Title 21 of the Code of Federal Regulations

Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP).

It is divided into three chapters:

• Chapter I — Food and Drug Administration
• Chapter II — Drug Enforcement Administration
• Chapter III — Office of National Drug Control Policy

Chapter I

Most of the Chapter I regulations are based on the Federal Food, Drug, and Cosmetic Act.

Notable sections:

• 11 — electronic records and electronic signature related
• 50 Protection of human subjects in clinical trials
• 54 Financial Disclosure by Clinical Investigators
  • 56 Institutional Review Boards that oversee clinical trials
  • 58 Good Laboratory Practices (GLP) for nonclinical studies
  
  
  The 100 series are regulations pertaining to food:
  
  
  • 101, especially 101.9 — Nutrition facts label related
  • (c)(2)(ii) — Requirement to include trans fat values
  • (c)(8)(iv) — Vitamin and mineral values
  • 106-107 requirements for infant formula
  • 110 et seq. cGMP for food products
  • 170 food additives
  • 190 dietary supplements
  
  
  The 200 and 300 series are regulations pertaining to pharmaceuticals :
  
  
  • 202-203 Drug advertising and marketing
  • 210 et seq. cGMP for pharmaceuticals
  • 310 et seq. Requirements for new drugs
  • 328 et seq. Specific requirements for over-the-counter (OTC) drugs.
  
  
  The 500 series are regulations for......

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