CNPR EXAM QUESTIONS AND ANSWERS (VERIFIED ANSWERS) (LATEST UPDATE
2026-2027) UPDATE!!
Question 1
Which federal agency is primarily responsible for regulating prescription drug
advertising in the United States?
A. Centers for Disease Control and Prevention (CDC)
B. Food and Drug Administration (FDA)
C. Drug Enforcement Administration (DEA)
D. National Institutes of Health (NIH)
Answer: B. Food and Drug Administration (FDA)
Rationale: The FDA’s Center for Drug Evaluation and Research (CDER) oversees
prescription drug marketing, labeling, and advertising to ensure claims are
accurate and not misleading. The DEA regulates controlled substances, while the
CDC and NIH focus more on research and public health.
Question 2
What does “off-label use” mean in pharmaceutical sales?
A. Use of a drug that is not FDA-approved at all
B. Use of an FDA-approved drug for a purpose not included in its official labeling
C. Marketing a drug without approval
D. Using a generic drug instead of a brand name drug
Answer: B. Use of an FDA-approved drug for a purpose not included in its
official labeling
Rationale: Physicians may legally prescribe drugs for off-label use, but
pharmaceutical reps cannot promote or market these uses. Doing so can lead to
FDA violations and penalties for the manufacturer.
Question 3
Which law prohibits the promotion of false or misleading claims about drugs?
A. Hatch-Waxman Act
B. Food, Drug, and Cosmetic Act (FD&C Act)
C. Kefauver-Harris Amendment
D. Orphan Drug Act
,Answer: B. Food, Drug, and Cosmetic Act (FD&C Act)
Rationale: The FD&C Act gives the FDA authority to regulate labeling and
advertising of prescription drugs. It prohibits misbranding or false claims. The
Kefauver-Harris Amendment strengthened drug safety/efficacy standards but is
part of the FD&C framework.
Question 4
A pharmaceutical representative is asked about adverse effects not listed in the
official labeling. What should the rep do?
A. Provide personal opinion on side effects
B. Ignore the question to avoid risk
C. Refer the healthcare provider to the company’s medical affairs department
D. Provide anecdotal patient stories
Answer: C. Refer the healthcare provider to the company’s medical affairs
department
Rationale: Reps must stay within FDA-approved product labeling. Off-label
questions should be referred to the medical affairs or medical science liaison
(MSL) team, which can provide scientific, compliant responses.
Question 5
Which of the following is an example of a Schedule II controlled substance?
A. Diazepam
B. Oxycodone
C. Codeine cough syrup
D. Alprazolam
Answer: B. Oxycodone
Rationale: Schedule II drugs have high potential for abuse and dependence but
also accepted medical use. Diazepam (Valium) and alprazolam (Xanax) are
Schedule IV, while codeine cough syrup may be Schedule V depending on
formulation.
Question 6
What does “bioavailability” refer to?
A. A drug’s distribution in body tissues
B. The rate of drug excretion from the body
C. The proportion of the drug that enters systemic circulation unchanged
D. The process of drug metabolism in the liver
Answer: C. The proportion of the drug that enters systemic circulation
,unchanged
Rationale: Bioavailability measures the fraction of an administered drug that
reaches circulation to exert its therapeutic effect. Oral drugs often have lower
bioavailability due to first-pass metabolism.
Question 7
The Hatch-Waxman Act of 1984 is most closely associated with:
A. Expanding orphan drug protections
B. Facilitating the approval of generic drugs
C. Strengthening FDA advertising regulations
D. Prohibiting direct-to-consumer advertising
Answer: B. Facilitating the approval of generic drugs
Rationale: The Hatch-Waxman Act created the Abbreviated New Drug Application
(ANDA) process, allowing generics to be approved based on bioequivalence
without repeating costly clinical trials.
Question 8
Which of the following is the primary role of a CNPR-certified pharmaceutical
sales representative?
A. Provide medical treatment directly to patients
B. Communicate accurate drug information to healthcare providers
C. Prescribe medications under supervision
D. Conduct original clinical trials
Answer: B. Communicate accurate drug information to healthcare providers
Rationale: Pharmaceutical reps educate providers on FDA-approved drug uses,
benefits, and risks, ensuring compliant, evidence-based communication. They
cannot prescribe or treat patients.
Question 9
The “first-pass effect” primarily affects drugs given by which route?
A. Intravenous
B. Subcutaneous
C. Oral
D. Inhalation
Answer: C. Oral
Rationale: Drugs taken orally are absorbed in the GI tract and pass through the
liver before reaching systemic circulation, where metabolism reduces their
bioavailability. IV drugs bypass this effect.
, Question 10
Which regulatory document must be reviewed by pharmaceutical reps before
promoting a drug?
A. Medical journals
B. FDA-approved package insert (PI)
C. Company’s marketing brochure
D. Clinical trial recruitment ads
Answer: B. FDA-approved package insert (PI)
Rationale: The PI (also called prescribing information) is the legally binding
document that contains indications, contraindications, dosage, and safety
information. All promotion must align with it.
Question 11
The Orphan Drug Act provides incentives for developing drugs for diseases
affecting:
A. More than 500,000 people in the U.S.
B. Fewer than 200,000 people in the U.S.
C. Only pediatric patients
D. Developing countries only
Answer: B. Fewer than 200,000 people in the U.S.
Rationale: Orphan drug designation provides tax credits, market exclusivity, and
FDA support for rare disease treatments.
Question 12
Which is an example of pharmacokinetics?
A. Drug–drug interactions
B. Mechanism of action at a receptor site
C. How a drug is absorbed, distributed, metabolized, and excreted
D. Patient adherence to therapy
Answer: C. How a drug is absorbed, distributed, metabolized, and excreted
Rationale: Pharmacokinetics is “what the body does to the drug.”
Pharmacodynamics is “what the drug does to the body.”
Question 13
The DEA regulates drugs based on:
A. Clinical trial results
B. Potential for abuse and accepted medical use
2026-2027) UPDATE!!
Question 1
Which federal agency is primarily responsible for regulating prescription drug
advertising in the United States?
A. Centers for Disease Control and Prevention (CDC)
B. Food and Drug Administration (FDA)
C. Drug Enforcement Administration (DEA)
D. National Institutes of Health (NIH)
Answer: B. Food and Drug Administration (FDA)
Rationale: The FDA’s Center for Drug Evaluation and Research (CDER) oversees
prescription drug marketing, labeling, and advertising to ensure claims are
accurate and not misleading. The DEA regulates controlled substances, while the
CDC and NIH focus more on research and public health.
Question 2
What does “off-label use” mean in pharmaceutical sales?
A. Use of a drug that is not FDA-approved at all
B. Use of an FDA-approved drug for a purpose not included in its official labeling
C. Marketing a drug without approval
D. Using a generic drug instead of a brand name drug
Answer: B. Use of an FDA-approved drug for a purpose not included in its
official labeling
Rationale: Physicians may legally prescribe drugs for off-label use, but
pharmaceutical reps cannot promote or market these uses. Doing so can lead to
FDA violations and penalties for the manufacturer.
Question 3
Which law prohibits the promotion of false or misleading claims about drugs?
A. Hatch-Waxman Act
B. Food, Drug, and Cosmetic Act (FD&C Act)
C. Kefauver-Harris Amendment
D. Orphan Drug Act
,Answer: B. Food, Drug, and Cosmetic Act (FD&C Act)
Rationale: The FD&C Act gives the FDA authority to regulate labeling and
advertising of prescription drugs. It prohibits misbranding or false claims. The
Kefauver-Harris Amendment strengthened drug safety/efficacy standards but is
part of the FD&C framework.
Question 4
A pharmaceutical representative is asked about adverse effects not listed in the
official labeling. What should the rep do?
A. Provide personal opinion on side effects
B. Ignore the question to avoid risk
C. Refer the healthcare provider to the company’s medical affairs department
D. Provide anecdotal patient stories
Answer: C. Refer the healthcare provider to the company’s medical affairs
department
Rationale: Reps must stay within FDA-approved product labeling. Off-label
questions should be referred to the medical affairs or medical science liaison
(MSL) team, which can provide scientific, compliant responses.
Question 5
Which of the following is an example of a Schedule II controlled substance?
A. Diazepam
B. Oxycodone
C. Codeine cough syrup
D. Alprazolam
Answer: B. Oxycodone
Rationale: Schedule II drugs have high potential for abuse and dependence but
also accepted medical use. Diazepam (Valium) and alprazolam (Xanax) are
Schedule IV, while codeine cough syrup may be Schedule V depending on
formulation.
Question 6
What does “bioavailability” refer to?
A. A drug’s distribution in body tissues
B. The rate of drug excretion from the body
C. The proportion of the drug that enters systemic circulation unchanged
D. The process of drug metabolism in the liver
Answer: C. The proportion of the drug that enters systemic circulation
,unchanged
Rationale: Bioavailability measures the fraction of an administered drug that
reaches circulation to exert its therapeutic effect. Oral drugs often have lower
bioavailability due to first-pass metabolism.
Question 7
The Hatch-Waxman Act of 1984 is most closely associated with:
A. Expanding orphan drug protections
B. Facilitating the approval of generic drugs
C. Strengthening FDA advertising regulations
D. Prohibiting direct-to-consumer advertising
Answer: B. Facilitating the approval of generic drugs
Rationale: The Hatch-Waxman Act created the Abbreviated New Drug Application
(ANDA) process, allowing generics to be approved based on bioequivalence
without repeating costly clinical trials.
Question 8
Which of the following is the primary role of a CNPR-certified pharmaceutical
sales representative?
A. Provide medical treatment directly to patients
B. Communicate accurate drug information to healthcare providers
C. Prescribe medications under supervision
D. Conduct original clinical trials
Answer: B. Communicate accurate drug information to healthcare providers
Rationale: Pharmaceutical reps educate providers on FDA-approved drug uses,
benefits, and risks, ensuring compliant, evidence-based communication. They
cannot prescribe or treat patients.
Question 9
The “first-pass effect” primarily affects drugs given by which route?
A. Intravenous
B. Subcutaneous
C. Oral
D. Inhalation
Answer: C. Oral
Rationale: Drugs taken orally are absorbed in the GI tract and pass through the
liver before reaching systemic circulation, where metabolism reduces their
bioavailability. IV drugs bypass this effect.
, Question 10
Which regulatory document must be reviewed by pharmaceutical reps before
promoting a drug?
A. Medical journals
B. FDA-approved package insert (PI)
C. Company’s marketing brochure
D. Clinical trial recruitment ads
Answer: B. FDA-approved package insert (PI)
Rationale: The PI (also called prescribing information) is the legally binding
document that contains indications, contraindications, dosage, and safety
information. All promotion must align with it.
Question 11
The Orphan Drug Act provides incentives for developing drugs for diseases
affecting:
A. More than 500,000 people in the U.S.
B. Fewer than 200,000 people in the U.S.
C. Only pediatric patients
D. Developing countries only
Answer: B. Fewer than 200,000 people in the U.S.
Rationale: Orphan drug designation provides tax credits, market exclusivity, and
FDA support for rare disease treatments.
Question 12
Which is an example of pharmacokinetics?
A. Drug–drug interactions
B. Mechanism of action at a receptor site
C. How a drug is absorbed, distributed, metabolized, and excreted
D. Patient adherence to therapy
Answer: C. How a drug is absorbed, distributed, metabolized, and excreted
Rationale: Pharmacokinetics is “what the body does to the drug.”
Pharmacodynamics is “what the drug does to the body.”
Question 13
The DEA regulates drugs based on:
A. Clinical trial results
B. Potential for abuse and accepted medical use
