History of Pharmacopoeia MCQs With Answer

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History of Pharmacopoeia MCQs With Answer helps B. Pharm students grasp how official drug standards evolved from early apothecary recipes to modern, legally enforceable compendia. Learn the origins of the term “pharmacopoeia,” milestones like the British Pharmacopoeia (BP), United States Pharmacopeia (USP), Indian Pharmacopoeia (IP), Japanese Pharmacopoeia (JP), European Pharmacopoeia (Ph. Eur.), and WHO’s International Pharmacopoeia. Understand monographs, general chapters, reference standards, quality control, standardization, harmonization (PDG/ICH), and how compendia support GMP, regulatory compliance, and patient safety. This SEO-friendly guide covers key dates, institutions, and transitions from materia medica to assay-driven standards crucial for B. Pharm exams and industry readiness. Now let’s test your knowledge with 50 MCQs on this topic.

Q1. The word “pharmacopoeia” derives from Greek roots meaning what?

  • Drug-making
  • Drug-selling
  • Drug-writing
  • Drug-healing

Correct Answer: Drug-making

Q2. What was the primary historical purpose of pharmacopoeias?

  • To advertise new medicines
  • To provide official standards for the identity, strength, and purity of medicines
  • To teach dispensing techniques only
  • To replace physicians’ textbooks

Correct Answer: To provide official standards for the identity, strength, and purity of medicines

Q3. Which text is widely regarded as the first pharmacopoeia officially sanctioned by a municipal authority?

  • Antidotarium Nicolai
  • Dispensatorium of Valerius Cordus (Nuremberg, 1546)
  • De Materia Medica
  • Pharmacopoea Londinensis

Correct Answer: Dispensatorium of Valerius Cordus (Nuremberg, 1546)

Q4. The first edition of the British Pharmacopoeia (BP) was published in which year?

  • 1618
  • 1820
  • 1864
  • 1955

Correct Answer: 1864

Q5. The Pharmacopoea Londinensis, an important precursor to the BP, was first published in:

  • 1498
  • 1546
  • 1618
  • 1699

Correct Answer: 1618

Q6. In which year was the first United States Pharmacopeia (USP) published?

  • 1789
  • 1820
  • 1864
  • 1888

Correct Answer: 1820

Q7. Which organization currently publishes the USP–NF?

  • Food and Drug Administration (FDA)
  • U.S. Pharmacopeial Convention (USP)
  • American Medical Association (AMA)
  • World Health Organization (WHO)

Correct Answer: U.S. Pharmacopeial Convention (USP)

Q8. The first Indian Pharmacopoeia (IP) was published in:

  • 1940
  • 1951
  • 1955
  • 1966

Correct Answer: 1955

Q9. Which body currently oversees and publishes the Indian Pharmacopoeia?

  • Central Drugs Standard Control Organization (CDSCO)
  • Indian Pharmacopoeia Commission (IPC), Ghaziabad
  • Medical Council of India (MCI)
  • Pharmacy Council of India (PCI)

Correct Answer: Indian Pharmacopoeia Commission (IPC), Ghaziabad

Q10. The WHO published the first edition of the International Pharmacopoeia in:

  • 1920
  • 1951
  • 1964
  • 1969

Correct Answer: 1951

Q11. The European Pharmacopoeia is coordinated by which institution?

  • European Medicines Agency (EMA)
  • European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe
  • European Commission
  • World Health Organization (WHO)

Correct Answer: European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe

Q12. The first edition of the Japanese Pharmacopoeia (JP) was issued in:

  • 1760
  • 1820
  • 1886
  • 1911

Correct Answer: 1886

Q13. What is the main goal of the Pharmacopeial Discussion Group (PDG)?

  • Approve new drugs for marketing
  • Harmonize general chapters and excipient monographs among USP, Ph. Eur., and JP
  • Publish national formularies
  • Train pharmacists globally

Correct Answer: Harmonize general chapters and excipient monographs among USP, Ph. Eur., and JP

Q14. The National Formulary (NF) in the United States began in 1888 and later combined with USP to form:

  • USP–NF
  • USP–BP
  • USP–IP
  • USP–JP

Correct Answer: USP–NF

Q15. A pharmacopoeial monograph typically contains:

  • Therapeutic guidelines and dosing schedules
  • Identity tests, purity tests, assay procedures, and acceptance criteria
  • Marketing approval status
  • Hospital purchasing policies

Correct Answer: Identity tests, purity tests, assay procedures, and acceptance criteria

Q16. In compendia like USP and BP, “General Notices” primarily serve to:

  • List all approved brand names
  • Provide interpretive rules and applicability of standards throughout the compendium
  • Publish regulatory penalties
  • Summarize clinical trials

Correct Answer: Provide interpretive rules and applicability of standards throughout the compendium

Q17. Why are pharmacopoeias critical to Good Manufacturing Practice (GMP)?

  • They replace batch records
  • They supply validated test methods and specifications for quality control
  • They determine product prices
  • They eliminate the need for stability studies

Correct Answer: They supply validated test methods and specifications for quality control

Q18. Pharmacopoeial reference standards (e.g., USP RS) are used mainly to:

  • Formulate new drugs
  • Calibrate analytical methods and confirm identity and potency
  • Replace all laboratory reagents
  • Test clinical efficacy

Correct Answer: Calibrate analytical methods and confirm identity and potency

Q19. In many jurisdictions, the “official” status of a pharmacopoeia means:

  • Its standards are legally enforceable for marketed products
  • It is optional guidance
  • It applies only to herbal medicines
  • It is used only in academia

Correct Answer: Its standards are legally enforceable for marketed products

Q20. The creation of the BP in 1864 unified which previously separate pharmacopoeias?

  • London, Edinburgh, and Dublin
  • London, Paris, and Berlin
  • Oxford, Cambridge, and Glasgow
  • Dublin, Belfast, and Cork

Correct Answer: London, Edinburgh, and Dublin

Q21. How does a pharmacopoeia differ from traditional materia medica texts?

  • Materia medica gives therapeutic uses; pharmacopoeias provide quality standards and analytical tests
  • Both only list historical anecdotes
  • Pharmacopoeias focus on botany; materia medica on chemistry
  • There is no difference

Correct Answer: Materia medica gives therapeutic uses; pharmacopoeias provide quality standards and analytical tests

Q22. Historically, a key driver for pharmacopoeias was to control:

  • Advertising costs
  • Adulteration and variability in compounded medicines
  • Hospital staffing
  • Patent filings

Correct Answer: Adulteration and variability in compounded medicines

Q23. Which preparation’s safety concerns notably pushed standardization in early compendia?

  • Syrup of figs
  • Tincture of opium (laudanum)
  • Table salt
  • Distilled water

Correct Answer: Tincture of opium (laudanum)

Q24. Interim updates between major pharmacopoeial editions are often issued as:

  • Advertising inserts
  • Addenda and supplements
  • Newspapers
  • Dissertations

Correct Answer: Addenda and supplements

Q25. Which analytical technique’s adoption marked the modern era of pharmacopoeial monographs?

  • Organoleptic evaluation only
  • High-performance liquid chromatography (HPLC)
  • Alchemy
  • Bloodletting

Correct Answer: High-performance liquid chromatography (HPLC)

Q26. The International Pharmacopoeia primarily aims to:

  • Set prices for essential medicines
  • Provide international quality standards, especially for essential medicines and public health programs
  • Accredit pharmacies
  • Grant patents

Correct Answer: Provide international quality standards, especially for essential medicines and public health programs

Q27. In USP, proposed revisions are exposed for public comment through:

  • Federal Register
  • Pharmacopeial Forum
  • British Medical Journal
  • Lancet

Correct Answer: Pharmacopeial Forum

Q28. The body that oversees the British Pharmacopoeia today is best described as:

  • British Pharmacopoeia Commission under the MHRA
  • General Medical Council
  • NHS England
  • Royal Pharmaceutical Society

Correct Answer: British Pharmacopoeia Commission under the MHRA

Q29. Which statement about herbal standards is correct?

  • Herbal drugs are excluded from all modern pharmacopoeias
  • Modern compendia include monographs for herbal drugs and preparations with quality tests
  • Only the USP includes herbal standards
  • Only the JP includes herbal standards

Correct Answer: Modern compendia include monographs for herbal drugs and preparations with quality tests

Q30. Which document governs the legal recognition of IP standards in India?

  • Drugs and Cosmetics Act, 1940
  • Pharmacy Act, 1948
  • Patents Act, 1970
  • Companies Act, 2013

Correct Answer: Drugs and Cosmetics Act, 1940

Q31. Which of the following best differentiates monographs from general chapters?

  • Monographs apply to specific articles; general chapters provide methods and requirements applicable across many articles
  • Both are identical in scope
  • General chapters set prices; monographs set clinical doses
  • Monographs are optional; general chapters are legal

Correct Answer: Monographs apply to specific articles; general chapters provide methods and requirements applicable across many articles

Q32. Which are considered “official compendia” in U.S. law?

  • USP–NF only
  • Homeopathic Pharmacopeia of the United States (HPUS) only
  • British Pharmacopoeia only
  • Both USP–NF and HPUS

Correct Answer: Both USP–NF and HPUS

Q33. Why were early pharmacopoeias often written in Latin?

  • It was the language of trade
  • It was a universal scholarly language facilitating uniform standards
  • It was mandated by the Pope
  • It was the simplest language for laypersons

Correct Answer: It was a universal scholarly language facilitating uniform standards

Q34. Valerius Cordus is historically significant because he:

  • Founded the USP
  • Compiled the Dispensatorium sanctioned by Nuremberg
  • Chaired the Indian Pharmacopoeia Commission
  • Led the Council of Europe

Correct Answer: Compiled the Dispensatorium sanctioned by Nuremberg

Q35. The transition from recipe-based to standards-based pharmacopoeias was driven mainly by:

  • Decline of chemistry
  • Industrialization and the need for reproducible quality control
  • Growth of folk medicine
  • Reduced trade

Correct Answer: Industrialization and the need for reproducible quality control

Q36. The European Pharmacopoeia’s first volume appeared in:

  • 1951
  • 1964
  • 1969
  • 1975

Correct Answer: 1969

Q37. Which statement best reflects the role of compendial reference substances?

  • They are used as dosage forms
  • They serve as measurement anchors for identity and potency in assays
  • They are solely for toxicology
  • They are substitutes for GMP

Correct Answer: They serve as measurement anchors for identity and potency in assays

Q38. Which is true about the USP–NF and excipients?

  • Excipients are not covered at all
  • Excipients have monographs specifying quality attributes
  • Excipients are covered only in appendices
  • Excipients are banned from compendia

Correct Answer: Excipients have monographs specifying quality attributes

Q39. The shift from apothecaries’ weights to the metric system in pharmacopoeias improved:

  • Packaging design
  • Global standardization and measurement accuracy
  • Drug prices
  • Marketing speed

Correct Answer: Global standardization and measurement accuracy

Q40. In the U.S., the triad used to describe compendial quality for drugs is:

  • Safety, efficacy, cost
  • Identity, strength, quality, and purity
  • Potency, price, packaging
  • Safety, labeling, shelf life

Correct Answer: Identity, strength, quality, and purity

Q41. Which best describes the difference between a pharmacopoeia and a formulary?

  • Pharmacopoeia sets quality standards; a formulary guides selection and therapeutic use
  • Both only list prices
  • Formularies set analytical tests; pharmacopoeias set clinical doses
  • There is no difference

Correct Answer: Pharmacopoeia sets quality standards; a formulary guides selection and therapeutic use

Q42. The BP includes which category alongside human medicines?

  • Cosmetics only
  • Traditional Chinese medicine only
  • Veterinary monographs (BP Veterinary)
  • Food additives only

Correct Answer: Veterinary monographs (BP Veterinary)

Q43. The initial editions of pharmacopoeias primarily standardized:

  • Advertising language
  • Recipes, strengths, and identities of compounded preparations
  • Clinical protocols
  • Hospital staffing levels

Correct Answer: Recipes, strengths, and identities of compounded preparations

Q44. Which compendium was a crucial step toward uniform standards across Europe under the Council of Europe?

  • British Pharmacopoeia
  • European Pharmacopoeia
  • USP–NF
  • Japanese Pharmacopoeia

Correct Answer: European Pharmacopoeia

Q45. In India, which statement is accurate about IP and traditional systems?

  • IP includes all Ayurvedic medicines
  • Ayurvedic standards are published separately from IP
  • IP covers only veterinary medicines
  • IP is not legally recognized

Correct Answer: Ayurvedic standards are published separately from IP

Q46. Which best explains why harmonization (e.g., PDG) matters to industry?

  • It allows higher prices
  • It reduces duplicative testing and facilitates global supply chains
  • It eliminates stability studies
  • It replaces national regulations

Correct Answer: It reduces duplicative testing and facilitates global supply chains

Q47. The move from simple titrations to chromatographic assays in monographs improved:

  • Color of labels
  • Sensitivity and specificity of quality control
  • Marketing strategy
  • Packaging integrity

Correct Answer: Sensitivity and specificity of quality control

Q48. Which symbol historically associated with prescriptions reflects the medical heritage but is not a pharmacopoeial standard?

  • ℞
  • Ω
  • π
  • ∞

Correct Answer: ℞

Q49. A typical pathway for creating or revising a monograph includes:

  • Secret drafting with no feedback
  • Proposal, public consultation, expert committee approval, and publication
  • Company press release only
  • Court approval

Correct Answer: Proposal, public consultation, expert committee approval, and publication

Q50. The growth of international trade in the 19th and 20th centuries increased the need for pharmacopoeias because they:

  • Determined customs tariffs
  • Provided common, enforceable quality benchmarks across markets
  • Replaced clinical trials
  • Eliminated patents

Correct Answer: Provided common, enforceable quality benchmarks across markets

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