Code of Federal Regulations (CFR) overview MCQs With Answer

Code of Federal Regulations (CFR) overview MCQs With Answer

The Code of Federal Regulations (CFR) is the codified body of rules issued by U.S. federal agencies that govern pharmaceutical development, manufacturing, labeling, safety, and distribution. For B. Pharm students, understanding CFR structure—especially Title 21 relating to Food and Drugs—and key parts such as cGMP (21 CFR Parts 210–211), IND/NDA requirements, labeling, and electronic records (21 CFR Part 11) is essential for quality, compliance, and patient safety. This concise, keyword-rich overview links regulatory concepts to practical pharmacy practice, inspections, and documentation control. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which Title of the Code of Federal Regulations primarily governs Food and Drugs relevant to pharmaceuticals?

• Title 9
• Title 21
• Title 42
• Title 49

Correct Answer: Title 21

Q2. What do 21 CFR Parts 210 and 211 primarily address?

• Bioresearch monitoring
• Good laboratory practices (GLP)
• Current Good Manufacturing Practices (cGMP) for drugs
• Device premarket approval

Correct Answer: Current Good Manufacturing Practices (cGMP) for drugs

Q3. Which CFR part covers electronic records and electronic signatures requirements?

• 21 CFR Part 11
• 21 CFR Part 58
• 21 CFR Part 314
• 21 CFR Part 820

Correct Answer: 21 CFR Part 11

Q4. The CFR is organized by:

• Chapters, sections, and articles only
• Titles, chapters, and subchapters
• Titles, chapters, parts, and sections
• Volumes, pages, and annexes

Correct Answer: Titles, chapters, parts, and sections

Q5. Which CFR part specifically details requirements for drugs intended for human clinical trials (IND)?

• 21 CFR Part 812
• 21 CFR Part 314
• 21 CFR Part 312
• 21 CFR Part 211

Correct Answer: 21 CFR Part 312

Q6. Which regulatory document is not legally binding but provides FDA’s current thinking and recommendations?

• Guidance document
• CFR regulation
• Federal statute
• Final rule

Correct Answer: Guidance document

Q7. Which CFR part contains requirements for Investigational New Drug (IND) safety reporting to the FDA?

• 21 CFR Part 314.80
• 21 CFR Part 312.32
• 21 CFR Part 211.194
• 21 CFR Part 201.56

Correct Answer: 21 CFR Part 312.32

Q8. What is the Federal Register’s role relative to the CFR?

• It publishes final agency regulations after codification
• It publishes proposed rules, final rules, notices, and presidential documents before they are codified in the CFR
• It replaces the CFR annually
• It is an internal FDA memo collection

Correct Answer: It publishes proposed rules, final rules, notices, and presidential documents before they are codified in the CFR

Q9. Under cGMP, which document must describe procedures for production and process controls?

• Investigator’s brochure
• Master Production Batch Record
• Certificate of Analysis only
• Marketing authorization

Correct Answer: Master Production Batch Record

Q10. Which CFR part addresses stability testing and labeling of OTC drugs?

• 21 CFR Part 211
• 21 CFR Part 314
• 21 CFR Part 201
• 21 CFR Part 330

Correct Answer: 21 CFR Part 330

Q11. What is the primary purpose of 21 CFR Part 820?

• Regulate drug packaging materials
• Establish Quality System Regulation for medical devices
• Define labeling rules for dietary supplements
• Specify requirements for new drug applications

Correct Answer: Establish Quality System Regulation for medical devices

Q12. Which CFR section requires maintenance of records of distribution, complaints, and recalls?

• 21 CFR Part 11
• 21 CFR Part 211
• 21 CFR Part 207
• 21 CFR Part 58

Correct Answer: 21 CFR Part 211

Q13. What does “incorporation by reference” mean in CFR context?

• Including external materials in a regulation by referring to them instead of reproducing text
• Repealing a previously issued regulation
• Referencing an internal agency memo without public access
• Annexing a foreign regulation verbatim

Correct Answer: Including external materials in a regulation by referring to them instead of reproducing text

Q14. Which CFR part deals primarily with Good Laboratory Practice (GLP) for nonclinical studies?

• 21 CFR Part 58
• 21 CFR Part 312
• 21 CFR Part 211
• 21 CFR Part 820

Correct Answer: 21 CFR Part 58

Q15. What is required by 21 CFR Part 207 regarding establishment registration?

• Annual drug stability studies only
• Registration of drug establishments and listing of drug products
• Medical device labeling requirements
• Electronic submission of all clinical trial data

Correct Answer: Registration of drug establishments and listing of drug products

Q16. Under 21 CFR, which document must be submitted for approval to market a new chemical entity for humans?

• ANDA (Abbreviated New Drug Application)
• IND (Investigational New Drug application)
• NDA (New Drug Application)
• 510(k)

Correct Answer: NDA (New Drug Application)

Q17. Which CFR provision requires documentation of cleaning, maintenance, and calibration of equipment?

• 21 CFR Part 58
• 21 CFR Part 211
• 21 CFR Part 314
• 21 CFR Part 11

Correct Answer: 21 CFR Part 211

Q18. What is the significance of 21 CFR Part 314?

• It governs food additive petitions
• It outlines NDA requirements and postmarketing responsibilities for drugs
• It covers occupational safety in labs
• It prescribes device quality systems

Correct Answer: It outlines NDA requirements and postmarketing responsibilities for drugs

Q19. Which requirement is central to cGMP regarding personnel?

• Personnel may work without training if supervised
• Written procedures, training, and hygiene to prevent contamination
• Only management requires GMP training
• Personnel records may be verbal

Correct Answer: Written procedures, training, and hygiene to prevent contamination

Q20. What is an ANDA used for under CFR regulations?

• Approval of a novel biologic
• Approval for a generic drug showing bioequivalence
• Device market clearance
• Clinical trial initiation

Correct Answer: Approval for a generic drug showing bioequivalence

Q21. Which CFR part requires adverse event reporting for marketed drugs?

• 21 CFR Part 314.80
• 21 CFR Part 211.22
• 21 CFR Part 58.30
• 21 CFR Part 201.5

Correct Answer: 21 CFR Part 314.80

Q22. Under CFR, what is a “batch record” intended to ensure?

• Marketing strategy consistency
• Traceability, reproducibility, and documentation of manufacturing steps
• Patent exclusivity
• Only cost accounting

Correct Answer: Traceability, reproducibility, and documentation of manufacturing steps

Q23. Which CFR part deals with prescription drug labeling requirements, including adequate directions for use and package inserts?

• 21 CFR Part 201
• 21 CFR Part 58
• 21 CFR Part 11
• 21 CFR Part 820

Correct Answer: 21 CFR Part 201

Q24. What does “cGMP” stand for and imply?

• Current Good Manufacturing Practice — emphasizes up-to-date compliance and quality
• Certified Good Manufacturing Procedure — an ISO standard
• Clinical Good Medical Practice — clinical trial conduct
• Controlled Generic Manufacturing Policy — generic drug pricing

Correct Answer: Current Good Manufacturing Practice — emphasizes up-to-date compliance and quality

Q25. Which CFR provision addresses impurity limits and drug specifications?

• 21 CFR Part 211 and 314 guidance on specifications and release testing
• 21 CFR Part 58 exclusively
• 21 CFR Part 820 for device impurities
• 21 CFR Part 11 for impurity documentation

Correct Answer: 21 CFR Part 211 and 314 guidance on specifications and release testing

Q26. What is the role of FDA inspections in CFR enforcement?

• Inspections are optional and advisory only
• They verify compliance with CFR requirements and can lead to warning letters or enforcement
• They replace the need for written SOPs
• They only inspect financial records

Correct Answer: They verify compliance with CFR requirements and can lead to warning letters or enforcement

Q27. Which CFR part provides regulations for postmarketing reporting of increased risk or new safety information?

• 21 CFR Part 314.80 and related postmarketing safety reporting
• 21 CFR Part 211.25 only
• 21 CFR Part 58.6
• 21 CFR Part 820.198

Correct Answer: 21 CFR Part 314.80 and related postmarketing safety reporting

Q28. In regulatory terms, what is a “validation” as required by cGMP?

• A marketing approval letter
• Documentation that a process consistently produces a product meeting predetermined specifications
• An optional activity for small firms
• A financial audit of production costs

Correct Answer: Documentation that a process consistently produces a product meeting predetermined specifications

Q29. How are CFR regulations updated or changed?

• By secret agency memos only
• Through rulemaking published in the Federal Register followed by codification into the CFR
• By automatic annual revision without notice
• Only by acts of Congress without agency input

Correct Answer: Through rulemaking published in the Federal Register followed by codification into the CFR

Q30. Which of the following best describes the relationship between CFR and FDA guidance documents?

• Guidance documents have the same legal force as CFR regulations
• Guidance documents provide the FDA’s interpretation and recommendations but are not legally binding like the CFR
• CFR defers to guidance documents for legal enforcement
• Guidance documents are only for international agencies

Correct Answer: Guidance documents provide the FDA’s interpretation and recommendations but are not legally binding like the CFR

G S Sachin

I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.

Mail- Sachin@pharmacyfreak.com