Establishing a retail or wholesale drug store requires compliance with multiple legal requirements governed by the Drugs and Cosmetics Act, state drug control authorities, and Good Distribution Practices. B.Pharm students must learn licensing procedures, pharmacist qualification and registration, premises and storage standards, temperature-controlled supply chain management, record-keeping, prescription rules for Schedule drugs (H, H1, X), narcotics control, labeling, inspections, and license renewal. Understanding documentation, returns, recalls, and pharmacist responsibilities ensures safe, lawful pharmacy practice and public health protection. This concise review highlights statutory obligations and practical compliance points to prepare you for professional roles and regulatory inspections. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. Which authority normally issues retail and wholesale drug licenses in most jurisdictions?
- Central Ministry of Finance
- State Drug Control Authority
- Local Municipal Corporation
- Pharmacy Owners Association
Correct Answer: State Drug Control Authority
Q2. Who must be present and responsible at a retail pharmacy while it is open for dispensing?
- A registered pharmacist
- The store owner only
- A sales clerk with basic training
- A medical representative
Correct Answer: A registered pharmacist
Q3. Which qualification typically allows a candidate to register as a practicing pharmacist?
- Diploma in Pharmacy (D.Pharm) or Bachelor of Pharmacy (B.Pharm) with registration
- Certificate in first aid
- Any bachelor’s degree
- Pharmacy technician course without registration
Correct Answer: Diploma in Pharmacy (D.Pharm) or Bachelor of Pharmacy (B.Pharm) with registration
Q4. What type of license is required to buy and sell drugs in bulk to pharmacies and institutions?
- Retail drug license
- Wholesale drug license
- Manufacturing license
- Import license
Correct Answer: Wholesale drug license
Q5. Which practice is essential for legally handling temperature-sensitive pharmaceuticals?
- Cold chain maintenance with temperature monitoring
- Storing them with non-medical products
- Using any available refrigerator without records
- Keeping them at room temperature regardless
Correct Answer: Cold chain maintenance with temperature monitoring
Q6. Which schedule requires pharmacies to maintain a separate register with patient and prescriber details and sale particulars?
- Schedule M
- Schedule H1
- Schedule H
- Schedule D
Correct Answer: Schedule H1
Q7. Sale of Schedule H medicines is legally allowed under which condition?
- When dispensed only on a valid prescription from a registered prescriber
- Whenever the customer requests them
- When sold by a wholesaler only
- When labeled as over-the-counter
Correct Answer: When dispensed only on a valid prescription from a registered prescriber
Q8. Who is authorized to inspect a retail or wholesale drug store for regulatory compliance?
- Drug Inspector from the state drug control authority
- Local police inspector
- Municipal garbage inspector
- Chief Medical Officer only
Correct Answer: Drug Inspector from the state drug control authority
Q9. How must a valid drug license be shown at a dispensing premises?
- Kept locked in a cabinet only
- Displayed prominently at the premises
- Registered online only without physical display
- Shown only during inspections
Correct Answer: Displayed prominently at the premises
Q10. What is the typical legal requirement for selling prescription-only medicines without a prescription?
- Permitted for emergency use without records
- Prohibited; sale requires a valid prescription
- Allowed if the pharmacist knows the patient
- Allowed only for small quantities
Correct Answer: Prohibited; sale requires a valid prescription
Q11. Online sale of prescription medicines generally requires which of the following?
- No license if the store is registered physically
- Specific compliance: valid license, prescription verification, and regulatory approvals
- Only a bank account for transactions
- Only promotional approval from manufacturer
Correct Answer: Specific compliance: valid license, prescription verification, and regulatory approvals
Q12. Which law principally regulates narcotic and psychotropic substances in many countries?
- Food Safety Act
- Narcotic Drugs and Psychotropic Substances (NDPS) Act
- Consumer Protection Act
- Trade Marks Act
Correct Answer: Narcotic Drugs and Psychotropic Substances (NDPS) Act
Q13. Who is primarily responsible for initiating a drug recall when safety issues emerge?
- The retail pharmacist
- The manufacturer or marketing authorization holder
- The patient who bought the drug
- The local hospital
Correct Answer: The manufacturer or marketing authorization holder
Q14. Which of these is NOT a component of Good Distribution Practices (GDP)?
- Temperature-controlled transport
- Documented traceability and records
- Uncontrolled access to storage areas
- Qualified personnel and security
Correct Answer: Uncontrolled access to storage areas
Q15. What action should a pharmacy take when drugs reach their expiry date?
- Continue to sell at discount
- Quarantine and dispose or return as per regulatory procedures
- Mix with non-expired stock to hide expiry
- Donate without documentation
Correct Answer: Quarantine and dispose or return as per regulatory procedures
Q16. Is it mandatory that the owner of a pharmacy must be a registered pharmacist?
- Yes, the owner must always be a registered pharmacist
- No, owner need not be a pharmacist but a registered pharmacist must be employed
- Yes, and they must also be the sole dispenser
- No, any layperson can run it without pharmacist
Correct Answer: No, owner need not be a pharmacist but a registered pharmacist must be employed
Q17. Which records should wholesalers and retailers maintain for traceability?
- Only cash transaction records
- Purchase invoices, sale invoices, and batch records
- Only verbal communications
- Manufacturer’s marketing brochures
Correct Answer: Purchase invoices, sale invoices, and batch records
Q18. What labeling information is typically mandatory on a packaged drug sold at retail?
- Manufacturer name, batch number, manufacturing and expiry dates, and maximum retail price (MRP)
- Only the brand logo
- Name of the pharmacist who sold it
- Customer’s address
Correct Answer: Manufacturer name, batch number, manufacturing and expiry dates, and maximum retail price (MRP)
Q19. Selling a medicine above the printed Maximum Retail Price (MRP) is legally:
- Allowed with customer consent
- Prohibited
- Allowed during business hours only
- Allowed if branded product
Correct Answer: Prohibited
Q20. Which schedule contains medicines that require strict record of sale and retention of prescription (commonly highly controlled drugs)?
- Schedule H
- Schedule X
- Schedule M
- Schedule Y
Correct Answer: Schedule X
Q21. Transfer of a drug license to another person or premises generally requires:
- Automatic transfer without permission
- Prior approval from the drug control authority
- No action if within the same city
- Only informing the local police
Correct Answer: Prior approval from the drug control authority
Q22. Which body registers pharmacists to legally practice in a state?
- State Pharmacy Council
- State Health Insurance Authority
- Drug manufacturers’ association
- Local Chamber of Commerce
Correct Answer: State Pharmacy Council
Q23. A pharmacy’s standard operating procedures (SOPs) are important because they:
- Are optional and rarely useful
- Provide documented procedures for dispensing, storage, and returns and ensure regulatory compliance
- Replace the need for licenses
- Only list employee salaries
Correct Answer: Provide documented procedures for dispensing, storage, and returns and ensure regulatory compliance
Q24. Who should be contacted first if a drug inspector identifies deficiencies during an inspection?
- The manufacturer’s CEO directly
- The state drug control authority with corrective action plan
- The local newspaper
- The customers of the pharmacy
Correct Answer: The state drug control authority with corrective action plan
Q25. Which of the following is a pharmacist’s legal and ethical duty at dispensing?
- Provide medicine without checking prescription
- Counsel the patient on proper use, dosage, and storage as appropriate
- Modify prescription drugs arbitrarily
- Sell expired medicines if requested
Correct Answer: Counsel the patient on proper use, dosage, and storage as appropriate
Q26. For vaccines and many biologics, the recommended cold chain temperature range is:
- 15–25 °C
- 2–8 °C
- -20–0 °C
- 30–40 °C
Correct Answer: 2–8 °C
Q27. Maintaining pharmacovigilance at retail and wholesale level primarily involves:
- Ignoring adverse event reports
- Reporting suspected adverse drug reactions to appropriate authorities or marketing authorization holders
- Only reporting when asked by customers
- Publishing promotional materials
Correct Answer: Reporting suspected adverse drug reactions to appropriate authorities or marketing authorization holders
Q28. Which of the following best describes invoice and prescription retention practice?
- Not necessary for compliance
- Maintain accurate invoices and required prescription records for the period specified by law for audits and traceability
- Dispose of all records weekly
- Only keep digital copies without backup
Correct Answer: Maintain accurate invoices and required prescription records for the period specified by law for audits and traceability
Q29. Non-compliance with drug store legal requirements can result in:
- No consequences at all
- License suspension or cancellation, fines, and legal action
- Only a verbal warning from customers
- Immediate imprisonment without process
Correct Answer: License suspension or cancellation, fines, and legal action
Q30. Which action ensures traceability in the supply chain for a batch of medicines?
- Keeping no records to protect privacy
- Maintaining batch numbers, supplier details, dates of receipt and supply in registers
- Relying solely on verbal agreements with suppliers
- Selling based on shelf placement only
Correct Answer: Maintaining batch numbers, supplier details, dates of receipt and supply in registers
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