Title 21 of the Code of Federal Regulations

Title 21 Of The Code Of Federal Regulations

Title 21 of the Code of Federal Regulations

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Description:
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

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:



    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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