amendment of 1962
D. Hatch-Waxman Act of 1984
