Dispensing of proprietary products and controlled substances is a critical subject for B. Pharm students, blending pharmacy law, safe dispensing practices, and patient care. This topic covers prescription validation, drug scheduling, secure storage, inventory control, labeling, record keeping, and measures to prevent diversion of controlled substances like opioids. Mastery of regulatory frameworks, pharmacovigilance, counseling for proprietary brands, and ethical responsibilities ensures rational, legal, and safe medication use. These MCQs are designed to deepen practical understanding and prepare you for examinations and real-world pharmacy practice. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What best defines a proprietary product in pharmacy?
- A brand-name medicine marketed under a trademarked trade name
- A medicine sold only in hospitals
- A generic drug sold without a brand
- A compounded formulation prepared in the pharmacy
Correct Answer: A brand-name medicine marketed under a trademarked trade name
Q2. Which statement correctly describes a controlled substance?
- A medication that is always available over the counter
- A drug with potential for abuse and legal restrictions on its possession and dispensing
- An herbal supplement with no regulatory oversight
- A vitamin preparation used under prescription
Correct Answer: A drug with potential for abuse and legal restrictions on its possession and dispensing
Q3. What is the primary purpose of regulations governing controlled substances?
- To increase sales of proprietary brands
- To prevent misuse, diversion and protect public health while allowing legitimate medical use
- To eliminate all access to pain medications
- To standardize pill color across manufacturers
Correct Answer: To prevent misuse, diversion and protect public health while allowing legitimate medical use
Q4. Who is authorized to write a valid prescription for a controlled substance?
- Registered medical practitioner or licensed prescriber authorized by law
- Any pharmacy technician
- Pharmaceutical salesperson
- Family member of the patient
Correct Answer: Registered medical practitioner or licensed prescriber authorized by law
Q5. Which is a key mandatory element on a dispensing label?
- Patient name and clear dosage instructions
- The pharmacy owner’s home address only
- Manufacturer’s quarterly sales figures
- Advertising slogans for the drug
Correct Answer: Patient name and clear dosage instructions
Q6. In many regulatory frameworks (e.g., Drugs and Cosmetics Act variants), Schedule X drugs are characterized by which requirement?
- They can be sold freely without prescription
- They require strict records, separate registers and retention of prescriptions for audit
- They are exclusively herbal remedies
- They are products sold only online
Correct Answer: They require strict records, separate registers and retention of prescriptions for audit
Q7. Which details should a controlled-drug dispensing register typically include?
- Date, drug name, quantity dispensed, patient name, prescriber name/registration, and dispenser signature
- Only the drug manufacturer name
- The pharmacy’s weekly revenue
- Color of the pill and manufacturer logo
Correct Answer: Date, drug name, quantity dispensed, patient name, prescriber name/registration, and dispenser signature
Q8. Which of the following is NOT considered a proprietary product?
- A drug marketed under a brand name
- A formulation sold under a trademarked trade name
- The generic INN (International Nonproprietary Name) sold without brand labeling
- A branded combination product from a pharmaceutical company
Correct Answer: The generic INN (International Nonproprietary Name) sold without brand labeling
Q9. Best practice for storing controlled substances in a retail pharmacy includes:
- Keeping them in a locked cabinet or safe with restricted access and audit logs
- Placing them on open shelves next to OTC cough syrups
- Storing them with expired stock to use first
- Leaving them at the dispensing counter overnight
Correct Answer: Keeping them in a locked cabinet or safe with restricted access and audit logs
Q10. Pharmacovigilance primarily involves:
- Development of new drug molecules only
- Monitoring, detecting and reporting adverse drug reactions and safety signals
- Marketing strategies for proprietary drugs
- Measuring pharmacy sales volumes
Correct Answer: Monitoring, detecting and reporting adverse drug reactions and safety signals
Q11. Which element is essential to validate a prescription legally before dispensing?
- Prescriber’s signature and identification or registration/license number
- Pharmacist’s personal opinion about the drug’s color
- Patient’s family income details
- Manufacturer’s marketing authorization
Correct Answer: Prescriber’s signature and identification or registration/license number
Q12. Under what circumstance can an emergency supply of a controlled medicine be made without a formal prescription?
- Never under any circumstance
- Only in an immediate life-threatening situation following legal and ethical guidelines
- When the patient requests it for convenience
- When the drug is out of stock at nearby pharmacies
Correct Answer: Only in an immediate life-threatening situation following legal and ethical guidelines
Q13. What is the correct action for a pharmacy when receiving expired controlled substances?
- Return or dispose them through authorized destruction procedures and documented chain-of-custody
- Mix them with current stock to dilute potency
- Sell them at a discount without disclosure
- Donate them to another pharmacy without records
Correct Answer: Return or dispose them through authorized destruction procedures and documented chain-of-custody
Q14. Which inventory control technique helps prioritize management of high-cost or high-use medicines?
- ABC analysis to focus on high-value items
- Mix-and-match approach
- Random stock checking only
- Color coding by manufacturer logo
Correct Answer: ABC analysis to focus on high-value items
Q15. Drug diversion in the context of controlled substances refers to:
- The authorized distribution to hospitals
- Unauthorized rerouting of drugs from legal supply chains to illicit use
- The process of returning drugs to wholesalers
- The transfer of drugs between pharmacies within a chain
Correct Answer: Unauthorized rerouting of drugs from legal supply chains to illicit use
Q16. A correct labeling requirement for proprietary products includes which of the following?
- Brand name, generic name (INN), strength, dosage form and manufacturer details
- Only the brand slogan and logo
- Only the manufacturing batch number without drug name
- Only the pharmacy’s promotional text
Correct Answer: Brand name, generic name (INN), strength, dosage form and manufacturer details
Q17. Who should normally dispense Schedule X or similarly restricted drugs in a community pharmacy?
- A registered pharmacist following legal procedures and recording requirements
- A cashier or trainee without supervision
- Any customer requesting the item
- A marketing representative from the manufacturer
Correct Answer: A registered pharmacist following legal procedures and recording requirements
Q18. Which prescription detail is crucial for tracking controlled-drug prescriptions during audits?
- Prescriber’s registration or license number
- Patient’s education level
- Pharmacy staff’s home addresses
- Manufacturer’s quarterly profit margin
Correct Answer: Prescriber’s registration or license number
Q19. For most conventional medicines, what storage condition is generally recommended unless otherwise specified?
- Store as per manufacturer’s instructions, commonly 15–25°C (room temperature)
- Keep them in direct sunlight to sterilize
- Freeze all oral tablets below 0°C
- Store every medicine at body temperature
Correct Answer: Store as per manufacturer’s instructions, commonly 15–25°C (room temperature)
Q20. Which statement best differentiates OTC medicines from prescription-only medicines?
- OTC medicines are considered safe for use without a prescriber’s supervision when used as directed
- OTC medicines always require a pharmacist to administer them
- Prescription medicines are free of side effects
- OTC medicines are illegal to sell in pharmacies
Correct Answer: OTC medicines are considered safe for use without a prescriber’s supervision when used as directed
Q21. What does PDMP stand for in the context of controlled substance monitoring?
- Pharmacy Drug Management Procedure
- Prescription Drug Monitoring Program
- Product Distribution and Marketing Plan
- Patient Drug Measurement Protocol
Correct Answer: Prescription Drug Monitoring Program
Q22. The most immediate risk of mislabeling a dispensed medication is:
- Medication errors leading to patient harm or therapeutic failure
- Improved patient adherence
- Increased manufacturer profits
- Faster shelf turnover
Correct Answer: Medication errors leading to patient harm or therapeutic failure
Q23. One advantage of proprietary (branded) products in patient care is:
- Brand recognition that may improve patient trust and adherence when quality is consistent
- They are always cheaper than generics
- They never cause adverse reactions
- They require no prescription control
Correct Answer: Brand recognition that may improve patient trust and adherence when quality is consistent
Q24. Controlled substances are scheduled primarily based on:
- Their color and packaging only
- Their potential for abuse, dependence and medical use or therapeutic value
- The manufacturer’s profit margin
- The pharmacy’s sales targets
Correct Answer: Their potential for abuse, dependence and medical use or therapeutic value
Q25. Why should pharmacies retain copies or records of controlled-drug prescriptions?
- To enable audits, trace dispensing events and help prevent diversion or misuse
- To send advertising to patients annually
- To increase inventory turnover artificially
- To avoid communicating with prescribers
Correct Answer: To enable audits, trace dispensing events and help prevent diversion or misuse
Q26. What does “double checking” mean in the dispensing process?
- Independent verification of the prescription and dispensed product by another qualified person
- Scanning the barcode twice at checkout only for billing
- Asking the patient to return the medicine next day for confirmation
- Cleaning the dispensing counter twice daily
Correct Answer: Independent verification of the prescription and dispensed product by another qualified person
Q27. Which document typically authorizes sale of prescription-only drugs (e.g., Schedule H)?
- A valid prescription from an authorized prescriber
- An invoice from the wholesaler only
- A verbal request from a neighbor
- A manufacturer’s promotional leaflet
Correct Answer: A valid prescription from an authorized prescriber
Q28. What is the recommended approach for disposing seized or recalled controlled substances?
- Follow regulatory procedures for supervised destruction with documentation and witness signatures
- Flush them down the sink without record
- Return them to any customer who asks
- Burn them in the pharmacy yard without notice
Correct Answer: Follow regulatory procedures for supervised destruction with documentation and witness signatures
Q29. Which counseling point is essential when dispensing opioid analgesics?
- Discuss risk of sedation, dependence, safe storage, and adherence to prescribed dosing
- Recommend combining with alcohol for faster relief
- Advise to double the dose if pain persists immediately
- Suggest sharing the medicine with family members
Correct Answer: Discuss risk of sedation, dependence, safe storage, and adherence to prescribed dosing
Q30. For electronic prescriptions of controlled substances, what is a critical requirement?
- Secure authentication, encryption and an audit trail to prevent tampering and enable verification
- Sending the prescription via public social media
- Printing only the prescriber’s name without signature
- Using any email address with no security checks
Correct Answer: Secure authentication, encryption and an audit trail to prevent tampering and enable verification
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.
Mail- Sachin@pharmacyfreak.com