Offences and penalties under sale provisions MCQs With Answer

Offences and penalties under sale provisions MCQs With Answer

This concise, focused review of offences and penalties under sale provisions is designed for B. Pharm students preparing for exams and professional practice. It explains key concepts in pharmacy law—sale provisions, authorised sale, unauthorised sale, misbranding, adulteration, spurious drugs, record-keeping, and prescription requirements—highlighting legal liabilities and types of penalties under the Drugs and Cosmetics Act and related regulations. Emphasis is on practical scenarios, enforcement authorities, and common offences committed in retail and wholesale drug distribution. Clear definitions, penalty ranges, and preventive practices help students link theory to clinical pharmacy and ethical dispensing. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary purpose of sale provisions in drug law?

  • To regulate manufacture only
  • To control the sale, distribution and supply of drugs
  • To set retail prices exclusively
  • To license medical practitioners

Correct Answer: To control the sale, distribution and supply of drugs

Q2. Which authority is primarily responsible for enforcing sale provisions at the state level?

  • Central Bureau of Investigation
  • State Drug Control Authorities / Drug Inspector
  • Municipal Corporation
  • Commercial Tax Department

Correct Answer: State Drug Control Authorities / Drug Inspector

Q3. Selling a prescription-only medicine without a valid prescription is generally punishable by:

  • A written warning only
  • Imprisonment and/or fine
  • Community service
  • No action if first offence

Correct Answer: Imprisonment and/or fine

Q4. Misbranding of a drug refers to which of the following?

  • Contamination during manufacturing
  • False, misleading, or inadequate labeling or claims
  • Sale without license
  • Storing below recommended temperature

Correct Answer: False, misleading, or inadequate labeling or claims

Q5. Adulteration of a drug means:

  • Change in packaging design
  • Presence of inferior or contaminated substances that reduce quality
  • Delaying distribution to increase price
  • Failure to register a trademark

Correct Answer: Presence of inferior or contaminated substances that reduce quality

Q6. A spurious drug is best defined as:

  • A genuine drug with expired date
  • A drug fraudulently manufactured or falsely claimed and sold as another drug
  • A drug stored in incorrect conditions
  • A generic equivalent of a branded drug

Correct Answer: A drug fraudulently manufactured or falsely claimed and sold as another drug

Q7. Schedule H drugs require which condition for sale?

  • No prescription and free sale
  • Sale only on presentation of a valid prescription
  • Sale only to hospitals
  • Sale only after 48 hours of purchase

Correct Answer: Sale only on presentation of a valid prescription

Q8. Schedule X drugs differ from Schedule H primarily because they:

  • Are available over the counter
  • Require stricter record-keeping and retention of prescriptions
  • Are only for veterinary use
  • Have no labeling requirements

Correct Answer: Require stricter record-keeping and retention of prescriptions

Q9. Dispensing medicines without a valid retail licence most likely results in:

  • Mandatory job transfer
  • Seizure of drugs, fine and possible prosecution
  • Only advisory notice
  • Compulsory attendance at a workshop

Correct Answer: Seizure of drugs, fine and possible prosecution

Q10. Which practice most directly constitutes misbranding?

  • Storing tablets at room temperature
  • Labeling a drug with an incorrect active ingredient or strength
  • Dispensing after verifying prescription
  • Supplying generic substitution with consent

Correct Answer: Labeling a drug with an incorrect active ingredient or strength

Q11. Record-keeping for sale provisions is important because it:

  • Increases stock value
  • Supports traceability, regulatory compliance and forensic audit in offences
  • Reduces need for staff training
  • Eliminates the need for invoices

Correct Answer: Supports traceability, regulatory compliance and forensic audit in offences

Q12. Which action by a pharmacist helps prevent offences under sale provisions?

  • Accepting verbal prescriptions without documentation
  • Verifying prescription validity and maintaining sales records
  • Mixing different bulk drugs for discount
  • Failing to label dispensed medicines

Correct Answer: Verifying prescription validity and maintaining sales records

Q13. False claims about a drug’s efficacy in promotional materials is classified as:

  • An administrative oversight only
  • Illegal advertising and an offence under sale and drug control laws
  • Acceptable if no customers complain
  • A clinical practice issue only

Correct Answer: Illegal advertising and an offence under sale and drug control laws

Q14. The immediate legal consequence of supplying a spurious drug to a patient may include:

  • Issuing a discount coupon
  • Criminal prosecution and civil liability
  • Only internal disciplinary action
  • Mandatory free replacement without penalty

Correct Answer: Criminal prosecution and civil liability

Q15. Inventory checks and batch-wise records help primarily to detect:

  • Marketing opportunities
  • Unauthorized diversion, expiry and counterfeit penetration
  • Staff attendance issues
  • Patient counseling time

Correct Answer: Unauthorized diversion, expiry and counterfeit penetration

Q16. Which is considered an offence under sale provisions?

  • Dispensing medicines exactly as per a valid prescription
  • Altering batch numbers on labels to hide defects
  • Maintaining temperature logs
  • Reporting an adverse drug reaction

Correct Answer: Altering batch numbers on labels to hide defects

Q17. When a drug inspector finds an offence, a common initial administrative action is to:

  • Recommend new product launches
  • Seize suspected stock and issue a show-cause notice
  • Close the pharmacy permanently without process
  • Provide free training materials

Correct Answer: Seize suspected stock and issue a show-cause notice

Q18. Which of the following best describes “unauthorised sale”?

  • Selling at a discount during festivals
  • Selling drugs without required licence, prescription or beyond permitted channels
  • Selling expired promotional samples only
  • Selling to registered hospitals

Correct Answer: Selling drugs without required licence, prescription or beyond permitted channels

Q19. The sale of prescription medicines directly to the public via general advertising is:

  • Permitted if price is displayed
  • Prohibited and may attract legal action
  • Recommended by regulators
  • Allowed only on weekends

Correct Answer: Prohibited and may attract legal action

Q20. Poor record retention after sale-related inspections may lead to:

  • Reduction in license fees
  • Presumption of regulatory non-compliance and penalties
  • Automatic renewal of licence
  • No consequences

Correct Answer: Presumption of regulatory non-compliance and penalties

Q21. Which practice reduces the risk of committing offences under sale provisions?

  • Accepting any prescription without checking credentials
  • Following standard operating procedures and training staff
  • Deliberately withholding invoices
  • Mixing batches to meet demand

Correct Answer: Following standard operating procedures and training staff

Q22. Selling medicines past their expiry date is categorized as:

  • Good business practice
  • An offence that endangers public health
  • Acceptable for low-value items
  • Allowed if disclosed to the buyer

Correct Answer: An offence that endangers public health

Q23. Which documentation is essential when dispensing controlled prescription drugs?

  • Only verbal acknowledgment from patient
  • Maintained prescription copy and sales register entries
  • No documentation is necessary
  • Only the drug label

Correct Answer: Maintained prescription copy and sales register entries

Q24. A licensed pharmacist finds a batch suspected to be counterfeit. Best immediate step is to:

  • Return to supplier without documenting
  • Quarantine the batch, document findings and inform regulatory authority
  • Sell at a discount to clear stock
  • Mix with genuine stock to dilute risk

Correct Answer: Quarantine the batch, document findings and inform regulatory authority

Q25. Penalties for offences under sale provisions can include which of the following combinations?

  • Only community service
  • Suspension/cancellation of licence, fines and criminal prosecution
  • Only verbal reprimand
  • Only mandatory training

Correct Answer: Suspension/cancellation of licence, fines and criminal prosecution

Q26. Which of the following activities can amount to illegal retail practice?

  • Dispensing prescription drugs using forged prescriptions
  • Providing patient counselling after dispensing
  • Maintaining temperature-controlled storage
  • Returning unopened expired stock for proper disposal

Correct Answer: Dispensing prescription drugs using forged prescriptions

Q27. Regulatory recall of a marketed drug due to safety concerns is typically triggered by:

  • Positive sales trends
  • Quality defects, adverse events or spurious/misbranded evidence
  • Expiring marketing campaign
  • Stock overage

Correct Answer: Quality defects, adverse events or spurious/misbranded evidence

Q28. Ethical dispensing to comply with sale provisions includes:

  • Fulfilling all prescriptions without verification
  • Checking prescription authenticity, counseling and proper labeling
  • Substituting without informing patient
  • Ignoring storage conditions

Correct Answer: Checking prescription authenticity, counseling and proper labeling

Q29. Which statement about penalties for sale-related offences is correct?

  • Penalties are uniform across all jurisdictions worldwide
  • Penalties vary by law but commonly include fines, imprisonment and licence actions
  • There are never any criminal consequences
  • Only manufacturers are liable, not sellers

Correct Answer: Penalties vary by law but commonly include fines, imprisonment and licence actions

Q30. The best long-term strategy for pharmacies to minimize offences under sale provisions is to:

  • Ignore regulatory updates until inspected
  • Implement compliance systems, continuous staff training and quality assurance
  • Focus solely on increasing sales
  • Avoid record-keeping to reduce paperwork

Correct Answer: Implement compliance systems, continuous staff training and quality assurance

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