Legal requirements and infrastructural needs for hospital pharmacy MCQs With Answer

Introduction: Legal requirements and infrastructural needs for hospital pharmacy MCQs With Answer is a focused practice resource designed for M.Pharm students preparing for exams and practical hospital pharmacy roles. This set explains regulatory frameworks, license types, controlled-drug handling, record-keeping obligations, and compliance under major acts relevant to Indian hospital practice. It also emphasizes essential infrastructure: storage zones, cold chain, aseptic compounding areas, ventilation, safety, and documentation systems. Questions are intended to deepen conceptual understanding and test applied knowledge needed to design, manage, audit, or work in a compliant hospital pharmacy environment. Answers are provided to aid revision and self-assessment.

Q1. Which central legislation primarily governs the import, manufacture, distribution and sale of drugs in India?

• Pharmacy Act, 1948
• Drugs and Cosmetics Act, 1940
• Narcotic Drugs and Psychotropic Substances Act, 1985
• Medicines and Healthcare Products Regulatory Agency (MHRA) rules

Correct Answer: Drugs and Cosmetics Act, 1940

Q2. Under which act is the registration of pharmacists and regulation of pharmacy education mainly conducted in India?

• Drugs and Cosmetics Act, 1940
• Clinical Establishments Act
• Pharmacy Act, 1948
• Goods and Services Tax Act

Correct Answer: Pharmacy Act, 1948

Q3. Which Schedule of the Drugs and Cosmetics Rules lists drugs that can be sold only against a prescription from a registered medical practitioner?

• Schedule X
• Schedule H
• Schedule M
• Schedule G

Correct Answer: Schedule H

Q4. What is the legally required method of storage for narcotic and psychotropic substances in a hospital pharmacy?

• Open shelf with restricted access
• Double-locked steel cabinet/safe with separate controlled register
• Standard refrigerator with key lock
• Storage inside ward cabinets managed by nursing staff

Correct Answer: Double-locked steel cabinet/safe with separate controlled register

Q5. What is the recommended temperature range for storage of most routine vaccines in a hospital pharmacy cold chain?

• -20°C to -10°C
• 2°C to 8°C
• 15°C to 25°C
• Below -70°C

Correct Answer: 2°C to 8°C

Q6. Which record is specifically required to document receipt, issue and balance of controlled or narcotic drugs?

• Drug purchase order book
• Controlled drug / narcotic register
• Temperature monitoring log
• Prescription retention file

Correct Answer: Controlled drug / narcotic register

Q7. For aseptic preparation of parenteral products, what clean area classification is required at the primary work zone (e.g., laminar airflow workstation)?

• ISO Class 8 (Grade D)
• ISO Class 7 (Grade C)
• ISO Class 5 (Grade A)
• No specific ISO classification needed

Correct Answer: ISO Class 5 (Grade A)

Q8. Which staffing requirement is legally essential for operation of a hospital pharmacy?

• At least one registered pharmacist in charge during operating hours
• Full-time hospital administrator supervising dispensing
• Only technicians may be employed if pharmacist is remote
• Registered medical practitioner must be present at the pharmacy

Correct Answer: At least one registered pharmacist in charge during operating hours

Q9. Which authority issues licenses for manufacture of drugs and for running a wholesale / retail drug business in most Indian states?

• Central Drugs Laboratory
• State Drug Control Authority / State Licensing Authority
• Pharmacy Council of India
• Drug Controller General of India (DCGI) only

Correct Answer: State Drug Control Authority / State Licensing Authority

Q10. What primary document should a hospital pharmacy maintain to ensure consistent handling of routine tasks (receiving, storage, dispensing, recalls)?

• Standard Operating Procedures (SOPs)
• Annual financial audit report
• Patient satisfaction survey
• Pharmaceutical marketing brochures

Correct Answer: Standard Operating Procedures (SOPs)

Q11. Which committee in a hospital is typically responsible for formulary development, medication policy and antibiotic stewardship?

• Quality Assurance Committee
• Drug and Therapeutics Committee (DTC)
• Infection Control Committee only
• Medical Records Committee

Correct Answer: Drug and Therapeutics Committee (DTC)

Q12. How should cytotoxic (hazardous) pharmaceutical waste from hospital pharmacy compounding ideally be disposed of according to best practice and biomedical waste rules?

• Flushed into the common sewer system
• Placed in yellow-coded bags and incinerated according to regulations
• Autoclaved and sent to landfill with regular waste
• Stored onsite indefinitely

Correct Answer: Placed in yellow-coded bags and incinerated according to regulations

Q13. Which of the following is an essential segregated functional area in an appropriately designed hospital pharmacy layout?

• General patient waiting area inside the dispensing counter
• Combined office-storage-dispensing single room
• Separate receiving, storage, dispensing and aseptic compounding areas
• On-ward storage only without central pharmacy

Correct Answer: Separate receiving, storage, dispensing and aseptic compounding areas

Q14. Which device is considered best practice for continuous monitoring of cold-chain refrigerators in hospital pharmacies?

• Analogue mercury thermometer checked weekly
• Digital temperature data logger with alarm and recorded logs
• Door placard indicating “Cold storage”
• Monthly manual temperature spot checks

Correct Answer: Digital temperature data logger with alarm and recorded logs

Q15. How frequently should temperature logs and cold chain records ideally be reviewed in a hospital pharmacy to detect excursions promptly?

• Annually
• Monthly
• Daily
• Only on supplier visits

Correct Answer: Daily

Q16. Which license is typically required for a hospital pharmacy to legally dispense medicines to patients within hospital premises?

• Manufacturing license
• Retail sale / dispensing license issued by the State Drug Control Authority
• Import license from Central Government
• Clinical trial license

Correct Answer: Retail sale / dispensing license issued by the State Drug Control Authority

Q17. To maintain vaccine and cold-chain integrity during power outages, which infrastructural provision is essential for a hospital pharmacy?

• Standard incandescent lighting
• Backup power source such as generator or UPS for refrigerators
• Windows for natural ventilation
• Extra shelving for ambient storage

Correct Answer: Backup power source such as generator or UPS for refrigerators

Q18. Which guideline is widely referenced internationally for sterile compounding practices and cleanroom requirements for pharmacy aseptic processing?

• ICH Q9
• USP <797> (United States Pharmacopeia chapter for sterile compounding)
• Nutrition facts labelling guideline
• Good Laboratory Practice (GLP) E6

Correct Answer: USP <797> (United States Pharmacopeia chapter for sterile compounding)

Q19. What type of room pressure relationship is required for safe compounding of hazardous (cytotoxic) drugs to protect staff and environment?

• Positive pressure relative to surrounding areas
• Negative pressure with appropriate containment ventilation
• Neutral pressure with open windows
• No special pressure requirement

Correct Answer: Negative pressure with appropriate containment ventilation

Q20. For legal compliance, how long should prescription records and dispensing registers generally be retained by a hospital pharmacy under common regulatory requirements?

• 6 months
• 1 year
• At least 3 years
• Indefinitely without review

Correct Answer: At least 3 years

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