Code of Federal Regulations, Title 21 Food and Drugs 300-499, Revised as of April 1, 2021

Title 21 of the Code of Federal Regulations governs food and drugs, including human and animal use, biologics, cosmetics, medical devices, radiological health, and controlled substances. Updates are published annually by April, with publication following within six months.

Format: Paperback / softback
Length: 404 pages
Publication date: 30 April 2022
Publisher: Rowman & Littlefield

Title 21 is a comprehensive set of regulations established by the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of the National Drug Control Agency (ONDCP). These regulations cover a wide range of food and drug-related areas, including human and animal use, biologics, cosmetics, medical devices, radiological health, and controlled substances.

The regulations are updated and revised on an annual basis, with the latest additions and revisions being published by April. Once published, the regulations take effect within six months.

Title 21 plays a crucial role in ensuring the safety, effectiveness, and security of food and drugs in the United States. It provides a framework for regulating the manufacture, distribution, and marketing of these products, as well as for monitoring and enforcing compliance with applicable laws and regulations.

The regulations encompass a diverse range of topics, including the approval process for new drugs and medical devices, the safety standards for food and cosmetics, the control of drug trafficking and abuse, and the regulation of prescription drugs. They also address the safety and effectiveness of biologics, such as vaccines and gene therapies, and the use of radiological health technologies, such as X-rays and radiation therapy.

In addition to these regulatory provisions, Title 21 also includes provisions related to drug recalls, emergency response, and international cooperation. It provides for the enforcement of penalties and sanctions against individuals and organizations that violate the law, and it establishes mechanisms for reporting and investigating potential safety concerns.

Overall, Title 21 is a critical component of the U.S. food and drug regulatory system, and it plays a vital role in protecting the public health and well-being of individuals and communities throughout the country.

Weight: 585g
Dimension: 229 x 152 x 22 (mm)
ISBN-13: 9781636718378