Schedule V – details and significance MCQs With Answer is essential for B. Pharm students studying controlled substances, regulatory pharmacy practice, and clinical pharmacology. Schedule V drugs have the lowest potential for abuse among controlled substances, accepted medical uses, and include certain codeine-containing cough syrups, diphenoxylate combinations, and pregabalin. Understanding Schedule V covers pharmacology, dependence risk, dosing, prescribing and dispensing rules, recordkeeping, storage, and legal responsibilities of pharmacists. This topic links drug classification to patient safety, monitoring, and medication counseling. Mastering these details helps future pharmacists ensure compliance, prevent diversion, and deliver safe therapy. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. Which of the following best describes Schedule V controlled substances?
- Substances with the highest potential for abuse and no medical use
- Substances with no regulatory control
- Substances with the lowest potential for abuse among scheduled drugs and accepted medical uses
- Illicit substances banned in all countries
Correct Answer: Substances with the lowest potential for abuse among scheduled drugs and accepted medical uses
Q2. How does the abuse potential of Schedule V substances compare to Schedule III substances?
- Higher than Schedule III
- Lower than Schedule III
- Equal to Schedule III
- Not comparable
Correct Answer: Lower than Schedule III
Q3. Which of the following is a typical example of a Schedule V product?
- Pure morphine sulfate tablets
- Codeine-containing cough syrup in limited concentrations
- Heroin
- Fentanyl patches
Correct Answer: Codeine-containing cough syrup in limited concentrations
Q4. Which schedule is pregabalin (Lyrica) classified under in the United States?
- Schedule I
- Schedule II
- Schedule V
- Not scheduled
Correct Answer: Schedule V
Q5. Diphenoxylate combined with atropine (used as an antidiarrheal) is commonly classified as:
- Schedule I
- Schedule II
- Schedule V
- Non-controlled substance
Correct Answer: Schedule V
Q6. Which federal agency is primarily responsible for enforcing the Controlled Substances Act and scheduling decisions?
- Food and Drug Administration (FDA)
- Drug Enforcement Administration (DEA)
- Centers for Disease Control and Prevention (CDC)
- World Health Organization (WHO)
Correct Answer: Drug Enforcement Administration (DEA)
Q7. Which statement about prescription requirements for Schedule V drugs is most accurate?
- They never require a prescription in any jurisdiction
- They usually require a prescription, though some limited OTC sales are permitted in certain jurisdictions
- They are always sold over-the-counter without restrictions
- They can only be used in hospital settings
Correct Answer: They usually require a prescription, though some limited OTC sales are permitted in certain jurisdictions
Q8. Under U.S. federal law, what is the maximum number of refills permitted for a Schedule V prescription within six months?
- No refills allowed
- Up to 5 refills
- Unlimited refills
- One refill only
Correct Answer: Up to 5 refills
Q9. Compared with Schedule II substances, Schedule V drugs have:
- Higher risk of physical dependence
- Lower risk of dependence
- Exactly the same dependence risk
- No pharmacological effects
Correct Answer: Lower risk of dependence
Q10. Which is a primary professional responsibility of a pharmacist handling Schedule V medications?
- Monitor for misuse, counsel patients, and maintain accurate records
- Promote sales without counseling
- Ignore prescription history
- Delegate all checks to pharmacy technicians without oversight
Correct Answer: Monitor for misuse, counsel patients, and maintain accurate records
Q11. What is the primary mechanism of action of pregabalin, a Schedule V drug?
- Opioid receptor agonist
- Binds to the alpha2-delta subunit of voltage-gated calcium channels to reduce neurotransmitter release
- Selective serotonin reuptake inhibitor
- Benzodiazepine receptor agonist
Correct Answer: Binds to the alpha2-delta subunit of voltage-gated calcium channels to reduce neurotransmitter release
Q12. Diphenoxylate/atropine is primarily used therapeutically as a:
- Bronchodilator
- Diuretic
- Antidiarrheal agent
- Antihypertensive
Correct Answer: Antidiarrheal agent
Q13. For how long must pharmacies typically maintain controlled substance records according to DEA regulations?
- 6 months
- 2 years
- 10 years
- No recordkeeping required
Correct Answer: 2 years
Q14. Are oral prescriptions generally permitted for Schedule V substances?
- Yes, oral prescriptions are generally permitted
- No, only written prescriptions are allowed
- Only faxed prescriptions are allowed
- Only electronic prescriptions without oral contact are allowed
Correct Answer: Yes, oral prescriptions are generally permitted
Q15. Which schedule represents substances with the highest potential for abuse?
- Schedule I
- Schedule IV
- Schedule V
- Schedule III
Correct Answer: Schedule I
Q16. Which statement about Schedule V sales is true in some U.S. states?
- Certain Schedule V products may be sold over-the-counter with restrictions such as age limits and recordkeeping
- All Schedule V drugs are banned from sale
- Schedule V drugs can be dispensed without any pharmacist oversight
- Schedule V classification is identical across all countries
Correct Answer: Certain Schedule V products may be sold over-the-counter with restrictions such as age limits and recordkeeping
Q17. Which of the following drugs is NOT classified as Schedule V?
- Codeine-containing cough syrup with limited concentration
- Pregabalin
- Morphine
- Diphenoxylate/atropine combination
Correct Answer: Morphine
Q18. Which federal department provides scientific and medical evaluations to the DEA during scheduling decisions?
- Department of Health and Human Services (HHS)
- Department of Education (DOE)
- Department of Agriculture (USDA)
- Department of Transportation (DOT)
Correct Answer: Department of Health and Human Services (HHS)
Q19. Schedule V drugs commonly include which therapeutic categories?
- Antitussives, antidiarrheals, and some anticonvulsants
- General anesthetics only
- Antibiotics exclusively
- Only topical dermatologics
Correct Answer: Antitussives, antidiarrheals, and some anticonvulsants
Q20. Why is detailed knowledge of Schedule V important for B. Pharm students?
- To ensure patient safety, legal compliance, and prevention of diversion
- Only to increase sales of controlled drugs
- To avoid any patient counseling responsibilities
- It is irrelevant to pharmacy practice
Correct Answer: To ensure patient safety, legal compliance, and prevention of diversion
Q21. When Schedule V products are sold without a prescription where permitted, what practice is commonly required at the pharmacy?
- Check purchaser identification and maintain a sale record
- Sell without any documentation
- Require hospital admission
- Refer all sales to online vendors
Correct Answer: Check purchaser identification and maintain a sale record
Q22. Which statement about dependence on Schedule V drugs is most accurate?
- They cannot cause physical or psychological dependence under any circumstances
- They have lower dependence risk than higher schedules but dependence is still possible
- They always cause severe dependence in all patients
- Dependence is guaranteed after a single dose
Correct Answer: They have lower dependence risk than higher schedules but dependence is still possible
Q23. Under federal regulations, how long from the date written is a Schedule V prescription valid for refills?
- 6 months
- 1 month
- 2 years
- Indefinitely
Correct Answer: 6 months
Q24. Which tool is commonly used to track dispensing of controlled substances, including Schedule V, to detect misuse?
- Prescription Drug Monitoring Program (PDMP)
- Immunization registry
- Hospital bed tracking system
- Weather monitoring service
Correct Answer: Prescription Drug Monitoring Program (PDMP)
Q25. Which statement about international scheduling of controlled substances is correct?
- Scheduling criteria and specific classifications can vary between countries
- All countries use identical schedules and lists
- Only the United States has controlled substance schedules
- The World Health Organization directly controls national schedules
Correct Answer: Scheduling criteria and specific classifications can vary between countries
Q26. Which is true regarding combination products containing small amounts of controlled drugs?
- They may be classified as Schedule V when the amount of the controlled substance is limited
- They are always Schedule I
- They can never be scheduled
- They are always free of regulation
Correct Answer: They may be classified as Schedule V when the amount of the controlled substance is limited
Q27. What is an appropriate storage and record practice for Schedule V medications in a community pharmacy?
- Store under adequately secure conditions and maintain dispensing records
- Leave them on an open counter with no records
- Require permanent refrigeration for all Schedule V drugs
- Ship all Schedule V stock to patients directly without pharmacy oversight
Correct Answer: Store under adequately secure conditions and maintain dispensing records
Q28. Which adverse effects should be monitored in patients receiving pregabalin, a Schedule V medication?
- Dizziness and somnolence
- Severe hyperglycemia
- Profound bradycardia in all patients
- Severe neutropenia as a universal effect
Correct Answer: Dizziness and somnolence
Q29. Which agency enforces federal controlled substances law and coordinates with state authorities?
- Drug Enforcement Administration (DEA)
- Local pharmacy chain only
- Federal Reserve
- Food and Agriculture Organization
Correct Answer: Drug Enforcement Administration (DEA)
Q30. If a pharmacist suspects diversion or illegal use of a Schedule V medication, the appropriate immediate action is to:
- Refuse to dispense, document the concern, and report to appropriate authorities
- Continue dispensing without question
- Provide the drug at a discount
- Hide the concern and transfer stock to another pharmacy
Correct Answer: Refuse to dispense, document the concern, and report to appropriate authorities

I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.
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