Code of Federal Regulations Title 21 - Food and Drugs
Title 21 of the Code of Federal Regulations (CFR) – Food and Drugs governs the rules and regulations enforced primarily by the Food and Drug Administration (FDA), and also by the Drug Enforcement Administration (DEA) and other federal agencies. It is one of the most detailed and heavily referenced titles due to its importance in public health, safety, and commerce.
🔍 Overview of Title 21 – Food and Drugs
Title 21 outlines the legal framework for:
Food safety and labeling
Pharmaceutical drug approval and control
Medical devices
Biological products
Cosmetics
Veterinary products
Controlled substances
📘 Major Chapters in Title 21:
Chapter I — Food and Drug Administration (FDA), Department of Health and Human Services
This is the largest chapter and includes regulations on:
Food labeling and standards (Parts 100–199)
Drug approval and manufacturing (Parts 200–299)
Medical device regulations (Parts 800–898)
Biologics (like vaccines and blood products) (Parts 600–680)
Cosmetics (Part 700)
Good Manufacturing Practices (GMP)
Chapter II — Drug Enforcement Administration (DEA), Department of Justice
Covers controlled substances (Parts 1300–1399)
Rules on classification, registration, recordkeeping, and quotas for controlled drugs
Chapter III — Office of National Drug Control Policy
Contains limited regulatory provisions related to drug control policy coordination
🧪 Examples of Important Parts in Title 21:
| Part | Content |
|---|---|
| Part 11 | Electronic records and electronic signatures (used in clinical trials and drug approvals) |
| Part 101 | Food labeling requirements |
| Part 201 | Labeling of prescription and over-the-counter drugs |
| Part 210/211 | Current Good Manufacturing Practices (cGMP) for drugs |
| Part 312 | Investigational New Drug (IND) application procedures |
| Part 314 | New Drug Application (NDA) requirements |
| Part 820 | Quality system regulation for medical devices |
| Part 1308 | Schedules of controlled substances (DEA drug scheduling: Schedule I–V) |
🏛️ Agencies Involved:
FDA: Primary regulator of food, drugs, biologics, medical devices, cosmetics, and tobacco.
DEA: Regulates controlled substances and enforces drug laws.
USDA (sometimes, for food safety in meat and poultry alongside FDA).
⚖️ Purpose of Title 21 Regulations:
Ensure safety, efficacy, and honest labeling of consumer health products.
Prevent adulteration and misbranding.
Enforce scientific and ethical standards in drug development and food production.
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