Code of Federal Regulations (CFR) MCQs With Answer

Code of Federal Regulations (CFR) MCQs With Answer

The Code of Federal Regulations (CFR) is the backbone of U.S. pharmaceutical regulatory compliance, especially Title 21, which houses FDA rules for drugs, biologics, medical devices, and clinical research. For M. Pharm students specializing in Regulatory Affairs (MPH 104T), mastering the structure, scope, and key parts of the CFR is essential for submissions (IND, NDA, ANDA, BLA), cGMP/GLP compliance, labeling, pharmacovigilance, and device regulation. This MCQ set focuses on practical, exam-oriented understanding of critical CFR titles and parts such as 21 CFR 11, 58, 201, 207, 210/211, 312, 314, 320, 600/601, 803, 812, 820, and Part 4 for combination products. Each question is designed to sharpen recall, clarify scope, and build confidence for real-world regulatory decision-making.

Q1. Which CFR title primarily contains FDA regulations for foods, drugs, biologics, and medical devices?

• Title 21
• Title 45
• Title 9
• Title 49

Correct Answer: Title 21

Q2. Which statement best describes the CFR in the U.S. regulatory framework?

• The codification of general and permanent rules issued by federal agencies
• A compilation of statutes enacted by Congress
• The daily publication of proposed rules and agency notices
• Nonbinding recommendations to industry without legal force

Correct Answer: The codification of general and permanent rules issued by federal agencies

Q3. Which is true about the Electronic Code of Federal Regulations (eCFR)?

• It is updated daily but is not the official legal edition of the CFR
• It replaces the Federal Register for all official notices
• It is updated only once a year on January 1
• It contains only FDA-related regulations

Correct Answer: It is updated daily but is not the official legal edition of the CFR

Q4. What is the primary focus of 21 CFR Part 11?

• Electronic records and electronic signatures requirements
• Bioavailability and bioequivalence studies
• Institutional Review Boards composition
• Medical Device Reporting

Correct Answer: Electronic records and electronic signatures requirements

Q5. 21 CFR Parts 210 and 211 cover which area?

• cGMP for finished pharmaceuticals
• GLP for nonclinical laboratory studies
• Advertising for prescription drugs
• Bioequivalence requirements

Correct Answer: cGMP for finished pharmaceuticals

Q6. 21 CFR Part 58 (GLP) applies to:

• Nonclinical laboratory studies intended to support research or marketing permits for FDA-regulated products
• Clinical trials conducted under an IND
• Postmarketing safety reporting for approved devices
• Manufacturing of over-the-counter (OTC) drugs

Correct Answer: Nonclinical laboratory studies intended to support research or marketing permits for FDA-regulated products

Q7. 21 CFR Parts 50 and 56 respectively address:

• Protection of human subjects (informed consent) and Institutional Review Boards (IRBs)
• Drug labeling and advertising
• Device registration and listing
• Pharmacovigilance and Field Alert Reports

Correct Answer: Protection of human subjects (informed consent) and Institutional Review Boards (IRBs)

Q8. 21 CFR Part 312 primarily governs:

• Investigational New Drug (IND) applications
• New Drug Applications (NDAs)
• Drug Master Files (DMFs)
• Device quality systems

Correct Answer: Investigational New Drug (IND) applications

Q9. 21 CFR Part 314 covers:

• Applications for FDA approval to market a new drug (NDAs and ANDAs)
• Composition and responsibilities of IRBs
• Device adverse event reporting
• Electronic records and signatures

Correct Answer: Applications for FDA approval to market a new drug (NDAs and ANDAs)

Q10. Which CFR part specifies bioavailability and bioequivalence requirements for drug products?

• 21 CFR Part 320
• 21 CFR Part 201
• 21 CFR Part 312
• 21 CFR Part 210

Correct Answer: 21 CFR Part 320

Q11. Biologics License Applications (BLAs) and certain biologics requirements are addressed under:

• 21 CFR Parts 600–680 (especially Part 601)
• 21 CFR Part 314
• 21 CFR Part 210
• 21 CFR Part 58

Correct Answer: 21 CFR Parts 600–680 (especially Part 601)

Q12. 21 CFR Part 820 is most closely associated with:

• Quality System Regulation (QSR) for medical devices
• Drug GMPs for finished pharmaceuticals
• GLP for animal studies
• ANDA submission requirements

Correct Answer: Quality System Regulation (QSR) for medical devices

Q13. Medical Device Reporting (MDR) requirements for adverse events are found in:

• 21 CFR Part 803
• 21 CFR Part 806
• 21 CFR Part 812
• 21 CFR Part 56

Correct Answer: 21 CFR Part 803

Q14. Investigational Device Exemptions (IDE) are regulated under:

• 21 CFR Part 812
• 21 CFR Part 820
• 21 CFR Part 807
• 21 CFR Part 801

Correct Answer: 21 CFR Part 812

Q15. Prescription drug labeling content and format (e.g., physician labeling rule) are established in:

• 21 CFR Part 201
• 21 CFR Part 210
• 21 CFR Part 320
• 21 CFR Part 600

Correct Answer: 21 CFR Part 201

Q16. Which part sets cGMP and quality requirements for combination products?

• 21 CFR Part 4
• 21 CFR Part 2
• 21 CFR Part 54
• 21 CFR Part 330

Correct Answer: 21 CFR Part 4

Q17. The Prescription Drug Marketing Act (PDMA) regulations, including oversight of drug samples and certain wholesale distribution practices, are codified in:

• 21 CFR Part 203
• 21 CFR Part 205
• 21 CFR Part 202
• 21 CFR Part 211

Correct Answer: 21 CFR Part 203

Q18. Drug establishment registration, product listing, and National Drug Code (NDC) requirements are described in:

• 21 CFR Part 207
• 21 CFR Part 807
• 21 CFR Part 314
• 21 CFR Part 58

Correct Answer: 21 CFR Part 207

Q19. For NDAs, a Field Alert Report (FAR) must generally be submitted to FDA within:

• 3 working days of becoming aware of the problem
• 15 calendar days of event occurrence
• 5 calendar days of product complaint receipt
• 7 working days of lot release

Correct Answer: 3 working days of becoming aware of the problem

Q20. Drug Master Files (DMFs), including types and submission requirements, are specified in:

• 21 CFR 314.420
• 21 CFR 312.23
• 21 CFR 201.57
• 21 CFR 58.195

Correct Answer: 21 CFR 314.420

Download