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FDA Functions and Drug Management Practices

The document outlines various aspects of pharmacy practice, including the functions of the FDA, drug storage requirements, logistics and inventory management, roles of hospital and community pharmacists, and principles of Good Manufacturing Practices (GMP). It also discusses the Essential Drug List (EDL) and Essential Consumables List (ECL), as well as the importance of disinfectants and their concentrations in healthcare settings. Additionally, it highlights the significance of pharmacovigilance and the ethical responsibilities of pharmacists.

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Anant Sarnikar
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0% found this document useful (0 votes)
11 views32 pages

FDA Functions and Drug Management Practices

The document outlines various aspects of pharmacy practice, including the functions of the FDA, drug storage requirements, logistics and inventory management, roles of hospital and community pharmacists, and principles of Good Manufacturing Practices (GMP). It also discusses the Essential Drug List (EDL) and Essential Consumables List (ECL), as well as the importance of disinfectants and their concentrations in healthcare settings. Additionally, it highlights the significance of pharmacovigilance and the ethical responsibilities of pharmacists.

Uploaded by

Anant Sarnikar
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

Q1.

Functions of the Food & Drug Administration (FDA) include:

a) Licensing and regulation of drug manufacturing units

b) Approval of new drug formulations

c) Regulation of biomedical waste disposal

d) Enforcement of drug quality standards

Q2.

Drug storage requires consideration of:

a) Temperature control

b) Humidity and moisture regulation

c) Direct exposure to sunlight

d) Shelf-life monitoring

Q3.

Key elements of Logistics & Inventory Management are:

a) Procurement of medicines

b) Stock rotation (FIFO/FEFO)

c) Random, undocumented drug distribution

d) Monitoring of expiry dates

Q4.

Roles of a Hospital Pharmacist include:


a) Monitoring drug interactions

b) Patient counseling on medication use

c) Prescribing drugs independently

d) Ensuring rational drug therapy

Q5.

Community Pharmacy services include:

a) Dispensing prescription and OTC drugs

b) Health screening programs

c) Vaccination services

d) Conducting surgical procedures

Q6.

Principles of Good Manufacturing Practices (GMP) ensure:

a) Quality assurance throughout production

b) Proper documentation

c) Validation of manufacturing processes

d) Marketing strategies for drug promotion

Q7.

Commonly used hospital disinfectants are:

a) Sodium hypochlorite

b) Phenol

c) Chlorhexidine
d) Aspirin

Q8.

Disinfectant concentrations correctly used:

a) Sodium hypochlorite 1% for surface cleaning

b) Formaldehyde 40% as fumigant

c) Glutaraldehyde 2% for instruments

d) Normal saline 0.9% as surface disinfectant

Q9.

The Essential Drug List (EDL) ensures:

a) Availability of cost-effective medicines

b) Medicines based on public health relevance

c) Inclusion of irrational drug combinations

d) Quality-assured drugs at all healthcare levels

Q10.

The Essential Consumables List (ECL) includes:

a) Bandages and syringes

b) Cotton swabs

c) Surgical gloves

d) Luxury cosmetic products

Q11.
FDA inspections focus on:

a) Sanitation of premises

b) Proper labeling of drugs

c) Adequacy of quality control labs

d) Advertising jingles of pharmaceutical companies

Q12.

Cold storage of vaccines requires:

a) 2–8°C temperature range

b) Continuous temperature monitoring

c) Storage with food items

d) Backup power supply

Q13.

Inventory control techniques include:

a) ABC analysis

b) VED analysis

c) FIFO/FEFO system

d) Randomized issuing

Q14.

Hospital pharmacist’s ethical responsibilities are:

a) Maintaining patient confidentiality

b) Ensuring safe dispensing


c) Providing unauthorized narcotics

d) Promoting rational drug use

Q15.

Community pharmacist roles in public health include:

a) Health education

b) Tobacco cessation counseling

c) Monitoring adverse drug reactions

d) Performing chemotherapy

Q16.

Core GMP documentation involves:

a) Batch production records

b) Standard operating procedures (SOPs)

c) Quality assurance reports

d) Product advertisement leaflets

Q17.

Chlorhexidine is used for:

a) Surgical scrub

b) Handwash solutions

c) Oral mouth rinse

d) Intravenous injection
Q18.

Biomedical Waste categories include:

a) Human anatomical waste

b) Contaminated sharps

c) Radioactive isotopes

d) Soiled waste (dressings, cotton, etc.)

Q19.

Hospital pharmacy storage areas require:

a) Segregation of narcotics

b) Fire safety arrangements

c) Proper ventilation

d) Storage of medicines in washrooms

Q20.

EDL criteria for drug selection include:

a) Efficacy and safety profile

b) Cost-effectiveness

c) Local disease prevalence

d) Popularity among film stars

Q21.

FDA responsibilities include:

a) Drug quality control


b) Clinical trial approval

c) Monitoring adverse drug reactions

d) Conducting political campaigns

Q22.

Storage of narcotic drugs requires:

a) Double-lock system

b) Authorized access only

c) Regular audit of stocks

d) Open access for all staff

Q23.

Pharmacy & Therapeutics Committee (PTC) in hospitals:

a) Evaluates new drug requests

b) Prepares hospital formulary

c) Ensures rational drug use

d) Promotes brand loyalty

Q24.

Community pharmacy advantages include:

a) Accessibility to patients

b) Continuity of care

c) Professional counseling

d) Unauthorized clinical trials


Q25.

GMP requirements for production areas are:

a) Controlled environment

b) Pest control measures

c) Good lighting

d) Storage of patient records

Q26.

Alcohol-based disinfectants are effective for:

a) Skin preparation

b) Hand rubs

c) Surface disinfection

d) Sterilizing surgical implants

Q27.

WHO EDL objectives include:

a) Promoting rational prescribing

b) Universal access to essential medicines

c) Encouraging generic drug use

d) Maximizing profit margins

Q28.

Hospital inventory levels include:


a) Minimum stock level

b) Maximum stock level

c) Reorder level

d) Celebrity-endorsed stock

Q29.

Duties of a hospital pharmacist include:

a) Reviewing prescriptions for errors

b) Advising physicians on drug selection

c) Supervising compounding

d) Issuing medical fitness certificates

Q30.

Community pharmacy preventive roles include:

a) Vaccination drives

b) Screening for diabetes and hypertension

c) Counseling for family planning

d) Performing appendectomy

Q31.

GMP validation processes include:

a) Process validation

b) Cleaning validation

c) Analytical method validation


d) Political party validation

Q32.

Hospital disinfectants used for high-level disinfection are:

a) 2% Glutaraldehyde

b) 6% Hydrogen peroxide

c) 70% Ethanol

d) Plain water

Q33.

EDL benefits include:

a) Reduced treatment cost

b) Easy procurement process

c) Rational use of medicines

d) Unrestricted inclusion of any new drug

Q34.

Consumables in ECL include:

a) Syringes

b) Surgical masks

c) I.V. sets

d) Diamond jewelry

Q35.
Hospital pharmacy logistics require:

a) Proper storage conditions

b) Tracking expiry dates

c) Distribution according to needs

d) Random allocation to staff

Q36.

Cold chain monitoring involves:

a) Temperature log maintenance

b) Alarm systems for deviations

c) Backup power generators

d) Mixing with non-medical items

Q37.

FDA role in clinical research includes:

a) Approving trial protocols

b) Ensuring patient safety

c) Regulating ethical practices

d) Approving celebrity endorsements

Q38.

Storage conditions for antibiotics generally require:

a) Dry and cool environment

b) Away from sunlight


c) Below freezing temperature always

d) Properly labeled containers

Q39.

Hospital pharmacist contribution to pharmacovigilance:

a) Reporting adverse drug reactions

b) Educating staff on drug safety

c) Monitoring medication errors

d) Concealing ADR reports

Q40.

Community pharmacy impact on healthcare:

a) Improves access to medicines

b) Reduces healthcare burden

c) Provides health awareness

d) Replaces tertiary hospitals

✅ Answers (Wrong Option in Each Q)


Q1 → c

Q2 → c

Q3 → c

Q4 → c
Q5 → d

Q6 → d

Q7 → d

Q8 → d

Q9 → c

Q10 → d

Q11 → d

Q12 → c

Q13 → d

Q14 → c

Q15 → d

Q16 → d

Q17 → d

Q18 → c

Q19 → d

Q20 → d

Q21 → d

Q22 → d

Q23 → d

Q24 → d

Q25 → d

Q26 → d

Q27 → d

Q28 → d
Q29 → d

Q30 → d

Q31 → d

Q32 → d

Q33 → d

Q34 → d

Q35 → d

Q36 → d

Q37 → d

Q38 → c

Q39 → d

Q40 → d

Food & Drug Administration (FDA)

Q1. The primary role of FDA in India is:

a) Drug discovery research

b) Regulating drug quality, safety & efficacy

c) Import of vaccines only

d) Clinical trial approvals for animals

Q2. The central authority of FDA in India works under which ministry?

a) Ministry of Health & Family Welfare

b) Ministry of Commerce

c) Ministry of Chemicals & Fertilizers

d) Ministry of Agriculture
Q3. FDA regulates all except:

a) Medical devices

b) Cosmetics

c) Food supplements

d) Textiles

Q4. The first and foremost step in FDA drug approval is:

a) Post-marketing surveillance

b) Clinical trials on humans

c) Submission of New Drug Application (NDA)

d) Preclinical testing

Q5. Which of the following is a function of FDA at the state level?

a) Import approval

b) Licensing of drug manufacturing units

c) Conducting national drug policy reviews

d) International collaboration

Drug Storage

Q6. The most sensitive factor in drug storage is:

a) Humidity

b) Temperature

c) Light

d) All of the above

Q7. Cold chain drugs are stored at:

a) 15–25 °C
b) 8–15 °C

c) 2–8 °C

d) –20 °C

Q8. Drugs like nitroglycerin should be stored in:

a) Dark amber glass bottles

b) Plastic containers

c) Aluminum foils

d) Paper packets

Q9. Controlled drugs are kept in:

a) Refrigerator

b) Wooden cupboard

c) Locked cupboard with restricted access

d) Freezer

Q10. The main aim of proper drug storage is:

a) Reduce cost

b) Maintain potency, stability, and safety

c) Reduce patient waiting time

d) Avoid overprescription

Logistics & Inventory Management

Q11. ABC analysis in inventory management is based on:

a) Cost significance of items

b) Expiry date of items

c) Alphabetical arrangement
d) Frequency of drug usage

Q12. In VED analysis, “E” stands for:

a) Expensive

b) Essential

c) Economic

d) Emergency

Q13. FIFO in drug stores refers to:

a) First in, First out

b) First in, Final out

c) Fast in, Fast out

d) First item, First out

Q14. Which inventory method ensures that short shelf-life drugs are used before expiry?

a) LIFO

b) FIFO

c) Random picking

d) EOQ

Q15. The scientific calculation to minimize both storage cost & ordering cost is:

a) EOQ (Economic Order Quantity)

b) ABC Analysis

c) VED Analysis

d) XYZ Method

Role of Hospital Pharmacist

Q16. Which of the following is NOT a primary role of hospital pharmacist?


a) Patient counseling

b) Dispensing prescriptions

c) Surgical treatment

d) Monitoring adverse drug reactions

Q17. Hospital pharmacist plays an important role in:

a) Rational use of drugs

b) Preventing drug interactions

c) Therapeutic drug monitoring

d) All of the above

Q18. Pharmacovigilance in hospitals is primarily handled by:

a) Doctors only

b) Nurses only

c) Pharmacists along with doctors

d) Patients

Q19. Hospital pharmacists contribute to drug policy by:

a) Managing inventory only

b) Participating in drug & therapeutics committees

c) Manufacturing herbal products

d) Running hospitals

Q20. Which of the following is a direct patient-care role of hospital pharmacists?

a) Counseling on drug adherence

b) Performing surgery

c) Diagnosing diseases

d) Hospital financing
Community Pharmacy

Q21. Community pharmacy is defined as:

a) Pharmacy inside a hospital only

b) A retail pharmacy providing medicines and advice to the public

c) A wholesale drug distributor

d) A medical equipment supplier

Q22. The first responsibility of community pharmacist is:

a) Profit-making

b) Ensuring safe and rational drug use

c) Preparing herbal formulations

d) Conducting clinical research

Q23. Community pharmacists maintain:

a) Patient medication records

b) Stock ledgers

c) Controlled drug registers

d) All of the above

Q24. The role of a community pharmacist includes:

a) Health promotion and disease prevention

b) Educating patients about self-medication risks

c) Vaccination services (in some countries)

d) All of the above

Q25. Which legal document is required for community pharmacy operation?

a) Drug License
b) Passport

c) Driving License

d) Tax ID

Good Manufacturing Practices (GMP)

Q26. GMP was introduced to ensure:

a) Cheaper drugs

b) Quality, safety, and efficacy of medicines

c) Faster drug approval

d) More generic drugs in market

Q27. GMP guidelines are issued in India under:

a) Schedule M of Drugs & Cosmetics Act

b) Schedule C of Drugs & Cosmetics Act

c) Pharmacy Act 1948

d) Indian Penal Code

Q28. GMP requires documentation of:

a) Batch manufacturing records

b) Standard operating procedures

c) Quality control reports

d) All of the above

Q29. Cross-contamination in GMP refers to:

a) Mixing of two different drugs unintentionally

b) Over-labeling

c) Reusing old containers


d) Using duplicate barcodes

Q30. GMP training of workers should be done:

a) Once in lifetime

b) Only at recruitment

c) At regular intervals

d) Only after inspections

Disinfectants & Concentrations

Q31. The effective concentration of alcohol used as disinfectant is:

a) 20%

b) 40%

c) 70%

d) 95%

Q32. Sodium hypochlorite used for surface disinfection is usually:

a) 0.05%

b) 0.1%

c) 1%

d) 10%

Q33. Formaldehyde fumigation is generally done at:

a) 0.1%

b) 1%

c) 2%

d) 40%

Q34. Phenol disinfectant is usually effective at:


a) 0.1%

b) 1%

c) 5%

d) 10%

Q35. The main role of disinfectants in hospitals is:

a) Eliminate all microorganisms completely

b) Reduce microbial load to safe level

c) Kill spores only

d) Preserve food items

EDL & ECL

Q36. Essential Drugs List (EDL) is prepared by:

a) World Health Organization (WHO)

b) Indian Pharmacopoeia Commission only

c) Central Bureau of Health

d) Pharmacy Council of India

Q37. The main purpose of EDL is:

a) To provide all latest branded medicines

b) To promote rational, affordable drug use

c) To encourage expensive drug imports

d) To provide only antibiotics

Q38. ECL refers to:

a) Essential Cosmetic List

b) Essential Consumables List


c) Emergency Chemical List

d) Essential Clinical List

Q39. Consumables in ECL include:

a) Syringes, gloves, cotton, dressings

b) Antibiotics only

c) X-ray machines

d) Vitamins

Q40. Inclusion of drugs in EDL is based mainly on:

a) Cost & demand

b) Safety, efficacy, and public health need

c) International market trends

d) Manufacturer preference

✅ Answers
1→b

2→a

3→d

4→d

5→b

6→d

7→c

8→a

9→c
10 → b

11 → a

12 → b

13 → a

14 → b

15 → a

16 → c

17 → d

18 → c

19 → b

20 → a

21 → b

22 → b

23 → d

24 → d

25 → a

26 → b

27 → a

28 → d

29 → a

30 → c

31 → c

32 → c

33 → d
34 → c

35 → b

36 → a

37 → b

38 → b

39 → a

40 → b

📘 Pharmacist – Hard Definition Test


(MCQs)
Q1.

Which of the following best describes Pharmacology, a core branch of pharmacy science?

a) The study of plant-derived chemicals and their cultivation methods

b) The systematic study of drugs, including their sources, effects, mechanisms, and therapeutic
uses

c) The study of the structure and function of the human body at microscopic level

d) The statistical analysis of drug consumption in large populations

Q2.

The classification of drugs is important in pharmacology. Which statement correctly defines this
process?

a) It is the method of dividing drugs into groups based on dosage schedule only

b) It is the systematic arrangement of drugs according to properties, mechanism of action, and


therapeutic use
c) It is the random grouping of medicines by their color and packaging

d) It is the study of financial cost of medicines to patients

Q3.

Drug dose forms are essential for clinical use. Which definition matches this concept?

a) They are the chemical tests used to identify the presence of a drug in blood

b) They are the physical forms in which drugs are manufactured and administered, such as
tablets, capsules, and injections

c) They are the traditional herbal mixtures used in community practice

d) They are the schedules maintained for dispensing and distribution of drugs

Q4.

Which of the following statements defines Bioavailability most accurately?

a) The ratio of the cost of drug to its effectiveness in the population

b) The proportion of a drug that reaches systemic circulation in an unchanged form after
administration

c) The process by which a drug is excreted through urine and feces

d) The property of a drug that determines its shelf life under storage

Q5.

Indication of a drug refers to which of the following?

a) The clinical condition or disease for which a drug is prescribed and found effective

b) The laboratory test used to confirm a drug in blood plasma

c) The warning sign that a drug should not be used

d) The storage instructions required for maintaining stability of a drug


Q6.

The term Contraindication in pharmacology is defined as:

a) A therapeutic use of a drug under normal conditions

b) A factor, condition, or situation in which a drug should not be used because it may cause
harm

c) The maximum safe dose of a drug that can be prescribed

d) A process of dividing drugs into over-the-counter and prescription drugs

Q7.

Which of the following statements defines an Adverse Drug Reaction (ADR)?

a) A planned pharmacological effect that occurs at the recommended dose

b) An unwanted, harmful effect that occurs at normal doses used in humans for prevention,
diagnosis, or treatment

c) The response of a drug when taken in overdose beyond the therapeutic dose

d) The action of a drug on microorganisms like bacteria

Q8.

The role of antibiotics can best be defined as:

a) Chemicals that increase appetite and metabolism in humans

b) Substances that inhibit or destroy the growth of microorganisms, thus used in the treatment
of infections

c) Agents that promote tissue growth and healing of fractures

d) Substances used for reducing inflammation and fever only


Q9.

Which of the following defines Clinical Pharmacology?

a) The application of drug knowledge in humans, focusing on therapeutic effects, safety, and
monitoring

b) The study of chemical structures of drugs in laboratories only

c) The management of storage and supply of medicines in hospital pharmacy

d) The analysis of trends in consumption of antibiotics across populations

Q10.

Neuropharmacology is specifically concerned with:

a) The study of drugs acting on cardiovascular system

b) The study of drugs acting on the nervous system and their effects on neural processes

c) The study of dental anesthetics and analgesics

d) The arrangement of drugs into pharmacological schedules

Q11.

Psychopharmacology can best be defined as:

a) The study of how drugs influence mood, behavior, and mental health

b) The classification of drugs according to their pharmacopoeial standards

c) The branch dealing with antibiotics and antiviral agents

d) The science of pharmacy management at community level

Q12.

Which of the following statements correctly defines Cardiovascular Pharmacology?


a) It is the branch of pharmacology dealing with drugs acting on the heart and blood vessels

b) It is the study of drugs acting on the immune system only

c) It is the science of making tablets for antihypertensive drugs

d) It is the legal control of cardiovascular medicines

Q13.

Pharmacy Epidemiology is defined as:

a) The legal control of drugs in the population

b) The study of drug usage, effects, and safety in large populations

c) The economic analysis of drug costs in society

d) The industrial process of drug manufacturing

Q14.

Indian Pharmacopoeia (IP) is:

a) A commercial book used for selling branded medicines

b) The official book of drug standards in India that provides specifications for quality, purity, and
strength

c) A private reference manual for pharmacy students

d) A handbook on herbal medicines

Q15.

British Pharmacopoeia (BP) is:

a) The official book of standards for drugs in the United Kingdom

b) A journal of pharmacy research


c) A patient counseling handbook

d) An industry guide for clinical trials

Q16.

Which statement best defines the Pharmacy Act 1948 in India?

a) An act regulating the education and profession of pharmacy, ensuring standards of


pharmacists in India

b) An act controlling the manufacture and sale of cosmetics

c) A law for patent rights of pharmaceutical industries

d) A law governing the taxation of medicines in India

Q17.

The Drugs & Cosmetics Act 1940 is specifically concerned with:

a) Regulations on import, manufacture, distribution, and sale of drugs and cosmetics in India

b) Regulations on only the export of medicines

c) Quality standards for Indian food products

d) Clinical trial rules for foreign companies only

Q18.

Good Manufacturing Practices (GMP) are defined as:

a) A set of guidelines ensuring that pharmaceutical products are consistently produced and
controlled with quality standards

b) Rules for drug pricing and marketing strategies

c) Training programs for hospital pharmacists

d) A system of inventory management in drug stores


Q19.

Which of the following best defines an Essential Drug List (EDL)?

a) A list of medicines considered essential to meet the priority healthcare needs of a population

b) A schedule of expensive branded medicines only

c) A guideline for storing drugs in hospitals

d) A list of expired drugs banned by the government

Q20.

Biomedical Waste Management Rules are designed for:

a) Maintaining hospital inventory records

b) Segregation, collection, treatment, and disposal of waste generated during diagnosis and
treatment

c) Reducing the financial cost of hospital medicines

d) Training pharmacists in rural healthcare practices

✅ Answers
1→b

2→b

3→b

4→b

5→a

6→b
7→b

8→b

9→a

10 → b

11 → a

12 → a

13 → b

14 → b

15 → a

16 → a

17 → a

18 → a

19 → a

20 → b

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